fentanyl Buccal mucosa, Oromucosal

FEN-ta-nil SIT-rate

Buccal mucosa route(Film;Lozenge/Troche;Tablet)

Due to the risk of fatal respiratory depression, immediate-release transmucosal fentanyl is contraindicated in opioid non-tolerant patients and in management of acute or postoperative pain, including headache/migraines. Keep out of reach of children. Use with CYP3A4 inhibitors may cause fatal respiratory depression. When prescribing, do not convert patients on a mcg per mcg basis from any other oral transmucosal fentanyl product. When dispensing, do not substitute with any other fentanyl products. Contains fentanyl, a Schedule II controlled substance with abuse liability similar to other opioid analgesics. Only available through a restricted program called the Transmucosal Immediate Release Fentanyl Risk Evaluation and Mitigation Strategy (TIRF REMS) Access program. Outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors are required to enroll in the program .

Commonly used brand name(s)

In the U.S.

• Actiq


• Fentora


• Onsolis

Available Dosage Forms:

• Tablet


• Lozenge/Troche


• Film

Therapeutic Class: Analgesic

Chemical Class: Fentanyl

Uses For fentanyl

Fentanyl belongs to the group of medicines called narcotic analgesics, which are medicines used to relieve pain. The oral transmucosal or buccal form of fentanyl is used to treat breakthrough cancer pain. Breakthrough episodes of cancer pain are the flares of pain which “breaks through” the medication used to control the persistent pain. Oral transmucosal or buccal fentanyl is only used in patients who are already taking narcotic analgesics.

Fentanyl acts in the central nervous system (CNS) to relieve pain. Some of its side effects are also caused by actions in the CNS. When a narcotic is used for a long time, it may become habit-forming (causing mental or physical dependence). However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by reducing the dose gradually over a period of time before treatment is stopped completely. Your doctor will take this into consideration when deciding on the amount of oral transmucosal or buccal fentanyl you should receive.

fentanyl is available only with your doctor's prescription. Buccal fentanyl film is available only under a restricted distribution program called FOCUS® Program.

Before Using fentanyl

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For fentanyl, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to fentanyl or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of buccal fentanyl in children below 18 years of age, or oral transmucosal fentanyl in children below 16 years of age. Safety and efficacy have not been established in these age groups.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of oral transmucosal or buccal fentanyl in the elderly. However, elderly patients may be more sensitive to the effects of narcotic analgesics than younger adults and are more likely to have age-related kidney disease, which may require caution and an adjustment in the dose for patients receiving oral transmucosal or buccal fentanyl.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking fentanyl, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using fentanyl with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Naltrexone

Using fentanyl with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adinazolam


• Alfentanil


• Alprazolam


• Amiodarone


• Amobarbital


• Amprenavir


• Anileridine


• Aprepitant


• Aprobarbital


• Bromazepam


• Brotizolam


• Buprenorphine


• Butabarbital


• Butalbital


• Butorphanol


• Carisoprodol


• Chloral Hydrate


• Chlordiazepoxide


• Chlorpromazine


• Chlorzoxazone


• Citalopram


• Clarithromycin


• Clobazam


• Clonazepam


• Clorazepate


• Clorgyline


• Codeine


• Crizotinib


• Dantrolene


• Dezocine


• Diazepam


• Diltiazem


• Erythromycin


• Estazolam


• Ethchlorvynol


• Fentanyl


• Fluconazole


• Flunitrazepam


• Fluphenazine


• Flurazepam


• Fosamprenavir


• Fospropofol


• Furazolidone


• Halazepam


• Hydrocodone


• Hydromorphone


• Imatinib


• Iproniazid


• Isocarboxazid


• Itraconazole


• Ketazolam


• Ketoconazole


• Levorphanol


• Linezolid


• Lopinavir


• Lorazepam


• Lormetazepam


• Medazepam


• Meperidine


• Mephenesin


• Mephobarbital


• Meprobamate


• Metaxalone


• Methocarbamol


• Methohexital


• Midazolam


• Moclobemide


• Morphine


• Morphine Sulfate Liposome


• Nalbuphine


• Nefazodone


• Nelfinavir


• Nialamide


• Nicardipine


• Nifedipine


• Nitrazepam


• Nordazepam


• Opium


• Oxazepam


• Oxycodone


• Oxymorphone


• Pargyline


• Paroxetine


• Pazopanib


• Pentazocine


• Pentobarbital


• Perphenazine


• Phenelzine


• Phenobarbital


• Prazepam


• Procarbazine


• Prochlorperazine


• Promazine


• Promethazine


• Propoxyphene


• Quazepam


• Ranolazine


• Rasagiline


• Remifentanil


• Ritonavir


• Secobarbital


• Selegiline


• Sertraline


• Sibutramine


• Sodium Oxybate


• Sufentanil


• Tapentadol


• Temazepam


• Thiethylperazine


• Thiopental


• Thioridazine


• Toloxatone


• Tranylcypromine


• Triazolam


• Trifluoperazine


• Troleandomycin


• Vemurafenib

Using fentanyl with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Atazanavir


• Azithromycin


• Carbamazepine


• Clotrimazole


• Dirithromycin


• Econazole


• Indinavir


• Josamycin


• Mepartricin


• Miconazole


• Miokamycin


• Nevirapine


• Phenytoin


• Rifampin


• Rokitamycin


• Roxithromycin


• Saquinavir


• Spiramycin


• Voriconazole

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using fentanyl with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use fentanyl, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol


• Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of fentanyl. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse, or history of or


• Drug dependence, especially narcotic abuse or dependence, history of—Dependence may be more likely to develop.

• Diabetes—Use with caution. Oral transmucosal fentanyl contains sugar.

• Emphysema or other chronic lung disease or


• Head injuries—Use with caution. Some of the side effects of oral transmucosal or buccal fentanyl can cause serious problems in patients who have these medical problems.

• Hypotension (low blood pressure) or


• Mental illness or


• Seizures, history of or


• Slow heartbeat or other heart problems—Oral transmucosal or buccal fentanyl can make these conditions worse.

• Kidney disease or


• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of fentanyl

Oral transmucosal or buccal fentanyl comes with patient instructions. If you are switching from the oral transmucosal form of fentanyl to buccal form, make sure you read the patient instructions carefully. These forms are very different.

It is very important that you understand the requirements of the FOCUS® program, and become familiar with the FOCUS® educational materials and Medication Guide. Ask your doctor or pharmacist before starting buccal fentanyl film treatment.

• How to use oral transmucosal fentanyl:


• Keep medication in sealed pouch until ready to use.


• The foil package should be opened with scissors immediately prior to product use.


• Place the medicine in mouth between the cheek and lower gum, occasionally moving the medicine from one side to the other using the handle.


• The medicine should be sucked, not chewed.


• Suck the medicine over a 15-minute period.

• How to use buccal fentanyl:


• Keep the medication in sealed pouch until ready to use.


• Remove the tablet from the blister unit just before product use. Do not push the tablet through the blister as this may cause damage to the tablet.


• Do not store the tablet after removing it from the blister package. It should be used immediately.


• Place the medicine in your mouth between the upper cheek and gum, above a back molar.


• Allow the tablet to dissolve. It usually takes around 14 to 25 minutes for the tablet to dissolve completely.


• Do not suck, chew, or swallow the tablet. If the tablet did not dissolve completely after 30 minutes, you may swallow it with a glass of water.

To use the buccal fentanyl film:

• The foil package should be opened with scissors immediately prior to product use.


• Separate the layers of the foil package and remove the film. Do not cut or tear the film.


• Use your tongue to wet the side of your cheek, or rinse your mouth with water to wet the area in your mouth where you will place the film.


• Hold the film in place on your clean, dry finger with the pink side facing up.


• Press the film against your cheek. Hold it there for 5 seconds.


• Leave the film in place until it dissolves. It usually dissolves within 15 to 30 minutes after you apply it. Do not touch or move the film while it dissolves.


• If your doctor tells you to use more than one film, place the new film on the other side of your mouth.


• Do not eat any food until the film dissolves. You may drink water or other liquids after 5 minutes.

Use only the brand of fentanyl that your doctor prescribed. Different brands may not work the same way.

Dosing

The dose of fentanyl will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of fentanyl. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For cancer pain:
  
  • For buccal dosage form (film):
    
    • Adults—At first, one 200 microgram (mcg) film during an episode of breakthrough cancer pain. Your doctor may increase your dose as needed. However, patients should not use fentanyl for more than four 200 mcg film per episode of breakthrough pain a day.
    
    
    • Children—Use and dose must be determined by the doctor.
    
    
  
  
  • For buccal dosage form (tablets):
    
    • Adults—At first, 100 micrograms (mcg) during an episode of breakthrough cancer pain. Dosing may be repeated if pain is not relieved by a single dose. Redosing may start 30 minutes after taking fentanyl and the same dosage strength should be used. Your doctor may increase your dose as needed. Patients should not use more than 4 tablets per episode of breakthrough pain. Patients should record their use over several episodes of breakthrough cancer pain and review their experience with their doctor to determine if a dosage adjustment is warranted.
    
    
    • Children—Use and dose must be determined by the doctor.
    
    
  
  
  • For oral transmucosal dosage form (lozenge):
    
    • Adults—At first, 200 micrograms (mcg) during an episode of breakthrough cancer pain. Redosing may start 15 minutes after the previous dose has been completed (30 minutes after the start of the previous dose). Patients should not use more than 2 units per episode of breakthrough pain. Patients should record their use over several episodes of breakthrough cancer pain and review their experience with their doctors to determine if a dosage adjustment is warranted.
    
    
    • Children—Use and dose must be determined by the doctor.
    
    
  
  

Missed Dose

If you miss a dose of fentanyl, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Do not use if the foil pouch has been opened. A temporary storage bottle is provided as part of the Actiq® Welcome Kit. This container is to be used by patients or their caregivers in the event that a partially consumed unit cannot be disposed of promptly. If additional assistance is required, refer to 1-800-615-0187.

Dispose of any unopened buccal fentanyl tablets that are no longer needed. To dispose, remove the buccal fentanyl tablets from the blister packages and flush down the toilet. Do not flush the blister packages or cartons down the toilet. If additional assistance is required, call 1-800-896-5855.

To dispose any unneeded buccal fentanyl film: remove the film from its foil package and flush down the toilet. Do not flush the foil packages or cartons down the toilet. If additional assistance is required, call 1-800-526-3840.

Precautions While Using fentanyl

It is very important that your doctor check your progress at regular visits. This will allow your doctor to make sure that fentanyl is working properly and to check you for any problems or unwanted effects that may be caused by fentanyl.

Oral transmucosal or buccal fentanyl contains a medicine in an amount which can be fatal to a child. Patients and their caregivers should keep oral transmucosal or buccal fentanyl out of the reach of children and discard open units properly.

Do not use buccal fentanyl film if you need pain medicine for just a short time, such as during a headache or migraine attack, or when recovering from surgery or an injury.

fentanyl will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the other medicines listed above while you are using fentanyl.

Oral transmucosal or buccal fentanyl may cause some people to become drowsy, dizzy, or lightheaded, or to feel a false sense of well-being. Make sure you know how you react to fentanyl before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert and clearheaded. These effects usually go away after a few days of treatment, when your body gets used to the medicine. However, check with your doctor if drowsiness that is severe enough to interfere with your activities continues for more than a few days.

Dizziness, lightheadedness, or even fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve dizziness or lightheadedness.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are using fentanyl. Serious side effects can occur if your medical doctor or dentist gives you certain other medicines without knowing that you are using oral transmucosal or buccal fentanyl.

If you have been using fentanyl regularly for several weeks or more, do not suddenly stop using it without first checking with your doctor. You may be directed to gradually reduce the amount you are using before stopping treatment completely to lessen the chance of withdrawal side effects.

Using too much oral transmucosal or buccal fentanyl, or taking too much of another narcotic while using oral transmucosal or buccal fentanyl, may cause an overdose. If this occurs, get emergency help right away. An overdose can cause severe breathing problems (breathing may even stop), unconsciousness, and death. Serious signs of an overdose include very slow breathing (fewer than 8 breaths a minute) and drowsiness that is so severe that you are not able to answer when spoken to or, if asleep, cannot be awakened. Other signs of an overdose may include cold, clammy skin; low blood pressure; pinpoint pupils of the eyes; and slow heartbeat. It may be best to have a family member or a friend check on you several times a day when you start using a narcotic regularly, and whenever your dose is increased, so that he or she can get help for you if you cannot do so yourself.

Check with your dentist at regular times while using fentanyl. fentanyl contains sugar and may increase your chance for tooth decay or other trouble with your teeth or gums.

fentanyl may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Do not use buccal fentanyl if you have taken a monoamine oxidase (MAOI) inhibitor (e.g., isocarboxazid [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]) in the past 2 weeks.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

fentanyl Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Black, tarry, stools


• blurred vision


• chest pain


• confusion


• convulsions


• cough


• decreased urine


• difficult or labored breathing


• dizziness


• dry mouth


• fainting


• fever or chills


• increased thirst


• irregular heartbeat


• lightheadedness


• loss of appetite


• lower back or side pain


• mood changes


• muscle pain or cramps


• nausea or vomiting


• nervousness


• numbness or tingling in the hands, feet, or lips


• painful or difficult urination


• pale skin


• pounding in the ears


• rapid breathing


• shortness of breath


• sneezing


• sore throat


• sunken eyes


• swelling of the hands, ankles, feet, or lower legs


• tightness in the chest


• troubled breathing with exertion


• ulcers, sores, or white spots in the mouth


• unusual bleeding or bruising


• unusual tiredness or weakness


• wheezing


• wrinkled skin

Less common

• Abdominal or stomach pain


• change in walking and balance


• clumsiness or unsteadiness


• decreased awareness or responsiveness


• decreased frequency of urination


• headache


• muscle twitching or jerking


• pounding in the ears


• rhythmic movement of the muscles


• seeing, hearing, or feeling things that are not there


• seizures


• severe constipation


• severe sleepiness


• shakiness in the legs, arms, hands, or feet


• slow or fast heartbeat


• thinking abnormalities


• trembling or shaking of the hands or feet

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Extremely shallow or slow breathing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Back pain


• diarrhea


• difficulty having a bowel movement (stool)


• difficulty in moving


• discouragement


• feeling sad or empty


• irritability


• lack or loss of strength


• loss of interest or pleasure


• muscle stiffness


• pain in the joints


• sleepiness or unusual drowsiness


• sleeplessness


• tiredness


• trouble concentrating


• trouble sleeping


• unable to sleep


• weight loss

Less common

• Changes in vision


• excessive muscle tone


• feeling of constant movement of self or surroundings


• feeling of warmth or heat


• flushing or redness of the skin, especially on the face and neck


• irritation, pain, or sores at the site of application


• itching skin


• muscle tension or tightness


• rash


• sensation of spinning


• sweating

Incidence not known

• Tooth pain


• trouble with gums


• trouble with teeth

After you stop using fentanyl, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

• Restlessness


• speech disorder


• stomach cramps


• weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: fentanyl Buccal mucosa, Oromucosal side effects (in more detail)

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Torecan

Generic Name: thiethylperazine (Oral route, Intramuscular route, Rectal route)

thye-eth-il-PER-a-zeen

Commonly used brand name(s)

In the U.S.

• Torecan

Available Dosage Forms:

• Suppository


• Tablet


• Solution

Therapeutic Class: Antiemetic

Pharmacologic Class: Phenothiazine

Chemical Class: Piperazine (class)

Uses For Torecan

Thiethylperazine is a phenothiazine medicine. It is used to treat nausea and vomiting.

This medicine is available only with your doctor's prescription.

Before Using Torecan

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Children are usually more sensitive than adults to the effects of phenothiazine medicines such as thiethylperazine. Certain side effects, such as muscle spasms of the face, neck, and back, tic-like or twitching movements, inability to move the eyes, twisting of the body, or weakness of the arms and legs, are more likely to occur in children, especially those with severe illness or dehydration.

Geriatric

Elderly patients are usually more sensitive to the effects of phenothiazine medicines such as thiethylperazine. Confusion; difficult or painful urination; dizziness; drowsiness; feeling faint; or dryness of mouth, nose, or throat may be more likely to occur in elderly patients. Also, nightmares or unusual excitement, nervousness, restlessness, or irritability may be more likely to occur in elderly patients. In addition, uncontrolled movements may be more likely to occur in elderly patients taking thiethylperazine.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Cisapride


• Grepafloxacin


• Sparfloxacin

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Fentanyl


• Gatifloxacin


• Ibutilide


• Isradipine


• Levorphanol


• Methadone


• Metrizamide


• Morphine


• Morphine Sulfate Liposome


• Moxifloxacin


• Octreotide


• Oxycodone


• Pentamidine


• Procarbazine


• Tramadol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Belladonna


• Belladonna Alkaloids


• Betel Nut


• Evening Primrose


• Meperidine


• Phenylalanine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse—This medicine, if taken together with alcohol, may lower the blood pressure and cause CNS depressant effects, such as severe drowsiness

• Asthma attack or


• Other lung diseases—Thiethylperazine may cause secretions to become thick so that it might be difficult to cough them up, for example, during an asthma attack

• Blood disease or


• Heart or blood vessel disease—This medicine may cause more serious conditions to develop

• Difficult urination or


• Enlarged prostate—This medicine may cause urinary problems to get worse

• Glaucoma—This medicine may cause an increase in inner eye pressure

• Liver disease—Thiethylperazine may accumulate in the body, increasing the chance of side effects, such as muscle spasms

• Parkinson's disease or


• Seizure disorders—The chance of thiethylperazine causing seizures or uncontrolled movements is greater when these conditions are present

Proper Use of Torecan

Thiethylperazine is used only to relieve or prevent nausea and vomiting. Use it only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of side effects.

For patients taking this medicine by mouth:

• This medicine may be taken with food or a full glass (8 ounces) of water or milk to reduce stomach irritation.

For patients using the suppository form of this medicine :

• To insert suppository: First, remove foil wrapper and moisten the suppository with cold water. Lie down on your side and use your finger to push the suppository well up into the rectum. If the suppository is too soft to insert, chill it in the refrigerator for 30 minutes or run cold water over it before removing the foil wrapper.


• Wash your hands with soap and water.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For nausea and vomiting:
  
  • For oral dosage form (tablets):
    
    • Adults—10 milligrams (mg) one to three times a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For injection dosage form:
    
    • Adults—10 mg one to three times a day, injected into a muscle.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For rectal dosage form (suppositories):
    
    • Adults—10 mg one to three times a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Torecan

If you are going to be taking this medicine for a long time, your doctor should check your progress at regular visits, especially during the first few months of treatment with this medicine. This will allow your dosage to be changed if necessary to meet your needs.

Thiethylperazine will add to the effects of alcohol and other CNS depressants (medicines that cause you to feel drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine .

This medicine may cause some people to have blurred vision or to become dizzy, lightheaded, drowsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert or able to see well.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If the problem continues or gets worse, check with your doctor.

When using thiethylperazine on a regular basis, make sure your doctor knows if you are taking large amounts of aspirin or other salicylates at the same time (as for arthritis or rheumatism). Effects of too much aspirin, such as ringing in the ears, may be covered up by this medicine.

Thiethylperazine may cause dryness of the mouth, nose, and throat. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Torecan Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Less common or rare

• Abdominal or stomach pains


• aching muscles and joints


• blurred vision, change in color vision, or difficulty in seeing at night


• confusion (especially in the elderly)


• convulsions (seizures)


• difficulty in speaking or swallowing


• fast heartbeat


• fever and chills


• inability to move eyes


• lip smacking or puckering


• loss of balance control


• mask-like face


• muscle spasms (especially of face, neck, and back)


• nausea, vomiting, or diarrhea


• nightmares (continuing)


• nosebleeds


• puffing of cheeks


• rapid or fine, worm-like movements of tongue


• shuffling walk


• skin itching (severe)


• sore throat and fever


• stiffness of arms or legs


• swelling of arms, hands, and face


• tic-like or twitching movements


• trembling and shaking of hands and fingers


• twisting movements of body


• uncontrolled chewing movements


• uncontrolled movements of arms or legs


• unusual bleeding or bruising


• unusual excitement, nervousness, restlessness, or irritability


• unusual tiredness or weakness


• weakness of arms and legs


• yellow eyes or skin

Symptoms of overdose

• Confusion (severe)


• convulsions (seizures)


• dizziness (severe)


• drowsiness (severe)


• dry mouth (severe)


• hyperextension of neck and trunk


• inability to move eyes


• loss of consciousness


• spasms of face and neck


• stuffy nose


• troubled breathing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Dizziness


• drowsiness

Less common or rare

• Constipation


• dizziness or lightheadedness, especially when getting up from a lying or sitting position


• dryness of mouth, nose and throat


• fainting


• fever


• headache


• ringing or buzzing in ears


• skin rash

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Torecan side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Torecan resources

• Torecan Side Effects (in more detail)
• Torecan Use in Pregnancy & Breastfeeding
• Torecan Drug Interactions
• Torecan Support Group
• 0 Reviews for Torecan - Add your own review/rating

• Torecan Prescribing Information (FDA)


• Torecan Concise Consumer Information (Cerner Multum)

Compare Torecan with other medications

• Nausea/Vomiting

Habitrol Step 3 Drug Facts

Dosage Form: patch, extended release
Drug Facts

Active ingredient

Nicotine, 7mg delivered over 24 hours

Purpose

Stop smoking aid

Uses

Use reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.

Warnings

If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known.

Do not use

• if you continue to smoke, chew tobacco, use snuff, use nicotine gum, or use another nicotine patch or other nicotine containing products

Ask a doctor before use if you have

• heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.


• high blood pressure not controlled with medication. Nicotine can increase your blood pressure.


• an allergy to adhesive tape or have skin problems, because you are more likely to get rashes.

Ask a doctor or a pharmacist before use if you are

• using a non-nicotine stop smoking drug


• taking a prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.

When using this product

• do not smoke even when not wearing the patch. The nicotine in your skin will still be entering your bloodstream for several hours after you take off the patch.


• if you have vivid dreams or other sleep disturbances remove this patch at bedtime

Stop use and ask a doctor if

• skin redness caused by the patch does not go away after four days, or if your skin swells, or you get a rash


• irregular heartbeat or palpitations occur


• you get symptoms of nicotine overdose, such as nausea, vomiting, dizziness, weakness and rapid heartbeat.

Keep out of reach of children and pets.

Used patches have enough nicotine to poison children and pets. If swallowed, get medical help or contact a Poison Control Center right away. Save pouch to use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch.

Directions

• If you are under 18 years of age, ask a doctor before use


• before using this product, read the enclosed self-help guide for complete directions and other information


• stop smoking completely when you begin using the patch


• if you smoke more than 10 cigarettes per day, use the following schedule below:


• if you smoke 10 or less cigarettes per day, start with Step 2 for 6 weeks, then Step 3 for 2 weeks and then stop
  
  
  


• apply one new patch every 24 hours on skin that is dry, clean and hairless


• remove backing from patch and immediately press onto skin. Hold for 10 seconds.


• wash hands after applying or removing patch. Save pouch to use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch.


• the used patch should be removed and a new one applied to a different skin site at the same time each day


• if you have vivid dreams, you may remove the patch at bedtime and apply a new one in the morning


• do not wear more than one patch at a time


• do not cut patch in half or into smaller pieces


• do not leave patch on for more than 24 hours because it may irritate your skin and loses strength after 24 hours


• to avoid possible burns, remove patch  before  undergoing any MRI (magnetic resonance imaging) procedures


• stop using the patch at the end of 8 weeks. If you still feel the need to use the patch talk to your doctor.

Other information

store at 20-25°C (68-77°F)

Inactive ingredients

acrylate adhesive, aluminized polyester, cellulose paper, methacrylic acid copolymer

Comments or Questions?

Call 1-800-585-8682

Distributed by:

CVS Pharmacy

One CVS Drive

Woonsocket, RI 02895

Principal Display Panel

Step 3, 7mg

HABITROL PATCH  NICOTINE TRANSDERMAL SYSTEM, STEP 3 nicotine  patch, extended release

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 0067-4850 Route of Administration TRANSDERMAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NICOTINE (NICOTINE) NICOTINE 7 mg  in 24 h

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0067-4850-14 14 POUCH In 1 BOX, UNIT-DOSE contains a POUCH 1 1 PATCH In 1 POUCH This package is contained within the BOX, UNIT-DOSE (0067-4850-14) and contains a PATCH 1 24 h In 1 PATCH This package is contained within a POUCH and a BOX, UNIT-DOSE (0067-4850-14)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020076	02/26/2003

Labeler - Novartis Consumer Health, Inc. (879821635)

Revised: 02/2010Novartis Consumer Health, Inc.

More Habitrol Step 3 Drug Facts resources

• Habitrol Step 3 Drug Facts Side Effects (in more detail)
• Habitrol Step 3 Drug Facts Use in Pregnancy & Breastfeeding
• Habitrol Step 3 Drug Facts Drug Interactions
• Habitrol Step 3 Drug Facts Support Group
• 42 Reviews for Habitrol Step 3 Drug Facts - Add your own review/rating

Compare Habitrol Step 3 Drug Facts with other medications

• Smoking Cessation

SudoGest Sinus & Allergy

Generic Name: chlorpheniramine and pseudoephedrine (klor fen EER a meen and soo doe e FED rin)

Brand Names: AccuHist Drops, Allerest Maximum Strength, Brexin L.A., Colfed-A, D-Amine-SR, Dayquil Allergy, Deconamine, Dicel, Dicel Chewables, Dura-Tap/PD, Durafed, Duratuss DA, Dynahist-ER Pediatric, Genaphed Plus, Histade, Histex, Kronofed-A, Kronofed-A-Jr, LoHist-D, Mintex, Neutrahist Drops, Re2+30, Rescon-Ed, Suclor, SudaHist, Sudal-12 Chewable, Sudal-12 Tannate, Sudogest Cold & Allergy, SudoGest Sinus & Allergy, Tavist-DA, Triaminic Cold and Allergy, Triaminic Softchew Cold and Allergy, Triaminic Softchews Allergy Runny Nose and Congestion

What is SudoGest Sinus & Allergy (chlorpheniramine and pseudoephedrine)?

Chlorpheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of chlorpheniramine and pseudoephedrine is used to treat symptoms of the common cold or seasonal allergies, including sneezing, runny or stuffy nose, and itchy, watery eyes.

Chlorpheniramine and pseudoephedrine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about SudoGest Sinus & Allergy (chlorpheniramine and pseudoephedrine)?

There are many brands and forms of this medication available and not all brands are listed on this leaflet.

Do not use chlorpheniramine and pseudoephedrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. You should not use this medication if you are allergic to chlorpheniramine or pseudoephedrine, or if you have severe high blood pressure or coronary artery disease, narrow-angle glaucoma, a stomach ulcer, or if you are unable to urinate.

Do not use this medication during an asthma attack.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of chlorpheniramine and pseudoephedrine. Older adults may be more likely to have side effects from this medicine. Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

What should I discuss with my healthcare provider before taking SudoGest Sinus & Allergy (chlorpheniramine and pseudoephedrine)?

Do not use chlorpheniramine and pseudoephedrine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. You should not use this medication if you are allergic to chlorpheniramine or pseudoephedrine, or if you have:

• 
  

  severe or uncontrolled high blood pressure;

  
  


• 
  

  severe coronary artery disease;

  
  


• 
  

  narrow angle glaucoma;

  
  


• 
  

  a stomach ulcer;

  
  


• 
  

  if you are unable to urinate; or

  
  


• 
  

  if you are having an asthma attack.

  
  

Ask a doctor or pharmacist if it is safe for you to take this medication if you have:

• kidney disease;


• liver disease;


• 
  

  diabetes;

  
  


• 
  

  glaucoma;

  
  


• 
  

  circulation problems;

  
  


• 
  

  heart disease or high blood pressure;

  
  


• 
  

  overactive thyroid;

  
  


• 
  

  a seizure disorder such as epilepsy;

  
  


• 
  

  asthma, emphysema or chronic bronchitis; or

  
  


• 
  

  urination problems or an enlarged prostate.

  
  

FDA pregnancy category C. It is not known whether chlorpheniramine and pseudoephedrine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether chlorpheniramine and pseudoephedrine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Older adults may be more likely to have side effects from this medicine.

Artificially sweetened liquid cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.

How should I take SudoGest Sinus & Allergy (chlorpheniramine and pseudoephedrine)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

The chewable tablet must be chewed before swallowing.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

This medication can cause unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

If you need surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since cold medicine is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include some of the serious side effects listed in this medication guide.

What should I avoid while taking SudoGest Sinus & Allergy (chlorpheniramine and pseudoephedrine)?

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of chlorpheniramine and pseudoephedrine. Ask a doctor or pharmacist before using any other cold, allergy, or sleep medicine. Chlorpheniramine and pseudoephedrine are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains an antihistamine or decongestant.

Avoid taking this medication if you also take diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

SudoGest Sinus & Allergy (chlorpheniramine and pseudoephedrine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have a serious side effect such as:

• 
  

  fast or pounding heartbeats;

  
  


• 
  

  confusion, hallucinations, unusual thoughts or behavior;

  
  


• 
  

  severe dizziness, anxiety, restless feeling, nervousness;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  easy bruising or bleeding, unusual weakness; or

  
  


• 
  

  seizure (black-out or convulsions).

  
  

Less serious side effects may include:

• 
  

  blurred vision;

  
  


• 
  

  dry nose or mouth;

  
  


• 
  

  nausea, stomach pain, constipation, loss of appetite;

  
  


• 
  

  dizziness, drowsiness;

  
  


• 
  

  problems with memory or concentration;

  
  


• 
  

  ringing in your ears; or

  
  


• 
  

  feeling restless or excited (especially in children).

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1 800 FDA 1088.

What other drugs will affect SudoGest Sinus & Allergy (chlorpheniramine and pseudoephedrine)?

Before using this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as other cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by chlorpheniramine.

Tell your doctor about all other medications you use, especially:

• 
  

  mecamylamine (Inversine);

  
  


• 
  

  methyldopa (Aldomet);

  
  


• 
  

  reserpine;

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others;

  
  


• 
  

  a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Solfoton); or

  
  


• 
  

  an antidepressant such as amitriptyline (Elavil, Vanatrip), doxepin (Sinequan), nortriptyline (Pamelor), and others.

  
  

This list is not complete and other drugs may interact with chlorpheniramine and pseudoephedrine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More SudoGest Sinus & Allergy resources

• SudoGest Sinus & Allergy Use in Pregnancy & Breastfeeding
• SudoGest Sinus & Allergy Drug Interactions
• 0 Reviews for SudoGest Sinus & Allergy - Add your own review/rating

• AccuHist Drops Prescribing Information (FDA)


• Biohist LA Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Deconamine MedFacts Consumer Leaflet (Wolters Kluwer)


• Deconamine SR Controlled-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Duotan Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• QDALL 24-Hour Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

Compare SudoGest Sinus & Allergy with other medications

• Hay Fever
• Sinusitis

Where can I get more information?

• Your pharmacist can provide more information about chlorpheniramine and pseudoephedrine.

Alaway Drug Facts

Dosage Form: eye drops
Drug Facts

Active ingredient

Ketotifen 0.025%

(equivalent to ketotifen fumerate 0.035%)

Purpose

Antihistamine

Uses

For the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.

Warnings

Do not use

• if you are sensitive to any ingredient in this product


• if solution changes color or becomes cloudy


• to treat contact lens related irritation

When using this product

• remove contact lenses before use


• wait at least 10 minutes before re-inserting contact lenses after use


• do not touch tip of container to any surface to avoid contamination


• replace cap after each use

Stop use and ask doctor if you experience any of the following:

• eye pain


• changes in vision


• redness of the eyes


• itching that worsens or lasts more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 3 years and older: put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day.

Children under 3 years of age: consult a doctor

Other Information

Store at 4-25°C (39-77°F)

Inactive ingredients

benzalkorium chloride, 0.01%, glycerin, sodium hydroxide and/or hydrochloric acid and water for injection.

Questions or Comments?

Toll Free Product Information Call: 1-800-553-5340

Package/Label Principal Display Panel

NDC 24208-601-10

Bausch & Lomb

Alaway®

Ketotifen Fumarate Ophthalmic Solution

Antihistamine Eye Drops

60 Day Supply

Up To 12 Hours

Eye Itch Relief in Minutes!

▪ Original Prescription Strength

▪ Adults and children 3 years and older

STERILE 0.34 FL OZ (10 mL)

ALAWAY  ketotifen fumarate  solution/ drops

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 24208-601 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KETOTIFEN FUMARATE (KETOTIFEN) KETOTIFEN FUMARATE 0.345 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength GLYCERIN   SODIUM HYDROXIDE   HYDROCHLORIC ACID   WATER   BENZALKONIUM CHLORIDE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 24208-601-10 1 BOTTLE In 1 CARTON contains a BOTTLE, DROPPER 1 10 mL In 1 BOTTLE, DROPPER This package is contained within the CARTON (24208-601-10)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA021996	12/01/2006

Labeler - Bausch & Lomb Incorporated (807927397)

Establishment
Name	Address	ID/FEI	Operations
Bausch & Lomb Incorporated		807927397	ANALYSIS, LABEL, MANUFACTURE, PACK, RELABEL, REPACK, STERILIZE

Establishment
Name	Address	ID/FEI	Operations
SIFAVITOR S.r.l.		338490579	ANALYSIS, API MANUFACTURE

Revised: 04/2010Bausch & Lomb Incorporated

More Alaway Drug Facts resources

• Alaway Drug Facts Side Effects (in more detail)
• Alaway Drug Facts Use in Pregnancy & Breastfeeding
• Alaway Drug Facts Support Group
• 4 Reviews for Alaway Drug Facts - Add your own review/rating

Compare Alaway Drug Facts with other medications

• Conjunctivitis, Allergic

H.P. Acthar Gel

repository corticotropin

Dosage Form: injection
FULL PRESCRIBING INFORMATION

Indications and Usage for H.P. Acthar Gel

Infantile spasms:

H.P. Acthar Gel (repository corticotropin injection) is indicated as monotherapy for the treatment of infantile spasms in infants and children under 2 years of age.

Multiple Sclerosis:

H.P. Acthar Gel (repository corticotropin injection) is indicated for the treatment of acute exacerbations of multiple sclerosis in adults. Controlled clinical trials have shown H.P. Acthar Gel to be effective in speeding the resolution of acute exacerbations of multiple sclerosis. However, there is no evidence that it affects the ultimate outcome or natural history of the disease.

Rheumatic Disorders:

As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis, Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), Ankylosing spondylitis.

Collagen Diseases:

During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis).

Dermatologic Diseases:

Severe erythema multiforme, Stevens-Johnson syndrome

Allergic States:

Serum sickness.

Ophthalmic Diseases:

Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis; optic neuritis; chorioretinitis; anterior segment inflammation.

Respiratory Diseases:

Symptomatic sarcoidosis

Edematous State:

To induce a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus.

H.P. Acthar Gel Dosage and Administration

Specific Recommended Dosage Regimen for Infantile Spasms in Infants and Children Under 2 Years of Age

In the treatment of infantile spasms, H.P. Acthar Gel must be administered intramuscularly. The recommended regimen is a daily dose of 150 U/m2 (divided into twice daily intramuscular injections of 75 U/m2) administered over a 2-week period. Dosing with H.P. Acthar Gel should then be gradually tapered over a 2-week period to avoid adrenal insufficiency. The following is one suggested tapering schedule: 30 U/m2 in the morning for 3 days; 15 U/m2 in the morning for 3 days; 10 U/m2 in the morning for 3 days; and 10 U/m2 every other morning for 6-days.


H.P. Acthar Gel is typically dosed based on body surface area (BSA). For calculation of body surface area, use the following formula

Recommended Dosage Regimen for the Treatment of Acute Exacerbations in Adults with Multiple Sclerosis.

The recommended dose is daily intramuscular or subcutaneous doses of 80-120 units for 2-3 weeks for acute exacerbations.

Dosage should be individualized according to the medical condition of each patient. Frequency and dose of the drug should be determined by considering the severity of the disease and the initial response of the patient.

Although drug dependence does not occur, sudden withdrawal of H.P. Acthar Gel after prolonged use may lead to adrenal insufficiency or recurrent symptoms which make it difficult to stop the treatment. It may be necessary to taper the dose and increase the injection interval to gradually discontinue the medication.

Recommended Dosage Regimen for Other Indications for Adults and Children Over 2 Years of Age

Dosage should be individualized according to the disease under treatment and the general medical condition of each patient. Frequency and dose of the drug should be determined by considering severity of the disease and the initial response of the patient.

The usual dose of H.P. Acthar Gel is 40-80 units given intramuscularly or subcutaneously every 24-72 hours.

Although drug dependence does not occur, sudden withdrawal of H.P. Acthar Gel after prolonged use may lead to adrenal insufficiency or recurrent symptoms which make it difficult to stop the treatment. It may be necessary to taper the dose and increase the injection interval to gradually discontinue the medication.

Preparation

H.P. Acthar Gel should be warmed to room temperature before using.

Caution should be taken not to over-pressurize the vial prior to withdrawing the product.

Dosage Forms and Strengths

5 mL multi-dose vial containing 80 USP Units per mL.

Contraindications

H.P. Acthar Gel is contraindicated for intravenous administration.

H.P. Acthar Gel is contraindicated where congenital infections are suspected in infants.

Administration of live or live attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of H.P Acthar Gel.

H.P. Acthar Gel is contraindicated in patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, adrenocortical hyperfunction or sensitivity to proteins of porcine origin.

Warnings and Precautions

The adverse effects of H.P. Acthar Gel are related primarily to its steroidogenic effects. Not all of the adverse events described below have been seen after treatment with H.P. Acthar Gel, but might be expected to occur. [see Adverse Reactions (6.3)].

Infections

H.P. Acthar Gel may increase the risks related to infections with any pathogen, including viral, bacterial fungal, protozoan or helminthic infections. Patients with latent tuberculosis or tuberculin reactivity should be observed closely, and if therapy is prolonged, chemoprophylaxis should be instituted.

Cushing's Syndrome and Adrenal Insufficiency Upon Withdrawal

Treatment with H.P. Acthar Gel can cause hypothalamic-pituitary-axis (HPA) suppression and Cushing's syndrome. These conditions should be monitored especially with chronic use.

Suppression of the HPA may occur following prolonged therapy with the potential for adrenal insufficiency after withdrawal of the medication. Patients should be monitored for signs of insufficiency such as weakness, hyperpigmentation, weight loss, hypotension and abdominal pain.

The symptoms of adrenal insufficiency in infants treated for infantile spasms can be difficult to identify. The symptoms are non-specific and may include anorexia, fatigue, lethargy, weakness, excessive weight loss, hypotension and abdominal pain. It is critical that parents and caregivers be made aware of the possibility of adrenal insufficiency when discontinuing H.P. Acthar Gel and should be instructed to observe for, and be able to recognize, these symptoms [see Information for Patients (17)]

The recovery of the adrenal gland may take from days to months so patients should be protected from the stress (e.g. trauma or surgery) by the use of corticosteroids during the period of stress.

The adrenal insufficiency may be minimized in adults and infants by tapering of the dose when discontinuing treatment.

Signs or symptoms of Cushing's syndrome may occur during therapy but generally resolve after therapy is stopped. Patients should be monitored for these signs and symptoms such as deposition of adipose tissue in characteristics sites (e.g., moon face, truncal obesity), cutaneous striae, easy bruisability, decreased bone mineralization, weight gain, muscle weakness, hyperglycemia, and hypertension.

Elevated Blood Pressure, Salt and Water Retention and Hypokalemia

H.P. Acthar Gel can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium and calcium. Dietary salt restriction and potassium supplementation may be necessary. Caution should be used in the treatment of patients with hypertension, congestive heart failure, or renal insufficiency.

Vaccination

Administration of live or live attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of H.P. Acthar Gel. Killed or inactivated vaccines may be administered; however, the response to such vaccines can not be predicted. Other immunization procedures should be undertaken with caution in patients who are receiving H.P. Acthar Gel, especially when high doses are administered, because of the possible hazards of neurological complications and lack of antibody response.

Masking Symptoms of Other Diseases

H.P. Acthar Gel often acts by masking symptoms of other diseases/disorders without altering the course of the other disease/disorder. Patients should be monitored carefully during and for a period following discontinuation of therapy for signs of infection, abnormal cardiac function, hypertension, hyperglycemia, change in body weight and fecal blood loss.

Gastrointestinal Perforation and Bleeding

H.P. Acthar Gel can cause GI bleeding and gastric ulcer. There is also an increased risk for perforation in patients with certain gastrointestinal disorders. Signs of gastrointestinal perforation, such as peritoneal irritation, may be masked by the therapy. Use caution where there is the possibility of impending perforation, abscess or other pyogenic infections, diverticulitis, fresh intestinal anastomoses, and active or latent peptic ulcer.

Behavioral and Mood Disturbances

Use of H.P. Acthar Gel may be associated with central nervous system effects ranging from euphoria, insomnia, irritability (especially in infants), mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated.

Comorbid Diseases

Patients with a comorbid disease may have that disease worsened. Caution should be used when prescribing H.P. Acthar Gel in patients with diabetes and myasthenia gravis.

Ophthalmic Effects

Prolonged use of H.P. Acthar Gel may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves and may enhance the establishment of secondary ocular infections due to fungi and viruses.

Immunogenicity Potential

H.P. Acthar Gel is immunogenic. Limited available data suggest that a patient may develop antibodies to H.P. Acthar Gel after chronic administration and loss of endogenous ACTH and H.P. Acthar Gel activity. Prolonged administration of H.P. Acthar Gel may increase the risk of hypersensitivity reactions. Sensitivity to porcine protein should be considered before starting therapy and during the course of treatment should symptoms arise.

Use in Patients with Hypothyroidism or Liver Cirrhosis

There is an enhanced effect in patients with hypothyroidism and in those with cirrhosis of the liver.

Negative Effects on Growth and Physical Development

Long-term use of H.P. Acthar Gel may have negative effects on growth and physical development in children. Changes in appetite are seen with H.P. Acthar Gel therapy, with the effects becoming more frequent as the dose or treatment period increases. These effects are reversible once H.P. Acthar Gel therapy is stopped. Growth and physical development of pediatric patients on prolonged therapy should be carefully monitored.

Decrease in Bone Density

Decrease in bone formation and an increase in bone resorption both through an effect on calcium regulation (i.e. decreasing absorption and increasing excretion) and inhibition of osteoblast function may occur. These, together with a decrease in the protein matrix of the bone (secondary to an increase in protein catabolism) and reduced sex hormone production, may lead to inhibition of bone growth in children and adolescents and to the development of osteoporosis at any age. Special consideration should be given to patients at increased risk of osteoporosis (i.e., postmenopausal women) before initiating therapy, and bone density should be monitored in patients on long term therapy.

Use in Pregnancy

H.P. Acthar Gel has been shown to have an embryocidal effect. Apprise women of potential harm to the fetus. [see Use in Specific Populations (8.1)]

Adverse Reactions

Please refer to Adverse Reactions in Infants and Children Under 2 Years of Age (Section 6.1.1) for consideration when treating patients with Infantile Spasms. The adverse reactions presented in Section 6.2 are primarily provided for consideration in use in adults and in children over 2 years of age, but these adverse reactions should also be considered when treating infants and children under 2 years of age.

H.P. Acthar Gel causes the release of endogenous cortisol from the adrenal gland. Therefore all the adverse effects known to occur with elevated cortisol may occur with H.P. Acthar Gel administration as well. Common adverse reactions include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gain.

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in practice.

.1 Adverse Reactions in Infants and Children Under 2 Years of Age

While the types of adverse reactions seen in infants and children under age 2 treated for infantile spasms are similar to those seen in older patients, their frequency and severity may be different due to the very young age of the infant, the underlying disorder, the duration of therapy and the dosage regimen. Below is a summary of adverse reactions specifically tabulated from source data derived from retrospective chart reviews and clinical trials in children under 2 years of age treated for infantile spasms. The number of patients in controlled trials at the recommended dose was too few to provide meaningful incidence rates or to permit a meaningful comparison to the control groups.

TABLE: Incidence (%) of Treatment Emergent Adverse Events Occurring in ≥ 2% of H.P. Acthar Gel (repository corticotropin injection) Infants and Children under 2 years of Age

System Organ Class	Recommended 75 U/m2 bid n=122, (%)	150 U/m2 qd n=37 (%)
1Specific infections that occurred at ≥2% were candidiasis, otitis media, pneumonia and upper respiratory tract infections.
2 In the treatment of Infantile Spasms, other types of seizures/convulsions may occur because some patients with infantile spasms progress to other forms of seizures (for example, Lennox-Gastaut Syndrome). Additionally the spasms sometimes mask other seizures and once the spasms resolve after treatment, the other seizures may become visible.
Cardiac disorders
Cardiac Hypertrophy	3	0
Endocrine disorders
Cushingoid	3	22
Gastrointestinal disorders
Constipation	0	5
Diarrhea	3	14
Vomiting	3	5
General disorders and administration site conditions
Irritability	7	19
Pyrexia	5	8
Infections and infestations
Infection1	20	46
Investigations
Weight gain	1	3
Metabolism and nutrition disorders
Increased appetite	0	5
Decreased appetite	3	3
Nervous system disorders
Convulsion2	12	3
Respiratory, thoracic and mediastinal disorders
Nasal Congestion	1	5
Skin and subcutaneous tissue disorders
Acne	0	14
Rash	0	8
Vascular disorders
Hypertension	11	19

These adverse reactions may also be seen in adults and children over 2 years of age when treated for other purposes and with different doses and regimens.

Postmarketing Experience

The following adverse reactions associated with the use of H.P. Acthar Gel have been identified from postmarketing experience with H.P. Acthar Gel. Only adverse events that are not listed above as adverse events reported from retrospective chart reviews and non-sponsor conducted clinical trials and those not discussed elsewhere in labeling, are listed in this section. Because the adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or establish a causal relationship to use with H.P. Acthar Gel. Events are categorized by system organ class. Unless otherwise noted these adverse events have been reported in infants, children and adults.

.1 Allergic Reactions

Allergic responses have presented as dizziness, nausea and shock (adults only).

.2 Cardiovascular

Necrotizing angitis (adults only) and congestive heart failure.

.3 Dermatologic

Skin thinning (adults only), facial erythema and increased sweating (adults only).

.4 Endocrine

Decreased carbohydrate tolerance (infants only) and hirsutism.

.5 Gastrointestinal

Pancreatitis (adults only), abdominal distention and ulcerative esophagitis.

.6 Metabolic

Hypokalemic alkalosis (infants only).

.7 Musculoskeletal

Muscle weakness and vertebral compression fractures (infants only).

.8 Neurological

Headache (adults only), vertigo (adults only), subdural hematoma, intracranial hemorrhage (adults only), and reversible brain shrinkage (usually secondary to hypertension) (infants only).

Possible Additional Steroidogenic Effects

Based on steroidogenic effects of H.P. Acthar Gel certain adverse events may be expected due to the pharmacological effects of corticosteroids. The adverse events that may occur but have not been reported for H.P. Acthar Gel are:

.1 Dermatologic

Impaired wound healing, abscess, petechiae and ecchymoses, and suppression of skin test reactions.

.2 Endocrine

Menstrual irregularities.

.3 Metabolic

Negative nitrogen balance due to protein catabolism.

.4 Musculoskeletal

Loss of muscle mass and aseptic necrosis of femoral and humeral heads.

.5 Neurological

Increased intracranial pressure with papilledema, (pseudo-tumor cerebri) usually after treatment, and subdural effusion.

.6 Ophthalmic

Exophthalmos.

Drug Interactions

Formal drug-drug interaction studies have not been performed.

H.P. Acthar Gel may accentuate the electrolyte loss associated with diuretic therapy.

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Class C: H.P. Acthar Gel has been shown to have an embryocidal effect. There are no adequate and well-controlled studies in pregnant women. H.P. Acthar Gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from H.P. Acthar Gel, when treating a nursing mother, a decision should be made whether to discontinue nursing or to discontinue the drug, considering the risk and benefit to the mother.

Pediatric Use

H.P. Acthar Gel is indicated as monotherapy for the treatment of infantile spasms in infants and children less than 2 years of age. Both serious and other adverse reactions in this population are discussed in Warnings and Adverse Reactions in Infants and Children Under 2 Years of Age [see Sections 5 and 6.1.1].

The efficacy of H.P. Acthar Gel for the treatment of infantile spasms in infants and children less than 2 years of age was evaluated in a randomized, single blinded (video EEG interpreter blinded) clinical trial and an additional active control supportive trial [see Clinical Studies (14)]. A responding patient was defined as having both complete cessation of spasms and elimination of hypsarrhythmia.

Safety in the pediatric population for infantile spasms was evaluated by retrospective chart reviews and data from non-sponsor conducted clinical trials [see Adverse Reactions (6.1.1)]. While the types of adverse reactions seen in infants and children under 2 years of age treated for infantile spasms are similar to those seen in older patients, their frequency and severity may be different due to the very young age of the infant, the underlying disorder, the duration of therapy and the dosage regimen. Effects on growth are of particular concern [see Warnings and Precautions (5.12)]. Serious adverse reactions observed in adults may also occur in children [see Warnings and Precautions (5)].

Overdosage

While chronic exposure to H.P. Acthar Gel at high doses can be associated with a variety of potential serious adverse effects, it is not expected that a single high dose, or even several large doses, has the potential for serious adverse effects compared to a standard dose. There have been no reports of death or acute overdose symptoms from H.P. Acthar Gel in clinical studies or in the published literature.

The intramuscular route of administration makes it unlikely that an inadvertent acute overdose will occur. The typical daily dose of H.P. Acthar Gel to treat an infant that has a BSA of 0.4 m2 would be 60 U/day. Using the 1-cc syringe supplied with H.P. Acthar Gel, the maximum amount that can be injected is 80 U/injection, which is a well-tolerated single dose.

H.P. Acthar Gel Description

H.P. Acthar Gel is a highly purified sterile preparation of the adrenocorticotropic hormone in 16% gelatin to provide a prolonged release after intramuscular or subcutaneous injection. Also contains 0.5% phenol, not more than 0.1% cysteine (added), sodium hydroxide and/or acetic acid to adjust pH and water for injection.

ACTH is a 39 amino acid peptide with the following chemical formula:

H-	Ser-	Tyr-	Ser-	Met-	Glu-	His-	Phe-	Arg-	Trp-	Gly-
	1	2	3	4	5	6	7	8	9	10
	Lys-	Pro-	Val-	Gly-	Lys-	Lys-	Arg-	Arg-	Pro-	Val-
	11	12	13	14	15	16	17	18	19	20
	Lys-	Val-	Try-	Pro-	Asp-	Gly-	Ala-	Glu-	Asp-	Gln-
	21	22	23	24	25	26	27	28	29	30
	Leu-	Ala-	Glu-	Ala-	Phe-	Pro-	Leu-	Glu-	Phe-	OH
	31	32	33	34	35	36	37	38	39

H.P. Acthar Gel - Clinical Pharmacology

Mechanism of Action

The mechanism of action of H.P. Acthar Gel in the treatment of infantile spasms is unknown.

H.P. Acthar Gel and endogenous ACTH stimulate the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances. Prolonged administration of large doses of H.P. Acthar Gel induces hyperplasia and hypertrophy of the adrenal cortex and continuous high output of cortisol, corticosterone and weak androgens. The release of endogenous ACTH is under the influence of the nervous system via the regulatory hormone released from the hypothalamus and by a negative corticosteroid feedback mechanism. Elevated plasma cortisol suppresses ACTH release.

H.P. Acthar Gel is also reported to bind to melanocortin receptors.

The trophic effects of endogenous ACTH and H.P. Acthar Gel on the adrenal cortex are not well understood beyond the fact that they appear to be mediated by cyclic AMP.

ACTH rapidly disappears from the circulation following its intravenous administration; in people, the plasma half-life is about 15 minutes. The pharmacokinetics of H.P. Acthar Gel have not been adequately characterized.

The maximal effects of a trophic hormone on a target organ are achieved when optimal amounts of hormone are acting continuously. Thus, a fixed dose of H.P. Acthar Gel will demonstrate a linear increase in adrenocortical secretion with increasing duration for the infusion.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Adequate and well-controlled studies have not been done in animals. Human use has not been associated with an increase in malignant disease. [see Warnings and Precautions (5.14) and Use in Specific Populations (8.1)].

Clinical Studies

The effectiveness of H.P. Acthar Gel as a treatment for infantile spasms was demonstrated in a single blinded (video EEG interpreter blinded) clinical trial in which patients were randomized to receive either a 2 week course of treatment with H.P. Acthar Gel (75 U/m2 intramuscular twice daily) or prednisone (1 mg/kg by mouth twice daily). The primary outcome was a comparison of the number of patients in each group who were treatment responders, defined as a patient having complete suppression of both clinical spasms and hypsarrhythmia on a full sleep cycle video EEG performed 2 weeks following treatment initiation, rated by an investigator blinded to treatment. Thirteen of 15 patients (86.7%) responded to H.P. Acthar Gel as compared to 4 of 14 patients (28.6%) given prednisone (p<0.002). The 2-week treatment was followed by a 2-week period of taper. Nonresponders to the prednisone treatment were eligible to receive H.P. Acthar Gel treatment. Seven of 8 patients (87.5%) responded to H.P Acthar Gel after not responding to prednisone. Similarly, the 2 nonresponder patients from the H.P. Acthar Gel treatment were eligible to receive treatment with prednisone. One of the 2 patients (50%) responded to the prednisone treatment after not responding to H.P.Acthar Gel.

A supportive single-blind, randomized clinical trial comparing high-dose, long-duration treatment (150 U/m2 once daily for 3 weeks, n=30) of H.P. Acthar Gel with low-dose, short-duration treatment (20 U once daily for 2 weeks, n=29) for the treatment of infantile spasms was also evaluated in infants and children less than 2 years of age. Nonresponders (defined as in the previously described study) in the low-dose group received a dose escalation at 2 weeks to 30 U once daily. Nominal statistical superiority of the high dose treatment, as compared to the low dose treatment, was observed for cessation of spasms but not for the resolution of hypsarrhythmia.

HOW SUPPLIED / STORAGE AND HANDLING

H.P. Acthar Gel (repository corticotropin injection) is supplied as 5 mL multi-dose vial (63004-7731-1) containing 80 USP Units per mL. H.P. Acthar Gel (repository corticotropin injection) should be warmed to room temperature before using. Do not over pressurize the vial prior to withdrawing the product.

Store H.P. Acthar Gel (repository corticotropin injection) under refrigeration between 2°-8°C (36°-46°F). Product is stable for the period indicated on the label when stored under the conditions described.

Patient Counseling Information

Caretakers of patients with infantile spasms should be informed of the availability of a Medication Guide, and they should be instructed to read the Medication Guide prior to administering H.P Acthar Gel. Patients should be instructed to take H.P. Acthar Gel only as prescribed. They should not stop treatment suddenly unless instructed by their physician to do so.

Patients, their caregivers and families should be advised as to the importance of the need for careful monitoring while on and during titration from H.P. Acthar Gel treatment and the importance of not missing and scheduled doctor’s appointments.

Patients, their caregivers and families should be advised that if the patient develops an infection or fever they should contact their physician. They should be educated that a fever may not necessarily be present during infection. The patient should also try to limit contact with other people with infections to minimize the risk of infection while taking H.P. Acthar Gel. [see Warnings and Precautions (5.1) and Adverse Reactions (6.1.1)]

Patients, their caregivers and families should be advised that if the patient experiences an increase in blood pressure they should contact their physician. [see Warnings and Precautions (5.3) and Adverse Reactions (6.1.1)]

Patients, their caregivers and families should be advised that if the patient or the caregiver notices blood or a change in color of the patient’s stool they should contact their physician. [see Warnings and Precautions (5.6)].

Caregivers and families of infants and children treated with H.P. Acthar Gel should be informed that the patient may show signs of irritability and sleep disturbances. These effects are reversible once H.P. Acthar Gel therapy is stopped. [see Warnings and Precautions (5.7) and Adverse Reactions (6.1.1)].

Patients, their caregivers and families should be advised that changes in appetite, most often leading to weight gain, are seen with H.P. Acthar Gel therapy, becoming more frequent as the dose or treatment period increases. These effects are reversible once H.P. Acthar Gel therapy is stopped. [see Warnings and Precautions (5.12) and Adverse Reactions (6.1.1].

Patients, their caregivers and families should be advised that the patient may be monitored for signs of adrenal insufficiency such as weakness, fatigue, lethargy, anorexia, weight loss, hypotension, abdominal pain or hyperpigmentation (adults only) after treatment has stopped. Since the recovery of the adrenal gland varies from days to months, patients may need to be protected from the stress of trauma or surgery by the use of corticosteroids during the period of stress. [see Warnings and Precautions (5.2)].

Patients should be advised not to be vaccinated with live or live attenuated vaccines during treatment with H.P. Acthar Gel. Additionally, other immunization procedures in patients or in family members who will be in contact with the patient should be undertaken with caution while the patient is taking H.P. Acthar Gel. [see Warnings and Precautions (5.4)].

Patients, their caregivers and families should be advised that prolonged use of H.P. Acthar Gel in children may result in Cushing’s syndrome and associated adverse reactions, may inhibit skeletal growth, and may cause osteoporosis and decreased bone density. If prolonged use is necessary, H.P. Acthar Gel should be given intermittently along with careful observation. [see Warnings and Precautions (5.2), (5.12), and (5.13) and Adverse Reactions (6.1.1)].

Patients, their caregivers and families should be informed that H.P. Gel may mask symptoms of other diseases/disorders without altering the course of the other disease/disorder. The patient will need to be monitored carefully during and for a period following discontinuation of therapy for signs of infection, abnormal cardiac function, hypertension, hyperglycemia, change in body weight, and fecal blood loss. [see Warnings and Precautions (5.5)].

In the treatment of Infantile Spasms, other types of seizures may occur because some patients with infantile spasms progress to other forms of seizures (for example, Lennox-Gastaut Syndrome). Additionally the spasms sometimes mask other seizures and once the spasms resolve after treatment with H.P. Acthar Gel, the other seizures may become visible. Parents and caregivers should inform their physician of any new onset of seizures so that appropriate management can then be instituted. [see Adverse Reactions (6.1.1)].

H.P. Acthar ® Gel

(repository corticotropin injection)

Manufactured for Questcor Pharmaceuticals, Inc.

Questcor Pharmaceuticals, Inc.

26118 Research Road

Hayward, CA 94545 USA

phone (800) 411-3065

          (510) 400-0700

fax     (510) 400-0799

PL065/Rev. 03  No. 1350

Issued: 06/2011

MEDICATION GUIDE

H.P. Acthar® Gel (H P AK-thar jel)

(repository corticotropin Injection)

This Medication Guide provides information only about the use of H.P. Acthar Gel for the treatment of Infantile Spasms. If your doctor prescribes H.P. Acthar Gel for you or your child for any other reason, talk to your doctor for information about how this medicine is used to treat your medical condition.

Read this Medication Guide before your child receives H.P Acthar Gel and each time you refill your child’s prescription. There may be new information. This Medication Guide does not take the place of talking with your doctor about your child’s medical condition or treatment.

What is the most important information I should know about H.P. Acthar Gel?

H.P. Acthar Gel can cause serious side effects including:

1. Increased risk of infections. H.P Acthar Gel is a medicine that can affect your child’s immune system. When your child is taking H.P. Acthar Gel, it can lower the ability of your child’s immune system to fight infections. H.P. Acthar Gel may:

• make your child more likely to get new infections


• worsen an infection that your child already has


• cause an inactive infection to become active, such as tuberculosis (TB

Before starting H.P. Acthar Gel, tell your doctor if your child has:

• an infection or signs of an infection, such as:
  
  • fever
  
  
  • cough
  
  
  • vomiting
  
  
  • diarrhea
  
  
  • other signs of flu or illness
  
  


• a family member with an infection or signs of an infection

While taking H.P. Acthar Gel, your child should:

• stay away from people who are sick or who have infections


• tell your doctor right away if your child has any sign of infection such as:
  
  • fever (but your child may not have a fever with an infection)
  
  
  • cough
  
  
  • vomiting
  
  
  • diarrhea or
  
  
  • other signs of illness or flu and
  
  
  • any open cuts or sores on his or her body
  
  

2. Effects on the adrenal gland after stopping H.P. Acthar Gel.

When your child stops taking H.P. Acthar Gel, his or her body may not produce enough of a hormone called cortisol on its own (adrenal insufficiency). Your child may need to take steroid medicine to protect the body until the adrenal gland recovers and is working well again, especially to protect the body if they have surgery or trauma. Do not stop giving your child injections of H.P. Acthar Gel without talking to your doctor first. Your doctor will tell you when and how to slowly stop giving the injections to avoid serious side effects.

While slowly stopping your child’s injections of H.P. Acthar Gel or after you stop giving the injections, call your doctor right away if your child has any of the following:

• appears weak


• loses weight or has a decrease in appetite


• appears pale


• has stomach pain


• appears sick or is with fever

3. Effects on the adrenal gland while taking H.P. Acthar Gel

When your child is taking H.P. Acthar Gel, his or her adrenal gland may produce too much cortisol. This can cause symptoms of Cushing’s syndrome. Cushing’s syndrome is more common in children who take H.P. Acthar Gel for a long time.

Symptoms of Cushing’s syndrome include:

• increased upper body fat around the neck, but not the arms and legs


• weight gain


• rounded or "moon" face


• thin skin, easy bruising, and stretch marks on thighs, belly and trunk


• slowed growth rates in children


• weak bones (osteoporosis)

While receiving treatment with H.P. Acthar Gel other side effects can happen that are like side effects that happen due to treatment with steroid medicines. The risk of getting side effects may increase the longer your child is treated with H.P. Acthar Gel. Side effects may include:

• increased blood pressure.Your doctor may check your child’s blood pressure during treatment. If your child’s blood pressure increases, your doctor may talk with you about possible treatment choices.


• too much water in the body (water retention), increased amount of body salts, and low potassium in the blood. H.P. Acthar Gel may cause your child to have an increased amount of body salts and water that stays in the body, and may lower the amount of potassium in your child’s blood. Follow your doctor’s instructions about if you need to decrease your child’s salt intake or if you need to feed your child foods high in potassium.

4. Your child should not receive certain vaccines during treatment with H.P. Acthar Gel.Your child may receive killed or inactivated vaccines while receiving H.P. Acthar Gel. Before your child receives any vaccines, talk to your doctor about which vaccines are safe for your child. Certain vaccines could cause your child to have serious side effects, or the vaccine may not be effective.

5. Hiding (masking) symptoms of other conditions or diseases.It may be more difficult for your doctor to diagnose other conditions or diseases in your child during treatment with H.P. Acthar Gel. During treatment and after treatment ends, tell your doctor if your child has:

• any signs or symptoms of infection. See number 1 of this section in the Medication Guide.


• changes in body weight


• bloody or black tarry stool


• vomiting


• stomach pain


• excessive tiredness


• increased thirst


• fast heart rate


• difficulty breathing

6. Stomach and intestinal problems. H.P. Acthar Gel may cause bleeding of the stomach or intestine. Your child has an increased risk for bleeding from the stomach or having a stomach ulcer. Tell your doctor if your child has any pain in the stomach area (abdominal pain), vomits blood, or has bloody or black stools.

7. Changes in mood and behavior.During treatment with H.P. Acthar Gel your child may be irritable, have rapid changes in his or her mood, be depressed, have other changes in his or her behavior, or have trouble sleeping.

Tell your doctor if your child has any of the side effects or symptoms listed above.

What is H.P. Acthar Gel?

H.P. Acthar Gel is a prescription medicine that is used to treat infantile spasms in infants and children under 2 years of age.

What should I tell my doctor before my child takes H.P. Acthar Gel?

Before your child takes H.P. Acthar Gel, read the section above “What is the most important information I should know about H.P. Acthar Gel?” and tell your doctor if your child has:

• an infection


• Diabetes


• heart problems


• kidney problems


• stomach or intestinal problems


• thyroid problems


• liver problems


• neuromuscular problems


• convulstions or seizuers


• had exposure to someone with Tuberculosis (TB)


• a previous allergic reaction such as hives, itching or trouble breathing, to H.P. Acthar Gel or pork products


• had recent surgery


• had a recent vaccination or is scheduled to receive a vaccination


• a family member who is receiving vaccinations

Tell your doctor about all the medicines your child takes, including prescription and non-prescription medicines, vitamins and herbal supplements. Do not start giving a new medicine to your child without first speaking to your doctor.

How should I give H.P. Acthar Gel to my child? H.P. Acthar Gel is given as an injection into the muscle. Do not inject it under the skin, into a vein, or give it to your child by mouth.

• Inject H.P. Acthar Gel exactly as your doctor tells you. Your doctor will tell you where to give the injection, how much to give, how often and when to give it to your child.


• Do not use H.P. Acthar Gel until your doctor has taught you how to give the injection to your child.


• To give H.P. Acthar Gel:
  
  • Take the bottle from the refrigerator. Do not open the bottle or pry the cap (rubber stopper) off.
  
  
  • Warm the contents by rolling the bottle between your hands for a few minutes.
  
  
  • Wash your hands
  
  
  • Prepare the skin where you are going to give the injection by wiping it with a new sterile alcohol wipe. Before givi