Ami-Lac

Pronunciation: KAL-see-uhm/GLYE-seen
Generic Name: Calcium/Glycine
Brand Name: Examples include Ami-Lac and Titralac

Ami-Lac is used for:

Treating acid indigestion, heartburn, and sour stomach. It may also be used for other conditions as determined by your doctor.

Ami-Lac is an antacid. It works by neutralizing acid in the stomach.

Do NOT use Ami-Lac if:

• you are allergic to any ingredient in Ami-Lac


• you are also taking citrate salts (found in some calcium supplements, antacids, and laxatives)


• you have a history of high blood calcium levels

Contact your doctor or health care provider right away if any of these apply to you.

Before using Ami-Lac:

Some medical conditions may interact with Ami-Lac. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have Alzheimer disease, sarcoidosis, kidney problems, kidney stones, appendicitis, diarrhea, a stomach or intestinal blockage, severe constipation, low parathyroid levels, or an ileostomy


• if you have recently had stomach bleeding

Some MEDICINES MAY INTERACT with Ami-Lac. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Cation exchange resins (eg, sodium polystyrene sulfonate) and citrate salts (found in some calcium supplements, antacids, and laxatives) because the actions and side effects of Ami-Lac may be increased


• Anticoagulants (eg, warfarin), quinidine, or sulfonylureas (eg, glyburide) because the actions and side effects of these medicines may be increased


• Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), beta-blockers (eg, propranolol), bisphosphonates (eg, risedronate), cephalosporins (eg, cephalexin), corticosteroids (eg, hydrocortisone), cyclosporine, delavirdine, digoxin, imidazoles (eg, ketoconazole), mycophenolate, penicillamine, quinolones (eg, ciprofloxacin), tetracyclines (eg, doxycycline), thyroid hormones (eg, levothyroxine), or verapamil because the effectiveness of these medicines may be decreased, especially when taken at the same time as Ami-Lac

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ami-Lac may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Ami-Lac:

Use Ami-Lac as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Ami-Lac may be taken with or without food.


• Do not use Ami-Lac within 2 hours before or after taking a beta-blocker (eg, propranolol), bisphosphonate (eg, risedronate), cephalosporin (eg, cephalexin), corticosteroid (eg, hydrocortisone), delavirdine, digoxin, imidazole (eg, ketoconazole), penicillamine, sulfonylurea (eg, glyburide), or tetracyclines (eg, doxycycline) because Ami-Lac may decrease the effectiveness of these medicines.


• If you miss a dose of Ami-Lac and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Ami-Lac.

Important safety information:

• Do not exceed the recommended dose or use the maximum dose for more than 2 weeks without checking with your doctor.


• If your symptoms do not improve within 2 weeks or if they become worse, or if you experience black, tarry stools or vomit that looks like coffee grounds, check with your doctor.


• Different products may have different dosing instructions for CHILDREN on the package labeling. Follow the dosing instructions provided on the package labeling or by your doctor. If you are unsure of what dose to give a child, check with your doctor.


• PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Ami-Lac, discuss with your doctor the benefits and risks of using Ami-Lac during pregnancy. If you are or will be breast-feeding while you are using Ami-Lac, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Ami-Lac:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); headache; increased stomach pain; increased urination; loss of appetite; muscle weakness; nausea; slow reflexes; vomiting; weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Ami-Lac side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Ami-Lac:

Store Ami-Lac at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ami-Lac out of the reach of children and away from pets.

General information:

• If you have any questions about Ami-Lac, please talk with your doctor, pharmacist, or other health care provider.


• Ami-Lac is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Ami-Lac. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Ami-Lac resources

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

Compare Ami-Lac with other medications

• Duodenal Ulcer
• Erosive Esophagitis
• GERD
• Indigestion
• Stomach Ulcer

Rupafin 10mg Tablets

1. Name Of The Medicinal Product

Rupafin

2. Qualitative And Quantitative Composition

Each tablet contains:

10 mg of rupatadine (as fumarate)

Excipients: lactose

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Tablet.

Round, light salmon coloured tablets.

4. Clinical Particulars

4.1 Therapeutic Indications

Symptomatic treatment of allergic rhinitis and urticaria in adults and adolescents (over 12 years of age).

4.2 Posology And Method Of Administration

Adults and adolescents (over 12 years of age)

The recommended dose is 10 mg (one tablet) once a day, with or without food.

Elderly

Rupafin should be used with caution in elderly people (see section 4.4).

Paediatric patients

Rupafin 10 mg Tablets is not recommended for use in children below age 12 due to a lack of data on safety and efficacy.

Patients with renal or hepatic insufficiency

As there is no clinical experience in patients with impaired kidney or liver functions, the use of Rupafin 10 mg Tablets is at present not recommended in these patients.

4.3 Contraindications

Hypersensitivity to rupatadine or to any of the excipients.

4.4 Special Warnings And Precautions For Use

The administration of Rupafin with grapefruit juice is not recommended (see section 4.5).

Cardiac safety of rupatadine was assessed in a thorough QT/QTc study. Rupatadine up to 10 times therapeutic dose did not produce any effect on the ECG and hence raises no cardiac safety concerns. However rupatadine should be used with caution in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia, patients with ongoing pro-arrhythmic conditions, such as clinically significant bradycardia, acute myocardial ischemia.

Rupafin 10 mg Tablets should be used with caution in elderly patients (65 years and older). Although no overall differences in effectiveness or safety were observed in clinical trials, higher sensitivity of some older individuals cannot be excluded due to the low number of elderly patients enrolled (see section 5.2).

Regarding use in children less than 12 years old and in patients with renal or hepatic impairment, see section 4.2.

Due to the presence of lactose monohydrate in Rupafin 10 mg tablets, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Interaction with ketoconazole or erythromycin: The concomitant administration of rupatadine 20 mg and ketoconazole or erythromycin increases the systemic exposure to rupatadine 10 times and 2-3 times respectively. These modifications were not associated with an effect on the QT interval or with an increase of the adverse reactions in comparison with the drugs when administered separately. However, rupatadine should be used with caution when it is administered concomitantly with these drug substances and other inhibitors of the isozyme CYP3A4.

Interaction with grapefruit:The concomitant administration of grapefruit juice increased 3.5 times the systemic exposure of rupatadine. Grapefruit juice should not be taken simultaneously.

Interaction with alcohol:After administration of alcohol, a dose of 10 mg of rupatadine produced marginal effects in some psychomotor performance tests although they were not significantly different from those induced by intake of alcohol only. A dose of 20 mg increased the impairment caused by the intake of alcohol.

Interaction with CNS depressants: As with other antihistamines, interactions with CNS depressants cannot be excluded.

Interaction with statins: Asymptomatic CPK increases have been uncommonly reported in rupatadine clinical trials. The risk of interactions with statins, some of which are also metabolised by the cytochrome P450 CYP3A4 isoenzyme, is unknown. For these reasons, rupatadine should be used with caution when it is coadministered with statins.

4.6 Pregnancy And Lactation

Data on a limited number (2) exposed pregnancies indicate no adverse effects of rupatadine on pregnancy or on the health of the foetus/newborn child. To date, no other relevant epidemiological data are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). Caution should be exercised when prescribing rupatadine to pregnant women.

Rupatadine is excreted in animal milk. It is unknown whether rupatadine is excreted into breast milk. Due to the lack of human data, caution should be exercised when prescribing rupatadine to lactating milk.

4.7 Effects On Ability To Drive And Use Machines

Rupatadine 10 mg had no influence on the ability to drive and use machines. Nevertheless, care should be taken before driving or using machinery until the patient's individual reaction on rupatadine has been established.

4.8 Undesirable Effects

Rupatadine 10 mg has been administered to over 2025 patients in clinical studies, 120 of whom received rupatadine for at least 1 year.

The most common adverse reactions in controlled clinical studies were somnolence (9.5%), headache (6.9%) and fatigue (3.2%).

The majority of adverse reactions observed in clinical trials were mild to moderate in severity and usually did not require cessation of therapy. The frequencies are summarised according to the following scheme:

System Organ Class	Common (	Uncommon (
Investigations		Blood creatine phosphokinase increased, Alanine aminotransferase increased, Aspartate aminotransferase increased, Liver function test abnormal, Weight increased
Nervous system disorders	Somnolence, Headache, Dizziness	Disturbance in attention
Respiratory, thoracic and mediastinal disorders		Epistaxis, Nasal dryness, Pharyngitis, Cough, Dry throat, Pharyngolaryngeal pain, Rhinitis
Gastrointestinal disorders	Dry mouth	Nausea, Abdominal pain upper, Diarrhoea, Dyspepsia, Vomiting, Abdominal pain, Constipation
Skin and subcutaneous tissue disorders		Rash
Musculoskeletal and connective tissue disorders		Back pain, Arthralgia, Myalgia
Metabolism and nutrition disorders		Increased appetite
General disorders and administration site conditions	Fatigue, Asthenia	Thirst, Malaise, Pyrexia
Psychiatric disorders		Irritability

4.9 Overdose

No case of overdose has been reported. In a clinical safety study rupatadine at daily dose of 100 mg during 6 days was well tolerated. The most common adverse reaction was somnolence. If accidental ingestion of very high doses occurs symptomatic treatment together with the required supportive measures should be given.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: other antihistamines for systemic use, ATC code: R06A X28.

Rupatadine is a second generation antihistamine, long-acting histamine antagonist, with selective peripheral H₁-receptor antagonist activity. Some of the metabolites (desloratadine and its hydroxylated metabolites) retain an antihistaminic activity and may partially contribute to the overall efficacy of the drug.

In vitro studies with rupatadine at high concentration have shown an inhibition of the degranulation of mast cells induced by immunological and non-immunological stimuli as well as the release of cytokines, particularly of the TNF_α in human mast cells and monocytes. The clinical relevance of the observed experimental data remains to be confirmed.

Chronic idiopathic urticaria was studied as a clinical model for urticarial conditions, since the underlying pathophysiology is similar, regardless of etiology, and because chronic patients can be more easily recruited prospectively. Since histamine release is a causal factor in all urticarial diseases, rupatadine is expected to be effective in providing symptomatic relief for other urticarial conditions, in addition to chronic idiopathic urticaria, as advised in clinical guidelines.

Clinical trials in volunteers (n= 375) and patients (n=2650) with allergic rhinitis and chronic idiopathic urticaria did not show significant effect on the electrocardiogram when rupatadine was administered at doses ranging from 2 mg to 100 mg.

In a placebo-controlled trials in patients with Chronic Idiopathic Urticaria, rupatadine was effective reducing the mean pruritus score from baseline over the 4 week treatment period (change vs baseline: rupatadine 57.5%, placebo 44.9%) and decreasing the mean number of wheals (54.3% vs 39.7%).

5.2 Pharmacokinetic Properties

Absorption and bioavailability

Rupatadine is rapidly absorbed after oral administration, with a t_max of approximately 0.75 hours after intake. The mean C_max was 2.6 ng/ml after a single oral dose of 10 mg and 4.6 ng/ml after a single oral dose of 20 mg. Pharmacokinetics of rupatadine was linear for a dose between 10 and 40 mg. After a dose of 10 mg once a day for 7 days, the mean C_max was 3.8 ng/ml. The plasma concentration followed a bi-exponential drop-off with a mean elimination half-life of 5.9 hours. The binding-rate of rupatadine to plasma proteins was 98.5-99%.

As rupatadine has never been administered to humans by intravenous route, no data is available on its absolute bioavailability.

Effect of the intake of food

Intake of food increased the systemic exposure (AUC) to rupatadine by about 23%. The exposure to one of its active metabolites and to the main inactive metabolite was practically the same (reduction of about 5% and 3% respectively). The time taken to reach the maximum plasma concentration (t_max) of rupatadine was delayed by 1 hour. The maximum plasma concentration (C_max) was not affected by food intake. These differences had no clinical significance.

Metabolism and elimination

In a study of excretion in humans (40 mg of ¹⁴C-rupatadine), 34.6% of the radioactivity administered was recovered in urine and 60.9% in faeces collected over 7 days. Rupatadine undergoes considerable pre-systemic metabolism when administered by oral route. The amounts of unaltered active substance found in urine and faeces were insignificant. This means that rupatadine is almost completely metabolised. In vitro metabolism studies in human liver microsomes indicate that rupatadine is mainly metabolised by the cytochrome P450 (CYP 3A4).

Specific patient groups

In a study on healthy volunteers to compare the results in young adults and elderly patients, the values for AUC and C_max for rupatadine were higher in the elderly than in young adults. This is probably due to a decrease of the first-pass hepatic metabolism in the elderly. These differences were not observed in the metabolites analysed. The mean elimination half-life of rupatadine in elderly and young volunteers was 8.7 hours and 5.9 hours respectively. As these results for rupatadine and for its metabolites were not clinically significant, it was concluded that it is not necessary to make any adjustment when using a dose of 10 mg in the elderly.

5.3 Preclinical Safety Data

Preclinical data reveal no special hazard for humans based on conventional studies of pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential.

More than 100 times the clinically recommended dose (10 mg) of rupatadine did neither extend the QTc or QRS interval nor produce arrhythmia in various species of animals such as rats, guinea pigs and dogs. Rupatadine and one of its main active metabolites in humans, 3-hydroxydesloratadine, did not affect the cardiac action potential in isolated dog Purkinje fibres at concentrations at least 2000 times greater than the C_max reached after the administration of a dose of 10 mg in humans. In a study that evaluated the effect on cloned human HERG channel, rupatadine inhibited that channel at a concentration 1685 times greater than the C_max obtained after the administration of 10 mg of rupatadine. Desloratadine, the metabolite with the greatest activity, had no effect at a 10 micromolar concentration. Studies of tissue distribution in rats with radiolabelled rupatadine showed that rupatadine does not accumulate in heart tissue.

In the rat, a significant reduction of male and female fertility occurred at the high dose of 120 mg/kg/day, providing C_max 268 times those measured in humans at the therapeutic dose (10 mg/day). Foetal toxicity (growth delay, incomplete ossification, minor skeletal findings) was reported in rats at maternotoxic dose-levels only (25 and 120 mg/kg/day). In rabbits, no evidence of developmental toxicity was noted at doses up to 100 mg/kg. The developmental No Adverse Effect Levels were determined at 5 mg/kg/day in rats and 100 mg/kg/day in rabbits, yielding C_max 45 and 116 times higher, respectively, than those measured in humans at the therapeutic dose (10 mg/day).

6. Pharmaceutical Particulars

6.1 List Of Excipients

Pregelatinised maize starch

Microcrystalline cellulose

Red iron oxide (E-172)

Yellow iron oxide (E-172)

Lactose monohydrate

Magnesium stearate

6.2 Incompatibilities

Not applicable

6.3 Shelf Life

3 years

6.4 Special Precautions For Storage

Keep the blister in the outer carton in order to protect from light.

6.5 Nature And Contents Of Container

PVC/PVDC/aluminium blister.

Packs of 3, 7, 10, 15, 20, 30, 50 and 100 tablets. Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

J. Uriach & Cía., S.A.

Av. Camí Reial, 51-57

08184 Palau-solità i Plegamans (Spain)

8. Marketing Authorisation Number(S)

PL 11906/0007

9. Date Of First Authorisation/Renewal Of The Authorisation

24/10/2007

10. Date Of Revision Of The Text

22/12/2009

alpha 1-proteinase inhibitor

Generic Name: alpha 1-proteinase inhibitor (AL fa 1-PRO tee nase in HIB i tor)

Brand names: Aralast, Aralast NP, Prolastin, Zemaira, Prolastin-C, Glassia

What is alpha 1-proteinase inhibitor?

Alpha 1-proteinase inhibitor is a protein, also called alpha 1-antitrypsin. This protein occurs naturally in the body and is important for preventing the breakdown of tissues in the lungs.

In people who lack the alpha 1-antitrypsin protein, breakdown of lung tissues can lead to emphysema (damage to the air sacs in the lungs).

Alpha 1-proteinase inhibitor is used to treat alpha 1-antitrypsin deficiency in people who have symptoms of emphysema.

Alpha 1-antitrypsin deficiency is a genetic (inherited) disorder and alpha 1-proteinase inhibitor will not cure this condition.

Alpha 1-proteinase inhibitor may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about alpha 1-proteinase inhibitor?

You should not use this medication if you have ever had an allergic reaction to alpha 1-proteinase inhibitor, or if you have an IgA deficiency or antibody against IgA.

Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing, difficulty breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

You will most likely receive your first few doses of this medication in a hospital or clinic setting where your vital signs can be watched closely in case the medication causes serious side effects.

Alpha 1-proteinase inhibitor is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

What should I discuss with my health care provider before using alpha 1-proteinase inhibitor?

You should not use this medication if you have ever had an allergic reaction to alpha 1-proteinase inhibitor, or if you have an IgA deficiency or antibody against IgA.

Before you receive alpha 1-proteinase inhibitor, tell your doctor about all of your medication conditions.

FDA pregnancy category C. Alpha 1-proteinase inhibitor may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether alpha 1-proteinase inhibitor 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.

Alpha 1-proteinase inhibitor is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

How should I use alpha 1-proteinase inhibitor?

Alpha 1-proteinase inhibitor is usually given once per week. Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Alpha 1-proteinase inhibitor is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to use your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine.

You will most likely receive your first few doses of this medication in a hospital or clinic setting where your vital signs can be watched closely in case the medication causes serious side effects.

You will need to mix alpha 1-proteinase inhibitor with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication. After mixing alpha 1-proteinase inhibitor with a diluent, you must use the medicine within 3 hours. It is best not to mix your alpha 1-proteinase inhibitor dose until you are ready to give the injection. The mixture should look clear or slightly yellow-green and may have a few small particles in it.

Do not shake the medication vial (bottle). Vigorous shaking can ruin the medicine. You may gently swirl the medication while mixing.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Store the Aralast brand of this medication in the refrigerator. Do not freeze. Store Prolastin or Zemaira at cool room temperature (no warmer than 77 degrees F), away from moisture and heat. Aralast may also be stored at room temperature but you must use it within 30 days after removing it from the refrigerator.

Do not use this medication after the expiration date on the medicine label has passed.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose of alpha 1-proteinase inhibitor.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of alpha 1-proteinase inhibitor is not expected to produce life-threatening symptoms.

What should I avoid while taking alpha 1-proteinase inhibitor?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using alpha 1-proteinase inhibitor.

Alpha 1-proteinase inhibitor side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing, difficulty breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• 
  

  chest pain, severe headache, buzzing in your ears, uneven heartbeats;

  
  


• 
  

  fast heart rate;

  
  


• 
  

  problems with vision; or

  
  


• 
  

  fever, chills, runny nose, skin rash, and joint pain.

  
  

Less serious side effects may include:

• 
  

  drowsiness, dizziness, weakness;

  
  


• 
  

  cough, sore throat, stuffy nose;

  
  


• 
  

  pain or bleeding where the medication was injected;

  
  


• 
  

  warmth, redness, or tingly feeling under your skin;

  
  


• 
  

  nausea, diarrhea, stomach pain;

  
  


• 
  

  headache; or

  
  


• 
  

  mild itching.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Alpha 1-proteinase inhibitor Dosing Information

Usual Adult Dose for Alpha-1 Proteinase Inhibitor Deficiency:

60 mg/kg body weight once weekly by intravenous infusion at a rate not exceeding 0.08 mL/kg body weight/minute.

What other drugs will affect alpha 1-proteinase inhibitor?

There may be other drugs that can interact with alpha 1-proteinase inhibitor. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More alpha 1-proteinase inhibitor resources

• Alpha 1-proteinase inhibitor Side Effects (in more detail)
• Alpha 1-proteinase inhibitor Dosage
• Alpha 1-proteinase inhibitor Use in Pregnancy & Breastfeeding
• Alpha 1-proteinase inhibitor Support Group
• 2 Reviews for Alpha-proteinase inhibitor - Add your own review/rating

• Aralast Advanced Consumer (Micromedex) - Includes Dosage Information


• Aralast NP Prescribing Information (FDA)


• Aralast NP MedFacts Consumer Leaflet (Wolters Kluwer)


• Glassia Prescribing Information (FDA)


• Glassia Consumer Overview


• Glassia Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• Prolastin-C Prescribing Information (FDA)


• Zemaira Prescribing Information (FDA)


• Zemaira Consumer Overview

Compare alpha 1-proteinase inhibitor with other medications

• Alpha-1 Proteinase Inhibitor Deficiency

Where can I get more information?

• Your pharmacist can provide more information about alpha 1-proteinase inhibitor.

See also: alpha-proteinase inhibitor side effects (in more detail)

Lupron

Generic Name: leuprolide (Intradermal route, Intramuscular route, Subcutaneous route)

LOO-proe-lide AS-e-tate

Commonly used brand name(s)

In the U.S.

• Eligard


• Lupron


• Lupron Depot


• Lupron Depot-Ped


• Viadur

Available Dosage Forms:

• Powder for Solution


• Powder for Suspension, 3 Month


• Solution


• Powder for Suspension, 1 Month


• Powder for Suspension, 6 Month


• Kit


• Powder for Suspension, 4 Month


• Powder for Suspension

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Leuprolide

Uses For Lupron

Leuprolide is a man-made version of a hormone that is similar to the one normally released from the hypothalamus gland in the brain. It is used to treat a number of medical problems. These include:

• Anemia caused by bleeding of uterine leiomyomas (tumors in the uterus).


• Cancer of the prostate, advanced.


• Central precocious puberty (CPP), a condition that causes early puberty in boys (before 9 years of age) and in girls (before 8 years of age).


• Pain due to endometriosis.

When given regularly to men and boys, leuprolide decreases testosterone levels. Reducing the amount of testosterone in the body is one way of treating cancer of the prostate.

When given regularly to women, leuprolide decreases estrogen levels. Reducing the amount of estrogen in the body is one way of treating endometriosis. By shrinking tumors in the uterus, leuprolide helps stop anemia by decreasing the vaginal bleeding from these tumors. Iron supplements should be used to help treat the anemia.

When given to boys and girls experiencing early puberty, leuprolide slows down the development of the genital areas in both sexes and breast development in girls. This medicine delays puberty in a child only as long as the child continues to receive it.

Suppressing estrogen can cause thinning of the bones or slowing of growth. This is a problem for adult women whose bones are no longer growing like the bones of children. Slowing the growth of bones is a positive effect in girls and boys whose bones grow too fast when puberty begins too early. Boys and girls may benefit by adding inches to their adult height when leuprolide helps their bones grow at the proper and expected rate for children.

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

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, leuprolide is used in certain patients with the following medical condition:

• Cancer of the breast.

Before Using Lupron

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

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of leuprolide pediatric injection in children. However, use is not recommended in children younger than 2 years of age. Leuprolide pediatric injection will stop having an effect on a child treated for central precocious puberty soon after the child stops using it, and puberty will advance normally. It is not known if using leuprolide around the time of puberty causes changes in boys' and girls' future abilities to have babies. Their chances of having children later are thought to be normal. It is especially important that you discuss with the child's doctor the benefit of this medicine as well as the risk of using it.

Appropriate studies have not been performed on the relationship of age to the effects of Eligard®, Lupron® injection, Lupron Depot®, Lupron Depot®-3 month, Lupron Depot®-4 month, Lupron Depot®-6 month, or Viadur® in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Eligard®, Lupron® injection, Lupron Depot®, Lupron Depot®-3 month, Lupron Depot®-4 month, or Lupron Depot®-6 month in the elderly.

No information is available on the relationship of age to the effects of leuprolide pediatric injection and Viadur® in geriatric patients.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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:

• Benzyl alcohol allergy, history of—Using Lupron® injection (certain brand) may cause a skin reaction.

• Brain problems (e.g., brain tumors), history of or


• Pituitary gland problem or


• Seizures or epilepsy, history of or


• Stroke, history of—Use with caution. May make these conditions worse.

• Changes in vaginal bleeding from an unknown cause (for use for endometriosis or anemia due to tumors of the uterus)—Leuprolide may delay diagnosis or worsen condition. The reason for the bleeding should be determined before leuprolide is used.

• Conditions that increase the chances of developing thinning bones or


• Osteoporosis (thinning of the bones), family history of—It is important that your doctor know if you already have an increased risk of osteoporosis. Some things that can increase your risk for having osteoporosis include cigarette smoking, alcohol abuse, and a family history of osteoporosis or easily broken bones. Some medicines, such as corticosteroids (cortisone-like medicines) or anticonvulsants (seizure medicine), can also cause thinning of the bones when used for a long time.

• Congestive heart failure or


• Diabetes or


• Electrolyte imbalance or


• Heart or blood vessel disease or


• Heart rhythm problems (e.g., congenital long QT syndrome) or


• Hyperglycemia (high sugar in the blood)—Use with caution. May make these conditions worse in patients treated for prostate cancer.

• Nerve problems caused by bone lesions in the spine (in treatment of cancer of the prostate) or


• Problems in passing urine (in treatment cancer of the prostate)—Conditions may get worse for a short time after leuprolide treatment is started. Your doctor will want to follow your condition carefully.

Proper Use of leuprolide

This section provides information on the proper use of a number of products that contain leuprolide. It may not be specific to Lupron. Please read with care.

For leuprolide injections (Eligard®, Lupron® injection, Lupron Depot®, Lupron Depot®-Ped 1-month or 3-month, Lupron Depot®-3 month, Lupron Depot®-4 month, or Lupron Depot®-6 month):

• A nurse or other trained health professional may give you this medicine. This medicine is given as a shot under your skin or into a muscle.


• You may be taught how to give this medicine at home. Make sure you understand all of the instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.


• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas.


• Use a new needle and syringe each time you inject your medicine.


• Before each injection, look carefully at the medicine to check for any particles or a change in color. You should not use medicine that has changed color or has particles in it.


• If you have any questions about any of this, check with your doctor.

Each package of leuprolide injection contains patient directions. Read the instructions carefully and make sure you understand:

• How to prepare the injection.


• Proper use of disposable syringes.


• How to give the injection.


• How long the injection is stable.

The long-acting form of this medicine (depot) may be given once every month or once every 3 to 12 months. Your schedule depends on the reason you are using this medicine. To stay on the right schedule with the medicine, make sure you keep all appointments.

If you are to receive the leuprolide implant (Viadur®):

• Viadur® is an implant that is surgically placed under the skin of the upper arm. Your doctor will treat the arm with numbing medicine and then cut a small incision to insert the implant with a special tool. The incision will be closed with surgical strips. An adhesive bandage will be placed over the arm and should be left on for 24 hours.


• After the implant is put in place, you should keep the arm clean and dry, and should not swim or bathe for 24 hours. You should avoid any heavy lifting or strenuous exercise for 48 hours after the implant is put into the arm.


• The surgical strips can be removed after at least 3 days or as soon as the incision is healed.


• The implant will be left in place for one year and then removed. If needed, your doctor will then insert a new implant to continue treatment for another year.


• Viadur® comes with patient instructions. Read these instructions carefully.

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

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 cancer of the prostate:
  
  • The dose varies depending on the specific product used.
  
  


• For central precocious puberty:
  
  • Children 2 years of age and older—Dose is based on body weight and must be determined by your doctor. The starting dose for the once daily product is 50 microgram (mcg) per kilogram (kg) of body weight injected under the skin once a day. The starting dose for the once monthly product is 0.3 milligrams (mg) per kg of body weight or 7.5 mg, 11.25 mg, or 15 mg injected into a muscle every 4 weeks. The 3-month product dose is 11.25 mg or 30 mg injected into a muscle as a single injection every 12 weeks. Your doctor may increase your dose as needed.
  
  
  • Children younger than 2 years of age—Use is not recommended.
  
  


• For anemia caused by tumors of the uterus or endometriosis:
  
  • Adults—The dose given depends on the specific product used. Some examples are 3.75 milligrams (mg) injected into a muscle once a month for up to 3 months or 11.25 mg injected into a muscle as a single injection to last for 3 months. .
  
  

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

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.

The mixed suspension should be discarded if not used right away. Eligard® must be used within 30 minutes after mixing, and Lupron Depot® must be used within 2 hours after mixing.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using Lupron

It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

For female patients: You should not receive this medicine if you are pregnant or may become pregnant. Using this medicine while you are pregnant can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

For patients receiving leuprolide for central precocious puberty (CPP):

• If you are a female patient, you may have occasional bleeding or spotting. If you continue to have heavy bleeding or regular periods after 2 months of using this medicine, call your doctor.


• If you develop a rash or irritation at the injection site, check with your doctor right away.

For patients receiving leuprolide for endometriosis or for anemia caused by tumors of the uterus:

• For the first few days of treatment, the symptoms of your condition may get worse. This is normal. Do not stop taking this medicine. Talk with your doctor if you have concerns about this.


• During the time you are receiving leuprolide, your menstrual period may not be regular or you may not have a menstrual period at all. This is to be expected when being treated with this medicine. If regular menstruation does not begin within 60 to 90 days after you stop receiving this medicine, check with your doctor.


• During the time you are receiving leuprolide, you should use birth control methods that do not contain hormones. If you have any questions about this, check with your doctor.


• If you suspect you may have become pregnant, stop using this medicine and check with your doctor. There is a chance that continued use of leuprolide during pregnancy could cause birth defects or a miscarriage.

When you first start using this medicine for prostate cancer treatment, some of your symptoms might get worse for a short time. You might also have new symptoms. You might have bone pain, back pain, a tingling or numbness in the body, blood in the urine, or trouble urinating. These symptoms should improve within a few weeks. Tell your doctor if you have any new symptoms or your symptoms get worse.

Patients receiving leuprolide for advanced prostate cancer:

• This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.


• This medicine may increase your risk of having a heart attack or stroke. Check with your doctor right away if you are having chest pain or discomfort; pain or discomfort in the arms, jaw, back, or neck; confusion; shortness of breath; nausea or vomiting, or sweating.


• This medicine can cause changes in heart rhythms, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

This medicine can cause decreases in bone mineral density, which may lead to osteoporosis or weakened bones. Talk with your doctor about how this risk will affect you.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.

Do not stop using or changing the dose of Lupron® injection without checking first with your doctor.

Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.

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.

Lupron 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:

For adultsLess common

• Fast or irregular heartbeat

Rare

• Bone, muscle, or joint pain


• fainting


• fast or irregular breathing


• numbness or tingling of the hands or feet


• puffiness or swelling of the eyelids or around the eyes


• shortness of breath


• skin rash, hives, or itching


• sudden, severe decrease in blood pressure and collapse


• tightness in the chest or wheezing


• troubled breathing

For males only (adults)More common

• Arm, back, or jaw pain


• bloody or cloudy urine


• blurred vision


• burning while urinating


• chest pain or discomfort


• chest tightness or heaviness


• difficult or labored breathing


• difficult, burning, or painful urination


• difficulty with moving


• dizziness


• frequent urge to urinate


• headache


• increased urge to urinate during the night


• muscle pain or stiffness


• nausea


• nervousness


• pain in the joints


• pale skin


• pounding in the ears


• slow or fast heartbeat


• sweating


• troubled breathing with exertion


• unusual bleeding or bruising


• unusual tiredness or weakness


• waking to urinate at night

Rare

• Pain in the groin or legs (especially in the calves of the legs)

Incidence not known

• Altered mental status


• cardiovascular collapse


• double vision


• visual changes


• vomiting

For females only (adults)Rare

• Anxiety


• deepening of voice


• increased hair growth


• mental depression


• mood changes

For childrenRare

• Body pain


• burning, itching, redness, or swelling at the injection site


• skin rash

For females only (children)—expected in first few weeksRare

• Vaginal bleeding (continuing)


• white vaginal discharge (continuing)

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:

For adultsMore common

• Sudden sweating and feelings of warmth (also called hot flashes)

Less common

• Bleeding, bruising, burning, itching, pain, redness, or swelling at the injection site


• decreased interest in sexual intercourse


• swelling of the feet or lower legs


• swelling or increased tenderness of the breasts


• trouble with sleeping


• weight gain

For females only (adults)More common

• Light, irregular vaginal bleeding


• stopping of menstrual periods

Less common

• Burning, dryness, or itching of the vagina


• pelvic pain

For males only (adults)More common

• Back pain


• chills


• constipation


• cough


• diarrhea


• fever


• general feeling of discomfort or illness


• loss of appetite


• pain or discomfort at the injection site


• redness of the face, neck, arms, and occasionally, upper chest


• runny nose


• shivering


• sleeplessness


• sore throat


• sudden sweating


• trouble sleeping


• unable to sleep


• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Less common

• Bone pain


• decreased size of the testicles


• inability to have or keep an erection

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: Lupron 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 Lupron resources

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

• Lupron Consumer Overview


• Lupron MedFacts Consumer Leaflet (Wolters Kluwer)


• Leuprolide Prescribing Information (FDA)


• Eligard Consumer Overview


• Eligard Prescribing Information (FDA)


• Eligard Kit MedFacts Consumer Leaflet (Wolters Kluwer)


• Leuprolide Acetate Monograph (AHFS DI)


• Lupron Depot MedFacts Consumer Leaflet (Wolters Kluwer)


• Lupron Depot Prescribing Information (FDA)


• Lupron Depot-PED Prescribing Information (FDA)


• Lupron Depot-PED Kit MedFacts Consumer Leaflet (Wolters Kluwer)


• Viadur Prescribing Information (FDA)


• Viadur Implant MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Lupron with other medications

• Breast Cancer, Adjuvant
• Endometriosis
• Hirsutism
• Prostate Cancer
• Uterine Fibroids

Hypurin Bovine Neutral Cartridges

1. Name Of The Medicinal Product

Hypurin® Bovine Neutral

2. Qualitative And Quantitative Composition

Crystalline Insulin Ph Eur (Bovine) 100IU/ml.

Neutral Insulin Injection Ph Eur (Bovine)

For excipients, see 6.1

3. Pharmaceutical Form

Solution for injection

A clear, colourless solution

4. Clinical Particulars

4.1 Therapeutic Indications

The treatment of insulin dependent diabetes mellitus.

May be used for diabetics who require an insulin of prompt onset and short duration. It is a suitable preparation for admixture with longer acting insulins. It is particularly useful where intermittent, short term or emergency therapy is required, during initial stabilisation and in the treatment of labile diabetes.

4.2 Posology And Method Of Administration

To be determined by the physician according to the needs of the patient.

Usually administered subcutaneously but where necessary it may be given intramuscularly or intravenously. After subcutaneous injection onset of action occurs within 30-60 minutes with an overall duration of 6-8 hours. Maximum effect is exerted over the mid-range.

4.3 Contraindications

Hypoglycaemia.

Hypersensitivity to insulin or to any of the excipients.

4.4 Special Warnings And Precautions For Use

Hypoglycaemia: Susceptibility to hypoglycaemia may be increased by an inaccurate or excessive dosage of insulin, the omission of a meal by the patient or increased physical activity. Correct insulin administration and awareness of the symptoms of hypoglycaemia are essential to reduce the risk of hypoglycaemia (see section 4.9).

Blood or urinary glucose concentrations should be monitored and the urine tested for ketones by patients on insulin therapy.

Newly diagnosed diabetic patients may experience fluctuating insulin requirements during the first weeks, months or even years of treatment (the so-called 'honeymoon period').

Patients transferred to Hypurin® Bovine insulins from other commercially available preparations may require dosage adjustments.

The warning symptoms of hypoglycaemia may be changed, be less pronounced or absent in certain risk groups who should be advised accordingly. These include patients:

- in whom glycaemic control is greatly improved, e.g. by intensified insulin therapy

- with a long history of diabetes

- who are elderly

- receiving concomitant treatment with certain medicinal products e.g. beta blockers or clonidine.

Elderly diabetic patients are more susceptible to episodes of severe, rapid onset hypoglycaemia.

Combination of Hypurin® insulins with pioglitazone: Cases of cardiac failure have been reported when thiazolidinediones are used in combination with insulin, especially in patients with risk factors for development of cardiac heart failure. This should be kept in mind if treatment with the combination of pioglitazone and Hypurin® is considered. If the combination is used, patients should be observed for signs and symptoms of heart failure, weight gain and oedema. Pioglitazone should be discontinued if any deterioration in cardiac symptoms occurs.

Insulin requirements may increase during illness (this includes infection and accidental and surgical trauma), puberty or emotional upset.

Insulin resistance is frequently associated with lipid disorders, hypertension and ischaemic heart disease. Patients with insulin resistance usually require more than 200 units of insulin daily. Insulin resistance of the type manifested by greatly increased insulin requirements may be due to factors including antibody formation although some diseases, such as infections, endocrine hyperfunctional states (e.g. acromegaly, Cushing's syndrome, thyrotoxicosis) or stress can contribute to insulin resistance.

Insulin requirements may decrease with liver disease, disease of the adrenal, pituitary or thyroid glands and coeliac disease. In patients with severe renal impairment, insulin requirements may fall and dosage reduction may be necessary. The compensatory response to hypoglycaemia may also be impaired.

Insulin requirements may be increased in the premenstrual period but may be reduced during or after a menstrual cycle.

Insulin requirements are usually reduced but occasionally increased during periods of increased activity.

Increase in subcutaneous blood flow, brought about by factors such as a hot bath, may increase the rate of absorption of insulin.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Drugs that may increase the requirement for insulin

Antipyschotics: chloropromazine

Corticosteroids

Diazoxide

Diuretics: thiazide diuretics or loop diuretics

Sympathomimetic agents

Thyroid hormone replacement therapy

Smoking may also antagonise the hypoglycaemic effect of insulin

Drugs that may decrease the requirement for insulin

ACE inhibitors

Alcohol: moderate or large amounts of alcohol (more than 2 units per day for women and more than 3 units per day for men) can decrease the requirements for insulin and may lead to hypoglycaemic attacks. Episodic heavy drinking ('binge' drinking) carries a particularly high risk of hypoglycaemic episodes.

Anabolic steroids

Analgesics: NSAIDS, or salicylates, particularly large doses of aspirin

Androgens: testosterone may enhance the hypoglycaemic effect of insulin

Anti-arrhythmics: disopyramide.

Concomitant use of insulin with quinidine may increase the risk of hypoglycaemia occurring.

Anti-depressants: monoamine oxidase inhibitors or fluoxetine.

Concomitant use of amitriptyline with insulin may lead to hypoglycaemia.

Antihypertensives: guanethidine

Antimalarials: concomitant use of insulin with antimalarials such as chloroquine or quinine may increase the risk of hypoglycaemia occurring.

Fenfluramine

Hormone antagonists: octreotide

Lipid-regulating drugs: fibrates

Mebendazole

Pentoxifylline: the hypoglycaemic activity of insulin may be potentiated by concomitant administration of high-dose pentoxifylline injection.

Tetracyclines: tetracyclines such as oxytetracycline

Drugs that may increase or decrease the requirements for insulin

Antihypertensives: clonidine. Signs and symptoms of hypoglycaemia may be masked by clonidine.

Beta blockers: beta blockers. Some of the warning signs of insulin-induced hypoglycaemia may be masked.

Calcium channel blockers: nifedipine may occasionally impair glucose tolerance.

Cyclophosphamide

Isoniazid

Lipid-regulating drugs: gemfibrozil

Oral contraceptives

4.6 Pregnancy And Lactation

Pregnancy

A decreased requirement for insulin may be observed in the early stages of pregnancy. However, in the second and third trimesters, insulin requirements may increase. Insulin requirements should therefore be assessed frequently by an experienced diabetic physician.

Maternal insulin requirements may decrease after delivery. As this decrease can be at an unpredictable rate, the maternal blood glucose should be closely monitored.

Congenital abnormality is more common in offspring of diabetic than non-diabetic women.

Lactation

Caution should be exercised when prescribing to lactating women. Lactating women may require adjustments in insulin dose and diet.

4.7 Effects On Ability To Drive And Use Machines

The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia. This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or operating machinery).

Patients should be advised to take precautions to avoid hypoglycaemia whilst driving, this is particularly important in those who have reduced or absent awareness of the warning signs of hypoglycaemia or have frequent episodes of hypoglycaemia. The advisability of driving should be considered in these circumstances.

4.8 Undesirable Effects

Metabolic disorders:

• Hypoglycaemia is the most common adverse effect associated with insulin therapy. For symptoms of hypoglycaemia, refer to section 4.9, Overdosage.

• Hypokalaemia may occur with insulin therapy.

• Insulin therapy may lead to weight gain.

General disorders and administration site conditions:

Lipodystrophy (atrophy or hypertrophy of the fat tissue) may occur at the injection site. Stinging or sensations of warmth or burning at the site of injection may also occur.

Immune system disorders:

Insulin hypersensitivity can occur with animal insulins, but appears less likely with purified insulins and there is minimal evidence that such effects occur with Hypurin insulins. Allergic reactions to phenol and m-cresol contained as preservative and to zinc and protamine may occur.

• Local hypersensitivity: Local allergic reactions to insulin such as pruritus, erythema and oedema may occur at the injection site.

• Generalised hypersensitivity: Generalised hypersensitivity may produce urticaria, nausea, dyspnoea or wheezing and, in rare cases, anaphylactic reactions.Severe, angioedema is a rare adverse effect of insulin treatment occurring most often at the initiation of therapy.

4.9 Overdose

a) Symptoms

Overdosage causes hypoglycaemia. Symptoms include yawning, hunger, pallor, restlessness, weakness, sweating, trembling, confusion, anxiety, nervousness, excitement, irritability, aggression, altered behaviour, deep respiration, cramps, headache, paraesthesia and/or numbness of the nose, mouth, fingers or toes, reduced consciousness, visual disturbance, including blurred vision and double vision, slurred speech, difficulty in finding words, difficulty in concentration, drowsiness, fatigue, convulsions, hemiplegia, paralysis, tachycardia and/or palpitations, myocardial ischaemia and cerebral oedema which, if untreated, will lead to collapse, coma and/or irreversible brain damage.

Hypokalaemia may also occur with insulin overdose.

b) Treatment

Mild hypoglycaemia will respond to oral administration of glucose or sugar and rest.

Moderately severe hypoglycaemia can be treated by intramuscular or subcutaneous injection of glucagon followed by oral carbohydrate when the patient is sufficiently recovered.

For patients who are comatose or who have failed to respond to glucagon injection an intravenous injection of strong Dextrose Injection BP should be given.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

ATC Code – A10A A

Insulin output from the pancreas of a healthy person is about 50 units per day, which is sufficient to maintain the fasting blood sugar concentration in the range 0.8 + 0.2mg/ml. In diabetes mellitus, the blood sugar rises in an uncontrolled manner. Parenterally administered insulin causes a fall in blood sugar concentration and increased storage of glycogen in the liver. In the diabetic it raises the respiratory quotient after a carbohydrate meal and prevents the formation of ketone bodies. The rise in blood sugar concentration caused by adrenaline and corticosteroids, glucagon and posterior pituitary extract is reversed by insulin.

5.2 Pharmacokinetic Properties

Insulin is rapidly absorbed from subcutaneous tissue or muscle following injection.

Insulin is metabolised mainly in the liver and a small amount is excreted in the urine.

The plasma half life is 4 to 5 minutes. The half life after subcutaneous injection is about 4 hours and after intramuscular injection about 2 hours.

5.3 Preclinical Safety Data

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections.

6. Pharmaceutical Particulars

6.1 List Of Excipients

m-Cresol

Phenol

Sodium phosphate

Glycerol

Water for injections

6.2 Incompatibilities

Neutral Insulin must not be mixed with solutions containing aminophylline.

6.3 Shelf Life

36 months.

Following injection of the first dose the product should be used within 28 days. Discard any unused material after this time.

6.4 Special Precautions For Storage

Store at 2^oC - 8^oC.

Do not freeze.

Cartridges in use must not be stored in a refrigerator.

Chemical and physical in-use stability has been demonstrated for 28 days at 25°C.

From a microbiological point of view the opening carries a risk of microbial contamination and aseptic handling is a necessity.

In use storage times and conditions are the responsibility of the user.

6.5 Nature And Contents Of Container

1.5ml neutral glass cartridge sealed with a bromobutyl rubber bung and metal closure in packs of five.

3ml neutral glass cartridge sealed with a bromobutyl rubber bung and metal closure in packs of five.

6.6 Special Precautions For Disposal And Other Handling

The cartridge must not be used if the contents have been frozen or it contains lumps that do not disperse on mixing.

7. Marketing Authorisation Holder

Wockhardt UK Ltd

Ash Road North

Wrexham

LL13 9UF

U.K.

8. Marketing Authorisation Number(S)

PL 29831/0127

9. Date Of First Authorisation/Renewal Of The Authorisation

8^th April 2008

10. Date Of Revision Of The Text

23 June 2011

Ak-Chlor

Generic Name: chloramphenicol (Ophthalmic route)

klor-am-FEN-i-kol

Commonly used brand name(s)

In the U.S.

• Ocu-Chlor

In Canada

• Ak-Chlor


• Chloromycetin


• Chloroptic


• Fenicol


• Isopto Fenicol


• Minims Chloramphenicol 0.5%


• Ophtho-Chloram


• Pentamycetin Ophthalmic Solution 0.25%


• Pentamycetin Ophthalmic Solution 0.5%


• Pms-Chloramphenicol


• Sopamycetin

Available Dosage Forms:

• Solution


• Ointment


• Powder for Solution

Therapeutic Class: Antibiotic

Chemical Class: Chloramphenicol (class)

Uses For Ak-Chlor

Chloramphenicol belongs to the family of medicines called antibiotics. Chloramphenicol ophthalmic preparations are used to treat infections of the eye. This medicine may be given alone or with other medicines that are taken by mouth for eye infections.

Chloramphenicol is available only with your doctor's prescription.

Before Using Ak-Chlor

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

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of this medicine in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of this medicine in the elderly with use in other age groups.

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 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.

• Citalopram


• Voriconazole

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.

• Ceftazidime


• Chlorpropamide


• Cyclosporine


• Dicumarol


• Fosphenytoin


• Phenytoin


• Rifampin


• Rifapentine


• Tacrolimus


• Tetanus Toxoid


• Tolbutamide

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of chloramphenicol

This section provides information on the proper use of a number of products that contain chloramphenicol. It may not be specific to Ak-Chlor. Please read with care.

For patients using the eye drop form of chloramphenicol:

• Although the bottle may not be full, it contains exactly the amount of medicine your doctor ordered.


• To use:
  
  • First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 1 or 2 minutes to allow the medicine to come into contact with the infection.
  
  
  • If you think you did not get the drop of medicine into your eye properly, use another drop.
  
  
  • To keep the medicine as germ-free as possible, do not touch the applicator tip or dropper to any surface (including the eye). Also, keep the container tightly closed.
  
  

To use the eye ointment form of chloramphenicol:

• First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Squeeze a thin strip of ointment into this space. A 1-cm (approximately 1/3-inch) strip of ointment is usually enough, unless you have been told by your doctor to use a different amount. Let go of the eyelid and gently close the eyes. Keep the eyes closed for 1 or 2 minutes to allow the medicine to come into contact with the infection.


• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). After using chloramphenicol eye ointment, wipe the tip of the ointment tube with a clean tissue and keep the tube tightly closed.

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if your symptoms begin to clear up after a few days. If you stop using this medicine too soon, your symptoms may return. Do not miss any doses.

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 eye infection:
  
  • For ophthalmic ointment dosage form:
    
    • Adults and children—Use every three hours.
    
    
  
  
  • For ophthalmic solution (eye drops) dosage form:
    
    • Adults and children—One drop every one to four hours.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply 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.

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 Ak-Chlor

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

Ak-Chlor 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:

Rare - may also occur weeks or months after you stop using this medicine

• Pale skin


• sore throat and fever


• unusual bleeding or bruising


• unusual tiredness or weakness

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

Less common

• Itching, redness, skin rash, swelling, or other sign of irritation not present before use of this medicine

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:

Less common

• Burning or stinging

After application, eye ointments may be expected to cause your vision to blur for a few minutes.

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.

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More Ak-Chlor resources

• Ak-Chlor Drug Interactions
• Ak-Chlor Support Group
• 0 Reviews for Ak-Chlor - Add your own review/rating

• chloramphenicol ophthalmic Concise Consumer Information (Cerner Multum)

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