Vinate GT

Generic Name: prenatal multivitamins (PRE nay tal VYE ta mins)

Brand Names: Advance Care Plus, Bright Beginnings, Cavan Folate, Cavan One, Cavan-Heme OB, Cenogen Ultra, CitraNatal Rx, Co Natal FA, Complete Natal DHA, Complete-RF, CompleteNate, Concept OB, Docosavit, Dualvit OB, Duet, Edge OB, Elite OB 400, Femecal OB, Folbecal, Folcaps Care One, Folivan-OB, Foltabs, Gesticare, Icar Prenatal, Icare Prenatal Rx, Inatal Advance, Infanate DHA, Kolnatal DHA, Lactocal-F, Marnatal-F, Maternity, Maxinate, Mission Prenatal, Multi-Nate 30, Multinatal Plus, Nata 29 Prenatal, Natachew, Natafort, Natelle, Neevo, Nestabs, Nexa Select with DHA, Novanatal, NovaStart, O-Cal Prenatal, OB Complete, OB Natal One, Ob-20, Obtrex DHA, OptiNate, Paire OB Plus DHA, PNV Select, PNV-Total, PR Natal 400, Pre-H-Cal, Precare, PreferaOB, Premesis Rx, PrenaCare, PrenaFirst, PrenaPlus, Prenatabs OBN, Prenatabs Rx, Prenatal 1 Plus 1, Prenatal Elite, Prenatal Multivitamins, Prenatal Plus, Prenatal S, Prenatal-U, Prenate Advanced Formula, Prenate DHA, Prenate Elite, Prenavite FC, PreNexa, PreQue 10, Previte Rx, PrimaCare, Pruet DHA, RE OB Plus DHA, Renate, RightStep, Rovin-NV, Se-Care, Se-Natal One, Se-Plete DHA, Se-Tan DHA, Select-OB, Seton ET, Strongstart, Stuart Prenatal with Beta Carotene, Tandem OB, Taron-BC, Tri Rx, TriAdvance, TriCare, Trimesis Rx, Trinate, Triveen-PRx RNF, UltimateCare Advance, Ultra-Natal, Vemavite PRX 2, VeNatal FA, Verotin-BY, Verotin-GR, Vinacal OR, Vinatal Forte, Vinate Advanced (New Formula), Vinate AZ, Vinate Care, Vinate Good Start, Vinate II (New Formula), Vinate III, Vinate One, Vitafol-OB, VitaNatal OB plus DHA, Vitaphil, Vitaphil Aide, Vitaphil Plus DHA, Vitaspire, Viva DHA, Vol-Nate, Vol-Plus, Vol-Tab Rx, Vynatal F.A., Zatean-CH, Zatean-PN

What are Vinate GT (prenatal multivitamins)?

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

Prenatal vitamins are a combination of many different vitamins that are normally found in foods and other natural sources.

Prenatal vitamins are used to provide the additional vitamins needed during pregnancy. Minerals may also be contained in prenatal multivitamins.

Prenatal vitamins may also be used for purposes not listed in this medication guide.

What is the most important information I should know about prenatal vitamins?

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

Never take more than the recommended dose of a multivitamin. Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the multivitamin.

What should I discuss with my healthcare provider before taking prenatal vitamins?

Many vitamins can cause serious or life-threatening side effects if taken in large doses. Do not take more of this medication than directed on the label or prescribed by your doctor.

Before taking prenatal vitamins, tell your doctor about all of your medical conditions.

You may need to continue taking prenatal vitamins if you breast-feed your baby. Ask your doctor about taking this medication while breast-feeding.

How should I take prenatal vitamins?

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.

Never take more than the recommended dose of prenatal vitamins.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Take your prenatal vitamin with a full glass of water.

Swallow the regular tablet or capsule whole. Do not break, chew, crush, or open it.

The chewable tablet must be chewed or allowed to dissolve in your mouth before swallowing. You may also allow the chewable tablet to dissolve in drinking water, fruit juice, or infant formula (but not milk or other dairy products). Drink this mixture right away.

Use prenatal vitamins regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat. Keep prenatal vitamins in their original container. Storing vitamins in a glass container can ruin the medication.

What happens if I miss a dose?

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 if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

What should I avoid while taking prenatal vitamins?

Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Avoid the regular use of salt substitutes in your diet if your multivitamin contains potassium. If you are on a low-salt diet, ask your doctor before taking a vitamin or mineral supplement.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the prenatal vitamin.

Prenatal vitamins 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.

When taken as directed, prenatal vitamins are not expected to cause serious side effects. Less serious side effects may include:

• 
  

  upset stomach;

  
  


• 
  

  headache; or

  
  


• 
  

  unusual or unpleasant taste in your mouth.

  
  

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 prenatal vitamins?

Vitamin and mineral supplements can interact with certain medications, or affect how medications work in your body. Before taking a prenatal vitamin, tell your doctor if you also use:

• 
  

  diuretics (water pills);

  
  


• 
  

  heart or blood pressure medications;

  
  


• 
  

  tretinoin (Vesanoid);

  
  


• 
  

  isotretinoin (Accutane, Amnesteen, Clavaris, Sotret);

  
  


• 
  

  trimethoprim and sulfamethoxazole (Cotrim, Bactrim, Gantanol, Gantrisin, Septra, TMP/SMX); or

  
  


• 
  

  an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Cataflam, Voltaren), indomethacin (Indocin), meloxicam (Mobic), and others.

  
  

This list is not complete and other drugs may interact with prenatal vitamins. 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 Vinate GT resources

• Vinate GT Use in Pregnancy & Breastfeeding
• Vinate GT Drug Interactions
• Vinate GT Support Group
• 0 Reviews for Vinate GT - Add your own review/rating

• Cal-Nate MedFacts Consumer Leaflet (Wolters Kluwer)


• CareNatal DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• CitraNatal 90 DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• CitraNatal Assure Prescribing Information (FDA)


• CitraNatal Harmony Prescribing Information (FDA)


• Concept DHA Prescribing Information (FDA)


• Docosavit Prescribing Information (FDA)


• Duet DHA with Ferrazone MedFacts Consumer Leaflet (Wolters Kluwer)


• Folbecal MedFacts Consumer Leaflet (Wolters Kluwer)


• Folcal DHA Prescribing Information (FDA)


• Folcaps Care One Prescribing Information (FDA)


• Gesticare DHA Prescribing Information (FDA)


• Gesticare DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• Inatal Advance Prescribing Information (FDA)


• Inatal Ultra Prescribing Information (FDA)


• Multi-Nate DHA Prescribing Information (FDA)


• Multi-Nate DHA Extra Prescribing Information (FDA)


• MultiNatal Plus MedFacts Consumer Leaflet (Wolters Kluwer)


• Natelle One Prescribing Information (FDA)


• Neevo Caplets MedFacts Consumer Leaflet (Wolters Kluwer)


• Neevo DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• OB Complete 400 MedFacts Consumer Leaflet (Wolters Kluwer)


• Paire OB Plus DHA Prescribing Information (FDA)


• PreNexa MedFacts Consumer Leaflet (Wolters Kluwer)


• PreNexa Prescribing Information (FDA)


• PreferaOB Prescribing Information (FDA)


• Prenatal Plus Prescribing Information (FDA)


• Prenatal Plus Iron Prescribing Information (FDA)


• Prenate Elite Prescribing Information (FDA)


• Prenate Elite MedFacts Consumer Leaflet (Wolters Kluwer)


• Prenate Elite tablets


• Prenate Essential Prescribing Information (FDA)


• PrimaCare Advantage MedFacts Consumer Leaflet (Wolters Kluwer)


• PrimaCare ONE capsules


• PrimaCare One MedFacts Consumer Leaflet (Wolters Kluwer)


• Renate DHA Prescribing Information (FDA)


• Se-Natal 19 Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Se-Natal 19 Prescribing Information (FDA)


• Tandem DHA Prescribing Information (FDA)


• Tandem OB Prescribing Information (FDA)


• TriAdvance Prescribing Information (FDA)


• Triveen-One MedFacts Consumer Leaflet (Wolters Kluwer)


• Triveen-PRx RNF Prescribing Information (FDA)


• UltimateCare ONE NF Prescribing Information (FDA)


• Ultra NatalCare MedFacts Consumer Leaflet (Wolters Kluwer)


• Vinate AZ Prescribing Information (FDA)


• Vitafol-One MedFacts Consumer Leaflet (Wolters Kluwer)


• Zatean-CH Prescribing Information (FDA)

Compare Vinate GT with other medications

• Vitamin/Mineral Supplementation during Pregnancy/Lactation

Where can I get more information?

• Your pharmacist can provide more information about prenatal vitamins.

Perfect Coat Studio Shampoo

Dosage Form: FOR ANIMAL USE ONLY

Concentrated Shampoo...A Little Cleans A Lot

Perfect Coat Studio premium concentrate shampoo's with extraordinarily rich cleansing and conditioning properties, remove dirt, and other build up without stripping your pets skin and coat of it's natural oils.

Antibacterial Formula Specially formulated to help deodorize dog's coat.

Tea Tree Oil Deeply conditions and protects your pet's skin and coat.

Crisp apple Scent eaves coat fresh and sweet smelling.

Directions for Use

Wet pet completely. Apply a small amount of shampoo starting at the head and neck and work back to the tail and legs. Add a little more water and massage to form a rich lather. Rinse completely. Follow with Perfect Coat Studio Creme Rinse for an extra soft and healthy skin and coat!

Active Ingredients

Triclosan

Ingredients

Water, Sodium Laureth Sulfate, Sodium Chloride, Disodium Oleamido MEA Sulfosuccinate, Cocamide DEA, Disodium Cocamphodiacetate, Cocamidoprpyl Betaine, Glycerin, Fragrance, Citric Acid, Propylene Glycol, Tea Tree Oil, Diazolidinyl Urea, Methylparaben, propylparaben, D C Green 8, FD C Blue 1, FD C Yellow 5.

Perfect Coat

Studio

Concentrated

Shampoo

Deodorizes

with

Tee Tree Oil

Antibacterial

Crisp Apple Scent

NET WT. 8 FL. OZ. US (236ml)

PERFECT COAT STUDIO  concentrated shampoo antibacterial  shampoo

Product Information Product Type OTC ANIMAL DRUG NDC Product Code (Source) 24730-672 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICLOSAN (TRICLOSAN) TRICLOSAN 0.354 g  in 236 g

Inactive Ingredients Ingredient Name Strength Water   SODIUM LAURYL SULFATE   SODIUM CHLORIDE   COCAMIDOPROPYL BETAINE   GLYCERIN   CITRIC ACID   PROPYLENE GLYCOL   TEA TREE OIL   DIAZOLIDINYL UREA   METHYLPARABEN   PROPYLPARABEN   D&C GREEN NO. 8   FD&C BLUE NO. 1   FD&C YELLOW NO. 5

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 24730-672-12 236 g In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/01/2001

Labeler - United Pet Group (931135730)

Establishment
Name	Address	ID/FEI	Operations
JUNGLE LABORATORIES CORPORATION		032615270	manufacture

Revised: 04/2010United Pet Group

Interbi

Interbi may be available in the countries listed below.

Ingredient matches for Interbi

Terbinafine

Terbinafine hydrochloride (a derivative of Terbinafine) is reported as an ingredient of Interbi in the following countries:

• Indonesia

International Drug Name Search

irbesartan

Generic Name: irbesartan (ir be SAR tan)

Brand Names: Avapro

What is irbesartan?

Irbesartan is in a group of drugs called angiotensin II receptor antagonists. Irbesartan keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow.

Irbesartan is used to treat high blood pressure (hypertension). It is sometimes given together with other blood pressure medications.

Irbesartan is also used to treat kidney problems caused by type 2 diabetes.

Irbesartan may also be used for purposes not listed in this medication guide.

What is the most important information I should know about irbesartan?

Do not use irbesartan if you are pregnant. Stop using this medication and tell your doctor right away if you become pregnant. You should not use this medication if you are allergic to irbesartan.

Before you take irbesartan, tell your doctor if you have kidney or liver disease, congestive heart failure, or if you are dehydrated.

Drinking alcohol can further lower your blood pressure and may increase certain side effects of irbesartan. Do not use potassium supplements or salt substitutes while you are taking irbesartan, unless your doctor has told you to.

Your blood pressure will need to be checked often. Visit your doctor regularly.

If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms.

In rare cases, irbesartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

What should I discuss with my healthcare provider before taking irbesartan?

You should not use this medication if you are allergic to irbesartan.

To make sure you can safely take irbesartan, tell your doctor if you have any of these other conditions:

• kidney disease;


• liver disease;


• 
  

  congestive heart failure; or

  
  


• 
  

  if you are dehydrated.

  
  

FDA pregnancy category D. Do not use irbesartan if you are pregnant. Stop using this medication and tell your doctor right away if you become pregnant. Irbesartan can cause injury or death to the unborn baby if you take the medicine during your second or third trimester. Use effective birth control while taking irbesartan. It is not known whether irbesartan passes into breast milk or if it could harm a nursing baby. You should not breast-feed while taking irbesartan.

How should I take irbesartan?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Irbesartan may be taken with or without food.

Your blood pressure will need to be checked often. Visit your doctor regularly.

If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Store at room temperature away from moisture and heat.

See also: Irbesartan dosage (in more detail)

What happens if I miss a dose?

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 fast or slow heartbeat, feeling light-headed, or fainting.

What should I avoid while taking irbesartan?

Drinking alcohol can further lower your blood pressure and may increase certain side effects of irbesartan. Do not use potassium supplements or salt substitutes while you are taking irbesartan, unless your doctor has told you to. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Irbesartan 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. In rare cases, irbesartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine. Call your doctor at once if you have a serious side effect such as:

• 
  

  feeling like you might pass out;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting; or

  
  


• 
  

  swelling, weight gain, feeling short of breath.

  
  

Less serious side effects may include:

• 
  

  diarrhea;

  
  


• 
  

  heartburn, upset stomach;

  
  


• 
  

  mild dizziness; or

  
  


• 
  

  tired feeling.

  
  

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.

Irbesartan Dosing Information

Usual Adult Dose for Diabetic Nephropathy:

Initial dose: 150 mg orally once a day with or without food.
Maintenance dose: 150 to 300 mg orally once a day.

Usual Adult Dose for Hypertension:

Initial dose: 150 mg orally once a day with or without food.
Maintenance dose: 150 to 300 mg orally once a day.

Usual Pediatric Dose for Hypertension:

6 to 12 years:
Initial dose: 75 mg once daily.
Maintenance dose: 75 mg to 150 mg once daily.

13 to 18 years:
Initial dose: 150 mg once daily.
Maintenance dose: 150 mg to 300 mg once daily.

What other drugs will affect irbesartan?

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

• 
  

  a diuretic (water pill); or

  
  


• 
  

  a non-steroidal anti-inflammatory drug (NSAID) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others.

  
  

This list is not complete and other drugs may interact with irbesartan. 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 irbesartan resources

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

• irbesartan Advanced Consumer (Micromedex) - Includes Dosage Information


• Irbesartan Professional Patient Advice (Wolters Kluwer)


• Irbesartan MedFacts Consumer Leaflet (Wolters Kluwer)


• Irbesartan Monograph (AHFS DI)


• Avapro Prescribing Information (FDA)


• Avapro Consumer Overview

Compare irbesartan with other medications

• Diabetic Kidney Disease
• High Blood Pressure

Where can I get more information?

• Your pharmacist can provide more information about irbesartan.

See also: irbesartan side effects (in more detail)

Hydrocortisone and Pramoxine Cream

Dosage Form: rectal kit
Hydrocortisone Acetate 2.5% Pramoxine HCl 1% Cream Kit

DESCRIPTION:

Topical corticosteroids are anti-inflammatory and anti-pruritic agents. The chemical name, molecular formula and molecular weight for active ingredients are presented below.

Hydrocortisone acetate

Pregn-4-ene-3,20-dione,21-(acetyloxy)-11, 17-dihydroxy-, (11-beta)-

Molecular Formula: C23H32O6

Molecular weight: 404.50

Pramoxine hydrochloride

4-(3-(p-n-butoxyphenoxy)propyl)morpholine hydrochloride

Formula: C17H28ClNO3

Molecular weight: 329.86

INGREDIENTS:

Hydrocortisone Acetate 2.5% Pramoxine HCl 1% Cream

Contains hydrocortisone acetate 25mg w/w and pramoxine hydrochloride 10mg w/w


ACTIVE INGREDIENTS:

HYDROCORTISONE ACETATE 2.5%

PRAMOXINE HCl 1%


INACTIVE INGREDIENTS: CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, CETEARETH-20,

CETEARYL ALCOHOL, DIMETHICONE, GLYCERIN, PHENOXYETHANOL, PENTYLENE GLYCOL, PURIFIED WATER, STEARIC ACID, STEARYL ALCOHOL, TETRASODIUM EDTA.

CLINICAL PHARMACOLOGY:

Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions.


The mechanism of anti-inflammatory activity of topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.


Pramoxine hydrochloride is a topical anesthetic agent which provides temporary relief from itching and pain. It acts by stabilizing the neuronal membrane of nerve endings with which it comes into contact.

PHARMACOKINETICS:

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.


Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses. (See DOSAGE and ADMINISTRATION.)


Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

INDICATIONS AND USAGE:

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

CONTRAINDICATIONS:

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

WARNINGS AND PRECAUTIONS:

General: Systemic absorption of topical corticosteroids has produced reversible hypothalamicpituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.


Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area and under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation test. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.


Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. (See Precautions-Pediatric Use.)


If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.


In the presence of dermatological infections, the use of an appropriate antifungal or anti-bacterial agent should be instituted. If a favorable response does not occur promptly the corticosteroid should be discontinued until the infection has been adequately controlled.


Information for the Patient: Patients using topical corticosteroids should receive the following information and instructions:

1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.

2. Patients should be advised not to use this medication for any disorder other than for which it was prescribed.

3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.

4. Patients should report any signs of local adverse reactions especially under occlusive dressings.

5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.


Laboratory Tests: The following tests may be helpful in evaluating the HPA axis suppression: Urinary free cortisol test, ACTH stimulation test

NONCLINICAL TOXICOLOGY:

Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids. Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

USE IN PREGNANCY:

Teratogenic Effects: Pregnancy Category C: Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

NURSING MOTHERS:

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable amounts in breast milk.


Systemically administered corticosteroids are secreted into breast milk in quantities NOT likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Pediatric Use: Pediatric patients may demonstrate greater susceptibility to topical corticosteroid induced HPA axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio.


Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome, and intra-cranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.


Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

ADVERSE REACTIONS:

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence:


Burning

Hypertrichosis

Maceration of the skin

Itching

Acneiform eruptions

Secondary infection

Irritation

Hypopigmentation

Skin atrophy

Dryness

Perioral dermatitis

Striae

Folliculitis

Allergic contact dermatitis

Miliaria


To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE:

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (See PRECAUTIONS.)

DOSAGE AND ADMINISTRATION:

Topical corticosteroids are generally applied to the affected area as a thin film three to four times daily depending on the severity of the condition. Occlusive dressing may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

HOW SUPPLIED:

Hydrocortisone Acetate 2.5% Pramoxine HCl 1% Cream is a topical cream and is supplied in the following:


1 oz. Tube KIT (NDC 68032-470-91)

Each KIT Contains: 1- 1oz. (30 g) tube (NDC 68032-470-01), 1 Applicator, and 6 Pramoxine HCl 1% Premoistened Anorectal Wipes (NDC 68032-471-06)


4 gram Tube KIT (NDC 68032-472-91)

Each KIT Contains: 30 Single-Use 4 g tubes (NDC 68032-472-04), 30 Single-Use Applicators, and 18 Pramoxine HCl 1% Premoistened Anorectal Wipes (NDC 68032-471-06)


KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN


Store at 25ºC (77ºF); excursions permitted to 15º - 30ºC (59º - 86ºF) [see USP Controlled Room Temperature].


See back of carton for complete directions for use.


Rx Only


Manufactured for:

River’s Edge Pharmaceuticals, LLC

Suwanee, GA 30024

Rev. 1/10

472-10

PACKAGING:

HYDROCORTISONE ACETATE PRAMOXINE HCL  hydrocortisone acetate, pramoxine hydrochloride  kit

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68032-470

Packaging # NDC Package Description Multilevel Packaging 1 68032-470-91 1 KIT In 1 CARTON None

QUANTITY OF PARTS Part # Package Quantity Total Product Quantity Part 1 1 TUBE, WITH APPLICATOR   30 g Part 2 1 PACKET   1 mL

Part 1 of 2 HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE  hydrocortisone acetate, pramoxine hydrochloride  cream

Product Information       Route of Administration RECTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE ACETATE (HYDROCORTISONE) HYDROCORTISONE ACETATE 25 mg  in 1 g PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 10 mg  in 1 g

Inactive Ingredients Ingredient Name Strength SAFFLOWER OIL   CETOSTEARYL ALCOHOL   DIMETHICONE   GLYCERIN   PHENOXYETHANOL   WATER   STEARIC ACID   STEARYL ALCOHOL   EDETATE SODIUM

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 30 g In 1 TUBE, WITH APPLICATOR None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/01/2010 01/13/2011

Part 2 of 2 PRAMOXINE HYDROCHLORIDE  pramoxine hydrochloride  cloth

Product Information NDC Product Code (Source) 68032-471     Route of Administration RECTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 10 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE   GLYCERIN   PHENOXYETHANOL   POTASSIUM SORBATE   WATER   SODIUM CITRATE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 6 PACKET In 1 CARTON contains a PACKET (68032-471-06) 1 68032-471-06 1 mL In 1 PACKET This package is contained within the CARTON

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 03/01/2010 01/13/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/01/2010	01/13/2011

Labeler - River's Edge Pharmaceuticals, LLC (133879135)

Revised: 05/2011River's Edge Pharmaceuticals, LLC

More Hydrocortisone and Pramoxine Cream resources

• Hydrocortisone and Pramoxine Cream Side Effects (in more detail)
• Hydrocortisone and Pramoxine Cream Use in Pregnancy & Breastfeeding
• Hydrocortisone and Pramoxine Cream Drug Interactions
• Hydrocortisone and Pramoxine Cream Support Group
• 16 Reviews for Hydrocortisone and Pramoxine - Add your own review/rating

Compare Hydrocortisone and Pramoxine Cream with other medications

• Dermatitis
• Dermatological Disorders
• Hemorrhoids
• Psoriasis

Epinephrine (Adrenaline) Injection 1:1000 Minijet (International Medication Systems)

1. Name Of The Medicinal Product

Adrenaline (Epinephrine) Injection 1:1,000 Minijet.

2. Qualitative And Quantitative Composition

Adrenaline (Epinephrine) 1mg per ml.

3. Pharmaceutical Form

Sterile aqueous solution for intramuscular or subcutaneous administration.

4. Clinical Particulars

4.1 Therapeutic Indications

Emergency treatment of anaphylaxis or acute angioneurotic oedema with airways obstruction, or acute allergic reactions.

4.2 Posology And Method Of Administration

For the relief of life-threatening angioneurotic oedema and anaphylactic shock, adrenaline should be administered by intramuscular injection .

For acute allergic reactions due to insect stings etc.: Intramuscular or subcutaneous injection.

The presentation with the 0.25″ integral needle is intended for self-administration by the subcutaneous route and the presentation with the 1.5″ integral needle is for paramedic use by subcutaneous or intramuscular injection.

Adults and children over 12 years: 0.5 ml (0.5 mg), administered slowly. The dose may be repeated every 5 to 15 minutes as needed.

This presentation may not be suitable for small or prepubertal patients over 12 years of age who require a smaller dose.

Elderly: as for adults, use with caution.

Children (up to age of 12): not recommended

4.3 Contraindications

Contraindications are relative as this product is intended for use in life-threatening emergencies.

Other than in the emergency situation, the following contraindications should be considered: hyperthyroidism, hypertension, ischaemic heart disease, diabetes mellitus, and closed angle glaucoma.

4.4 Special Warnings And Precautions For Use

These special warnings and precautions are relative as this product is intended for use in life-threatening situations.

Administer slowly with caution to elderly patients and to patients with ischaemic heart disease, hypertension, diabetes mellitus, hyperthyroidism or psychoneurosis. Use with extreme caution in patients with long-standing bronchial asthma and emphysema who have developed degenerative heart disease. Anginal pain may be induced when coronary insufficiency is present.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The effects of adrenaline may be potentiated by tricyclic antidepressants. Volatile liquid anaesthetics such as halothane increase the risk of adrenaline-induced ventricular arrhythmias and acute pulmonary oedema if hypoxia is present. Severe hypertension and bradycardia may occur with non-selective beta-blocking drugs such as propranolol. Propranolol also inhibits the bronchodilator effect of adrenaline. The risk of cardiac arrhythmias is higher when adrenaline is given to patients receiving digoxin, quinidine, fluorohydrocarbons or cocaine. Adrenaline -induced hyperglycaemia may lead to loss of blood-sugar control in diabetic patients treated with hypoglycaemic agents.

The vasoconstrictor and pressor effects of adrenaline, mediated by its alpha-adrenergic action, may be enhanced by concomitant administration of drugs with similar effects, such as ergot alkaloids or oxytocin. Adrenaline specifically reverses the antihypertensive effects of adrenergic neurone blockers such as guanethidine with the risk of severe hypertension.

4.6 Pregnancy And Lactation

Adrenaline crosses the placenta. There is some evidence of a slightly increased incidence of congenital abnormalities. Injection of adrenaline may cause foetal tachycardia, cardiac irregularities, extrasystoles and louder heart sounds. In labour, adrenaline may delay the second stage. Adrenaline should only be used in pregnancy if the potential benefits outweigh the risks to the foetus.

Adrenaline is excreted in breast milk, but as pharmacologically active plasma concentrations are not achieved by the oral route, the use of adrenaline in breast-feeding mothers is presumed to be safe.

4.7 Effects On Ability To Drive And Use Machines

Not applicable; this preparation is intended for use only in emergencies.

4.8 Undesirable Effects

The potentially severe adverse effects of adrenaline arise from its effect upon blood pressure and cardiac rhythm. Ventricular fibrillation may occur and severe hypertension may lead to cerebral haemorrhage and pulmonary oedema. Symptomatic adverse effects are anxiety, dyspnoea, restlessness, palpitations, tachycardia, anginal pain, tremor, weakness, dizziness, headache, cold extremities, nausea, vomiting, sweating, local ischaemic necrosis. Biochemical effects include inhibition of insulin secretion and hyperglycaemia even with low doses, gluconeogenesis, glycolysis, lipolysis and ketogenesis.

4.9 Overdose

Symptoms: cardiac arrhythmias leading to ventricular fibrillation and death, severe hypertension leading to pulmonary oedema and cerebral haemorrhage.

Treatment: combined alpha- and beta-adrenergic blocking agents such as labetalol may counteract the effects of adrenaline, or a beta-blocking agent may be used to treat any supraventricular arrhythmias and phentolamine to control the alpha-mediated effects on the peripheral circulation. Rapidly acting vasodilators such as nitrates and sodium nitroprusside may also be helpful.

Immediate resuscitation support must be available.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Adrenaline is a direct-acting sympathomimetic agent exerting its effect on alpha- and beta-adrenoceptors. Major effects are increased systolic blood pressure, reduced diastolic pressure, tachycardia, hyperglycaemia and hypokalaemia. It is a powerful cardiac stimulant. It has vasopressor properties and is a bronchodilator.

5.2 Pharmacokinetic Properties

Adrenaline is rapid in onset and of short duration and is rapidly distributed to the heart, spleen, several glandular tissues and adrenergic nerves. It crosses the placenta and is excreted in breast milk. It is approximately 50% bound to plasma proteins. The onset of action is rapid and after i.v. infusion the half-life is approximately 5-10 minutes.

Adrenaline is rapidly metabolised in the liver and tissues by oxidative deamination and O-methylation followed by reduction or by conjugation with glucuronic acid or sulphate. Up to 90% of the i.v. dose is excreted in the urine as metabolites.

5.3 Preclinical Safety Data

Not applicable since Adrenaline (Epinephrine) Injection has been used in clinical practice for many years and its effects in man are well known.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Citric Acid Monohydrate USP

Sodium Citrate Dihydrate USP

Sodium Chloride USP

Sodium Bisulphite USP

Hydrochloric Acid 10% w/v USP

Water for Injection USP

6.2 Incompatibilities

Adrenaline should not be mixed with sodium bicarbonate; the solution is oxidised to adrenochrome and then forms polymers.

6.3 Shelf Life

9 months.

6.4 Special Precautions For Storage

Store below 25°C. Protect from light.

6.5 Nature And Contents Of Container

The solution is contained in a USP type I glass vial with an elastomeric closure which meets all the relevant USP specifications. Two presentations are available; one for patient self-administration with a 0.25″ integral needle and one for paramedic use with a 1.5″ integral needle. Both are 1ml presentations.

6.6 Special Precautions For Disposal And Other Handling

The container is specially designed for use with the IMS Minijet injector.

7. Marketing Authorisation Holder

International Medication Systems (UK) Limited

208 Bath Road

Slough

Berkshire

SL1 3WE

UK

8. Marketing Authorisation Number(S)

PL 03265/0030

9. Date Of First Authorisation/Renewal Of The Authorisation

Date first granted: 8 February 1978

Date renewed: 31 August 2000

10. Date Of Revision Of The Text

14 October 2005

POM

Norditropin

Generic Name: somatropin (soe ma TROE pin)

Brand Names: Genotropin, Genotropin Miniquick, Humatrope, Norditropin, Norditropin Cartridge, Norditropin FlexPro Pen, Norditropin Nordiflex Pen, Nutropin, Nutropin AQ, Omnitrope, Saizen, Serostim, Tev-tropin, Zorbtive

What is Norditropin (somatropin)?

Somatropin is a form of human growth hormone. Human growth hormone is important in the body for the growth of bones and muscles.

Somatropin is used to treat growth failure in children and adults who lack natural growth hormone, and in those with chronic kidney failure, Noonan syndrome, Turner syndrome, Prader-Willi syndrome, short stature at birth with no catch-up growth, and other causes. Somatropin is also used to prevent severe weight loss in people with AIDS, or to treat short bowel syndrome.

Somatropin may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Norditropin (somatropin)?

Before you receive somatropin, tell your doctor about all your past and present medical conditions, especially allergies, trauma, surgery, diabetes, cancer, breathing problems, liver or kidney disease, scoliosis, high blood pressure, pancreas disorder, underactive thyroid, or a brain tumor.

Also tell your doctor about all other medications you use, especially steroids or diabetes medications. Your dosages of these medicines may need to be changed when you start using somatropin. Do not stop using a steroid suddenly or change any of your medication doses without your doctor's advice.

If you have Prader-Willi syndrome and are using somatropin, call your doctor promptly if you develop signs of lung or breathing problems such as shortness of breath, coughing, or new or increased snoring.

Call your doctor at once if you have sudden and severe pain in your upper stomach with nausea and vomiting, fast heartbeat, increased thirst or urination, weight loss, or vision changes and sudden, severe pain behind your eyes.

What should I discuss with my healthcare provider before using Norditropin (somatropin)?

Before you receive somatropin, tell your doctor if you have ever had an allergic reaction to a growth hormone medicine, or to drug preservatives such as benzyl alcohol, metacresol or glycerin. You should not use this medication if you are allergic to somatropin, or if you have:

• 
  

  diabetic retinopathy (a serious eye condition caused by diabetes);

  
  


• 
  

  cancer; or

  
  


• 
  

  Prader-Willi syndrome and are also overweight or have sleep apnea or severe respiratory (lung) problems.

  
  

You should also not use somatropin if you have a serious medical condition after having:

• 
  

  open heart surgery or stomach surgery;

  
  


• 
  

  trauma or other medical emergency; or

  
  


• 
  

  breathing problems (such as lung failure).

  
  

To make sure you can safely take somatropin, tell your doctor if you have any of these other conditions:

• 
  

  liver disease;

  
  


• 
  

  kidney disease (or if you are on dialysis);

  
  


• 
  

  diabetes;

  
  


• 
  

  a pituitary gland disorder;

  
  


• 
  

  scoliosis;

  
  


• 
  

  high blood pressure (hypertension);

  
  


• 
  

  a pancreas disorder (especially in children);

  
  


• 
  

  a history of cancer;

  
  


• 
  

  carpal tunnel syndrome;

  
  


• 
  

  underactive thyroid; or

  
  


• 
  

  a brain tumor or lesion.

  
  

FDA pregnancy category B. Some brands of somatropin are not expected to harm an unborn baby, including Genotropin, Omnitrope, Saizen, Serostim, and Zorbtive. FDA pregnancy category C. It is not known whether certain other brands of somatropin will harm an unborn baby, including Humatrope, Norditropin, Nutropin, and Tev-tropin. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether somatropin passes into breast milk or if it could harm a nursing baby. Do not use somatropin without telling your doctor if you are breast-feeding a baby.

How should I use Norditropin (somatropin)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your dose and brand of somatropin, and how often you give it will depend on what you are being treated for. Follow the directions on your prescription label.

Somatropin is injected into a muscle or under the skin. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Use a different place on your body each time you give the injection. Your care provider will show you the best places on your body to inject the medication. Do not inject into the same place two times in a row. Do not inject this medicine into skin or muscle that is red, sore, infected, or injured.

Do not shake the medication bottle or you may ruin the medicine. When mixing somatropin with a diluent (liquid), use a gentle swirling motion. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

Use a disposable needle only once. 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.

To be sure this medication is helping your condition and not causing harm, your blood and growth progress will need to be tested often. Your eyes may also need to be checked. Visit your doctor regularly.

If you are being treated for short bowel syndrome, follow the diet plan created for you by your doctor or nutrition counselor to help control your condition. Somatropin is not a cure for short bowel syndrome.

If you use a form of somatropin that comes in a cartridge for use with an injection pen, use only the pen injection system provided with the somatropin brand you use.

How you store this medicine will depend on what brand you are using and what diluent you are mixing somatropin with. After mixing somatropin, you may need to use it right away or you may be able to store it for later use. Read and carefully follow the instructions provided with your medicine about proper storage of somatropin before and after it has been mixed. Ask your pharmacist if you have any questions about proper storage of your medication.

Throw away any somatropin left over after the expiration date on the label has passed.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Call your doctor if you miss more than 3 doses in a row.

What happens if I overdose?

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

Overdose can cause tremors or shaking, cold sweats, increased hunger, headache, drowsiness, weakness, dizziness, fast heartbeat, and nausea. Long-term overdose may cause excessive growth.

What should I avoid while using Norditropin (somatropin)?

If you use Zorbtive to treat short bowel syndrome, avoid drinking fruit juices or soda beverages. Follow the instructions of your doctor or nutrition counselor about what types of liquids you should drink while using Zorbtive.

Avoid drinking alcohol if you have short bowel syndrome. Alcohol can irritate your stomach and could make your condition worse.

Norditropin (somatropin) side effects

If you have Prader-Willi syndrome, call your doctor promptly if you develop signs of lung or breathing problems such as shortness of breath, coughing, or new or increased snoring. Rare cases of serious breathing problems have occurred in patients with Prader-Willi syndrome who use somatropin.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• 
  

  severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;

  
  


• 
  

  increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss;

  
  


• 
  

  sudden and severe pain behind your eyes, vision changes;

  
  


• 
  

  swelling in your head, face, hands, or feet; or

  
  


• 
  

  numbness or tingling in your wrist, hand, or fingers.

  
  

Less serious side effects may include:

• 
  

  headache, feeling tired;

  
  


• 
  

  redness, soreness, swelling, rash, itching, pain, or bruising where the medicine was injected;

  
  


• 
  

  pain in your arms or legs, joint stiffness or pain;

  
  


• 
  

  muscle pain; or

  
  


• 
  

  cold symptoms such as stuffy nose, sneezing, sore throat.

  
  

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 Norditropin (somatropin)?

Before using somatropin, tell your doctor if you use insulin or take oral (by mouth) medicine to treat diabetes. Somatropin may affect blood sugar levels and you may need to adjust your dose of the diabetes medication. Do not change the dose of your diabetes medication without your doctor's advice.

Tell your doctor if you use any type of steroid medicine such as cortisone, dexamethasone, methylprednisolone, prednisone, and others. Steroids can make somatropin less effective and your doses may need to be adjusted. Do not stop using a steroid suddenly. Follow your doctor's instructions.

Tell your doctor about all other medications you use, especially cyclosporine (Gengraf, Neoral, Sandimmune), seizure medication, birth control pills, anabolic steroids, or hormone replacement medications for men or women.

This list is not complete and other drugs may interact with somatropin. 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 Norditropin resources

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

• Norditropin Prescribing Information (FDA)


• Norditropin MedFacts Consumer Leaflet (Wolters Kluwer)


• Norditropin Advanced Consumer (Micromedex) - Includes Dosage Information


• Somatropin Professional Patient Advice (Wolters Kluwer)


• Genotropin MedFacts Consumer Leaflet (Wolters Kluwer)


• Genotropin Prescribing Information (FDA)


• Humatrope Prescribing Information (FDA)


• Humatrope Cartridge MedFacts Consumer Leaflet (Wolters Kluwer)


• Nutropin Prescribing Information (FDA)


• Nutropin Subcutaneous, Injection Advanced Consumer (Micromedex) - Includes Dosage Information


• Nutropin MedFacts Consumer Leaflet (Wolters Kluwer)


• Nutropin AQ Prescribing Information (FDA)


• Nutropin AQ MedFacts Consumer Leaflet (Wolters Kluwer)


• Nutropin Depot Prescribing Information (FDA)


• Omnitrope Consumer Overview


• Omnitrope MedFacts Consumer Leaflet (Wolters Kluwer)


• Omnitrope Prescribing Information (FDA)


• Saizen MedFacts Consumer Leaflet (Wolters Kluwer)


• Saizen Prescribing Information (FDA)


• Serostim Prescribing Information (FDA)


• Serostim MedFacts Consumer Leaflet (Wolters Kluwer)


• Tev-Tropin Prescribing Information (FDA)


• Tev-Tropin MedFacts Consumer Leaflet (Wolters Kluwer)


• Zorbtive Prescribing Information (FDA)


• Zorbtive Consumer Overview


• Zorbtive MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Norditropin with other medications

• Adult Human Growth Hormone Deficiency
• Hypopituitarism
• Noonan's Syndrome
• Pediatric Growth Hormone Deficiency
• Short Stature for Age
• Turner's Syndrome

Where can I get more information?

• Your pharmacist can provide more information about somatropin.

See also: Norditropin side effects (in more detail)