Oralten Troche

Oralten Troche may be available in the countries listed below.

Ingredient matches for Oralten Troche

Clotrimazole

Clotrimazole is reported as an ingredient of Oralten Troche in the following countries:

• Israel

International Drug Name Search

Tenoxicam Etyc

Tenoxicam Etyc may be available in the countries listed below.

Ingredient matches for Tenoxicam Etyc

Tenoxicam

Tenoxicam is reported as an ingredient of Tenoxicam Etyc in the following countries:

• Colombia

International Drug Name Search

Colivet

Colivet may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Colivet

Colistin Sulfate

Colistin sulfate (a derivative of Colistin) is reported as an ingredient of Colivet in the following countries:

• France


• Germany


• Luxembourg


• Poland

Neomycin

Neomycin sulfate (a derivative of Neomycin) is reported as an ingredient of Colivet in the following countries:

• Norway

International Drug Name Search

CatabonHi

CatabonHi may be available in the countries listed below.

Ingredient matches for CatabonHi

Dopamine

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

• Japan

International Drug Name Search

Phenylephrine Minims

Phenylephrine Minims may be available in the countries listed below.

Ingredient matches for Phenylephrine Minims

Phenylephrine

Phenylephrine is reported as an ingredient of Phenylephrine Minims in the following countries:

• Belgium

International Drug Name Search

Flurbiprofen Sodium Ophthalmic Solution

Ingredient matches for Flurbiprofen Sodium Ophthalmic Solution

Flurbiprofen

Flurbiprofen sodium salt (a derivative of Flurbiprofen) is reported as an ingredient of Flurbiprofen Sodium Ophthalmic Solution in the following countries:

• United States

International Drug Name Search

Ritin

Ritin may be available in the countries listed below.

Ingredient matches for Ritin

Loratadine

Loratadine is reported as an ingredient of Ritin in the following countries:

• Turkey

International Drug Name Search

Piperital

Piperital may be available in the countries listed below.

Ingredient matches for Piperital

Piperacillin

Piperacillin sodium salt (a derivative of Piperacillin) is reported as an ingredient of Piperital in the following countries:

• Italy

International Drug Name Search

Doxycycline CF

Doxycycline CF may be available in the countries listed below.

Ingredient matches for Doxycycline CF

Doxycycline

Doxycycline monohydrate (a derivative of Doxycycline) is reported as an ingredient of Doxycycline CF in the following countries:

• Netherlands

International Drug Name Search

Nalidixic Acid Malpharm

Nalidixic Acid Malpharm may be available in the countries listed below.

Ingredient matches for Nalidixic Acid Malpharm

Nalidixic Acid

Nalidixic Acid is reported as an ingredient of Nalidixic Acid Malpharm in the following countries:

• Hong Kong


• Singapore

International Drug Name Search

Kontagripp Sandoz

Kontagripp Sandoz may be available in the countries listed below.

Ingredient matches for Kontagripp Sandoz

Ibuprofen

Ibuprofen is reported as an ingredient of Kontagripp Sandoz in the following countries:

• Germany

International Drug Name Search

Mova nitrat pipette

Mova nitrat pipette may be available in the countries listed below.

Ingredient matches for Mova nitrat pipette

Silver Nitrate

Silver Nitrate is reported as an ingredient of Mova nitrat pipette in the following countries:

• Poland

International Drug Name Search

Desoximetasone Cream

Pronunciation: dess-OX-ee-MET-ah-sone
Generic Name: Desoximetasone
Brand Name: Examples include Topicort and Topicort LP

Desoximetasone Cream is used for:

Relieving inflammation and itching of the skin.

Desoximetasone Cream is a topical adrenocortical steroid. The precise way it works is unclear, but it is thought to reduce skin inflammation (redness, swelling, itching, and irritation) by stopping the production of certain chemicals in the body.

Do NOT use Desoximetasone Cream if:

• you are allergic to any ingredient in Desoximetasone Cream

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

Before using Desoximetasone Cream:

Some medical conditions may interact with Desoximetasone Cream. 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 a skin infection, measles, thinning of the skin, tuberculosis (TB), chicken pox, shingles, a positive TB skin test, or have recently had a vaccination

Some MEDICINES MAY INTERACT with Desoximetasone Cream. Because little, if any, of Desoximetasone Cream is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Desoximetasone Cream 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 Desoximetasone Cream:

Use Desoximetasone Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Apply a small amount of medicine to the affected area(s). Gently rub the medicine in until it is evenly distributed. Wash your hands after applying the medicine, unless your hands are part of the treated area.


• Do not cover the treated area(s) with bandages or other dressings unless advised to do so by your health care provider.


• If you miss a dose of Desoximetasone Cream, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use Desoximetasone Cream.

Important safety information:

• Desoximetasone Cream is for external use only. Avoid contact with eyes and other mucous membranes (nostrils, mouth). If Desoximetasone Cream gets in your eyes, flush them with cool tap water immediately.


• Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.


• Do not use Desoximetasone Cream for other skin conditions at a later time.


• If Desoximetasone Cream was prescribed to treat the diaper area of a child, avoid using tight-fitting diapers or plastic pants.


• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Desoximetasone Cream.


• Desoximetasone Cream should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Desoximetasone Cream while you are pregnant. It is not known if Desoximetasone Cream is found in breast milk. If you are or will be breast-feeding while you use Desoximetasone Cream, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Desoximetasone Cream:

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:

Mild, temporary stinging when first applied.

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); itching, burning, redness, or swelling not present before using Desoximetasone Cream.

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: Desoximetasone 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. Desoximetasone Cream may be harmful if swallowed.

Proper storage of Desoximetasone Cream:

Store Desoximetasone Cream at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Desoximetasone Cream out of the reach of children and away from pets.

General information:

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


• Desoximetasone Cream 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 Desoximetasone Cream. 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 Desoximetasone resources

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

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• Atopic Dermatitis
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Itisona

Itisona may be available in the countries listed below.

Ingredient matches for Itisona

Betamethasone

Betamethasone 17α-valerate (a derivative of Betamethasone) is reported as an ingredient of Itisona in the following countries:

• Venezuela

International Drug Name Search

Flukloxacillin Meda

Flukloxacillin Meda may be available in the countries listed below.

Ingredient matches for Flukloxacillin Meda

Flucloxacillin

Flucloxacillin sodium salt (a derivative of Flucloxacillin) is reported as an ingredient of Flukloxacillin Meda in the following countries:

• Sweden

International Drug Name Search

Hexalgin

Hexalgin may be available in the countries listed below.

Ingredient matches for Hexalgin

Metamizole

Metamizole sodium anhydrous (a derivative of Metamizole) is reported as an ingredient of Hexalgin in the following countries:

• Bulgaria

International Drug Name Search

Texa

Texa may be available in the countries listed below.

Ingredient matches for Texa

Cetirizine

Cetirizine dihydrochloride (a derivative of Cetirizine) is reported as an ingredient of Texa in the following countries:

• South Africa

International Drug Name Search

PMS-Dexamethasone

PMS-Dexamethasone may be available in the countries listed below.

Ingredient matches for PMS-Dexamethasone

Dexamethasone

Dexamethasone is reported as an ingredient of PMS-Dexamethasone in the following countries:

• Canada

Dexamethasone 21-(disodium phosphate) (a derivative of Dexamethasone) is reported as an ingredient of PMS-Dexamethasone in the following countries:

• Canada

International Drug Name Search

Desquam-X Wash

benzoyl peroxide

Dosage Form: topical solution
WATER BASE

Desquam-X 5 Wash

(5% benzoyl peroxide)

WATER BASE

Desquam-X 10 Wash

(10% benzoyl peroxide)

Rx only

Desquam-X Wash Description

DESQUAM-X5 (5% benzoyl peroxide) and DESQUAM-X10 (10% benzoyl peroxide) brand topical therapeutic anti-acne cleansers contains benzoyl peroxide (5% and 10% respectively) in a lathering water base of sodium octoxynol- 3 sulfonate, dioctyl sodium sulfo-succinate, magnesium aluminum silicate, methylcellulose and EDTA.

Molecular structure

Desquam-X Wash - Clinical Pharmacology

The effectiveness of benzoyl peroxide in the treatment of acne vulgaris is primarily attributable to its antibacterial activity, especially with respect to Propionibacterium acnes, the predominant organism in sebaceous follicles and comedones.1,2 The antibacterial activity of this compound is presumably due to the release of active or free-radical oxygen capable of oxidizing bacterial proteins.3 In acne patients treated topically with benzoyl peroxide, resolution of the acne usually coincides with reduction in the levels of P. acnes and free fatty acids (FFA). Mild desquamation is another observed action of topically applied benzoyl peroxide and may also play a role in the drug’s effectiveness in acne.3 Studies also indicate that topical benzoyl peroxide may exert a se-bostatic effect with a resultant reduction of skin surface lipids.4,5

Benzoyl peroxide has been shown to be absorbed by the skin, where it is metabolized to benzoic acid and then excreted as benzoate in the urine.6

Indications and Usage for Desquam-X Wash

DESQUAM-X 5 and DESQUAM-X 10 Wash are indicated for the topical treatment of mild to moderate acne. In more severe cases, it may be used as an adjunct in therapeutic regimens including benzoyl peroxide gels, antibiotics, retinoic acid products and sulfur/salicylic acid-containing preparations. The improvement of the treated condition is dependent on the degree and type of acne, the frequency of use of Desquam-X Wash and the nature of other therapies employed.

Contraindications

This product should not be used in patients known to be sensitive to benzoyl peroxide or any other of the listed ingredients.

Precautions

General:

Avoid contact with eyes and other mucous membranes. For external use only. In patients known to be sensitive to the following substances, there is a possibility of cross-sensitization: benzoic acid derivatives (including certain topical anesthetics) and cinnamon.

Information for Patients:

This product may bleach colored fabric or hair. Concurent use with PABA-containing sunscreens may result in transient discoloration of the skin.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Based upon considerable evidence, benzoyl peroxide is not considered to be a carcinogen. However, in one study, using mice known to be highly susceptible to cancer, there was evidence for benzoyl peroxide as a tumor promoter. Benzoyl peroxide has been found to be inactive as a mutagen in the Ames Salmonella and other assays, including the mouse dominant lethal assay. This assay is frequently used to assess the effect of substances on spermatogenesis.

Pregnancy (Category C):

Animal reproduction studies have not been conducted with benzoyl peroxide (Desquam-X Wash). It is also not known whether benzoyl peroxide can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Benzoyl peroxide should be given to a pregnant woman only if clearly needed.

Nursing Mothers:

It is not known whether this drug is excreted in human milk. Caution should be exercised when benzoyl peroxide is administered to a nursing woman.

Pediatric Use:

Safety and effectiveness in children below the age of 12 have not been established.

Adverse Reactions

Adverse reactions which may be encountered with topical benzoyl peroxide include excessive drying (manifested by marked peeling, erythema and possible edema), and allergic contact sensitization.

Excessive dryness would appear to occur in approximately 2 patients in 50.

Pertinent literature would seem to indicate that allergic sensitization to benzoyl peroxide may occur in 10 to 25 patients in 1,000.7,8,9 There is one reference that reports an occurrence of sensitization in 5 of 100 patients.10

Overdosage

In the event that excessive scaling, erythema or edema occur, the use of this preparation should be discontinued. If the reaction is judged to be due to excessive use and not allergenicity, after symptoms and signs subside, a reduced dosage schedule may be cautiously tried.

To hasten resolution of the adverse effects, emollients, cool compresses and/or topical corticosteroid preparations may be used.

Desquam-X Wash Dosage and Administration

Shake well before use. Wash affected areas once or twice daily, avoiding contact with eyes or mucous membranes. Wet skin areas to be treated prior to administration; apply Desquam-X Wash, work to a full lather, rinse thoroughly and pat dry. The amount of drying or peeling may be controlled by modification of dose frequency or drug concentration.

How is Desquam-X Wash Supplied

Desquam-X Wash (5%): 5 oz. plastic bottle, NDC 10631-284-05.

Desquam-X Wash (10%): 5 oz. plastic bottle, NDC 10631-285-05.

Store at controlled room temperature (59°-86°F; 15°-30°C).

REFERENCES

1. Kligman AM, Leyden JJ, Stewart R: New uses for benzoyl peroxide: A broad-spectrum antimicrobial agent. Int J Derm 16:413-417, 1977.


2. Leyden JJ, Stewart R, Kligman AM: Updated invivo methods for evaluating topical antimicrobial agents on human skin. J Invest Dermatol 72:165-170, 1979.


3. Fulton JE, Farzad-Bakshandeh A, Bradley S: Studies on the mechanism of action of topical benzoyl peroxide and vitamin-A acid in acne vulgaris. J Cut Path 1:191-200, 1974.


4. Fanta D, Jurecka W: Autora-diographic investigation on benzoyl peroxide treated skin. ActaDermatovener 58:361-362, 1978.


5. Fanta D, Muller MM: Effect of benzoyl peroxide on skin surface lipids. Dermatologica 158:55-59, 1979.


6. Nacht S, Yeung D, Beasley J, Anjo M, Maibach HI: Benzoyl peroxide invitro and invivo skin penetration and metabolic disposition. Presented to Soc for Invest Derm, June 9-14, 1979. Amsterdam.


7. Eaglstein WH: Allergic contact dermatitis to benzoyl peroxide. Arch Dermatol 97:527, 1968.


8. Pace WE: A benzoyl peroxide-sulfur cream for acne vulgaris. Canad Med Assoc J 93:252-253, 1965.


9. Vasarinsh P: Benzoyl peroxide-sulfur lotions in acne vulgaris — a controlled study. Cutis 5(1):65-69, 1969.


10. Fanta D: Clinical and experimental studies with benzoyl peroxide in the treatment of acne. Hautzart 29:481- 486, 1978.

RANBAXY

Jacksonville, FL 32257 USA

Revised June 2008

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

Desquam-X Wash (5%)

140 gram bottle (front)

140 gram bottle (back)

Desquam-X Wash (10%)

140 gram bottle (front)

140 gram bottle (back)

DESQUAM-X  WASH benzoyl peroxide  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 10631-284 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 5 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength EDETIC ACID   MAGNESIUM ACETATE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 10631-284-05 148 mL In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/27/2008

DESQUAM-X  WASH benzoyl peroxide  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 10631-285 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 10 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength EDETIC ACID   MAGNESIUM ACETATE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 10631-285-05 148 mL In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/02/2008

Labeler - Ranbaxy Laboratories Inc. (169932519)

Registrant - Ranbaxy Laboratories Inc. (169932519)

Establishment
Name	Address	ID/FEI	Operations
Contract Pharmaceuticals Limited		248761249	manufacture

Revised: 11/2009Ranbaxy Laboratories Inc.

More Desquam-X Wash resources

• Desquam-X Wash Side Effects (in more detail)
• Desquam-X Wash Use in Pregnancy & Breastfeeding
• Desquam-X Wash Drug Interactions
• Desquam-X Wash Support Group
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Atenololo DOC

Atenololo DOC may be available in the countries listed below.

Ingredient matches for Atenololo DOC

Atenolol

Atenolol is reported as an ingredient of Atenololo DOC in the following countries:

• Italy

International Drug Name Search

Proxigen

Proxigen may be available in the countries listed below.

Ingredient matches for Proxigen

Piroxicam

Piroxicam is reported as an ingredient of Proxigen in the following countries:

• Colombia

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Aminalonum

Aminalonum may be available in the countries listed below.

Ingredient matches for Aminalonum

Aminobutyric Acid, þ-

Aminobutyric Acid, þ- is reported as an ingredient of Aminalonum in the following countries:

• Latvia

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Caluniatin

Caluniatin may be available in the countries listed below.

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Kallidinogenase

Kallidinogenase is reported as an ingredient of Caluniatin in the following countries:

• Japan

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Soluciones Parenterales

Soluciones Parenterales may be available in the countries listed below.

Ingredient matches for Soluciones Parenterales

Potassium Chloride

Potassium Chloride is reported as an ingredient of Soluciones Parenterales in the following countries:

• Argentina

Sodium Bicarbonate

Sodium Bicarbonate is reported as an ingredient of Soluciones Parenterales in the following countries:

• Argentina

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Clozapine-Hexal

Clozapine-Hexal may be available in the countries listed below.

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Clozapine

Clozapine is reported as an ingredient of Clozapine-Hexal in the following countries:

• Poland


• South Africa

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Enalapril Perugen

Enalapril Perugen may be available in the countries listed below.

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Enalapril

Enalapril is reported as an ingredient of Enalapril Perugen in the following countries:

• Peru

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Paracetamol Alpharma ApS

Paracetamol Alpharma ApS may be available in the countries listed below.

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Paracetamol

Paracetamol is reported as an ingredient of Paracetamol Alpharma ApS in the following countries:

• Singapore

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Lansoprazol Lareq

Lansoprazol Lareq may be available in the countries listed below.

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Lansoprazole

Lansoprazole is reported as an ingredient of Lansoprazol Lareq in the following countries:

• Spain

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Apo-Meloxicam

Apo-Meloxicam may be available in the countries listed below.

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Meloxicam

Meloxicam is reported as an ingredient of Apo-Meloxicam in the following countries:

• Canada

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Biperin

Biperin may be available in the countries listed below.

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Biperiden

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

• Taiwan

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Omeprazolo ratiopharm

Omeprazolo ratiopharm may be available in the countries listed below.

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Omeprazole

Omeprazole is reported as an ingredient of Omeprazolo ratiopharm in the following countries:

• Italy

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Tinidazol Ecar

Tinidazol Ecar may be available in the countries listed below.

Ingredient matches for Tinidazol Ecar

Tinidazole

Tinidazole is reported as an ingredient of Tinidazol Ecar in the following countries:

• Colombia

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Heparin Na

Heparin Na may be available in the countries listed below.

Ingredient matches for Heparin Na

Heparin

Heparin sodium salt (a derivative of Heparin) is reported as an ingredient of Heparin Na in the following countries:

• Japan

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Kaliumchlorid-Lösung Bernburg

Kaliumchlorid-Lösung Bernburg may be available in the countries listed below.

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Potassium Chloride

Potassium Chloride is reported as an ingredient of Kaliumchlorid-Lösung Bernburg in the following countries:

• Germany

International Drug Name Search

Medotam

Medotam may be available in the countries listed below.

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Piracetam

Piracetam is reported as an ingredient of Medotam in the following countries:

• Vietnam

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Oméprazole Alter

Oméprazole Alter may be available in the countries listed below.

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Omeprazole

Omeprazole is reported as an ingredient of Oméprazole Alter in the following countries:

• France

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Garamycin

In some countries, this medicine may only be approved for veterinary use.

In the US, Garamycin (gentamicin systemic) is a member of the drug class aminoglycosides and is used to treat Bacteremia, Bacterial Endocarditis Prevention, Bacterial Infection, Bone infection, Brucellosis, Burns - External, Cystic Fibrosis, Endocarditis, Endometritis, Febrile Neutropenia, Intraabdominal Infection, Kidney Infections, Meningitis, Pelvic Inflammatory Disease, Peritonitis, Plague, Pneumonia, Rabbit Fever, Skin Infection and Surgical Prophylaxis.

US matches:

• Garamycin Solution


• Garamycin


• Garamycin Ophthalmic


• Garamycin Injection


• Garamycin Topical


• Garamycin Eye Ointment

Ingredient matches for Garamycin

Gentamicin

Gentamicin sulfate (a derivative of Gentamicin) is reported as an ingredient of Garamycin in the following countries:

• Bahrain


• Bosnia & Herzegowina


• Canada


• Croatia (Hrvatska)


• Denmark


• Ethiopia


• Greece


• Guyana


• Hong Kong


• Iceland


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Kormakin

Kormakin may be available in the countries listed below.

Ingredient matches for Kormakin

Amikacin

Amikacin sulfate (a derivative of Amikacin) is reported as an ingredient of Kormakin in the following countries:

• Philippines

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Navirel

Navirel may be available in the countries listed below.

Ingredient matches for Navirel

Vinorelbine

Vinorelbine is reported as an ingredient of Navirel in the following countries:

• Czech Republic


• Germany

Vinorelbine tartrate (a derivative of Vinorelbine) is reported as an ingredient of Navirel in the following countries:

• Denmark


• Finland


• Netherlands


• Norway


• Poland


• Slovakia


• Sweden

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Lacomin

Lacomin may be available in the countries listed below.

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Ketorolac

Ketorolac tromethamine (a derivative of Ketorolac) is reported as an ingredient of Lacomin in the following countries:

• Mexico

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Chenodiol

Ingredient matches for Chenodiol

Chenodeoxycholic Acid

Chenodiol (USAN) is known as Chenodeoxycholic Acid in the US.

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Glossary

USAN	United States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

CSI

CSI may be available in the countries listed below.

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Ceftriaxone

Ceftriaxone disodium salt (a derivative of Ceftriaxone) is reported as an ingredient of CSI in the following countries:

• India

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Floxyfral

Floxyfral may be available in the countries listed below.

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Fluvoxamine

Fluvoxamine is reported as an ingredient of Floxyfral in the following countries:

• Tunisia

Fluvoxamine maleate (a derivative of Fluvoxamine) is reported as an ingredient of Floxyfral in the following countries:

• Austria


• Belgium


• France


• Luxembourg


• Switzerland

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Lantaus

Lantaus may be available in the countries listed below.

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Insulin Glargine

Insulin Glargine is reported as an ingredient of Lantaus in the following countries:

• Bangladesh

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Salora

Salora may be available in the countries listed below.

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Loratadine

Loratadine is reported as an ingredient of Salora in the following countries:

• Bangladesh

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Anival

Anival may be available in the countries listed below.

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Amoxicillin

Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Anival in the following countries:

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Clavulanate

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Carbenicillin

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BANM	British Approved Name (Modified)

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Esvat

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Simvastatin

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Lincomycin

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Dominal

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RenAmin

Dosage Form: Injection Pharmacy Bulk Package

RenAmin Description

RenAmin® (Amino Acid) Injection is a sterile, nonpyrogenic, hypertonic solution of essential and nonessential amino acids in a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion.

Each 100 mL of RenAmin® (Amino Acid) Injection contains:

Amino Acids	6.5 g
Total Nitrogen	1 g
pH (pH adjusted with glacial acetic acid)	6.0 (5.0 to 7.0)

Essential Amino Acids

Valine - C5H11NO2	820 mg
Leucine - C6H13NO2	600 mg
Isoleucine - C6H13NO2	500 mg
Methionine - C5H11NO2S	500 mg
Phenylalanine - C9H11NO2	490 mg
Lysine (added as the hydrochloride salt) - C6H14N2O2	450 mg
Histidine - C6H9N3O2	420 mg
Threonine - C4H9NO3	380 mg
Tryptophan - C11H12N2O2	160 mg

Nonessential Amino Acids

Arginine – C6H14N4O2	630 mg
Alanine – C3H7NO2	560 mg
Proline – C5H9NO2	350 mg
Glycine – C2H5NO2	300 mg
Serine – C3H7NO3	300 mg
Tyrosine-C9H11NO3	40 mg

Anion Profile per Liter*

Acetate (1)		60 mEq
Chloride (2)		31 mEq
	* Balanced by ions from amino acids (1) derived from pH adjustment with glacial acetic acid (2) contributed by the Lysine Hydrochloride
3 mEq/L sodium bisulfite added as stabilizer
Osmolarity (calc.)		600 mOsmol/L

RenAmin - Clinical Pharmacology

RenAmin® (Amino Acid) Injection provides biologically utilizable source material for protein synthesis when used with appropriate calorie sources (such as hypertonic dextrose or fat emulsion), electrolytes, vitamins and minerals.

As a concentrated source of essential amino acids, RenAmin® (Amino Acid) Injection provides maximal protein intake with low volume administration. The essential amino acids are included as approximately 60% w/w of total amino acids. Each 250 mL unit of this injection meets or exceeds the recommended daily intake of essential amino acids. Nonessential amino acids have been included to meet requirements established in investigations of acute and chronic renal failure patients fed parenterally. The 40% w/w of nonessential amino acids includes histidine (considered an essential amino acid in renal failure), arginine, and other nonessential amino acids as additional sources of nitrogen that have been shown to enhance nitrogen balance and weight gain.

Indications and Usage for RenAmin

RenAmin® (Amino Acid) Injection is indicated as an adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance in potentially reversible renal decompensation when the alimentary tract cannot or should not be used; gastrointestinal absorption of protein is impaired; or metabolic requirements for protein are substantially increased, as with extensive burns.

Contraindications

Severe uncorrected electrolyte and acid base imbalance

Severe liver disease or hepatic coma

Hyperammonemia

Hypersensitivity to one or more amino acids

Decreased circulating blood volume

Warnings

This injection is for compounding only, not for direct infusion.

Proper administration of RenAmin® (Amino Acid) Injection requires a knowledge of fluid and electrolyte balance and nutrition as well as clinical expertise in recognition and treatment of the complications which may occur.

Administration of amino acid solutions to a patient with hepatic insufficiency may result in serum amino acid imbalances, hyperammonemia, stupor and coma.

Hyperammonemia is of special significance in infants. This reaction appears to be related to a deficiency of the urea cycle amino acids of genetic or product origin. It is essential that blood ammonia be measured frequently in infants.

This injection has no added electrolytes. Clinically significant hypocalcemia, hypophosphatemia or hypomagnesemia may occur. Electrolyte replacement may become necessary.

Contains sodium bisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

This injection should not be administered simultaneously with blood through the same infusion set because of the possibility of pseudoagglutination.

RenAmin® (Amino Acid) Injection does not replace dialysis and conventional supportive therapy in patients with renal failure.

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicatesthat patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 μg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

Precautions

It is essential to provide adequate calories concurrently if parenterally administered amino acids are to be retained by the body and utilized for protein synthesis. Concentrated dextrose solutions are an effective source of such calories.

With the administration of RenAmin® (Amino Acid) Injection in combination with highly concentrated dextrose solutions, hyperglycemia, glycosuria and hyperosmolar syndrome may result. Blood and urine glucose should be monitored on a routine basis in patients receiving this therapy.

Sudden cessation in administration of a concentrated dextrose solution may result in insulin reaction due to continued endogenous insulin production. Parenteral nutrition mixtures should be withdrawn slowly.

Electrolytes may be added to RenAmin® (Amino Acid) Injection as dictated by the patient's electrolyte profile.

Strongly hypertonic nutrient solutions should be administered through an indwelling intravenous catheter with the tip located in the superior vena cava.

Care should be taken to avoid excess fluid accumulation, particularly in patients with renal disease, pulmonary insufficiency and heart disease.

During amino acid administration in the absence of supporting carbohydrate metabolism, an accumulation of ketone bodies in the blood often occurs. Correction of ketonemia usually can be accomplished by administering some carbohydrates.

Drug product contains no more than 25 μg/L of aluminum.

Laboratory Tests

Frequent clinical evaluation and laboratory determinations are necessary for proper monitoring during administration.

Studies should include blood urea nitrogen, blood sugar, serum proteins, kidney and liver function tests, electrolytes, acid-base balance, hemogram, carbon dioxide combining power or content, serum osmolarities, blood cultures and blood ammonia levels. Circulating blood volume should be determined, if indicated.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Studies with RenAmin® (Amino Acid) Injection have not been performed to evaluate carcinogenesis potential, mutagenic potential, or effects on fertility.

Pregnancy:

Teratogenic Effects

Pregnancy Category C.

Animal reproduction studies have not been conducted with RenAmin® (Amino Acid) Injection. It is also not known whether RenAmin® (Amino Acid) Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. RenAmin® (Amino Acid) Injection should be given to a pregnant woman only if clearly needed.

Nursing Mothers:

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for adverse reactions, e.g., hyperammonemia in nursing infants, caution should be exercised when RenAmin® (Amino Acid) Injection is administered to a nursing mother.

Pediatric Use:

Safety and effectiveness of RenAmin® (Amino Acid) Injection have not been established by adequate and well-controlled studies in pediatric patients.

Geriatric Use:

Clinical studies of RenAmin® (Amino Acid) Injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from other younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or drug therapy.

SPECIAL PRECAUTIONS

Administration of amino acid solutions and other nutrients via central or peripheral venous catheter may be associated with complications which can be prevented or minimized by careful attention to all aspects of the procedure. This includes attention to solution preparation, administration and patient monitoring. It is essential that a carefully prepared protocol, based on current medical practices, be followed, preferably by an experienced team.

Although a detailed discussion of the complications is beyond the scope of this insert, the following summary lists those based on current literature:

Technical:

The placement of a central venous catheter should be regarded as a surgical procedure. The physician should be fully acquainted with various techniques of catheter insertion as well as recognition and treatment of complications. For details of techniques and placement sites consult the medical literature. X-ray is the best means of verifying catheter placement. Complications known to occur from the placement of central venous catheters are pneumothorax, hemothorax, hydrothorax, artery puncture and transection, injury to the brachial plexus, malposition of the catheter, formulation of arteriovenous fistula, phlebitis, thrombosis, cardiac arrhythmia and catheter embolus.

Septic:

The constant risk of sepsis is present during administration of parenteral nutrition solution. Since contaminated solutions and infusion catheters are potential sources of infection, it is imperative that the preparation of the solution and the placement and care of catheters be accomplished under controlled aseptic conditions. If fever develops, the solution, its delivery system and the site of the indwelling catheter should be changed.

Metabolic:

The following metabolic complications have been reported: metabolic acidosis, hypophosphatemia, alkalosis, hyperglycemia and glycosuria, osmotic diuresis and dehydration, rebound hypoglycemia, elevated liver enzymes, hypo- and hypervitaminosis, electrolyte imbalances and hyperammonemia. Frequent clinical evaluation and laboratory determinations are necessary, especially during the first few days of therapy, to prevent or minimize these complications.

Special Precautions in Patients with Renal Insufficiency

Frequent laboratory studies are necessary in patients with renal insufficiency. In renal failure, hyperglycemia may not be reflected by glycosuria. Blood glucose must be determined frequently, often every six hours to guide dosage of dextrose, and insulin should be given, if required.

Special Precautions in Pediatric Patients

RenAmin® (Amino Acid) Injection should be used with special caution in pediatric patients with acute renal failure, especially low birth weight infants. Laboratory and clinical monitoring of pediatric patients, especially those who are nutritionally depleted, must be extensive and frequent. See Children section under DOSAGE AND ADMINISTRATION for additional information. Frequent monitoring of blood glucose is required in low birth weight or septic infants, as hypertonic dextrose infusion involves a greater risk of hyperglycemia in such patients.

Adverse Reactions

See WARNINGS and PRECAUTIONS

Adverse effects include metabolic, electrolyte, acid-base and fluid imbalances unless special care with monitoring and corrective management is maintained during RenAmin® (Amino Acid) injection administration.

Infusion of any hypertonic solution can result in local inflammatory reactions. Policies and procedures should be established for the recognition and management of such reactions.

RenAmin Dosage and Administration

If a patient is unable to take oral nourishment for a prolonged period of time, institution of total parenteral nutrition (TPN) with exogenous calories should be considered.

Fat emulsion coadministration should be considered when prolonged (more than 5 days) parenteral nutrition is required in order to prevent essential fatty acid deficiency (EFAD). Serum lipids should be monitored for evidence of EFAD in patients maintained on fat free TPN.

Adult:

The total daily dose of RenAmin® (Amino Acid) Injection depends on the patient's metabolic requirement and clinical response. The determination of nitrogen balance and accurate daily body weights, corrected for fluid balance, are probably the best means of assessing individual nitrogen requirements.

Nutritional management of renal decompensation includes providing sufficient amino acid and caloric support for protein synthesis while not exceeding renal capacity for excretion of metabolic wastes. A dosage of 2.5 to 5.0 grams of nitrogen per day with adequate calories will maintain nitrogen equilibrium in most patients with uremia. If more nitrogen and calories are required, higher dosages may be administered, provided great care is taken to avoid exceeding limits of fluid intake or glucose tolerance.

Dosage should be guided by fluid, glucose and nitrogen tolerances, as well as metabolic and clinical responses. The rate of increase in blood urea nitrogen concentration generally diminishes when infusion of amino acids is accompanied by adequate calories. However, excessive intake of protein or increased protein catabolism may alter this response.

The usual daily dose ranges from 250 to 500 mL of RenAmin® (Amino Acid) Injection equivalent to 2.5 to 5.0 grams of nitrogen in 16.2 to 32.5 grams of amino acids.

Adequate calories should be administered simultaneously.

Patients receiving RenAmin® (Amino Acid) Injection should be monitored carefully and their electrolyte requirements individualized. Electrolyte supplementation may be required. This injection contains approximately 60 mEq acetate and 31 mEq chloride.

Electrolyte (phosphorous, potassium and magnesium) concentrations usually fall during administration of RenAmin® (Amino Acid) Injection. Particular care should be taken in the presence of cardiac arrhythmias or digitalis toxicity to assure that these electrolytes are supplemented when necessary.

Children:

Pediatric requirements vary depending upon growth, nutritional state and degree of renal insufficiency. A dosage of 0.5 to 1.0 gram of amino acids per kilogram body weight per day will meet the requirements of the majority of pediatric patients. Initial daily dosage should be low and increased slowly. More than one gram of essential amino acids per kilogram of body weight per day is not recommended. The total volume of nutritional solution, and the rate at which it is administered, will vary with the child’s age, nutritional and growth state, as well as the degree of renal failure. See Special Precautions in Pediatric Patients for additional information.

Maintenance vitamins, additional electrolytes and trace elements should be administered as required.

Central Vein Administration:

Hypertonic mixtures of amino acids and dextrose may be administered safely by continuous infusion through a central vein catheter with the tip located in the vena cava. In addition to meeting nitrogen needs, the administration rate is governed, especially during the first few days of therapy, by the patient's tolerance to dextrose. Daily intake of amino acids and dextrose should be increased gradually to the maximum required dose as indicated by frequent determinations of urine and blood sugar levels.

Uremic patients frequently are glucose intolerant. Provision of adequate calories in the form of hypertonic dextrose may require the administration of exogenous insulin to prevent hyperglycemia and glycosuria.

Parenteral nutrition may be started at lower administration rates and with infusates containing lower concentrations of dextrose; dextrose content and rate may be gradually increased to estimated caloric needs as the patient’s glucose tolerance increases. The patient’s fluid, nitrogen and glucose tolerance should be the determining factor of the rate of administration.

Sudden cessation in administration of concentrated dextrose solutions may result in insulin reactions due to continued endogenous insulin production. Such solutions should be withdrawn slowly.

Peripheral Vein Administration:

For patients requiring parenteral nutrition in whom the central vein route is not indicated, this injection can be mixed with low concentration dextrose solutions and administered by peripheral vein with fat emulsions.

Intravenous fat emulsions provide approximately 1.1 kcal/mL (10%) or 2.0 kcal/mL (20%) and may be administered along with amino acid-dextrose solutions through a short Y-connector near the infusion site to supplement caloric intake. Fat, however, should not be the sole caloric intake since studies have indicated that glucose is more nitrogen sparing in the stressed patient.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Use of a final filter is recommended during administration of all parenteral solutions where possible.

Do not use unless solution is clear and vacuum is present. Unit must be used with a vented set or a nonvented set with a vented spike adapter.

RenAmin® (Amino Acid) Injection in the Pharmacy Bulk Package is intended for use in the preparation of sterile, intravenous admixtures. Additives may be incompatible with the fluid withdrawn from this container. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. When compounding admixtures, use aseptic technique. Mix thoroughly. Do not store any unused portion of RenAmin® (Amino Acid) Injection.

Solutions should be used promptly after mixing. Any storage should be under refrigeration and limited to a brief period of time, preferably less than 24 hours.

DIRECTIONS FOR USE OF THE PHARMACY BULK PACKAGE CONTAINER

For compounding only, not for direct infusion.

1. The Pharmacy Bulk Package is to be used only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area).

2. Remove outer seal and metal disc.

3. Swab surface of stopper using approved technique.

4. Insert vented connector of solution transfer set and suspend unit. Refer to directions accompanying set.

Note: The closure shall be penetrated only one time with a suitable sterile transfer device or dispensing set which allows measured dispensing of the contents.

5. Once container closure has been penetrated, withdrawal of contents should be completed without delay. After initial entry, maintain contents at room temperature (25ºC/77ºF) and dispense within 4 hours.

How is RenAmin Supplied

RenAmin® (Amino Acid) Injection is available in glass Pharmacy Bulk Packages as follows:

2A6222	250 mL	NDC 0338-0471-02
2A6223	500 mL	NDC 0338-0471-03

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended the product be stored at room temperature (25ºC/77ºF): brief exposure up to 40ºC does not adversely affect the product, Protect from light until immediately prior to use.

*For Bar Code Position Only

071941631

Baxter Healthcare Corporation

Clintec Nutrition Division

Deerfield, IL, 60015 USA

Printed in USA

©Copyright 1997, 2000, Baxter Healthcare Corporation. All rights reserved.

07-19-41-631

RenAmin  valine, leucine, isoleucine, methionine, phenylalanine, lysine, histidine, threonine, tryptophan, arginine, alanine, proline, glycine, serine and tyrosine  injection

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0338-0471 Route of Administration INTRAVENOUS DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength Leucine (leucine) Active 600 MILLIGRAM  In 100 MILLILITER Phenylalanine (Phenylalanine) Active 490 MILLIGRAM  In 100 MILLILITER Lysine (Lysine) Active 450 MILLIGRAM  In 100 MILLILITER Methionine (Methionine) Active 500 MILLIGRAM  In 100 MILLILITER Isoleucine (Isoleucine) Active 500 MILLIGRAM  In 100 MILLILITER Valine (Valine) Active 820 MILLIGRAM  In 100 MILLILITER Histidine (Histidine) Active 420 MILLIGRAM  In 100 MILLILITER Threonine (Threonine) Active 380 MILLIGRAM  In 100 MILLILITER Tryptophan (Tryptophan) Active 160 MILLIGRAM  In 100 MILLILITER Alanine (Alanine) Active 560 MILLIGRAM  In 100 MILLILITER Glycine (Glycine) Active 300 MILLIGRAM  In 100 MILLILITER Arginine (Arginine) Active 630 MILLIGRAM  In 100 MILLILITER Proline (Proline) Active 350 MILLIGRAM  In 100 MILLILITER Tyrosine (Tyrosine) Active 40 MILLIGRAM  In 100 MILLILITER Serine (Serine) Active 300 MILLIGRAM  In 100 MILLILITER Nitrogen Inactive   Water Inactive   Glacial Acetic Acid Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0338-0471-02 250 mL (MILLILITER) In 1 BOTTLE, GLASS None 2 0338-0471-03 500 mL (MILLILITER) In 1 BOTTLE, GLASS None

Revised: 05/2006Baxter Healthcare Corporation

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