Diclofenac-Retard

Diclofenac-Retard may be available in the countries listed below.

Ingredient matches for Diclofenac-Retard

Diclofenac

Diclofenac is reported as an ingredient of Diclofenac-Retard in the following countries:

• Serbia

International Drug Name Search

Invirase

In the US, Invirase (saquinavir systemic) is a member of the drug class protease inhibitors and is used to treat HIV Infection and Nonoccupational Exposure.

US matches:

• Invirase

UK matches:

• Invirase 200 mg hard capsules and 500 mg film-coated tablets (SPC)

Ingredient matches for Invirase

Saquinavir

Saquinavir is reported as an ingredient of Invirase in the following countries:

• Bulgaria


• Ireland


• Peru

Saquinavir mesilate (a derivative of Saquinavir) is reported as an ingredient of Invirase in the following countries:

• Australia


• Austria


• Bahrain


• Belgium


• Botswana


• Brazil


• Cambodia


• Canada


• Chile


• Colombia


• Croatia (Hrvatska)


• Czech Republic


• Denmark


• Ecuador


• Finland


• France


• Germany


• Ghana


• Greece


• Hong Kong


• Hungary


• Iceland


• Israel


• Italy


• Japan


• Kenya


• Laos


• Luxembourg


• Malawi


• Malaysia


• Mauritius


• Mexico


• Namibia


• Netherlands


• New Zealand


• Nigeria


• Norway


• Oman


• Philippines


• Poland


• Portugal


• Romania


• Russian Federation


• Saudi Arabia


• Serbia


• Slovakia


• Spain


• Sudan


• Sweden


• Switzerland


• Tanzania


• Uganda


• United Kingdom


• United States


• Uruguay


• Venezuela


• Vietnam


• Zambia


• Zimbabwe

International Drug Name Search

Glossary

SPC	Summary of Product Characteristics (UK)

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

Neo Sampoon

Neo Sampoon may be available in the countries listed below.

Ingredient matches for Neo Sampoon

Menfegol

Menfegol is reported as an ingredient of Neo Sampoon in the following countries:

• Hong Kong


• Singapore

International Drug Name Search

Topiramato Milo

Topiramato Milo may be available in the countries listed below.

Ingredient matches for Topiramato Milo

Topiramate

Topiramate is reported as an ingredient of Topiramato Milo in the following countries:

• Spain

International Drug Name Search

Novirax

Novirax may be available in the countries listed below.

Ingredient matches for Novirax

Acyclovir

Aciclovir is reported as an ingredient of Novirax in the following countries:

• Bangladesh


• Oman

International Drug Name Search

Progesterona L.CH.

Progesterona L.CH. may be available in the countries listed below.

Ingredient matches for Progesterona L.CH.

Progesterone

Progesterone is reported as an ingredient of Progesterona L.CH. in the following countries:

• Chile

International Drug Name Search

Pronoctan

Pronoctan may be available in the countries listed below.

Ingredient matches for Pronoctan

Lormetazepam

Lormetazepam is reported as an ingredient of Pronoctan in the following countries:

• Denmark

International Drug Name Search

Ethionamide

In the US, Ethionamide (ethionamide systemic) is a member of the drug class nicotinic acid derivatives and is used to treat Tuberculosis, Active.

US matches:

• Ethionamide

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

J04AD03

CAS registry number (Chemical Abstracts Service)

0000536-33-4

Chemical Formula

C8-H10-N2-S

Molecular Weight

166

Therapeutic Category

Antitubercular agent

Chemical Name

4-Pyridinecarbothioamide, 2-ethyl-

Foreign Names

• Ethionamidum (Latin)
• Ethionamid (German)
• Ethionamide (French)
• Etionamida (Spanish)

Generic Names

• Ethionamide (OS: USAN, BAN)
• Éthionamide (OS: DCF)
• Etionamide (OS: DCIT)
• Aethionamidum (IS)
• Bayer 5312 (IS: Bayer)
• Etionizina (IS)
• ETP (IS)
• TH 1314 (IS)
• Ethionamid (PH: Ph. Eur. 6)
• Ethionamide (PH: BP 2010, Ph. Eur. 6, Ph. Int. 4, USP 32, JP XV)
• Ethionamidum (PH: Ph. Int. 4, Ph. Eur. 6)

Brand Names

• Ethatyl
  Aventis, South Africa



• Ethide
  Lupin, India



• Ethomid
  Macleods, Georgia



• Etionamida
  Bestpharma, Chile



• Eton
  Umeda, Thailand



• Etyomid
  Koçak, Turkey



• Trecator
  Wyeth, United States



• Tubermin
  Meiji Seika Kaisha, Japan

International Drug Name Search

Glossary

BAN	British Approved Name
DCF	Dénomination Commune Française
DCIT	Denominazione Comune Italiana
IS	Inofficial Synonym
OS	Official Synonym
PH	Pharmacopoeia Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name

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

Nematox

Nematox may be available in the countries listed below.

Ingredient matches for Nematox

Albendazole

Albendazole is reported as an ingredient of Nematox in the following countries:

• Bangladesh

International Drug Name Search

Angiozem

Angiozem may be available in the countries listed below.

Ingredient matches for Angiozem

Diltiazem

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

• Philippines

International Drug Name Search

Betamethasone Ointment Augmented

Dosage Form: ointment, augmented
Betamethasone Dipropionate Ointment

(Augmented*) USP, 0.05%

(Potency expressed as betamethasone)

*Vehicle augments the penetration of the steroid

For Dermatologic Use Only - Not for Ophthalmic Use

Rx only

Betamethasone Ointment Augmented Description

Betamethasone Dipropionate Ointment (Augmented) USP, 0.05% contains betamethasone dipropionate, USP, a synthetic adrenocorticosteroid, for dermatologic use. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is the 17, 21-dipropionate ester of betamethasone.

Chemically, betamethasone dipropionate is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.6 and the following structural formula:

Betamethasone dipropionate is a white to creamy white, odorless powder insoluble in water; freely soluble in acetone and in chloroform; sparingly soluble in alcohol.

Each gram of Betamethasone Dipropionate Ointment (Augmented) USP, 0.05% contains: 0.643 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone) in an optimized vehicle of propylene glycol, USP; propylene glycol stearate; white wax, NF; and white petrolatum, USP.

Betamethasone Ointment Augmented - Clinical Pharmacology

The corticosteroids are a class of compounds comprising steroid hormones secreted by the adrenal cortex and their synthetic analogs. In pharmacologic doses, corticosteroids are used primarily for their anti-inflammatory and/or immunosuppressive effects.

Topical corticosteroids, such as betamethasone dipropionate, are effective in the treatment of corticosteroid-responsive dermatoses primarily because of their anti-inflammatory, antipruritic, and vasoconstrictive actions. However, while the physiologic, pharmacologic, and clinical effects of the corticosteroids are well known, the exact mechanisms of their actions in each disease are uncertain. Betamethasone dipropionate, a corticosteroid, has been shown to have topical (dermatologic) and systemic pharmacologic and metabolic effects characteristic of this class of drugs.

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. (see DOSAGE AND ADMINISTRATION.)

Topical corticosteroids can be absorbed through normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. (see DOSAGE AND ADMINISTRATION.)

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

Studies performed with Betamethasone Dipropionate Ointment (Augmented) indicate that it is in the super-high range of potency as compared with other topical corticosteroids.

Indications and Usage for Betamethasone Ointment Augmented

Betamethasone Dipropionate Ointment (Augmented) USP, 0.05% is a super-high potency corticosteroid indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years and older. The total dose should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis.

Contraindications

Betamethasone Dipropionate Ointment (Augmented) USP, 0.05% is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation.

Precautions

General

Systemic absorption of topical corticosteroids has produced reversible 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 corticosteroids, use over large surface areas, prolonged use and the addition of occlusive dressings. Use of more than one corticosteroid-containing product at the same time may increase total systemic glucocorticoid exposure. (See DOSAGE AND ADMINISTRATION.)

Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, 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. Patients should not be treated with amounts of Betamethasone Dipropionate Ointment (Augmented) greater than 50 g per week because of the potential for the drug to suppress HPA axis. Patients receiving super-potent corticosteroids should not be treated for more than 2 weeks at a time and only small areas should be treated at any one time due to the increased risk of HPA suppression.

At 14 g per day Betamethasone Dipropionate Ointment (Augmented) was shown to depress the plasma levels of adrenal cortical hormones following repeated application to diseased skin in patients with psoriasis. These effects were reversible upon discontinuation of treatment. At 7 g per day Betamethasone Dipropionate Ointment (Augmented) was shown to cause minimal inhibition of the HPA axis when applied 2 times daily for 2 to 3 weeks in healthy patients and in patients with psoriasis and eczematous disorders.

With 6 to 7 g of Betamethasone Dipropionate Ointment (Augmented) applied once daily for 3 weeks, no significant inhibition of the HPA axis was observed in patients with psoriasis and atopic dermatitis, as measured by plasma cortisol and 24-hour urinary 17-hydroxy-corticosteroid levels. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

Pediatric patients 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 antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled. Betamethasone Dipropionate Ointment (Augmented) should not be used in the treatment of rosacea or perioral dermatitis, and it should not be used on the face, groin, or in the axillae.

Information for Patients

Patients using topical corticosteroids should receive the following information and instructions. This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.

1. This medication is to be used as directed by the physician and should not be used longer than the prescribed time period. It is for external use only. Avoid contact with the eyes.


2. This medication should not be used for any disorder other than that for which it was prescribed.


3. The treated skin area should not be bandaged, otherwise covered or wrapped, so as to be occlusive. (see DOSAGE AND ADMINISTRATION.)


4. Patients should report to their physycian any signs of local adverse reactions.


5. Patients should be advised not to use Betamethasone Dipropionate Ointment (Augmented) in the treatment of diaper dermatitis. Betamethasone Dipropionate Ointment (Augmented) should not be applied in the diaper areas as diapers or plastic pants may constitute occlusive dressing (see DOSAGE AND ADMINISTRATION).


6. This medication should not be used on the face, underarms, or groin areas unless directed by the physician.


7. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, contact the physician.


8. Other corticosteroid-containing products should not be used with Betamethasone Dipropionate Ointment (Augmented).

Laboratory Tests

The following tests may be helpful in evaluating HPA axis suppression:

 

ACTH stimulation test

 

Urinary free cortisol test

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential of betamethasone dipropionate. Betamethasone was negative in the bacterial mutagenicity assay (Salmonella typhimurium and Escherichia coli), and in the mammalian cell mutagenicity assay (CHO/HGPRT). It was positive in the in-vitro, human lymphocyte chromosome aberration assay, and equivocal in the in-vivo mouse bone marrow micronucleus assay. This pattern of response is similar to that of dexamethasone and hydrocortisone. Studies in rabbits, mice and rats using intramuscular doses up to 1, 33 and 2 mg/kg, respectively, resulted in dose related increases in fetal resorptions in rabbits and mice.

Pregnancy

Teratogenic effects

Pregnancy category C

Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. Betamethasone dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. This dose is approximately 0.2 times the human topical dose of Betamethasone Dipropionate Ointment (Augmented) in mg/m2 of body surface area, assuming 100% absorption and the use in a 60 kg person of 7 g per day. The abnormalities observed included umbilical hernias, cephalocele and cleft palate. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Betamethasone Dipropionate Ointment (Augmented) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Betamethasone Dipropionate Ointment (Augmented) is administered to a nursing woman.

Pediatric Use

Use of Betamethasone Dipropionate Ointment (Augmented) in pediatric patients 12 years of age and younger is not recommended. (See CLINICAL PHARMACOLOGY and ADVERSE REACTIONS.)

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 intracranial 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 an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Chronic corticosteroid therapy may interfere with the growth and development of children.

Geriatric Use

Clinical studies of Betamethasone Dipropionate Ointment (Augmented) included 225 subjects who were 65 years of age and over and 46 subjects who were 75 years of age and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out.

Adverse Reactions

The local adverse reactions were reported with Betamethasone Dipropionate Ointment (Augmented) during controlled clinical trials were as follows: erythema, folliculitis, pruritus and vesiculation each occurring in less than 1% of patients.

The following additional local adverse reactions have been reported with topical corticosteroids, and they may occur more frequently with the use of occlusive dressings and higher potency corticosteroids. These reactions are listed in an approximately decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, skin atrophy, striae, and miliaria.

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.

Overdosage

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

Betamethasone Ointment Augmented Dosage and Administration

Apply a thin film of Betamethasone Dipropionate Ointment (Augmented) USP, 0.05% to the affected skin once or twice daily. Betamethasone Dipropionate Ointment (Augmented) is a super-high potency topical corticosteroid. Treatment with Betamethasone Dipropionate Ointment (Augmented) should be limited to 50 g per week.

As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

Betamethasone Dipropionate Ointment (Augmented) should not be used with occlusive dressings. Betamethasone Dipropionate Ointment (Augmented) should not be applied to the diaper area if the patient requires diapers or plastic pants as these garments may constitute occlusive dressing.

How is Betamethasone Ointment Augmented Supplied

Betamethasone Dipropionate Ointment (Augmented) USP, 0.05% is supplied in 15 g (NDC 51642-1317-1) and 50 g (NDC 51672-1317-3) tubes; boxes of one; and in a 5 g physician sample (tube only).

Store at 20° - 25°C (68° - 77°F) [see USP Controlled Room Temperature].

Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1

Revised: September, 2006

LPK-4528-1

265

PRINCIPAL DISPLAY PANEL - 50 g Carton

NDC 51672-1317-3

50 g

Betamethasone Dipropionate

Ointment (Augmented*) USP, 0.05%

(Potency expressed as betamethasone)

*Vehicle augments the penetration of the steroid.

FOR DERMATOLOGIC USE ONLY.

NOT FOR OPHTHALMIC USE.

Rx only

TARO

Keep this and all medications out of the reach of children.

BETAMETHASONE DIPROPIONATE  betamethasone dipropionate  ointment, augmented

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51672-1317 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Betamethasone Dipropionate (Betamethasone) Betamethasone 0.5 mg  in 1 g

Inactive Ingredients Ingredient Name Strength propylene glycol   propylene glycol stearate   petrolatum   white wax

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 51672-1317-5 5 g In 1 TUBE None 2 51672-1317-1 1 TUBE In 1 CARTON contains a TUBE 2 15 g In 1 TUBE This package is contained within the CARTON (51672-1317-1) 3 51672-1317-3 1 TUBE In 1 CARTON contains a TUBE 3 50 g In 1 TUBE This package is contained within the CARTON (51672-1317-3)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076753	10/12/2004

Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)

Establishment
Name	Address	ID/FEI	Operations
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE

Revised: 11/2011Taro Pharmaceuticals U.S.A., Inc.

Acix

Acix may be available in the countries listed below.

Ingredient matches for Acix

Acyclovir

Aciclovir is reported as an ingredient of Acix in the following countries:

• Poland

Aluminium Hydroxide

Aluminium Hydroxide hydrate (Algeldrate) (a derivative of Aluminium Hydroxide) is reported as an ingredient of Acix in the following countries:

• Czech Republic

International Drug Name Search

Zantac

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

In the US, Zantac (ranitidine systemic) is a member of the drug class H2 antagonists and is used to treat Duodenal Ulcer, Duodenal Ulcer Prophylaxis, Erosive Esophagitis, Gastric Ulcer Maintenance Treatment, Gastrointestinal Hemorrhage, GERD, Indigestion, Pathological Hypersecretory Conditions, Stomach Ulcer, Stress Ulcer Prophylaxis, Surgical Prophylaxis and Zollinger-Ellison Syndrome.

US matches:

• Zantac


• Zantac 150 EFFERdose Effervescent Tablets


• Zantac 25 mg EFFERdose Effervescent Tablets


• Zantac 75


• Zantac Syrup


• Zantac Tablets


• Zantac 150


• Zantac 300


• Zantac EFFERdose


• Zantac Cool Mint

UK matches:

• Zantac 75 Relief (SPC)
• Zantac 75 Relief Dissolve (SPC)
• Zantac Effervescent Tablets 150mg (GlaxoSmithKline UK) (SPC)
• Zantac Effervescent Tablets 300mg (GlaxoSmithKline UK) (SPC)
• Zantac Injection 50mg/2ml (GlaxoSmithKline UK) (SPC)
• Zantac Syrup (GlaxoSmithKline UK) (SPC)
• Zantac Tablets 150mg (GlaxoSmithKline UK) (SPC)
• Zantac Tablets 300mg (GlaxoSmithKline UK) (SPC)

Ingredient matches for Zantac

Ranitidine

Ranitidine is reported as an ingredient of Zantac in the following countries:

• Argentina


• Bahrain


• Bulgaria


• Cyprus


• Ethiopia


• Iran


• Israel


• Jordan


• Kuwait


• Lebanon


• Luxembourg


• Peru


• Qatar


• Romania


• Syria


• Taiwan


• Tunisia


• United Arab Emirates


• Vietnam


• Yemen

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

• Antigua & Barbuda


• Argentina


• Aruba


• Australia


• Austria


• Bahamas


• Bangladesh


• Barbados


• Belgium


• Bermuda


• Bosnia & Herzegowina


• Canada


• Cayman Islands


• Chile


• China


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• United States


• Venezuela

International Drug Name Search

Glossary

SPC	Summary of Product Characteristics (UK)

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

Nutropin

In the US, Nutropin (somatropin systemic) is a member of the drug class growth hormones and is used to treat Adult Human Growth Hormone Deficiency, Growth Retardation - Chronic Renal Failure, Hypopituitarism, Idiopathic Short Stature, Pediatric Growth Hormone Deficiency, Short Stature for Age and Turner's Syndrome.

US matches:

• Nutropin


• Nutropin AQ


• Nutropin AQ NuSpin


• Nutropin AQ Pen


• Nutropin AQ Vials


• Nutropin AQ NuSpin 10


• Nutropin AQ NuSpin 5


• Nutropin Aq Subcutaneous, Injection


• Nutropin Subcutaneous, Injection


• Nutropin Depot

Ingredient matches for Nutropin

Somatropine

Somatropine is reported as an ingredient of Nutropin in the following countries:

• Canada


• Greece


• Hungary


• Luxembourg


• Portugal


• United States

International Drug Name Search

Ramipril HCT Actavis

Ramipril/HCT Actavis may be available in the countries listed below.

Ingredient matches for Ramipril/HCT Actavis

Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of Ramipril/HCT Actavis in the following countries:

• Austria


• Switzerland

Ramipril

Ramipril is reported as an ingredient of Ramipril/HCT Actavis in the following countries:

• Austria


• Switzerland

International Drug Name Search