CYPROHEPTADINE HYDROCHLORIDE tablet

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

CYPROHEPTADINE HYDROCHLORIDE (UNII: NJ82J0F8QC) (CYPROHEPTADINE - UNII:2YHB6175DO)

Доступна с:

Physicians Total Care, Inc.

ИНН (Международная Имя):

CYPROHEPTADINE HYDROCHLORIDE

состав:

CYPROHEPTADINE 4 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Perennial and seasonal allergic rhinitis Vasomotor rhinitis Allergic conjunctivitis due to inhalant allergens and foods Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Amelioration of allergic reactions to blood or plasma Cold urticaria Dermatographism As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled. This drug should not be used in newborn or premature infants. Because of the higher risk of antihistamines for infants generally and for newborns and prematures in particular, antihistamine therapy is contraindicated in nursing mothers. Hypersensitivity to cyproheptadine and other drugs of similar chemical structure. Monoamine oxidase inhibitor therapy (see DRUG INTERACTIONS. ) Angle-closure glaucoma Stenosing peptic ulcer Symptomatic prostatic hypertrophy Bladder neck obstruction Pyloroduodenal obstruction Elderly, debilitated patients

Обзор продуктов:

Cyproheptadine hydrochloride tablets USP 4 mg are supplied as white, round, compressed tablets, debossed “cor” above the bisect and “150” below the bisect and the other side is plain. They are supplied as follows: Dispense in a well-closed container as defined in the USP. Use child-resistant closure (as required). Store at controlled room temperature 15° - 30°C (59° - 86°F) (see USP). KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Manufactured by: Corepharma LLC Middlesex, NJ 08846 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401 MF # 309-04 January 2007 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, OK       74146

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

CYPROHEPTADINE HYDROCHLORIDE - CYPROHEPTADINE HYDROCHLORIDE TABLET
PHYSICIANS TOTAL CARE, INC.
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DESCRIPTION
Cyproheptadine HCI, is an antihistaminic and antiserotonergic agent.
Cyproheptadine hydrochloride is a
white to slightly yellowish crystalline solid, with a molecular weight
of 350.89, which is soluble in
water, freely soluble in methanol, sparingly soluble in ethanol,
soluble in chloroform, and practically
insoluble in ether. It is the sesquihydrate of
4-(5_H_-dibenzo[_a,d_]cyclohepten-5-ylidene)-1-
methylpiperidine hydrochloride. The molecular formula of the anhydrous
salt is C
H N•HCl and the
structural formula of the anhydrous salt is:
Cyproheptadine hydrochloride is available for oral administration in 4
mg tablets. Inactive ingredients
include: lactose monohydrate, magnesium stearate, microcrystalline
cellulose, and pregelatinized starch.
CLINICAL PHARMACOLOGY
Cyproheptadine is a serotonin and histamine antagonist with
anticholinergic and sedative effects.
Antiserotonin and antihistamine drugs appear to compete with serotonin
and histamine, respectively, for
receptor sites.
PHARMACOKINETICS AND METABOLISM
After a single 4 mg oral dose of
C-labelled cyproheptadine HCl in normal subjects, given as tablets,
2-20% of the radioactivity was excreted in the stools. Only about 34%
of the stool radioactivity was
unchanged drug, corresponding to less than 5.7% of the dose. At least
40% of the administered
radioactivity was excreted in the urine. No detectable amounts of
unchanged drug were present in the
urine of patients on chronic 12-20 mg daily doses. The principal
metabolite found in human urine has
been identified as a quaternary ammonium glucuronide conjugate of
cyproheptadine. Elimination is
diminished in renal insufficiency.
INDICATIONS AND USAGE
Perennial and seasonal allergic rhinitis
Vasomotor rhinitis
21
21
14
Allergic conjunctivitis due to inhalant allergens and foods
Mild, uncomplicated allergic skin manifestations of urticaria and
angioedema.
Amelioration of allergic reactions to bloo