CYPROHEPTADINE HYDROCHLORIDE- cyproheptadine hydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Cyproheptadine Hydrochloride Tablets USP, 4 mg are available as white to off- white, round, flat-faced, beveled-edged tablets, debossed “4” on left side, “9” on right side of the scoring on one side and plain on the other side, containing 4 mg of cyproheptadine HCl packaged in bottles of 100 (NDC 50742-190-01) and 1,000 (NDC 50742-190-10) tablets. Tablets have functional scoring. PHARMACIST: Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured For: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408 Manufactured By: Ingenus Pharmaceuticals NJ, LLC Fairfield, NJ 07004 5517 Rev. 06/2017

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYPROHEPTADINE HYDROCHLORIDE- CYPROHEPTADINE HYDROCHLORIDE TABLET
REMEDYREPACK INC.
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CYPROHEPTADINE
HYDROCHLORIDE
TABLETS, USP
RX ONLY
DESCRIPTION
Cyproheptadine HCl USP, is an antihistaminic and antiserotonergic
agent.
Cyproheptadine hydrochloride USP 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 USP is available for oral administration
in 4 mg tablets. Inactive
ingredients include: lactose monohydrate, magnesium stearate,
microcrystalline cellulose, and sodium
starch glycolate.
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
to 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 to 20 mg daily doses. The principle
metabolite found in human urine has
been identified as a quaternary ammonium glucuronide conjugate of
cyproheptadine. Elimination is
diminished in renal insufficiency.
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INDICATIONS AND USAGE
Perennial and seasonal allergic rhinitis
Vasomotor rhinitis
Allergic conjunctivitis due to inhalant allergens and foods
Mild, uncomplicated allergic skin manifestations of urticari