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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-(5H-dibenzo[a,d]cyclohepten-5-ylidene)-1-methylpiperidine hydrochloride. The molecular formula of the anhydrous salt is C 21H 21N•HCl and the structural formula of the anhydrous salt is:
C 21H 21N• HCl M.W. 350.89
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 14C-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. - Cyproheptadine HCl Tablets USP 4mg
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INGREDIENTS AND APPEARANCE
CYPROHEPTADINE HYDROCHLORIDE
cyproheptadine hydrochloride tabletProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24689-816 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CYPROHEPTADINE HYDROCHLORIDE (UNII: NJ82J0F8QC) (CYPROHEPTADINE - UNII:2YHB6175DO) CYPROHEPTADINE HYDROCHLORIDE 4 mg Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color white Score 2 pieces Shape ROUND Size 7mm Flavor Imprint Code IT;68 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24689-816-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 05/21/2018 2 NDC:24689-816-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 05/21/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207555 05/15/2018 Labeler - Apnar Pharma (079568229) Establishment Name Address ID/FEI Business Operations InvaTech Pharma Solutions LLC 078602180 manufacture(24689-816) , analysis(24689-816)
