Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
CYPROHEPTADINE HYDROCHLORIDE (UNII: NJ82J0F8QC) (CYPROHEPTADINE - UNII:2YHB6175DO)
NCS HealthCare of KY, Inc dba Vangard Labs
CYPROHEPTADINE HYDROCHLORIDE
CYPROHEPTADINE HYDROCHLORIDE 4 mg
ORAL
PRESCRIPTION DRUG
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
Cyproheptadine Hydrochloride Tablets USP, 4 mg are available as white, round, flat-faced, beveled-edged tablets, bisected on one side with debossed “93” above the bisect and debossed “2929” below the bisect, plain on the other side, containing 4 mg of cyproheptadine HCl packaged in blisterpacks of 30 tablets. 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 In India By: EMCURE PHARMACEUTICALS LTD. Hinjwadi, Pune, India Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Iss. 7/2009
Abbreviated New Drug Application
CYPROHEPTADINE HYDROCHLORIDE- CYPROHEPTADINE HYDROCHLORIDE TABLET NCS HEALTHCARE OF KY, INC DBA VANGARD LABS ---------- 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: C H N• 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 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. INDICATIONS AND USAGE 21 21 21 21 14 Perennial and seasonal allergic rhinitis Vasomotor rhinitis Allergic conjunctivitis due to inhalant allergens and foods Mild, Przeczytaj cały dokument