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:

Trigen Laboratories

INN (International Name):

CYPROHEPTADINE HYDROCHLORIDE

Composition:

CYPROHEPTADINE HYDROCHLORIDE 4 mg

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. Newborn or Premature Infants This drug should not be used in newborn or premature infants. Nursing Mothers Because of the higher risk of antihistamines for infants generally and for newborns and prematures in particular, antihistamine therapy is contraindicated in nursing mothers. Other Conditions 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

Product summary:

Cyproheptadine Hydrochloride Tablets USP, 4 mg are available as white to off-white round convex tablets, engraved IT above bisect and 68 below bisect on one side with other side is plain, containing 4 mg of cyproheptadine HCl packaged in bottles of 100 and 1000 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 for: Trigen Laboratories, LLC. Bridgewater, NJ 08807 www.Trigenlab.com 888-9-TRIGEN (888-987-4436) Rev. 02/2017

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYPROHEPTADINE HYDROCHLORIDE- CYPROHEPTADINE HYDROCHLORIDE TABLET
TRIGEN LABORATORIES
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CYPROHEPTADINE HYDROCHLORIDE TABLETS, USP
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
Perennial and seasonal allergic rhinitis
Vasomotor rhinitis
21
21
21
21
14
Allergic conjunctivitis due to inhalant allergens and foods
Mild, uncomplicated allergic skin ma