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:

Bayshore Pharmaceuticals LLC

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 color, round flat face tablet with debossed “B137” on one side and scored on the other, containing 4 mg of cyproheptadine HCl packaged in HDPE 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). Bottles of 100 tablets: NDC 76385-130-01 Bottles of 1000 tablets: NDC 76385-130-10

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYPROHEPTADINE HYDROCHLORIDE- CYPROHEPTADINE HYDROCHLORIDE TABLET
BAYSHORE PHARMACEUTICALS LLC
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CYPROHEPTADINE HYDROCHLORIDE TABLETS USP
RX ONLY
DESCRIPTION
Cyproheptadine HCl, 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
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 as follows:
C
H
N• HCl M.W. 350.89
Cyproheptadine hydrochloride, USP is available for oral administration
in 4 mg tablets.
Each tablet contains: INACTIVES: Lactose Monohydrate, Microcrystalline
Cellulose,
Sodium Starch Glycolate and Magnesium Stearate.
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, uncompl