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:

AvKARE

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 ulc

Product summary:

Cyproheptadine Hydrochloride Tablets USP are available as white to off white, at-faced, bevel-edged, round shaped tablets, one side debossed with "CYP", the other side bisected, containing 4 mg of Cyproheptadine HCI packaged in bottles of 100: NDC 42291-225-01, and bottles of 1000: NDC 42291-225-10. PHARMACIST Dispense in a well-closed container as defined in the USP. Use child-resistant closure (as required). Store at 20º - 25º C (68º - 77º F) excursions permitted to 15º - 30º C (59º - 86º F) [see USP Controlled Room Temperature] Manufactured for: AvKARE Inc. Pulaski, TN 38478 Mfg. Rev. 09/13 AV Rev. 06/18 (P)

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYPROHEPTADINE HYDROCHLORIDE- CYPROHEPTADINE HYDROCHLORIDE TABLET
AVKARE
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CYPROHEPTADINE HCI TABLETS, USP
DESCRIPTION
Cyproheptadine HCl, is an antihistaminic and antiserotonergic agent.
Cyproheptadine
hydrochloride 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
H
N•HCl and the structural formula of the
anhydrous salt is:
Cyproheptadine hydrochloride 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, 2-20% 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
12-20 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
14
Allergic conjunctivitis due to inhalant allergens and foods
Mild, uncomplicated allergic skin manifestations of urticaria and
angioedema
Amelioration of allergic reactions