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:

TRUPHARMA, LLC

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 are available as white to off white, round, flat-faced, beveled edged tablets, debossed with “MCR and 109” separated by functional score on one side and plain on the other side, containing 4 mg of cyproheptadine HCI packaged in bottles of 100 (NDC 52817-210-10) and 500 tablets (NDC 52817-210-50). 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 by: Appco Pharma LLC Piscataway, NJ 08854 Distributed by: TruPharma, LLC Tampa, FL 33609 Revised: 02/2022 200223 Ver-04

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYPROHEPTADINE HYDROCHLORIDE - CYPROHEPTADINE HYDROCHLORIDE TABLET
TRUPHARMA, LLC
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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 powder, with
a molecular weight of 350.89, which is slightly soluble in water,
freely soluble in
methanol, sparingly soluble in alcohol, 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 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 HCI 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
21
21
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
Allergic conjunctivitis due to inhalant allergens and foods
Mild, uncomplicated allergic skin manifestations of urticaria and
a