CYPROHEPTADINE syrup

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CYPROHEPTADINE (UNII: 2YHB6175DO) (CYPROHEPTADINE - UNII:2YHB6175DO)

Available from:

Pharmaceutical Associates, Inc.

INN (International Name):

CYPROHEPTADINE

Composition:

CYPROHEPTADINE 2 mg in 5 mL

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 Syrup (Cyproheptadine Hydrochloride Oral Solution, USP) (2 mg/5 mL), a pale yellow, peppermint flavored liquid, is available in the following oral dosage forms: NDC 0121-0788-16 – Bottles of 16 fl oz (473 mL) NDC 0121-4788-05 – 5 mL Unit Dose Cups, 10 cups per tray NDC 0121-4788-10 – 10 mL Unit Dose Cups, 10 cups per tray Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYPROHEPTADINE- CYPROHEPTADINE SYRUP
PHARMACEUTICAL ASSOCIATES, INC.
----------
CYPROHEPTADINE HYDROCHLORIDE SYRUP
[CYPROHEPTADINE HYDROCHLORIDE ORAL SOLUTION, USP]
RX ONLY
DESCRIPTION
Each 5 mL (one teaspoonful) contains: Cyproheptadine hydrochloride 2
mg. Alcohol 5%.
INACTIVE INGREDIENTS: citric acid, D&C Yellow No.10, peppermint
flavor, purified water, sodium
benzoate, sodium citrate and sucrose.
Cyproheptadine hydrochloride is an antihistaminic and antiserotonergic
agent. Cyproheptadine
hydrochloride is a white to slightly yellowish, crystalline solid,
with a molecular weight of 350.88,
which is slightly 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:
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-labeled cyproheptadine HCl in normal subjects, given as tablets or
oral solution, 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 of
cyproheptadine oral solution. The
principal 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 inha