CYPROHEPTADINE HYDROCHLORIDE syrup

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CYPROHEPTADINE HYDROCHLORIDE (UNII: NJ82J0F8QC) (CYPROHEPTADINE - UNII:2YHB6175DO)

Available from:

Rising Pharmaceuticals, Inc.

INN (International Name):

CYPROHEPTADINE HYDROCHLORIDE

Composition:

CYPROHEPTADINE HYDROCHLORIDE 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. 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 obstruct

Product summary:

Cyproheptadine Hydrochloride Syrup (Cyproheptadine Hydrochloride Oral Solution, USP, 2 mg/5 mL) in a yellow, mint-flavored vehicle, is supplied in a pint (473 mL) container. (NDC 64980-504-48) Store at 20°-25°C (68°-77°F) excursion permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07663 Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02301 R7-10/20 EACH 5 mL (ONE TEASPOONFUL) CONTAINS: Cyproheptadine Hydrochloride 2 mg, Alcohol 5%, Sorbic Acid 0.1% added as preservative. USUAL DOSAGE: See accompanying package insert. Store at 20°-25°C (68°-77°F) excursion permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07663 Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02301 R-10/20

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYPROHEPTADINE HYDROCHLORIDE - CYPROHEPTADINE HYDROCHLORIDE SYRUP
RISING PHARMACEUTICALS, INC.
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CYPROHEPTADINE HYDROCHLORIDE SYRUP(CYPROHEPTADINE HYDROCHLORIDE ORAL
SOLUTION, USP)
RX ONLY
DESCRIPTION
EACH 5 ML (ONE TEASPOONFUL) CONTAINS: Cyproheptadine Hydrochloride 2
mg
INACTIVE INGREDIENTS: Alcohol 5%, citric acid, D&C Yellow #10,
flavors, purified water,
sodium citrate, sorbic acid (0.1% as preservative) and sucrose syrup.
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 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-(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:
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 HCI in normal subjects, given as tablets or syrup,
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
21
21
14
unchanged drug were present in the urine of patients on chronic 12-20
mg daily doses
of cyproheptadine syrup. 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
Allergic conjunctivitis due to