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:

Physicians Total Care, 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 obstruction El

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 54868-4338-0 . 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. Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02301 Distributed by: Actavis Mid Atlantic LLC                                    FORM NO. 1400 1877 Kawai Road                                                         VC108865 Lincolnton, NC 28092 USA REV. 10/10 Distributed by: Physicians Total Care, Inc. Tulsa, OK      74146 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. Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02301 Distributed by: Actavis Mid Atlantic LLC 1877 Kawai Road Lincolnton, NC 28092 USA

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYPROHEPTADINE HYDROCHLORIDE - CYPROHEPTADINE HYDROCHLORIDE SYRUP
PHYSICIANS TOTAL CARE, 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 HCI 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
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
21
21
14
INDICATIONS AND USAGE
Perennial and seasonal allergic rhinitis
Vasomotor rhinitis
Allergic