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:

Chartwell RX, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 obstruct

Product summary:

HOW SUPPLIED: Each tablet contains 4 mg of cyproheptadine hydrochloride, are white to off-white, round, flat faced, beveled edge tablets debossed with “CE 73” on one side and a score on other side. They are supplied as follows: bottles of 90 count, NDC 62135-236-90. Dispensing Information: Dispense in tight containers as defined by the USP/NF. Caution: Federal law prohibits dispensing without prescription. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured for: Chartwell RX, LLC Congers, NY 10920 Telephone Number-1-845-232-1683 L70791 Rev. 01/2023

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYPROHEPTADINE HYDROCHLORIDE- CYPROHEPTADINE HYDROCHLORIDE TABLET
CHARTWELL RX, LLC
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CYPROHEPTADINE HCL TABLETS USP
DESCRIPTION: Cyproheptadine HCl, is an antihistaminic and
antiserotonergic agent.
Cyproheptadine hydrochloride is a while 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
NHC1. and the
structural formula of the anhydrous salt is:
Cyproheptadine hydrochloride is available in 4 mg tablets.
EACH TABLET CONTAINS:
ACTIVE INGREDIENT:
Cyproheptad1ne Hydrochloride ...................... 4 mg
EACH TABLET CONTAINS:
INACTIVE INGREDIENTS:
Colloidal silicon dioxide, lactose monohydrate, magnesium stearate,
microcrystalline
cellulose, pregelatinized starch (corn), stearic acid.
CLINICAL PHARMACOLOGY:
Cyproheptadine HCI is a serotonin and histamine antagonist with
anticholinergic and
sedative effects. Antiserotonin and antihistamine drugs appears to
compete with
serotonin and histamine, respectively, for receptor sites.
21
21
PHARMACOKINETICS AND METABOLISM: After a single 4 mg oral dose of
14C-labeled
cyproheptadine HCl 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 significant difference in
the mean urinary
excretion exists between the tablet and syrup formulations. No
detectable amounts of
unchanged drug were present in the urine of patients of 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