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:

REMEDYREPACK INC.

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 urticarial 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 obstr

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 NDC: 70518-0565-00 30 in 1 BLISTER PACK PHARMACIST: Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required). Manufactured by: Appco Pharma LLC Piscataway, NJ 08854 Distributed by: TruPharma, LLC Tampa, FL 33609 Revised: 06/2019 200223 Ver-03 Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CYPROHEPTADINE HYDROCHLORIDE- CYPROHEPTADINE HYDROCHLORIDE TABLET
REMEDYREPACK INC.
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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 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.
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INDICATIONS AND USAGE
Perennial and seasonal allergic rhinitis
Vasomotor rhinitis
Allergic conjunctivitis due to inhalant allergens and foods
Mild, uncomplicated allergic skin manifestations of urticarial and