CYPROHEPTADINE HYDROCHLORIDE tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

C.O. Truxton, Inc.

INN (Διεθνής Όνομα):

CYPROHEPTADINE HYDROCHLORIDE

Σύνθεση:

CYPROHEPTADINE HYDROCHLORIDE 4 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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 Eld

Περίληψη προϊόντος:

Cyproheptadine Hydrochloride Tablets USP are available as white to off white, flat-faced, bevel-edged, round shaped tablets, one side debossed with “CYP”, the other side bisected, containing 4 mg of Cyproheptadine HCl packaged in bottles of 100 tablets, NDC 0463-6080-01 PHARMACIST: Dispense in a well-closed container as defined in the USP. Use child-resistant closure (as required). Store at 20° - 25° C (68° - 77° F) excursions permitted to 15° - 30° C (59° - 86° F) [see USP Controlled Room Temperature] Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Manufactured for: Cypress Pharmaceutical, Inc., Madison, MS 39110

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

CYPROHEPTADINE HYDROCHLORIDE - CYPROHEPTADINE HYDROCHLORIDE TABLET
C.O. TRUXTON, INC.
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CYPROHEPTADINE HYDROCHLORIDE TABLETS, USP RX ONLY
DESCRIPTION
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 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 C21H21N•HCl and the
structural formula of the anhydrous salt is:
Cyproheptadine hydrochloride 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
HCl in normal subjects, given as tablets, 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. The principle
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 inhalant allergens and foods
Mild, uncomplicated allergic skin manifestations of urticaria and
angioedema
Ameliora