CYPROHEPTADINE- cyproheptadine hydrochloride syrup

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Chartwell RX, LLC

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 Pyloro

Περίληψη προϊόντος:

Cyproheptadine Hydrochloride Syrup (Cyproheptadine Hydrochloride Oral Solution USP) 2 mg/5 mL in a yellow, peppermint-flavored vehicle is supplied in a 473 mL (16 fl oz) container (NDC 62135-949-47) and in a 946 mL (32 fl oz) container (NDC 62135-949-94). Store at 20° to 25°C (68° to 77°F) excursion permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure. Manufactured for: Chartwell RX, LLC. Congers, NY 10920 L70984 Rev. 07/2022

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

CYPROHEPTADINE- CYPROHEPTADINE HYDROCHLORIDE SYRUP
CHARTWELL RX, LLC
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CYPROHEPTADINE HYDROCHLORIDE SYRUP
(CYPROHEPTADINE HYDROCHLORIDE ORAL SOLUTION, USP)
2 MG/5 ML
RX ONLY
DESCRIPTION
EACH 5 ML (ONE TEASPOONFUL) CONTAINS: cyproheptadine hydrochloride 2
mg
INACTIVE INGREDIENTS: alcohol 5% (v/v), citric acid, D&C Yellow #10,
butylated
hydroxyanisole, peppermint flavor, sucralose, propylene glycol,
purified water, sodium
citrate, sorbic acid (0.1%, as preservative).
Cyproheptadine Hydrochloride is an antihistaminic and antiserotonergic
agent.
Cyproheptadine hydrochloride is a white to slightly yellowish,
crystalline solid, with a
molecular weight of 350.88, 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 hydrochloride 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
21
21
14
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
Perennial and seasonal