Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
CYPROHEPTADINE HYDROCHLORIDE (UNII: NJ82J0F8QC) (CYPROHEPTADINE - UNII:2YHB6175DO)
Rising Pharmaceuticals, Inc.
CYPROHEPTADINE HYDROCHLORIDE
CYPROHEPTADINE HYDROCHLORIDE 2 mg in 5 mL
ORAL
PRESCRIPTION DRUG
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 obstruct
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 64980-504-48) 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. Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07663 Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02301 R7-10/20 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. Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07663 Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02301 R-10/20
Abbreviated New Drug Application
CYPROHEPTADINE HYDROCHLORIDE - CYPROHEPTADINE HYDROCHLORIDE SYRUP RISING PHARMACEUTICALS, INC. ---------- 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 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 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 21 21 14 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 allergic rhinitis Vasomotor rhinitis Allergic conjunctivitis due to Izlasiet visu dokumentu