Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
CARBINOXAMINE MALEATE (UNII: 02O55696WH) (CARBINOXAMINE - UNII:982A7M02H5)
Breckenridge Pharmaceutical, Inc.
ORAL
PRESCRIPTION DRUG
Carbinoxamine maleate is effective for the symptomatic treatment of: Seasonal and perennial allergic rhinitis. Vasomotor rhinitis. Allergic conjunctivitis due to inhalant allergens and foods. Mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Dermatographism. As therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after the acute manifestations have been controlled. Amelioration of the severity of allergic reactions to blood or plasma. Carbinoxamine maleate is contraindicated in children younger than 2 years of age. Carbinoxamine maleate is contraindicated in nursing mothers. Carbinoxamine maleate is contraindicated in patients who are hypersensitive to the drug or on monoamine oxidase inhibitor therapy. (See Drug Interactions section).
Carbinoxamine Maleate Tablets, USP 4 mg are supplied as white, round, scored tablets, debossed “109” on one side and score over “C” on the other side, and is supplied in bottles of 100 tablets, NDC 51991-333-01. Carbinoxamine Maleate Oral Solution, 4 mg/5 mL is supplied as clear, colorless liquid with a bubble gum aroma, and is supplied in 4 fl. oz. bottles, NDC 51991-334-04.
Abbreviated New Drug Application
CARBINOXAMINE MALEATE- CARBINOXAMINE MALEATE TABLET CARBINOXAMINE MALEATE- CARBINOXAMINE MALEATE SYRUP BRECKENRIDGE PHARMACEUTICAL, INC. ---------- DESCRIPTION Carbinoxamine maleate is a histamine-H receptor blocking agent. Each tablet contains 4 mg carbinoxamine maleate and the following inactive ingredients: anhydrous lactose, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. Each 5 mL (teaspoonful) of oral solution contains 4 mg carbinoxamine maleate and the following inactive ingredients: artificial bubble gum flavor, citric acid (anhydrous), glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate (hydrous) and sorbitol solution. Carbinoxamine maleate is freely soluble in water. Its structure is: 2-[(4-chlorophenyl)-2-pyridinylmethoxy]- _N_, N _-dimethylethanamine_ (Z)-2-butenedioate (1:1) C H CIN O∙C H O MW = 406.86 CLINICAL PHARMACOLOGY MECHANISM OF ACTION Carbinoxamine maleate, an ethanolamine derivative, is an antihistamine with anticholinergic (drying) and sedative properties. Carbinoxamine appears to compete with histamine (type H1) for receptor sites on effector cells in the gastrointestinal tract, blood vessels and respiratory tract. PHARMACOKINETICS AND METABOLISM Carbinoxamine is well absorbed from the GI tract and appears to be extensively metabolized by the liver, and excreted in the urine as inactive metabolites within 24 hours. Virtually no intact drug is extended in the urine. 1 16 19 2 4 4 4 In a study comparing a controlled-release suspension and a solution of carbinoxamine, healthy volunteers were administered a single dose of 8 mg carbinoxamine. A time to maximum concentration (Tmax) was between 1.5 hours to 5 hours, a peak plasma concentration (Cmax) of about 24 ng/mL was observed and extent of exposure (AUC) was about 286 ng hr/mL. The serum half-life is reported to be 10 to 20 hours. DRUG/FOOD INTERACTIONS Carbinoxamine should not be used in patients with hypersensitivity to carbinoxamine. Carbinoxamine may increase the effect Læs hele dokumentet