Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
CARBINOXAMINE MALEATE (UNII: 02O55696WH) (CARBINOXAMINE - UNII:982A7M02H5)
Foxland Pharmaceuticals, 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 ).
Carbinoxamine maleate tablets, USP, 6 mg are supplied as a white, round tablet, debossed "404" on one side and "ADG" on the other side, in bottles of 20 tablets, NDC 69067-240-20. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure as defined in the official compendium.
Abbreviated New Drug Application
CARBINOXAMINE MALEATE- CARBINOXAMINE MALEATE TABLET FOXLAND PHARMACEUTICALS, INC. ---------- CARBINOXAMINE MALEATE TABLETS, USP 6 MG DESCRIPTION Carbinoxamine maleate is a histamine-H receptor blocking agent. Each tablet contains 6 mg carbinoxamine maleate and the following inactive ingredients: anhydrous lactose, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. 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 ClN O∙C H O MW=406.86 CLINICAL PHARMACOLOGY MECHANISM OF ACTIONS 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 effects of other drugs such as barbiturates, TCAs, MAO inhibitors such as Phenelzine (Nardil), Tranylcypromine (Parnate), or Selegiline (Eldepryl), alcohol, other antihistamines, and CNS depressants. Carbinoxamine can be taken with or without food. CARDIOVASCULAR EFFECTS Cardiac effects, including prolongation of QT int Preberite celoten dokument