Drug Catalog - Product Detail
CARBINOXAMINE MALEATE ORAL SOLUTION SOL 4MG/5ML 118ML
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 64376-0612-40 | PAR PHARMACEUTICAL | 118 | 4MG/5ML | SOLUTION |
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Description
DESCRIPTION Carbinoxamine maleate is a histamine-H 1 receptor blocking agent. Each tablet contains 4 mg carbinoxamine maleate. Inactive ingredients: anhydrous lactose, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. Each 5 mL (teaspoonful) of oral solution contains 4 mg carbinoxamine maleate. Inactive ingredients: artificial banana bubble gum flavor, citric acid (anhydrous), glycerin, purified water, sodium benzoate 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) Image from Drug Label Content
How Supplied
HOW SUPPLIED Carbinoxamine Maleate Tablets USP, 4 mg are supplied as white, round tablets scored and debossed “B” bisected “P” on one side and “605” on the other side, and supplied in bottles of 100 tablets, NDC 64376-605-01. Carbinoxamine Maleate Oral Solution, 4 mg/5 mL is supplied as clear, colorless liquid with a banana bubble gum flavor, and is supplied in 4 oz bottles NDC 64376-612-40 and 16 oz bottles NDC 64376-612-16. Storage and Handling Store at 20°-25°C (68°-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. Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977 Revised: 02/2018 500480-01
Indications & Usage
INDICATIONS AND USAGE 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.
Dosage and Administration
DOSAGE AND ADMINISTRATION Carbinoxamine maleate is contraindicated in children younger than 2 years of age (see CONTRAINDICATIONS ). Carbinoxamine maleate should be taken on an empty stomach with water. DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND THE RESPONSE OF THE PATIENT. Carbinoxamine maleate dosage should be based on the severity of the condition and the response of the patient. The drug is well tolerated in adult doses as high as 24 mg daily, in divided doses, over prolonged periods. On the other hand, some patients respond to as little as 4 mg daily. Clinical experience suggests the following dosage schedules: TABLETS Usual Adult Dosage: 1 or 2 tablets (4 to 8 mg) 3 to 4 times daily. Usual Child’s Dosage: Six to eleven years – 1/2 to 1 tablet (2 to 4 mg) 3 to 4 times daily. ORAL SOLUTION Usual Adult Dosage: 1 or 2 teaspoonfuls (4 to 8 mg) 3 to 4 times daily. Usual Child’s Dosage: (approximately 0.2 to 0.4 mg/kg/day, divided into 3 to 4 doses): Six to eleven years – 1/2 to 1 teaspoonful (2 to 4 mg) 3 to 4 times daily. Dosing for children 2 to 5 years of age should be based on weight whenever possible. The usual dosage for children 2 to 5 years of age is approximately 0.2 to 0.4 mg/kg/day, divided into 3 to 4 daily doses. In general, this corresponds to a dose of 1/4 to 1/2 teaspoonful (1 to 2 mg) 3 to 4 times daily.