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
Carbinoxamine maleate is contraindicated in children younger than 2 years of age (see CONTRAINDICATIONS).
Carbinoxamine maleate tablets 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 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:
- Over six years – 1 to 1½ tablets (4 to 6 mg) 3 or 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 – 0.4 mg/kg/day):
- Two to three years –½ teaspoonful (2 mg) 3 or 4 times daily.
- Three to six years –½ teaspoonful to 1 teaspoonful (2 to 4 mg) 3 or 4 times daily
- Over six years - 1 to 1½ teaspoonfuls (4 to 6 mg) 3 or 4 times daily.
|
HOW SUPPLIED
Carbinoxamine Maleate Tablets, USP 4 mg are supplied as white, round, scored tablets, debossed “PAL” on one side and score “4” on the other side, and are supplied in bottles of 100 tablets, NDC 0525-6748-01 and bottles of 500 tablets, NDC 0525-6748-05.
Carbinoxamine Maleate Oral Solution, 4 mg/5 mL is supplied as clear, colorless liquid with a bubble gum aroma, and is supplied in 4 oz bottles NDC 0525-6752-04 and 16 oz bottles NDC 0525-6752-16.
Store at controlled room temperature, 15°C to 30°C (59°F to 86°F) [See USP].
Dispense in a tight, light-resistant container with a child-resistant closure as defined in the official compendium.
Manufactured for:
Pamlab, L.L.C.
Covington, LA 70433
Manufactured by:
MIKART, INC.
Atlanta, GA 30318
Rev. 05/06 Code 838A00
|
