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Carbinoxamine (Carbinoxamine Maleate) - Indications and Dosage

 
 



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 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:

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 - ½ 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.

HOW SUPPLIED

Palgic (Carbinoxamine Maleate Tablets USP, 4 mg) is 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.

Palgic (Carbinoxamine Maleate Oral Solution, 4 mg/5 mL) is also 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

Code 838B00

Rev. 09/10

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