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Clemastine (Clemastine Fumarate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Clemastine Fumarate Syrup is indicated for the relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhea, pruritus and lacrimation. Clemastine Fumarate Syrup is indicated for use in pediatric populations (age 6 years through 12) and adults (see DOSAGE AND ADMINISTRATION).

It should be noted that clemastine fumarate is indicated for the relief of mild uncomplicated allergic skin manifestations of urticaria and angioedema at the 2 mg dosage level only.

DOSAGE AND ADMINISTRATION

DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND RESPONSE OF THE PATIENT.

Pediatric: Children aged 6 to 12 years:

For Symptoms Of Allergic Rhinitis -The starting dose is 1 teaspoonful (0.5 mg clemastine) twice daily. Since single doses of up to 2.25 mg clemastine were well tolerated by this age group, dosage may be increased as required, but not to exceed 6 teaspoonfuls daily (3 mg clemastine). For Urticaria and Angioedema -The starting dose is 2 teaspoonfuls (1 mg clemastine) twice daily, not to exceed 6 teaspoonfuls daily (3 mg clemastine).

Adults and Children 12 years and Over:

For Symptoms Of Allergic Rhinitis -The starting dose is 2 teaspoonfuls (1.0 mg clemastine) twice daily. Dosage may be increased as required, but not to exceed 12 teaspoonfuls daily (6 mg clemastine). For Urticaria and Angioedema -The starting dose is 4 teaspoonfuls (2 mg clemastine) twice daily, not to exceed 12 teaspoonfuls daily (6 mg clemastine).

HOW SUPPLIED

Clemastine Fumarate Syrup: clemastine 0.5 mg/5 mL (present as clemastine fumarate 0.67 mg/5 mL) is as a clear, colorless liquid with a fruity flavor, and supplied as follows:

120 mL bottle(NDC 54838-514-40)

473 mL (1 Pint) bottle (NDC 54838-514-80)

Store below 25°C (77°F). Store in an upright position. Dispense in a tight, light-resistant container.

Manufactured by:
Silarx Pharmaceuticals, Inc.
Spring Valley, NY 10977

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