Clemastine

Indications

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 (summary)

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).

Contraindications

CONTRAINDICATIONS Antihistamines are contraindicated in patients hypersensitive to the drug or to other antihistamines of similar chemical structure (see PRECAUTIONS - Drug Interactions ). Antihistamines should not be used in newborn or premature Infants. Because of the higher risk of antihistamines for infants generally and for newborns and prematures in particular, antihistamine therapy is contraindicated in nursing mothers (See PRECAUTIONS - Nursing Mothers ).

Warnings and precautions

WARNINGS Antihistamines should be used with considerable caution in patients with: narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, and bladder neck obstruction. Use with CNS Depressants: Clemastine fumarate has additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, etc.) Use in Activities Requiring Mental Alertness: Patients should be warned about engaging in activities requiring mental alertness such as driving a car or operating appliances, machinery, etc.

Storage and supply

HOW SUPPLIED Clemastine Fumarate Syrup: clemastine 0.5 mg/5 mL (present as clemastine fumarate, USP 0.67 mg/5 mL). A clear, colorless liquid with wild cherry flavor, in 120 mL bottle. 120 mL bottle (NDC 62135-713-41) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) . Manufactured for: Chartwell RX, LLC.

Source: Clemastine Fumarate (Clemastine Fumarate) — US FDA prescribing information, 2023-07-07, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.