Clemastine Fumarate
Clemastine Fumarate is listed in the FDA National Drug Code directory with 7 NDC codes, marketed under brand names including Clemastine Fumarate, CLEMSZA. Available dosage forms: powder, syrup, tablet.
Drug Details
- Generic Name
- Clemastine Fumarate
- Brand Names
- Clemastine Fumarate, CLEMSZA
- Application Number
- ANDA073399
- Sponsor
- STHREE CHEMICALS PRIVATE LIMITED
- NDC Codes
- 7
- Dosage Forms
- POWDER, SYRUP, TABLET
- Routes
- ORAL
- Active Ingredients
- CLEMASTINE FUMARATE
Indications and Usage
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 is indicated for the relief of mild uncomplicated allergic skin manifestations of urticaria and angioedema at the 2 mg dosage level only.
Warnings
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 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. Use in the Elderly (approximately 60 years or older) Antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients.