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 in Children
Safety and efficacy of clemastine fumarate have not been established in children under the age of 12 years.
Use in Pregnancy
Experience with this drug in pregnant women is inadequate to determine whether there exists a potential for harm to the developing fetus.
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.
There is currently no manufacturer warning information available for this drug.
Clemastine fumarate tablets are indicated for the relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhea, pruritus, and lacrimation.
Clemastine fumarate tablets are also indicated for the relief of mild, uncomplicated allergic skin manifestations of urticaria and angioedema.
It should be noted that clemastine is indicated for the dermatologic indications at the 2.68 mg dosage level only.
Clemastine fumarate belongs to the benzhydryl ether group of antihistaminic compounds. The chemical name is (+)-2-[-2- [(p-chloro-α-methyl-α-phenylbenzyl) oxy] ethyl]-1-methylpyrrolidine hydrogen fumarate. It has the following structural formula:
Each tablet for oral administration contains 2.68 mg clemastine fumarate. Inactive ingredients include lactose (monohydrate), hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and starch (corn).
