CLEMASZ- clemastine fumarate_tablet

Clemastine fumarate is an antihistamine with anticholinergic (drying) and sedative side effects. Antihistamines appear to compete with histamine for cell receptor sites on effector cells. The inherently long duration of antihistaminic effects of clemastine fumarate has been demonstrated in wheal and flare studies. In normal human subjects who received histamine injections over a 24-hour period, the antihistaminic activity of clemastine reached a peak at 5 to 7 hours, persisted for 10 to 12 hours and, in some cases, for as long as 24 hours. Pharmacokinetic studies in man utilizing 3 14

CLEMASZ trademark (Clemastine Fumarate Tablets USP) 2.68 mg are indicated for the relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhea, pruritus, and lacrimation. CLEMASZ trademark (Clemastine Fumarate Tablets USP) 2.68 mg are also indicated for the relief of mild, uncomplicated allergic skin manifestations of urticaria and angioedema. It should be noted that clemastine fumarate is indicated for the dermatologic indications at the 2.68 mg dosage level only.

DOSAGE AND ADMINISTRATION
DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND RESPONSE OF THE PATIENT. The maximum recommended dosage is one tablet three times daily. Many patients respond favorably to a single dose which may be repeated as required, but not to exceed three tablets daily.
CLEMASZ ™ (Clemastine Fumarate Tablets,USP) 2.68 mg
The maximum recommended dosage is one tablet three times daily. Many patients respond favorably to a single dose which may be repeated as required, but not to exceed three tablets daily.

ADVERSE REACTIONS
Transient drowsiness, the most common adverse reaction associated with clemastine fumarate, occurs relatively frequently and may require discontinuation of therapy in some instances. It should be noted that the following reactions have occurred with one or more antihistamines and, therefore, should be kept in mind when prescribing drugs belonging to this class, including clemastine. The most frequent adverse reactions are italicized. General: Cardiovascular System: Hematologic System: Nervous System: Sedation, sleepiness, dizziness, disturbed coordination GI System: GU System: Respiratory System:.
Antihistaminic Compounds
It should be noted that the following reactions have occurred with one or more antihistamines and, therefore, should be kept in mind when prescribing drugs belonging to this class, including clemastine. The most frequent adverse reactions are italicized. General: Cardiovascular System: Hematologic System: Nervous System: Sedation, sleepiness, dizziness, disturbed coordination GI System: GU System: Respiratory System:

CONTRAINDICATIONS
Because of the higher risk of antihistamines for infants generally and for newborns and prematures in particular, antihistamine therapy is contraindicated in nursing mothers. Antihistamines should Hypersensitivity to clemastine fumarate or other antihistamines of similar chemical structure. Monoamine oxidase inhibitor therapy (see Drug Interactions.
Usage in Lower Respiratory Disease
Antihistamines should Hypersensitivity to clemastine fumarate or other antihistamines of similar chemical structure. Monoamine oxidase inhibitor therapy (see Drug Interactions

Usage in Nursing Mothers
Because of the higher risk of antihistamines for infants generally and for newborns and prematures in particular, antihistamine therapy is contraindicated in nursing mothers.
Usage in Children
Safety and efficacy of clemastine fumarate have not been established in children under the age of 12 years.
Usage in Pregnancy
Experience with this drug in pregnant women is inadequate to determine whether there is exists a potential for harm to the developing fetus.
Usage in the Elderly (approximately 60 years or older)
Antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients.

Usage with CNS Depressants
Clemastine has additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, etc.).
Drug Interactions
MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines.

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. Safety and efficacy of clemastine fumarate have not been established in children under the age of 12 years. Experience with this drug in pregnant women is inadequate to determine whether there is exists a potential for harm to the developing fetus. Clemastine has additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, etc. Patients should be warned about engaging in activities requiring mental alertness such as driving a car or operating appliances, machinery, etc. Antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients.
OVERDOSAGE
Antihistamine overdosage reactions may vary from central nervous system depression to stimulation. Stimulation is particularly likely in children. Atropine-like signs and symptoms: dry mouth; fixed, dilated pupils; flushing; and gastrointestinal symptoms may also occur. If vomiting has not occurred spontaneously Saline cathartics Stimulants not Vasopressors may be used to treat hypotension.

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