CLEMASTINE FUMARATE TABLETS, USP Rx only

Clemastine belongs to the benzhydryl ether group of antihistaminic compounds. The chemical name is (+)-(2R)-2-[2-[[(R)-p-Chloro-α-methyl-α-phenylbenzyl]-oxy]ethyl]-1-methylpyrrolidine fumarate (1:1).

C₂₁H₂₆C1NO^.C₄H₄O₄ M.W. 459.97

Each tablet for oral administration contains 2.68 mg of clemastine fumarate, USP.

Inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, povidone, pregelatinized starch and stearic acid.

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 ³H and ¹⁴C labeled compound demonstrates that: clemastine is rapidly and nearly completely absorbed from the gastrointestinal tract, peak plasma concentrations are attained in 2 to 4 hours, and urinary excretion is the major mode of elimination.

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. 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.

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.

Clemastine fumarate should be used with caution in patients with: history of bronchial asthma, increased intraocular pressure, hyperthyroidism, cardiovascular disease, and hypertension.

Transient drowsiness, the most common adverse reaction associated with clemastine fumarate, occurs relatively frequently and may require discontinuation of therapy in some instances.

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 the conscious patient should be induced to vomit. This is best done by having him drink a glass of water or milk after which he should be made to gag. Precautions against aspiration must be taken, especially in infants and children.

If vomiting is unsuccessful gastric lavage is indicated within 3 hours after ingestion and even later if large amounts of milk or cream were given beforehand. Isotonic and 1/2 isotonic saline is the lavage solution of choice.

Saline cathartics, such as milk of magnesia, by osmosis draw water into the bowel and therefore, are valuable for their action in rapid dilution of bowel content.

Stimulants should not be used.

Vasopressors may be used to treat hypotension.

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

Clemastine Fumarate Tablets USP, 2.68 mg are white, round, scored tablets debossed with "93" and "308". Tablets are packaged in bottles of 100. (NDC 0093-0308-01)

Store at 20^o to 25^oC (68^o to 77^oF) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Manufactured For:

Teva Pharmaceuticals

Parsippany, NJ 07054

Rev. J 4/2022

NDC 0093-0308-01

Clemastine Fumarate Tablets, USP

2.68 mg

Rx only

100 Tablets