Brand Name
Clemsza
Generic Name
Clemastine
View Brand Information FDA approval date: December 17, 1997
Form: Syrup, Tablet
What is Clemsza (Clemastine)?
Clemastine Fumarate Tablets USP.
Approved To Treat
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Brand Information
CLEMSZA (Clemastine Fumarate)
1DESCRIPTION
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).
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.
2CLINICAL PHARMACOLOGY
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
3INDICATIONS AND USAGE
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.
4WARNINGS
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.
4.1Usage in Children
Safety and efficacy of clemastine fumarate have not been established in children under the age of 12 years.
4.2Usage 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.
4.3Usage with CNS Depressants
Clemastine has additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, etc.).
4.4Usage 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.
4.5Usage in the Elderly (approximately 60 years or older)
Antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients.
5PRECAUTIONS
Clemastine fumarate should be used with caution in patients with: history of bronchial asthma, increased intraocular pressure, hyperthyroidism, cardiovascular disease, and hypotension.
5.1Drug Interactions
MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines.
6ADVERSE REACTIONS
Transient drowsiness, the most common adverse reaction associated with clemastine fumarate, occurs relatively frequently and may require discontinuation of therapy in some instances.
6.1Antihistaminic 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:Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of the mouth, nose, and throat.
- Cardiovascular System:Hypotension, headache, palpitations, tachycardia, extrasystoles.
- Hematologic System:Hemolytic anemia, thrombocytopenia, agranulocytosis.
- Nervous System:Sedation, sleepiness, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesias, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, hysteria, neuritis, convulsions.
- GI System:Epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation.
- GU System:Urinary frequency, difficult urination, urinary retention, early menses.
- Respiratory System:Thickening of bronchial secretions, tightness of chest and wheezing, nasal stuffiness.
7OVERDOSAGE
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 spontaneouslythe 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.
Stimulantsshould notbe used.
Vasopressors may be used to treat hypotension.
8DOSAGE AND ADMINISTRATION
DOSAGE SHOULD BE INDIVIDUALIZED ACCORDING TO THE NEEDS AND RESPONSE OF THE PATIENT.
8.1Clemastine Fumarate Tablets 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.
9HOW SUPPLIED
Clemastine Fumarate Tablets USP, 2.68 mg are white, round, scored tablets debossed with "NH" and "268". Tablets are packaged in bottles of 30 (NDC 71085-081-30)
10NDC 71085-081-30 Clemastine Fumarate Tablets, USP2.68 mg Rx only Tablets
