CHLORMEZANONE
DESCRIPTION:
chlormezanone is (2-(P- Chlorophenyl) tetrahydro-3-methyl-
4H-1, 3-thiazin-4-one 1, 1-dioxide), a white, virtually tasteless, crystalline
powder with a solubility of less than 0.25 percent w/v in water.
ACTIONS/CLINICAL PHARMACOLOGY:
CHLORMEZANONE improves the emotional state by allaying mild anxiety, usually without impairing clarity of consciousness.
The relief of symptoms is often apparent in fifteen to thirty minutes after
administration and may last up to six hours or longer.
INDICATIONS AND USAGE:
CHLORMEZANONE is indicated for the treatment of mild anxiety and tension states.
The effectiveness of chlormezanone in long-term use, that is, more than 4
months, has not been assessed by systematic clinical studies. The physician
should periodically reassess the usefulness of the drug for the individual
patient.
CONTRAINDICATIONS:
Contraindicated in patients with a history of a previous hypersensitivity
reaction to chlormezanone.
WARNINGS:
Should drowsiness occur, the dose should be reduced. As with other CNS-acting
drugs, patients receiving chlormezanone should be warned against performing
potentially hazardous tasks which require complete mental alertness, such as
operating a motor vehicle or dangerous machinery. Patients should also be warned
of the possible additive effects which may occur when the drug is taken with
alcohol or other CNS-acting drugs.
USAGE IN PREGNANCY. Safe use of this preparation in pregnancy or lactation has
not been established, as no animal reproduction studies have been performed;
therefore, use of the drug in pregnancy, lactation, or in women of childbearing
age requires that the potential benefit of the drug be weighed against its
possible hazards to the mother and fetus.
PRECAUTIONS:
SEE WARNINGS
DRUG INTERACTIONS:
SEE WARNINGS
ADVERSE REACTIONS:
Adverse effects reported to occur with CHLORMEZANONE include drowsiness, drug rash,
dizziness, flushing, nausea, depression, edema, inability to void, weakness,
excitement, tremor, confusion, and headache. Rare instances of erythema
multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been
reported. Medication should be discontinued or modified as the case demands.
Jaundice, apparently of the cholestatic type, has been reported as occurring
rarely during the use of chlormezanone, but was reversible on discontinuance of
therapy.
OVERDOSAGE:
Overdose with amounts as low as 7 grams has resulted in coma, hypotension,
absence of reflexes, and flaccidity. Ingestion of higher doses may also result
in alternation between coma and excitement.
DOSAGE AND ADMINISTRATION:
The usual ADULT dosage is 200 mg orally three or four times daily but in some
patients 100 mg may suffice. The dosage for CHILDREN FROM 5 TO 12 YEARS is 50 mg
to 100 mg three or four times daily. Since the effect of CNS-acting drugs
varies, treatment, particularly in children, should begin with the lowest dosage
which may be increased as needed.
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