WARNINGS
SKELAXIN may enhance the effects of alcohol and other CNS depressants.
PRECAUTIONS
Metaxalone should be administered with great care to patients
with pre-existing liver damage. Serial liver function studies should be
performed in these patients.
False-positive Benedict’s tests, due to an unknown reducing substance, have
been noted. A glucose-specific test will differentiate findings.
Taking SKELAXIN with food may enhance general CNS depression; elderly
patients may be especially susceptible to this CNS effect. (See CLINICAL
PHARMACOLOGY: Pharmacokinetics and PRECAUTIONS: Information for Patients).
Information for Patients
SKELAXIN may impair mental and/or physical abilities required for
performance of hazardous tasks, such as operating machinery or driving a motor
vehicle, especially when used with alcohol or other CNS depressants.
Drug Interactions
SKELAXIN may enhance the effects of alcohol, barbiturates and
other CNS depressants.
Carcinogenesis, Mutagenesis, Impairment of
Fertility
The carcinogenic potential of metaxalone has not been
determined.
Pregnancy
Reproduction studies in rats have not revealed evidence of
impaired fertility or harm to the fetus due to metaxalone. Post marketing
experience has not revealed evidence of fetal injury, but such experience cannot
exclude the possibility of infrequent or subtle damage to the human fetus. Safe
use of metaxalone has not been established with regard to possible adverse
effects upon fetal development. Therefore, metaxalone tablets should not be used
in women who are or may become pregnant and particularly during early pregnancy
unless in the judgement of the physician the potential benefits outweigh the
possible hazards.
Nursing Mothers
It is not known whether this drug is secreted in human milk. As a
general rule, nursing should not be undertaken while a patient is on a drug
since many drugs are excreted in human milk.
Pediatric Use
Safety and effectiveness in children 12 years of age and below
have not been established.
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