June 30, 2016
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Skelaxin

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Skelaxin




Warnings
Precautions

WARNINGS

Serotonin syndrome (SS), which is potentially life-threatening, has been reported with metaxalone use. These reports generally occurred when metaxalone was used concomitantly with serotonergic drugs (such as tramadol or selective serotonin reuptake inhibitors (SSRIs)) or when metaxalone was used at doses higher than the recommended dose (see DRUG INTERACTIONS and OVERDOSAGE). Signs of SS may include clonus, agitation, diaphoresis, tremor, hyperreflexia, hypertonia, and temperature elevation.

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 PATIENT INFORMATION).

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.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 5/18/2016

Warnings
Precautions

Skelaxin - User Reviews

Skelaxin User Reviews

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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