SKELAXIN®
(Metaxalone) Tablets
SKELAXIN (metaxalone) is available as a 400 mg round, pale rose tablet and an 800 mg oval, pink scored tablet.
SKELAXIN (metaxalone) is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Metaxalone does not directly relax tense skeletal muscles in man.
Indications and Usage
SKELAXIN (metaxalone) is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomforts associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Metaxalone does not directly relax tense skeletal muscles in man.
Dosage and Administration
The recommended dose for adults and children over 12 years of age is one 800 mg tablet three to four times a day.
How Supplied
SKELAXIN (metaxalone) is available as an 800 mg oval, scored pink tablet inscribed with 8667 on the scored side and “S” on the other. Available in bottles of 100 (NDC 60793-136-01) and in bottles of 500 (NDC 60793-136-05).
Store at Controlled Room Temperature, between 15°C and 30°C (59°F and 86°F).
Rx Only
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.
Adverse Reactions
The most frequent reactions to metaxalone include:
CNS: drowsiness, dizziness, headache, and nervousness or “irritability”;
Digestive: nausea, vomiting, gastrointestinal upset.
Other adverse reactions are:
Immune System: hypersensitivity reaction, rash with or without pruritus;
Hematologic: leukopenia; hemolytic anemia;
Hepatobiliary: jaundice.
Though rare, anaphylactoid reactions have been reported with metaxalone.
REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO SKELAXIN
Below is a sample of reports where side effects / adverse reactions may be related to Skelaxin. The information is not vetted and should not be cosidered as verified clinical evidence.
Possible Skelaxin side effects / adverse reactions in 16 year old male
Reported by a consumer/non-health professional from United States on 2009-04-02
Patient: 16 year old male weighing 49.9 kg (109.8 pounds)
Reactions: Drug Screen Positive, Disorientation, Memory Impairment, Feeling Abnormal, Lethargy
Suspect drug(s):
Skelaxin
Dosage: 800 mg, prn
Administration route: Oral
Indication: Back Pain
Start date: 2009-02-01
Skelaxin
Indication: Neck Pain
Skelaxin
Indication: Pain in Extremity
Accutane
Other drugs received by patient: Lexapro; Antiinflammatory/antirheumatic Products
Possible Skelaxin side effects / adverse reactions in 53 year old female
Reported by a consumer/non-health professional from United States on 2009-04-02
Patient: 53 year old female
Reactions: Rash
Suspect drug(s):
Skelaxin
Other drugs received by patient: Prempro; Motrin
Possible Skelaxin side effects / adverse reactions in 55 year old male
Reported by a consumer/non-health professional from United States on 2009-04-02
Patient: 55 year old male weighing 62.1 kg (136.7 pounds)
Reactions: Psychomotor Hyperactivity, Fatigue, Insomnia, Feeling Jittery, Feeling Abnormal, Nervousness
Suspect drug(s):
Skelaxin
Other drugs received by patient: ACE Inhibitor NOS; Vitamins /90003601/; Supplements
DRUG INTERACTIONS
Drug Interactions
SKELAXIN may enhance the effects of alcohol, barbiturates and other CNS depressants.
Overdosage
Deaths by deliberate or accidental overdose have occurred with metaxalone, particularly in combination with antidepressants, and have been reported with this class of drug in combination with alcohol.
When determining the LD50 in rats and mice, progressive sedation, hypnosis and finally respiratory failure were noted as the dosage increased. In dogs, no LD50 could be determined as the higher doses produced an emetic action in 15 to 30 minutes.
Treatment - Gastric lavage and supportive therapy. Consultation with a regional poison control center is recommended.
Contraindications
Known hypersensitivity to any components of this product.
Known tendency to drug induced, hemolytic, or other anemias.
Significantly impaired renal or hepatic function.
