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.
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.
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
Prescribing Information as of April 2008.
Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620
Manufactured by: Corepharma LLC, Middlesex, NJ 08846
image of labelimage of label
SKELAXIN
metaxalone tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49999-363(NDC:60793-136)
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METAXALONE (UNII: 1NMA9J598Y) (METAXALONE - UNII:1NMA9J598Y) METAXALONE 800 mg
Inactive Ingredients
Ingredient Name Strength
ALGINIC ACID (UNII: 8C3Z4148WZ)
STARCH, CORN (UNII: O8232NY3SJ)
MAGNESIUM STEARATE (UNII: 70097M6I30)
Product Characteristics
Color pink Score 2 pieces
Shape OVAL Size 20mm
Flavor Imprint Code 8667;S
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49999-363-15 15 in 1 BOTTLE; Type 0: Not a Combination Product 12/14/2011
2 NDC:49999-363-20 20 in 1 BOTTLE; Type 0: Not a Combination Product 12/14/2011 06/01/2014
3 NDC:49999-363-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 12/14/2011
4 NDC:49999-363-60 60 in 1 BOTTLE; Type 0: Not a Combination Product 12/14/2011
5 NDC:49999-363-90 90 in 1 BOTTLE; Type 0: Not a Combination Product 12/14/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA013217 12/14/2011
Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758)
Establishment
Name& |
