SKELAXIN
Skelaxin is a muscle relaxant used to treat pain caused by muscle spasms.
Brand Name(s):
Skelaxin
Generic Name Metaxalone
Phonetic: (me tax' a lone)
Who is this for?
Metaxalone, a muscle relaxant, is used with rest, physical therapy, and other
measures to relax muscles and relieve pain and discomfort caused by strains,
sprains, and other muscle injuries. This medication is sometimes prescribed for
other uses; ask your doctor or pharmacist for more information.
When should I be careful taking it?
Before taking metaxalone,
tell your doctor and pharmacist if you are allergic to metaxalone or any other
drugs.
tell your doctor and pharmacist what prescription and nonprescription
medications you are taking, especially medications for seizures, allergies,
colds, or coughs; pain medications; sedatives; tranquilizers; and vitamins.
tell your doctor if you have or have ever had kidney disease, liver disease,
seizures, or a blood disorder.
tell your doctor if you are pregnant, plan to become pregnant, or are
breast-feeding. If you become pregnant while taking metaxalone, call your doctor
immediately.
you should know that this drug may make you drowsy. Do not drive a car or
operate machinery until you know how metaxalone affects you.
remember that alcohol can add to the drowsiness caused by this drug.
What side effects should I watch for?
Although side effects from metaxalone are not common, they can occur. Tell your
doctor if any of these symptoms are severe or do not go away:
drowsiness
dizziness
upset stomach
vomiting
headache
nervousness
If you experience any of the following symptoms, call your doctor immediately:
severe skin rash
difficulty breathing
yellowing of the skin or eyes
unusual bruising or bleeding
unusual tiredness or weakness
seizures
How should I take it?
Metaxalone comes as a tablet to take by mouth. It usually is taken three or four
times a day. Follow the directions on your prescription label carefully, and ask
your doctor or pharmacist to explain any part you do not understand. Take
metaxalone exactly as directed. Do not take more or less of it or take it more
often than prescribed by your doctor.
What happens if I miss a dose?
Take the missed dose as soon as you remember it. However, if it is almost time
for your next dose, skip the missed dose and continue your regular dosing
schedule. Do not take a double dose to make up for a missed one.
Where should I keep it?
Keep this medication in the container it came in, tightly closed, and out of
reach of children. Store it at room temperature, away from excess heat and
moisture (not in the bathroom). Throw away any medication that is outdated or no
longer needed. Ask your pharmacist about the proper disposal of your medication.
Skelaxin Patient Monograph
DCATEGORIES: Pain, musculoskeletal; FDA Approved 1962 Aug; Pregnancy Category C
Drug Classes: Musculoskeletal agents; Relaxants, skeletal muscle
BRAND NAMES: Skelaxin
COST OF THERAPY:
$29.94 (Musculoskeletal Pain; Skelaxin; 400 mg; 6 tablets/day; 10 day supply)
DESCRIPTION
Each pale rose, scored tablet contains: metaxalone, 400 mg.
Metaxalone has the following chemical name: 5-[(3,
4-dimethylphenoxy)methyl]-2-oxazolidinone.
CLINICAL PHARMACOLOGY
The mechanism of action of metaxalone in humans has not been established, but
may be due to general central nervous system depression. It has direct action on
the contractile mechanism of striated muscle, the motor end plate or the nerve
fiber.
INDICATIONS AND USAGE
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.
CONTRAINDICATIONS
Metaxalone is contraindicated in individuals who have shown hypersensitivity to
the drug. Metaxalone should not be administered to patients with a known
tendency to drug induced, hemolytic, or other anemias. It is contraindicated in
patients with significantly impaired renal or hepatic function.
PRECAUTIONS
Elevation in cephalin flocculation tests without concurrent changes in other
liver function parameters have been noted. Hence, it is recommended that
metaxalone be administered with great care to patients with pre-existing liver
damage and that serial liver function studies be performed as required.
False-positive Benedict's tests, due to an unknown reducing substance, have been
noted. A glucose-specific test will differentiate findings.
Pregnancy
Reproduction studies have been performed in rats and have revealed no evidence
of impaired fertility or harm to the fetus due to metaxalone. Reactions reports
from marketing experience have 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 judgment 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 nausea, vomiting,
gastrointestinal upset, drowsiness, dizziness, headache, and nervousness or
"irritability." Other adverse reactions are: hypersensitivity reactions,
characterized by a light rash with or without pruritus; leukopenia; hemolytic
anemia; jaundice.
OVERDOSAGE
Gastric lavage and supportive therapy as indicated. (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 15-30 minutes). No documented case of
major toxicity has been reported.
DOSAGE AND ADMINISTRATION
The recommended dose for adults and children over 12 years of age is 2 tablets
(800 mg) 3 to 4 times a day.
HOW SUPPLIED
Skelaxin is available as a 400 mg pale rose tablet, inscribed with "8862" on the
scored side and "C" on the other.
Storage: Store at controlled room temperature, between 15-30°C (59-86°F).