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Skelaxin
Overview
What is Skelaxin?
SKELAXIN (metaxalone) is available as an
800 mg oval, scored pink tablet.
Chemically, metaxalone is 5-[(3,5- dimethylphenoxy) methyl]-2-oxazolidinone.
The empirical formula is CHNO, which corresponds to a molecular
weight of 221.25. The structural formula is:
Metaxalone is a white to almost white, odorless crystalline powder freely
soluble in chloroform, soluble in methanol and in 96% ethanol, but practically
insoluble in ether or water.
Each tablet contains 800 mg metaxalone and the following inactive
ingredients: alginic acid, ammonium calcium alginate, B-Rose Liquid, corn starch
and magnesium stearate.
What does Skelaxin look like?
What are the available doses of Skelaxin?
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What should I talk to my health care provider before I take Skelaxin?
Sorry No records found
How should I use Skelaxin?
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.
The recommended dose for adults and children over 12 years of age is one 800 mg
tablet three to four times a day.
What interacts with Skelaxin?
Known hypersensitivity to any components of this product.
Known tendency to drug induced, hemolytic, or other anemias.
Significantly impaired renal or hepatic function.
What are the warnings of Skelaxin?
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What are the precautions of Skelaxin?
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).
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.
SKELAXIN may enhance the effects of alcohol, barbiturates and
other CNS depressants.
The carcinogenic potential of metaxalone has not been
determined.
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.
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.
Safety and effectiveness in children 12 years of age and below
have not been established.
What are the side effects of Skelaxin?
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.
What should I look out for while using Skelaxin?
Known hypersensitivity to any components of this product.
Known tendency to drug induced, hemolytic, or other anemias.
Significantly impaired renal or hepatic function.
SKELAXIN may enhance the effects of alcohol and other CNS depressants.
What might happen if I take too much Skelaxin?
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 LD in rats and mice,
progressive sedation, hypnosis and finally respiratory failure were noted as the
dosage increased. In dogs, no LD 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.
How should I store and handle Skelaxin?
Procedures for proper handling and disposal should be considered. Consideration should be given to handling and disposal according to guidelines issued for cytotoxic drugs. Several guidelines on this subject have been published. Caution should be exercised in the handling and preparation of Fludarabine Phosphate Injection solution. The use of latex gloves and safety glasses is recommended to avoid exposure in case of breakage of the vial or other accidental spillage. If the solution contacts the skin or mucous membranes, wash thoroughly with soap and water; rinse eyes thoroughly with plain water. Avoid exposure by inhalation or by direct contact of the skin or mucous membranes.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:Store at Controlled Room Temperature, between 15°C and 30°C (59°F and 86°F). Rx OnlySKELAXIN (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:Store at Controlled Room Temperature, between 15°C and 30°C (59°F and 86°F). Rx OnlySKELAXIN (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:Store at Controlled Room Temperature, between 15°C and 30°C (59°F and 86°F). Rx Only
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The mechanism of action of metaxalone in humans has not been
established, but may be due to general central nervous system depression.
Metaxalone has no direct action on the contractile mechanism of striated muscle,
the motor end plate or the nerve fiber.
The pharmacokinetics of metaxalone have been evaluated in healthy
adult volunteers after single dose administration of SKELAXIN under fasted and
fed conditions at doses ranging from 400 mg to 800 mg.
Peak plasma concentrations of metaxalone occur approximately 3
hours after a 400 mg oral dose under fasted conditions. Thereafter, metaxalone
concentrations decline log-linearly with a terminal half-life of 9.0 ± 4.8
hours. Doubling the dose of SKELAXIN from 400 mg to 800 mg results in a roughly
proportional increase in metaxalone exposure as indicated by peak plasma
concentrations (C) and area under the curve (AUC).
Dose proportionality at doses above 800 mg has not been studied. The absolute
bioavailability of metaxalone is not known.
The single-dose pharmacokinetic parameters of metaxalone in two groups of
healthy volunteers are shown in Table 1.
A randomized, two-way, crossover study was conducted in 42
healthy volunteers (31 males, 11 females) administered one 400 mg SKELAXIN
tablet under fasted conditions and following a standard high-fat breakfast.
Subjects ranged in age from 18 to 48 years (mean age = 23.5 ± 5.7 years).
Compared to fasted conditions, the presence of a high fat meal at the time of
drug administration increased C by 177.5% and
increased AUC (AUC, AUC) by
123.5% and 115.4%, respectively. Time-to-peak concentration (T) was also delayed (4.3 h
3.3 h) and terminal half-life was decreased (2.4 h 9.0 h) under fed conditions compared to fasted.
In a second food effect study of similar design, two 400 mg SKELAXIN tablets
(800 mg) were administered to healthy volunteers (N=59, 37 males, 22 females),
ranging in age from 18-50 years (mean age = 25.6± 8.7 years). Compared to fasted
conditions, the presence of a high fat meal at the time of drug administration
increased C by 193.6% and increased AUC (AUC, AUC) by 146.4% and 142.2%,
respectively. Time-to-peak concentration (T) was also
delayed (4.9 h 3.0 h) and terminal half-life
was decreased (4.2 h 8.0 h) under fed
conditions compared to fasted conditions. Similar food effect results were
observed in the above study when one SKELAXIN 800 mg tablet was administered in
place of two SKELAXIN 400 mg tablets. The increase in metaxalone exposure
coinciding with a reduction in half-life may be attributed to more complete
absorption of metaxalone in the presence of a high fat meal (Figure 1).
Although plasma protein binding and absolute bioavailability of
metaxalone are not known, the apparent volume of distribution (V/F ~ 800 L) and
lipophilicity (log P = 2.42) of metaxalone suggest that the drug is extensively
distributed in the tissues. Metaxalone is metabolized by the liver and excreted
in the urine as unidentified metabolites.
The effects of age on the pharmacokinetics of metaxalone were
determined following single administration of two 400 mg tablets (800 mg) under
fasted and fed conditions. The results were analyzed separately, as well as in
combination with the results from three other studies. Using the combined data,
the results indicate that the pharmacokinetics of metaxalone are significantly
more affected by age under fasted conditions than under fed conditions, with
bioavailability under fasted conditions increasing with age.
The bioavailability of metaxalone under fasted and fed conditions in three
groups of healthy volunteers of varying age is shown in Table 2.
The effect of gender on the pharmacokinetics of metaxalone was
assessed in an open label study, in which 48 healthy adult volunteers (24 males,
24 females) were administered two SKELAXIN 400 mg tablets (800 mg) under fasted
conditions. The bioavailability of metaxalone was significantly higher in
females compared to males as evidenced by C (2115
ng/mL 1335 ng/mL) and AUC (17884 ng·h/mL 10328
ng·h/mL). The mean half-life was 11.1 hours in females and 7.6 hours in males.
The apparent volume of distribution of metaxalone was approximately 22% higher
in males than in females, but not significantly different when adjusted for body
weight. Similar findings were also seen when the previously described combined
dataset was used in the analysis.
The impact of hepatic and renal disease on the pharmacokinetics
of metaxalone has not been determined. In the absence of such information,
SKELAXIN should be used with caution in patients with hepatic and/or renal
impairment.
Non-Clinical Toxicology
Known hypersensitivity to any components of this product.Known tendency to drug induced, hemolytic, or other anemias.
Significantly impaired renal or hepatic function.
SKELAXIN may enhance the effects of alcohol and other CNS depressants.
As adapalene gel has the potential to produce local irritation in some patients, concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, and products with high concentrations of alcohol, astringents, spices, or lime) should be approached with caution. Particular caution should be exercised in using preparations containing sulfur, resorcinol, or salicylic acid in combination with adapalene gel. If these preparations have been used, it is advisable not to start therapy with adapalene gel until the effects of such preparations in the skin have subsided.
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).
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.
SKELAXIN may enhance the effects of alcohol, barbiturates and other CNS depressants.
The carcinogenic potential of metaxalone has not been determined.
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.
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.
Safety and effectiveness in children 12 years of age and below have not been established.
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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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