SOMA
Carisoprodol is a muscle relaxant used to treat pain caused by muscle spasms.
Brand Name(s):
Carisoprodol Compound, Sodol Compound, Soma Compound
Generic Name Aspirin and Carisprodol
Who is this for?
This medication is a skeletal muscle relaxant used to relieve pain and
discomfort associated with musculoskeletal injuries and conditions.
When should I be careful taking it?
Tell your doctor if you have any pre-existing blood disorders, breathing
trouble, kidney or liver disease, a history of drug dependency or if you have
any allergies. Heavy drinking of alcohol may make your stomach and intestines
more susceptible to the irritating effects of this medication, increasing your
risk of stomach or intestinal bleeding. Limit the use of alcohol while taking
this medication since excessive drowsiness or depression can occur. This
medication should be used during pregnancy only if clearly needed. Discuss the
risks and benefits with your doctor. It is not known if this medication appears
in breast milk. Consult your doctor before breast-feeding.
What side effects should I watch for?
Stomach upset, headache, blurred vision, drowsiness, dizziness, lightheadedness,
hiccup or flushing may occur. If any of these effects continue or become
bothersome, inform your doctor. Notify your doctor immediately if you develop a
rapid heart rate, fainting, fever, breathing difficulties, skin rash or
depression while taking this medication. To avoid dizziness and lightheadedness
when rising from a seated or lying position, get up slowly. Also limit your
intake of alcoholic beverages which will aggravate these effects. Use caution
performing tasks requiring alertness if this medication causes you to feel
drowsy.
What happens if I miss a dose?
If you miss a dose, take it as soon as remembered; do not take it if it is near
the time for the next dose, instead, skip the missed dose and resume your usual
dosing schedule. Do not "double-up" the dose to catch up.
How should I take it?
Take this with food or milk if stomach upset occurs. Take this medication
exactly as directed. Do not increase the dose or take it more often or continue
taking this for longer than prescribed. Safety of long term use has not been
determined.
Where should I keep it?
Store at room temperature between 59 and 86 degrees F (15 to 30 degrees C) away
from heat and light. Do not store in the bathroom.
Carisoprodol Patient Monograph
Drug Classes: Skeletal Muscle Hyperactivity
BRAND NAMES: Artifar; Caridolin; Carisoma; Chinchen; Flexartal; Muslax; Myolax;
Neotica; Rela; Rotalin; Scutamil-C; Soma; Somadril
(Foreign Brand names outside U.S. in italics)
FOREIGN BRAND AVAILABILITY:
Artifar (Greece)
Carisoma (England; India)
Myolax (Thailand)
Somadril (Denmark; Norway; Sweden)
DESCRIPTION
Soma tablets are available as 350 mg round, white tablets. Chemically,
carisoprodol is N-isopropyl-2-methyl-2-propyl-1,3-propanediol dicarbamate.
Carisoprodol is a white, crystalline powder, having a mild, characteristic odor
and a bitter taste. It is very slightly soluble in water; freely soluble in
alcohol, in chloroform, and in acetone; its solubility is practically
independent of pH. Carisoprodol is present as a racemic mixture. The molecular
formula is C12H24N2O4, with a molecular weight of 260.33.
Other ingredients include alginic acid, magnesium stearate, potassium sorbate,
starch, tribasic calcium phosphate.
CLINICAL PHARMACOLOGY
Carisoprodol produces muscle relaxation in animals by blocking interneuronal
activity in the descending reticular formation and spinal cord. The onset of
action is rapid and effects last four to six hours.
INDICATIONS AND USAGE
Carisoprodol is indicated as an adjunct to rest, physical therapy, and other
measures for the relief of discomfort 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. Carisoprodol does not
directly relax tense skeletal muscles in man.
CONTRAINDICATIONS
Acute intermittent porphyria as well as allergic or idiosyncratic reactions to
carisoprodol or related compounds, such as meprobamate, mebutamate, or tybamate.
WARNINGS
Idiosyncratic Reactions: On very rare occasions, the first dose of carisoprodol
has been followed by idiosyncratic symptoms appearing within minutes or hours.
Symptoms Reported Include: Extreme weakness, transient quadriplegia, dizziness,
ataxia, temporary loss of vision, diplopia, mydriasis, dysarthria, agitation,
euphoria, confusion, and disorientation. Symptoms usually subside over the
course of the next several hours. Supportive and symptomatic therapy, including
hospitalization, may be necessary.
Usage in Pregnancy and Lactation: Safe usage of this drug in pregnancy or
lactation has not been established. Therefore, use of this drug in pregnancy, in
nursing mothers, or in women of childbearing potential requires that the
potential benefits of the drug be weighed against the potential hazards of the
mother and child. Carisoprodol is presenting breast milk of lactating mothers at
concentrations two to four times that of maternal plasma. This factor should be
taken into account when use of the drug is contemplated in breast-feeding
patients.
Use in Children: Because of limited clinical experience, carisoprodol is not
recommended for use in patients under 12 years of age.
Potentially Hazardous Tasks: Patients should be warned that this drug may impair
the mental and/or physical abilities required for the performance of potentially
hazardous tasks such as driving a motor vehicle or operating machinery.
Additive Effects: Since the effects of carisoprodol and alcohol or carisoprodol
and other CNS depressants or psychotropic drugs may be additive, appropriate
caution should be exercised with patients who take more than one of these agents
simultaneously.
PRECAUTIONS
Carisoprodol is metabolized in the liver and excreted by the kidney; to avoid
its excess accumulation, caution should be exercised in administration to
patients with compromised liver or kidney function.
ADVERSE REACTIONS
Central Nervous System: Drowsiness and other CNS effects may require dosage
reduction. Also observed: dizziness, vertigo, ataxia, tremor, agitation,
irritability, headache, depressive reactions, syncope, and insomnia. (See
WARNINGS, Idiosyncratic Reactions.)
Allergic or Idiosyncratic: Allergic or idiosyncratic reactions occasionally
develop. They are usually seen within the period of the first to fourth dose in
patients having had no previous contact with the drug. Skin rash, erythema
multiforme, pruritus, eosinophilia, and fixed drug eruption with cross reaction
to meprobamate have been reported with carisoprodol. Severe reactions have been
manifested by asthmatic episodes, fever, weakness, dizziness, angioneurotic
edema, smarting eyes, hypotension, and anaphylactoid shock. (See WARNINGS,
Idiosyncratic Reactions.)
In case of allergic or idiosyncratic reactions to carisoprodol, discontinue the
drug and initiate appropriate symptomatic therapy, which may include
epinephrine, antihistamines, and in severe cases corticosteroids. In evaluating
possible allergic reactions, also consider allergy to excipients (information on
excipients is available to physicians on request).
Cardiovascular: Tachycardia, postural hypotension, and facial flushing.
Gastrointestinal: Nausea, vomiting, hiccup, and epigastric distress.
Hematologic: Leukopenia, in which other drugs or viral infection may have been
responsible, and pancytopenia, attributed to phenylbutazone, have been reported.
No serious blood dyscrasias have been attributed to carisoprodol.
DRUG ABUSE AND DEPENDENCE
In dogs, no withdrawal symptoms occurred after abrupt cessation of carisoprodol
from dosages as high as 1 g/kg/day. In a study in man, abrupt cessation of 100
mg/kg/day (about five times the recommended daily adult dosage) was followed in
some subjects by mild withdrawal symptoms such as abdominal cramps, insomnia,
chilliness, headache, and nausea. Delirium and convulsions did not occur. In
clinical use, psychological dependence and abuse have been rare, and there have
been no reports of significant abstinence signs. Nevertheless, the drug should
be used with caution in addiction-prone individuals.
OVERDOSAGE
Overdosage of carisoprodol has produced stupor, coma, shock, respiratory
depression, and, very rarely, death. The effects of an overdosage of
carisoprodol and alcohol or other CNS depressants or psychotropic agents can be
additive even when one of the drugs has been taken in the usual recommended
dosage. Any drug remaining in the stomach should be removed and symptomatic
therapy given. Should respiration or blood pressure become compromised,
respiratory assistance, central nervous system stimulants, and pressor agents
should be administered cautiously as indicated. Carisoprodol is metabolized in
the liver and excreted by the kidney. Although carisoprodol overdosage
experience is limited, the following types of treatment have been used
successfully with the related drug meprobamate: diuresis, osmotic (mannitol)
diuresis, peritoneal dialysis, and hemodialysis (carisoprodol is dialyzable).
Careful monitoring of urinary output is necessary and caution should be taken to
avoid overhydration. Observe for possible relapse due to incomplete gastric
emptying and delayed absorption. Carisoprodol can be measured in biological
fluids by gas chromatography.1
DOSAGE AND ADMINISTRATION
The usual adult dosage of carisoprodol is one 350 mg tablet, three times daily
and at bedtime. Usage in patients under age 12 is not recommended.
REFERENCES
1. Douglas, J. F., et al.: J Pharm Sci 58: 145, 1969.
PATIENT INFORMATION
Carisoprodol is a muscle relaxant used to relieve the pain and stiffness of
muscle spasms and discomfort due to strain and sprain. Inform your physician if
you are pregnant or nursing. Do not take this medication with a monoamine
oxidase inhibitor. This medication may cause dizziness, drowsiness, or blurred
vision; use caution while driving or operating hazardous machinery. Do not take
any other sedating drugs or drink alcohol while taking carisoprodol. If
dizziness occurs, avoid sudden changes in posture. Take this medication with
food to avoid stomach upset. Notify your physician if you develop trouble
breathing, unexplained fever, severe weakness, vision changes, swelling, or skin
rash. Withdrawal symptoms may occur if therapy is suddenly stopped in a patient
on long-term or high-dose therapy.
HOW SUPPLIED
Soma Tablets 350 mg: Round, convex, white tablets, inscribed with SOMA on one
side and 37-WALLACE 2001 on the other side.
Storage: Store at controlled room temperature 15-30°C (59-86°F). Dispense in a
tight container.