Soma

Before taking Soma, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have a history of addictive behavior
• have a history of seizures
• have a history of kidney or liver disease
• are allergic to Soma or meprobamate
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Soma falls into category C. This medication may be given to a pregnant woman if her healthcare provider believes that its benefits to the pregnant woman outweigh any possible risks to her unborn baby.

Skeletal muscle relaxant; structurally and pharmacologically related to meprobamate, mebutamate, and tybamate.100 a

Administration

Administer orally with or without food.100

Dosage

Adults

250–350 mg 3 times daily and at bedtime.100

Prescribing Limits

Adults

Do not administer for more than 2–3 weeks.100

Metabolized by CYP2C19.100

Drugs Affecting Hepatic Microsomal Enzymes

CYP2C19 inhibitors: Potential pharmacokinetic interaction (increased exposure to carisoprodol and decreased exposure to meprobamate).100 Clinical importance unknown.100

CYP2C19 inducers: Potential pharmacokinetic interaction (decreased exposure to carisoprodol and increased exposure to meprobamate).100 Clinical importance unknown.100

Specific Drugs

Absorption

Bioavailability

Peak plasma concentrations achieved in approximately 1.5–2 hours.100 121

Food

High-fat meal does not affect pharmacokinetics.100

Onset

Usually within 30 minutes.a

Duration

4–6 hours.a

Special Populations

Patients with genetic CYP2C19 deficiency (i.e., poor metabolizers) may have fourfold increase in carisoprodol exposure and 50% decrease in meprobamate exposure compared with individuals with normal CYP2C19 function.100

Distribution

Extent

Crosses the placenta; distributes into milk in concentrations 2–4 times higher than concurrent maternal plasma concentrations.100 110 125

Elimination

Metabolism

Metabolized in the liver by CYP2C19.100 112

Several metabolites (meprobamate, hydroxycarisoprodol, hydroxymeprobamate) identified; meprobamate is main active metabolite.100 112 117

Elimination Route

Eliminated via both renal and nonrenal routes.100

Half-life

Carisoprodol: About 2 hours.100 121

Meprobamate: About 10 hours.100 121

Special Populations

May be removed by hemodialysis or peritoneal dialysis.100 Accumulation of carisoprodol may occur in patients with hepatic or renal impairment.100

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Carisoprodol is subject to control under the Federal Controlled Substances Act of 1970 as a schedule IV (C-IV) drug. Preparations containing the drug combined with codeine phosphate are subject to control as schedule III (C-III) drugs.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for alertness while you take Soma. Talk with your doctor.
• Use this medicine for short periods of time. If signs show up again, talk with the doctor.
• Do not take Soma for longer than you were told by your doctor.
• Avoid drinking alcohol while taking this medicine.
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• This medicine may be habit-forming with long-term use.
• If you have been taking Soma on a regular basis and you stop it all of a sudden, you may have signs of withdrawal. Do not stop taking this medicine all of a sudden without calling your doctor. Tell your doctor if you have any bad effects.
• Taking more of Soma or taking it more often than you have been told may cause it to not work as well. This is known as tolerance. Talk with your doctor if this medicine stops working well. Do not take more than ordered.
• Abuse and misuse of Soma by itself or with certain other drugs may cause seizures, slow or shallow breathing, changes in alertness, coma, or death. Talk with your doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Carisoprodol tablets, USP is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.

Carisoprodol tablets, USP should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [ see Dosage and Administration ( 2) ].

Carisoprodol tablets, USP is contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reaction to a carbamate such as meprobamate.