Muscle Relaxant

Soma

Approved 9 Apr 1959OralCapsule

The FDA lists this product in 3 strengths and forms.

Indications

SOMA is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Limitation of Use SOMA 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) ]. SOMA is a muscle relaxant indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.

(1) Limitations of Use

Should only be used for acute treatment periods up to two or three weeks (1)

Contraindications

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

Acute intermittent porphyria (4)
Hypersensitivity reactions to a carbamate such as meprobamate (4)

Warnings and precautions

Due to sedative properties, may impair ability to perform hazardous tasks such as driving or operating machinery (5.1)
Additive sedative effects when used with other CNS depressants including alcohol (5.1)
Cases of abuse, dependence and withdrawal (5.2, 9.2, 9.3)
Seizures (5.3)

5.1Sedation

SOMA has sedative properties (in the low back pain trials, 13% to 17% of patients who received SOMA experienced sedation compared to 6% of patients who received placebo) [ see ADVERSE REACTIONS (6.1) ] and 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. There have been post-marketing reports of motor vehicle accidents associated with the use of SOMA.

Since the sedative effects of SOMA and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) may be additive, appropriate caution should be exercised with patients who take more than one of these CNS depressants simultaneously.

5.2Abuse, Dependence, and Withdrawal Carisoprodol,

At a glance

Brand name: Soma
Active substance: carisoprodol
Pharmacologic class: Muscle Relaxant
Route: Oral
Dosage form: Capsule
Applicant: Mylan Speciality LP
Status: Discontinued
FDA approval: 9 Apr 1959
Application: NDA011792-003

Indications

(1) Limitations of Use

Should only be used for acute treatment periods up to two or three weeks (1)

Warnings and precautions

Due to sedative properties, may impair ability to perform hazardous tasks such as driving or operating machinery (5.1)
Additive sedative effects when used with other CNS depressants including alcohol (5.1)
Cases of abuse, dependence and withdrawal (5.2, 9.2, 9.3)
Seizures (5.3)

5.1Sedation

5.2Abuse, Dependence, and Withdrawal Carisoprodol,

Adverse reactions

Most common adverse reactions (incidence > 2%) are drowsiness, dizziness, and headache ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Viatris at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect rates observed in practice. The data described below are based on 1387 patients pooled from two double blind, randomized, multicenter, placebo controlled, one-week trials in adult patients with acute, mechanical, lower back pain [ see Clinical Studies (14) ].

In these studies, patients were treated with 250 mg of SOMA, 350 mg of SOMA, or placebo three times a day and at bedtime for seven days. The mean age was about 41 years old with 54% females and 46% males and 74 % Caucasian, 16 % Black, 9% Asian, and 2% other. There were no deaths and there were no serious adverse reactions in these two trials. In these two studies, 2.7%, 2%, and 5.4%, of patients treated with placebo, 250 mg of SOMA, and 350 mg of SOMA, respectively, discontinued due to adverse events; and 0.5%, 0.5%, and 1.8% of patients treated with placebo, 250 mg of SOMA, and 350 mg of SOMA, respectively, discontinued due to central nervous system adverse reactions.

Table 1 displays adverse reactions reported with frequencies greater than 2% and more frequently than placebo in patients treated with SOMA in the two trials described above. Table 1. Patients with Adverse Reactions in Controlled Studies Adverse Reaction Placebo (n=560) n (%) SOMA 250 mg (n=548) n (%) SOMA 350 mg (n=279) n (%) Drowsiness 31 (6) 73 (13) 47 (17) Dizziness 11 (2) 43 (8) 19 (7) Headache 11 (2) 26 (5) 9 (3)

6.2Post-marketing Experience

The following events have been reported during postapproval use of SOMA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiovascular: Tachycardia, postural hypotension, and facial flushing [ see Overdosage (10) ]. Central Nervous System: Drowsiness, dizziness, vertigo, ataxia, tremor, agitation, irritability, headache, depressive reactions, syncope, insomnia, and seizures [ see Overdosage (10) ].

Gastrointestinal: Nausea, vomiting, and epigastric discomfort. Hematologic: Leukopenia, pancytopenia

Soma

Indications

Contraindications

Warnings and precautions

5.1Sedation

5.2Abuse, Dependence, and Withdrawal Carisoprodol,

At a glance

Two medicines in one question?

Soma

Indications

Contraindications

Warnings and precautions

5.1Sedation

5.2Abuse, Dependence, and Withdrawal Carisoprodol,

At a glance

Two medicines in one question?

5.3Seizures

Interactions

7.1CNS Depressants

7.2CYP2C19 Inhibitors and Inducers

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

6.1Clinical Studies Experience

6.2Post-marketing Experience

Composition

Strengths and forms

Official product information