Carisoprodol Generic soma

Carisoprodol Clinical 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. 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)

 

Postmarketing 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.

Central Nervous System

Drowsiness, dizziness, vertigo, ataxia, tremor, agitation, irritability, headache, depressive reactions, syncope, insomnia, and seizures.

Gastrointestinal

Nausea, vomiting, and epigastric discomfort.

Hematologic

Leukopenia, pancytopenia

Carisoprodol Side Effects by Body System

Nervous system

Nervous system side effects are common and include drowsiness and sedation most often. There have been postmarketing reports of motor vehicle accidents associated with the use of carisoprodol. Dizziness, headache, tremor, agitation, insomnia, syncope and ataxia have also been reported.

Central respiratory depression may occur, particularly at high doses.

Other

Psychologic dependence and abuse of carisoprodol (often in combination with alcohol and other CNS depressants) have been reported.

Withdrawal symptoms after abrupt cessation of carisoprodol have been reported and may be due to dependency on the meprobamate metabolite. Such symptoms include abdominal pain, agitation, tremor, restlessness, anxiety, depression, insomnia, nausea, and sweating. Seizures have been reported rarely.

Hypersensitivity

Hypersensitivity effects include rash, pruritus and erythema multiforme. Asthma, fever, hypotension and anaphylaxis have been reported rarely.

Gastrointestinal

Gastrointestinal symptoms include nausea, vomiting, hiccups and epigastric distress.

Cardiovascular

Cardiovascular effects include tachycardia, hypotension, postural hypotension, and facial flushing.

Oncologic

Oncologic side effects have included mutagenicity and clastogenicity reported from in vitro animal cell assays

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