1 INDICATIONS AND USAGE Carisoprodol tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.

Limitation of Use Carisoprodol tablets 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 tablet is a muscle relaxant indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.

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

6 ADVERSE REACTIONS Most common adverse reactions (incidence > 2%) are drowsiness, dizziness, and headache ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Westminster Pharmaceuticals, LLC at 1-844-221-7294 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 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 [ see Clinical Studies (14) ].

In these studies, patients were treated with 250 mg of carisoprodol tablets, 350 mg of carisoprodol tablets, 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 carisoprodol tablets, and 350 mg of carisoprodol tablets, respectively, discontinued due to adverse events; and 0.5%, 0.5%, and 1.8% of patients treated with placebo, 250 mg of carisoprodol tablets, and 350 mg of carisoprodol tablets, 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 carisoprodol tablets in the two trials described above.

Table 1.

Patients with Adverse Reactions in Controlled Studies Adverse Reaction Placebo (n=560) n (%) Carisoprodol Tablets 250 mg (n=548) n (%) Carisoprodol Tablets 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) 6.2 Post-marketing Experience The following events have been reported during postapproval use of carisoprodol tablets.

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