Carisoprodol

CARISOPRODOL- carisoprodol tablet
Rebel Distributors Corp.

1 INDICATIONS AND USAGE

Carisoprodol Tablets are indicated for the relief of discomfort associated with acute, painful musculoskietal conditions in adults. Carisprodol Tablets should only be used for short periods (up to two or three weeks) brcause adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculosketal conditions are generally of short duration [see Dosage and Administration (2)].

2 DOSAGE AND ADMINISTRATION

The recommended dose of Carisoprodol is 350 mg three times a day and at bedtime. The recommended maximum duration of Carisiprodol use is up to two or three weeks

1 INDICATIONS AND USAGE

Carisoprodol Tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.

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)].

2 DOSAGE AND ADMINISTRATION

The recommended dose of Carisoprodol Tablets, USP is 350 mg three times a day and at bedtime. The recommended maximum duration of Carisoprodol Tablets, USP use is up to two or three weeks.

3 DOSAGE FORMS AND STRENGTHS

350 mg Tablets: white, round, unscored tablets debossed “2410 V” on one side and plain on the reverse side.

4 CONTRAINDICATIONS

Carisoprodol Tablets are contraindicated in patients with a history of acute intermittent porphyria or a hypersensitivity reaction to a carbamate such as meprobamate.

5 WARNINGS AND PRECAUTIONS

5.1 Sedation

Carisoprodol may have sedative properties (in the low back pain trials, 13% to 17% of patients who received carisoprodol 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.

Since the sedative effects of carisoprodol 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.

5.2 Drug Dependence, Withdrawal, and Abuse

In the postmarketing experience with carisoprodol, cases of dependence, withdrawal, and abuse have been reported with prolonged use. Most cases of dependence, withdrawal, and abuse occurred in patients who have had a history of addiction or who used carisoprodol in combination with other drugs with abuse potential. Withdrawal symptoms have been reported following abrupt cessation after prolonged use. To reduce the chance of carisoprodol dependence, withdrawal, or abuse, carisoprodol should be used with caution in addiction-prone patients and in patients taking other CNS depressants including alcohol, and carisoprodol should not be used more than two to three weeks for the relief of acute musculoskeletal discomfort.

One of the metabolites of carisoprodol, meprobamate (a controlled substance), may cause dependence [see Clinical Pharmacology (12.3)].

5.3 Seizures

There have been postmarketing reports of seizures in patients who received carisoprodol. Most of these cases have occurred in the setting of multiple drug overdoses (including drugs of abuse, illegal drugs, and alcohol) [see Overdosage (10)].

6 ADVERSE REACTIONS

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 839 patients pooled from a double blind, randomized, multicenter, placebo controlled, one-week trial in adult patients with acute, mechanical, lower back pain [see Clinical Studies (14)]. In the study, patients were treated with 350 mg of carisoprodol 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 the trial. In the study, 2.7% and 5.4% of patients treated with placebo and 350 mg of carisoprodol, respectively, discontinued due to adverse events; 0.5% and 1.8% of patients treated with placebo and 350 mg of carisoprodol, 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 in the trial described above.

Table 1. Patients with Adverse Reactions in the Controlled Study
Adverse Reaction Placebo
(n=560)
n (%)
Carisoprodol 350 mg
(n=279)
n (%)
Drowsiness 31 (6) 47 (17)
Dizziness 11 (2) 19 (7)
Headache 11 (2) 9 (3)

6.2 Postmarketing Experience

The following events have been reported during postapproval use of carisoprodol. 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.

7 DRUG INTERACTIONS

7.1 CNS Depressants

The sedative effects of carisoprodol and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic antidepressants) may be additive. Therefore, caution should be exercised with patients who take more than one of these CNS depressants simultaneously. Concomitant use of carisoprodol and meprobamate, a metabolite of carisoprodol, is not recommended [see Warnings and Precautions (5.1)].

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