Carisoprodol - Carisoprodol tablet

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

Carisoprodol 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. [

The recommended dose of carisoprodol tablets is 250 mg to 350 mg three times a day and at bedtime. The recommended maximum duration of carisoprodol tablets use is up to two or three weeks.

Carisoprodol Tablets USP 350 mg: round, convex, white tablets, debossed with SG 109 on one side

In a published animal reproduction study, pregnant mice administered carisoprodol orally at 2.6-and 4.1-times the maximum recommended human dose ([MRHD] of 1,400 mg per day [350 mg QID] based on body surface area [BSA] comparison) from gestation through weaning resulted in reduced fetal weights, postnatal weight gain, and postnatal survival

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

In a published pre- and post-natal development animal study, pregnant mice administered carisoprodol orally at 300 mg/kg/day, 750 mg/kg/day, or 1,200 mg/kg/day (approximately 1-, 2.6-, and 4.1-times the MRHD based on BSA comparison) from 7-days prior to gestation through birth and from lactation through weaning resulted in reduced fetal weights, postnatal weight gain, and postnatal survival at 2.6- and 4.1-times the MRHD.

• Due to sedative properties, may impair ability to perform hazardous tasks such as driving or operating machinery
  5.1 Sedation

  Carisoprodol has 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. There have been post-marketing reports of motor vehicle accidents associated with the use of carisoprodol.

  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.
• Additive sedative effects when used with other CNS depressants including alcohol
  5.1 Sedation

  Carisoprodol has 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. There have been post-marketing reports of motor vehicle accidents associated with the use of carisoprodol.

  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.
• Cases of abuse, dependence and withdrawal
  5.2 Abuse, Dependence, and Withdrawal

  Carisoprodol, the active ingredient in carisoprodol tablet, has been subject to abuse, dependence, and withdrawal, misuse and criminal diversion. [

  see Drug Abuse and Dependence (9.1, 9.2, 9.3)

  ]. Abuse of carisoprodol poses a risk of overdosage which may lead to death, CNS and respiratory depression, hypotension, seizures and other disorders [

  see Overdosage (10)

  ].

  Post-marketing experience cases of carisoprodol abuse and dependence have been reported in patients with prolonged use and a history of drug abuse. Although most of these patients took other drugs of abuse, some patients solely abused carisoprodol. Withdrawal symptoms have been reported following abrupt cessation of carisoprodol after prolonged use. Reported withdrawal symptoms included insomnia, vomiting, abdominal cramps, headache, tremors, muscle twitching, ataxia, hallucinations, and psychosis. One of carisoprodol’s metabolites, meprobamate (a controlled substance), may also cause dependence [

  see Clinical Pharmacology (12.3)

  ]

  To reduce the risk of carisoprodol abuse assess the risk of abuse prior to prescribing. After prescribing, limit the length of treatment to three weeks for the relief of acute musculoskeletal discomfort, keep careful prescription records, monitor for signs of abuse and overdose, and educate patients and their families about abuse and on proper storage and disposal.
  ,
  9.2 Abuse

  Abuse of carisoprodol poses a risk of overdosage which may lead to death, CNS and respiratory depression, hypotension, seizures and other disorders [

  see Warnings and Precautions(5.2)and Overdosage (10)

  ]. Patients at high risk of carisoprodol abuse may include those with prolonged use of carisoprodol, with a history of drug abuse, or those who use carisoprodol in combination with other abused drugs.

  Prescription drug abuse is the intentional non-therapeutic use of a drug, even once, for its rewarding psychological effects. Drug addiction, which develops after repeated drug abuse, is characterized by a strong desire to take a drug despite harmful consequences, difficulty in controlling its use, giving a higher priority to drug use than to obligations, increased tolerance, and sometimes physical withdrawal. Drug abuse and drug addiction are separate and distinct from physical dependence and tolerance (for example, abuse or addiction may not be accompanied by tolerance or physical dependence) [

  see Drug Abuse and Dependence (9.3)

  ].
  ,
  9.3 Dependence

  Tolerance is when a patient’s reaction to a specific dosage and concentration is progressively reduced in the absence of disease progression, requiring an increase in the dosage to maintain the same. Physical dependence is characterized by withdrawal symptoms after abrupt discontinuation or a significant dose reduction of a drug. Both tolerance and physical dependence have been reported with the prolonged use of carisoprodol. Reported withdrawal symptoms with carisoprodol include insomnia, vomiting, abdominal cramps, headache, tremors, muscle twitching, anxiety, ataxia, hallucinations, and psychosis. Instruct patients taking large doses of carisoprodol or those taking the drug for a prolonged time to not abruptly stop carisoprodol [

  see Warnings and Precautions (5.2)

  ].
• Seizures
  5.3 Seizures

  There have been post-marketing 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)

  ].