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U.S. Department of Health and Human Services

Safety

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Soma Compound (200 mg of carisoprodol and 325 mg of aspirin)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- April 2009

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


Summary View

 

Sections Modified

Summary of Changes to Contraindications and Warnings

CONTRAINDICATIONS

 

WARNINGS

  • Carisoprodol
    • Sedation
    • Drug Dependence, Withdrawal, and Abuse
  • Aspirin
    • Serious Gastrointestinal Adverse Reactions
    • Anaphylaxis and Anaphylactoid Reaction

 

PRECAUTIONS

  • Patients with impaired renal or hepatic function
  • Carisoprodol
    • Seizures
  • Aspirin
    • Gastrointestinal Adverse Reactions
  • Information for Patients
    • Carisoprodol
    • Aspirin
  • Drug Interactions
  • Carcinogenesis, Mutagenesis, Impairment of Fertility
  • Pregnancy Category

 

ADVERSE REACTIONS

  • Carisoprodol
  • Aspirin

CONTRAINDICATIONS

 

  • Soma Compound contraindicated in patients with a history of:
    • a serious GI complication..
    • aspirin induced asthma..
    • hypersensitivity reaction to a carbamate such as meprobamate

 

WARNINGS

  • Carisoprodol
    • Sedation
      • Carisoprodol may have sedative properties and may impair the mental and/or physical...
    • Drug Dependence, Withdrawal, and Abuse
      • In the postmarketing experience with carisoprodol, cases of dependence, withdrawal, and abuse have been reported with prolonged use
  • Aspirin
    • Serious Gastrointestinal Adverse Reactions
      • Aspirin can cause serious gastrointestinal (GI) adverse reactions including...
      • ...To minimize the risk for an aspirin-associated GI serious adverse reaction, the lowest
        effective aspirin dose should be used for the shortest possible duration.
    • Anaphylaxis and Anaphylactoid Reaction
      • Aspirin may cause an increased risk of serious anaphylaxis...
      • Patients with a serious anaphalaxis or anaphylactoid reaction should receive emergency care.

 

PRECAUTIONS

  • Patients with impaired renal or hepatic function
    • The safety and pharmacokinetics of Soma Compound in patients with renal or hepatic impairment have not been evaluated.
  • Carisoprodol
    • Since carisoprodol is excreted by the kidney and is metabolized in the liver, caution should be exercised if carisoprodol is administered to patients with impaired renal or hepatic function. Carisoprodol is dialyzable by hemodialysis and peritoneal dialysis.
    • Seizures
      • There have been postmarketing reports of seizures in patients..
  • Aspirin
    • Gastrointestinal Adverse Reactions
      • In addition to serious gastrointestinal adverse reactions, the use of aspirin is also associated
        with gastritis, gastrointestinal erosions, abdominal pain, heartburn, vomiting, and nausea.
  • Information for Patients
    • Patients should be advised to contact their health care provider if they experience any adverse reactions to Soma Compound.
    • Carisoprodol
      • Since carisoprodol may cause drowsiness and/or dizziness...
      • Patients should be advised to avoid alcoholic beverages...
      • Patients should be advised that treatment with carisoprodol should be limited to acute use...
    • Aspirin
      • Patients should be warned that aspirin can cause epigastric discomfort...
      • Patients should be informed of the symptoms of an anaphylactoid reaction or...
  • Drug Interactions
    • Carisoprodol: The sedative effects of carisoprodol and other CNS depressants...
    • Carisoprodol is metabolized in the liver by CYP2C19 to form meprobamate...
    • Aspirin
      • Alcohol: Concomitant use of aspirin with ≥ 3 alcoholic drinks may increase the risk of GI bleeding...
      • Anticoagulants...
      • Antihypertensives...
      • Corticosteroids...
      • Methotrexate...
      • Nonsteroidal anti-inflammatory drugs (NSAIDs)...
      • Oral Hypoglycemics Agents...
      • Products that effect urinary pH...
      • Uricosuric Agents...
  • Carcinogenesis, Mutagenesis, Impairment of Fertility
    • Carisoprodol: Long term studies in animals have not been performed to evaluate the carcinogenic potential of carisoprodol...
    • Aspirin: Administration of aspirin for 68 weeks in the feed of rats was not carcinogenic...
  • Pregnancy Category changed from C to D
    • Adequate animal reproduction studies have not been conducted with Soma Compound.
    • Carisoprodol: There are no data on the use of carisoprodol during human pregnancy...
      • Teratogenic effects...
      • Nonteratogenic effects...
    • Aspirin
      • Teratogenic effects: Prior to 30 weeks

 

ADVERSE REACTIONS

  • The following events have been reported during post-approval individual use of carisoprodol and aspirin.
  • Carisoprodol
    • Cardiovascular: Tachycardia, postural hypotension, and facial flushing
  • Aspirin
    • abdominal pain, anorexia
    • ...Other adverse reactions associated with the use of aspirin include elevated liver enzymes