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U.S. Department of Health and Human Services

Safety

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Soma Compound with Codeine (carisoprodol, aspirin, and codeine phosphate, USP) Tablets October 2008

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- October 2008

 

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 Reactions
  • Codeine Phosphate
    • Respiratory Depression
    • Abuse and Diversion
    • Dependence and Tolerance
    • Gastrointestinal Obstruction
    • Sedation
    • Hypotension

PRECAUTIONS

  • Patients with Impaired Renal or Hepatic Function
  • Carisoprodol
    • Seizures
  • Aspirin
    • Gastrointestinal Adverse Reactions
  • Codeine Phosphate
    • Obscuring Medical Conditions
    • Ultra-rapid Metabolizers of Codeine
    • Use in Patients with Pancreatic or Biliary Duct Disease
  • Information for Patients
    • Carisoprodol
    • Aspirin
    • Codeine Phosphate
  • Drug Interactions
    • Carisoprodol
    • Aspirin
    • Codeine Phosphate
  • Carcinogenesis, Mutagenesis, Impairment of Fertility
    • Carisoprodol
    • Aspirin
  • Pregnancy: Pregnancy Category D.
    • Carisoprodol
    • Aspirin
  • Labor and Delievery
    • Carisoprodol
    • Aspirin
    • Codeine Phosphate
  • Nursing Mothers
    • Carisoprodol
    • Aspirin
    • Codeine Phosphate
  • Pediatric Use
  • Geriatric Use

ADVERSE REACTIONS

  • Initial Section
  • Carisoprodol
  • Aspirin

See highlighted prescribing information for extensive labeling revisions to the following labeling sections: CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS.

CONTRAINDICATIONS

Soma Compound with Codeine is contraindicated in patients with a history of:
• a serious GI complication (i.e., bleeding, perforations, obstruction) due to aspirin use
• aspirin induced asthma (a symptom complex which occurs in patients who have asthma, rhinosinusitis, and nasal polyps who develop a severe, potentially fatal brochospasm shortly after taking aspirin or other NSAIDs)
• hypersensitivity reaction to a carbamate such as meprobamate...