Classes
DEA Class; Rx, schedule III
Common Brand Names; Soma Compound with Codeine
Analgesic and opioids combos
Description
Combination of a salicylate, central-acting muscle relaxant, and opiate agonist
Used for pain and muscle spasm relief and limited mobility associated with musculoskeletal conditions
Risk of dependence/abuse; limit therapy to 2 to 3 weeks; use in patients younger than 12 years is contraindicated
Uses/Indications
For the treatment of acute, painful musculoskeletal conditions (e.g., musculoskeletal pain, muscle spasm).
Contraindications
Hypersensitivity
Children younger than 16 years old because of potential for Reye syndrome
Bronchospastic reaction to aspirin
Peptic ulcer disease
Repeated administration in patients with anemia, cardiovascular, pulmonary, or renal disease
Porphyria
Postoperative use in children following tonsillectomy and/or adenoidectomy (see Black Box Warnings)
Adverse Effects
>10%
Codeine
Constipation
Drowsiness
Carisoprodol
Drowsiness (13-17%)
1-10%
Codeine
Hypotension, tachycardia or bradycardia, confusion, dizziness, false feeling of well being, headache, lightheadedness, malaise, paradoxical CNS stimulation, restlessness, rash, urticaria, anorexia, nausea, vomiting, xerostomia, ureteral spasm, urination decreased, LFT’s increased, burning at injection site, weakness, blurred vision, dyspnea, histamine release
Carisoprodol
Dizziness (7-8%)
Headache (3-5%)
Aspirin
Stomach pain, heartburn, nausea, vomiting, dyspepsia, tinnitus (high or chronic dose), rash, urticaria
Warnings
Particular caution in patients with history of GI bleed, alcoholism, or bleeding disorders
Avoid driving car or operating machinery
Avoid in severe renal impairment (ie, CrCl <10 mL/min)
May increase respiratory depressant effects; caution with head injury, COPD, or other conditions with decreased respiratory drive
Codeine and carisoprodol may cause tolerance/dependency
Pregnancy and Lactation
Pregnancy
Pregnancy category: D; avoid during pregnancy, particularly in third trimester because of risk for premature closure of the ductus arteriosus because of aspirin component; codeine may prolong delivery and cause respiratory depression/withdrawal symptoms in newborn
Lactation: excreted in breast milk; do not breast feed
Maximum Dosage
Adults
1,600 mg/day PO carisoprodol, 2,600 mg/day PO aspirin, and 128 mg/day PO codeine (8 tablets/day PO).
Geriatric
1,600 mg/day PO carisoprodol, 2,600 mg/day PO aspirin, and 128 mg/day PO codeine (8 tablets/day PO).
Adolescents
Safety and efficacy have not been established.
Children
12 years: Safety and efficacy have not been established.
1 to 11 years: Use is contraindicated.
Infants
Use is contraindicated.
How supplied
codeine/aspirin/carisoprodol
Tablet: Schedule III
16mg/325mg/200mg