codeine/aspirin/carisoprodol (Rx)

Brand and Other Names:Soma Compound with Codeine
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

codeine/aspirin/carisoprodol

tablet: Schedule III

  • 16mg/325mg/200mg

Musculoskeletal Pain

1-2 tab/cap PO QID for up to 2-3 weeks

Dosage Forms & Strengths

codeine/aspirin/carisoprodol

tablet: Schedule III

  • 16mg/325mg/200mg

Musculoskeletal Pain

<16 years: Safety & efficacy not established

16 years or older: As adults; 1-2 tab/cap PO QID for up to 2-3 weeks

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Interactions

Interaction Checker

and codeine/aspirin/carisoprodol

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            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%)

            Frequency Not Defined

            Carisoprodol

            • Cardiovascular: orthostatic hypotension, syncope, tachycardia, central nervous system: agitation, irritability, depression, allergic/idiosyncratic reactions (eg, pruritus, rash, dizziness), gastrointestinal: epigastric distress, N/V, facial flushing, weakness

            Aspirin

            • stomach pain, heartburn, nausea, vomiting, dyspepsia, tinnitus (high or chronic dose), rash, urticaria
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            Warnings

            Black Box Warnings

            Opioid analgesic risk evaluation and mitigation strategy (REMS)

            • To ensure that benefits of opioid analgesics outweigh risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products; under requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers
            • Healthcare providers are strongly encouraged to:
              • Complete a REMS-compliant education program
              • Counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products
              • Emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist
              • Consider other tools to improve patient, household, and community safety

            Addiction, abuse, and misuse

            • Risk of opioid addiction, abuse, and misuse, which can lead to overdose and death; assess each patient’s risk prior to prescribing and monitor all patients regularly for the development of these behaviors or conditions

            Life-threatening respiratory depression

            • Serious, life-threatening, or fatal respiratory depression may occur
            • Monitor for respiratory depression, especially during initiation or following a dose increase

            Accidental ingestion

            • Accidental ingestion of even 1 dose, especially by children, can result in a fatal overdose

            Neonatal opioid withdrawal syndrome

            • Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts
            • If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available

            Ultra-rapid metabolism of codeine and other risk factors for life-threatening respiratory depression in children

            • Respiratory depression and death reported in children who received codeine following tonsillectomy and/or adenoidectomy that were also ultra-rapid metabolizers of codeine due to CYP2D6 polymorphism
            • Contraindicated in children <12 years and in children <18 years following tonsillectomy and/or adenoidectomy; avoid use in adolescents 12-18 years who have risk factors that may increase sensitivity to respiratory depressant effects of codeine

            Interactions with drugs affecting cytochrome P450 isoenzymes

            • Use of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors requires careful consideration of the effects on parent drug, codeine, and active metabolite, morphine

            Risks from concomitant use with benzodiazepines or other CNS depressants

            • Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death
            • Reserve concomitant prescribing of codeine sulfate tablets and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate
            • Limit dosages and durations to minimum required
            • Follow patients for signs and symptoms of respiratory depression and sedation

            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)

            Cautions

            Gastrointestinal bleeding; particular caution in patients with history of GI bleed, alcoholism, or bleeding disorders

            Avoid driving car or operating machinery

            Reye syndrome may occur in children because of aspirin component; do not use for chickenpox or flu symptoms

            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

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            Pregnancy & Lactation

            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

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Codeine: Opioid agonist; analgesia

            Aspirin: Acts on hypothalamus to produce antipyresis; anti-inflammatory properties attributed to prostaglandin synthetase inhibition resulting in decreased formation of thromboxane A2

            Carisoprodol: Centrally acting skeletal muscle relaxant (no direct muscle relaxation); partially metabolized to meprobamate which elicits anxiolytic/sedative effects

            Pharmacogenomics

            10% of codeine is metabolized to morphine by CYP2D6; the active morphine metabolite has a higher affinity for opioid receptors

            CYP2D6 poor metabolizers may not achieve adequate analgesia

            Ultra-rapid metabolizers (up to 7% of Caucasians and up to 30% of Asian and African populations) may have increased toxicity due to rapid conversion

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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.