Adult Dosing
Acute musculoskeletal pain
- 1-2 tabs PO qid
- Max dose: 2 tabs qid
Note: Use upto 2-3 wks
Pediatric Dosing
Acute musculoskeletal pain
>16 yrs
- 1-2 tabs PO qid
- Max dose: 2 tabs qid
Note: Use upto 2-3 wks
[Outline]
See Supplemental Patient Information
- Respiratory depression and death have been reported in children receiving codeine after tonsillectomy and/or adenoidectomy. These patients had an evidence of being ultra-rapid metabolizers of codeine resulting from a CYP2D6 polymorphism (US Black Box warning)
- On prolonged therapy cases of dependence, withdrawal, and abuse have occurred; patients having history of addiction can be more susceptible. Psychological or physical dependence may occur along with tolerance of therapy. Contact state professional licensing board or state substances authority for information on how to prevent or detect abuse or diversion due to therapy
- Avoid therapy in patients taking CNS depressants including alcohol, and carisoprodol for more than 2-3 wks for the relief of acute musculoskeletal discomfort
- Avoid abrupt withdrawal of therapy
- Serious/fatal gastrointestinal (GI) adverse reactions including bleeding, perforation, and obstruction of the stomach, small intestine, or large intestine have occurred due to aspirin
- Use the lowest effective aspirin dose for the shortest possible duration
- Patients without known prior exposure to aspirin are more prone to serious anaphylaxis and anaphylactoid reactions; provide emergency care for such patients
- Gastrointestinal adverse reactions can be induced due to aspirin
- Geriatric, debilitated patients, in non-tolerant patients who are given large initial doses of opioids, and patients who are receiving concomitant respiratory depressants are more prone to opioid-associated respiratory depression; also patients with preexisting disorders such as chronic obstructive pulmonary disease (COPD), restrictive lung disease, decreased respiratory drive, increased intracranial pressure and/or respiratory depression are at a greater risk of opioid-associated respiratory depression
- Patients with dehydration or with the concomitant use of drugs associated with hypotension are more prone to hypotension
- Codeine may obscure the clinical course of patients with head injuries; signs and symptoms that are used for the diagnosis or for the monitoring of patients with acute abdominal conditions are also masked
- Symptoms of overdose may occur in patients with ultra-rapid metabolizers of codeine
- Safety and efficacy in patients with renal or hepatic impairment have not been established
Cautions: Use cautiously in
- Renal impairment
- Hepatic impairment
- History of aspirin-associated GI bleeding
- Ulcers (complicated ulcers)
- Gastritis
- History of peptic ulcer disease
- GERD
- Aspirin-associated ulcers (uncomplicated ulcers)
- Patients taking higher doses of aspirin
- Patients taking concomitant anticoagulants
- Patients using concomitant CNS depressants
- Patients taking NSAIDs
- Patients taking large amounts of alcohol
- History or risk of abuse
- Thrombocytopenia
- Surgery or trauma
- Intracranial lesion
- ICP increased
- History or risk of seizure
- Gout (high-dose ASA)
- Ultra-rapid CYP2D6 metabolizer
- Acute pancreatitis or biliary disease
- Acute abdomen
- Pulmonary disease
- Hypotension
- Dehydration
- Debilitated patients
- Geriatric patients
Supplemental Patient Information
- Advise patients to avoid engaging in activities requiring mental alertness such as operating hazardous machinery or driving an automobile
- Advise patients to avoid alcoholic beverages and to consult with their clinician before taking other CNS depressants
- Advise patients to contact their healthcare provider if musculoskeletal symptoms persists even after therapy of up to 2-3 wks
- Warn patients that serious GI complications could occur requiring hospitalization; GI complications may also result in death. Instruct patients to remain alert to symptoms of serious GI bleeding such as hematemesis, melena, hematochezia and immediately seek medical attention
- Instruct patients to remain alert to symptoms of anaphylactoid reaction or anaphylaxis; immediately seek emergency help
- Inform patients that therapy could produce psychological and physical dependence
Pregnancy Category:D
Breastfeeding: Not necessarily a reason to discontinue breastfeeding if carisoprodol is required by the mother. Slight sedation has occurred in a breastfed newborn infant on exposing carisoprodol during pregnancy and lactation; effect is more pronounced in newborns when exposed for the first time during nursing. Prefer an alternative agent especially while nursing a newborn or preterm infant. Avoid aspirin during breastfeeding, especially with very young infants; although a rare single low dose of aspirin daily is unlikely to cause problems in the infant. The risks with chronic high dose aspirin use are less clear. Monitor infant salicylate serum levels particularly in neonates. Avoid breastfeeding for 1-2 hrs after a dose to minimize antiplatelet effects. Higher dosages of oral narcotics in mothers while breastfeeding can cause infant drowsiness. Newborn infants are particularly sensitive to the effects of even small dosages of narcotic analgesics, particularly in the first week of life. Newborn's dosage is limited by the small volumes of colostrum in the first 2-3 days postpartum. Once the mother's milk comes in, it is best to use a nonnarcotic analgesic and limit the maternal dosage and duration of treatment with codeine and combinations to 4 days. Mothers with ultrarapid CYP2D6 metabolism may excrete unexpectedly higher amounts of morphine into their milk after use of codeine and increase the risk of adverse effects in infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 30 December 2010). Carisoprodol may reduce effective infant feeding (due to sedation) and/or decreased milk production. Nursing mothers should avoid the use of aspirin as it may lead to bleeding in the infant. Manufacturer advises to use the lowest dose of a product containing codeine for the shortest period of time to achieve the desired clinical effect; closely monitor mother-infant pairs and notify pediatricians about the use of codeine during breastfeeding. Manufacturer advises to use the product in a pregnant woman only if clearly needed.
US Trade Name(s)
- Soma compound with codeine
US Availability
aspirin/carisoprodol/codeine (generic)
- TABS: 325 mg/200 mg/16 mg
Soma compound with codeine
- TABS: 325 mg/200 mg/16 mg
Canadian Trade Name(s)
Canadian Availability
UK Trade Name(s)
UK Availability
Australian Trade Name(s)
Australian Availability
[Outline]
Drug Name: ASA 325 MG / carisoprodol 200 MG / codeine phosphate 16 MG Oral Tablet
Ingredient(s): Aspirin mixture with Carisoprodol and Codeine
Imprint: A138
Color(s): White, Yellow
Shape: Round
Size (mm): 6.00
Score: 1
Inactive Ingredient(s): d&c yellow #10 aluminum lake / corn starch / hydroxypropyl cellulose / lactose monohydrate / microcrystalline cellulose / silicon dioxide / sodium starch glycolate / stearic acid / zinc stearate
Drug Label Author:
Actavis Totowa LLC
DEA Schedule:
CIII
Drug Name: Soma Compound with Codeine (ASA 325 MG / carisoprodol 200 MG / codeine phosphate 16 MG) Oral Tablet
Ingredient(s): Aspirin mixture with Carisoprodol and Codeine
Imprint: SOMA;CC;WALLACE;2403
Color(s): White, Yellow
Shape: Oval
Size (mm): 17.00
Score: 1
Inactive Ingredient(s): croscarmellose sodium / microcrystalline cellulose / d&c yellow #10 / hydroxypropyl methylcellulose / magnesium stearate / povidine / sodium metabisulfite / starch / stearic acid
Drug Label Author:
MedPointe Pharmaceuticals
DEA Schedule:
CIII