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Trade Names:
Soma compound with codeine
- Tablets 200 mg carisoprodol, 325 mg aspirin, 16 mg codeine

Mechanism of Action

Pharmacology

Produces skeletal muscle relaxation, probably as a result of its sedative properties.

Inhibits prostaglandin synthesis, resulting in analgesia, anti-inflammatory activity, and inhibition of platelet aggregation.

Stimulates opiate receptors in the CNS.

Indications and Usage

Adjunct to rest, physical therapy, and other measures for the relief of pain, muscle spasm, and limited mobility associated with acute, painful musculoskeletal conditions.

Contraindications

Acute intermittent porphyria; bleeding disorders; allergic or idiosyncratic reactions to any component of product.

Dosage and Administration

PO 1 or 2 tablets 4 times daily.

General Advice

Administer without regard to meals, but administer with food if GI upset occurs.

Storage/Stability

Store at controlled room temperature (59° to 86°F). Protect from moisture.

Drug Interactions

By lowering the urinary pH, agents such as ammonium chloride can elevate plasma salicylate levels.

By raising urinary pH, antacids may increase salicylate elimination, decreasing plasma salicylate levels; conversely, discontinuing antacid therapy may increase levels.

Aspirin may enhance the potential for bleeding in patients on anticoagulants.

May enhance hypoglycemia.

Salicylate plasma levels may be decreased.

Increased risk of aspirin-induced fecal blood loss.

Increased risk of methotrexate toxicity.

Uricosuric effect of these agents may be decreased by large doses of aspirin, in addition, renal excretion of salicylate may be reduced.

Laboratory Test Interactions

May cause false-positive reading of urine glucose by copper reduction method ( Clinitest ) and false-negative readings by glucose oxidase method ( Clinistix ); may interfere with urine tests of 5-hydroxyindoleacetic acid, ketone, phenolsulfonphthalein, and vanillylmandelic acid.

May interfere with amylase and lipase determinations for up to 24 h after administration.

Adverse Reactions

Cardiovascular

Tachycardia; postural hypotension; facial flushing.

CNS

Drowsiness; dizziness; vertigo; ataxia; tremor; agitation; irritability; headache; depression; syncope; insomnia.

Sedation; dizziness.

Dermatologic

Rash; pruritus; urticaria.

EENT

Tinnitus.

Miosis.

GI

Nausea; vomiting; epigastric distress; hiccup.

Nausea; vomiting; gastritis; occult bleeding; constipation; diarrhea; gastric erosion.

Nausea; vomiting; constipation.

Hematologic

Leukopenia; pancytopenia.

Respiratory

Asthma.

Miscellaneous

Idiosyncratic reactions (including extreme weakness, transient quadriplegia, dizziness, ataxia, temporary loss of vision, diplopia, mydriasis, dysarthria, agitation, euphoria, confusion, disorientation); allergic reactions (including skin rash, erythema multiforme, pruritus, eosinophilia, and fixed drug eruptions.

Angioedema; aspirin intolerance (including rhinorrhea, shortness of breath, edema).

Precautions

Pregnancy

Category C .

Lactation

Carisoprodol, aspirin, and codeine are excreted in breast milk.

Children

Safety and efficacy in children younger than 12 yr of age not established.

Special Risk Patients

Use with caution in patients with compromised renal or hepatic function, in elderly or debilitated patients, patients with a history of gastritis or peptic ulcer, and addiction-prone individuals.

Drug dependence

Drug dependence of the morphine type may result.

Idiosyncratic reactions

Rarely first dose may cause idiosyncratic reactions. Monitor for signs of idiosyncratic reaction: extreme weakness, transient quadriplegia, dizziness, ataxia, double vision or temporary loss of vision, slurred speech, agitation, confusion, disorientation. Discontinue therapy and notify health care provider immediately if noted.

Sodium metabisulfite

Contains metabisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible patients.

Overdosage

Symptoms

Stupor, coma, shock, respiratory depression, rarely death

Headache, tinnitus, hearing difficulty, dim vision, dizziness, lassitude, hyperpnea, rapid breathing, thirst, nausea, vomiting, sweating, occasionally diarrhea, hyperthermia, dehydration, delirium, mental disturbances, skin eruptions, GI hemorrhage, pulmonary edema; CNS stimulation followed by increasing depression, stupor, coma

Pinpoint pupils, CNS depression, coma, respiratory failure, cardiovascular collapse

Patient Information

• Advise patient to take 1 to 2 tablets as prescribed, up to 4 times daily if needed for muscle pain, muscle spasm, or limited mobility.
• Advise patient to take without regard to meals but to take with food if GI upset occurs.
• Instruct patient to avoid alcoholic beverages and other depressants while taking this medication.
• Advise patient that drug may impair judgment, thinking, or motor skills, or cause drowsiness. Use caution while driving or performing other tasks requiring mental alertness until tolerance is determined.
• Advise patient to stop taking the drug and notify health care provider if any of the following symptoms occur: allergic reaction, unusual bleeding or bruising, shortness of breath, black or tarry stools, vomiting of blood or coffee ground-like material, excessive sedation, extreme weakness, paralysis, dizziness, stumbling, double vision or temporary loss of vision, slurred speech, agitation, confusion, disorientation.