Soma Compound With Codeine Recall
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Questions & Answers
Side Effects & Adverse Reactions
WARNINGS- On very rare occasions, the first dose of carisoprodol has been followed by idiosyncratic reactions with symptoms appearing within minutes or hours. These may include extreme weakness, transient quadriplegia, dizziness, ataxia, temporary loss of vision, diplopia, mydriasis, dysarthria, agitation, euphoria, confusion, and disorientation. Although symptoms usually subside over the course of the next several hours, discontinue ‘Soma’ Compound with Codeine and initiate appropriate supportive and symptomatic therapy, which may include epinephrine and/or antihistamines. In severe cases, corticosteroids may be necessary. Severe reactions have been manifested by asthmatic episodes, fever, weakness, dizziness, angioneurotic edema, smarting eyes, hypotension, and anaphylactoid shock.
The effects of carisoprodol with agents such as alcohol, other CNS depressants or psychotropic drugs may be additive. Appropriate caution should be exercised with patients who take one or more of these agents simultaneously with ‘Soma’ Compound with Codeine.
Contains sodium metabisulfate, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
INDICATIONS AND USAGE- ‘Soma’ Compound with Codeine is indicated as an adjunct to rest, physical therapy, and other measures for the relief of pain, muscle spasm, and limited mobility associated with acute, painful musculoskeletal conditions when the additional action of codeine is desired.
There is currently no drug history available for this drug.
DESCRIPTION- ‘Soma’ Compound with Codeine is a combination product containing carisoprodol, a centrally-acting muscle relaxant, plus aspirin, an analgesic with antipyretic and antiinflammatory properties and codeine phosphate, a centrally-acting narcotic analgesic. It is available as a two-layered, white and yellow, oval-shaped tablet for oral administration. Each tablet contains carisoprodol , USP 200 mg, aspirin 325 mg, and codeine phosphate, USP 16 mg. Chemically, carisoprodol is N-isopropyl-2- methyl-2-propyl-1,3-propanediol dicarbamate. Its empirical formula is C12H24N2O4, with a molecular weight of 260.34. The structural formula is:
Other ingredients: croscarmellose sodium, D&C Yellow #10, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, povidine, sodium metabisulfite, starch, stearic acid.