SOMA COMPOUND with CODEINE

SOMA COMPOUND WITH CODEINE- carisoprodol, aspirin and codeine phosphate tablet
MedPointe Pharmaceuticals

SOMA® COMPOUND with CODEINE
(carisoprodol, aspirin and codeine phosphate, USP)
200 mg + aspirin 325 mg + codeine phosphate 16 mg.
Warning: May be habit-forming.
Tablets

CIII

Rx Only

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 C12 H24 N2 O4 , with a molecular weight of 260.34. The structural formula is:

Image from Drug Label Content

Other ingredients: croscarmellose sodium, D&C Yellow #10, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, povidine, sodium metabisulfite, starch, stearic acid.

CLINICAL PHARMACOLOGY- Carisoprodol: Carisoprodol is a centrally acting muscle relaxant that does not directly relax tense skeletal muscles in man. The mode of action of Carisoprodol in relieving acute muscle spasm of local origin has not been clearly identified, but may be related to its sedative properties. In animals, carisoprodol has been shown to produce muscle relaxation by blocking interneuronal activity and depressing transmission of polysynaptic neurons in the spinal cord and in the descending reticular formation of the brain. The onset of action is rapid and lasts four to six hours.

Carisoprodol is metabolized in the liver and is excreted by the kidneys. It is dialyzable by peritoneal and hemodialysis.

Aspirin: Aspirin is a nonnarcotic analgesic with antiinflammatory and antipyretic activity. Inhibition of prostaglandin biosynthesis appears to account for most of its antiinflammatory and for at least part of its analgesic and antipyretic properties.

Aspirin is rapidly absorbed and almost totally hydrolyzed to salicylic acid following oral administration. Although aspirin has a half-life of only about 15 minutes, the apparent biologic half-life of salicylic acid in the therapeutic plasma concentration range is between 6 and 12 hours. Salicylic acid is eliminated by renal excretion and by biotransformation to inactive metabolite. Clearance of salicylic acid in the high-dose range is sensitive to urinary pH (see Drug Interactions) and is reduced by renal dysfunction.

Codeine Phosphate: Codeine phosphate is a centrally acting narcotic-analgesic. Its actions are qualitatively similar to morphine, but its potency is substantially less.

Clinical studies have shown that combining aspirin and codeine produces a significant additive effect in analgesic efficacy.

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.

CONTRAINDICATIONS — Acute intermittent porphyria; bleeding disorders; allergic or idiosyncratic reactions to carisoprodol, aspirin, codeine, or related compounds.

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.

PRECAUTIONS-General: To avoid excessive accumulation of carisoprodol, aspirin, or their metabolites, use ‘Soma’ Compound with Codeine with caution in patients with compromised liver or kidney function, or in elderly or debilitated patients (see CLINICAL PHARMACOLOGY). Use with caution in patients with history of gastritis or peptic ulcer, in patients on anticoagulant therapy, and in addiction-prone individuals.

Ultra-rapid Metabolizers of Codeine
Some individuals may be ultra-rapid metabolizers due to a specific CYP2D6*2×2 genotype. These individuals convert codeine into its active metabolite, morphine, more rapidly and completely than other people. This rapid conversion results in higher than expected serum morphine levels. Even at labeled dosage regiments, individuals who are ultra-rapid metabolizers may experience overdose symptoms such as extreme sleepiness, confusion or shallow breathing.

The prevalence of this CYP2D6 phenotype varies widely and has been estimated at 0.5 to 1% in Chinese and Japanese, 0.5 to 1% in Hispanics, 1-10% in Caucasians, 3% in African Americans, and 16-28% in North Africans, Ethiopians and Arabs. Data is not available for other ethnic groups.

When physicians prescribe codeine-containing drugs, they should choose the lowest effective dose for the shortest period of time and should inform their patients about these risks and the signs of morphine overdose. (See PRECAUTIONS-Nursing Mothers)

Information for Patients: Caution patients that this drug may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a motor vehicle or operating machinery.

Caution patients with a predisposition for gastrointestinal bleeding that concomitant use of aspirin and alcohol may have an additive effect in this regard.

Caution patients that dosage of medications used for gout, arthritis, or diabetes may have to be adjusted when aspirin is administered or discontinued (see Drug Interactions).

Caution patients that some people have a variation in a liver enzyme and change codeine into morphine more rapidly and completely than other people. These people are ultra-rapid metabolizers and are more likely to have a higher-than-normal levels of morphine in their blood after taking codeine which can result in overdose symptoms such as extreme sleepiness, confusion, or shallow breathing. In most cases, it is unknown if someone is an ultra-rapid codeine metabolizer.

Nursing mothers taking codeine can also have higher morphine levels in their breast milk if they are ultra-rapid metabolizers. These higher levels of morphine in breast milk may lead to life-threatening or fatal side effects in nursing babies. Instruct nursing mothers to watch for signs of morphine toxicity in their infants including increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness. Instruct nursing mothers to talk to the baby’s doctor immediately if they notice these signs and, if they cannot reach the doctor right away, to take the baby to an emergency room or call 911 (or local emergency services).

Drug Interactions: Clinically important interactions may occur when certain drugs are administered concomitantly with aspirin or aspirin–containing drugs.

1.Oral Anticoagulants-By interfering with platelet function or decreasing plasma prothrombin concentration, aspirin enhances the potential for bleeding in patients on anticoagulants.
2. Methotrexate-aspirin enhances the toxic effects of this drug.
3. Probenicid and Sulfinpyrazone-large doses of aspirin reduce the uricosuric effect of both drugs. Renal excretion of salicylate may also be reduced.
4. Oral Antidiabetic Drugs-enhancement of hypoglycemia may occur.
5. Antacids-to the extent that they raise urinary pH, antacids may substantially decrease plasma salicylate concentrations; conversely, their withdrawal can result in a substantial increase.
6. Ammonium Chloride-this and other drugs that acidify a relatively alkaline urine can elevate plasma salicylate concentrations.
7. Ethyl Alcohol-enhanced aspirin –induced fecal blood loss has been reported.
8.Corticosteroids- salicylate plasma levels may be decreased when adrenal corticosteroids are given, and may be increased substantially when they are discontinued.

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