Soma Compound with Codeine 16 MG / 325 MG / 200 MG Oral Tablet
– 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.
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.
Methotrexate-aspirin enhances the toxic effects of this drug.
Probenicid and Sulfinpyrazone-large doses of aspirin reduce the uricosuric effect of both drugs.
Renal excretion of salicylate may also be reduced.
Oral Antidiabetic Drugs-enhancement of hypoglycemia may occur.
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.
Ammonium Chloride-this and other drugs that acidify a relatively alkaline urine can elevate plasma salicylate concentrations.
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.
– Signs and symptoms: Any of the following which have been reported with the individual ingredients may occur and may be modified to a varying degree by the effects of the ingredients present in ‘Soma’ Compound with Codeine.
Carisoprodol- Stupor, coma, shock, respiratory depression, and, very rarely, death.
Overdosage with carisoprodol in combination with alcohol, other CNS depressants, or psychotropic agents can have additive effects, even when one of the agents has been taken in the usually recommended dosage.
Aspirin – Headache, tinnitus, hearing difficulty, dim vision, dizziness, lassitude, hyperpnea, rapid breathing, thirst, nausea, vomiting, sweating, and occasionally diarrhea are characteristic of mild to moderate salicycilate poisoning.
Salicylate poisoning should be considered in children with symptoms of vomiting, hyperpnea, and hyperthermia.
Hyperpnea is an early sign of salicylate poisoning, but dyspnea supervenes at plasma levels above 50 mg/dL.
These respiratory changes eventually lead to serious acid-base disturbances.
Metabolic acidosis is a constant finding in infants but occurs in older children only with severe poisoning; adults usually exhibit respiratory alkalosis initially and acidosis terminally.
Other symptoms of severe salicylate poisoning include hyperthermia, dehydration, delirium, and mental disturbances.
Skin eruptions, GI hemorrhage, or pulmonary edema are less common.
Early CNS stimulation is replaced by increasing depression, stupor, and coma.
Death is usually due to respiratory failure or cardiovascular collapse.
Codeine Phosphate-pinpoint pupils, CNS depression, coma, respiratory depression, and shock.
Treatment: General-Provide symptomatic and supportive treatment, as indicated.
Any drug remaining in the stomach should be removed using appropriate procedures and caution to protect the airway and prevent aspiration, especially in the stuporous or comatose patient.
Incomplete gastric emptying with delayed absorption of carisoprodol has been reported as a cause for relapse.
Should respiration or blood pressure become compromised, respiratory assistance, central nervous system stimulants, and pressor agents should be administered cautiously, as indicated.
Carisoprodol-The following have been used successfully in overdosage with the related drug meprobamate: diuretics, osmotic (mannitol) diuresis, peritoneal dialysis, and hemodialysis ( see CLINICAL PHARMACOLOGY ).
Careful monitoring of urinary output is necessary and caution should be taken to avoid overhydration.
Carisoprodol can be measured in biological fluid by gas chromatography (Douglas, J.F.,et al:J Pharm Sci 58:145,1969).
Aspirin-Since there are no specific antidotes for salicylate poisoning, the aim of treatment is to enhance elimination of salicylate and prevent or reduce further absorption; to correct any fluid electrolyte or metabolic imbalance; and to provide general and cardiorespiratory support.
If acidosis is present, intravenous sodium bicarbonate must be given, along with adequate hydration, until salicylate levels decrease to within the therapeutic range.
To enhance elimination, forced diuresis and alkalinization of urine may be beneficial.
The need for hemoperfusion or hemodialysis is rare and should be used only when other measures have failed.
Codeine Phosphate-Narcotic antagonists, such as nalorphine and levallorphan, may be indicated.
– ‘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 C 12 H 24 N 2 O 4 , 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.
‘Soma’ Compound with Codeine Tablets (carisoprodol 200 mg, aspirin 325 mg, and codeine phosphate, 16 mg) are oval, convex,, two-layered, and inscribed on the white layer with SOMA CC and on the yellow layer with WALLACE 2403.
The tablets are available in bottles of 100 (NDC 0037-2403-01).
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.
Pediatric Use: Safety and effectiveness in pediatric patients below the age of twelve have not been established.
Pregnancy-Teratogenic Effects: Pregnancy Category C.
Adequate animal reproduction studies have not been conducted with ‘Soma’ Compound with Codeine.
It is also not known whether ‘Soma’ Compound with Codeine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
‘Soma’ Compound with Codeine should be given to a pregnant woman only if clearly needed.
Studies in rodents have shown salicylates to be teratogenic when given in early gestation, and embryocidal when given in later gestation in doses considerably greater than usual therapeutic doses in humans.
Studies in women who took aspirin during pregnancy have not demonstrated an increased incidence of congenital abnormalities in the offspring.
Nursing Mothers: Carisoprodol is excreted in human milk in concentrations two-to-four times that in maternal plasma.
Aspirin is excreted in human milk in moderate amounts and can produce a bleeding tendency in nursing infants.
Because of the potential for serious adverse reaction in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the mother.
Codeine is secreted into human milk.
In women with normal codeine metabolism (normal CYP2D6 activity), the amount of codeine secreted into human milk is low and low dose-dependent.
Despite the common use of codeine products to manage postpartum pain, reports of adverse events in infants are rare.
However, some women are ultra-rapid metabolizers of codeine.
These women achieve higher-than-expected serum levels of codeine’s active metabolite, morphine, leading to higher-than-expected levels of morphine in breast milk and potentially dangerously high serum morphine levels in their breastfed infants.
Therefore, maternal use of codeine can potentially lead to serious adverse reactions, including death, in nursing infants.
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.
The risk of infant exposure to codeine and morphine through breat milk should be weighed against the benefits of breastfeeding for both the mother and baby.
Caution should be exercised when codeine is administered to a nursing woman.
If a codeine containing product is selected, the lowest dose should be prescribed for the shortest period of time to achieve the desired clinical effect.
Mothers using codeine should be informed about when to seek immediate medical care and how to identify the signs and symptoms of neonatal toxicity, such as drowsiness or sedation, difficulty breastfeeding, breathing difficulties, and decreased tone, in their baby.
Nursing mothers who are ultra-rapid metabolizers may also experience overdose symptoms such as extreme sleepiness, confusion or shallow breathing.
Prescribers should closely monitor mother-infant pairs and notify treating pediatricians about the use of codeine during breastfeeding.
( See PRECAUTIONS-General- Ultra-rapid Metabolizers of Codeine )
INFORMATION FOR PATIENTS
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).
DOSAGE AND ADMINISTRATION
– Usual Adult Dosage; 1 or 2 tablets, four times daily.
Not recommended for use in children under age twelve.