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Soma Compound with Codeine

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Soma Compound with Codeine

Soma Compound with Codeine

WARNINGS

Carisoprodol

Sedation

Carisoprodol has sedative properties and 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. There have been post-marketing reports of motor vehicle accidents associated with the use of carisoprodol.

Since the sedative effects of carisoprodol and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricylic antidepressants) may be additive, appropriate caution should be exercised with patients who take more than one of these CNS depressants simultaneously.

Drug Dependence, Withdrawal, and Abuse

In post-marketing experience with carisoprodol, cases of dependence, withdrawal, and abuse have been reported with prolonged use. Most cases of dependence, withdrawal, and abuse occurred in patients who have had a history of addiction or who used carisoprodol in combination with other drugs with abuse potential. However, there have been post-marketing adverse event reports of carisoprodol-associated abuse when used without other drugs with abuse potential. Withdrawal symptoms have been reported following abrupt cessation after prolonged use. To reduce the chance of carisoprodol dependence, withdrawal, or abuse, carisoprodol should be used with caution in addiction prone patients and in patients taking other CNS depressants including alcohol, and carisoprodol should not be used more than two to three weeks for the relief of acute musculoskeletal discomfort.

Carisoprodol, and one of its metabolites, meprobamate (a controlled substance), may cause dependence (see CLINICAL PHARMACOLOGY).

Aspirin

Serious Gastrointestinal Adverse Reactions

Aspirin can cause serious gastrointestinal (GI) adverse reactions including bleeding, perforation, and obstruction of the stomach, small intestine, or large intestine, which can be fatal. Aspirin-associated serious GI adverse reactions can occur anywhere along the GI tract, at any time, with or without warning symptoms. Patients at higher risk of aspirin-associated serious upper GI adverse reactions include patients with a history of aspirin associated GI bleeding from ulcers (complicated ulcers), a history of aspirin-associated ulcers (uncomplicated ulcers), geriatric patients, patients with poor baseline health status, patients taking higher doses of aspirin, and patients taking concomitant anticoagulants, NSAIDs, and/or large amounts of alcohol. To minimize the risk for aspirin-associated GI serious adverse reactions, the lowest effective aspirin dose should be used for the shortest possible duration.

Anaphylaxis and Anaphylactoid Reactions

Aspirin may cause an increased risk of serious anaphylaxis and anaphylactoid reactions, which can occur in patients without known prior exposure to aspirin (see CONTRAINDICATIONS). Patients with a serious anaphylaxis and anaphylactoid reaction should receive emergency care.

Codeine Phosphate

Respiratory Depression

Respiratory depression is a serious adverse reaction of opioid agonists, including codeine phosphate. Opioid-associated respiratory depression is more likely to occur in geriatric patients, debilitated patients, in non-tolerant patients who are given large initial doses of opioids, and in patients who are receiving concomitant respiratory depressants (e.g. other opioids, benzodiazepines, tricyclic antidepressants, phenothiazines, skeletal muscle relaxants, alcohol). In addition, patients with chronic obstructive pulmonary disease (COPD), restrictive lung disease, decreased respiratory drive, and/or respiratory depression are at a greater risk of opioid-associated respiratory depression. Opioid-associated respiratory depression may be increased in patients with increased intracranial pressure (e.g., patients with head trauma, intracranial lesions).

Abuse and Diversion

Codeine phosphate is a Schedule III controlled substance. Administration of opioids including codeine phosphate has been associated with abuse. Healthcare professionals should contact their State Professional Licensing Board or State Substances Authority for information on how to prevent or detect abuse or diversion of codeine phosphate.

Dependence and Tolerance

Use of opioids, including codeine phosphate, can result in psychological and/or physical dependence. Withdrawal symptoms associated with abrupt opioid discontinuation include restlessness, irritability, anxiety, lacrimation, rhinorrhea, sweating, chills, mydriasis, insomnia, diarrhea, tachypnea, tachycardia, and/or hypertension. The use of opioids, including codeine phosphate, use can result in tolerance – the need for increasing doses to maintain a desired effect in the absence of other factors (e.g., disease progression).

Gastrointestinal Obstruction

Opioids, including codeine phosphate, may cause gastrointestinal obstruction.

Sedation

Opioids, including codeine phosphate, may impair the mental and physical abilities required for the performance of potentially hazardous tasks such as driving a motor vehicle or operating machinery. Since the sedative effects of codeine phosphate and other CNS depressants (e.g., other opioids, benzodiazepines, tricyclic antidepressants, skeletal muscle relaxants, alcohol) may be additive, appropriate caution should be exercised with patients who take more than one of these CNS depressants simultaneously.

Hypotension

The use of opioids, including codeine phosphate, may cause hypotension. Opioid-associated hypotension is more likely in patients with dehydration or with the concomitant use of drugs associated with hypotension.

PRECAUTIONS

Patients with impaired renal or hepatic function

The safety and pharmacokinetics of Soma Compound with Codeine in patients with renal or hepatic impairment have not been evaluated.

Carisoprodol

Since carisoprodol is excreted by the kidney and is metabolized in the liver, caution should be exercised if carisoprodol is administered to patients with impaired renal or hepatic function. Carisoprodol is dialyzable by hemodialysis and peritoneal dialysis.

Seizures

There have been post-marketing reports of seizures in patients who received carisoprodol. Most of these cases have occurred in the setting of multiple drug overdoses (including drugs of abuse, illegal drugs, and alcohol) (see OVERDOSAGE).

Aspirin

Gastrointestinal Adverse Reactions

In addition to serious gastrointestinal adverse reactions, the use of aspirin is also associated with gastritis, gastrointestinal erosions, abdominal pain, heartburn, vomiting, and nausea (see WARNINGS, Serious Gastrointestinal Adverse Reactions).

Codeine Phosphate

Obscuring Medical Conditions

Opioids, including codeine phosphate, may obscure the clinical course of patients with head injuries because of the CNS depressive effects of opioids. In addition, opioids, including codeine phosphate, may obscure the symptoms and/or signs that are used for the diagnosis or for the monitoring of patients with acute abdominal conditions.

Ultra-rapid Metabolizers of Codeine

Some patients may be ultra-rapid metabolizers of codeine phosphate due to a specific CYP2D6*2x2 genotype. These patients convert codeine into its active metabolite, morphine, more rapidly and completely than patients who are normal metabolizers of codeine, resulting in higher than expected serum morphine levels. Even at labeled dosage regimens of codeine phosphate, patients who are ultra-rapid metabolizers may experience overdose symptoms such as respiratory depression, extreme sleepiness, or delirium. Toxic serum levels of morphine have been reported in infants of nursing mothers who may be ultra-rapid metabolizers (see PRECAUTIONS, Nursing Mothers). The prevalence of this CYP2D6 phenotype has been estimated at 16 to 28% in North Africans, Ethiopians, and Arabs; 1 to 10% in Caucasians; 3% in African Americans; and 0.5 to 1% in Chinese, Japanese, and Hispanics. Data is not available for other ethnic groups. When healthcare providers prescribe codeine-containing products, they should choose the lowest effective dose for the shortest period of time.

Use in Patients with Pancreatic or Biliary Duct Disease

Opioids, including codeine phosphate, should be used with caution in patients with pancreatic or biliary duct disease because opioids may cause spasm of the sphincter of Oddi and diminish pancreatic and/or biliary secretions.

Carcinogens, Mutagenesis, Impairments of Fertility:

No long-term studies of carcinogens have been done with Soma Compound with Codeine.

Carisoprodol

Long tern studies in animals have not been performed to evaluate the carcinogenic potential of carisoprodol.

Carisoprodol was not formally evaluated for genotoxicity. In published studies, carisoprodol was mutagenic in the in vitro mouse lymphoma cell assay in the absence of metabolizing enzymes, but was not mutagenic in the presence of metabolizing enzymes. Carisoprodol was clastogenic in the in vitro chromosomal aberration assay using Chinese hamster ovary cells with or without the presence of metabolizing enzymes. Other types of genotoxic tests resulted in negative findings. Carisoprodol was not mutagenic in the Ames reverse mutation assay using S. typhimurium strains with or without metabolizing enzymes, and was not clastogenic in an in vitro mouse micronucleus assay of circulating blood cells.

Carisoprodol was not formally evaluated for effects on fertility. Published reproductive studies of carisoprodol in mice found no alteration in fertility although an alteration in reproductive cycles characterized by a greater time spend in estrus was observed at a carisoprodol dose of 1200 mg/kg/day. In a 13-week toxicology study that did not determine fertility, mouse testes weight and sperm motility were reduced at a dose of 1200 mg/kg/day. In both studies, the no effect level was 750 mg/kg/day, corresponding to approximately 2.6 times the human equivalent dosage of 350 mg four times a day, based on a body surface area comparison.

The significance of these findings for human fertility is not known.

Aspirin

Administration of aspirin for 68 weeks in the feed of rats was not carcinogenic. In the Ames Salmonella assay, aspirin was not mutagenic; however, aspirin did induce chromosome aberrations in cultured human fibroblasts. Aspirin has been shown to inhibit ovulation in rats (see Pregnancy).

Pregnancy

Pregnancy Category D

It is not known whether Soma Compound with Codeine (carisoprodol, aspirin, and codeine phosphate tablets) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Adequate animal reproduction studies have not been conducted with Soma Compound with Codeine (carisoprodol, aspirin, and codeine phosphate tablets) . Soma Compound with Codeine (carisoprodol, aspirin, and codeine phosphate tablets) should be given to a pregnant woman only if clearly needed.

Carisoprodol

There are no data on the use of carisoprodol during human pregnancy. Animal studies indicate that carisoprodol crosses the placenta and results in adverse effects on fetal growth and postnatal survival. The primary metabolite of carisoprodol, meprobamate, is an approved anxiolyic. Retrospective, post-marketing studies do not show a consistent association between maternal use of meprobamate and an increased risk for particular congenital malformations.

Teratogenic effects: Animal studies have not adequately evaluated the teratogenic effects of carisoprodol. There was no increase in the incidence of congenital malformations noted in the reproductive studies in rats, rabbits, and mice treated with meprobamate. Retrospective, post-marketing studies of meprobamate during human pregnancy were equivocal for demonstrating an increased risk of congenital malformations following the first trimester exposure. Across studies that indicated an increased risk, the types of malformations were inconsistent.

Nonteratogenic effects: In animal studies, carisoprodol reduced fetal weights, postnatal weight gain, and postnatal survival at maternal doses equivalent to 1 to 1.5 times the human dose (based on a body surface area comparison). Rats exposed to meprobamate in-utero showed behavioral alterations that persisted into adulthood. For children exposed to meprobamate in-utero, one study found no adverse effects on mental or motor development or IQ scores. Carisoprodol should be used during pregnancy only if the potential benefit justifies the risk to the fetus.

Aspirin

Teratogenic effects: Prior to 30 weeks gestation, aspirin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Starting at 30 weeks gestation, aspirin should be avoided by pregnant women as premature closure of the fetal ductus arteriosus which may result in fetal pulmonary hypertension and fetal death. Salicylate products have also been associated with alterations in maternal and neonatal hemostasis mechanisms, decreased birth weight, increased incidence of intracranial hemorrhage in premature infants, stillbirths, and neonatal death. Studies in rodents have show 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.

Labor and Delivery

Carisoprodol

There is no information about the effects of carisoprodol on the mother and the fetus during labor and delivery.

Aspirin

Ingestion of aspirin within one week of delivery or during labor may prolong delivery or lead to excessive blood loss in the mother, fetus, or neonate. Prolonged labor due to prostaglandin inhibition has been reported with aspirin use.

Codeine Phosphate

The use of codeine phosphate during labor may lead to respiratory depression in the neonate.

Nursing Mothers

Carisoprodol

Very limited data in humans show that carisoprodol is present in break milk and may reach concentrations two to four times the maternal plasma concentrations. In one case report, a breast-fed infant received about 4 to 6% of the maternal daily dose though breast milk and experienced no adverse effects. However, milk production was inadequate and the baby was supplemented with formula. In lactation studies in mice, female pup survival and pup weight at weaning was decreased. This information suggests that maternal use of carisoprodol may lead to reduced or less effective infant feeding (due to sedation) and/or decreased milk production. Caution should be exercised when carisoprodol is administered to a nursing woman.

Aspirin

Nursing mothers should avoid the use of aspirin because salicylate is excreted in breast milk which may lead to bleeding in the infant.

Codeine Phosphate

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. Despite the common use of codeine products to manage postpartum pain, reports of codeine-associated adverse reactions in nursing infants are rare. Nursing mothers who are ultra-rapid metabolizers of codeine have higher-than-expected levels of morphine (the active metabolite of codeine) in their blood, leading to higher levels of morphine in their breast milk and potentially dangerously high serum morphine levels in their breastfed infants. Therefore, in nursing mothers who are ultra-rapid metabolizers of codeine, the maternal use of codeine can lead to serious adverse reactions, including death; in their nursing infants and in the nursing mothers (see PRECAUTIONS, Ultra-rapid Metabolizers of Codeine).

Prior to prescribing nursing mothers codeine phosphate, the risk of infant exposure to codeine and morphine through breast milk should be weighed against the benefits of breastfeeding for both the mother and the infant. 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. Prescribers should closely monitor mother-infant pairs and notify treating pediatricians about the use of codeine during breastfeeding.

Pediatric Use

The efficacy, safety, and pharmacokinetics of Soma Compound with Codeine in pediatric patients less than 16 years of age have not been established.

Geriatric Use

The efficacy, safety, and pharmacokinetics of Soma Compound with Codeine in pediatric patients over 65 years of age have not been established.

Last reviewed on RxList: 12/4/2009
This monograph has been modified to include the generic and brand name in many instances.

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