Soma (carisoprodol) dose, indications, adverse effects, interactions


5.21.2018 | Ava Lawman

Carisoprodol is not recommended for neonates, infants, children, or adolescents under the age of 16 years because safe and effective use has not been established in pediatric patients. No pediatric specific problems have been documented.

drowsiness / Early / 13.0-17.0 xerostomia / Early / 0-10.0 dizziness / Early / 7.0-8.0 headache / Early / 3.0-5.0 nausea / Early / 4.0-4.0 insomnia / Early / 1.5-1.5 vertigo / Early / Incidence not known syncope / Early / Incidence not known weakness / Early / Incidence not known tremor / Early / Incidence not known irritability / Delayed / Incidence not known agitation / Early / Incidence not known mydriasis / Early / Incidence not known lethargy / Early / Incidence not known diplopia / Early / Incidence not known asthenia / Delayed / Incidence not known rash (unspecified) / Early / Incidence not known fever / Early / Incidence not known pruritus / Rapid / Incidence not known urticaria / Rapid / Incidence not known flushing / Rapid / Incidence not known dyspepsia / Early / Incidence not known vomiting / Early / Incidence not known.

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Carisoprodol is contraindicated in patients with a known carbamate hypersensitivity because carisoprodol is metabolized to meprobamate.

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Carisoprodol should be used only when the benefits outweigh the risks. There are no data available on the effects of carisoprodol on the mother and the fetus during labor and obstetric delivery. Based on animal studies, carisoprodol crosses the placenta, and causes adverse effects on fetal growth and postnatal survival. Carisoprodol has not been studied in humans during pregnancy. Carisoprodol is considered to be in FDA pregnancy category C. It is unknown if carisoprodol would have effects on reproductive capacity.

Carisoprodol
Soma (carisoprodol) dose, indications, adverse effects, interactions

Carisoprodol is removed by hemodialysis and peritoneal dialysis. Renal impairment or renal failure can reduce the excretion rate of metabolites such as meprobamate (minor active metabolite). Carisoprodol is excreted in the urine and should be used with caution in patients with renal disease.

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Safety and efficacy have not been established.

To reduce abuse potential, the duration of therapy should not exceed 2 to 3 weeks; data supporting efficacy for prolonged periods are not available. 250 mg to 350 mg PO 3 times daily and at bedtime.

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Carisoprodol is contraindicated in acute intermittent porphyria because it can potentiate the disease.

NOTE: Carisoprodol is a controlled substance. To reduce abuse potential, limit duration of therapy to a maximum of 3 weeks. Health care providers are advised to assess the risk of abuse before prescribing, keep prescription records, monitor for signs of abuse/overdose, and educate patients and families about abuse potential and proper storage/disposal.

Breast-feeding babies should be monitored for sedation, GI upset, or other changes in behavior or activities. Consider the benefits of breast-feeding, the risk of potential drug exposure, and the risk of an untreated or inadequay treated condition. According to the manufacturer, carisoprodol should be used cautiously in breast-feeding mothers. However, the baby required supplementation with formula because milk production was inadequate. A case report indicated that a nursing baby received about 4—6% of the maternal dose through breast milk but did not experience adverse effects. Carisoprodol is distributed into breast milk and may reach concentrations of 2—4 times higher than those of maternal plasma. If a breast-feeding baby experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA. Based on evidence in lactating mice, the manufacturer suggests that maternal use of carisoprodol may result in reduced or less effective feeding (due to sedation) and/or decreased milk production.

Carisoprodol is metabolized in the liver and should be used with caution in patients with hepatic disease. Hepatic dysfunction can reduce the excretion rate and possibly lead to toxicity. The prevalence of CYP2C19 poor metabolizers in Caucasian and African American patients is approximay 3—5% and in Asian patients is approximay 15—20%. As compared with data from patients with normal CYP2C19 activity, patients who are poor CYP2C19 metabolizers have a 4-fold increased exposure to carisoprodol and a concomitant 50% reduced exposure to meprobamate. Cautious carisoprodol use is advised for patients with reduced CYP2C19 activity.

muscle paralysis / Delayed / Incidence not known visual impairment / Early / Incidence not known bronchospasm / Rapid / Incidence not known erythema multiforme / Delayed / Incidence not known anaphylactic shock / Rapid / Incidence not known angioedema / Rapid / Incidence not known anaphylactoid reactions / Rapid / Incidence not known pancytopenia / Delayed / Incidence not known seizures / Delayed / Incidence not known.

Carisoprodol is a centrally acting agent and can exacerbate CNS depression. Carisoprodol should be used with caution in patients with CNS depression. There may be an additive effect and an increase in CNS depression if carisoprodol is combined with ethanol or other CNS depressants. Use caution with simultaneous administration. Carisoprodol may impair mental or physical abilities required for driving or operating machinery; carisoprodol-associated motor vehicle accidents have occurred in post-market experience.

However, no specific dosage recommendations are available. Dosage should be modified depending on clinical response and degree of renal impairment, but no quantitative recommendations are available. Metabolites, including meprobamate, are excreted renally. Peritoneal dialysis Carisoprodol is removed by peritoneal dialysis. However, no specific dosage recommendations are available. Intermittent hemodialysis Carisoprodol is removed by hemodialysis.

Carisoprodol should be used with caution in patients with a seizure disorder. Seizures occurred in patients with and without medical history of seizures and have been reported during therapeutic use, overdose, and during withdrawal from prolonged use. Seizures have been reported rarely during post-marketing surveillance in temporal association with carisoprodol.

Dosage reduction may be necessary based on clinical response and degree of hepatic impairment; carisoprodol is primarily metabolized by the liver. Patients with reduced CYP2C19 activity (poor metabolizers) have a greater exposure to carisoprodol; use cautiously in these patients.

Central-acting skeletal muscle relaxant Used for pain relief from musculoskeletal conditions such as muscle spasm Metabolized to small quantities of meprobamate (an anxiolytic agent) Soma, Vanadom.

>= 16 years: 1400 mg/day PO (manufacturer dosage limits for Soma). < 16 years: Safety and efficacy have not been established.

According to the OBRA guidelines, most muscle relaxants are poorly tolerated by older adults due to anticholinergic side effects, sedation, and/or weakness. Chronic use in individuals with complications due to multiple sclerosis, spinal cord injuries, cerebral palsy, and other select conditions may be indicated, although close monitoring is warranted. Some muscle relaxants can cause anticholinergic effects, sedation, and are associated with an increased risk of fractures. However, periodic use (e.g., once every 3 months) for no more than 7 days may be appropriate when other interventions or alternative medications are not effective or indicated. The federal Omnibus Budget Reconciliation Act (OBRA) regulates the use of medications in residents of long-term care facilities. In addition, there is questionable effectiveness of the dosages tolerated by older adults. According to the Beers Criteria, skeletal muscle relaxants including carisoprodol are considered potentially inappropriate medications (PIMs) for use in geriatric patients and should be avoided because most muscle relaxants are poorly tolerated by older adults. The efficacy, safety, and pharmacokinetic parameter values of carisoprodol in geriatric patients over 65 years of age have not been established. Abrupt discontinuation of some muscle relaxants may cause or predispose individuals to seizures or hallucinations.

euphoria / Early / Incidence not known dysarthria / Delayed / Incidence not known confusion / Early / Incidence not known impaired cognition / Early / Incidence not known ataxia / Delayed / Incidence not known depression / Delayed / Incidence not known eosinophilia / Delayed / Incidence not known hypotension / Rapid / Incidence not known sinus tachycardia / Rapid / Incidence not known orthostatic hypotension / Delayed / Incidence not known leukopenia / Delayed / Incidence not known psychological dependence / Delayed / Incidence not known withdrawal / Early / Incidence not known.

Soma: - Store at controlled room temperature (between 68 and 77 degrees F) Vanadom: - Store at controlled room temperature (between 68 and 77 degrees F).

To reduce abuse potential, the duration of therapy should not exceed 2 to 3 weeks; data supporting efficacy for prolonged periods are not available. 250 mg to 350 mg PO 3 times daily and at bedtime.

Psychological dependence, drug abuse, drug misuse, and criminal diversion have been reported with prolonged use of carisoprodol and with meprobamate, one of the metabolites of carisoprodol. Avoid abrupt discontinuation of carisoprodol. Symptoms of withdrawal may include insomnia, vomiting, abdominal cramps, headache, tremors, muscle twitching, ataxia, hallucinations, and psychosis. Health care providers are also advised to assess the risk of abuse before prescribing, keep prescription records, monitor for signs of abuse/overdose, and educate patients and families about abuse potential and proper storage/disposal. Carisoprodol is a schedule IV controlled substance and should be used with caution in patients with a history of substance abuse or dependency. To reduce abuse potential, limit the duration of therapy to a maximum of 3 weeks. Withdrawal reactions after abrupt discontinuation of carisoprodol have also occurred, but appear to be mild and less severe than benzodiazepine withdrawal.

Administer the last daily dose at bedtime. To minimize gastric irritation, administer with food. May be administered with or without food.

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Muscle Relaxants, Centrally Acting, Plain Rx, schedule IV.

Carisoprodol/Soma/Vanadom Oral Tab: 250mg, 350mg.

Not recommended. 1400 mg/day PO (manufacturer dosage limits for Soma).

Carisoprodol