Carisoprodol
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Carisoprodol is a centrally-acting skeletal muscle relaxant. It is a colorless, crystalline powder, having a mild characteristic odor and a bitter taste. Carisoprodol is slightly soluble in water and freely soluble in alcohol, chloroform and acetone. The drug’s solubility is practically independent of pH. Carisoprodol is marketed in the United States under the brand name Soma, and in the United Kingdom and other countries under the brand names Sanoma and Carisoma. The drug is available by itself or mixed with aspirin and in one preparation (Soma Compound With Codeine) along with codeine and caffeine as well.
Carisoprodol is a muscle relaxer that works by blocking pain sensations between the nerves and the brain. Carisoprodol is used together with rest and physical therapy to treat injuries and other painful musculoskeletal conditions.
SOMA (carisoprodol) Tablets are available as 250 mg and 350 mg round, white tablets. Carisoprodol is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. Chemically, carisoprodol is N-isopropyl-2-methyl-2-propyl-1,3-propanediol dicarbamate and the molecular formula is C12H24N2O4, with a molecular weight of 260.33. The structural formula is:
Other ingredients in the SOMA drug product include alginic acid, magnesium stearate, potassium sorbate, starch, and tribasic calcium phosphate.
Carisoprodol PRECAUTIONS
Sedation
SOMA has sedative properties (in the low back pain trials, 13% to 17% of patients who received SOMA experienced sedation compared to 6% of patients who received placebo) 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 SOMA.
Since the sedative effects of SOMA and other CNS depressants (e.g., alcohol, benzodiazepines, opioids, tricyclic 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 the postmarketing experience with SOMA, 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 SOMA in combination with other drugs with abuse potential. However, there have been post-marketing adverse event reports of SOMA-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 SOMA dependence, withdrawal, or abuse, SOMA should be used with caution in addiction-prone patients and in patients taking other CNS depressants including alcohol, and SOMA should not be used more than two to three weeks for the relief of acute musculoskeletal discomfort.
SOMA, and one of its metabolites, meprobamate (a controlled substance), may cause dependence .
Seizures
There have been postmarketing reports of seizures in patients who received SOMA. Most of these cases have occurred in the setting of multiple drug overdoses (including drugs of abuse, illegal drugs, and alcohol) .
Nonclinical Toxicology
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long term studies in animals have not been performed to evaluate the carcinogenic potential of carisoprodol.
SOMA 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 vivo mouse micronucleus assay of circulating blood cells.
SOMA 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 spent 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.
Use In Specific Population
Pregnancy: Pregnancy Category C.
There are no data on the use of SOMA 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 anxiolytic. 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 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 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 1-1.5 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. SOMA should be used during pregnancy only if the potential benefit justifies the risk to the fetus.
Labor and Delivery
There is no information about the effects of SOMA on the mother and the fetus during labor and delivery.
Nursing Mothers
Very limited data in humans show that SOMA is present in breast milk and may reach concentrations two to four times the maternal plasma concentrations. In one case report, a breast fed infant received about 4-6% of the maternal daily dose through 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 were decreased. This information suggests that maternal use of SOMA may lead to reduced or less effective infant feeding (due to sedation) and/or decreased milk production. Caution should be exercised when SOMA is administered to a nursing woman.
Pediatric Use
The efficacy, safety, and pharmacokinetics of SOMA in pediatric patients less than 16 years of age have not been established.
Geriatric Use
The efficacy, safety, and pharmacokinetics of SOMA in patients over 65 years old have not been established.
Renal Impairment
The safety and pharmacokinetics of SOMA in patients with renal impairment have not been evaluated. Since SOMA is excreted by the kidney, caution should be exercised if SOMA is administered to patients with impaired renal function. Carisoprodol is dialyzable by hemodialysis and peritoneal dialysis.
Hepatic Impairment
The safety and pharmacokinetics of SOMA in patients with hepatic impairment have not been evaluated. Since SOMA is metabolized in the liver, caution should be exercised if SOMA is administered to patients with impaired hepatic function.
Patients with Reduced CYP2C19 Activity
Patients with reduced CYP2C19 activity have higher exposure to carisoprodol. Therefore, caution should be exercised in administration of SOMA to these patients.
Treatment of Carisoprodol Overdosage
Basic life support measures should be instituted as dictated by the clinical presentation of the SOMA overdose. Induced emesis is not recommended due to the risk of CNS and respiratory depression, which may increase the risk of aspiration pneumonia. Gastric lavage should be considered soon after ingestion (within one hour). Circulatory support should be administered with volume infusion and vasopressor agents if needed. Seizures should be treated with intravenous benzodiazepines and the reoccurrence of seizures may be treated with phenobarbital. In cases of severe CNS depression, airway protective reflexes may be compromised and tracheal intubation should be considered for airway protection and respiratory support.
The following types of treatment have been used successfully with an overdose of meprobamate, a metabolite of SOMA: activated charcoal (oral or via nasogastric tube), forced diuresis, peritoneal dialysis, and hemodialysis (carisoprodol is also dialyzable). Careful monitoring of urinary output is necessary and overhydration should be avoided. Observe for possible relapse due to incomplete gastric emptying and delayed absorption. For more information on the management of an overdose of SOMA, contact a Poison Control Center.
Carisoprodol side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using carisoprodol and call your doctor at once if you have any of these serious side effects:
- paralysis (loss of feeling);
- extreme weakness or lack of coordination;
- feeling light-headed, fainting;
- fast heartbeat;
- seizure (convulsions);
- vision loss; or
- agitation, confusion.
Less serious side effects may include:
- drowsiness, dizziness, tremor;
- headache;
- depression, feeling irritable;
- blurred vision;
- sleep problems (insomnia); or
- nausea, vomiting, hiccups, upset stomach.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Usage and legal status
Although reports from Norway have shown that carisoprodol has abuse potential as a product of meprobamate and/or potentiator of hydrocodone, dihydrocodeine, codeine and similar drugs, it continues to be prescribed in North America, alongside orphenadrine and cyclobenzaprine. In Europe, doctors favor cyclobenzaprine. In the United Kingdom, benzodiazepines are preferred instead. All of the above plus chlorzoxazone are used in Canada.
As of November 2007, carisoprodol (Somadril, Somadril comp.) has been taken off the market in Sweden due to problems with dependence and side effects. The agency overseeing pharmaceuticals has considered other drugs used with the same indications as carisoprodol to have the same or better effects without the risks of the drug. In May 2008 it was taken of the market in Norway as well.
In the EU, the European Medicines Agency has issued a release recommending that member states suspend marketing authorization for this product in the treatment of acute (not chronic) back pain.
In the United States, while carisoprodol is not a controlled substance under federal regulations, as of February 2010, carisoprodol is considered to be a schedule IV controlled substance by the states of Alabama, Arizona, Arkansas, Florida, Georgia, Hawaii, Indiana, Kentucky, Louisiana, Massachusetts, Minnesota, Mississippi, New Mexico, Nevada, Oklahoma, Oregon and Texas (scheduled using the states new controlled substance program which requires physicians to obtain, and include, a state “DPS” number as well as a DEA number on all controlled substances prescriptions) and Washington State. It is a Schedule III controlled substance in West Virginia. The rest of the United States, excluding the above named states, falls under the DEA scheduling for the drug, which considers carisoprodol a non-scheduled chemical, meaning that carisoprodol is considered a general prescription medication by the federal government of the United States, with oversight provided solely by the U.S. Food and Drug Administration (FDA).