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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:
SOMA is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.
SOMA should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration
Carisoprodol tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.
Carisoprodol tablets should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration.
Warnings and Precautions
Sedation
Carisoprodol has sedative properties (in the low back pain trials, 13% to 17% of patients who received Carisoprodol tablets USP 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 Carisoprodol.
Since the sedative effects of Carisoprodol 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 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.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long term 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 vivo 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 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.
Clinical Studies
The safety and efficacy of Carisoprodol for the relief of acute, idiopathic mechanical low back pain was evaluated in one, 7-day, double blind, randomized, multicenter, placebo controlled, U.S. trial (Study 1). Patients had to be 18 to 65 years old and had to have acute back pain (≤3 days of duration) to be included in the trial. Patients with chronic back pain; at increased risk for vertebral fracture (e.g., history of osteoporosis); with a history of spinal pathology (e.g., herniated nucleus pulposis, spondylolisthesis or spinal stenosis); with inflammatory back pain, or with evidence of a neurologic deficit were excluded from participation. Concomitant use of analgesics (e.g., acetaminophen, NSAIDs, tramadol, opioid agonists), other muscle relaxants, botulinum toxin, sedatives (e.g., barbiturates, benzodiazepines, promethazine hydrochloride), and anti-epileptic drugs was prohibited.
In Study 1, patients were randomized to one of two treatment groups (i.e., Carisoprodol 350 mg or placebo). In the study, patients received study medication three times a day and at bedtime for seven days.
The primary endpoints were the relief from starting backache and the global impression of change, as reported by patients, on Study Day 3. Both endpoints were scored on a 5-point rating scale from 0 (worst outcome) to 4 (best outcome) in the study.
The proportion of patients who used concomitant acetaminophen, NSAIDs, tramadol, opioid agonists, other muscle relaxants, and benzodiazepines was similar in the treatment groups.
The results for the primary efficacy evaluations in the acute, low back pain study are presented in Table 3.
| Study | Parameter | Placebo | Carisoprodol 350 mg |
|---|---|---|---|
|
|||
| 1 | Number of Patients | n=269 | n=273 |
| Relief from Starting Backache, Mean (SE)† | 1.4 (0.1) | 1.8 (0.1) | |
| Difference between Carisoprodol and Placebo, Mean (SE)† (95% Cl) |
0.4 (0.2, 0.6) |
||
| Global Impression of Change, Mean (SE)† | 1.9 (0.1) | 2.2 (0.1) | |
| Difference between Carisoprodol and Placebo, Mean (SE)† (95% Cl) |
0.3 (0.1, 0.4) |
||
Patients treated with Carisoprodol experienced improvement in function as measured by the Roland-Morris Disability Questionnaire (RMDQ) score on Days 3 and 7.
How Supplied/Storage and Handling
Carisoprodol tablets USP, 350 mg are white, round, debossed MP 58 on one side and blank on the other side.
| Bottles of 20 | NDC 53489-110-60 |
| Bottles of 30 | NDC 53489-110-07 |
| Bottles of 60 | NDC 53489-110-06 |
| Bottles of 100 | NDC 53489-110-01 |
| Bottles of 500 | NDC 53489-110-05 |
| Bottles of 1000 | NDC 53489-110-10 |
Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room Temperature]
DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.
Patient Counseling Information
Patients should be advised to contact their physician if they experience any adverse reactions to Carisoprodol.
Sedation
Patients should be advised that Carisoprodol may cause drowsiness and/or dizziness, and has been associated with motor vehicle accidents. Patients should be advised to avoid taking Carisoprodol before engaging in potentially hazardous activities such as driving a motor vehicle or operating machinery.
Avoidance of Alcohol and Other CNS Depressants
Patients should be advised to avoid alcoholic beverages while taking Carisoprodol and to check with their doctor before taking other CNS depressants such as benzodiazepines, opioids, tricyclic antidepressants, sedating antihistamines, or other sedatives.
Carisoprodol Should Only Be Used for Short-Term Treatment
Patients should be advised that treatment with Carisoprodol should be limited to acute use (up to two or three weeks) for the relief of acute, musculoskeletal discomfort. In the post-marketing experience with Carisoprodol, cases of dependence, withdrawal, and abuse have been reported with prolonged use. If the musculoskeletal symptoms still persist, patients should contact their healthcare provider for further evaluation.
Dizziness, drowsiness, headache, unusually fast heartbeat, low blood pressure, or face flushing may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Sometimes carisoprodol may cause a very rare but serious reaction (idiosyncratic) that occurs within minutes or hours of the first dose of this medication. Seek immediate medical attention and do not take more of the medication if you experience: extreme weakness, inability to move your legs/arms, shaky/unsteady movement, pain in your joints, vision changes (double vision, inability to see), widened pupils, mental/mood changes (e.g., agitation, restlessness, unexplained mood swings, confusion).A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.PRECAUTIONS: Before taking carisoprodol, tell your doctor or pharmacist if you are allergic to it; or to meprobamate, tybamate, or mebutamate; or if you have any other allergies. Also tell your doctor if you have ever had an unusual reaction to carisoprodol or any of the medications listed above.This medication should not be used if you have a certain medical condition. Before using this medication, tell your doctor if you have: acute intermittent porphyria.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver problems, history of regular alcohol/drug abuse, asthma, seizure disorder.To reduce dizziness and lightheadedness, get up slowly when rising from a seated or lying position.This drug may make you dizzy or drowsy; use caution engaging in activities requiring alertness such as driving, swimming or using machinery. Avoid alcoholic beverages.This medication is not recommended for use during pregnancy. It may rarely harm an unborn baby. Consult your doctor for more details and to discuss reliable forms of birth control. If you become pregnant while taking this medication, tell your doctor immediately.This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
