Carisoprodol Generic soma

Carisoprodol is a white, crystalline powder. Meprobamate is a white powder. Both are available in tablet form.

Synonyms:Carisoprodol: N-isopropyl-2-methyl-2-propyl-1,3-propanediol dicarbamate; Soma®, Sodol®, Soprodol®, Soridol®. Meprobamate: Miltown®, Equanil®, Equagesic®, Meprospan®.

Source: Carisoprodol and meprobamate are available by prescription only. Carisoprodol itself is not a federally scheduled compound, while meprobamate is a Schedule IV drug. Soma® is available as a 350 mg strength round, white tablet; Soma® Compound is a 250 mg strength two-layered, white and light orange round tablet (also contains aspirin); and Soma® Compound with Codeine is a 250 mg strength two-layered, white and yellow oval tablet (also contains aspirin and codeine phosphate) and is a schedule III controlled substance. Miltown® is available as a 200 mg and 400 mg strength white tablet; Equanil® is a 200 mg and 400 mg strength tablet; and Equagesic® is a 200 mg strength two-layered, pink and yellow, round tablet (also contains aspirin).   Drug Class:Carisoprodol: muscle relaxant, CNS depressant; Meprobamate: antianxiety, CNS depressant.

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.

DRUG ABUSE AND DEPENDENCE

• Soma is not a controlled substance. Discontinuation of carisoprodol in animals or in humans after chronic administration can produce withdrawal signs, and there are published case reports of human carisoprodol dependence.
• In vitro studies demonstrate that carisoprodol elicits barbiturate-like effects. Animal behavioral studies indicate that carisoprodol produces rewarding effects. Monkeys self administer carisoprodol. Drug discrimination studies using rats indicate that carisoprodol has positive reinforcing and discriminative effects similar to barbital, meprobamate, and chlordiazepoxide.

Dosage Forms And Strengths

250 mg Tablets: round, convex, white tablets, inscribed with SOMA 250

350 mg Tablets: round, convex, white tablets, inscribed with SOMA 350

Storage and Handling

250 mg Tablets: round, convex, white tablets, inscribed with SOMA 250; available in bottles of 100 (NDC 0037-2250-10) and bottles of 30 (NDC 0037-2250-30).

350 mg Tablets: round, convex, white tablets, inscribed with SOMA 350; available in bottles of 100 (NDC 0037-2001-01).

Source: Carisoprodol and meprobamate are available by prescription only. Carisoprodol itself is not a federally scheduled compound, while meprobamate is a Schedule IV drug. Soma® is available as a 350 mg strength round, white tablet; Soma® Compound is a 250 mg strength two-layered, white and light orange round tablet (also contains aspirin); and Soma® Compound with Codeine is a 250 mg strength two-layered, white and yellow oval tablet (also contains aspirin and codeine phosphate) and is a schedule III controlled substance. Miltown® is available as a 200 mg and 400 mg strength white tablet; Equanil® is a 200 mg and 400 mg strength tablet; and Equagesic® is a 200 mg strength two-layered, pink and yellow, round tablet (also contains aspirin).

Carisoprodol may be habit-forming and should be used only by the person it was prescribed for. Carisoprodol should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. You may have withdrawal symptoms when you stop using carisoprodol after using it over a long period of time. Do not stop using this medication suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely. Carisoprodol can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase drowsiness and dizziness caused by carisoprodol.

Do not use Carisoprodol if you are allergic to carisoprodol or meprobamate (Equanil, Miltown), or if you have porphyria.

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have:

• epilepsy or other seizure disorder;
• liver disease; or
• kidney disease.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take carisoprodol.

This medication may be habit-forming and should be used only by the person it was prescribed for. Carisoprodol should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. You may have withdrawal symptoms when you stop using carisoprodol after using it over a long period of time. Withdrawal symptoms include stomach pain, sleep problems, headache, nausea, and seizure (convulsions). Do not stop using this medication suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether carisoprodol passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medication to a child younger than 12 years old..

Drug Class:Carisoprodol: muscle relaxant, CNS depressant; Meprobamate: antianxiety, CNS depressant.

Medicinal and Recreational Uses: Carisoprodol is a centrally acting skeletal muscle relaxant prescribed for the treatment of acute, musculoskeletal pain. Meprobamate is a major metabolite of carisoprodol, and is a CNS depressant in its own right, indicated for the management of anxiety disorders or for short-term treatment of anxiety symptoms. Use of these drugs begins with prescription for muscular pain or anxiety, and abuse develops for their sedative-hypnotic effects, resulting in increased dosage without medical advice, or continued use after pain or anxiety has subsided.

Potency, Purity and Dose: Carisoprodol is present as a racemic mixture. During treatment, the recommended dose of carisoprodol is for one 350 mg tablet taken three times daily and at bedtime (1400 mg/day). The usual dose for meprobamate is one

400 mg taken four times daily, or daily divided doses of up to 2400 mg. To control chronic pain, carisoprodol is often taken concurrently with other drugs, particularly opiates, benzodiazepines, barbiturates, and other muscle relaxants.

Route of Administration: Oral.

Pharmacodynamics: The pharmacological effects of carisoprodol appear to be due to the combination of the effects of carisoprodol and its active metabolite, meprobamate. Meprobamate is equipotent to carisoprodol. There is some evidence suggesting carisoprodol is a GABA A receptor indirect agonist with CNS chloride ion channel conductance effects. In animals, carisoprodol produces muscle relaxation by blocking interneuronal activity and depressing transmission of polysynaptic neurons in the descending reticular formation and spinal cord. It is unknown if this mechanism of action is also present in humans. In addition to the desired skeletal muscle relaxing effects, carisoprodol and meprobamate produce weak anticholinergic, antipyretic and analgesic properties.

Pharmacokinetics: Carisoprodol is rapidly absorbed from the gastrointestinal tract and rapidly distributed throughout the CNS. Protein binding is approximately 60%. Carisoprodol is predominantly dealkylated to meprobamate in the liver, and to a lesser extent hydroxylated to hydroxycarisoprodol and hydroxymeprobamate, followed by conjugation and excretion. The half-life of carisoprodol is approximately 100 minutes. Some individuals have impaired metabolism of carisoprodol, and exhibit a half life of 2-3 times that in normal subjects. The half-life of meprobamate is many times longer, between 6 and 17 hours. As a result of the significantly longer half-life of meprobamate relative to carisoprodol, accumulation of meprobamate during chronic therapy may occur.

Carisoprodol Side Effects

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. 

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.

Carisoprodol passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Duration of Effects: The effects of carisoprodol begin within 30 minutes of oral administration, and last for up to 4-6 hours. In overdose, coma may last from several hours to a day or more. Meprobamate has a much longer duration of effect than carisoprodol due to a much longer half-life.

Tolerance, Dependence and Withdrawal: Development of abuse and moderate physical and psychological dependence can occur with chronic use of both carisoprodol and meprobamate. Abrupt discontinuation of long-term use can be followed by mild withdrawal symptoms such as anxiety, abdominal cramps, insomnia, headache, nausea, vomiting, ataxia, tremor, muscle twitching, confusion, and occasionally chills, convulsions and hallucinations. Onset of withdrawal from meprobamate occurs within 12-48 hours following cessation of use, and can last a further 12-48 hours. Carisoprodol has been shown to produce cross-tolerance to barbiturates.

Drug Interactions: Alcohol enhances the impairment of physical abilities produced by carisoprodol, and increased sedation, extreme weakness, dizziness, agitation, euphoria and confusion may be observed. Alcohol also inhibits the metabolism of meprobamate and produces an additive depressant effect on the CNS that includes sleepiness, disorientation, incoherence and confusion. The concurrent administration of other centrally acting drugs such as opiates, benzodiazepines, barbiturates, and other muscle relaxants can contribute to impairment. Meprobamate may enhance the analgesic effects of other drugs.

Performance Effects: Very limited studies are available for carisoprodol, however, single oral doses of 700 mg have not been shown to affect psychomotor and cognitive tests within 3 hours of dosing, to a significant degree. In contrast, single doses of meprobamate are capable of causing significant performance impairment. Performance effects include impaired divided attention, impaired coordination and balance, slowed reflexes and increased reaction time. With chronic dosing of either drug, it is likely that decrements in psychomotor performance would be even more pronounced.

Effects on Driving: The drug manufacturer suggests patients should be warned that carisoprodol and meprobamate may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a motor vehicle. Reported signs of psychomotor and cognitive impairment in subjects found to be driving under the influence of carisoprodol/meprobamate include poor perception, impaired reaction time, slow driving, confusion, disorientation, inattentiveness, slurred or thick speech, slow responses, somnolence, lack of balance and coordination, unsteadiness, and difficulty standing, walking or exiting vehicles.

Logan et al., 2000 describes 21 driving under the influence cases where carisoprodol and/or meprobamate were the only drugs detected. The mean carisoprodol and meprobamate concentrations were 4.6 mg/L (range 0-15 mg/L) and 14.5 mg/L (range 1-36 mg/L), respectively. Signs of impairment were noted at blood concentrations as low as 1 mg/L of meprobamate, however, the most severe driving impairment and the most overt symptoms of intoxication occurred in drivers whose combined carisoprodol and meprobamate blood concentrations were greater than 10 mg/L. Signs consistent with CNS depression were typically observed, including poor balance and coordination, horizontal gaze nystagmus, slurred speech, dazed or groggy appearance, depressed reflexes, slow movements, disorientation to place and time, and a tendency to dose off or fall asleep. Many subjects were involved in accidents, and other observed driving behaviors included extreme lane travel and weaving, striking other vehicles and fixed objects, slow speed, and hit and run accidents where the subject appeared unaware they had hit another vehicle.

DEC Category: CNS depressant

DEC Profile: Horizontal gaze nystagmus present; vertical gaze nystagmus may be present in high doses; lack of convergence present; pupil size normal to dilated; reaction to light slow; pulse rate normal to down; blood pressure normal to down; body temperature normal to down. Other characteristic indicators may include slurred speech, drowsiness, disorientation, drunken behavior without the odor of alcohol, and poor performance on field sobriety tests.

Panel’s Assessment of Driving Risks: A single therapeutic dose of carisoprodol is unlikely to cause significant performance impairment. However, single therapeutic doses of meprobamate and chronic doses of carisoprodol may produce moderate to severe impairment of psychomotor skills associated with safe driving.

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