SOMA is used to help adults with acute, painful conditions of the musculoskeletal system feel better. SOMA should only be used for short periods (up to two or three weeks) because there isn't enough evidence that it works for longer use, and because most painful, acute musculoskeletal conditions don't last long.
DOSAGE AND ADMINISTRATION
SOMA should be taken between 250 mg and 350 mg three times a day and before bed.
SOMA should only be used for up to two or three weeks at the most.
DOSAGE FORMS AND STRENGTHS
250 mg Tablets are round, convex, white pills that say SOMA 250 350 mg on them. Tablets: white, round, convex tablets with SOMA 350 written on them.
SIGNALS TO STOP
SOMA shouldn't be given to people who have had an allergic reaction to a carbamate like meprobamate or who have a history of acute intermittent porphyria.
WARNINGS AND PRECAUTIONS
- Put to sleep
- SOMA makes people feel sleepy. In trials for low back pain, 13% to 17% of people who took SOMA felt sleepy, while only 6% of people who took a placebo did and can make it harder to think and/or move in ways that are needed to do potentially dangerous things like driving a car or running machinery. There have been reports of car accidents that happened after SOMA was on the market.
- Since the sedative effects of SOMA and other CNS depressants (like alcohol, benzodiazepines, opioids, and tricyclic antidepressants) may add up, patients who take more than one of these CNS depressants at the same time should be treated with extra care.
- Misuse, addiction, and withdrawal
- Carisoprodol, which is the main ingredient in SOMA, has been abused, depended on, withdrawn from, used wrongly, and sold illegally.
- Overdosing on SOMA can cause death, depression of the central nervous system and breathing, low blood pressure, seizures, and other problems .
- Carisoprodol abuse and dependence have been reported in patients who have used it for a long time and have a history of drug abuse. Even though most of these people also abused other drugs, some only abused carisoprodol. People who used SOMA for a long time and then stopped using it all of a sudden have reported withdrawal symptoms.
- Insomnia, vomiting, stomach cramps, headache, tremors, muscle twitching, ataxia, hallucinations, and psychosis were all reported as withdrawal symptoms. One of carisoprodol's effects is to make people sleepy.
- Before prescribing SOMA, the risk of abuse should be looked at to lower the chance of it being abused. Limit the length of treatment for acute musculoskeletal pain to three weeks, keep careful records of prescriptions, watch for signs of abuse and overdose, and teach patients and their families about abuse and how to store and get rid of the medicine properly.
- There have been reports of seizures in patients who took SOMA after it came out on the market.
- Most of these cases have involved multiple drug overdoses, including abuse drugs, illegal drugs, and alcohol.
REACTIONS THAT GO WRONG
- Clinical Studies Experience
- Because clinical studies are done under a wide range of different conditions, the rates of side effects seen in clinical studies of one drug cannot be directly compared to the rates seen in clinical studies of another drug, and the rates seen in practice may not match the rates seen in clinical studies.
- The information below is based on 1387 adults with acute mechanical lower back pain who took part in two double-blind, randomized, multicenter, placebo-controlled, one-week trials. In these studies, people were given 250 mg of SOMA, 350 mg of SOMA, or a fake drug (placebo) three times a day and before bed for a total of seven days. The average age was 41, and there were 54% women and 46% men. 74% were Caucasian, 16% were Black, 9% were Asian, and 2% were other.
- In these two trials, no one died and there were no very bad side effects. In these two studies, 2.7%, 2%, and 5.4% of people who were given a placebo, 250 mg of SOMA, and 350 mg of SOMA, respectively, stopped taking the drug because of side effects, and 0.5%, 0.5%, and 1.8% of people who were given a placebo, 250 mg of SOMA, and 350 mg of SOMA, respectively, stopped taking the drug because of side effects on the central nervous system.
- Experience After Marketing
The following things have been said to happen when SOMA is used after it has been approved. Because these reactions are reported voluntarily by a population whose size is unknown, it is not always possible to get a good estimate of how often they happen or prove that they are caused by the drug.
Cardiovascular: Fast heart rate, low blood pressure when standing up, and flushing of the face .
Central Nervous System: Drowsiness, dizziness, vertigo, ataxia, tremor, agitation, irritability, headache, depressive reactions, syncope, insomnia, and seizures [see Overdose (10)].
Gastrointestinal: Feeling sick, throwing up, and having pain in the stomach.
Hematologic: Leukopenia, pancytopenia
- CNS Depressants
- SOMA and other CNS depressants, like alcohol, benzodiazepines, opioids, and tricyclic antidepressants, may have the same effect of making you sleepy. So, patients who take more than one of these CNS depressants at the same time should be treated with care.
- Drugs that slow down or speed up CYP2C19
Meprobamate is made when CYP2C19 breaks down carisoprodol in the. When CYP2C19 inhibitors like omeprazole or fluvoxamine are taken with SOMA, the carisoprodol level could go up and the meprobamate level could go down. When CYP2C19 inducers like rifampin or St. John's Wort are taken with SOMA, carisoprodol could be less effective and meprobamate could be more effective. CYP2C19 was also made to work faster by low doses of aspirin. We don't know what the full effects of these possible changes in exposures are on the pharmacological effects or safety of SOMA.
Use in certain groups of people
- Pregnancy Risk Summary
- Carisoprodol has been used during pregnancy for many decades, and there is no evidence that the drug increases the risk of major birth defects, miscarriage, or other bad outcomes for the mother or baby. Data on meprobamate, which is the main metabolite of carisoprodol, do not show a consistent link between maternal use of meprobamate and an increased risk of major birth defects (see Data).
- In a published study on animal reproduction, pregnant mice were given oral doses of carisoprodol that were 2.6 and 4.1 times the maximum recommended human dose of 1400 mg per day (350 mg).
- It is not known what the average risk of major birth defects and miscarriage is for the population in question. There is always a chance that a baby will be born with a defect, die, or have something else bad happen. In the general U.S. population, the estimated background risk of major birth defects and miscarriage in clinically confirmed pregnancies is 2% to 4% and 15% to 20%, respectively.
- Risks of Breastfeeding
- Carisoprodol and its metabolite, meprobamate, are both found in breast milk, according to research that has already been published. There are no facts about how carisoprodol affects the amount of milk a cow makes. There is one report of an infant getting sleepy after its mother took carisoprodol and breastfed it.
- Since there have been no consistent reports of bad things happening to breastfed babies in the decades that SOMA has been used, the developmental and health benefits of breastfeeding should be taken into account along with the mother's clinical need for SOMA and any bad things that could happen to the baby because of SOMA or the underlying condition of the mother.
- Pediatric Use
- The effectiveness, safety, and pharmacokinetics of SOMA in children younger than 16 have not been proven.
- Geriatric Use
- The effectiveness, safety, and pharmacokinetics of SOMA in people older than 65 have not been proven.
- Renal Impairment
- We don't know how safe SOMA is for people with kidney disease or how it works in their bodies. SOMA is passed out of the body by the kidneys, so it should be given with care to people with poor kidney function. Both hemodialysis and peritoneal dialysis can be used to get rid of carisoprodol.
- Problems with the liver
- No research has been done on the safety and pharmacokinetics of SOMA in people with liver disease. SOMA is broken down in the liver, so patients with poor liver function should be careful if they are given SOMA.
- People whose CYP2C19 activity is lower
- Carisoprodol affects patients more who have less CYP2C19 activity. Since this is the case, SOMA should be given to these patients with care.
DRUG ABUSE AND DEPENDENCE
- Drugs That Can't Be Sold
- Soma contains carisoprodol, a Schedule IV controlled substance. Carisoprodol has been abused, used wrongly, and stolen for non-medical purposes [see Warnings and Precautions (5.2)].
- Abusing carisoprodol can cause overdose, which can cause death, depression of the central nervous system and breathing, low blood pressure, seizures, and other problems.
- People who have used carisoprodol for a long time, have a history of drug abuse, or use SOMA with other drugs that are also abused are more likely to abuse it.
- Prescription drug abuse is the use of a drug for reasons other than medical treatment, even if it's just once, because it makes you feel good. Repeated drug abuse leads to drug addiction, which is marked by a strong desire to take a drug despite its harmful effects, difficulty controlling its use, giving drug use more importance than responsibilities, increased tolerance, and sometimes physical withdrawal. Physical dependence and tolerance are not the same thing as drug abuse or drug addiction. For example, abuse or addiction may not go hand in hand with tolerance or physical dependence.
- Tolerance is when a patient's response to a certain dose and concentration gradually decreases without the disease getting worse. This means that the dose needs to be raised to keep the same effect. Withdrawal symptoms happen when a drug is suddenly stopped or a large amount of it is taken away. This is a sign of physical dependence. People who use SOMA for a long time report both tolerance and physical dependence. SOMA withdrawal can cause insomnia, vomiting, stomach cramps, headache, tremors, twitching muscles, anxiety, ataxia, hallucinations, and psychosis. Tell people who are taking large doses.