SOma Prescription

SOMA (carisoprodol) is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults.

SOMA (carisoprodol) 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

The recommended dose of SOMA (carisoprodol) is 250 mg to 350 mg three times a day and at bedtime. The recommended maximum duration of SOMA (carisoprodol) use is up to two or three weeks.

Dosage Forms And Strengths

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

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

Storage and Handling

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

OVERDOSE:If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

NOTES: Do not share this medication with others.

MISSED DOSE:If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE:Store in a tightly closed container at room temperature between 59-86 degrees F (15-30 degrees C) away from moisture and sunlight. Do not store in the bathroom. Keep all medicines away from children and pets.

Carisoprodol Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect rates observed in practice.

The data described below are based on 1387 patients pooled from two double blind, randomized, multicenter, placebo controlled, one-week trials in adult patients with acute, mechanical, lower back pain. In these studies, patients were treated with 250 mg of SOMA (carisoprodol) , 350 mg of SOMA (carisoprodol) , or placebo three times a day and at bedtime for seven days. The mean age was about 41 years old with 54% females and 46% males and 74 % Caucasian, 16 % Black, 9% Asian, and 2% other.

There were no deaths and there were no serious adverse reactions in these two trials. In these two studies, 2.7%, 2%, and 5.4%, of patients treated with placebo, 250 mg of SOMA (carisoprodol) , and 350 mg of SOMA (carisoprodol) , respectively, discontinued due to adverse events; and 0.5%, 0.5%, and 1.8% of patients treated with placebo, 250 mg of SOMA (carisoprodol) , and 350 mg of SOMA (carisoprodol) , respectively, discontinued due to central nervous system adverse reactions.

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.

What is the most important information I should know about 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. 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.

What should I discuss with my healthcare provider before taking carisoprodol?

Do not use this medication 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.

Soma (Carisoprodol) DRUG INTERACTIONS

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: melatonin, other muscle relaxants (e.g., cyclobenzaprine, methocarbamol).

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-anxiety drugs (e.g., diazepam), anti-seizure drugs (e.g., carbamazepine), medicine for sleep (e.g., zolpidem, temazepam), narcotic pain relievers (e.g., codeine), psychiatric medications (e.g., phenothiazines such as chlorpromazine or tricyclics such as amitriptyline), tranquilizers. Alcoholic beverages will also increase the drowsiness effect.

Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.