In the U.S.—

In Canada—

• Antianxiety agent

Meprobamate (me-proe-BA-mate) is used to relieve nervousness or tension. This medicine should not be used for nervousness or tension caused by the stress of everyday life.

Meprobamate is available only with your doctor's prescription, in the following dosage forms:

Oral
• Extended-release capsules (U.S. and Canada)
• Tablets (U.S. and Canada)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For meprobamate, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to meprobamate or to medicines like meprobamate such as carbromal, carisoprodol, mebutamate, or tybamate. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Meprobamate has been reported to increase the chance of birth defects if taken during the first 3 months of pregnancy.

Breast-feeding—Meprobamate passes into the breast milk and may cause drowsiness in babies of mothers taking this medicine.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of meprobamate in children with use in other age groups.

Older adults—Elderly people may be especially sensitive to the effects of meprobamate. This may increase the chance of side effects during treatment.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking meprobamate, it is especially important that your health care professional know if you are taking any of the following:

• Central nervous system (CNS) depressants (medicines that cause drowsiness) or
• Tricyclic antidepressants (medicine for depression)—Taking these medicines with meprobamate may increase the CNS depressant effects

• Alcohol abuse (or history of) or
• Drug abuse or dependence (or history of)—Dependence on meprobamate may develop

• Epilepsy—The risk of seizures may be increased

• Kidney disease or
• Liver disease—Higher blood levels of meprobamate may occur, increasing the chance of side effects

• Porphyria—Meprobamate may make the condition worse

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much is taken, it may become habit-forming.

Dosing—

The dose of meprobamate will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of meprobamate. If your dose is different, do not change it unless your doctor tells you to do so:

• For regular (short-acting) tablets:
  • Adults and children 12 years of age and older: 400 milligrams three or four times a day, or 600 milligrams two times a day.
  • Children 6 to 12 years of age: 100 to 200 milligrams two or three times a day.
  • Children up to 6 years of age: Dose must be determined by the doctor.
• For long-acting dosage forms (extended-release tablets):
  • Adults and children 12 years of age or older: 400 to 800 milligrams two times a day, in the morning and at bedtime.
  • Children 6 to 12 years of age: 200 milligrams two times a day, in the morning and at bedtime.
  • Children up to 6 years of age: Dose must be determined by the doctor.

Missed dose—

If you miss a dose of this medicine and remember within an hour or so of the missed dose, take it right away. However, if you do not remember until later, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children. Overdose of meprobamate is very dangerous in children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

If you will be taking this medicine regularly for a long time:

• Your doctor should check your progress at regular visits.
• Check with your doctor at least every 4 months to make sure you need to continue taking this medicine.

If you will be taking this medicine in large doses or for a long time, do not stop taking it without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are taking this medicine.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests, such as the metyrapone test and the phentolamine test, may be affected by this medicine.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Taking an overdose of meprobamate or taking alcohol or other CNS depressants with meprobamate may lead to unconsciousness and possibly death. Some signs of an overdose are severe confusion, drowsiness, or weakness; shortness of breath or slow or troubled breathing; slurred speech; staggering; and slow heartbeat.

This medicine may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Even if taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert .

Meprobamate may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• Less common
  • Skin rash, hives, or itching 
  
  

• Rare
  • Confusion;  fast, pounding, or irregular heartbeat;  sore throat and fever;  unusual bleeding or bruising;  unusual excitement ;  wheezing, shortness of breath, or troubled breathing  
  
  

• Symptoms of overdose
  • Confusion (severe);  dizziness or lightheadedness (continuing);  drowsiness (severe);  shortness of breath or slow or troubled breathing;  slow heartbeat;  slurred speech;  staggering;  weakness (severe) 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Clumsiness or unsteadiness;  drowsiness  
  
  

• Less common
  • Blurred vision or change in near or distant vision;  diarrhea;  dizziness or lightheadedness ;  false sense of well-being;  headache;  nausea or vomiting;  unusual tiredness or weakness 
  
  

After you stop using this medicine, your body may need time to adjust. If you took this medicine in high doses or for a long time, this may take about 2 days. During this period of time check with your doctor if you notice any of the following side effects:

• Clumsiness or unsteadiness;  confusion ;  convulsions (seizures);  hallucinations (seeing, hearing, or feeling things that are not there);  increased dreaming;  muscle twitching ;  nausea or vomiting;  nervousness or restlessness;  nightmares;  trembling;  trouble in sleeping 

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.