Meprobamate is a white powder with a characteristic odor and a bitter taste. It is slightly soluble in water, freely soluble in acetone and alcohol, and sparingly soluble in ether. The structural formula of meprobamate is:

C₉H₁₈N2O4....................M.W. 218.25

Meprobamate Tablets USP 200 mg and 400 mg for oral administration contain the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, starch (corn) and stearic acid.

Meprobamate tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually do not require treatment with an anxiolytic. The effectiveness of meprobamate tablets in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.

Meprobamate Tablets USP: The usual adult daily dosage is 1200 mg to 1600 mg, in three or four divided doses; a daily dosage above 2400 mg is not recommended. The usual daily dosage for children ages six to twelve years is 200 mg to 600 mg, in two or three divided doses.

Not recommended for children under age 6 (see Usage in Children).

Meprobamate Tablets USP 200 mg are scored, round, white tablets imprinted 591-B supplied in bottles of 100 and 1000.

Meprobamate Tablets USP 400 mg are scored, round, white tablets imprinted 591-A supplied in bottles of 100 and 1000.

Dispense in well-closed container with child-resistant closure.

Store at controlled room temperature: 15°-30°C (59°-86°F). [See USP.]

Watson Laboratories, Inc. Corona, CA 92880, USA. Revised: April 2004. FDA Rev date: 4/25/2001

Central Nervous System

Drowsiness, ataxia, dizziness, slurred speech, headache, vertigo, weakness, paresthesias, impairment of visual accommodation, euphoria, overstimulation, paradoxical excitement, fast EEG activity.

Gastrointestinal

Nausea, vomiting, diarrhea.

Cardiovascular

Palpitation, tachycardia, various forms of arrhythmia, transient ECG changes, syncope; also hypotensive crisis (including one fatal case).

Allergic or Idiosyncratic

Allergic or idiosyncratic reactions are usually seen within the period of the first to fourth dose in patients having had no previous contact with the drug. Milder reactions are characterized by an itchy, urticarial, or erythematous maculopapular rash which may be generalized or confined to the groin. Other reactions have included leukopenia, acute nonthrombocytopenic purpura, petechiae, ecchymoses, eosinophilia, peripheral edema, adenopathy, fever, fixed drug eruption with cross reaction to carisoprodol, and cross sensitivity between meprobamate/mebutamate and meprobamate/carbromal.

More severe hypersensitivity reactions, rarely reported, include hyperpyrexia, chills, angioneurotic edema, bronchospasm, oliguria and anuria. Also, anaphylaxis, erythema multiforme, exfoliative dermatitis, stomatitis, proctitis, Stevens-Johnson syndrome and bullous dermatitis, including one fatal case of the latter following administration of meprobamate in combination with prednisolone.

In case of allergic or idiosyncratic reactions to meprobamate, discontinue the drug and initiate appropriate symptomatic therapy, which may include epinephrine, antihistamines, and in severe cases, corticosteroids. In evaluating possible allergic reactions, also consider allergy to excipients.

Hematologic

(See also Allergic or Idiosyncratic.) Agranulocytosis and aplastic anemia have been reported. These cases rarely were fatal. Rare cases of thrombocytopenic purpura have been reported.

Other

Exacerbation of porphyric symptoms.

No information provided.

Drug Dependence

Physical dependence, psychological dependence, and abuse have occurred. When chronic intoxication from prolonged use occurs, it usually involves ingestion of greater than recommended doses and is manifested by ataxia, slurred speech, and vertigo. Therefore, careful supervision of dose and amounts prescribed is advised, as well as avoidance of prolonged administration, especially for alcoholics and other patients with a known propensity for taking excessive quantities of drugs.

Sudden withdrawal of the drug after prolonged and excessive use may precipitate recurrence of preexisting symptoms such as anxiety, anorexia, insomnia, or withdrawal reactions such as vomiting, ataxia, tremors, muscle twitching, confusional states, hallucinosis, and rarely, convulsive seizures. Such seizures are more likely to occur in persons with central nervous system damage or pre-existent or latent convulsive disorders. Onset of withdrawal symptoms occurs usually within 12 to 48 hours after discontinuation of meprobamate; symptoms usually cease within the next 12 to 48 hours.

When excessive dosage has continued for weeks or months, dosage should be reduced gradually over a period of one or two weeks rather than abruptly stopped. Alternatively, a long-acting barbiturate may be substituted, then gradually withdrawn.

Potentially Hazardous Tasks

Patients should be warned that meprobamate may impair the mental and/or physical abilities required for performance of potentially hazardous tasks such as driving or operating machinery.

Additive Effects

Since the effects of meprobamate and alcohol or meprobamate and other CNS depressants or psychotropic drugs may be additive, appropriate caution should be exercised with patients who take more than one of these agents simultaneously.

Usage in Pregnancy and Lactation

An increased risk of congenital malformations associated with the use of minor tranquilizers (meprobamate, chlordiazepoxide and diazepam) during the first trimester of pregnancy has been suggested in several studies. Because use of these drugs is rarely a matter of urgency, their use during this period should almost always be avoided. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. Patients should be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physician about the desirability of discontinuing the drug.

Meprobamate passes the placental barrier. It is present both in umbilical cord blood at or near maternal plasma levels and in breast milk of lactating mothers at concentrations two to four times that of maternal plasma. When use of meprobamate is contemplated in breastfeeding patients, the drug's higher concentration in breast milk as compared to maternal plasma should be considered.

Usage in Children

Meprobamate tablets should not be administered to children under age six, since there is a lack of documented evidence for safety and effectiveness in this age group.

The lowest effective dose should be administered, particularly to elderly and/or debilitated patients, in order to preclude oversedation.

The possibility of suicide attempts should be considered and the least amount of drug feasible should be dispensed at any one time.

Meprobamate is metabolized in the liver and excreted by the kidney; to avoid its excess accumulation, caution should be exercised in administration to patients with compromised liver or kidney function.

Meprobamate occasionally may precipitate seizures in epileptic patients.

Geriatric use

Clinical studies of meprobamate tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Suicidal attempts with meprobamate have resulted in drowsiness, lethargy, stupor, ataxia, coma, shock, vasomotor, and respiratory collapse. Some suicidal attempts have been fatal.

The following data on meprobamate tablets have been reported in the literature and from other sources. These data are not expected to correlate with each case (considering factors such as individual susceptibility and length of time from ingestion to treatment), but represent the usual ranges reported.

Acute simple overdose (meprobamate alone): Death has been reported with ingestion of as little as 12 g meprobamate and survival with as much as 40 g.

Blood Levels

0.5-2 mg% represents the usual blood level range of meprobamate after therapeutic doses. The level may occasionally be as high as 3 mg%.

3-10 mg% usually corresponds to findings of mild to moderate symptoms of overdosage, such as stupor or light coma.

10-20 mg% usually corresponds to deeper coma, requiring more intensive treatment. Some fatalities occur.

At levels greater than 20 mg%, more fatalities than survivals can be expected.

Acute combined overdose (meprobamate with alcohol or other CNS depressants or psychotropic drugs): Since effects can be additive, a history of ingestion of a low dose of meprobamate plus any of these compounds (or of a relative low blood or tissue level) cannot be used as a prognostic indicator.

In cases where excessive doses have been taken, sleep ensues rapidly and blood pressure, pulse, and respiratory rates are reduced to basal levels. Any drug remaining in the stomach should be removed and symptomatic therapy given. Should respiration or blood pressure become compromised, respiratory assistance, central nervous system stimulants, and pressor agents should be administered cautiously as indicated. Meprobamate is metabolized in the liver and excreted by the kidney. Diuresis, osmotic (mannitol) diuresis, peritoneal dialysis, and hemodialysis have been used successfully. Careful monitoring of urinary output is necessary and caution should be taken to avoid overhydration. Relapse and death, after initial recovery, have been attributed to incomplete gastric emptying and delayed absorption. Meprobamate can be measured in biological fluids by two methods: colorimetric (Hoffman, A.J. and Ludwig, B.J.: J Amer Pharm Assn 48: 740, 1959) and gas chromatographic (Douglas, J.F. et al: Anal Chem 39: 956, 1967).

Acute intermittent porphyria as well as allergic or idiosyncratic reactions to meprobamate or related compounds such as carisoprodol, mebutamate, tybamate, or carbromal.

Meprobamate is a carbamate derivative which has been shown in animal studies to have effects at multiple sites in the central nervous system including the thalamus and limbic system.

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

MEPROBAMATE - ORAL

(meh-PRO-buh-mate)

USES: This medication is used to treat symptoms of anxiety and nervousness. Meprobamate should only be used for short periods of time. It belongs to a class of drugs known as anxiolytics. It works by affecting certain areas of the brain to help decrease symptoms of anxiety and nervousness.

HOW TO USE: Take this medication by mouth with or without food, usually 3-4 times daily or as directed by your doctor.

Dosage is based on your age, medical condition, and response to therapy. Adults should not take more than 2400 milligrams in a 24-hour period.

This medication is usually taken as needed for anxiety symptoms. If your anxiety is severe, take it regularly as directed by your doctor. In this case, to help you remember, take it at the same times each day. Do not take more or less of this medication than prescribed by your doctor. Doing so may increase side effects.

This medication may cause dependence, especially if it has been used regularly for an extended time or if it has been used in high doses. In such cases, withdrawal reactions (e.g., shakiness, confusion, nausea, vomiting, and rarely seizures) may occur if you suddenly stop taking this drug. To prevent withdrawal reactions when stopping extended, regular treatment with this drug, gradually reduce the dosage as directed. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.

Though very unlikely, abnormal drug-seeking behavior (addiction) is possible with this medication. To lessen the risk of becoming addicted, do not increase your dose, take it more frequently, or take it for a longer time than prescribed. Properly stop the medication when so directed.

When used for an extended period, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well.

Inform your doctor if your condition persists or worsens (e.g., your symptoms increase).

SIDE EFFECTS: Drowsiness, dizziness, staggering, slurred speech, headache, nausea, vomiting, and vision problems may occur. These side effects often lessen over time. If any of these effects persist or worsen, tell 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.

Tell your doctor immediately if any of these unlikely but serious side effects occur: tingling/numbness in hands/feet, feeling hyperactive, diarrhea.

Tell your doctor immediately if any of these rare but very serious side effects occur: easy bruising/bleeding, fast/irregular heartbeat, fainting, swollen glands (lymph nodes), swollen hands/legs, signs of anemia (e.g., worsening tiredness, rapid breathing, pale skin, fast heartbeat while resting), signs of severe infection (e.g., fever, shaking chills, body aches, sore throat).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: 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 meprobamate, tell your doctor or pharmacist if you are allergic to it; or to carisoprodol, mebutamate, tybamate, or carbromal; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain liver/blood problem (porphyria).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain damage, drug/alcohol abuse, liver problems, mental/mood disorders (e.g., depression, thoughts of suicide), seizures.

This drug may make you dizzy or drowsy. Use caution while driving, using machinery, or taking part in any other activity that requires alertness. Avoid alcoholic beverages because they may increase the risk of this drug's side effects.

To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially low blood pressure and drowsiness.

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, notify your doctor immediately.

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

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

This drug should not be used with the following medications because very serious interactions may occur: sodium oxybate.

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting meprobamate.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, clonazepam, diazepam, zolpidem), muscle relaxants (e.g., methocarbamol), narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone).

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

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.

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. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others. It is against the law.

Keep all medical appointments. Your doctor will periodically monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you are taking this on a regular schedule and 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 at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.