Meprobamate

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

Meprobamate may be found in some form under the following brand names:

• Equagesic

• Equanil

• Mb-tab

• Micrainin

• Miltown

• Pmb

• Trancot

Meprobamate is part of the drug class:

• Carbamates

Meprobamate affects chemicals in your brain that may become unbalanced and cause anxiety.

Meprobamate is used to relieve anxiety, nervousness, and tension associated with anxiety disorders.

Meprobamate may also be used for purposes other than those listed in this medication guide.

Meprobamate is used to relieve nervousness or tension. meprobamate should not be used for nervousness or tension caused by the stress of everyday life.

Meprobamate is available only with your doctor's prescription.

If you will be taking meprobamate 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 meprobamate.

If you will be taking meprobamate 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.

meprobamate 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 meprobamate.

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

If you think you or someone else may have taken an overdose of meprobamate, 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.

meprobamate 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 meprobamate 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.

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

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).

Meprobamate Tablets USP 200 mg are white to off white, round, biconvex, uncoated tablets debossed with "L125" on one side and break line on other side.

NDC 62332-019-30         Bottle of 30
NDC 62332-019-31         Bottle of 100
NDC 62332-019-91         Bottle of 1000
Meprobamate Tablets USP 400 mg are white to off white, round, biconvex, uncoated tablets debossed with "L105" on one side and break line on other side.

NDC 62332-020-30        Bottle of 30
NDC 62332-020-31        Bottle of 100
NDC 62332-020-91        Bottle of 1000
Dispense in well-closed container with child-resistant closure.
Store at controlled room temperature, excursions permitted to 15°C-30°C (59°F-86°F).

Preserve in well closed container.

Call your doctor for medical advice about side effects.
You may report side effects to Alembic Pharmaceuticals Limited at 1-866 210 9797 or FDA at 1-800-FDA-1088.

Manufactured by:
Alembic Pharmaceuticals Limited
(Formulation Division),
Panelav 389350, Gujarat, India

Manufactured for:
Alembic Pharmaceuticals, Inc.
750 Route 202, Bridgewater, NJ 08807
USA

Revised: 01/2016

Anxiety: Oral:

Children ≥6 years: 200 to 600 mg/day in 2 to 3 divided doses

Discontinuation: In patients with excessive dosage continued for weeks or months, meprobamate should be tapered off gradually over 1 to 2 weeks to avoid withdrawal symptoms such as anxiety, anorexia, or insomnia.

Adolescents: Refer to adult dosing.

Concerns related to adverse effects:

• Allergic reactions: May occur in patients with history of dermatological condition (usually by fourth dose).

• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving). Effects may be potentiated when used with other sedative drugs or ethanol.

Disease-related concerns:

• Depression: Use with caution in patients with depression or suicidal tendencies.

• Drug abuse: Use with caution in patients with a history of drug abuse or acute alcoholism; potential for drug dependency exists. Tolerance, psychological and physical dependence may occur with prolonged use.

• Hepatic impairment: Use with caution in patients with hepatic impairment.

• Renal impairment: Use with caution in patients with renal impairment.

• Seizure disorder: Use with caution in patients with a history of seizure disorder.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Other warnings/precautions:

• Withdrawal: Abrupt discontinuation may precipitate withdrawal. In patients with excessive dosage continued for weeks or months, meprobamate should be tapered off gradually over 1 to 2 weeks to avoid withdrawal symptoms such as anxiety, anorexia, or insomnia.

Applies to meprobamate: oral tablet

General

CNS effects such as drowsiness and dizziness may occur, but these usually resolve as treatment continues; allergic or idiosyncratic reactions have occurred and are generally seen within the first to fourth dose.[Ref]

Nervous system

Frequency not reported: Drowsiness, ataxia, dizziness, slurred speech, headache, weakness, paresthesia, overstimulation, fast EEG activity[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity reactions
Frequency not reported: Itchy, urticarial, or erythematous maculopapular rash, anaphylaxis, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, bullous dermatitis, fixed drug eruption with cross reaction to carisoprodol, cross sensitivity between meprobamate/mebutamate and meprobamate/carbromal[Ref]

Hypersensitivity reactions have been reported in about 2% of patients. Milder hypersensitivity reactions are characterized by an itchy, urticarial, or erythematous maculopapular rash which may be generalized or localized to the groin. More serious hypersensitivity reactions have included rare reports of anaphylaxis, hypotension and collapse; erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, and bullous dermatitis (1 fatal case).[Ref]

Dermatologic

Frequency not reported: Erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, bullous dermatitis, angioneurotic edema[Ref]

Respiratory

Frequency not reported: Bronchospasm[Ref]

Cardiovascular

Frequency not reported: Palpitation, tachycardia, arrhythmias, transient ECG changes, syncope, hypotensive crisis, peripheral edema[Ref]

Gastrointestinal

Frequency not reported: Nausea, vomiting, diarrhea, stomatitis, proctitis[Ref]

Hematologic

Rare (0.01% to 0.1%): thrombocytopenic purpura
Frequency not reported: Leukopenia, acute nonthrombocytopenic purpura, petechiae, ecchymosis, eosinophilia, adenopathy, agranulocytosis, aplastic anemia, pancytopenia[Ref]

Metabolic

Frequency not reported: Exacerbation of porphyria[Ref]

Ocular

Frequency not reported: Impaired visual accommodation

Other

Rare (0.01% to 0.1%): hyperpyrexia
Frequency not reported: Vertigo, fever, chills[Ref]

Psychiatric

Frequency not reported: Euphoria, paradoxical excitement, withdrawal symptoms[Ref]

Genitourinary

Frequency not reported: Oliguria, anuria[Ref]

Some side effects of meprobamate may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.