Methocarbamol Tablets

METHOCARBAMOL TABLETS, USP

Rev. 07/09

Rx Only

Methocarbamol Tablets, USP, a carbamate derivative of guaifenesin, are a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The structural formula is:

                  Methocarbamol structural formula

The chemical name for Methocarbamol is 3-(2-Methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C₁₁H₁₅NO₅. Its molecular weight is 241.24.

Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n-hexane.

Each tablet, for oral administration, contains 500 mg or 750 mg of methocarbamol, USP. In addition each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, Lactose Monohydrate, Magnesium Stearate, Methylcellulose, Microcrystalline Cellulose, Pregelatinized Starch and Sodium Starch Glycolate.

The mechanism of action of methocarbamol in humans has not been established, but may be due to general central nervous system (CNS) depression. It has no direct action on the contractile mechanism of striated muscle, the motor end plate or the nerve fiber.

Methocarbamol Tablets are indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of methocarbamol has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.

Methocarbamol Tablets are contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components.

Since methocarbamol may possess a general CNS depressant effect, patients receiving Methocarbamol Tablets should
be cautioned about combined effects with alcohol and other CNS depressants.

Safe use of Methocarbamol Tablets has not been established with regard to possible adverse effects upon fetal development.  There have been reports of fetal and congenital abnormalities following in utero exposure to methocarbamol. Therefore, Methocarbamol Tablets should not be used in women who are or may become pregnant and particularly during early pregnancy unless in the judgment of the physician the potential benefits outweigh the possible hazards (see PRECAUTIONS : Pregnancy).

Adverse reactions reported coincident with the administration of methocarbamol include:

Body as a Whole: Anaphylactic reaction, angioneurotic edema, fever, headache

Cardiovascular System: Bradycardia, flushing, hypotension, syncope, thrombophlebitis

Digestive System: Dyspepsia, jaundice (including cholestatic jaundice), nausea and vomiting

Hemic and Lymphatic System:  Leukopenia

Immune System: Hypersensitivity reactions

Nervous System: Amnesia, confusion, diplopia, dizziness or lightheadedness, drowsiness, insomnia, mild muscular incoordination, nystagmus, sedation, seizures (including grand mal), vertigo

Skin and Special Senses: Blurred vision, conjunctivitis, nasal congestion, metallic taste, pruritus, rash, urticaria

Limited information is available on the acute toxicity of methocarbamol. Overdose of methocarbamol is frequently in conjunction with alcohol or other CNS depressants and includes the following symptoms: nausea, drowsiness, blurred vision, hypotension, seizures, and coma.

In post-marketing experience, deaths have been reported with an overdose of methocarbamol alone or in the presence of other CNS depressants, alcohol or psychotropic drugs.

500 mg – Adults: Initial dosage, 3 tablets q.i.d.; maintenance dosage, 2 tablets q.i.d.
750 mg – Adults: Initial dosage, 2 tablets q.i.d.; maintenance dosage, 1 tablet q.4h. or 2 tablets t.i.d.

Six grams a day are recommended for the first 48 to 72 hours of treatment. (For severe conditions 8 grams a day may be administered.) Thereafter, the dosage can usually be reduced to approximately 4 grams a day.

Methocarbamol Tablets 500 mg: White, Round, Scored, Compressed Tablet; Debossed “West-ward 290”

Bottles of 7 tablets

Bottles of 14 tablets
Bottles of 20 tablets

Bottles of 30 tablets

Bottles of 40 tablets
Bottles of 60 tablets

Methocarbamol Tablets 750 mg: White, Capsule Shaped, Scored Tablet; Debossed “West-ward 292”

Bottles of 7 tablets
Bottles of 12 tablets

Bottles of 20 tablets

Bottles of 30 tablets

Bottles of 40 tablets

Bottles of 60 tablets
Bottles of 90 tablets

Bottles of 100 tablets

Store at 20-25^oC (68-77^oF) [See USP Controlled Room Temperature]. Protect from light and moisture.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Manufactured by:
West-ward Pharmaceutical Corp.
Eatontown, NJ 07724

Repackaged by:

Rebel Distributors Corp

 Thousand Oaks, CA 91320