Methocarbamol

Indications and Usage Section INDICATIONS AND USAGE Methocarbamol Tablets USP, 500 mg and 750 mg 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.

DOSAGE AND ADMINISTRATION Methocarbamol Tablets, USP, 500 mg – Adults: Initial dosage: 3 tablets four times daily Maintenance dosage: 2 tablets four times daily Methocarbamol Tablets, USP, 750 mg – Adults: Initial dosage: 2 tablets four times daily Maintenance dosage: 1 tablet every 4 hours or 2 tablets three times daily 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.

Contraindications CONTRAINDICATIONS Methocarbamol Tablets USP, 500 mg and 750 mg are contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components.

Adverse Reactions Section ADVERSE REACTIONS 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.

Drug Interactions See WARNINGS and PRECAUTIONS for interaction with CNS drugs and alcohol. Methocarbamol may inhibit the effect of pyridostigmine bromide. Therefore, methocarbamol should be used with caution in patients with myasthenia gravis receiving anticholinesterase agents.

DESCRIPTION Methocarbamol Tablets USP, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is 3 - (2-methoxyphenoxy) -1, 2- propanediol 1-carbamate and has the empirical formula C 11 H 15 NO 5 . Its molecular weight is 241.24. The structural formula is shown below. 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. Methocarbamol Tablets USP, 500 mg is available as a light orange colored, round, film-coated tablets, engraved with 'B134' on one side and scored on the other side, containing 500 mg of methocarbamol, USP for oral administration. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxyprolyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 500 mg contains Opadry 13H530000 (Orange) (hypromellose, titanium dioxide, propylene glycol, FD&C yellow #6/Sunset Yellow FCF Aluminum Lake, polysorbate 20) as coating material. Methocarbamol Tablets USP, 750 mg is available as an orange colored, capsule shaped, film coated tablets, engraved with 'B135' on one side and plain on the other side, containing 750 mg of methocarbamol, USP for oral administration. It contains Opadry 13H530001 (Orange) as coating material. The inactive ingredients present are corn starch, low substituted hydroxypropyl cellulose, hydroxyprolyl cellulose, sodium starch glycolate, povidone, sodium lauryl sulfate, colloidal silicon dioxide, stearic acid, magnesium stearate, and purified water. Methocarbamol Tablets USP, 750 mg contain Opadry 13H530001 (Orange) (hypromellose, titanium dioxide, propylene glycol, D&C Yellow #10 Aluminum Lake, FD&C yellow #6/Sunset Yellow FCC Aluminum Lake, polysorbate 20) as coating material. structure.jpg

Overdosage Section OVERDOSAGE 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. Treatment Management of overdose includes symptomatic and supportive treatment. Supportive measures include maintenance of an adequate airway, monitoring urinary output and vital signs, and administration of intravenous fluids if necessary. The usefulness of hemodialysis in managing overdose is unknown.

HOW SUPPLIED Methocarbamol Tablets USP, 500 mg are white in color, round, beveled edge, biconvex film-coated tablet debossed with “500” above the score line on one side and “METT” on the other side. They are supplied as follows: Bottles of 10 NDC 87063-040-10 (repackaged from NDC 59651-340-XX) Bottles of 20 NDC 87063-040-20 (repackaged from NDC 59651-340-XX) Bottles of 30 NDC 87063-040-30 (repackaged from NDC 59651-340-XX) Bottles of 60 NDC 87063-040-60 (repackaged from NDC 59651-340-XX) Bottles of 90 NDC 87063-040-90 (repackaged from NDC 59651-340-XX) Bottles of 100 NDC 87063-040-01 (relabeled from NDC 59651-340-01) Methocarbamol Tablets USP, 750 mg are white in color, biconvex capsule shaped film-coated tablet, debossed with “METT” on one side and “750” on the other side. They are supplied as follows: Bottles of 10 NDC 87063-041-10 (repackaged from NDC 59651-341-XX) Bottles of 20 NDC 87063-041-20 (repackaged from NDC 59651-341-XX) Bottles of 30 NDC 87063-041-30 (repackaged from NDC 59651-341-XX) Bottles of 60 NDC 87063-041-60 (repackaged from NDC 59651-341-XX) Bottles of 90 NDC 87063-041-90 (repackaged from NDC 59651-341-XX) Bottles of 100 NDC 87063-041-01 (relabeled from NDC 59651-341-01) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in tight container. For more information, call Aurobindo Pharma USA, Inc.at 1-866-850-2876. Relabeled and Repackaged by: Enovachem PHARMACEUTICALS Torrance, CA 90501