Methocarbamol

Indications and Usage Section INDICATIONS AND USAGE Methocarbamol tablets, USP 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, 500 mg — Adults: Initial dosage: 3 tablets 4 times daily. Maintenance dosage: 2 tablets 4 times daily Methocarbamol, 750 mg — Adults: Initial dosage: 2 tablets 4 times daily. Maintenance dosage: 1 tablet 4 times daily or 2 tablets 3 times daily Methocarbamol, 1000 mg — Adults: Initial dosage: 1 1⁄2 tablets 4 times daily. Maintenance dosage: 1 tablets 4 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 Methocarbamol tablets are contraindicated in patients hypersensitive to methocarbamol or to any of the tablet components.

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 To report SUSPECTED ADVERSE REACTIONS, contact Granules USA, Inc. at 1-877-770-3183 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch Repackaged By: Preferred Pharmaceuticals Inc.

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, 500 mg, 750 mg, and 1000 mg, a carbamate derivative of gualfenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is a 3-(2 methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C11H15NO5. 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 Tablet, 500 mg is available as an orange, film coated, round concave tablet containing 500 mg of methocarbamol, USP for oral administration. The inactive ingredients present are microcrystalline cellulose, croscarmellose sodium, FD&C Yellow 6 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, triacetin, titanium dioxide. Methocarbamol Tablet, 750 mg is available as a yellow, film coated, modified capsule shaped tablet containing 750 mg of methocarbamol, USP for oral administration. The inactive ingredients present are microcrystalline cellulose, croscarmellose sodium, iron oxide yellow, iron oxide red, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, triacetin, titanium dioxide. Methocarbamol tablet, 1000 mg is available as an orange, film coated, oblong-shaped tablet containing 1000 mg of methocarbamol, USP for oral administration. The inactive ingredients present in methocarbamol tablets 1000 mg are same as those present in methocarbamol tablets 500 mg. Methocarbamol Structure

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 light orange colored, round shaped film coated tablets debossed with "G" above the score line onone side and "500" on other side. They are supplied as follows Bottles of 30 tablets NDC 76420-893-30 (repackaged from 70010-754-XX) Bottles of 60 tablets NDC 76420-893-60 (repackaged from 70010-754-XX) Bottles of 90 tablets NDC 76420-893-90 (repackaged from 70010-754-XX) Bottles of 100 tablets NDC 76420-893-01 (repackaged from 70010-754-01) Bottles of 120 tablets NDC 76420-893-12 (repackaged from 70010-754-XX) Bottles of 500 tablets NDC 76420-893-05 (repackaged from 70010-754-05) Methocarbamol tablets, USP 750 mg are light orange colored, caplet shaped film coated tablets debossed with "G" on one side and"750" on other side. Bottles of 30 tablets NDC 76420-894-30 (repackaged from 70010-770-XX) Bottles of 60 tablets NDC 76420-894-60 (repackaged from 70010-770-XX) Bottles of 90 tablets NDC 76420-894-90 (repackaged from 70010-770-XX) Bottles of 100 tablets NDC 76420-894-01 (repackaged from 70010-770-01) Bottles of 120 tablets NDC 76420-894-12 (repackaged from 70010-770-XX) Bottles of 500 tablets NDC 76420-894-05 (repackaged from 70010-770-05) Store between 20oC and 25oC (68oF and 77o F) [see USP Controlled Room Temperature]. Dispense in tight container. Repackaged and Relabeled by: Enovachem PHARMACEUTICALS Torrance, CA 90501