Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Methocarbamol Tablets, USP, 500 mg tablets are white, round, film-coated tablets, debossed "G173" on one side, plain and scored on the other side. They are supplied as follows: Bottles of 18 NDC 72789-499-18 Bottles of 20 NDC 72789-499-20 Bottles of 28 NDC 72789-499-28 Store at 20º to 25º C (68º to 77º F) [see USP Controlled Room Temperature].; PRINCIPAL DISPLAY PANEL Methocarbamol 500 mg Rx Only 72789499 Label
- HOW SUPPLIED Methocarbamol Tablets, USP, 500 mg tablets are white, round, film-coated tablets, debossed "G173" on one side, plain and scored on the other side. They are supplied as follows: Bottles of 18 NDC 72789-499-18 Bottles of 20 NDC 72789-499-20 Bottles of 28 NDC 72789-499-28 Store at 20º to 25º C (68º to 77º F) [see USP Controlled Room Temperature].
- PRINCIPAL DISPLAY PANEL Methocarbamol 500 mg Rx Only 72789499 Label
Overview
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 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 Tablets, USP 500 mg are available as a white, round, scored, film-coated tablet containing 500 mg of methocarbamol, USP for oral administration. The inactive ingredients present are microcrystalline cellulose, croscarmellose sodium, povidone (k-30), sodium lauryl sulfate, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, polysorbate 80. Methocarbamol Tablets, USP 750 mg are available as a white, capsule-shaped, film-coated tablet containing 750 mg of methocarbamol, USP for oral administration. The inactive ingredients present are microcrystalline cellulose, croscarmellose sodium, povidone (k-30), sodium lauryl sulfate, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, polysorbate 80. Methocarbamol structural formula
Indications & 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 & 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.
Warnings & Precautions
WARNINGS Since methocarbamol may possess a general CNS depressant effect, patients receiving Methocarbamol Tablets, USP should be cautioned about combined effects with alcohol and other CNS depressants. Safe use of Methocarbamol Tablets, USP 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, USP 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 ). Use in Activities Requiring Mental Alertness Methocarbamol may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle. Patients should be cautioned about operating machinery, including automobiles, until they are reasonably certain that methocarbamol therapy does not adversely affect their ability to engage in such activities.
Contraindications
Methocarbamol Tablets, USP 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
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.
Storage & Handling
Store at 20º to 25º C (68º to 77º F) [see USP Controlled Room Temperature].
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