methocarbamol

FDA Drug Profile — Methocarbamol, methocarbamol, ATMEKSI, Tanlor, ROBAXIN

Drug Details

Generic Name
methocarbamol
Brand Names
Methocarbamol, methocarbamol, ATMEKSI, Tanlor, ROBAXIN, METHOCARBAMOL
Application Number
ANDA040489
Sponsor
Advanced Rx of Tennessee, LLC
NDC Codes
50
Dosage Forms
TABLET, INJECTION, SUSPENSION, TABLET, FILM COATED, INJECTION, SOLUTION
Routes
ORAL, INTRAVENOUS, INTRAMUSCULAR
Active Ingredients
METHOCARBAMOL

Indications and Usage

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.

Warnings

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.