Methocarbamol

WARNINGS Since methocarbamol may possess a general CNS depressant effect, patients receiving methocarbamol should be cautioned about combined effects with alcohol and other CNS depressants. Safe use of methocarbamol has not been established with regard to possible adverse effects upon fetal development. There have been very rare reports of fetal and congenital abnormalities following in utero exposure to methocarbamol. Therefore, methocarbamol 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.

ADVERSE REACTIONS The following adverse reactions have been reported coincident with the administration of methocarbamol. Some events may have been due to an overly rapid rate of intravenous injection. Body as a whole : Anaphylactic reaction, angioneurotic edema, fever, headache Cardiovascular system : Bradycardia, flushing, hypotension, syncope, thrombophlebitis In most cases of syncope there was spontaneous recovery. In others, epinephrine, injectable steroids, and/or injectable antihistamines were employed to hasten recovery. 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 light-headedness, drowsiness, insomnia, mild muscular incoordination, nystagmus, sedation, seizures (including grand mal), vertigo The onset of convulsive seizures during intravenous administration of methocarbamol has been reported in patients with seizure disorders. The psychic trauma of the procedure may have been a contributing factor. Although several observers have reported success in terminating epileptiform seizures with methocarbamol, its administration to patients with epilepsy is not recommended (see PRECAUTIONS, General ). Skin and special senses : Blurred vision, conjunctivitis, nasal congestion, metallic taste, pruritus, rash, urticaria Other : Pain and sloughing at the site of injection To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals, Inc. at 1-866-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .