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The mean elimination half-life of methocarbamol in elderly healthy volunteers was slightly prolonged compared to a younger, healthy population. The fraction of bound methocarbamol was slightly decreased in the elderly versus younger volunteers. Renally Impaired
The clearance of methocarbamol in eight renally-impaired patients on maintenance hemodialysis was reduced about 40 percent compared to 17 normal subjects, although the mean elimination half-life in these two groups was similar. Hepatically Impaired
In eight patients with cirrhosis secondary to alcohol abuse, the mean total clearance of methocarbamol was reduced approximately 70 percent compared to that obtained in eight age- and weight-matched normal subjects. The percent of methocarbamol bound to plasma proteins was decreased. CONTRAINDICATIONS Methocarbamol Injection should not be administered to patients with known or suspected renal pathology, due to the presence of polyethylene glycol 300 in the vehicle. Methocarbamol injection is contraindicated in patients hypersensitive to methocarbamol or to any of the injection components. WARNINGS Since methocarbamol may possess a general CNS depressant effect, patients receiving methocarbamol injection should be cautioned about combined effects with alcohol and other CNS depressants. There have been very rare reports of fetal and congenital abnormalities following in utero exposure to methocarbamol, therefore methocarbamol injection 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. 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. PRECAUTIONS General Since methocarbamol injection is hypertonic, vascular extravasation must be avoided. Caution should be observed in using the injectable form in patients with suspected or known seizure disorders. DRUG INTERACTIONS Interaction with CNS drugs and alcohol causing a general CNS depressant effect. Methocarbamol may inhibit the effect of pyridostigmine bromide. Therefore, methocarbamol should be used with caution in patients with myasthenia gravis receiving anticholinesterase agents. Drug/Laboratory Test Interactions Methocarbamol may cause a color interference in certain screening tests for 5-hydroxyindoleacetic acid (5-HIAA) using nitrosonaphthol reagent and in screening tests for urinary vanillylmandelic acid (VMA) using the Gitlow method. PREGNANCY Teratogenic Effects-Pregnancy Category C
Methocarbamol injection should be given to a pregnant woman only if clearly needed. NURSING MOTHERS It is not known whether methocarbamol or its metabolites are excreted in human milk. Caution should be exercised when methocarbamol injection is administered to a nursing woman. PEDIATRIC USE Safety and effectiveness of methocarbamol injection in pediatric patients have not been established except in tetanus. ADVERSE REACTIONS The following adverse reactions have been reported coincident with the administration of methocarbamol. Body as a whole: Anaphylactic reaction, angioneurotic edema, fever, headache Cardiovascular system: Bradycardia, flushing, hypotension, syncope, thrombophlebitis Digestive system: Dyspepsia, 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, vertigo Administration to patients with epilepsy is not recommended. Skin and special senses: Blurred vision, conjunctivitis, nasal congestion, metallic taste, pruritus, rash, urticaria Other: Pain and sloughing at the site of injection OVERDOSAGE Overdose of methocarbamol is frequently in conjunction with alcohol or other CNS depressants. 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. For additional Safety Information, please see Full Prescribing Information. You are encouraged to report Adverse Drug Events (ADEs) to American Regent Inc. at 1-800-734-9236 or to the FDA by visiting www.fda.gov/MedWatch or calling 1-800-FDA-1088.