ATMEKSI

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE ATMEKSI (methocarbamol) oral suspension is a muscle relaxant indicated as: an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions in patients 16 and older. 1.1 Acute, painful musculoskeletal conditions. ATMEKSI is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions in patients 16 and older. Dosage and administration 2 DOSAGE AND ADMINISTRATION Adults Initial dosage: 1,500 mg (10 mL) 4 times daily Maintenance dosage: 750 mg (5 mL) every 4 hours or 1,500 mg (10 mL) 3 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. 2.1 Important Dosage and Administration Instructions Initial dosage: 1,500 mg (10 mL) 4 times daily Maintenance dosage: 750 mg (5 mL) every 4 hours or 1,500 mg (10 mL) 3 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. Inform the patient to shake the drug product for at least 30 seconds to ensure it is uniform before administration. Warnings and cautions 5 WARNINGS AND PRECAUTIONS ATMEKSI may potentiate the effects of CNS (central nervous system) depressants and alcohol ( 5.1 ) ATMEKSI may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle ( 5.2 ) 5.1 CNS Depressants and Alcohol Use ATMEKSI may potentiate the effects of CNS (central nervous system) depressants and alcohol. Patients receiving ATMEKSI (methocarbamol) Oral Suspension should be cautioned about combined effects with alcohol and other CNS depressants [ see Drug Interactions (7.1) ]. 5.2 Use in Activities Requiring Mental Alertness ATMEKSI 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. Drug interactions 7 DRUG INTERACTIONS ATMEKSI may inhibit the effect of pyridostigmine bromide. Patients with myasthenia gravis should be monitored closely for symptoms of myasthenia gravis such as weakness. If symptoms of myasthenia gravis are observed, treatment with ATMEKSI should be stopped immediately ( 7.2 ) Laboratory test interference: Methocarbamol may cause color interference in the following screening tests: 5-hydroxyindoleacetic acid (using nitrosonaphthol reagent) and VMA (Giltow method) ( 7.3 ) 7.1 CNS drugs and alcohol ATMEKSI may potentiate the effects of CNS (central nervous system) depressants and alcohol [ see Warnings and Precautions (5.1) ]. 7.2 Pyridostigmine Bromide ATMEKSI may inhibit the effect of pyridostigmine bromide. Patients with myasthenia gravis should be monitored closely for symptoms of myasthenia gravis such as weakness. If symptoms of myasthenia gravis are observed, treatment with ATMEKSI should be stopped immediately. 7.3 Drug/Laboratory Test Interactions ATMEKSI may cause 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.