Methocarbamol

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.

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.

Oral Suspension: 750 mg/5 mL of methocarbamol as a white to off-white suspension with a fruit flavor oral suspension: 750 mg/5 mL

4.1 Hypersensitivity ATMEKSI is contraindicated in patients hypersensitive to methocarbamol or to any of the oral suspension components. Hypersensitivity to ATMEKSI or any component in the product ( 4.1 )

4.1 Hypersensitivity ATMEKSI is contraindicated in patients hypersensitive to methocarbamol or to any of the oral suspension components. Hypersensitivity to ATMEKSI or any component in the product ( 4.1 )

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.

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.

The following serious adverse reaction is described elsewhere in the labeling: Interactions with CNS Depressants and Alcohol [ see Warnings and Precautions (5.1) ] The following adverse reactions associated with the use of methocarbamol have been identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions reported 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. Body: Anaphylactic reaction, angioneurotic edema, fever, headache ( 6 ) Cardiovascular system: Bradycardia, flushing, hypotension, syncope, thrombophlebitis ( 6 ) Digestive system: Dyspepsia, jaundice (including cholestatic jaundice), nausea and vomiting ( 6 ) Hemic and lymphatic system: Leukopenia ( 6 ) Immune system: Hypersensitivity reactions ( 6 ) Nervous system: Amnesia, confusion, diplopia, dizziness or lightheadedness, drowsiness, insomnia, mild muscular incoordination, nystagmus, sedation, seizures (including grand mal), vertigo ( 6 ) Skin and special senses: Blurred vision, conjunctivitis, nasal congestion, metallic taste, pruritus, rash and urticaria ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Rosemont Pharmaceuticals, LLC. at 1-844-638-2235 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

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.

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.

Lactation: The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ATMEKSI and any potential adverse effects on the breastfed infant from methocarbamol or the underlying maternal condition .

8.1 Pregnancy Risk Summary Limited data from case reports over decades of use with methocarbamol during pregnancy have not identified an increased risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized patients is 2 to 4% and 15 to 20% respectively.

8.2 Lactation Risk Summary There are no data on the presence of methocarbamol or its metabolites in human milk, the effects on a breastfed infant or the effects on milk production. Methocarbamol and/or its metabolite are present in animal milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ATMEKSI and any potential adverse effects on the breastfed infant from ATMEKSI or the underlying maternal condition.

8.4 Pediatric Use Safety and effectiveness of methocarbamol oral suspension in pediatric patients below the age of 16 have not been established.

8.1 Pregnancy Risk Summary Limited data from case reports over decades of use with methocarbamol during pregnancy have not identified an increased risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized patients is 2 to 4% and 15 to 20% respectively.

8.2 Lactation Risk Summary There are no data on the presence of methocarbamol or its metabolites in human milk, the effects on a breastfed infant or the effects on milk production. Methocarbamol and/or its metabolite are present in animal milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ATMEKSI and any potential adverse effects on the breastfed infant from ATMEKSI or the underlying maternal condition.

8.4 Pediatric Use Safety and effectiveness of methocarbamol oral suspension in pediatric patients below the age of 16 have not been established.