ATMEKSI

ATMEKSI (methocarbamol) Oral Suspension is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. The chemical name of methocarbamol is (±)1,2-Propanediol, 3-(2-methoxyphenoxy)-, 1-carbamate, or (±)-3-(o-Methoxyphenoxy)-1,2-propanediol 1-carbamate and has the empirical formula C11H15NO5. Its molecular weight is 241.24g/mol. The structural formula is shown below: Methocarbamol is a white powder, sparingly soluble in water and in chloroform, soluble in alcohol (only with heating), insoluble in benzene and in n -hexane. ATMEKSI (methocarbamol) Oral Suspension is a white to off-white suspension with a fruit flavor and a pH range of 3.2 – 4.8. ATMEKSI (methocarbamol) Oral Suspension contains the following inactive ingredients: citric acid monohydrate, glycerin, magnesium aluminum silicate, purified water, sodium benzoate, sodium carboxymethylcellulose, sodium citrate, sucralose and fruit flavor. formula

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.

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. 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.

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 )

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.