Atmeksi Drug Information

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.

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.

• The following serious adverse reaction is described elsewhere in the labeling: Interactions with CNS Depressants and Alcohol 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 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 and urticaria 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.

CNS drugs and alcohol

ATMEKSI may potentiate the effects of CNS (central nervous system) depressants and alcohol.

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.

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.

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

Clinical Presentation Deaths have been reported with an overdose of methocarbamol alone and when methocarbamol was used with other CNS depressants, including alcohol. Limited information is available on the acute toxicity of methocarbamol. Symptoms of overdose include the following: respiratory depression, nausea, drowsiness, blurred vision, hypotension, seizures, coma, and death.

Other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants) can have an additive effect, even when taken at recommended dosages. Treatment of Overdose The standard of treatment is supportive care, including monitoring for CNS and respiratory depression and managing airway as needed, monitoring urinary output and vital signs, and administration of intravenous fluids if necessary. Hypotension should be treated with intravenous fluids and vasopressors as needed.

Gastrointestinal decontamination procedures (including emesis) should generally be avoided because aspiration may result from CNS depression and seizures. Extracorporeal elimination such as hemodialysis or plasmapheresis has no proven clinical benefit. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.