MOTPOLY XR 200 mg/1
lacosamide · CAPSULE, EXTENDED RELEASE · Aucta Pharmaceuticals, Inc.
MOTPOLY XR is a capsule, extended release containing lacosamide at 200 mg/1, taken oral. Manufactured by Aucta Pharmaceuticals, Inc..
Key Facts
- Brand Name
- MOTPOLY XR
- Generic Name
- lacosamide
- NDC Code (Product)
73289-0065- Manufacturer
- Aucta Pharmaceuticals, Inc.
- Strength
- 200 mg/1
- Dosage Form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule V (Controlled)
- Application #
- NDA216185
- Marketing Start
- 05/05/2023
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE MOTPOLY XR is indicated for: Treatment of partial-onset seizures in adults and in pediatric patients weighing at least 50 kg ( 1.1 ) Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and in pediatric patients weighing at least 50 kg (1.2) 1.1 Partial-Onset Seizures MOTPOLY XR is indicated for the treatment of partial-onset seizures in adults and in pediatric patients weighing at least 50 kg. 1.2 Primary Generalized Tonic-Clonic Seizures MOTPOLY XR is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and in pediatric patients weighing at least 50 kg. Additional pediatric use information is approved for UCB Inc.'s Vimpat (lacosamide) tablets, oral solution, and intravenous solution. However, due to UCB Inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Adults (17 years and older): Initial dosage for monotherapy for the treatment of partial-onset seizures is 200 mg once daily (2.1) Initial dosage for adjunctive therapy for the treatment of partial-onset seizures or primary generalized tonic-clonic seizures is 100 mg once daily (2.1) Maximum recommended dosage for monotherapy and adjunctive therapy is 400 mg once daily (2.1) Pediatric patients weighing at least 50 kg: Initial dosage for treatment of partial-onset seizures or adjunctive therapy for primary generalized tonic-clonic seizures is 100 mg once daily (2.1) Increase dosage based on clinical response and tolerability, no more frequently than once per week (2.1) Dose adjustment is recommended for severe renal impairment(2.1, 12.3) Dose adjustment is recommended for mild or moderate hepatic impairment; use in patients with severe hepatic impairment is not recommended(2.4,12.3) MOTPOLY XR capsules should be swallowed whole with liquid. Do not open, chew, or crush the capsules(2.5) 2.1 Dosage Information The recommended dosage for monotherapy and adjunctive therapy for partial-onset seizures and for adjunctive therapy for primary generalized tonic-clo…
Contraindications
4 CONTRAINDICATIONS None . None ( 4 )
Drug Interactions
7 DRUG INTERACTIONS 7.1 Strong CYP3A4 or CYP2C9 Inhibitors Patients with renal or hepatic impairment who are taking strong inhibitors of CYP3A4 and CYP2C9 may have a significant increase in exposure to MOTPOLY XR. Dose reduction may be necessary in these patients. 7.2 Concomitant Medications that Affect Cardiac Conduction MOTPOLY XR should be used with caution in patients on concomitant medications that affect cardiac conduction (sodium channel blockers, beta-blockers, calcium channel blockers, potassium channel blockers) including those that prolong PR interval (including sodium channel blocking AEDs), because of a risk of AV block, bradycardia, or ventricular tachyarrhythmia. In such patients, obtaining an ECG before beginning MOTPOLY XR, and after MOTPOLY XR is titrated to steady-state, is recommended. 7.3 CNS Depressants Concomitant administration of lacosamide and alcohol or other CNS depressant drugs has not been evaluated in clinical studies. Because of the potential of MOTPOLY XR to cause CNS depression, as well as other cognitive and/or neuropsychiatric adverse reactions, MOTPOLY XR should be used with extreme caution if used in combination with alcohol and other CNS depre…
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in the labeling: Suicidal Behavior and Ideation [ see Warnings and Precautions (5.1) ] Dizziness and Ataxia [ see Warnings and Precautions (5.2) ] Cardiac Rhythm and Conduction Abnormalities [ see Warnings and Precautions (5.3) ] Syncope [ see Warnings and Precautions (5.4) ] Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity Reactions [ see Warnings and Precautions (5.6) ] Adjunctive therapy: Most common adverse reactions in adults (≥10% and greater than placebo) are diplopia, headache, dizziness, nausea, and somnolence ( 6.1 ) Monotherapy: Most common adverse reactions are similar to those seen in adjunctive therapy studies ( 6.1 ) Pediatric patients: Adverse reactions are similar to those seen in adult patients ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aucta Pharmaceuticals, Inc. at 1-800-655-9902 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compare…
Frequently Asked Questions
What is MOTPOLY XR used for?
MOTPOLY XR contains lacosamide. It is a capsule, extended release taken oral. Consult your doctor for specific uses.
Is MOTPOLY XR a controlled substance?
Yes, MOTPOLY XR is classified as CV under the DEA Controlled Substances Act.
What is the generic name for MOTPOLY XR?
The generic name for MOTPOLY XR is lacosamide. There are 12 other brand versions of lacosamide.
What is the NDC code for MOTPOLY XR 200 mg/1?
The NDC (National Drug Code) for MOTPOLY XR 200 mg/1 is 73289-0065, listed by Aucta Pharmaceuticals, Inc..