Lacosamide Oral Solution 10 mg/mL
Lacosamide Oral Solution · SOLUTION · Ascend Laboratories, LLC
Lacosamide oral solution is a prescription medication used to treat seizures in patients with epilepsy. This liquid formulation contains 10 mg of lacosamide per milliliter and is taken by mouth.
Key Facts
- Brand Name
- Lacosamide Oral Solution
- Generic Name
- Lacosamide Oral Solution
- NDC Code (Product)
67877-732- Manufacturer
- Ascend Laboratories, LLC
- Strength
- 10 mg/mL
- Dosage Form
- SOLUTION
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule V (Controlled)
- Application #
- ANDA214672
- Marketing Start
- 05/20/2022
Recall History
Camber Pharmaceuticals, Inc
Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content
Apotex Corp.
Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Lacosamide oral solution is indicated for: Treatment of partial-onset seizures in patients 1 month of age and older ( 1.1 ) Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older ( 1.2 ) 1.1 Partial-Onset Seizures Lacosamide oral solution is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. 1.2 Primary Generalized Tonic-Clonic Seizures Lacosamide oral solution is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older.
Dosage & Administration
2. DOSAGE AND ADMINISTRATION Adults (17 years and older): Initial dosage for monotherapy for the treatment of partial-onset seizures is 100 mg twice daily ( 2.1 ) Initial dosage for adjunctive therapy for the treatment of partial-onset seizures or primary generalized tonic- clonic seizures is 50 mg twice daily ( 2.1 ) Maximum recommended dosage for monotherapy and adjunctive therapy is 200 mg twice daily ( 2.1 ) Pediatric Patients 1 month to less than 17 years: The recommended dosage is based on body weight and is administered orally twice 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. 4, 12.3 ) Dose adjustment is recommended for mild or moderate hepatic impairment; use in patients with severe hepatic impairment is not recommended ( 2. 5, 12.3 ) 2.1 Dosage Information The recommended dosage for monotherapy and adjunctive therapy for partial-onset seizures in patients 1 month of age and older and for adjunctive therapy for primary generalized tonic-clonic seizures in patients 4 years of age and older is included in Table 1. In pediatric patients, …
Contraindications
4 CONTRAINDICATIONS None. None
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 Lacosamide oral solution. Dose reduction may be necessary in these patients. 7.2 Concomitant Medications that Affect Cardiac Conduction Lacosamide oral solution 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 Lacosamide oral solution, and after Lacosamide oral solution is titrated to steady-state, is recommended. In addition, these patients should be closely monitored if they are administered lacosamide through the intravenous route [ see Warnings and Precautions ( 5.3 ) ].
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 Ajenat Pharmaceuticals, LLC at 1-727-234-8872 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 direc…
Frequently Asked Questions
What is Lacosamide Oral Solution used for?
Lacosamide oral solution is a prescription medication used to treat seizures in patients with epilepsy. This liquid formulation contains 10 mg of lacosamide per milliliter and is taken by mouth.
Is Lacosamide Oral Solution a controlled substance?
Yes, Lacosamide Oral Solution is classified as CV under the DEA Controlled Substances Act.
What is the generic name for Lacosamide Oral Solution?
The generic name for Lacosamide Oral Solution is Lacosamide Oral Solution. There are no other listed brand versions of Lacosamide Oral Solution.
What is the NDC code for Lacosamide Oral Solution 10 mg/mL?
The NDC (National Drug Code) for Lacosamide Oral Solution 10 mg/mL is 67877-732, listed by Ascend Laboratories, LLC.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)