Lacosamide 10 mg/mL
Lacosamide · SOLUTION · ANI Pharmaceuticals, Inc.
Lacosamide is a solution containing lacosamide at 10 mg/mL, taken oral. Manufactured by ANI Pharmaceuticals, Inc..
Key Facts
- Brand Name
- Lacosamide
- Generic Name
- Lacosamide
- NDC Code (Product)
70954-488- Manufacturer
- ANI Pharmaceuticals, Inc.
- Strength
- 10 mg/mL
- Dosage Form
- SOLUTION
- Route
- ORAL
- Marketing Status
- DEA Schedule
- Schedule V (Controlled)
- Application #
- ANDA216151
- Marketing Start
- 08/26/2022
Recall History
Camber Pharmaceuticals, Inc
Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Apotex Corp.
Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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 injection is indicated for: Treatment of partial-onset seizures in patients 4 years 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 injection is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. Pediatric use information is approved for UCB, Inc.'s VIMPAT® (lacosamide) injection. However, due to UCB, Inc.'s marketing exclusivity rights, this drug product is not labeled with that information. 1.2 Primary Generalized Tonic-Clonic Seizures Lacosamide 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 4 years 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) Injection: for intravenous use only when oral administration is temporarily not feasible; the recommended dosage is based on body weight and is administered two or three times daily over 15 to 60 minutes; obtaining ECG before initiation is recommended in certain patients (2.7, 5.3) 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 d…
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 lacosamide. Dose reduction may be necessary in these patients. 7.2 Concomitant Medications that Affect Cardiac Conduction Lacosamide 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, and after lacosamide 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 Somerset Therapeutics, LLC at 1- 800-417-9175 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 compared to rates in th…
Frequently Asked Questions
What is Lacosamide used for?
Lacosamide contains Lacosamide. It is a solution taken oral. Consult your doctor for specific uses.
Is Lacosamide a controlled substance?
Yes, Lacosamide is classified as CV under the DEA Controlled Substances Act.
What is the generic name for Lacosamide?
The generic name for Lacosamide is Lacosamide. There are 1 other brand versions of Lacosamide.
What is the NDC code for Lacosamide 10 mg/mL?
The NDC (National Drug Code) for Lacosamide 10 mg/mL is 70954-488, listed by ANI Pharmaceuticals, Inc..