Drugplain

Eslicarbazepine acetate 600 mg/1

Eslicarbazepine acetate · TABLET · Torrent Pharmaceuticals Limited

No Recall History
Plain English

Eslicarbazepine acetate is an anti-seizure medication taken by mouth as a tablet to help control seizures in people with epilepsy. It may be used alone or combined with other anti-seizure drugs as part of a treatment plan.

Key Facts

Brand Name
Eslicarbazepine acetate
Generic Name
Eslicarbazepine acetate
NDC Code (Product)
13668-540
Manufacturer
Torrent Pharmaceuticals Limited
Strength
600 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA211227
Marketing Start
05/06/2025

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective126 reports
seizure110 reports
off label use102 reports
condition aggravated56 reports
hyponatraemia51 reports
somnolence46 reports
product use in unapproved indication41 reports
dizziness38 reports
generalised tonic-clonic seizure33 reports
drug interaction30 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Eslicarbazepine acetate tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older. Eslicarbazepine acetate tablets are indicated for the treatment of partial-onset seizures in patients 4 years of age and older. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION • Adult Patients: The recommended initial dosage of eslicarbazepine acetate is 400 mg once daily. For some patients, treatment may be initiated at 800 mg once daily if the need for seizure reduction outweighs an increased risk of adverse reactions. Increase the dose in weekly increments of 400 mg to 600 mg once daily, based on clinical response and tolerability, to a recommended maintenance dosage of 800 mg to 1,600 mg once daily. ( 2.2 ) • Pediatric Patients: The recommended dosage of eslicarbazepine acetate is based on body weight and is administered orally once daily. Increase the dose in weekly intervals based on clinical response and tolerability, to the recommended maintenance dosage ( 2.2 ). • Patients with Moderate or Severe Renal Impairment: Reduce dosage by 50%. ( 2.4 ) 2.1 Important Administration Instructions Instruct patients to administer eslicarbazepine acetate tablets either as whole or as crushed tablets. Instruct patients to take eslicarbazepine acetate tablets either with or without food. The eslicarbazepine acetate dosing regimen depends on age, weight, and renal function. 2.2 General Dosing Recommendations Monotherapy and Adjunctive …

Contraindications

4 CONTRAINDICATIONS Eslicarbazepine acetate tablets are contraindicated in patients with a hypersensitivity to eslicarbazepine acetate or oxcarbazepine [see Warnings and Precautions ( 5.2 , 5.3 , and 5.4 )]. Hypersensitivity to eslicarbazepine acetate or oxcarbazepine. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS • Carbamazepine: May need dose adjustment for eslicarbazepine acetate or carbamazepine. ( 2.3 , 5.6 , 7.1 ) • Phenytoin: Higher dosage of eslicarbazepine acetate may be necessary and dose adjustment may be needed for phenytoin. ( 2.3 , 7.1 , 7.2 ) • Phenobarbital or Primidone: Higher dosage of eslicarbazepine acetate may be necessary. ( 2.3 , 7.1 ) • Hormonal Contraceptives: Eslicarbazepine acetate may decrease the effectiveness of hormonal contraceptives. ( 7.4 , 8.3 ) 7.1 Other Antiepileptic Drugs Several AEDs (e.g., carbamazepine, phenobarbital, phenytoin, and primidone) can induce enzymes that metabolize eslicarbazepine acetate and can cause decreased plasma concentrations of eslicarbazepine [see Clinical Pharmacology ( 12.3 )] . Higher doses of eslicarbazepine acetate may be needed [see Dosage and Administration ( 2.4 )] . 7.2 CYP2C19 Substrates Eslicarbazepine acetate can inhibit CYP2C19, which can cause increased plasma concentrations of drugs that are metabolized by this isoenzyme (e.g., phenytoin, clobazam, and omeprazole) [see Clinical Pharmacology ( 12.3 )] . Dose adjustment may be needed. 7.3 CYP3A4 Substrates In vivo studies suggest that eslicarbaze…

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are described in more detail in the Warnings and Precautions section of the label: • Suicidal Behavior and Ideation [see Warnings and Precautions ( 5.1 )] • Serious Dermatologic Reactions [see Warnings and Precautions ( 5.2 )] • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions ( 5.3 )] • Anaphylactic Reactions and Angioedema [see Warnings and Precautions ( 5.4 )] • Hyponatremia [see Warnings and Precautions ( 5.5 )] • Neurological Adverse Reactions [see Warnings and Precautions ( 5.6 )] • Drug Induced Liver Injury [see Warnings and Precautions ( 5.8 )] • Abnormal Thyroid Function Tests [see Warnings and Precautions ( 5.9 )] • Pancytopenia, Agranulocytosis, and Leukopenia [see Warnings and Precautions ( 5.10 )] • Most common adverse reactions in adult patients receiving eslicarbazepine acetate (≥4% and ≥2% greater than placebo): dizziness, somnolence, nausea, headache, diplopia, vomiting, fatigue, vertigo, ataxia, blurred vision, and tremor. ( 6.1 ) • Adverse reactions in pediatric patients are similar to those seen in adult patients. To report SUSPECTED ADVERSE…

Frequently Asked Questions

What is Eslicarbazepine acetate used for?

Eslicarbazepine acetate is an anti-seizure medication taken by mouth as a tablet to help control seizures in people with epilepsy. It may be used alone or combined with other anti-seizure drugs as part of a treatment plan.

Is Eslicarbazepine acetate a controlled substance?

Eslicarbazepine acetate is not classified as a controlled substance by the DEA.

What is the generic name for Eslicarbazepine acetate?

The generic name for Eslicarbazepine acetate is Eslicarbazepine acetate. There are 9 other brand versions of Eslicarbazepine acetate.

What is the NDC code for Eslicarbazepine acetate 600 mg/1?

The NDC (National Drug Code) for Eslicarbazepine acetate 600 mg/1 is 13668-540, listed by Torrent Pharmaceuticals Limited.

Product NDC

13668-540

Package NDC

13668-540-05

Other Eslicarbazepine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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