PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.) Zimbabwe · MCAZ

ESLICARBATOL 800

ESLICARBAZEPINE

2025/13.1/6666 TABLET; ORAL 800MG nervous system INN generic

What it does

Eslicarbazepine is a medication used to help control seizures in people with epilepsy.

Commonly used for: epilepsy, seizures

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

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Sourcing - Kenya only

Registration & product details

Registration no.
2025/13.1/6666
Registration date
2025-02-17
Expiry date
2027-12-31
Status
PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.)
Active ingredient
ESLICARBAZEPINE
Dosage form
TABLET; ORAL
Strength
800MG
Pack size
-
Therapeutic class
-
ATC class (WHO)
N03AF - Carboxamide derivatives
Drug group
NERVOUS SYSTEM
RxNorm RxCUI
1482502
Manufacturer / MAH
Torrent Pharmaceutical Ltd
Applicant / LTR
TORRENT PHARMACEUTICALS
Country of origin
-
Manufacturer location
Plot No. Z104-106, Dahej SEZ Phase II, Taluka Vagra, Dahej, Bharuch, Gujarat 392130, India

Source: Medicines Control Authority of Zimbabwe · fetched 2026-04-18 08:22:07 · updated 2026-09-16 04:30:06

Drug Interactions

71
Check interactions

Severe (7)

Antiepileptics - decreases absorption

Iron chelators (dexrazoxane) might decrease the absorption of antiepileptics (fosphenytoin, phenytoin). Avoid.

Severe Theoretical

Antiepileptics - decreases exposure

Lumacaftor is predicted to decrease the exposure to antiepileptics (carbamazepine, fosphenytoin, phenobarbital, phenytoin, primidone). Avoid.

Severe Theoretical

Antiepileptics - decreases concentration

St John’s wort is predicted to decrease the concentration of antiepileptics (fosphenytoin, phenobarbital, phenytoin, primidone). Avoid.

Severe Theoretical

Antiepileptics - increases risk of overheating and dehydration

Hydroxyzine potentially increases the risk of overheating and dehydration when given with antiepileptics (zonisamide). Avoid in children.

Severe Theoretical

Antiepileptics - increases risk of overheating and dehydration

Haloperidol potentially increases the risk of overheating and dehydration when given with antiepileptics (zonisamide). Avoid in children.

Severe Theoretical

Antiepileptics - decreases absorption

Dexrazoxane might decrease the absorption of antiepileptics (fosphenytoin, phenytoin). Avoid.

Severe Theoretical

Antiepileptics - increases risk of overheating and dehydration

Oxybutynin potentially increases the risk of overheating and dehydration when given with antiepileptics (zonisamide). Avoid in children.

Severe Theoretical

Moderate (27)

Antiepileptics - increases concentration

Intravenous chloramphenicol increases the concentration of antiepileptics (fosphenytoin, phenytoin) and antiepileptics (fosphenytoin, phenytoin) affect the concentration of intravenous chloramphenicol

Moderate Study

Antiepileptics - decreases concentration

Diazoxide decreases the concentration of antiepileptics (fosphenytoin, phenytoin) and antiepileptics (fosphenytoin, phenytoin) are predicted to decrease the effects of diazoxide. Monitor concentration

Moderate Anecdotal

Antiepileptics - increases concentration

Disulfiramincreasestheconcentrationofantiepileptics (fosphenytoin,phenytoin).Monitorconcentrationandadjust dose.rStudy →AlsoseeTABLE12p.1520

Moderate Study

Antiepileptics - increases concentration

Fluorouracilincreasestheconcentrationofantiepileptics (fosphenytoin,phenytoin).Monitorconcentrationandadjust dose.rAnecdotal 1xidneppA|snoitcaretnI A1 https://www.facebook.c (Books-Courses-Medic

Moderate Anecdotal

Antiepileptics - decreases concentration

Folates are predicted to decrease the concentration of antiepileptics (fosphenytoin, phenobarbital, phenytoin, primidone). Monitor concentration and adjust dose.

Moderate Study

Unknown (37)

Antiepileptics - increases risk of overheating and dehydration

Acetazolamide potentially increases the risk of overheating and dehydration when given with antiepileptics (zonisamide). Avoid in children.

Unknown Theoretical

Antiepileptics - increases risk of visual disturbances

Alcohol potentially increases the risk of visual disturbances when given with antiepileptics (retigabine).

Unknown Study

Antiepileptics - decreases exposure

Enzalutamide is predicted to slightly decrease the exposure to antiepileptics (brivaracetam).

Unknown Theoretical

Antiepileptics - decreases exposure

Apalutamidepotentiallydecreasestheexposureto antiepileptics(valproate).nTheoretical

Unknown Theoretical

Antiepileptics - increases concentration

Capecitabine increases the concentration of antiepileptics (fosphenytoin, phenytoin).

Unknown Anecdotal

Data from BNF 85 (British National Formulary). This is not a substitute for professional medical advice. Matched via: class

Disclaimer: This information is sourced from Medicines Control Authority of Zimbabwe (Zimbabwe). Always consult a qualified healthcare professional before using any medication.

About this medicine

Eslicarbazepine is a medication used to help control seizures in people with epilepsy.

What it treats

  • epilepsy
  • seizures

How it works

Eslicarbazepine works by stabilizing electrical activity in the brain, which helps prevent seizures.

Who it's for

This medication is for individuals diagnosed with epilepsy who experience seizure episodes.

Drug class

Antiepileptics

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: eslicarbazepine

BNF-referenced

Eslicarbazepine is an antiepileptic drug used primarily for the treatment of partial-onset seizures in adults and children. It is a derivative of carbamazepine and is believed to stabilize hyperexcitable neuronal membranes, thereby reducing seizure activity.

Indications

  • Partial-onset seizures
  • Epilepsy

Dosage

Children: Refer to the BNF for Children for specific dosing guidelines.

Adults: Refer to the BNF for specific dosing guidelines.

Mechanism of action

Eslicarbazepine's anticonvulsant properties are thought to involve the inhibition of voltage-gated sodium channels, which leads to a stabilization of neuronal membranes and a reduction in the excitability of neurons, contributing to its effectiveness in controlling seizures.

Pharmacodynamics

Eslicarbazepine exhibits a dose-dependent effect on seizure control, with its efficacy linked to the modulation of ion channels, particularly sodium channels. This modulation decreases the likelihood of action potential generation, thereby reducing neuronal excitability and seizure frequency.

Pharmacokinetics

Eslicarbazepine is rapidly absorbed after oral administration, with peak plasma concentrations typically reached within 1 to 4 hours. It undergoes extensive metabolism in the liver, primarily via glucuronidation, and has a half-life of approximately 13 hours. The drug is eliminated mainly through the urine, with renal clearance being a significant pathway. Its pharmacokinetics can be affected by factors such as age, liver function, and concomitant medications.

Interactions

  • eslicarbazepine+statins: Moderate (decreases exposure)
  • eslicarbazepine+atorvastatin: Moderate (decreases exposure)
  • eslicarbazepine+erlotinib: Unknown (decreases exposure)
  • eslicarbazepine+gefitinib: Unknown (decreases exposure)
  • eslicarbazepine+imatinib: Unknown (decreases exposure)
  • eslicarbazepine+rosuvastatin: Unknown (decreases exposure)

Pregnancy

There is limited data on the use of eslicarbazepine in pregnancy. It is important to weigh the potential benefits against the risks.

Breast-feeding

Eslicarbazepine is excreted in breast milk. Caution is advised when administering to nursing mothers.

Storage

Store at room temperature, away from moisture and heat. Keep out of reach of children.

Formulations

  • Tablets

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: Eslicarbazepineacetate

BNF-referenced

Eslicarbazepine acetate is an antiepileptic drug used primarily for the management of focal seizures, with or without secondary generalization. It is a prodrug that is converted into its active metabolite, eslicarbazepine, which exhibits anticonvulsant properties. The drug is typically administered orally and is indicated for both monotherapy and adjunctive therapy in seizure disorders.

Indications

  • Monotherapy of focal seizures
  • Adjunctive therapy for focal seizures with or without secondary generalization

Dosage

Children: Refer to the BNF for Children for specific dosing recommendations.

Adults: Initially 400 mg once daily for 1–2 weeks, then increase to 800 mg once daily (maximum per dose 1.2 g).

Mechanism of action

Eslicarbazepine acetate is converted to the active metabolite eslicarbazepine, which is believed to exert its anticonvulsant effects by inhibiting voltage-gated sodium channels. This action stabilizes the inactivated state of these channels, thereby preventing excessive neuronal firing. Additionally, eslicarbazepine has been shown to inhibit T-type calcium channels, which may also contribute to its efficacy in seizure control.

Pharmacodynamics

Eslicarbazepine acetate is associated with dose- and concentration-dependent effects, including an increase in heart rate and prolongation of the PR interval on an electrocardiogram. These pharmacodynamic effects must be monitored, particularly in patients with existing cardiac conditions.

Pharmacokinetics

Eslicarbazepine acetate is rapidly absorbed and converted into its active metabolite, eslicarbazepine, following oral administration. The drug has a half-life allowing for once-daily dosing in most cases. Eslicarbazepine is primarily metabolized in the liver and eliminated via the kidneys. Caution is advised in patients with hepatic or renal impairment, as dose adjustments may be necessary.

Contra-indications

  • Familial short QT syndrome
  • Second- or third-degree AV block

Adverse effects

  • Headache
  • Dizziness
  • Nausea
  • Vomiting
  • Fatigue
  • Hyponatraemia
  • Allergic skin reactions
  • Memory impairment
  • Irritability
  • Tinnitus
  • Generalised rash
  • Drug reaction with eosinophilia and systemic symptoms (DRESS)

Interactions

  • Caution with concurrent use of other antiepileptics
  • Potential interactions with drugs that affect heart rate or PR interval
  • Avoid abrupt withdrawal of other antiepileptic medications when initiating treatment

Precautions

  • Caution in elderly patients
  • Use with caution in patients with hepatic impairment
  • Use with caution in patients with renal impairment
  • Gradual withdrawal recommended to avoid seizure exacerbation
  • Monitor for signs of DRESS syndrome

Pregnancy

Avoid unless potential benefit justifies the risk to the fetus, as animal studies show adverse effects.

Breast-feeding

Avoid as eslicarbazepine acetate is present in milk in animal studies.

Storage

Store in a cool, dry place away from direct sunlight, and out of reach of children.

Formulations

  • Oral tablet
  • Modified-release tablet
BNF 85 (British National Formulary) p.362 BNF for Children 2019-2020 p.224 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: eslicarbazepine

PubChem CID 9881504

Molecular formula: C15H14N2O2

Mechanism of action

The precise mechanism(s) by which eslicarbazepine exerts anticonvulsant activity is unknown but is thought to involve inhibition of voltage-gated sodium channels.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

Molecular reference: Eslicarbazepineacetate

PubChem CID 179344

Molecular formula: C17H16N2O3

Mechanism of action

Eslicarbazepine acetate is converted to the active metabolite eslicarbazepine which carries out its anticonvulsant activity. The exact mechanism of action is unknown, but it is thought to involve the inhibition of voltage-gated sodium channels. In in vitro electrophysiological studies, eslicarbazepine was shown to inhibit repeated neuronal firing by stabilizing the inactivated state of voltage-gated sodium channels and preventing their return to the activated state. In vitro studies also showed eslicarbazepine inhibiting T-type calcium channels, which likely also has a role in anticonvulsant activity.

Pharmacodynamics

Eslicarbazepine acetate is associated with a dose- and concentration-dependant increase in heart rate and prolongation of PR interval.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.