International reference: 3 US FDA recalls for this ingredient

Failed Impurities/Degradation Specificattion (oxcarbazepine)

Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that contain blister cards filled with Ibuprofen tablets, 600mg drug product, were found to be mis-labeled with blister card print identifying the product as AHP Oxcarbazepine Tablets, 300mg, lot #142544 (oxcarbazepine)

Failed Tablet Specifications: Broken Tablets Present. (oxcarbazepine)

US-market enforcement records (OpenFDA), shown for reference - not specific to this product in Kenya.

Registered Kenya · PPB

TRILEPTAL 600MG

OXCARBAZEPINE

10178 600MG NEW/INNOVATOR INN generic

What it does

Oxcarbazepine is an antiepileptic medicine used to help control seizures.

Commonly used for: seizures (epilepsy)

Read more in plain English ↓

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

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Registration & product details

Registration no.
10178
Registration date
-
Expiry date
-
Status
Registered
Active ingredient
OXCARBAZEPINE
Dosage form
600MG
Strength
-
Pack size
PACK OF 50 TABLETS
Therapeutic class
NEW/INNOVATOR
Manufacturer / MAH
Nvs Kenya
Applicant / LTR
NVS KENYA LIMITED
Country of origin
FOREIGN
Manufacturer location
Mogadishu Road, off Lunga Lunga Road, Industrial Area, Nairobi, Kenya

Source: Pharmacy and Poisons Board · fetched 2026-01-28 20:11:10 · updated 2026-08-03 04:11:22

Drug Interactions

77
Check interactions

Severe (10)

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

Bictegravir - decreases exposure

Oxcarbazepineispredictedtodecreasetheexposureto bictegravir.Avoid.oTheoretical

Severe Theoretical

Velpatasvir - decreases exposure

Oxcarbazepineispredictedtodecreasetheexposureto velpatasvir.Avoid.rTheoretical https://www.facebook.c (Books-Courses-Medic

Severe Theoretical

Voxilaprevir - decreases concentration

Oxcarbazepine is predicted to decrease the concentration of voxilaprevir. Avoid.

Severe Theoretical

Moderate (26)

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 (41)

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 Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About this medicine

Oxcarbazepine is an antiepileptic medicine used to help control seizures.

What it treats

  • seizures (epilepsy)

How it works

It helps stabilize electrical activity in the brain, reducing the frequency of seizures.

Who it's for

This medicine is for people who experience seizures.

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: Oxcarbazepine

BNF-referenced

Oxcarbazepine is an antiepileptic medication primarily used for the treatment of focal seizures and generalized tonic-clonic seizures. It functions by stabilizing neuronal membranes and inhibiting excessive neuronal firing, thereby reducing the frequency of seizures. The drug is a prodrug, converted in the body to its active metabolite, monohydroxy derivative (MHD), which is responsible for its therapeutic effects.

Indications

  • Focal seizures
  • Generalized tonic-clonic seizures
  • Adjunctive therapy for epilepsy

Dosage

Adults: For adults, the usual starting dose is 600 mg daily, given in two divided doses, which can be adjusted based on clinical response, typically increased in increments of 300 mg weekly. The maximum recommended dose is 2400 mg daily.

Mechanism of action

Oxcarbazepine and its active metabolite, MHD, primarily exert their anti-epileptic effects by blocking voltage-gated sodium channels. This blockade stabilizes hyperexcited neuronal membranes and inhibits the repetitive firing of neurons, which is characteristic of seizure activity. Additionally, oxcarbazepine may enhance potassium conductance and modulate calcium channels, contributing to its seizure-preventing properties.

Pharmacodynamics

As an anticonvulsant, oxcarbazepine reduces seizure frequency by inhibiting abnormal electrical activity in the brain. It has been linked to rare hematologic abnormalities, including agranulocytosis and aplastic anemia, necessitating regular monitoring of blood parameters. Dermatological reactions, ranging from mild rashes to severe conditions like Stevens-Johnson Syndrome, have been noted, especially in patients with specific HLA alleles, thus requiring close monitoring and immediate discontinuation upon the first sign of skin reactions.

Pharmacokinetics

Oxcarbazepine is rapidly absorbed after oral administration, with peak plasma concentrations occurring within 4 to 6 hours. It is extensively metabolized in the liver, primarily to its active metabolite MHD, which has a longer half-life than the parent compound. The elimination half-life of oxcarbazepine is approximately 1 to 2 hours, while MHD has a half-life of 9 to 11 hours. The drug is primarily excreted in the urine, both as metabolites and unchanged drug.

Contra-indications

  • Hypersensitivity to oxcarbazepine or any of its components
  • History of severe skin reactions associated with carbamazepine

Adverse effects

  • Dizziness
  • Somnolence
  • Fatigue
  • Nausea
  • Vomiting
  • Ataxia
  • Visual disturbances
  • Headache
  • Hyponatremia
  • Rash
  • Agranulocytosis
  • Aplastic anemia
  • Toxic epidermal necrolysis
  • Stevens-Johnson syndrome

Interactions

  • Oxcarbazepine may decrease the effectiveness of hormonal contraceptives
  • Severe interaction with bictegravir, velpatasvir, and voxilaprevir (decreases exposure)
  • Moderate interaction with guanfacine (decreases concentration)
  • Possible interaction with ciclosporin, dolutegravir, erlotinib, gefitinib, and sorafenib (decreases exposure)
  • Unknown interactions with statins (decreases exposure)

Precautions

  • Monitor for signs of blood dyscrasias
  • Screen for HLA-A*3101 and HLA-B*1502 alleles in at-risk populations
  • Use caution in patients with a history of psychiatric disorders
  • Consider electrolyte levels before starting treatment

Pregnancy

Oxcarbazepine is classified as category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Oxcarbazepine is excreted in breast milk. Caution should be exercised when administering to nursing mothers.

Storage

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

Formulations

  • 250 mg tablet
  • 300 mg tablet
  • Oral suspension
BNF 85 (British National Formulary) p.373 BNF for Children 2019-2020 p.231 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: Oxcarbazepine

PubChem CID 34312

Molecular formula: C15H12N2O2

Mechanism of action

The exact mechanism through which oxcarbazepine and its active metaoblite, MHD, exert their anti-epileptic effects is unclear, but is thought to primarily involve the blockade of voltage-gated sodium channels. The opening and closing of sodium channels allows for the propagation of action potentials along neurons - in epilepsy, these action potentials can occur in excess of that required for normal function, and the repetitive and pathological firing of these action potentials leads to seizure activity. Both oxcarbazepine and MHD are thought to inhibit seizure activity by binding to the inactive state of voltage-gated sodium channels, thus prolonging the period in which the receptor is unavailable for action potential propagation. This helps to stabilize hyperexcited neuronal membranes, inhibit repetitive neuron firing, and prevent the spread of seizure activity within the CNS without affecting normal neuronal transmission. Increased potassium conductance and modulation of voltage-activated calcium channels is also thought to play a role in the anti-seizure activity of oxcarbazepine. Inhibition of glutamatergic activity was thought to contribute to oxcarbazepine's activity, but this effect could not be replicated _in vivo_. The pharmacological activity of Trileptal (oxcarbazepine) is primarily exerted through the 10-monohydroxy metabolite (MHD) of oxcarbazepine. The precise mechanism by which oxcarbazepine and MHD exert their antiseizure effect is unknown; however, in vitro electrophysiological studies indicate that they produce blockade of voltage-sensitive sodium channels, resulting in stabilization of hyperexcited neural membranes, inhibition of repetitive neuronal firing, and diminution of propagation of synaptic impulses. These actions are thought to be important in the prevention of seizure spread in the intact brain. In addition, increased potassium conductance and modulation of high-voltage activated calcium channels may contribute to the anticonvulsant effects of the drug. No significant interactions of oxcarbazepine or MHD with brain neurotransmitter or modulator receptor sites have been demonstrated.

Pharmacodynamics

Oxcarbazepine is an anticonvulsant drug that reduces the incidence of seizures in epilepsy by inhibiting abnormal electrical activity in the brain. There have been rare reports of oxcarbazepine resulting in the development of hematologic abnormalities, including agranulocytosis and aplastic anemia. Patients should be undergo frequent laboratory testing and should be monitored closely for signs and symptoms of blood dyscrasias. Oxcarbazepine has also been associated with the development of dermatologic reactions which can progress from a simple rash to potentially fatal reactions such as toxic epidermal necrolysis (TEN) or Stevens-Johnson Syndrome (SJS). Patients with the HLA-A 3101 and/or HLA-B 1502 alleles may be at higher risk of this reaction. Oxcarbazepine should be discontinued at the first sign of a drug-induced skin reaction.

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

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.