Composition: Each uncoated tablet contains Oxcarbazepine IP 150 mg, 300 mg or 600 mg, depending on strength.
Usage: Treatment of partial-onset (focal) seizures as prescribed; pain treatment is not an established general indication.
Category: Antiepileptic Drugs
Therapeutic category: Antiepileptic / Anticonvulsant
SKU: Oxcarbazepine Tablets
Categories: Pharmaceutical Exporter India, Pharmaceutical Formulations India, WHO GMP Certified Formulations
Oxcarbazepine Tablets IP is listed for pharmaceutical business-to-business enquiries. Exact active ingredients, formulation, strength, pack configuration and manufacturer details should be confirmed against the product label and approved technical documentation before ordering.
Manufacturer: Healthy Life Pharma Pvt. Ltd. (manufacturing and certification details require verification)
Exporter: Healthy Inc (export credentials require verification)
Oxcarbazepine is an antiseizure medication used in the management of partial-onset (focal) seizures, either alone or with other antiseizure medicines according to the locally approved prescribing information. It is a keto analogue of carbamazepine and acts principally through its active monohydroxy derivative (MHD).
This listing describes uncoated oral tablets in three supplied IP strengths: 150 mg, 300 mg and 600 mg. Specific indications, age ranges, packaging and market authorizations depend on approved product labeling.
| Variant | Per-tablet composition | Dosage form | Standard |
|---|---|---|---|
| Oxcarbazepine Tablets 150 mg | Oxcarbazepine IP 150 mg | Uncoated tablet | IP |
| Oxcarbazepine Tablets 300 mg | Oxcarbazepine IP 300 mg | Uncoated tablet | IP |
| Oxcarbazepine Tablets 600 mg | Oxcarbazepine IP 600 mg | Uncoated tablet | IP |
Generic name: Oxcarbazepine. CAS: 28721-07-5. Therapeutic class: Antiepileptic / Anticonvulsant. Pack configuration, shelf life and product-specific analytical specifications are subject to confirmation.
Manufacture of conventional uncoated oxcarbazepine tablets requires appropriate controls for raw-material quality, blend uniformity, compression, tablet integrity, dissolution and packaging stability. The exact excipient system, processing method, humidity controls and protective packaging must be validated for the registered formulation.
Claims regarding a particular plant, equipment, manufacturing process or WHO-GMP certification should be supported by current facility documentation before publication.
Quality evaluation may include identification, assay, uniformity of dosage units, dissolution, related substances, microbial quality where relevant and stability testing. Acceptance criteria should follow the applicable Indian Pharmacopoeia monograph and approved finished-product specification. Numerical release limits must not be assumed without documentation.
Oxcarbazepine is converted to an active monohydroxy metabolite (MHD), which is believed to help stabilize neuronal membranes primarily by blocking voltage-sensitive sodium channels and reducing repetitive neuronal firing. It is used for focal seizures under clinician supervision.
Pain: Oxcarbazepine is sometimes used off-label for selected neuropathic pain conditions, but this is not a broadly approved or established primary indication. Do not present it as a general painkiller.
Depending on the destination market, registration may require approved labeling, product dossier, stability data, Certificate of Analysis, manufacturing licenses and country-specific certificates. Availability of CTD/ACTD files, COPP, FSC, WHO-GMP evidence and shipment terms should be confirmed with the supplier rather than presumed.
Q: Which strengths are listed?
A: Oxcarbazepine IP 150 mg, 300 mg and 600 mg uncoated tablets.
Q: Is oxcarbazepine a pain medicine?
A: It is primarily an antiseizure medicine. Use for pain may be off-label and should be assessed by a clinician.
Q: Can treatment be stopped suddenly?
A: No. Abrupt withdrawal can increase seizure frequency; changes should be supervised by the prescriber.
Q: Does it affect birth-control pills?
A: Yes. It can reduce effectiveness of some hormonal contraceptives. Discuss additional or alternative contraception with a healthcare professional.
Take only as directed by the treating clinician. Dose selection and titration depend on age, seizure type, concomitant antiseizure medicines, kidney function and tolerability. Tablets are taken orally according to the product label; do not change or stop treatment without medical advice. Dose adjustment may be necessary in significant renal impairment.
Common adverse effects include dizziness, drowsiness, headache, nausea, vomiting, double vision and impaired coordination. Important risks include hyponatremia (low blood sodium), serious skin reactions including Stevens–Johnson syndrome/toxic epidermal necrolysis, hypersensitivity reactions, mood changes and suicidal thoughts or behavior. HLA-B*1502-associated skin reaction risk may warrant genetic consideration in certain ancestry groups under local guidance. Cross-hypersensitivity can occur in people allergic to carbamazepine. Review pregnancy, interactions, driving safety and hormonal contraceptive effectiveness with a prescriber.
Seek urgent medical assessment for a severe rash, facial swelling, confusion, worsening seizures or suicidal thoughts.
Store in accordance with the approved product label, protected from unsuitable moisture and heat, and keep tablets in their original pack. A fixed storage temperature or shelf life cannot be confirmed from the supplied compositions. Keep out of reach of children.