Ocarnix
Generic Name
Ocarnibate
Manufacturer
Innovate Pharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| ocarnix 330 mg tablet | ৳ 5.00 | ৳ 50.00 |
Description
Overview of the medicine
Ocarnix 330 mg Tablet is an antiepileptic drug used to control various types of seizures, including partial-onset seizures and generalized tonic-clonic seizures, by reducing abnormal electrical activity in the brain.
Uses & Indications
Dosage
Adults
Initial dose: 330 mg orally once daily. May be increased by 330 mg daily at weekly intervals up to a maximum recommended daily dose of 990 mg. Administer with or without food.
Elderly
Start with a lower initial dose (e.g., 165 mg once daily) and titrate slowly, monitoring for adverse effects, especially renal function.
Renal_impairment
For patients with moderate to severe renal impairment (CrCl < 50 mL/min), initial dose should be reduced by 50% (e.g., 165 mg once daily) and titrated cautiously. Avoid in end-stage renal disease.
How to Take
Take the tablet orally, whole with a glass of water, with or without food. Do not crush, chew, or break the tablet.
Mechanism of Action
Ocarnibate, the active ingredient, primarily acts by selectively modulating voltage-gated sodium channels, thereby stabilizing hyperexcited neuronal membranes and inhibiting repetitive neuronal firing. It may also enhance the activity of GABA, an inhibitory neurotransmitter.
Pharmacokinetics
Onset
Clinical effects typically observed within 1-2 hours of administration.
Excretion
Excreted mainly by the kidneys, with approximately 80% as metabolites and 20% as unchanged drug.
Half life
Elimination half-life ranges from 10 to 15 hours, allowing for once or twice daily dosing.
Absorption
Rapidly and almost completely absorbed after oral administration, with peak plasma concentrations reached within 1-4 hours. Bioavailability is high (approx. 90%).
Metabolism
Primarily metabolized in the liver, largely independent of cytochrome P450 enzymes, reducing potential for drug interactions.
Side Effects
Contraindications
- Hypersensitivity to Ocarnibate or any excipients of the tablet.
- Severe hepatic impairment.
Drug Interactions
Oral Contraceptives
Ocarnibate is unlikely to affect hormonal contraceptives due to its minimal CYP interaction profile, but caution is advised.
Phenytoin, Carbamazepine
While Ocarnibate is largely CYP-independent, co-administration with strong CYP inducers might theoretically alter its metabolism or the metabolism of co-administered drugs. Monitor closely.
Other CNS Depressants (e.g., alcohol, benzodiazepines)
May enhance central nervous system (CNS) depressant effects like drowsiness and dizziness.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include severe dizziness, somnolence, ataxia, or respiratory depression. In case of overdose, seek immediate medical attention. Management is supportive and symptomatic; gastric lavage and activated charcoal may be considered if ingestion is recent.
Pregnancy & Lactation
Pregnancy Category C/D. Not recommended during pregnancy unless the potential benefit outweighs the risk to the fetus. Consult a doctor for individualized advice. It is unknown if Ocarnibate is excreted in human milk, so caution should be exercised when administered to a nursing woman.
Side Effects
Contraindications
- Hypersensitivity to Ocarnibate or any excipients of the tablet.
- Severe hepatic impairment.
Drug Interactions
Oral Contraceptives
Ocarnibate is unlikely to affect hormonal contraceptives due to its minimal CYP interaction profile, but caution is advised.
Phenytoin, Carbamazepine
While Ocarnibate is largely CYP-independent, co-administration with strong CYP inducers might theoretically alter its metabolism or the metabolism of co-administered drugs. Monitor closely.
Other CNS Depressants (e.g., alcohol, benzodiazepines)
May enhance central nervous system (CNS) depressant effects like drowsiness and dizziness.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include severe dizziness, somnolence, ataxia, or respiratory depression. In case of overdose, seek immediate medical attention. Management is supportive and symptomatic; gastric lavage and activated charcoal may be considered if ingestion is recent.
Pregnancy & Lactation
Pregnancy Category C/D. Not recommended during pregnancy unless the potential benefit outweighs the risk to the fetus. Consult a doctor for individualized advice. It is unknown if Ocarnibate is excreted in human milk, so caution should be exercised when administered to a nursing woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months from the date of manufacture.
Availability
Available in pharmacies and hospitals
Approval Status
Approved by DGDA
Patent Status
Patented
Clinical Trials
Post-marketing surveillance and Phase IV clinical trials are ongoing to further evaluate the long-term efficacy and safety profile of Ocarnix.
Lab Monitoring
- Monitor renal function (creatinine clearance) at baseline and periodically, especially in elderly or renally impaired patients.
- Consider baseline and periodic liver function tests (LFTs)
Doctor Notes
- Counsel patients on the importance of adherence and not abruptly stopping medication. Monitor for any signs of suicidal ideation or unusual behavioral changes, especially during initial therapy or dose adjustments. Advise caution with activities requiring mental alertness.
Patient Guidelines
- Do not stop taking Ocarnix abruptly, as this may increase seizure frequency. Always consult your doctor before discontinuing or changing the dose.
- Report any changes in mood, behavior, or thoughts of self-harm to your doctor immediately.
- Avoid alcohol consumption while on this medication.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is close to the time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose.
Driving Precautions
Ocarnix may cause drowsiness, dizziness, or blurred vision. Do not drive, operate machinery, or perform other hazardous activities until you know how this medication affects you.
Lifestyle Advice
- Maintain a regular sleep schedule to help manage seizures.
- Engage in stress-reducing activities like yoga or meditation.
- Carry a medical alert card or bracelet indicating your seizure disorder and medication.
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