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Trileptal

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Overview

What is Trileptal?

TRILEPTAL is an antiepileptic drug available as 150 mg, 300 mg, and 600 mg film-coated tablets for oral administration. TRILEPTAL is also available as a 300 mg/5 mL (60 mg/mL) oral suspension. Oxcarbazepine is 10,11-Dihydro-10-oxo-5-dibenz[b,]azepine-5-carboxamide, and its structural formula is:

Oxcarbazepine is a white to faintly orange crystalline powder. It is slightly soluble in chloroform, dichloromethane, acetone, and methanol and practically insoluble in ethanol, ether and water. Its molecular weight is 252.27.

TRILEPTAL film-coated tablets contain the following inactive ingredients: colloidal silicon dioxide, crospovidone, hydroxypropyl methylcellulose, iron oxide, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide.

TRILEPTAL oral suspension contains the following inactive ingredients: ascorbic acid; dispersible cellulose; ethanol; macrogol stearate; methyl parahydroxybenzoate; propylene glycol; propyl parahydroxybenzoate; purified water; sodium saccharin; sorbic acid; sorbitol; yellow-plum-lemon aroma.



What does Trileptal look like?



What are the available doses of Trileptal?

Film-

c

oated Tablets:

Oral Suspension:

 

What should I talk to my health care provider before I take Trileptal?

How should I use Trileptal?

TRILEPTAL is indicated for use as monotherapy or adjunctive therapy in the treatment of partial seizures in adults and as monotherapy in the treatment of partial seizures in pediatric patients aged 4 years and above with epilepsy, and as adjunctive therapy in pediatric patients aged 2 years and above with partial seizures. 

Initiate TRILEPTAL with a dose of 600 mg/day, given twice-a-day. If clinically indicated, the dose may be increased by a maximum of 600 mg/day at approximately weekly intervals; the maximum recommended daily dose is 1200 mg/day. Daily doses above 1200 mg/day show somewhat greater effectiveness in controlled trials, but most patients were not able to tolerate the 2400 mg/day dose, primarily because of CNS effects.

Dosage adjustment is recommended with concomitant use of strong CYP3A4 enzyme inducers or UGT inducers, which include certain antiepileptic drugs (AEDs) [].


What interacts with Trileptal?

Sorry No Records found


What are the warnings of Trileptal?

Sorry No Records found


What are the precautions of Trileptal?

Sorry No Records found


What are the side effects of Trileptal?

Sorry No records found


What should I look out for while using Trileptal?

TRILEPTAL is contraindicated in patients with a known hypersensitivity to oxcarbazepine or to any of its components, or to eslicarbazepine acetate [].


What might happen if I take too much Trileptal?


How should I store and handle Trileptal?

Storage and Stability:Tablets150 mg Film-Coated Tablets:Bottle of 100……………………………………………………………………………………………...NDC 0078-0456-05Unit Dose (blister pack)Box of 100 (strips of 10)………………………………………………………………………………....NDC 0078-0456-35300 mg Film-Coated Tablets:  Bottle of 100……………………………………………………………………………………………...NDC 0078-0337-05Unit Dose (blister pack)Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0337-06600 mg Film-Coated Tablets:Bottle of 100……………………………………………………………………………………………...NDC 0078-0457-05Unit Dose (blister pack)Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0457-35Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP).Suspension300 mg/5 mL (60 mg/mL) Oral Suspension:Bottle containing 250 mL of oral suspension……………………………………………………………NDC 0078-0357-52Store TRILEPTAL oral suspension in the original container. Shake well before using.Use within 7 weeks of first opening the bottle.Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Tablets150 mg Film-Coated Tablets:Bottle of 100……………………………………………………………………………………………...NDC 0078-0456-05Unit Dose (blister pack)Box of 100 (strips of 10)………………………………………………………………………………....NDC 0078-0456-35300 mg Film-Coated Tablets:  Bottle of 100……………………………………………………………………………………………...NDC 0078-0337-05Unit Dose (blister pack)Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0337-06600 mg Film-Coated Tablets:Bottle of 100……………………………………………………………………………………………...NDC 0078-0457-05Unit Dose (blister pack)Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0457-35Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP).Suspension300 mg/5 mL (60 mg/mL) Oral Suspension:Bottle containing 250 mL of oral suspension……………………………………………………………NDC 0078-0357-52Store TRILEPTAL oral suspension in the original container. Shake well before using.Use within 7 weeks of first opening the bottle.Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Tablets150 mg Film-Coated Tablets:Bottle of 100……………………………………………………………………………………………...NDC 0078-0456-05Unit Dose (blister pack)Box of 100 (strips of 10)………………………………………………………………………………....NDC 0078-0456-35300 mg Film-Coated Tablets:  Bottle of 100……………………………………………………………………………………………...NDC 0078-0337-05Unit Dose (blister pack)Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0337-06600 mg Film-Coated Tablets:Bottle of 100……………………………………………………………………………………………...NDC 0078-0457-05Unit Dose (blister pack)Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0457-35Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP).Suspension300 mg/5 mL (60 mg/mL) Oral Suspension:Bottle containing 250 mL of oral suspension……………………………………………………………NDC 0078-0357-52Store TRILEPTAL oral suspension in the original container. Shake well before using.Use within 7 weeks of first opening the bottle.Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Tablets150 mg Film-Coated Tablets:Bottle of 100……………………………………………………………………………………………...NDC 0078-0456-05Unit Dose (blister pack)Box of 100 (strips of 10)………………………………………………………………………………....NDC 0078-0456-35300 mg Film-Coated Tablets:  Bottle of 100……………………………………………………………………………………………...NDC 0078-0337-05Unit Dose (blister pack)Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0337-06600 mg Film-Coated Tablets:Bottle of 100……………………………………………………………………………………………...NDC 0078-0457-05Unit Dose (blister pack)Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0457-35Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP).Suspension300 mg/5 mL (60 mg/mL) Oral Suspension:Bottle containing 250 mL of oral suspension……………………………………………………………NDC 0078-0357-52Store TRILEPTAL oral suspension in the original container. Shake well before using.Use within 7 weeks of first opening the bottle.Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Tablets150 mg Film-Coated Tablets:Bottle of 100……………………………………………………………………………………………...NDC 0078-0456-05Unit Dose (blister pack)Box of 100 (strips of 10)………………………………………………………………………………....NDC 0078-0456-35300 mg Film-Coated Tablets:  Bottle of 100……………………………………………………………………………………………...NDC 0078-0337-05Unit Dose (blister pack)Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0337-06600 mg Film-Coated Tablets:Bottle of 100……………………………………………………………………………………………...NDC 0078-0457-05Unit Dose (blister pack)Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0457-35Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP).Suspension300 mg/5 mL (60 mg/mL) Oral Suspension:Bottle containing 250 mL of oral suspension……………………………………………………………NDC 0078-0357-52Store TRILEPTAL oral suspension in the original container. Shake well before using.Use within 7 weeks of first opening the bottle.Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Tablets150 mg Film-Coated Tablets:Bottle of 100……………………………………………………………………………………………...NDC 0078-0456-05Unit Dose (blister pack)Box of 100 (strips of 10)………………………………………………………………………………....NDC 0078-0456-35300 mg Film-Coated Tablets:  Bottle of 100……………………………………………………………………………………………...NDC 0078-0337-05Unit Dose (blister pack)Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0337-06600 mg Film-Coated Tablets:Bottle of 100……………………………………………………………………………………………...NDC 0078-0457-05Unit Dose (blister pack)Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0457-35Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP).Suspension300 mg/5 mL (60 mg/mL) Oral Suspension:Bottle containing 250 mL of oral suspension……………………………………………………………NDC 0078-0357-52Store TRILEPTAL oral suspension in the original container. Shake well before using.Use within 7 weeks of first opening the bottle.Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Tablets150 mg Film-Coated Tablets:Bottle of 100……………………………………………………………………………………………...NDC 0078-0456-05Unit Dose (blister pack)Box of 100 (strips of 10)………………………………………………………………………………....NDC 0078-0456-35300 mg Film-Coated Tablets:  Bottle of 100……………………………………………………………………………………………...NDC 0078-0337-05Unit Dose (blister pack)Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0337-06600 mg Film-Coated Tablets:Bottle of 100……………………………………………………………………………………………...NDC 0078-0457-05Unit Dose (blister pack)Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0457-35Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP).Suspension300 mg/5 mL (60 mg/mL) Oral Suspension:Bottle containing 250 mL of oral suspension……………………………………………………………NDC 0078-0357-52Store TRILEPTAL oral suspension in the original container. Shake well before using.Use within 7 weeks of first opening the bottle.Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Tablets150 mg Film-Coated Tablets:Bottle of 100……………………………………………………………………………………………...NDC 0078-0456-05Unit Dose (blister pack)Box of 100 (strips of 10)………………………………………………………………………………....NDC 0078-0456-35300 mg Film-Coated Tablets:  Bottle of 100……………………………………………………………………………………………...NDC 0078-0337-05Unit Dose (blister pack)Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0337-06600 mg Film-Coated Tablets:Bottle of 100……………………………………………………………………………………………...NDC 0078-0457-05Unit Dose (blister pack)Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0457-35Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP).Suspension300 mg/5 mL (60 mg/mL) Oral Suspension:Bottle containing 250 mL of oral suspension……………………………………………………………NDC 0078-0357-52Store TRILEPTAL oral suspension in the original container. Shake well before using.Use within 7 weeks of first opening the bottle.Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Tablets150 mg Film-Coated Tablets:Bottle of 100……………………………………………………………………………………………...NDC 0078-0456-05Unit Dose (blister pack)Box of 100 (strips of 10)………………………………………………………………………………....NDC 0078-0456-35300 mg Film-Coated Tablets:  Bottle of 100……………………………………………………………………………………………...NDC 0078-0337-05Unit Dose (blister pack)Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0337-06600 mg Film-Coated Tablets:Bottle of 100……………………………………………………………………………………………...NDC 0078-0457-05Unit Dose (blister pack)Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0457-35Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP).Suspension300 mg/5 mL (60 mg/mL) Oral Suspension:Bottle containing 250 mL of oral suspension……………………………………………………………NDC 0078-0357-52Store TRILEPTAL oral suspension in the original container. Shake well before using.Use within 7 weeks of first opening the bottle.Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Tablets150 mg Film-Coated Tablets:Bottle of 100……………………………………………………………………………………………...NDC 0078-0456-05Unit Dose (blister pack)Box of 100 (strips of 10)………………………………………………………………………………....NDC 0078-0456-35300 mg Film-Coated Tablets:  Bottle of 100……………………………………………………………………………………………...NDC 0078-0337-05Unit Dose (blister pack)Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0337-06600 mg Film-Coated Tablets:Bottle of 100……………………………………………………………………………………………...NDC 0078-0457-05Unit Dose (blister pack)Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0457-35Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP).Suspension300 mg/5 mL (60 mg/mL) Oral Suspension:Bottle containing 250 mL of oral suspension……………………………………………………………NDC 0078-0357-52Store TRILEPTAL oral suspension in the original container. Shake well before using.Use within 7 weeks of first opening the bottle.Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Tablets150 mg Film-Coated Tablets:Bottle of 100……………………………………………………………………………………………...NDC 0078-0456-05Unit Dose (blister pack)Box of 100 (strips of 10)………………………………………………………………………………....NDC 0078-0456-35300 mg Film-Coated Tablets:  Bottle of 100……………………………………………………………………………………………...NDC 0078-0337-05Unit Dose (blister pack)Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0337-06600 mg Film-Coated Tablets:Bottle of 100……………………………………………………………………………………………...NDC 0078-0457-05Unit Dose (blister pack)Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0457-35Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP).Suspension300 mg/5 mL (60 mg/mL) Oral Suspension:Bottle containing 250 mL of oral suspension……………………………………………………………NDC 0078-0357-52Store TRILEPTAL oral suspension in the original container. Shake well before using.Use within 7 weeks of first opening the bottle.Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Tablets150 mg Film-Coated Tablets:Bottle of 100……………………………………………………………………………………………...NDC 0078-0456-05Unit Dose (blister pack)Box of 100 (strips of 10)………………………………………………………………………………....NDC 0078-0456-35300 mg Film-Coated Tablets:  Bottle of 100……………………………………………………………………………………………...NDC 0078-0337-05Unit Dose (blister pack)Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0337-06600 mg Film-Coated Tablets:Bottle of 100……………………………………………………………………………………………...NDC 0078-0457-05Unit Dose (blister pack)Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0457-35Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP).Suspension300 mg/5 mL (60 mg/mL) Oral Suspension:Bottle containing 250 mL of oral suspension……………………………………………………………NDC 0078-0357-52Store TRILEPTAL oral suspension in the original container. Shake well before using.Use within 7 weeks of first opening the bottle.Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Tablets150 mg Film-Coated Tablets:Bottle of 100……………………………………………………………………………………………...NDC 0078-0456-05Unit Dose (blister pack)Box of 100 (strips of 10)………………………………………………………………………………....NDC 0078-0456-35300 mg Film-Coated Tablets:  Bottle of 100……………………………………………………………………………………………...NDC 0078-0337-05Unit Dose (blister pack)Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0337-06600 mg Film-Coated Tablets:Bottle of 100……………………………………………………………………………………………...NDC 0078-0457-05Unit Dose (blister pack)Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0457-35Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP).Suspension300 mg/5 mL (60 mg/mL) Oral Suspension:Bottle containing 250 mL of oral suspension……………………………………………………………NDC 0078-0357-52Store TRILEPTAL oral suspension in the original container. Shake well before using.Use within 7 weeks of first opening the bottle.Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Tablets150 mg Film-Coated Tablets:Bottle of 100……………………………………………………………………………………………...NDC 0078-0456-05Unit Dose (blister pack)Box of 100 (strips of 10)………………………………………………………………………………....NDC 0078-0456-35300 mg Film-Coated Tablets:  Bottle of 100……………………………………………………………………………………………...NDC 0078-0337-05Unit Dose (blister pack)Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0337-06600 mg Film-Coated Tablets:Bottle of 100……………………………………………………………………………………………...NDC 0078-0457-05Unit Dose (blister pack)Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0457-35Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP).Suspension300 mg/5 mL (60 mg/mL) Oral Suspension:Bottle containing 250 mL of oral suspension……………………………………………………………NDC 0078-0357-52Store TRILEPTAL oral suspension in the original container. Shake well before using.Use within 7 weeks of first opening the bottle.Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Tablets150 mg Film-Coated Tablets:Bottle of 100……………………………………………………………………………………………...NDC 0078-0456-05Unit Dose (blister pack)Box of 100 (strips of 10)………………………………………………………………………………....NDC 0078-0456-35300 mg Film-Coated Tablets:  Bottle of 100……………………………………………………………………………………………...NDC 0078-0337-05Unit Dose (blister pack)Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0337-06600 mg Film-Coated Tablets:Bottle of 100……………………………………………………………………………………………...NDC 0078-0457-05Unit Dose (blister pack)Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0457-35Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP).Suspension300 mg/5 mL (60 mg/mL) Oral Suspension:Bottle containing 250 mL of oral suspension……………………………………………………………NDC 0078-0357-52Store TRILEPTAL oral suspension in the original container. Shake well before using.Use within 7 weeks of first opening the bottle.Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Tablets150 mg Film-Coated Tablets:Bottle of 100……………………………………………………………………………………………...NDC 0078-0456-05Unit Dose (blister pack)Box of 100 (strips of 10)………………………………………………………………………………....NDC 0078-0456-35300 mg Film-Coated Tablets:  Bottle of 100……………………………………………………………………………………………...NDC 0078-0337-05Unit Dose (blister pack)Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0337-06600 mg Film-Coated Tablets:Bottle of 100……………………………………………………………………………………………...NDC 0078-0457-05Unit Dose (blister pack)Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0457-35Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP).Suspension300 mg/5 mL (60 mg/mL) Oral Suspension:Bottle containing 250 mL of oral suspension……………………………………………………………NDC 0078-0357-52Store TRILEPTAL oral suspension in the original container. Shake well before using.Use within 7 weeks of first opening the bottle.Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Tablets150 mg Film-Coated Tablets:Bottle of 100……………………………………………………………………………………………...NDC 0078-0456-05Unit Dose (blister pack)Box of 100 (strips of 10)………………………………………………………………………………....NDC 0078-0456-35300 mg Film-Coated Tablets:  Bottle of 100……………………………………………………………………………………………...NDC 0078-0337-05Unit Dose (blister pack)Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0337-06600 mg Film-Coated Tablets:Bottle of 100……………………………………………………………………………………………...NDC 0078-0457-05Unit Dose (blister pack)Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0457-35Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP).Suspension300 mg/5 mL (60 mg/mL) Oral Suspension:Bottle containing 250 mL of oral suspension……………………………………………………………NDC 0078-0357-52Store TRILEPTAL oral suspension in the original container. Shake well before using.Use within 7 weeks of first opening the bottle.Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Tablets150 mg Film-Coated Tablets:Bottle of 100……………………………………………………………………………………………...NDC 0078-0456-05Unit Dose (blister pack)Box of 100 (strips of 10)………………………………………………………………………………....NDC 0078-0456-35300 mg Film-Coated Tablets:  Bottle of 100……………………………………………………………………………………………...NDC 0078-0337-05Unit Dose (blister pack)Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0337-06600 mg Film-Coated Tablets:Bottle of 100……………………………………………………………………………………………...NDC 0078-0457-05Unit Dose (blister pack)Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0457-35Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP).Suspension300 mg/5 mL (60 mg/mL) Oral Suspension:Bottle containing 250 mL of oral suspension……………………………………………………………NDC 0078-0357-52Store TRILEPTAL oral suspension in the original container. Shake well before using.Use within 7 weeks of first opening the bottle.Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Tablets150 mg Film-Coated Tablets:Bottle of 100……………………………………………………………………………………………...NDC 0078-0456-05Unit Dose (blister pack)Box of 100 (strips of 10)………………………………………………………………………………....NDC 0078-0456-35300 mg Film-Coated Tablets:  Bottle of 100……………………………………………………………………………………………...NDC 0078-0337-05Unit Dose (blister pack)Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0337-06600 mg Film-Coated Tablets:Bottle of 100……………………………………………………………………………………………...NDC 0078-0457-05Unit Dose (blister pack)Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0457-35Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP).Suspension300 mg/5 mL (60 mg/mL) Oral Suspension:Bottle containing 250 mL of oral suspension……………………………………………………………NDC 0078-0357-52Store TRILEPTAL oral suspension in the original container. Shake well before using.Use within 7 weeks of first opening the bottle.Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Tablets150 mg Film-Coated Tablets:Bottle of 100……………………………………………………………………………………………...NDC 0078-0456-05Unit Dose (blister pack)Box of 100 (strips of 10)………………………………………………………………………………....NDC 0078-0456-35300 mg Film-Coated Tablets:  Bottle of 100……………………………………………………………………………………………...NDC 0078-0337-05Unit Dose (blister pack)Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0337-06600 mg Film-Coated Tablets:Bottle of 100……………………………………………………………………………………………...NDC 0078-0457-05Unit Dose (blister pack)Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0457-35Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP).Suspension300 mg/5 mL (60 mg/mL) Oral Suspension:Bottle containing 250 mL of oral suspension……………………………………………………………NDC 0078-0357-52Store TRILEPTAL oral suspension in the original container. Shake well before using.Use within 7 weeks of first opening the bottle.Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Tablets150 mg Film-Coated Tablets:Bottle of 100……………………………………………………………………………………………...NDC 0078-0456-05Unit Dose (blister pack)Box of 100 (strips of 10)………………………………………………………………………………....NDC 0078-0456-35300 mg Film-Coated Tablets:  Bottle of 100……………………………………………………………………………………………...NDC 0078-0337-05Unit Dose (blister pack)Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0337-06600 mg Film-Coated Tablets:Bottle of 100……………………………………………………………………………………………...NDC 0078-0457-05Unit Dose (blister pack)Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0457-35Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP).Suspension300 mg/5 mL (60 mg/mL) Oral Suspension:Bottle containing 250 mL of oral suspension……………………………………………………………NDC 0078-0357-52Store TRILEPTAL oral suspension in the original container. Shake well before using.Use within 7 weeks of first opening the bottle.Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].


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Clinical Information

Chemical Structure

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Clinical Pharmacology

The pharmacological activity of TRILEPTAL is primarily exerted through the 10-monohydroxy metabolite (MHD) of oxcarbazepine []. The precise mechanism by which oxcarbazepine and MHD exert their anti-seizure 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.

Non-Clinical Toxicology
TRILEPTAL is contraindicated in patients with a known hypersensitivity to oxcarbazepine or to any of its components, or to eslicarbazepine acetate [].

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Array

Clinically significant hyponatremia (sodium <125 mmol/L) can develop during TRILEPTAL use. In the 14 controlled epilepsy studies 2.5% of TRILEPTAL-treated patients (38/1,524) had a sodium of less than 125 mmol/L at some point during treatment, compared to no such patients assigned placebo or active control (carbamazepine and phenobarbital for adjunctive and monotherapy substitution studies, and phenytoin and valproate for the monotherapy initiation studies). Clinically significant hyponatremia generally occurred during the first 3 months of treatment with TRILEPTAL, although there were patients who first developed a serum sodium <125 mmol/L more than 1 year after initiation of therapy. Most patients who developed hyponatremia were asymptomatic but patients in the clinical trials were frequently monitored and some had their TRILEPTAL dose reduced, discontinued, or had their fluid intake restricted for hyponatremia. Whether or not these maneuvers prevented the occurrence of more severe events is unknown. Cases of symptomatic hyponatremia and syndrome of inappropriate antidiuretic hormone secretion (SIADH) have been reported during postmarketing use. In clinical trials, patients whose treatment with TRILEPTAL was discontinued due to hyponatremia generally experienced normalization of serum sodium within a few days without additional treatment.

Measurement of serum sodium levels should be considered for patients during maintenance treatment with TRILEPTAL, particularly if the patient is receiving other medications known to decrease serum sodium levels (e.g., drugs associated with inappropriate ADH secretion) or if symptoms possibly indicating hyponatremia develop (e.g., nausea, malaise, headache, lethargy, confusion, obtundation, or increase in seizure frequency or severity).

The following serious adverse reactions are described below and elsewhere in the labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).