oxcarbazepine 300 MG Oral Tablet Trileptal
1 INDICATIONS AND USAGE TRILEPTAL is indicated for use as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in adults and as monotherapy in the treatment of partial-onset seizures in pediatric patients aged 4 years and above, and as adjunctive therapy in pediatric patients aged 2 years and above with partial-onset seizures. TRILEPTAL is indicated for: Adults: Monotherapy or adjunctive therapy in the treatment of partial-onset seizures Pediatrics: - Monotherapy in the treatment of partial-onset seizures in children 4-16 years - Adjunctive therapy in the treatment of partial-onset seizures in children 2-16 years ( 1 )
Novartis Pharmaceuticals Corporation
OVAL YELLOW TE TE CG CG
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16 HOW SUPPLIED/STORAGE AND HANDLING Tablets 150 mg film-coated Tablets: pale grey-green, ovaloid, slightly biconvex, scored on both sides. Imprinted with “T/D” on one side and “C/G” on the other side. Bottle of 100……………………………………………………………………………………………...NDC 0078-0456-05 Unit Dose (blister pack) Box of 100 (strips of 10)………………………………………………………………………………....NDC 0078-0456-35 300 mg film-coated Tablets: yellow, ovaloid, slightly biconvex, scored on both sides. Imprinted with “TE/TE” on one side and “CG/CG” on the other side. Bottle of 100……………………………………………………………………………………………...NDC 0078-0337-05 Unit Dose (blister pack) Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0337-06 600 mg film-coated Tablets: light pink, ovaloid, slightly biconvex, scored on both sides. Imprinted with “TF/TF” on one side and “CG/CG” on the other side. Bottle of 100……………………………………………………………………………………………...NDC 0078-0457-05 Unit Dose (blister pack) Box of 100 (strips of 10)…………………………………………………………………………………NDC 0078-0457-35 Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Dispense in tight container (USP). Suspension 300 mg/5 mL (60 mg/mL) Oral Suspension: off-white to slightly brown or slightly red suspension. Available in amber glass bottles containing 250 mL of oral suspension. Supplied with a 10 mL dosing syringe and press-in bottle adapter. Bottle containing 250 mL of oral suspension……………………………………………………………NDC 0078-0357-52 Store TRILEPTAL oral suspension in the original container. Shake well before using. Use within 7 weeks of first opening the bottle. Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].
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