Rufinamide 400 mg Oral Film-Coated Tablet, 120 Tablets/Bottle

Rufinamide — 400MG, Film-coated tablet, bottle of 120 tablets

Rufinamide is a film-coated tablet for oral use. Rufinamide tablets are indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults. Rufinamide tablets are indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in pediatric patients 1 year of age and older, and in adults ( 1 )

• Active ingredient or product type: RUFINAMIDE
• Strength/concentration: 400MG
• Dosage form and route: Film-coated tablet, Oral
• Exact package presentation: bottle of 120 tablets
• NDC/item number: 68462-714-08
• Manufacturer: GLENMARK PHARM
• Storage/handling: Store the tablets at 20°C to 25°C (68°F to 77°F); excursions permitted to 15ºC to 30°C (59ºF to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.
• Status: Rx only

Important safety information: • Monitor patients for new or worsening depression, suicidal thoughts/behavior, and unusual changes in mood or behavior ( 5.1 ) • Central nervous system reactions can occur ( 5.2 ) • Use caution when administering rufinamide with other drugs that shorten the QT interval ( 5.3 ) • Discontinue rufinamide if multi-organ hypersensitivity reaction occurs ( 5.4 ) • Withdraw rufinamide gradually to minimize the risk of precipitating seizures, seizure exacerbation, or status epilepticus ( 5.5 ) 5.1 Suic

Refer to the current product labeling for complete indications, preparation or administration instructions, contraindications, warnings, precautions, and storage requirements.