iloperidone 12 MG Oral Tablet
1. INDICATIONS AND USAGE Iloperidone tablets are an atypical antipsychotic agent indicated for the treatment of schizophrenia in adults. ( 1 , 14 ) In choosing among treatments, prescribers should consider the ability of iloperidone tablets to prolong the QT interval and the use of other drugs first. Prescribers should also consider the need to titrate iloperidone tablets slowly to avoid orthostatic hypotension, which may lead to delayed effectiveness compared to some other drugs that do not require similar titration. ( 2 , 5 , 14 ) Iloperidone tablets are indicated for the treatment of schizophrenia in adults. When deciding among the alternative treatments available for this condition, the prescriber should consider the finding that iloperidone is associated with prolongation of the QTc interval [see Warnings and Precautions (5.3) ] . Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia which can result in sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether iloperidone tablets will cause torsade de pointes or increase the rate of sudden death is not yet known. Patients must be titrated to an effective dose of iloperidone tablets. Thus, control of symptoms may be delayed during the first 1 to 2 weeks of treatment compared to some other antipsychotic drugs that do not require a similar titration. Prescribers should be mindful of this delay when selecting an antipsychotic drug for the treatment of schizophrenia [see Dosage and Administration (2.1) and Clinical Studies (14) ] .
Mylan Pharmaceuticals Inc.
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16. HOW SUPPLIED/STORAGE AND HANDLING
ILOPERIDONE tablets are white to off-white, round, flat with beveled edges uncoated tablet, debossed with "050", "051", "052", "053", "054", "055", or "056" on one side and plain on other side. Tablets are supplied in the following strengths and package configurations: Package Configuration Tablet Strength ( mg ) NDC Code Bottles of 60 1 mg 0378-0630-91 Bottles of 100 0378-0630-01 Cartons of 100(10x10’s) Unit dose blister 0378-0630-88 Bottles of 60 2 mg 0378-0631-91 Bottles of 100 0378-0631-01 Cartons of 100(10x10’s) Unit dose blister 0378-0631-88 Bottles of 60 4 mg 0378-0632-91 Bottles of 100 0378-0632-01 Cartons of 100(10x10’s) Unit dose blister 0378-0632-88 Bottles of 60 6 mg 0378-0633-91 Bottles of 100 0378-0633-01 Cartons of 100(10x10’s) Unit dose blister 0378-0633-88 Bottles of 60 8 mg 0378-0634-91 Bottles of 100 0378-0634-01 Cartons of 100(10x10’s) Unit dose blister 0378-0634-88 Bottles of 60 10 mg 0378-0635-91 Bottles of 100 0378-0635-01 Cartons of 100(10x10’s) Unit dose blister 0378-0635-88 Bottles of 60 12 mg 0378-0636-91 Bottles of 100 0378-0636-01 Cartons of 100(10x10’s) Unit dose blister 0378-0636-88 Storage : Store
ILOPERIDONE tablets at 25°C (77°F); excursions permitted to 15° to 30 °C (59° to 86°F) [See USP Controlled Room Temperature ]. Protect
ILOPERIDONE tablets from exposure to light and moisture.
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