ence
10 OVERDOSAGE
10.1 Signs, Symptoms, and Laboratory Findings
10.2 Management of Overdose
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 Urinary Retention
17.2 Psychiatric Symptoms
17.3 Central Nervous System Effects
17.4 Suicidal Thinking and Behavior
17.5 Pregnancy
--------------------------------------------------------------------------------
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
POTIGA™ is indicated as adjunctive treatment of partial-onset seizures in patients aged 18 years and older.
2 DOSAGE AND ADMINISTRATION
The initial dosage should be 100 mg 3 times daily (300 mg per day). The dosage should be increased gradually at weekly intervals by no more than 50 mg 3 times daily (increase in the daily dose of no more than 150 mg per day) up to a maintenance dosage of 200 mg to 400 mg 3 times daily (600 mg to 1,200 mg per day), based on individual patient response and tolerability. This information is summarized in Table 1 under General Dosing. In the controlled clinical trials, 400 mg 3 times daily showed limited evidence of additional improvement in seizure reduction, but an increase in adverse events and discontinuations, compared to the 300 mg 3 times daily dosage. The safety and efficacy of doses greater than 400 mg 3 times daily (1,200 mg per day) have not been examined in controlled trials.
No adjustment in dosage is required for patients with mild renal or hepatic impairment (see General Dosing, Table 1). Dosage adjustment is required in patients with moderate and greater renal or hepatic impairment (see Dosing in Specific Populations, Table 1).
POTIGA should be given orally in 3 equally divided doses daily, with or without food.
POTIGA Tablets should be swallowed whole.
If POTIGA is discontinued, the dosage should be gradually reduced over a period of at least 3 weeks, unless safety concerns require abrupt withdrawal.
Table 1. Dosing Recommendations Specific Population
Initial Dose
Titration
Maximum Dose
General Dosing
General population (including patients with mild renal or hepatic impairment)
100 mg 3 times daily
(300 mg per day)
Increase by no more than 50 mg 3 times daily, at weekly intervals
400 mg 3 times daily
(1,200 mg per day)
Dosing in Specific Populations
Geriatrics
(patients >65 years)
50 mg 3 times daily
(150 mg per day)
Increase by no more than 50 mg 3 times daily, at weekly intervals
250 mg 3 times daily
(750 mg per day)
Renal impairment
(patients with CrCL <50 mL per min or end-stage renal disease on dialysis)
50 mg 3 times daily
(150 mg per day)
200 mg 3 times daily
(600 mg per day)
Hepatic impairment
(patients with Child-Pugh 7-9)
50 mg 3 times daily
(150 mg per day)
250 mg 3 times daily
(750 mg per day)
Hepatic impairment
(patients with Child-Pugh >9)
50 mg 3 times daily
(150 mg per day)
200 mg 3 times daily
(600 mg per day)
3 DOSAGE FORMS AND STRENGTHS
50 mg, purple, round, film-coated tablets debossed with “RTG 50” on one side.
200 mg, yellow, oblong, film-coated tablets debossed with “RTG-200” on one side.
300 mg, g |
