quo; Patients in whom the seizure frequency decreased are shown in the remaining four categories.
Figure 3. Proportion of Patients Exhibiting Different Percent Reductions During the Maintenance Phase Over Baseline in Primary Generalized Tonic-Clonic Seizure Frequency.
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied FYCOMPA Tablets
2 mg are orange, round, biconvex, film-coated tablets debossed with “2” on one side and “Є 275” on the other. They are supplied as follows:
Bottles of 30 NDC 62856-272-30
Bottles of 90 NDC 62856-272-90
4 mg are red, round, biconvex, film-coated tablets debossed with “4” on one side and “Є 277” on the other. They are supplied as follows:
Bottles of 30 NDC 62856-274-30
Bottles of 90 NDC 62856-274-90
6 mg are pink, round, biconvex, film-coated tablets debossed with “6” on one side and “Є 294” on the other. They are supplied as follows:
Bottles of 30 NDC 62856-276-30
Bottles of 90 NDC 62856-276-90
8 mg are purple, round, biconvex, film-coated tablets debossed with “8” on one side and “Є 295” on the other. They are supplied as follows:
Bottles of 30 NDC 62856-278-30
Bottles of 90 NDC 62856-278-90
10 mg are green, round, biconvex, film-coated tablets debossed with “10” on one side and “Є 296” on the other. They are supplied as follows:
Bottles of 30 NDC 62856-280-30
Bottles of 90 NDC 62856-280-90
12 mg are blue, round, biconvex, film-coated tablets debossed with “12” on one side and “Є 297” on the other. They are supplied as follows:
Bottles of 30 NDC 62856-282-30
Bottles of 90 NDC 62856-282-90
FYCOMPA Oral Suspension
0.5 mg/mL is a white to off-white opaque liquid. It is supplied in a round amber PET bottle with a child-resistant closure. It is packaged with a dispenser set that provides two 20-mL graduated oral dosing syringes and a push-in bottle adapter.
Bottle containing 340 mL NDC 62856-290-38
16.2 Storage Tablets: store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]
Oral Suspension: Do not store above 30°C (86°F). Do not freeze. Use within 90 days after the first opening of the bottle.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
Administration of Oral Suspension
Advise patients who are prescribed the oral suspension to shake the bottle well before every administration and to use the adaptor and oral dosing syringe provided. Advise patients that a household teaspoon or tablespoon is not an adequate measuring device. Instruct patients to discard any unused FYCOMPA oral suspension remaining 90 days after first opening the bottle [see Dosag |
