DOSAGE AND ADMINISTRATION
The recommended starting dose of Toviaz is 4 mg once daily. Based upon individual response and tolerability, the dose may be increased to 8 mg once daily.
The daily dose of Toviaz should not exceed 4 mg in the following populations:
- Patients with severe renal impairment (CLCR <30 mL/min).
- Patients taking potent CYP3A4 inhibitors, such as ketoconazole, itraconazole and clarithromycin.
Toviaz is not recommended for use in patients with severe hepatic impairment (Child-Pugh C) [ see
WARNINGS AND PRECAUTIONS (5.4, 5.6, 5.7)
,
USE IN SPECIFIC POPULATIONS (8.6, 8.7), and
DRUG INTERACTIONS
].
Toviaz should be taken with liquid and swallowed whole. Toviaz can be administered with or without food, and should not be chewed, divided, or crushed.
DOSAGE FORMS AND STRENGTHS
Toviaz (fesoterodine fumarate) extended-release tablets 4 mg are light blue, oval, biconvex, film-coated and engraved with "FS" on one side.
Toviaz (fesoterodine fumarate) extended-release tablets 8 mg are blue, oval, biconvex, film-coated and engraved with "FT" on one side.
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HOW SUPPLIED/STORAGE AND HANDLING
Toviaz (fesoterodine fumarate) extended-release tablets 4 mg are light blue, oval, biconvex, film-coated and engraved with "FS" on one side. They are supplied as follows:
| Bottles of 30 |
NDC 54868-6156-0
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|
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Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture.
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