Telbivudine how supplied

Telbivudine
TYZEKA® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Overdosage
Clinical Studies
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Sheng Shi, M.D. [2]

How Supplied

Tablets

Tyzeka 600 mg tablets are white to slightly yellowish film-coated, ovaloid-shaped tablets, imprinted with “LDT” on one side.

Bottle of 30 tablets (NDC 0078-0538-15) with child-resistant closure.

Store Tyzeka tablets in original container at 25ºC (77ºF), excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature].

Oral Solution

Tyzeka (telbivudine) oral solution is a clear, colorless to pale yellow, passion fruit flavored liquid. Tyzeka oral solution contains 100 mg of telbivudine per 5 milliliters.

Bottle containing 300 mL oral solution (NDC 0078-0539-85) with child-resistant closure and embossed dosing cup. The dosing cup is intended for measurement of Tyzeka oral solution only.

Store Tyzeka oral solution in original container at 25ºC (77ºF), excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature]. Use within two months after opening the bottle. Do not freeze.

For all medical inquiries call: 1-877-8-Tyzeka (1-877-889-9352).

Keep this and all drugs out of the reach of children.

References

Adapted from the FDA Package Insert.