Entecavir how supplied

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

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

How Supplied

BARACLUDE® (entecavir) Tablets and Oral Solution are available in the following strengths and configurations of plastic bottles with child-resistant closures:

BARACLUDE Oral Solution is a ready-to-use product; dilution or mixing with water or any other solvent or liquid product is not recommended. Each bottle of the oral solution is accompanied by a dosing spoon that is calibrated in 1 mL increments up to 10 mL [see Patient Counseling Information (17.1)].

Storage

BARACLUDE Tablets should be stored in a tightly closed container at 25° C (77° F); excursions permitted between 15–30° C (59–86° F) [see USP Controlled Room Temperature].

BARACLUDE Oral Solution should be stored in the outer carton at 25° C (77° F); excursions permitted between 15–30° C (59–86° F) [see USP Controlled Room Temperature]. Protect from light. After opening, the oral solution can be used up to the expiration date on the bottle. The bottle and its contents should be discarded after the expiration date.

References

Adapted from the FDA Package Insert.