Ticarcillin clavulanate how supplied

Jump to navigation Jump to search
Ticarcillin/Clavulanate
TIMENTIN® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Overdosage
Dosage and Administration
How Supplied
Labels and Packages

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

How Supplied

  • Each 3.1‑gram vial of TIMENTIN for Injection contains sterile ticarcillin disodium equivalent to 3 grams ticarcillin and sterile clavulanate potassium equivalent to 0.1 gram clavulanic acid.

NDC 0029-6571-26 3.1‑gram Vial.

  • Each 31‑gram Pharmacy Bulk Package of TIMENTIN for Injection contains sterile ticarcillin disodium equivalent to 30 grams ticarcillin and sterile clavulanate potassium equivalent to 1 gram clavulanic acid.

NDC 0029-6579-21 31‑gram Pharmacy Bulk Package.

  • Each 100‑mL single-dose GALAXY Container (PL 2040 Plastic) of TIMENTIN Injection contains ticarcillin disodium equivalent to 3.0 grams ticarcillin and clavulanate potassium equivalent to 0.1 gram clavulanic acid.

NDC 0029-6575-31 100 mL GALAXY Container (PL 2040 Plastic).

3.1-gram Vials and 31-gram Pharmacy Bulk Packages of TIMENTIN for Injection should be stored at or below 25°C (77°F).

GALAXY Containers (PL 2040 Plastic) of TIMENTIN Injection should be stored at or below -20°C (-4°F). Avoid unnecessary handling of containers.

Thawing of Plastic Containers: Thaw frozen container at room temperature 22°C (72°F) or in a refrigerator 4°C (39°F). [Do not force thaw by immersion in water baths or by microwave irradiation.] Check for minute leaks by squeezing container firmly. If leaks are detected discard solution as sterility may be impaired. Do not add supplementary medication.

The container should be visually inspected. Thawed solutions should not be used unless clear; solutions will be light to dark yellow in color. Components of the solution may precipitate in the frozen state and will dissolve upon reaching room temperature with little or no agitation. If, after visual inspection, the solution remains cloudy or if an insoluble precipitate is noted or if any seals or outlet ports are not intact, the container should be discarded.

The thawed solution is stable for 24 hours at room temperature 22°C (72°F) or for 7 days under refrigeration 4°C (39°F).

Do not refreeze.[1]

References

  1. "TIMENTIN (TICARCILLIN DISODIUM AND CLAVULANATE POTASSIUM) INJECTION, POWDER, FOR SOLUTION TIMENTIN (TICARCILLIN DISODIUM AND CLAVULANATE POTASSIUM) INJECTION, SOLUTION [GLAXOSMITHKLINE LLC]". Text " accessdate" ignored (help)

Adapted from the FDA Package Insert.