Drug Information for TIMENTIN (ticarcillin disodium and clavulanate potassium) INJECTIONGALAXY (PL 2040) Plastic Container (Product Package) (GlaxoSmithKline LLC): DESCRIPTION

TIMENTIN is an injectable antibacterial combination consisting of the semisynthetic antibiotic, ticarcillin disodium, and the ß-lactamase inhibitor, clavulanate potassium (the potassium salt of clavulanic acid), for intravenous administration. Ticarcillin is derived from the basic penicillin nucleus, 6-amino-penicillanic acid.

Chemically, ticarcillin disodium is N-(2-Carboxy-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]hept-6-yl)-3-thiophenemalonamic acid disodium salt and may be represented as:

Clavulanic acid is produced by the fermentation of Streptomyces clavuligerus. It is a ß-lactam structurally related to the penicillins and possesses the ability to inactivate a wide variety of ß-lactamases by blocking the active sites of these enzymes. Clavulanic acid is particularly active against the clinically important plasmid-mediated ß-lactamases frequently responsible for transferred drug resistance to penicillins and cephalosporins.

Chemically, clavulanate potassium is potassium (Z)-(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylate and may be represented structurally as:

TIMENTIN is an iso-osmotic, sterile, nonpyrogenic, frozen solution consisting of 3.0 grams ticarcillin as ticarcillin disodium and 0.1 gram clavulanic acid as clavulanate potassium. Approximately 0.3 gram sodium citrate hydrous, USP, is added as a buffer. Sodium hydroxide is used to adjust pH and convert ticarcillin monosodium to ticarcillin disodium. The pH may have been adjusted with hydrochloric acid. The solution is intended for intravenous use after thawing to room temperature. The pH of thawed solution ranges from 5.5 to 7.5.

For the 3.1 gram of TIMENTIN in the GALAXY^® (PL 2040) Plastic Container, the theoretical total sodium content of the 100-mL solution is 18.7 mEq (429 mg), of which 15.6 mEq (359 mg) is contributed by the ticarcillin disodium component of TIMENTIN. The total theoretical potassium content of the 100-mL solution is 0.50 mEq (19.63 mg).

This plastic container is fabricated from a specially designed multilayer plastic (PL 2040). Solutions are in contact with the polyethylene layer of this container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. The suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers, as well as by tissue culture toxicity studies.