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Theophylline in 5% Dextrose Injections USP (theophylline in dextrose excel container) are sterile, nonpyrogenic solutions intended for intravenous administration, prepared from theophylline and dextrose in Water for Injection USP.

Composition - Each 100 mL contains

Water for Injection USP, qs

Theophylline is structurally classified as a methylxanthine. It occurs as a white, odorless, crystalline powder with a bitter taste. Anhydrous theophylline has the chemical name 1H-Purine-2, 6-dione, 3,7-dihydro-1, 3-dimethyl-, and is represented by the following structural formula:

The formulas of the active ingredients are:

Theophylline, Anhydrous, USP

Hydrous Dextrose USP

The molecular formula of anhydrous theophylline is C₇H₈N₄O₂ with a molecular weight of 180.17. The molecular formula of hydrous dextrose is C₆H₁₂O₆•H₂O with a molecular weight of 198.17.

The EXCEL Container is Latex-free; PVC-free; and DEHP-free.

The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.

The closure system has two ports; the one for the administration set has a tamper evident plastic protector. Refer to the Directions for Use of the container.

Last reviewed on RxList: 8/28/2008
This monograph has been modified to include the generic and brand name in many instances.