Theophylline 5% Dextrose Injection Flexible

DRUG DESCRIPTION

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:

Theophylline Structural Formula Illustration

The molecular formula of anhydrous theophylline is C7H8N4O2 with a molecular weight of 180.17.

Dextrose, USP is chemically designated D-glucose, monohydrate (C6H12O6H2O), a hexose sugar freely soluble in water. It has the following structural formula:

The molecular weight is 198.17.

Water for Injection, USP is chemically designated H2O.

Theophylline 200, 400 and 800 mg in 5% Dextrose Injection, USP are sterile, nonpyrogenic solutions of theophylline, anhydrous and dextrose in water for injection. See Table in HOW SUPPLIED for summary of contents and characteristics of these solutions. The solutions contain no bacteriostatic, antimicrobial agent or added buffer and are intended only for use as a single-dose administration. When smaller doses are required, the unused portion should be discarded.

The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain of its chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25C/77F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.



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