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    • Theophylline 5% Dextrose Injection Viaflex

    DRUG DESCRIPTION

    Theophylline in 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution of Theophylline, Anhydrous, USP in 5% Dextrose Injection. It contains no antimicrobial agents. 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 Hydrous, USP has the chemical name D-Glucose monohydrate and is represented by the following structural formula:

    Theophylline in 5% Dextrose Injection, USP is intended for intravenous administration. Composition, osmolarity, pH and caloric content are shown in Table I.

    Table I.

      Size (mL) Composition Osmolarity* (mOsmol/L) (calc) pH Caloric Content (kcal/L)
    Theophylline Anhydrous, USP (mg/container) Dextrose Hydrous, USP(g/L)
    200 mg Theophyllinein
    5% Dextrose Injection, USP    		 50 200 50 275 4.5(3.5 to 6.5) 170
    100 200 50 263 4.5(3.5 to 6.5) 170
    400 mg Theophylline in 5% Dextrose Injection, USP 100 400 50 275 4.5 (3.5 to 6.5) 170
    250 400 50 261 4.5 (3.5 to 6.5) 170
    500 400 50 257 4.5 (3.5 to 6.5) 170
    1000 400 50 255 4.5 (3.5 to 6.5) 170
    800 mg Theophylline in 5% Dextrose Injection, USP 250 800 50 270 4.5 (3.5 to 6.5) 170
    500 800 50 261 4.5 (3.5 to 6.5) 170
    1000 800 50 257 4.5 (3.5 to 6.5) 170
    *Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions ( ? 600 mOsmol/L) may cause vein damage.

    This VIAFLEX Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). VIAFLEX Plus on the container indicates the presence of a drug additive in a drug vehicle. The VIAFLEX Plus plastic container system utilizes the same container as the VIAFLEX plastic container system. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety 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.



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