THEOPHYLLINE IN DEXTROSE injection solution

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

THEOPHYLLINE ANHYDROUS (UNII: 0I55128JYK) (THEOPHYLLINE ANHYDROUS - UNII:0I55128JYK)

Boleh didapati daripada:

Hospira, Inc.

INN (Nama Antarabangsa):

THEOPHYLLINE ANHYDROUS

Komposisi:

THEOPHYLLINE ANHYDROUS 160 mg in 100 mL

Jenis preskripsi:

PRESCRIPTION DRUG

Status kebenaran:

New Drug Application

Ciri produk

THEOPHYLLINE IN DEXTROSE- THEOPHYLLINE IN DEXTROSE INJECTION, SOLUTION
HOSPIRA, INC.
----------
THEOPHYLLINE 200, 400 AND 800 MG
IN 5% DEXTROSE INJECTION, USP
FLEXIBLE PLASTIC CONTAINER
DO NOT ADMIX WITH OTHER DRUGS
R only
_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:
The molecular formula of anhydrous theophylline is C H N O with a
molecular weight of 180.17.
Dextrose, USP is chemically designated D-glucose, monohydrate (C H O
• H O), a hexose sugar
freely soluble in water. It has the following structural formula:
x
7
8
4
2
6
12
6
2
The molecular weight is 198.17.
Water for Injection, USP is chemically designated H O.
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 25°C/77°F 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 wi