THEOPHYLLINE IN DEXTROSE- theophylline anhydrous and dextrose injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

THEOPHYLLINE ANHYDROUS (UNII: 0I55128JYK) (THEOPHYLLINE ANHYDROUS - UNII:0I55128JYK), DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)

Available from:

B. Braun Medical Inc.

INN (International Name):

THEOPHYLLINE ANHYDROUS

Composition:

THEOPHYLLINE ANHYDROUS 80 mg in 100 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Theophylline in 5% Dextrose Injection USP is indicated as an adjunct to inhaled beta-2 selective agonists and systemically administered corticosteroids for the treatment of acute exacerbations of the symptoms and reversible airflow obstruction associated with asthma and other chronic lung diseases, e.g., emphysema and chronic bronchitis. Theophylline in 5% Dextrose Injection USP is contraindicated in patients with a history of hypersensitivity to theophylline or other components in the product. Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.

Product summary:

Theophylline in 5% Dextrose Injection USP is supplied sterile and nonpyrogenic in EXCEL® Containers. The 500 mL containers are packaged 24 per case. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product. Storage in automated dispensing machines: Brief exposure up to 2 weeks to ultraviolet or fluorescent light does not adversely affect the product labeling legibility; prolonged exposure can cause fading of the red label. Rotate stock frequently.

Authorization status:

New Drug Application

Summary of Product characteristics

THEOPHYLLINE IN DEXTROSE- THEOPHYLLINE ANHYDROUS AND DEXTROSE
INJECTION, SOLUTION
B. BRAUN MEDICAL INC.
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THEOPHYLLINE IN 5% DEXTROSE INJECTION USP
DO NOT ADMIX WITH OTHER DRUGS.
DESCRIPTION
Theophylline in 5% Dextrose Injection USP is sterile, nonpyrogenic
solution intended for intravenous
administration, prepared from theophylline and dextrose in Water for
Injection USP.
COMPOSITION - EACH 100 ML CONTAINS:
SOLUTION
ANHYDROUS
THEOPHYLLINE USP
HYDROUS
DEXTROSE USP
PH
CALCULATED OSMOLARITY
MOS MOL/LITER
Water for Injection USP, qs
0.08% Theophylline in 5%
Dextrose Injection USP
80 mg
5 g
4.7
(3.5–
6.5)
255
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:
The molecular formula of anhydrous theophylline is C H N O with a
molecular weight of 180.17.
The molecular formula of hydrous dextrose is C H O •H O with a
molecular weight of 198.17.
Not made with natural rubber latex, PVC or DEHP.
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.
7
8
4
2
6
12
6
2
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION
Theophylline has two distinct actions in the airways of patients with
reversible ob