Reviews Theophylline in 5% Dextrose Injection Viaflex


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Theophylline in 5% Dextrose Injection Viaflex Drug Description
THEOPHYLLINE IN DEXTROSE
(theophylline anhydrous) Injection, Solution
USP in Plastic Container
VIAFLEX Plus Container
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:








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.Last reviewed on RxList: 2/10/2009




Theophylline in 5% Dextrose Injection Viaflex Drug Description
THEOPHYLLINE IN DEXTROSE
(theophylline anhydrous) Injection, Solution
USP in Plastic Container
VIAFLEX Plus Container
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:








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.Last reviewed on RxList: 2/10/2009




Theophylline in 5% Dextrose Injection Viaflex Drug Description
THEOPHYLLINE IN DEXTROSE
(theophylline anhydrous) Injection, Solution
USP in Plastic Container
VIAFLEX Plus Container
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:








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.Last reviewed on RxList: 2/10/2009




Theophylline in 5% Dextrose Injection Viaflex Drug Description
THEOPHYLLINE IN DEXTROSE
(theophylline anhydrous) Injection, Solution
USP in Plastic Container
VIAFLEX Plus Container
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:








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.Last reviewed on RxList: 2/10/2009




Theophylline in 5% Dextrose Injection Viaflex Drug Description
THEOPHYLLINE IN DEXTROSE
(theophylline anhydrous) Injection, Solution
USP in Plastic Container
VIAFLEX Plus Container
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:








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.Last reviewed on RxList: 2/10/2009





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