MedPath
FDA Approval

Nitroglycerin In Dextrose

Baxter Healthcare Company (DUNS: 005083209)

August 22, 2016

HUMAN PRESCRIPTION DRUG LABEL

Nitroglycerin(40 mg in 100 mL)

Manufacturing Establishments (1)

Baxter Healthcare Corporation

Baxter Healthcare Company

194684502

Products (3)

Nitroglycerin In Dextrose

0338-1051

NDA019970

NDA (C73594)

INTRAVENOUS

August 22, 2016

ALCOHOLInactive
Code: 3K9958V90MClass: IACTQuantity: 0.84 mL in 100 mL
Code: G59M7S0WS3Class: ACTIBQuantity: 40 mg in 100 mL
DEXTROSE MONOHYDRATEInactive
Code: LX22YL083GClass: IACTQuantity: 5 g in 100 mL
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACTQuantity: 105 mg in 100 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT

Nitroglycerin In Dextrose

0338-1047

NDA019970

NDA (C73594)

INTRAVENOUS

August 22, 2016

HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
Code: G59M7S0WS3Class: ACTIBQuantity: 10 mg in 100 mL
DEXTROSE MONOHYDRATEInactive
Code: LX22YL083GClass: IACTQuantity: 5 g in 100 mL
ALCOHOLInactive
Code: 3K9958V90MClass: IACTQuantity: 0.84 mL in 100 mL
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACTQuantity: 105 mg in 100 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT

Nitroglycerin In Dextrose

0338-1049

NDA019970

NDA (C73594)

INTRAVENOUS

August 22, 2016

Code: G59M7S0WS3Class: ACTIBQuantity: 20 mg in 100 mL
DEXTROSE MONOHYDRATEInactive
Code: LX22YL083GClass: IACTQuantity: 5 g in 100 mL
ALCOHOLInactive
Code: 3K9958V90MClass: IACTQuantity: 0.84 mL in 100 mL
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACTQuantity: 105 mg in 100 mL
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT

Drug Labeling Information

DESCRIPTION SECTION

DESCRIPTION

Nitroglycerin is 1,2,3-propanetriol trinitrate, an organic nitrate whose structural formula is

Nitroglycerin Structural Formula

whose empiric formula is C3H5N3O9, and whose molecular weight is 227.09. The organic nitrates are vasodilators, active on both arteries and veins.

Dextrose (Dextrose Hydrous, USP) is D-glucose monohydrate, a hexose sugar whose structural formula is

Dextrose Structural Formula

whose empiric formula is C6H12O6 • H2O, and whose molecular weight is 198.17.

Dextrose is derived from corn.

Nitroglycerin in 5% Dextrose Injection is a sterile, nonpyrogenic solution of nitroglycerin and dextrose in water for injection. The solution is clear and practically colorless. Each 100 mL contains 10 mg, 20 mg, or 40 mg nitroglycerin (added as Diluted Nitroglycerin, USP with propylene glycol); 5 g Dextrose Hydrous, USP; 0.84 mL Alcohol, USP (added as a dissolution aid); and 105 mg Citric Acid Hydrous, USP (added as a buffer). The pH of the solution is adjusted with sodium hydroxide and, if necessary, hydrochloric acid.

Although dry nitroglycerin is explosive, nitroglycerin in 5% dextrose is not.

Composition, osmolarity and pH are given in Table 1.

  • Normal physiologic osmolarity range is approximately 280 to 310 mOsmol/L. Administration of substantially hypertonic solutions (≥600 mOsmol/L) may cause vein damage.

Table 1

Composition

*Osmolarity
(mOsmol/L)
(calc)

pH

Nitroglycerin
(mcg/mL)

Dextrose
Hydrous, USP
(g/L)

25 mg Nitroglycerin
in 5% Dextrose Injection

100

50

428

4.0

(3.0 to 5.0)

50 mg Nitroglycerin
in 5% Dextrose Injection

200

50

440

4.0

(3.0 to 5.0)

100 mg Nitroglycerin
in 5% Dextrose Injection

400

50

465

4.0

(3.0 to 5.0)


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