Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Dopamine Hydrochloride in 5% Dextrose Injection, USP, is supplied in 250 and 500 mL single-dose flexible plastic containers (the solutions are clear to slightly yellow in appearance) as follows. Each 100 mL contains 5 grams of hydrous dextrose in Water for Injection. Unit of Sale Total Strength/Total Volume (Concentration) NDC 0409-7809-22 Case of 12 single-dose flexible containers 400 mg/250 mL (1,600 mcg/mL) NDC 0409-0042-12 Case of 12 single-dose flexible containers 400 mg/250 mL (1,600 mcg/mL) NDC 0409-7809-24 Case of 12 single-dose flexible containers 800 mg/500 mL (1,600 mcg/mL) NDC 0409-7810-22 Case of 12 single-dose flexible containers 800 mg/250 mL (3,200 mcg/mL) NDC 0409-1858-12 Case of 12 single-dose flexible containers 800 mg/250 mL (3,200 mcg/mL) Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Discard unused portion.; PRINCIPAL DISPLAY PANEL - 250 mL Bag Label - WR-1540 TO OPEN — TEAR AT NOTCH Each 100 mL contains dopamine hydrochloride 160 mg; dextrose, hydrous 5 g in water for injection; sodium metabisulfite added 50 mg. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. 269 mOsmol/liter (calc.) ph 3.8 (2.5 to 4.5). Single-dose container. Discard unused portion. For intravenous use. Usual dosage: see insert. WARNING: CONTAINS SULFITES. Drug additives should not be made to this solution. The overwrap is a moisture and oxygen barrier. Do not remove unit from overwrap until ready for use. Visually inspect overwrap for tears or holes. Discard unit if overwrap is damaged or if solution is darker than slightly yellow or discolored in any other way. Use unit promptly when overwrap is opened. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. See insert. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. Rx only 250 mL NDC 0409-7809-11 DOPAMINE HCl in 5% Dextrose Injection, USP 400 mg/250 mL (1,600 mcg/mL) Single-dose container F WR-1540 Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Hospira PRINCIPAL DISPLAY PANEL - 250 mL Bag Label - WR-1540; PRINCIPAL DISPLAY PANEL - 250 mL Bag Label - IM-4355 250 mL NDC 0409-7809-11 DOPAMINE HCl in 5% Dextrose Injection, USP 400 mg/250 mL (1,600 mcg/mL) EACH 100 mL CONTAINS DOPAMINE HYDROCHLORIDE 160 mg; DEXTROSE, HYDROUS 5 g IN WATER FOR INJECTION; SODIUM METABISULFITE ADDED 50 mg. MAY CONTAIN HYDROCHLORIC ACID AND/OR SODIUM HYDROXIDE FOR pH ADJUSTMENT. 269 mOsmol/LITER (CALC.) pH 3.8 (2.5 to 4.5). SINGLE-DOSE CONTAINER. DISCARD UNUSED PORTION. FOR INTRAVENOUS USE. USUAL DOSAGE: SEE INSERT. WARNING: CONTAINS SULFITES. DRUG ADDITIVES SHOULD NOT BE MADE TO THIS SOLUTION. STERILE NONPYROGENIC. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. MUST NOT BE USED IN SERIES CONNECTIONS. Rx ONLY 7 OTHER Hospira IM-4355 DISTRIBUTED BY HOSPIRA, INC., LAKE FOREST, IL 60045 USA PRINCIPAL DISPLAY PANEL - 250 mL Bag Label - IM-4355; PRINCIPAL DISPLAY PANEL - 500 mL Bag Label - WR-1543 TO OPEN — TEAR AT NOTCH Each 100 mL contains dopamine hydrochloride 160 mg; dextrose, hydrous 5 g in water for injection; sodium metabisulfite added 50 mg. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. 269 mOsmol/liter (calc.) ph 3.8 (2.5 to 4.5). Single-dose container. Discard unused portion. For intravenous use. Usual dosage: see insert. WARNING: CONTAINS SULFITES. Drug additives should not be made to this solution. The overwrap is a moisture and oxygen barrier. Do not remove unit from overwrap until ready for use. Visually inspect overwrap for tears or holes. Discard unit if overwrap is damaged or if solution is darker than slightly yellow or discolored in any other way. Use unit promptly when overwrap is opened. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. See insert. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. Rx only 500 mL NDC 0409-7809-31 DOPAMINE HCl in 5% Dextrose Injection, USP 800 mg/500 mL (1,600 mcg/mL) Single-dose container F WR-1543 Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Hospira PRINCIPAL DISPLAY PANEL - 500 mL Bag Label - WR-1543; PRINCIPAL DISPLAY PANEL - 500 mL Bag Label - IM-4356 500 mL NDC 0409-7809-31 DOPAMINE HCl in 5% Dextrose Injection, USP 800 mg/500 mL (1,600 mcg/mL) EACH 100 mL CONTAINS DOPAMINE HYDROCHLORIDE 160 mg; DEXTROSE, HYDROUS 5 g IN WATER FOR INJECTION; SODIUM METABISULFITE ADDED 50 mg. MAY CONTAIN HYDROCHLORIC ACID AND/OR SODIUM HYDROXIDE FOR pH ADJUSTMENT. 269 mOsmol/LITER (CALC.) pH 3.8 (2.5 to 4.5). SINGLE-DOSE CONTAINER. DISCARD UNUSED PORTION. FOR INTRAVENOUS USE. USUAL DOSAGE: SEE INSERT. WARNING: CONTAINS SULFITES. DRUG ADDITIVES SHOULD NOT BE MADE TO THIS SOLUTION. STERILE NONPYROGENIC. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. MUST NOT BE USED IN SERIES CONNECTIONS. Rx ONLY 7 OTHER Hospira IM-4356 DISTRIBUTED BY HOSPIRA, INC., LAKE FOREST, IL 60045 USA PRINCIPAL DISPLAY PANEL - 500 mL Bag Label - IM-4356; PRINCIPAL DISPLAY PANEL - 250 mL Bag Label - WR-1544 TO OPEN — TEAR AT NOTCH Each 100 mL contains dopamine hydrochloride 320 mg; dextrose, hydrous 5 g in water for injection; sodium metabisulfite added 50 mg. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. 286 mOsmol/liter (calc.) ph 3.8 (2.5 to 4.5). Single-dose container. Discard unused portion. For intravenous use. Usual dosage: see insert. WARNING: CONTAINS SULFITES. Drug additives should not be made to this solution. The overwrap is a moisture and oxygen barrier. Do not remove unit from overwrap until ready for use. Visually inspect overwrap for tears or holes. Discard unit if overwrap is damaged or if solution is darker than slightly yellow or discolored in any other way. Use unit promptly when overwrap is opened. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. See insert. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. Rx only 250 mL NDC 0409-7810-11 DOPAMINE HCl in 5% Dextrose Injection, USP 800 mg/250 mL (3,200 mcg/mL) Single-dose container F WR-1544 Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Hospira PRINCIPAL DISPLAY PANEL - 250 mL Bag Label - WR-1544; PRINCIPAL DISPLAY PANEL - 250 mL Bag Label - IM-4357 250 mL NDC 0409-7810-11 DOPAMINE HCl in 5% Dextrose Injection, USP 800 mg/250 mL (3,200 mcg/mL) EACH 100 mL CONTAINS DOPAMINE HYDROCHLORIDE 320 mg; DEXTROSE, HYDROUS 5 g IN WATER FOR INJECTION; SODIUM METABISULFITE ADDED 50 mg. MAY CONTAIN HYDROCHLORIC ACID AND/OR SODIUM HYDROXIDE FOR pH ADJUSTMENT. 286 mOsmol/LITER (CALC.) pH 3.8 (2.5 to 4.5). SINGLE- DOSE CONTAINER. DISCARD UNUSED PORTION. FOR INTRAVENOUS USE. USUAL DOSAGE: SEE INSERT. WARNING: CONTAINS SULFITES. DRUG ADDITIVES SHOULD NOT BE MADE TO THIS SOLUTION. STERILE NONPYROGENIC. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. MUST NOT BE USED IN SERIES CONNECTIONS. Rx ONLY 7 OTHER IM-4357 Hospira DISTRIBUTED BY HOSPIRA, INC., LAKE FOREST, IL 60045 USA PRINCIPAL DISPLAY PANEL - 250 mL Bag Label - IM-4357; PRINCIPAL DISPLAY PANEL - 250 mL Bag Label -13444-01 TO OPEN — TEAR AT NOTCH Each 100 mL contains dopamine hydrochloride 160 mg; dextrose, hydrous 5 g in water for injection; sodium metabisulfite added 50 mg. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. 269 mOsmol/liter (calc.) pH 2.5 to 4.5 Single-dose container. Discard unused portion. For intravenous use only. Recommended Dosage: See Prescribing Information WARNING: CONTAINS SULFITES. Drug additives should not be made to this solution. The overwrap is a moisture and oxygen barrier. Do not remove unit from overwrap until ready for use. Visually inspect overwrap for tears or holes. Discard unit if overwrap is damaged or if solution is darker than slightly yellow or discolored in any other way. Use unit promptly when overwrap is opened. Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. Not made with natural rubber latex. Rx only 7 OTHER 250 mL NDC 0409-0042-01 DOPAMINE HCl in 5% Dextrose Injection, USP 400 mg/250 mL (1,600 mcg/mL) Single-dose container 13444-01 Hospira Distributed by Hospira, Inc., Lake Forest, IL 60045 USA PRINCIPAL DISPLAY PANEL - 250 mL Bag Label -13444-01; PRINCIPAL DISPLAY PANEL - 250 mL Bag Label-12726-02 250 mL NDC 0409-0042-01 DOPAMINE HCl in 5% Dextrose Injection, USP 400 mg/250 mL (1,600 mcg/mL) Each 100 mL contains dopamine hydrochloride 160 mg; dextrose, hydrous 5 g in water for injection; sodium metabisulfite added 50 mg. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. 269 mOsmol/liter (calc.) pH 2.5 to 4.5 Single-dose container . Discard unused portion . For intravenous use only. Recommended Dosage: See Prescribing Information. Warning: contains sulfites. Drug additives should not be made to this solution. Sterile, nonpyrogenic. Use only if solution is clear and container is undamaged. Not made with natural rubber latex. Rx only 5 OTHER MADE IN GERMANY Hospira Distributed by Hospira, Inc., Lake Forest, IL 60045 USA 12726-02 PRINCIPAL DISPLAY PANEL - 250 mL Bag Label-12726-02; PRINCIPAL DISPLAY PANEL - 250 mL Bag Label -13445-01 TO OPEN — TEAR AT NOTCH Each 100 mL contains dopamine hydrochloride 320mg; dextrose, hydrous 5 g in water for injection; sodium metabisulfite added 50 mg. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. 286 mOsmol/liter (calc.) pH 2.5 to 4.5 Single-dose container. Discard unused portion. For intravenous use only. Recommended Dosage: See Prescribing Information. WARNING: CONTAINS SULFITES. Drug additives should not be made to this solution. The overwrap is a moisture and oxygen barrier. Do not remove unit from overwrap until ready for use. Visually inspect overwrap for tears or holes. Discard unit if overwrap is damaged or if solution is darker than slightly yellow or discolored in any other way. Use unit promptly when overwrap is opened. Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. Not made with natural rubber latex. Rx only 7 OTHER 250 mL NDC 0409-1858-01 DOPAMINE HCl in 5% Dextrose Injection, USP 800 mg/250 mL (3,200 mcg/mL) Single-dose container 13445-01 Hospira Distributed by Hospira, Inc., Lake Forest, IL 60045 USA PRINCIPAL DISPLAY PANEL - 250 mL Bag Label -13445-01; PRINCIPAL DISPLAY PANEL - 250 mL Bag Label-12727-02 250 mL NDC 0409-1858-01 DOPAMINE HCl in 5% Dextrose Injection, USP 800 mg/250 mL (3,200 mcg/mL) Each 100 mL contains dopamine hydrochloride 320 mg; dextrose, hydrous 5 g in water for injection; sodium metabisulfite added 50 mg. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. 286 mOsmol/liter (calc.) pH 2.5 to 4.5 Single-dose container. Discard unused portion . For intravenous use only. Recommended Dosage : See Prescribing Information. Warning: contains sulfites Drug additives should not be made to this solution. Sterile, nonpyrogenic. Use only if solution is clear and container is undamaged. Not made with natural rubber latex . Rx only 5 OTHER MADE IN GERMANY Hospira Distributed by Hospira, Inc., Lake Forest, IL 60045 USA 12727-02 PRINCIPAL DISPLAY PANEL - 250 mL Bag Label-12727-02
- 16 HOW SUPPLIED/STORAGE AND HANDLING Dopamine Hydrochloride in 5% Dextrose Injection, USP, is supplied in 250 and 500 mL single-dose flexible plastic containers (the solutions are clear to slightly yellow in appearance) as follows. Each 100 mL contains 5 grams of hydrous dextrose in Water for Injection. Unit of Sale Total Strength/Total Volume (Concentration) NDC 0409-7809-22 Case of 12 single-dose flexible containers 400 mg/250 mL (1,600 mcg/mL) NDC 0409-0042-12 Case of 12 single-dose flexible containers 400 mg/250 mL (1,600 mcg/mL) NDC 0409-7809-24 Case of 12 single-dose flexible containers 800 mg/500 mL (1,600 mcg/mL) NDC 0409-7810-22 Case of 12 single-dose flexible containers 800 mg/250 mL (3,200 mcg/mL) NDC 0409-1858-12 Case of 12 single-dose flexible containers 800 mg/250 mL (3,200 mcg/mL) Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Discard unused portion.
- PRINCIPAL DISPLAY PANEL - 250 mL Bag Label - WR-1540 TO OPEN — TEAR AT NOTCH Each 100 mL contains dopamine hydrochloride 160 mg; dextrose, hydrous 5 g in water for injection; sodium metabisulfite added 50 mg. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. 269 mOsmol/liter (calc.) ph 3.8 (2.5 to 4.5). Single-dose container. Discard unused portion. For intravenous use. Usual dosage: see insert. WARNING: CONTAINS SULFITES. Drug additives should not be made to this solution. The overwrap is a moisture and oxygen barrier. Do not remove unit from overwrap until ready for use. Visually inspect overwrap for tears or holes. Discard unit if overwrap is damaged or if solution is darker than slightly yellow or discolored in any other way. Use unit promptly when overwrap is opened. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. See insert. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. Rx only 250 mL NDC 0409-7809-11 DOPAMINE HCl in 5% Dextrose Injection, USP 400 mg/250 mL (1,600 mcg/mL) Single-dose container F WR-1540 Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Hospira PRINCIPAL DISPLAY PANEL - 250 mL Bag Label - WR-1540
- PRINCIPAL DISPLAY PANEL - 250 mL Bag Label - IM-4355 250 mL NDC 0409-7809-11 DOPAMINE HCl in 5% Dextrose Injection, USP 400 mg/250 mL (1,600 mcg/mL) EACH 100 mL CONTAINS DOPAMINE HYDROCHLORIDE 160 mg; DEXTROSE, HYDROUS 5 g IN WATER FOR INJECTION; SODIUM METABISULFITE ADDED 50 mg. MAY CONTAIN HYDROCHLORIC ACID AND/OR SODIUM HYDROXIDE FOR pH ADJUSTMENT. 269 mOsmol/LITER (CALC.) pH 3.8 (2.5 to 4.5). SINGLE-DOSE CONTAINER. DISCARD UNUSED PORTION. FOR INTRAVENOUS USE. USUAL DOSAGE: SEE INSERT. WARNING: CONTAINS SULFITES. DRUG ADDITIVES SHOULD NOT BE MADE TO THIS SOLUTION. STERILE NONPYROGENIC. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. MUST NOT BE USED IN SERIES CONNECTIONS. Rx ONLY 7 OTHER Hospira IM-4355 DISTRIBUTED BY HOSPIRA, INC., LAKE FOREST, IL 60045 USA PRINCIPAL DISPLAY PANEL - 250 mL Bag Label - IM-4355
- PRINCIPAL DISPLAY PANEL - 500 mL Bag Label - WR-1543 TO OPEN — TEAR AT NOTCH Each 100 mL contains dopamine hydrochloride 160 mg; dextrose, hydrous 5 g in water for injection; sodium metabisulfite added 50 mg. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. 269 mOsmol/liter (calc.) ph 3.8 (2.5 to 4.5). Single-dose container. Discard unused portion. For intravenous use. Usual dosage: see insert. WARNING: CONTAINS SULFITES. Drug additives should not be made to this solution. The overwrap is a moisture and oxygen barrier. Do not remove unit from overwrap until ready for use. Visually inspect overwrap for tears or holes. Discard unit if overwrap is damaged or if solution is darker than slightly yellow or discolored in any other way. Use unit promptly when overwrap is opened. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. See insert. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. Rx only 500 mL NDC 0409-7809-31 DOPAMINE HCl in 5% Dextrose Injection, USP 800 mg/500 mL (1,600 mcg/mL) Single-dose container F WR-1543 Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Hospira PRINCIPAL DISPLAY PANEL - 500 mL Bag Label - WR-1543
- PRINCIPAL DISPLAY PANEL - 500 mL Bag Label - IM-4356 500 mL NDC 0409-7809-31 DOPAMINE HCl in 5% Dextrose Injection, USP 800 mg/500 mL (1,600 mcg/mL) EACH 100 mL CONTAINS DOPAMINE HYDROCHLORIDE 160 mg; DEXTROSE, HYDROUS 5 g IN WATER FOR INJECTION; SODIUM METABISULFITE ADDED 50 mg. MAY CONTAIN HYDROCHLORIC ACID AND/OR SODIUM HYDROXIDE FOR pH ADJUSTMENT. 269 mOsmol/LITER (CALC.) pH 3.8 (2.5 to 4.5). SINGLE-DOSE CONTAINER. DISCARD UNUSED PORTION. FOR INTRAVENOUS USE. USUAL DOSAGE: SEE INSERT. WARNING: CONTAINS SULFITES. DRUG ADDITIVES SHOULD NOT BE MADE TO THIS SOLUTION. STERILE NONPYROGENIC. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. MUST NOT BE USED IN SERIES CONNECTIONS. Rx ONLY 7 OTHER Hospira IM-4356 DISTRIBUTED BY HOSPIRA, INC., LAKE FOREST, IL 60045 USA PRINCIPAL DISPLAY PANEL - 500 mL Bag Label - IM-4356
- PRINCIPAL DISPLAY PANEL - 250 mL Bag Label - WR-1544 TO OPEN — TEAR AT NOTCH Each 100 mL contains dopamine hydrochloride 320 mg; dextrose, hydrous 5 g in water for injection; sodium metabisulfite added 50 mg. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. 286 mOsmol/liter (calc.) ph 3.8 (2.5 to 4.5). Single-dose container. Discard unused portion. For intravenous use. Usual dosage: see insert. WARNING: CONTAINS SULFITES. Drug additives should not be made to this solution. The overwrap is a moisture and oxygen barrier. Do not remove unit from overwrap until ready for use. Visually inspect overwrap for tears or holes. Discard unit if overwrap is damaged or if solution is darker than slightly yellow or discolored in any other way. Use unit promptly when overwrap is opened. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. See insert. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. Rx only 250 mL NDC 0409-7810-11 DOPAMINE HCl in 5% Dextrose Injection, USP 800 mg/250 mL (3,200 mcg/mL) Single-dose container F WR-1544 Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Hospira PRINCIPAL DISPLAY PANEL - 250 mL Bag Label - WR-1544
- PRINCIPAL DISPLAY PANEL - 250 mL Bag Label - IM-4357 250 mL NDC 0409-7810-11 DOPAMINE HCl in 5% Dextrose Injection, USP 800 mg/250 mL (3,200 mcg/mL) EACH 100 mL CONTAINS DOPAMINE HYDROCHLORIDE 320 mg; DEXTROSE, HYDROUS 5 g IN WATER FOR INJECTION; SODIUM METABISULFITE ADDED 50 mg. MAY CONTAIN HYDROCHLORIC ACID AND/OR SODIUM HYDROXIDE FOR pH ADJUSTMENT. 286 mOsmol/LITER (CALC.) pH 3.8 (2.5 to 4.5). SINGLE- DOSE CONTAINER. DISCARD UNUSED PORTION. FOR INTRAVENOUS USE. USUAL DOSAGE: SEE INSERT. WARNING: CONTAINS SULFITES. DRUG ADDITIVES SHOULD NOT BE MADE TO THIS SOLUTION. STERILE NONPYROGENIC. USE ONLY IF SOLUTION IS CLEAR AND CONTAINER IS UNDAMAGED. MUST NOT BE USED IN SERIES CONNECTIONS. Rx ONLY 7 OTHER IM-4357 Hospira DISTRIBUTED BY HOSPIRA, INC., LAKE FOREST, IL 60045 USA PRINCIPAL DISPLAY PANEL - 250 mL Bag Label - IM-4357
- PRINCIPAL DISPLAY PANEL - 250 mL Bag Label -13444-01 TO OPEN — TEAR AT NOTCH Each 100 mL contains dopamine hydrochloride 160 mg; dextrose, hydrous 5 g in water for injection; sodium metabisulfite added 50 mg. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. 269 mOsmol/liter (calc.) pH 2.5 to 4.5 Single-dose container. Discard unused portion. For intravenous use only. Recommended Dosage: See Prescribing Information WARNING: CONTAINS SULFITES. Drug additives should not be made to this solution. The overwrap is a moisture and oxygen barrier. Do not remove unit from overwrap until ready for use. Visually inspect overwrap for tears or holes. Discard unit if overwrap is damaged or if solution is darker than slightly yellow or discolored in any other way. Use unit promptly when overwrap is opened. Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. Not made with natural rubber latex. Rx only 7 OTHER 250 mL NDC 0409-0042-01 DOPAMINE HCl in 5% Dextrose Injection, USP 400 mg/250 mL (1,600 mcg/mL) Single-dose container 13444-01 Hospira Distributed by Hospira, Inc., Lake Forest, IL 60045 USA PRINCIPAL DISPLAY PANEL - 250 mL Bag Label -13444-01
- PRINCIPAL DISPLAY PANEL - 250 mL Bag Label-12726-02 250 mL NDC 0409-0042-01 DOPAMINE HCl in 5% Dextrose Injection, USP 400 mg/250 mL (1,600 mcg/mL) Each 100 mL contains dopamine hydrochloride 160 mg; dextrose, hydrous 5 g in water for injection; sodium metabisulfite added 50 mg. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. 269 mOsmol/liter (calc.) pH 2.5 to 4.5 Single-dose container . Discard unused portion . For intravenous use only. Recommended Dosage: See Prescribing Information. Warning: contains sulfites. Drug additives should not be made to this solution. Sterile, nonpyrogenic. Use only if solution is clear and container is undamaged. Not made with natural rubber latex. Rx only 5 OTHER MADE IN GERMANY Hospira Distributed by Hospira, Inc., Lake Forest, IL 60045 USA 12726-02 PRINCIPAL DISPLAY PANEL - 250 mL Bag Label-12726-02
- PRINCIPAL DISPLAY PANEL - 250 mL Bag Label -13445-01 TO OPEN — TEAR AT NOTCH Each 100 mL contains dopamine hydrochloride 320mg; dextrose, hydrous 5 g in water for injection; sodium metabisulfite added 50 mg. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. 286 mOsmol/liter (calc.) pH 2.5 to 4.5 Single-dose container. Discard unused portion. For intravenous use only. Recommended Dosage: See Prescribing Information. WARNING: CONTAINS SULFITES. Drug additives should not be made to this solution. The overwrap is a moisture and oxygen barrier. Do not remove unit from overwrap until ready for use. Visually inspect overwrap for tears or holes. Discard unit if overwrap is damaged or if solution is darker than slightly yellow or discolored in any other way. Use unit promptly when overwrap is opened. Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. After removing the overwrap, check for minute leaks by squeezing container firmly. If leaks are found, discard solution as sterility may be impaired. Not made with natural rubber latex. Rx only 7 OTHER 250 mL NDC 0409-1858-01 DOPAMINE HCl in 5% Dextrose Injection, USP 800 mg/250 mL (3,200 mcg/mL) Single-dose container 13445-01 Hospira Distributed by Hospira, Inc., Lake Forest, IL 60045 USA PRINCIPAL DISPLAY PANEL - 250 mL Bag Label -13445-01
- PRINCIPAL DISPLAY PANEL - 250 mL Bag Label-12727-02 250 mL NDC 0409-1858-01 DOPAMINE HCl in 5% Dextrose Injection, USP 800 mg/250 mL (3,200 mcg/mL) Each 100 mL contains dopamine hydrochloride 320 mg; dextrose, hydrous 5 g in water for injection; sodium metabisulfite added 50 mg. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. 286 mOsmol/liter (calc.) pH 2.5 to 4.5 Single-dose container. Discard unused portion . For intravenous use only. Recommended Dosage : See Prescribing Information. Warning: contains sulfites Drug additives should not be made to this solution. Sterile, nonpyrogenic. Use only if solution is clear and container is undamaged. Not made with natural rubber latex . Rx only 5 OTHER MADE IN GERMANY Hospira Distributed by Hospira, Inc., Lake Forest, IL 60045 USA 12727-02 PRINCIPAL DISPLAY PANEL - 250 mL Bag Label-12727-02
Overview
Dopamine Hydrochloride in 5% Dextrose Injection, USP is a sterile, nonpyrogenic, premixed solution of dopamine hydrochloride in 5% dextrose injection for intravenous infusion. Each 100 mL contains 160 mg (1,600 mcg/mL) or 320 mg (3,200 mcg/mL) of dopamine HCl; 5 grams of hydrous dextrose, in Water for Injection, and 50 mg of sodium metabisulfite (a stabilizer); pH = 2.5 to 4.5, and the following osmolar concentrations: 269, or 286 mOsmol/liter, respectively. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Dopamine HCl is chemically designated 3, 4-dihydroxyphenethylamine hydrochloride (C 8 H 11 NO 2 ∙ HCl), a white crystalline powder freely soluble in water. Dopamine HCl has a molecular weight of 189.64 and it has the following structural formula: Dopamine (also referred to as 3-hydroxytyramine) is a naturally occurring endogenous catecholamine. Dextrose, USP is chemically designated D-glucose monohydrate (C 6 H 12 O 6 ∙ H 2 O), a hexose sugar freely soluble in water. The molecular weight of dextrose (D-glucose) monohydrate is 198.17 and it has the following structural formula: Water for Injection, USP is chemically designated H 2 O. Chemical Structure Chemical Structure
Indications & Usage
Dopamine Hydrochloride in Dextrose Injection is indicated to improve hemodynamic status in patients in distributive shock, or shock due to reduced cardiac output. Dopamine HCl in Dextrose Injection is a catecholamine indicated to improve hemodynamic status in patients in shock. ( 1 )
Dosage & Administration
• Correct hypovolemia, acidosis, and hypoxia prior to use. ( 2.1 ) • Administer in a large vein with an infusion pump preferably in an intensive care setting. ( 2.1 ) • Recommended starting dosage in adults and pediatric patients is 2 to 5 mcg/kg/minute as a continuous intravenous infusion. Titrate in 5 to 10 mcg/kg/minute increments based on hemodynamic response and tolerability, up to not more than 50 mcg/kg/minute. ( 2.2 ) • See the Full Prescribing Information for important preparation instructions and drug incompatibilities. ( 2.3 ) 2.1 Administration Instructions Correct Hypovolemia, Acidosis, and Hypoxia Address hypovolemia, acidosis, and hypoxia before initiating Dopamine HCl in Dextrose Injection. If patient does not respond to therapy, suspect occult hypovolemia. Acidosis may reduce the effectiveness of dopamine [see Warnings and Precautions (5.1) ] . Administration Dopamine HCl in Dextrose Injection is a premixed infusion solution that does not require dilution prior to intravenous administration. Administer Dopamine HCl in Dextrose Injection into a large vein [see Warnings and Precautions (5.1) ] with the use of an infusion pump preferably in an intensive care setting. Remove outer wrap (moisture and oxygen barrier) only when ready to administer the product. Discard product if outer wrap is damaged (e.g., tears or holes). Inspect Dopamine HCl in Dextrose Injection for particulate matter and discoloration prior to administration (the solution is clear to slightly yellow). Do not administer if the solution is darker than slightly yellow or the container is damaged. Use higher concentration premixed solutions (e.g., 3,200 mcg/mL or 1,600 mcg/mL strengths) in patients requiring fluid restriction. Discontinuation When discontinuing Dopamine HCl in Dextrose Injection, gradually reduce the infusion rate while expanding blood volume with intravenous fluids [see Warnings and Precautions (5.3) ]. 2.2 Recommended Dosage The recommended starting dosage in adults and pediatric patients is 2 to 5 mcg/kg/minute as a continuous intravenous infusion [see Dosage and Administration (2.3) ] . Titrate the infusion rate in 5 to 10 mcg/kg/minute increments based on hemodynamic response and tolerability, up to but not more than 50 mcg/kg/minute. Infusion rates may be calculated using the following formula: Infusion Rate (mL/hour) = [Dose (mcg/kg/minute) × Weight (kg) × 60 (minutes/hour)] Concentration (mcg/mL) Example calculations for infusion rates are as follows: Example 1: for a 60 kg person at the recommended initial dose of 2 mcg/kg/minute using a 1,600 mcg/mL concentration, the infusion rate would be as follows: Infusion Rate (mL/hour) = [2 (mcg/kg/minute) × 60 (kg) × 60 (minutes/hour) ] = 4.5 (mL/hour) 1,600 (mcg/mL) Example 2: for a 70 kg person at a dose of 5 mcg/kg/minute using a 3,200 mcg/mL concentration, the infusion rate would be as follows: Infusion Rate (mL/hour) = [5 (mcg/kg/minute) × 70 (kg) × 60 (minutes/hour) ] = 6.56 (mL/hour) 3,200 (mcg/mL) 2.3 Drug Incompatibilities Dopamine HCl in Dextrose Injection is incompatible with the following products; therefore, avoid simultaneous administration (through the same infusion set): • Sodium bicarbonate or other alkalinizing substances, because dopamine is inactivated in alkaline solution. • Blood, because of the risk of pseudoagglutination of red cells • Iron salts Do not add additional medications in the premixed infusion solution.
Warnings & Precautions
• Tissue ischemia : Severe peripheral and visceral vasoconstriction can occur. Address hypovolemia prior to use, monitor extremities, and infuse into large vein. ( 5.1 ) • Cardiac arrhythmias : Monitor closely. ( 5.2 ) • Hypotension after abrupt discontinuation : Gradually reduce infusion rate while expanding blood volume with intravenous fluids. ( 5.3 ) • Severe hypersensitivity reactions due to sodium metabisulfite excipient : May cause anaphylaxis including life-threatening or less severe asthmatic episodes in susceptible individuals. ( 5.4 ) 5.1 Tissue Ischemia Administration of dopamine to patients who are hypotensive from hypovolemia can result in severe peripheral and visceral vasoconstriction, decreased renal perfusion and hypouresis, tissue hypoxia, lactic acidosis, and poor systemic blood flow despite "normal" blood pressure. Address hypovolemia prior to initiating Dopamine HCl in Dextrose Injection [see Dosage and Administration (2.2) ] . Gangrene of the extremities has occurred in patients with occlusive vascular disease or who received prolonged or high dose infusions. Monitor for changes to the skin of the extremities in susceptible patients. Extravasation of Dopamine HCl in Dextrose Injection may cause necrosis and sloughing of surrounding tissue. To reduce the risk of extravasation, infuse into a large vein [see Dosage and Administration (2.1) ] , check the infusion site frequently for free flow, and monitor for signs of extravasation. Emergency Treatment of Extravasation To prevent sloughing and necrosis in areas in which extravasation has occurred, infiltrate the ischemic area as soon as possible, using a syringe with a fine hypodermic needle with: • 5 to 10 mg of phentolamine mesylate in 10 to 15 mL of 0.9% Sodium Chloride Injection in adults • 0.1 to 0.2 mg/kg of phentolamine mesylate up to a maximum of 10 mg per dose in pediatric patients. Sympathetic blockade with phentolamine causes immediate and conspicuous local hyperemic changes if the area is infiltrated within 12 hours. 5.2 Cardiac Arrhythmias Dopamine may cause arrhythmias. Monitor patients with arrhythmias and treat appropriately. 5.3 Hypotension after Abrupt Discontinuation Sudden cessation of the infusion rate may result in marked hypotension. Gradually reduce the infusion rate while expanding blood volume with intravenous fluids. 5.4 Severe Hypersensitivity Reactions due to Sodium Metabisulfite Excipient Dopamine HCl in Dextrose Injection, contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.
Contraindications
Dopamine is contraindicated in patients with pheochromocytoma. Patients with pheochromocytoma. ( 4 )
Adverse Reactions
The following adverse reactions are described elsewhere in the labeling: • Tissue Ischemia [see Warnings and Precautions (5.1) ] • Cardiac Arrhythmias [see Warnings and Precautions (5.2) ] • Hypotension [see Warnings and Precautions (5.3) ] • Severe Hypersensitivity Reactions [see Warnings and Precautions (5.4) ] The following adverse reactions have been identified during post-approval use of dopamine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiac Disorders : anginal pain, palpitation Gastrointestinal Disorders : nausea, vomiting Metabolism and Nutrition Disorders : azotemia Nervous System Disorders : headache, anxiety Respiratory Disorders : dyspnea Skin and Subcutaneous Tissue Disorders : piloerection Vascular Disorders : hypertension The most common adverse reaction is localized vasoconstriction due to extravasation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Drug Interactions
See Table 1 for clinically significant drug interactions with dopamine. Table 1: Clinically Significant Drug Interactions with Dopamine Halogenated Anesthetics Clinical Impact: Concomitant use may increase cardiac autonomic irritability and can sensitize the myocardium to the action of dopamine which may lead to ventricular arrhythmias and hypertension. Intervention: Monitor cardiac rhythm. Examples: desflurane, enflurane, isoflurane, and sevoflurane. MAO Inhibitors Clinical Impact: Because dopamine is metabolized by monoamine oxidase (MAO), inhibition of this enzyme prolongs and potentiates the effect of dopamine which may result in severe hypertension and cardiac arrhythmia. Intervention: Reduce the recommended starting dosage to no greater than one-tenth (1/10) of the recommended dose in patients who have been treated with MAO inhibitors within two to three weeks prior to the administration of Dopamine HCl in Dextrose Injection. Examples: isocarboxazid, phenelzine, tranylcypromine, rasagiline, selegiline, linezolid. Tricyclic Antidepressants Clinical Impact: Concomitant use may potentiate the cardiovascular effects of dopamine (e.g., hypertension). Intervention: Monitor blood pressure. Examples: amitriptyline, desipramine, doxepin, imipramine, nortriptyline. Vasopressors Clinical Impact: Concomitant use may result in severe hypertension. Intervention: Monitor blood pressure. Examples: norepinephrine, epinephrine, oxytocin. • Halogenated anesthetics : Can sensitize the myocardium to the effects of dopamine and can produce ventricular arrhythmias and hypertension. ( 7 ) • MAO inhibitors : Risk of severe hypertension. Reduce recommended Dopamine HCl in Dextrose Injection dosage. ( 7 ) • Tricyclic antidepressants : Risk of hypertension. Monitor blood pressure. ( 7 ) • Vasopressors : Risk of severe hypertension. Monitor blood pressure. ( 7 )
Storage & Handling
Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Discard unused portion.
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