Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Morphine Sulfate Injection, USP is supplied as a sterile solution in single-dose Carpuject™ cartridges for use ONLY with the Carpuject™ Holders and NexJect™ prefilled syringes for intravenous administration, and available as follows: Unit of Sale Concentration (per total volume) NDC 0409-1890-01 Carton of 10 1 mL fill in 2.5 mL Carpuject™ Single-dose cartridge with Luer Lock for the Carpuject™ Syringe System 2 mg/mL NDC 0409-1891-01 Carton of 10 1 mL fill in 2.5 mL Carpuject™ Single-dose cartridge with Luer Lock for the Carpuject™ Syringe System 4 mg/mL NDC 0409-1892-01 Carton of 10 1 mL fill in 2.5 mL Carpuject™ Single-dose cartridge with Luer Lock for the Carpuject™ Syringe System 8 mg/mL NDC 0409-1893-01 Carton of 10 1 mL fill in 2.5 mL Carpuject™ Single-dose cartridge with Luer Lock for the Carpuject™ Syringe System 10 mg/mL NDC 0409-1894-01 Carton of 10 1 mL fill in 2.5 mL Carpuject™ Single-dose cartridge with Luer Lock for the Carpuject™ Syringe System 15 mg/mL NDC 0409-1890-23 Clamshell of 10 1 mL fill in 1.5 mL NexJect™ Single-dose Prefilled Syringe with Luer Lock 2 mg/mL NDC 0409-1891-23 Clamshell of 10 1 mL fill in 1.5 mL NexJect™ Single-dose Prefilled Syringe with Luer Lock 4 mg/mL NDC 0409-1892-23 Clamshell of 10 1 mL fill in 1.5 mL NexJect™ Single-dose Prefilled Syringe with Luer Lock 8 mg/mL NDC 0409-1893-23 Clamshell of 10 1 mL fill in 1.5 mL NexJect™ Single-dose Prefilled Syringe with Luer Lock 10 mg/mL Carpuject™ Single-dose cartridges with Luer Lock are packaged in a Slim-Pak™ tamper detection package. Note that a needle is not included with Carpuject™ Single-dose cartridges and Nexject™ Single-dose Prefilled Syringes. Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature] until ready to use. PROTECT FROM LIGHT. DO NOT FREEZE. Contains no preservative or antioxidant. DISCARD ANY UNUSED PORTION. DO NOT HEAT-STERILIZE.; PRINCIPAL DISPLAY PANEL - 2 mg/mL Cartridge Label 1 mL Single-dose Carpuject™ Sterile Cartridge Unit with Luer Lock NDC 0409-1890-03 Rx only Morphine Sulfate Injection, USP CII 2 mg/mL Intravenous Use Only Protect from light and freezing. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Hospira PAA193040 PRINCIPAL DISPLAY PANEL - 2 mg/mL Cartridge Label; PRINCIPAL DISPLAY PANEL - 2 mg/mL Cartridge Carton NDC 0409-1890-01 Contains 10 of NDC 0409-1890-03 Rx only 1mL Single-dose 10 Carpuject™ Sterile Cartridge Units with Luer Lock Needle not included SLIM-PAK™ Tamper Detection Package Morphine Sulfate Injection, USP CII 2 mg/mL Intravenous Use Only Carpuject Cartridges are to be used ONLY with Carpuject Holders. Hospira PRINCIPAL DISPLAY PANEL - 2 mg/mL Cartridge Carton; PRINCIPAL DISPLAY PANEL - 4 mg/mL Cartridge Label 1 mL Single-dose Carpuject™ Sterile Cartridge Unit with Luer Lock NDC 0409-1891-03 Rx only Morphine Sulfate Injection, USP 4 mg/mL CII Intravenous Use Only Protect from light and freezing. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Hospira PAA194123 PRINCIPAL DISPLAY PANEL - 4 mg/mL Cartridge Label; PRINCIPAL DISPLAY PANEL - 4 mg/mL Cartridge Carton NDC 0409-1891-01 Contains 10 of NDC 0409-1891-03 Rx only 1mL Single-dose 10 Carpuject™ Sterile Cartridge Units with Luer Lock Needle not included SLIM-PAK™ Tamper Detection Package Morphine Sulfate Injection, USP CII 4 mg/mL Intravenous Use Only Carpuject Cartridges are to be used ONLY with Carpuject Holders. Hospira PRINCIPAL DISPLAY PANEL - 4 mg/mL Cartridge Carton; PRINCIPAL DISPLAY PANEL - 8 mg/mL Cartridge Label 1 mL Single-dose Carpuject™ Sterile Cartridge Unit with Luer Lock NDC 0409-1892-03 Rx only Morphine Sulfate Injection, USP 8 mg/mL CII Intravenous Use Only Protect from light and freezing. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Hospira PAA194126 PRINCIPAL DISPLAY PANEL - 8 mg/mL Cartridge Label; PRINCIPAL DISPLAY PANEL - 8 mg/mL Cartridge Carton NDC 0409-1892-01 Contains 10 of NDC 0409-1892-03 Rx only 1mL Single-dose 10 Carpuject™ Sterile Cartridge Units with Luer Lock Needle not included SLIM-PAK™ Tamper Detection Package Morphine Sulfate Injection, USP CII 8 mg/mL Intravenous Use Only Carpuject Cartridges are to be used ONLY with Carpuject Holders. Hospira PRINCIPAL DISPLAY PANEL - 8 mg/mL Cartridge Carton; PRINCIPAL DISPLAY PANEL - 10 mg/mL Cartridge Label 1 mL Single-dose Carpuject™ Sterile Cartridge Unit with Luer Lock NDC 0409-1893-03 Rx only Morphine Sulfate Injection, USP 10 mg/mL CII Intravenous Use Only Protect from light and freezing. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Hospira PAA194129 PRINCIPAL DISPLAY PANEL - 10 mg/mL Cartridge Label; PRINCIPAL DISPLAY PANEL - 10 mg/mL Cartridge Carton NDC 0409-1893-01 Contains 10 of NDC 0409-1893-03 Rx only 1mL Single-dose 10 Carpuject™ Sterile Cartridge Units with Luer Lock Needle not included SLIM-PAK™ Tamper Detection Package Morphine Sulfate Injection, USP CII 10 mg/mL Intravenous Use Only Carpuject Cartridges are to be used ONLY with Carpuject Holders. Hospira PRINCIPAL DISPLAY PANEL - 10 mg/mL Cartridge Carton; PRINCIPAL DISPLAY PANEL - 2 mg/mL Syringe Label TWIST & PULL Tamper Seal NDC 0409-1890-13 Morphine Sulfate Injection, USP CII 2 mg / mL INTRAVENOUS USE ONLY Protect from light and freezing. Preservative-Free Rx only 1 mL Single-dose syringe PAA140549 LOT #####AA EXP DMMMYYYY PRINCIPAL DISPLAY PANEL - 2 mg/mL Syringe Label; PRINCIPAL DISPLAY PANEL - 2 mg/mL Syringe Luer Lock Label Morphine Sulfate Injection, USP CII 2 mg / mL PAA140545 PRINCIPAL DISPLAY PANEL - 2 mg/mL Syringe Luer Lock Label; PRINCIPAL DISPLAY PANEL - 2 mg/mL Syringe Luer Lock Cello Pack Label NDC 0409-1890-23 Preservative-Free Morphine Sulfate Injection, USP CII 2 mg / mL INTRAVENOUS USE ONLY Rx only 10 NexJect 1 mL Single-dose syringes with luer lock Needle not included Protect from light and freezing. Opaque covering needed until contents are used. Store at 20 to 25°C (68 to 77°F). (See USP Controlled Room Temperature.) Sterile Aqueous Injection Usual Dosage: See Package Insert. Each mL contains morphine sulfate 2 mg, edetate disodium 0.2 mg, citric acid 0.4 mg, and sodium chloride 8.5 mg. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH to 3.0 (2.5 to 4.0). The injection is not to be used if its color is darker than pale yellow, if it is discolored in any other way, or if it contains a precipitate. PRINCIPAL DISPLAY PANEL - 2 mg/mL Syringe Luer Lock Cello Pack Label; PRINCIPAL DISPLAY PANEL - 4 mg/mL Syringe Label TWIST & PULL Tamper Seal NDC 0409-1891-13 Morphine Sulfate Injection, USP CII 4 mg / mL INTRAVENOUS USE ONLY Protect from light and freezing. Preservative-Free Rx only 1 mL Single-dose syringe PAA140550 LOT #####AA EXP DMMMYYYY PRINCIPAL DISPLAY PANEL - 4 mg/mL Syringe Label; PRINCIPAL DISPLAY PANEL - 4 mg/mL Syringe Luer Lock Label Morphine Sulfate Injection, USP CII 4 mg / mL PAA140547 PRINCIPAL DISPLAY PANEL - 4 mg/mL Syringe Luer Lock Label; PRINCIPAL DISPLAY PANEL - 4 mg/mL Syringe Luer Lock Cello Pack Label NDC 0409-1891-23 Preservative-Free Morphine Sulfate Injection, USP CII 4 mg / mL INTRAVENOUS USE ONLY Rx only 10 NexJect 1 mL Single-dose syringes with luer lock Needle not included Protect from light and freezing. Opaque covering needed until contents are used. Store at 20 to 25°C (68 to 77°F). (See USP Controlled Room Temperature.) Sterile Aqueous Injection Usual Dosage: See Package Insert. Each mL contains morphine sulfate 4 mg, edetate disodium 0.2 mg, citric acid 0.4 mg, and sodium chloride 8.4 mg. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH to 3.0 (2.5 to 4.0). The injection is not to be used if its color is darker than pale yellow, if it is discolored in any other way, or if it contains a precipitate. PRINCIPAL DISPLAY PANEL - 4 mg/mL Syringe Luer Lock Cello Pack Label; PRINCIPAL DISPLAY PANEL - 8 mg/mL Syringe Label TWIST & PULL Tamper Seal NDC 0409-1892-13 Morphine Sulfate Injection, USP CII 8 mg / mL INTRAVENOUS USE ONLY Protect from light and freezing. Preservative-Free Rx only 1 mL Single-dose syringe PAA140561 LOT #####AA EXP DMMMYYYY PRINCIPAL DISPLAY PANEL - 8 mg/mL Syringe Label; PRINCIPAL DISPLAY PANEL - 8 mg/mL Syringe Luer Lock Label Morphine Sulfate Injection, USP CII 8 mg / mL PAA140544 PRINCIPAL DISPLAY PANEL - 8 mg/mL Syringe Luer Lock Label; PRINCIPAL DISPLAY PANEL - 8 mg/mL Syringe Luer Lock Cello Pack Label NDC 0409-1892-23 Preservative-Free Morphine Sulfate Injection, USP CII 8 mg / mL INTRAVENOUS USE ONLY Rx only 10 NexJect 1 mL Single-dose syringes with luer lock Needle not included Protect from light and freezing. Opaque covering needed until contents are used. Store at 20 to 25°C (68 to 77°F). (See USP Controlled Room Temperature.) Sterile Aqueous Injection Usual Dosage: See Package Insert. Each mL contains morphine sulfate 8 mg, edetate disodium 0.2 mg, citric acid 0.4 mg, and sodium chloride 8 mg. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH to 3.0 (2.5 to 4.0). The injection is not to be used if its color is darker than pale yellow, if it is discolored in any other way, or if it contains a precipitate. PRINCIPAL DISPLAY PANEL - 8 mg/mL Syringe Luer Lock Cello Pack Label; PRINCIPAL DISPLAY PANEL - 10 mg/mL Syringe Label TWIST & PULL Tamper Seal NDC 0409-1893-13 Morphine Sulfate Injection, USP CII 10 mg / mL INTRAVENOUS USE ONLY Protect from light and freezing. Preservative-Free Rx only 1 mL Single-dose syringe PAA140548 LOT #####AA EXP DMMMYYYY PRINCIPAL DISPLAY PANEL - 10 mg/mL Syringe Label; PRINCIPAL DISPLAY PANEL - 10 mg/mL Syringe Luer Lock Label Morphine Sulfate Injection, USP CII 10 mg / mL PAA140546 PRINCIPAL DISPLAY PANEL - 10 mg/mL Syringe Luer Lock Label; PRINCIPAL DISPLAY PANEL - 10 mg/mL Syringe Luer Lock Cello Pack Label NDC 0409-1893-23 Preservative-Free Morphine Sulfate Injection, USP CII 10 mg / mL INTRAVENOUS USE ONLY Rx only 10 NexJect 1 mL Single-dose syringes with luer lock Needle not included Protect from light and freezing. Opaque covering needed until contents are used. Store at 20 to 25°C (68 to 77°F). (See USP Controlled Room Temperature.) Sterile Aqueous Injection Usual Dosage: See Package Insert. Each mL contains morphine sulfate 10 mg, edetate disodium 0.2 mg, citric acid 0.4 mg, and sodium chloride 7.8 mg. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH to 3.0 (2.5 to 4.0). The injection is not to be used if its color is darker than pale yellow, if it is discolored in any other way, or if it contains a precipitate. PRINCIPAL DISPLAY PANEL - 10 mg/mL Syringe Luer Lock Cello Pack Label
- 16 HOW SUPPLIED/STORAGE AND HANDLING Morphine Sulfate Injection, USP is supplied as a sterile solution in single-dose Carpuject™ cartridges for use ONLY with the Carpuject™ Holders and NexJect™ prefilled syringes for intravenous administration, and available as follows: Unit of Sale Concentration (per total volume) NDC 0409-1890-01 Carton of 10 1 mL fill in 2.5 mL Carpuject™ Single-dose cartridge with Luer Lock for the Carpuject™ Syringe System 2 mg/mL NDC 0409-1891-01 Carton of 10 1 mL fill in 2.5 mL Carpuject™ Single-dose cartridge with Luer Lock for the Carpuject™ Syringe System 4 mg/mL NDC 0409-1892-01 Carton of 10 1 mL fill in 2.5 mL Carpuject™ Single-dose cartridge with Luer Lock for the Carpuject™ Syringe System 8 mg/mL NDC 0409-1893-01 Carton of 10 1 mL fill in 2.5 mL Carpuject™ Single-dose cartridge with Luer Lock for the Carpuject™ Syringe System 10 mg/mL NDC 0409-1894-01 Carton of 10 1 mL fill in 2.5 mL Carpuject™ Single-dose cartridge with Luer Lock for the Carpuject™ Syringe System 15 mg/mL NDC 0409-1890-23 Clamshell of 10 1 mL fill in 1.5 mL NexJect™ Single-dose Prefilled Syringe with Luer Lock 2 mg/mL NDC 0409-1891-23 Clamshell of 10 1 mL fill in 1.5 mL NexJect™ Single-dose Prefilled Syringe with Luer Lock 4 mg/mL NDC 0409-1892-23 Clamshell of 10 1 mL fill in 1.5 mL NexJect™ Single-dose Prefilled Syringe with Luer Lock 8 mg/mL NDC 0409-1893-23 Clamshell of 10 1 mL fill in 1.5 mL NexJect™ Single-dose Prefilled Syringe with Luer Lock 10 mg/mL Carpuject™ Single-dose cartridges with Luer Lock are packaged in a Slim-Pak™ tamper detection package. Note that a needle is not included with Carpuject™ Single-dose cartridges and Nexject™ Single-dose Prefilled Syringes. Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature] until ready to use. PROTECT FROM LIGHT. DO NOT FREEZE. Contains no preservative or antioxidant. DISCARD ANY UNUSED PORTION. DO NOT HEAT-STERILIZE.
- PRINCIPAL DISPLAY PANEL - 2 mg/mL Cartridge Label 1 mL Single-dose Carpuject™ Sterile Cartridge Unit with Luer Lock NDC 0409-1890-03 Rx only Morphine Sulfate Injection, USP CII 2 mg/mL Intravenous Use Only Protect from light and freezing. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Hospira PAA193040 PRINCIPAL DISPLAY PANEL - 2 mg/mL Cartridge Label
- PRINCIPAL DISPLAY PANEL - 2 mg/mL Cartridge Carton NDC 0409-1890-01 Contains 10 of NDC 0409-1890-03 Rx only 1mL Single-dose 10 Carpuject™ Sterile Cartridge Units with Luer Lock Needle not included SLIM-PAK™ Tamper Detection Package Morphine Sulfate Injection, USP CII 2 mg/mL Intravenous Use Only Carpuject Cartridges are to be used ONLY with Carpuject Holders. Hospira PRINCIPAL DISPLAY PANEL - 2 mg/mL Cartridge Carton
- PRINCIPAL DISPLAY PANEL - 4 mg/mL Cartridge Label 1 mL Single-dose Carpuject™ Sterile Cartridge Unit with Luer Lock NDC 0409-1891-03 Rx only Morphine Sulfate Injection, USP 4 mg/mL CII Intravenous Use Only Protect from light and freezing. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Hospira PAA194123 PRINCIPAL DISPLAY PANEL - 4 mg/mL Cartridge Label
- PRINCIPAL DISPLAY PANEL - 4 mg/mL Cartridge Carton NDC 0409-1891-01 Contains 10 of NDC 0409-1891-03 Rx only 1mL Single-dose 10 Carpuject™ Sterile Cartridge Units with Luer Lock Needle not included SLIM-PAK™ Tamper Detection Package Morphine Sulfate Injection, USP CII 4 mg/mL Intravenous Use Only Carpuject Cartridges are to be used ONLY with Carpuject Holders. Hospira PRINCIPAL DISPLAY PANEL - 4 mg/mL Cartridge Carton
- PRINCIPAL DISPLAY PANEL - 8 mg/mL Cartridge Label 1 mL Single-dose Carpuject™ Sterile Cartridge Unit with Luer Lock NDC 0409-1892-03 Rx only Morphine Sulfate Injection, USP 8 mg/mL CII Intravenous Use Only Protect from light and freezing. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Hospira PAA194126 PRINCIPAL DISPLAY PANEL - 8 mg/mL Cartridge Label
- PRINCIPAL DISPLAY PANEL - 8 mg/mL Cartridge Carton NDC 0409-1892-01 Contains 10 of NDC 0409-1892-03 Rx only 1mL Single-dose 10 Carpuject™ Sterile Cartridge Units with Luer Lock Needle not included SLIM-PAK™ Tamper Detection Package Morphine Sulfate Injection, USP CII 8 mg/mL Intravenous Use Only Carpuject Cartridges are to be used ONLY with Carpuject Holders. Hospira PRINCIPAL DISPLAY PANEL - 8 mg/mL Cartridge Carton
- PRINCIPAL DISPLAY PANEL - 10 mg/mL Cartridge Label 1 mL Single-dose Carpuject™ Sterile Cartridge Unit with Luer Lock NDC 0409-1893-03 Rx only Morphine Sulfate Injection, USP 10 mg/mL CII Intravenous Use Only Protect from light and freezing. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA Hospira PAA194129 PRINCIPAL DISPLAY PANEL - 10 mg/mL Cartridge Label
- PRINCIPAL DISPLAY PANEL - 10 mg/mL Cartridge Carton NDC 0409-1893-01 Contains 10 of NDC 0409-1893-03 Rx only 1mL Single-dose 10 Carpuject™ Sterile Cartridge Units with Luer Lock Needle not included SLIM-PAK™ Tamper Detection Package Morphine Sulfate Injection, USP CII 10 mg/mL Intravenous Use Only Carpuject Cartridges are to be used ONLY with Carpuject Holders. Hospira PRINCIPAL DISPLAY PANEL - 10 mg/mL Cartridge Carton
- PRINCIPAL DISPLAY PANEL - 2 mg/mL Syringe Label TWIST & PULL Tamper Seal NDC 0409-1890-13 Morphine Sulfate Injection, USP CII 2 mg / mL INTRAVENOUS USE ONLY Protect from light and freezing. Preservative-Free Rx only 1 mL Single-dose syringe PAA140549 LOT #####AA EXP DMMMYYYY PRINCIPAL DISPLAY PANEL - 2 mg/mL Syringe Label
- PRINCIPAL DISPLAY PANEL - 2 mg/mL Syringe Luer Lock Label Morphine Sulfate Injection, USP CII 2 mg / mL PAA140545 PRINCIPAL DISPLAY PANEL - 2 mg/mL Syringe Luer Lock Label
- PRINCIPAL DISPLAY PANEL - 2 mg/mL Syringe Luer Lock Cello Pack Label NDC 0409-1890-23 Preservative-Free Morphine Sulfate Injection, USP CII 2 mg / mL INTRAVENOUS USE ONLY Rx only 10 NexJect 1 mL Single-dose syringes with luer lock Needle not included Protect from light and freezing. Opaque covering needed until contents are used. Store at 20 to 25°C (68 to 77°F). (See USP Controlled Room Temperature.) Sterile Aqueous Injection Usual Dosage: See Package Insert. Each mL contains morphine sulfate 2 mg, edetate disodium 0.2 mg, citric acid 0.4 mg, and sodium chloride 8.5 mg. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH to 3.0 (2.5 to 4.0). The injection is not to be used if its color is darker than pale yellow, if it is discolored in any other way, or if it contains a precipitate. PRINCIPAL DISPLAY PANEL - 2 mg/mL Syringe Luer Lock Cello Pack Label
- PRINCIPAL DISPLAY PANEL - 4 mg/mL Syringe Label TWIST & PULL Tamper Seal NDC 0409-1891-13 Morphine Sulfate Injection, USP CII 4 mg / mL INTRAVENOUS USE ONLY Protect from light and freezing. Preservative-Free Rx only 1 mL Single-dose syringe PAA140550 LOT #####AA EXP DMMMYYYY PRINCIPAL DISPLAY PANEL - 4 mg/mL Syringe Label
- PRINCIPAL DISPLAY PANEL - 4 mg/mL Syringe Luer Lock Label Morphine Sulfate Injection, USP CII 4 mg / mL PAA140547 PRINCIPAL DISPLAY PANEL - 4 mg/mL Syringe Luer Lock Label
- PRINCIPAL DISPLAY PANEL - 4 mg/mL Syringe Luer Lock Cello Pack Label NDC 0409-1891-23 Preservative-Free Morphine Sulfate Injection, USP CII 4 mg / mL INTRAVENOUS USE ONLY Rx only 10 NexJect 1 mL Single-dose syringes with luer lock Needle not included Protect from light and freezing. Opaque covering needed until contents are used. Store at 20 to 25°C (68 to 77°F). (See USP Controlled Room Temperature.) Sterile Aqueous Injection Usual Dosage: See Package Insert. Each mL contains morphine sulfate 4 mg, edetate disodium 0.2 mg, citric acid 0.4 mg, and sodium chloride 8.4 mg. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH to 3.0 (2.5 to 4.0). The injection is not to be used if its color is darker than pale yellow, if it is discolored in any other way, or if it contains a precipitate. PRINCIPAL DISPLAY PANEL - 4 mg/mL Syringe Luer Lock Cello Pack Label
- PRINCIPAL DISPLAY PANEL - 8 mg/mL Syringe Label TWIST & PULL Tamper Seal NDC 0409-1892-13 Morphine Sulfate Injection, USP CII 8 mg / mL INTRAVENOUS USE ONLY Protect from light and freezing. Preservative-Free Rx only 1 mL Single-dose syringe PAA140561 LOT #####AA EXP DMMMYYYY PRINCIPAL DISPLAY PANEL - 8 mg/mL Syringe Label
- PRINCIPAL DISPLAY PANEL - 8 mg/mL Syringe Luer Lock Label Morphine Sulfate Injection, USP CII 8 mg / mL PAA140544 PRINCIPAL DISPLAY PANEL - 8 mg/mL Syringe Luer Lock Label
- PRINCIPAL DISPLAY PANEL - 8 mg/mL Syringe Luer Lock Cello Pack Label NDC 0409-1892-23 Preservative-Free Morphine Sulfate Injection, USP CII 8 mg / mL INTRAVENOUS USE ONLY Rx only 10 NexJect 1 mL Single-dose syringes with luer lock Needle not included Protect from light and freezing. Opaque covering needed until contents are used. Store at 20 to 25°C (68 to 77°F). (See USP Controlled Room Temperature.) Sterile Aqueous Injection Usual Dosage: See Package Insert. Each mL contains morphine sulfate 8 mg, edetate disodium 0.2 mg, citric acid 0.4 mg, and sodium chloride 8 mg. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH to 3.0 (2.5 to 4.0). The injection is not to be used if its color is darker than pale yellow, if it is discolored in any other way, or if it contains a precipitate. PRINCIPAL DISPLAY PANEL - 8 mg/mL Syringe Luer Lock Cello Pack Label
- PRINCIPAL DISPLAY PANEL - 10 mg/mL Syringe Label TWIST & PULL Tamper Seal NDC 0409-1893-13 Morphine Sulfate Injection, USP CII 10 mg / mL INTRAVENOUS USE ONLY Protect from light and freezing. Preservative-Free Rx only 1 mL Single-dose syringe PAA140548 LOT #####AA EXP DMMMYYYY PRINCIPAL DISPLAY PANEL - 10 mg/mL Syringe Label
- PRINCIPAL DISPLAY PANEL - 10 mg/mL Syringe Luer Lock Label Morphine Sulfate Injection, USP CII 10 mg / mL PAA140546 PRINCIPAL DISPLAY PANEL - 10 mg/mL Syringe Luer Lock Label
- PRINCIPAL DISPLAY PANEL - 10 mg/mL Syringe Luer Lock Cello Pack Label NDC 0409-1893-23 Preservative-Free Morphine Sulfate Injection, USP CII 10 mg / mL INTRAVENOUS USE ONLY Rx only 10 NexJect 1 mL Single-dose syringes with luer lock Needle not included Protect from light and freezing. Opaque covering needed until contents are used. Store at 20 to 25°C (68 to 77°F). (See USP Controlled Room Temperature.) Sterile Aqueous Injection Usual Dosage: See Package Insert. Each mL contains morphine sulfate 10 mg, edetate disodium 0.2 mg, citric acid 0.4 mg, and sodium chloride 7.8 mg. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH to 3.0 (2.5 to 4.0). The injection is not to be used if its color is darker than pale yellow, if it is discolored in any other way, or if it contains a precipitate. PRINCIPAL DISPLAY PANEL - 10 mg/mL Syringe Luer Lock Cello Pack Label
Overview
Morphine Sulfate Injection, USP is an opioid agonist, available in 2 mg/mL, 4 mg/mL, 8 mg/mL, 10 mg/mL, and 15 mg/mL (1 mL fill in 2.5 mL Carpuject™ Single‑dose cartridge with Luer Lock for the Carpuject™ Syringe System) and 2 mg/mL, 4 mg/mL, 8 mg/mL, and 10 mg/mL (1 mL fill in 1.5 mL NexJect™ Single-dose Prefilled Syringe with Luer Lock). When exposed to air it gradually loses water of hydration, and darkens on prolonged exposure to light. The chemical name is 7,8-Didehydro-4,5-epoxy-17-methyl-(5α,6α)-morphinan-3,6-diol sulfate (2: 1) (salt), pentahydrate, with the following chemical structure: (C 17 H 19 NO 3 ) 2 • H 2 SO 4 • 5H 2 O Molecular Weight is 758.83 Morphine sulfate USP is an odorless, white crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol:water partition coefficient of morphine is 1.42 at physiologic pH and the pKa is 7.9 for the tertiary nitrogen (the majority is ionized at pH 7.4). Morphine Sulfate Injection, USP is a sterile, nonpyrogenic solution of morphine sulfate, free of antioxidants and preservatives to be administered by the intravenous route. For the single-dose Carpuject™ cartridges for intravenous administration : Each milliliter of sterile solution contains 2 mg, 4 mg, 8 mg, 10 mg, or 15 mg Morphine Sulfate Injection, USP and the following inactive ingredients: 0.2 mg edetate disodium, 0.4 mg citric acid for the 2 mg, 4 mg, 8 mg and 10 mg Morphine Sulfate Injection, USP or 0.8 mg citric acid for the 15 mg Morphine Sulfate Injection, USP, sodium chloride to adjust isotonicity and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. The pH range is 2.5 to 4.0. For the single-dose NexJect™ syringes for intravenous administration : Each milliliter of sterile solution contains 2 mg, 4 mg, 8 mg, or 10 mg Morphine Sulfate Injection, USP and the following inactive ingredients: 0.2 mg edetate disodium, 0.4 mg citric acid for the 2 mg, 4 mg, 8 mg, and 10 mg Morphine Sulfate Injection, USP, sodium chloride to adjust isotonicity and water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. The pH range is 2.5 to 4.0. Chemical Structure
Indications & Usage
Morphine Sulfate Injection is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Morphine Sulfate Injection is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including Morphine Sulfate Injection, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. ( 1 , 5.1 ) Limitations of Use: Because of the risks of addiction, abuse, misuse, overdose, and death , which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1) ] , reserve opioid analgesics, including Morphine Sulfate Injection , for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Dosage & Administration
• Morphine Sulfate Injection should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks. ( 2.1 ) • Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals. Reserve titration to higher doses of Morphine Sulfate Injection for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks. ( 2.1 , 5 ) • Many acute pain conditions (e.g., the pain that occurs with a number of surgical procedures or acute musculoskeletal injuries) require no more than a few days of an opioid analgesic. Clinical guidelines on opioid prescribing for some acute pain conditions are available. ( 2.1 ) • Initiate the dosing regimen for each patient individually, taking into account the patient’s underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse. ( 2.1 , 5.1 ) • Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with Morphine Sulfate Injection. Consider this risk when selecting an initial dose and when making dose adjustments. ( 2.1 , 5.2 ) • Direct Intravenous Injection: The usual starting dose in adults is 0.1 mg to 0.2 mg per kg every 4 hours as needed for pain management. ( 2.2 ) • Periodically reassess patients receiving Morphine Sulfate Injection to evaluate the continued need for opioid analgesics to maintain pain control, for the signs or symptoms of adverse reactions, and for the development of addiction, abuse, or misuse. ( 2.3 ) • Do not rapidly reduce or abruptly discontinue Morphine Sulfate Injection in a physically-dependent patient. ( 2.4 , 5.14 ) 2.1 Important Dosage and Administration Instructions • Morphine Sulfate Injection is for intravenous administration. • Morphine Sulfate Injection is available in five concentrations as Carpuject™ cartridges for use with the Carpuject Holder ONLY, and in four concentrations as NexJect™ syringes for intravenous administration. Dosing errors can result in accidental overdose and death. Avoid dosing errors that may result from confusion between mg and mL and confusion with morphine injections of different concentrations when prescribing, dispensing, and administering Morphine Sulfate Injection. Ensure that the dose is communicated and dispensed accurately. • Morphine Sulfate Injection should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks. • Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals [see Warnings and Precautions (5) ] . Because the risk of overdose increases as opioid doses increase, reserve titration to higher doses of Morphine Sulfate Injection for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks. • Many acute pain conditions (e.g., the pain that occurs with a number of surgical procedures or acute musculoskeletal injuries) require no more than a few days of an opioid analgesic. Clinical guidelines on opioid prescribing for some acute pain conditions are available. • There is variability in the opioid analgesic dose and duration needed to adequately manage pain due both to the cause of pain and to individual patient factors. Initiate the dosing regimen for each patient individually, taking into account the patient's underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse [see Warnings and Precautions (5.1) ] . • Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with Morphine Sulfate Injection. Consider this risk when selecting an initial dose and when making dose adjustments [see Warnings and Precautions (5.2) ] . • Morphine must be injected slowly; rapid intravenous administration may result in chest wall rigidity. • Inspect Morphine Sulfate Injection for particulate matter and discoloration prior to administration. Do not use if color is darker than pale yellow, if it is discolored in any other way, or if it contains a precipitate. 2.2 Initial Dosage Direct Intravenous Injection Use the lowest dose necessary to achieve adequate analgesia. Adults : Initiate treatment in a dosing range of 0.1 mg to 0.2 mg per kg every 4 hours as needed to manage pain. Administer the injection slowly. 2.3 Titration and Maintenance of Therapy Titrate the dose based upon the individual patient’s response to their initial dose of Morphine Sulfate Injection. Individually titrate Morphine Sulfate Injection to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving Morphine Sulfate Injection to assess the maintenance of pain control, signs and symptoms of opioid withdrawal, and other adverse reactions, as well as to reassess for the development of addiction, abuse, or misuse [see Warnings and Precautions (5.1, 5.14) ] . If after increasing the dosage, unacceptable opioid-related adverse reactions are observed, (including an increase in pain after dosage increase), consider reducing the dosage [see Warnings and Precautions (5) ] . Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions. 2.4 Safe Reduction and Discontinuation of Morphine Sulfate Injection When a patient who has been taking Morphine Sulfate Injection regularly and may be physically dependent no longer requires therapy with Morphine Sulfate Injection, taper the dose gradually, by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. Do not rapidly reduce or abruptly discontinue Morphine Sulfate Injection in patients who may be physically dependent on opioids [see Warnings and Precautions (5.14) , Drug Abuse and Dependence (9.3) ] .
Warnings & Precautions
• Cardiovascular Instability : High doses are excitatory. Have naloxone injection and resuscitative equipment immediately available. ( 5.5 ) • Opioid-Induced Hyperalgesia and Allodynia : Opioid-Induced Hyperalgesia (OIH) occurs when an opioid analgesic paradoxically causes an increase in pain, or an increase in sensitivity to pain. If OIH is suspected, carefully consider appropriately decreasing the dose of the current opioid analgesic or opioid rotation. ( 5.6 ) • Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients : Monitor closely, particularly during initiation and titration. ( 5.7 ) • Adrenal Insufficiency : If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. ( 5.9 ) • Severe Hypotension : Monitor during dosage initiation and titration. Avoid use of Morphine Sulfate Injection in patients with circulatory shock. ( 5.10 ) • Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness : Monitor for sedation and respiratory depression. Avoid use of Morphine Sulfate Injection in patients with impaired consciousness or coma. ( 5.11 ) 5.1 Addiction, Abuse, and Misuse Morphine Sulfate Injection contains morphine, a Schedule II controlled substance. As an opioid, Morphine Sulfate Injection exposes users to the risks of addiction, abuse, and misuse [see Drug Abuse and Dependence (9) ]. Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed Morphine Sulfate Injection. Addiction can occur at recommended dosages and if the drug is misused or abused. The risk of opioid-related overdose or overdose-related death is increased with higher opioid doses, and this risk persists over the course of therapy. In postmarketing studies, addiction, abuse, misuse, and fatal and non-fatal opioid overdose were observed in patients with long-term opioid use [see Adverse Reactions (6) ] . Assess each patient's risk for opioid addiction, abuse, or misuse prior to prescribing Morphine Sulfate Injection, and monitor all patients receiving morphine sulfate for the development of these behaviors and conditions. Risks are increased in patients with a personal or family history of substance abuse (including drug or alcohol abuse or addiction) or mental illness (e.g., major depression). The potential for these risks should not, however, prevent the proper management of pain in any given patient. Patients at increased risk may be prescribed opioids such as Morphine Sulfate Injection but use in such patients necessitates intensive counseling about the risks and proper use of Morphine Sulfate Injection along with intensive monitoring for signs of addiction, abuse, and misuse. Opioids are sought for nonmedical use and are subject to diversion from legitimate prescribed use. Strategies to reduce these risks include prescribing the drug in the smallest appropriate quantity. Contact local state professional licensing board or state-controlled substances authority for information on how to prevent and detect abuse or diversion of this product. 5.2 Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. Management of respiratory depression may include close observation, supportive measures, and use of opioid overdose reversal agents (e.g., naloxone, nalmefene) , depending on the patient's clinical status [see Overdosage (10) ] . Carbon dioxide (CO 2 ) retention from opioid-induced respiratory depression can exacerbate the sedating effects of opioids. While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of Morphine Sulfate Injection, the risk is greatest during the initiation of therapy or following a dosage increase. Because of a delay in the maximum CNS effect with intravenously administered Morphine Sulfate Injection (30 min), rapid administration may result in overdosing. The respiratory depression may be severe and could require intervention [see Overdosage (10) ] . To reduce the risk of respiratory depression, proper dosing and titration of Morphine Sulfate Injection are essential [see Dosage and Administration (2.3) ] . Overestimating the Morphine Sulfate Injection dosage when converting patients from another opioid product can result in a fatal overdose with the first dose. Opioids can cause sleep-related breathing disorders including central sleep apnea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the opioid dosage using best practices for opioid taper [see Dosage and Administration (2.3) ] . 5.3 Risks from Concomitant Use with Benzodiazepines or Other Central Nervous System Depressants Profound sedation, respiratory depression, coma, and death may result from the concomitant use of Morphine Sulfate Injection with benzodiazepines and/or other CNS depressants, including alcohol (e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids [gabapentin or pregabalin], and other opioids). Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioid analgesics alone. Because of similar pharmacological properties, it is reasonable to expect similar risk with the concomitant use of other CNS depressant drugs with opioid analgesics [see Drug Interactions (7) ] . If the decision is made to prescribe a benzodiazepine or other CNS depressant concomitantly with an opioid analgesic, prescribe the lowest effective dosages and minimum durations of concomitant use. In patients already receiving an opioid analgesic, prescribe a lower initial dose of the benzodiazepine or other CNS depressant than indicated in the absence of an opioid, and titrate based on clinical response. If an opioid analgesic is initiated in a patient already taking a benzodiazepine or other CNS depressant, prescribe a lower initial dose of the opioid analgesic, and titrate based on clinical response. Monitor patients closely for signs and symptoms of respiratory depression and sedation. Advise both patients and caregivers about the risks of respiratory depression and sedation when Morphine Sulfate Injection is used with benzodiazepines or other CNS depressants (including alcohol and illicit drugs). Advise patients not to drive or operate heavy machinery until the effects of concomitant use of the benzodiazepine or other CNS depressant have been determined. Screen patients for risk of substance use disorders, including opioid abuse and misuse, and warn them of the risk for overdose and death associated with the use of additional CNS depressants including alcohol and illicit drugs [see Drug Interactions (7) ] . 5.4 Neonatal Opioid Withdrawal Syndrome Use of Morphine Sulfate Injection for an extended period of time during pregnancy can result in withdrawal in the neonate. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. Observe newborns for signs of neonatal opioid withdrawal syndrome and manage accordingly. Advise pregnant women using opioids for an extended period of time of the risk of neonatal opioid withdrawal syndrome and ensure that management by neonatology experts will be available at delivery [see Use in Specific Populations (8.1) ] . 5.5 Cardiovascular Instability While low doses of intravenously administered morphine have little effect on cardiovascular stability, high doses are excitatory, resulting from sympathetic hyperactivity and increase in circulatory catecholamines. Have naloxone injection and resuscitative equipment immediately available for use in case of life-threatening or intolerable side effects and whenever morphine therapy is being initiated. 5.6 Opioid-Induced Hyperalgesia and Allodynia Opioid-Induced Hyperalgesia (OIH) occurs when an opioid analgesic paradoxically causes an increase in pain, or an increase in sensitivity to pain. This condition differs from tolerance, which is the need for increasing doses of opioids to maintain a defined effect [see Drug Abuse and Dependence (9.3) ] . Symptoms of OIH include (but may not be limited to) increased levels of pain upon opioid dosage increase, decreased levels of pain upon opioid dosage decrease, or pain from ordinarily non-painful stimuli (allodynia). These symptoms may suggest OIH only if there is no evidence of underlying disease progression, opioid tolerance, opioid withdrawal, or addictive behavior. Cases of OIH have been reported, both with short-term and longer-term use of opioid analgesics. Though the mechanism of OIH is not fully understood, multiple biochemical pathways have been implicated. Medical literature suggests a strong biologic plausibility between opioid analgesics and OIH and allodynia. If a patient is suspected to be experiencing OIH, carefully consider appropriately decreasing the dose of the current opioid analgesic or opioid rotation (safely switching the patient to a different opioid moiety) [see Dosage and Administration (2.4) ; Warnings and Precautions (5.14) ] . 5.7 Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients The use of Morphine Sulfate Injection in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated. Patients with Chronic Pulmonary Disease: Morphine Sulfate Injection-treated patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at increased risk of decreased respiratory drive including apnea, even at recommended dosages of Morphine Sulfate Injection [see Warnings and Precautions (5.2) ] . Elderly, Cachectic, or Debilitated Patients: Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients because they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients [see Warnings and Precautions (5.2) ] . Monitor such patients closely, particularly when initiating and titrating Morphine Sulfate Injection and when Morphine Sulfate Injection is given concomitantly with other drugs that depress respiration [see Warnings and Precautions (5.2) ] . Alternatively, consider the use of non-opioid analgesics in these patients. 5.8 Interaction with Monoamine Oxidase Inhibitors Monoamine oxidase inhibitors (MAOIs) may potentiate the effects of morphine, including respiratory depression, coma, and confusion. Morphine Sulfate Injection should not be used in patients taking MAOIs or within 14 days of stopping such treatment. 5.9 Adrenal Insufficiency Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. If adrenal insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible. If adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids. Wean the patient off of the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers. Other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency. The information available does not identify any particular opioids as being more likely to be associated with adrenal insufficiency. 5.10 Severe Hypotension Morphine Sulfate Injection may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. There is increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs (e.g., phenothiazines or general anesthetics) [see Drug Interactions (7) ] . Monitor these patients for signs of hypotension after initiating or titrating the dosage of Morphine Sulfate Injection. In patients with circulatory shock, Morphine Sulfate Injection may cause vasodilation that can further reduce cardiac output and blood pressure. Avoid the use of Morphine Sulfate Injection in patients with circulatory shock. 5.11 Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness In patients who may be susceptible to the intracranial effects of CO 2 retention (e.g., those with evidence of increased intracranial pressure or brain tumors), Morphine Sulfate Injection may reduce respiratory drive, and the resultant CO 2 retention can further increase intracranial pressure. Monitor such patients for worsening of signs of increasing intracranial pressure. Monitor patients for signs of sedation and respiratory depression, particularly when initiating therapy with Morphine Sulfate Injection. Opioids may also obscure the clinical course in a patient with a head injury. Avoid the use of Morphine Sulfate Injection in patients with impaired consciousness or coma. 5.12 Risks of Gastrointestinal Complications Morphine Sulfate Injection is contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus. The morphine in Morphine Sulfate Injection may cause spasm of the sphincter of Oddi. Opioids may cause increases in serum amylase. Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms. Cases of opioid-induced esophageal dysfunction (OIED) have been reported in patients taking opioids. The risk of OIED may increase as the dose and/or duration of opioids increases. Regularly evaluate patients for signs and symptoms of OIED (e.g., dysphagia, regurgitation, non-cardiac chest pain) and, if necessary, adjust opioid therapy as clinically appropriate [see Clinical Pharmacology (12.2) ] . 5.13 Increased Risk of Seizures in Patients with Seizure Disorders The morphine in Morphine Sulfate Injection may increase the frequency of seizures in patients with seizure disorders and may increase the risk of seizures occurring in other clinical settings associated with seizures. Monitor patients with a history of seizure disorders for worsened seizure control during Morphine Sulfate Injection therapy. 5.14 Withdrawal Avoid the use of mixed agonist/antagonist (e.g., pentazocine, nalbuphine, and butorphanol) or partial agonist (e.g., buprenorphine) analgesics in patients who are receiving a full opioid agonist analgesic, including Morphine Sulfate Injection. In these patients, mixed agonist/antagonist and partial agonist analgesics may reduce the analgesic effect and/or precipitate withdrawal symptoms [see Drug Interactions (7) ] . When discontinuing Morphine Sulfate Injection in a physically-dependent patient, gradually taper the dosage [see Dosage and Administration (2.4) ] . Do not rapidly reduce or abruptly discontinue Morphine Sulfate Injection in these patients [see Drug Abuse and Dependence (9.3) ] . 5.15 Risks of Driving and Operating Machinery Morphine Sulfate Injection may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery. Warn patients not to drive or operate dangerous machinery unless they are tolerant to the effects of Morphine Sulfate Injection and know how they will react to the medication.
Boxed Warning
SERIOUS AND LIFE‑THREATENING RISKS FROM USE OF MORPHINE SULFATE INJECTION WARNING: SERIOUS AND LIFE‑THREATENING RISKS FROM USE OF MORPHINE SULFATE INJECTION See full prescribing information for complete boxed warning . • Morphine Sulfate Injection exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient's risk before prescribing and reassess regularly for these behaviors and conditions. ( 5.1 ) • Serious, life-threatening, or fatal respiratory depression may occur with use of Morphine Sulfate Injection, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of Morphine Sulfate Injection are essential. ( 5.2 ) • Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate. ( 5.3 , 7 ) • Advise pregnant women using opioids for an extended period of time of the risk of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery. ( 5.4 ) Addiction, Abuse, and Misuse Because the use of Morphine Sulfate Injection exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient's risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.1) ] . Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of Morphine Sulfate Injection, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of Morphine Sulfate Injection are essential [see Warnings and Precautions (5.2) ]. Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of Morphine Sulfate Injection and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see Warnings and Precautions (5.3) , Drug Interactions (7) ] . Neonatal Opioid Withdrawal Syndrome (NOWS) Advise pregnant women using opioids for an extended period of time of the risk of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery [see Warnings and Precautions (5.4) ] .
Contraindications
Morphine Sulfate Injection is contraindicated in patients with: • Significant respiratory depression [see Warnings and Precautions (5.2) ] • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.7) ] • Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days [see Warnings and Precautions (5.8) ] • Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.12) ] • Hypersensitivity to morphine (e.g., anaphylaxis) [see Adverse Reactions (6) ] • Significant respiratory depression. ( 4 ) • Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. ( 4 ) • Concurrent use of monoamine oxidase inhibitors (MAOIs) or use of MAOIs within the last 14 days. ( 4 ) • Known or suspected gastrointestinal obstruction, including paralytic ileus. ( 4 ) • Hypersensitivity to morphine. ( 4 )
Adverse Reactions
The following serious adverse reactions are described, or described in greater detail, in other sections: • Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1) ] • Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2) ] • Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions (5.3) ] • Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.4) ] • Cardiovascular Instability [see Warnings and Precautions (5.5) ] • Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions (5.6) ] • Adrenal Insufficiency [see Warnings and Precautions (5.9) ] • Severe Hypotension [see Warnings and Precautions (5.10) ] • Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.12) ] • Seizures [see Warnings and Precautions (5.13) ] • Withdrawal [see Warnings and Precautions (5.14) ] The following adverse reactions associated with the use of morphine were identified in clinical studies or postmarketing reports. Because some of these reactions were 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. Serious adverse reactions associated with Morphine Sulfate Injection included respiratory depression, apnea, and to a lesser degree, circulatory depression, respiratory arrest, shock, and cardiac arrest. Rarely, anaphylactoid reactions have been reported when morphine or other phenanthrene alkaloids of opium are administered intravenously. The most frequently observed adverse reactions included sedation, lightheadedness, dizziness, nausea, vomiting, constipation, and diaphoresis. Other possible adverse reactions included: Central Nervous System – Euphoria, dysphoria, weakness, headache, agitation, tremor, uncoordinated muscle movements, visual disturbances, transient hallucinations and disorientation. Gastrointestinal – Constipation, biliary tract spasm. Cardiovascular – Tachycardia, bradycardia, palpitation, faintness, syncope, and orthostatic hypotension. Genitourinary – Oliguria and urinary retention; an antidiuretic effect has been reported. Allergic – Pruritus, urticaria, and skin rashes. Anaphylactoid reactions have been reported following intravenous administration. Other – Opioid-induced histamine release may be responsible for the flushing of the face, diaphoresis, and pruritus often seen with these drugs. Wheals and urticaria at the site of injection are probably related to histamine release. Local tissue irritation, pain and induration have been reported following repeated subcutaneous injection. Morphine may alter temperature regulation in susceptible individuals and will depress the cough reflex. Serotonin syndrome : Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs. Adrenal insufficiency : Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Anaphylaxis : Anaphylaxis has been reported with ingredients contained in Morphine Sulfate Injection. Androgen deficiency : Cases of androgen deficiency have occurred with use of opioids for an extended period of time [see Clinical Pharmacology (12.2) ] . Hyperalgesia and Allodynia : Cases of hyperalgesia and allodynia have been reported with opioid therapy of any duration [see Warnings and Precautions (5.6) ]. Hypoglycemia : Cases of hypoglycemia have been reported in patients taking opioids. Most reports were in patients with at least one predisposing risk factor (e.g., diabetes). Opioid-induced esophageal dysfunction (OIED) : Cases of OIED have been reported in patients taking opioids and may occur more frequently in patients taking higher doses of opioids, and/or in patients taking opioids longer term [see Warnings and Precautions (5.12) ]. Adverse Reactions from Observational Studies A prospective, observational cohort study estimated the risks of addiction, abuse, and misuse in patients initiating long-term use of Schedule II opioid analgesics between 2017 and 2021. Study participants included in one or more analyses had been enrolled in selected insurance plans or health systems for at least one year, were free of at least one outcome at baseline, completed a minimum number of follow-up assessments, and either: 1) filled multiple extended-release/long-acting opioid analgesic prescriptions during a 90-day period (n=978); or 2) filled any Schedule II opioid analgesic prescriptions covering at least 70 of 90 days (n=1,244). Those included also had no dispensing of the qualifying opioids in the previous 6 months. Over 12 months: 1. approximately 1% to 6% of participants across the two cohorts newly met criteria for addiction, as assessed with two validated interview-based measures of moderate-to-severe opioid use disorder based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria, and 2. approximately 9% and 22% of participants across the two cohorts newly met criteria for prescription opioid abuse and misuse [defined in Drug Abuse and Dependence (9.2) ] , respectively, as measured with a validated self-reported instrument. A retrospective, observational cohort study estimated the risk of opioid-involved overdose or opioid overdose-related death in patients with new long-term use of Schedule II opioid analgesics from 2006 through 2016 (n=220,249). Included patients had been enrolled in either one of two commercial insurance programs, one managed care program, or one Medicaid program for at least 9 months. New long-term use was defined as having Schedule II opioid analgesic prescriptions covering at least 70 days’ supply over the 3 months prior to study entry and none during the preceding 6 months. Patients were excluded if they had an opioid-involved overdose in the 9 months prior to study entry. Overdose was measured using a validated medical code-based algorithm with linkage to the National Death Index database. The 5-year cumulative incidence estimates for opioid-involved overdose or opioid overdose-related death ranged from approximately 1.5% to 4% across study sites, counting only the first event during follow-up. Approximately 17% of first opioid overdoses observed over the entire study period (5‑11 years, depending on the study site) were fatal. Higher baseline opioid dose was the strongest and most consistent predictor of opioid-involved overdose or opioid overdose-related death. Study exclusion criteria may have selected patients at lower risk of overdose, and substantial loss to follow-up (approximately 80%) also may have biased estimates. The risk estimates from the studies described above may not be generalizable to all patients receiving opioid analgesics, such as those with exposures shorter or longer than the duration evaluated in the studies. The most serious adverse reactions encountered are respiratory depression, apnea, circulatory depression, respiratory arrest, shock, and cardiac arrest. Other common frequently observed adverse reactions include: sedation, lightheadedness, dizziness, nausea, vomiting, and constipation. ( 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
Table 1 includes clinically significant drug interactions with Morphine Sulfate Injection. Table 1: Clinically Significant Drug Interactions with Morphine Sulfate Injection Benzodiazepines and Other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death [see Warnings and Precautions (5.3) ] . Intervention: Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor patients closely for signs of respiratory depression and sedation. Examples: Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), other opioids, alcohol. Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome . Intervention: If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue Morphine Sulfate Injection if serotonin syndrome is suspected. Examples: Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (e.g., respiratory depression, coma) [see Warnings and Precautions (5.2 , 5.8) ]. Intervention: Do not use Morphine Sulfate Injection in patients taking MAOIs or within 14 days of stopping such treatment. If urgent use of an opioid is necessary, use test doses and frequent titration of small doses of other opioids (such as oxycodone, hydrocodone, oxymorphone, hydrocodone, or buprenorphine) to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and respiratory depression. Examples: phenelzine, tranylcypromine, linezolid. Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics Clinical Impact: May reduce the analgesic effect of Morphine Sulfate Injection and/or precipitate withdrawal symptoms. Intervention: Avoid concomitant use. Examples: butorphanol, nalbuphine, pentazocine, buprenorphine. Muscle Relaxants Clinical Impact: Morphine may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression. Intervention: Monitor patients for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of Morphine Sulfate Injection and/or the muscle relaxant as necessary. Examples: Cyclobenzaprine, metaxalone. Cimetidine Clinical Impact: Concomitant administration of Morphine Sulfate Injection and cimetidine has been reported to precipitate apnea, confusion, and muscle twitching in an isolated report. Intervention: Monitor patients for increased respiratory and CNS depression when receiving cimetidine concomitantly with Morphine Sulfate Injection. Diuretics Clinical Impact: Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone. Intervention: Monitor patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed. Anticholinergic Drugs Clinical Impact: The concomitant use of anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus. Intervention: Monitor patients for signs of urinary retention or reduced gastric motility when Morphine Sulfate Injection is used concomitantly with anticholinergic drugs. Oral P2Y 12 Inhibitors Clinical Impact: The co-administration of oral P2Y 12 inhibitors and intravenous morphine sulfate can decrease the absorption and peak concentration of oral P2Y 12 inhibitors and delay the onset of the antiplatelet effect. Intervention: Consider the use of a parenteral antiplatelet agent in the setting of acute coronary syndrome requiring co-administration of intravenous morphine sulfate. Examples: clopidogrel, prasugrel, ticagrelor. • Serotonergic Drugs : Concomitant use may result in serotonin syndrome. Discontinue Morphine Sulfate Injection if serotonin syndrome is suspected. ( 7 ) • Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics : Avoid use with Morphine Sulfate Injection because they may reduce analgesic effect of Morphine Sulfate Injection or precipitate withdrawal symptoms. ( 7 )
Storage & Handling
Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature] until ready to use. PROTECT FROM LIGHT. DO NOT FREEZE. Contains no preservative or antioxidant. DISCARD ANY UNUSED PORTION. DO NOT HEAT-STERILIZE.
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