Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Vasopressin in Sodium Chloride Injection is supplied as a clear, practically colorless solution for intravenous administration in single-dose 100 mL ready-to-use containers available as: Product Code Product Description NDC Number 2G3498 20 units vasopressin (0.2 units/mL) Supplied as 12 bags per carton 0338-9640-12 2G3499 40 units vasopressin (0.4 units/mL) Supplied as 12 bags per carton 0338-9647-12 Store in the refrigerator (2°C to 8°C [36°F to 46°F]). Protect from freezing. If needed, Vasopressin in Sodium Chloride Injection may be stored at room temperature up to 25°C (77°F) for up to 6 months. Discard after 6 months if stored at room temperature or until the expiration date printed on the carton and container label, whichever is earlier. Once stored at room temperature, do not place back in the refrigerator. The drug product must be stored in its light protective carton during storage. Manufactured by, Packed by, Distributed by: Baxter Healthcare Corporation Deerfield, IL 60015 USA Printed in USA 07-19-06-884 Baxter and Galaxy are trademarks of Baxter International Inc.; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label NDC 0338-9640-12 Vasopressin in 0.9% Sodium Chloride Injection 20 units per 100 mL ( 0.2 units/mL) For Intravenous Infusion Only 100 mL Single-Dose Container Discard Unused Portion Rx only Sterile Each mL of the 0.2 units/mL strength also contains 9 mg sodium chloride, 0.336 mg sodium DL-lactate, and water for injection. pH may have been adjusted with sodium hydroxide or hydrochloric acid. Dosage: See prescribing information. Store refrigerated (2°C to 8°C [36°F to 46°F]). If needed, product may be stored at room temperature up to 25°C (77°F) for up to 6 months. Discard after 6 months if stored at room temperature. Protect from light. Protect from freezing. Do not add supplemental medication or additives. Code 2G3498 Baxter Logo Baxter Healthcare Corporation, Deerfield, IL 60015 USA Product of USA 07-34-00-2342 BAR CODE 303389640127 Container Label NDC 0338-9647-12 Vasopressin in 0.9% Sodium Chloride Injection 40 units per 100 mL ( 0.4 units/mL) For Intravenous Infusion Only 100 mL Single-Dose Container Discard Unused Portion Rx only Sterile Each mL of the 0.4 units/mL strength also contains 9 mg sodium chloride, 0.336 mg sodium DL-lactate, and water for injection. pH may have been adjusted with sodium hydroxide or hydrochloric acid. Dosage: See prescribing information. Store refrigerated (2°C to 8°C [36°F to 46°F]). If needed, product may be stored at room temperature up to 25°C (77°F) for up to 6 months. Discard after 6 months if stored at room temperature. Protect from light. Protect from freezing. Do not add supplemental medication or additives. Code 2G3499 Baxter Logo Baxter Healthcare Corporation, Deerfield, IL 60015 USA Product of USA 07-34-00-2343 BAR CODE 303389647126 Carton Label Vasopressin in 0.9% Sodium Chloride Injection 20 units per 100 mL (0.2 units/mL) Vasopressin in 0.9% Sodium Chloride Injection 20 units per 100 mL (0.2 units/mL) NDC 0338-9640-12 Vasopressin in 0.9% Sodium Chloride Injection 20 units per 100 mL (0.2 units/mL) UNVARNISHED AREA FOR ON-LINE PRINTING OF LOT & EXP Bar Code 303389640127 For Intravenous Infusion only Each mL of the 0.2 units/mL strength also contains 9 mg sodium chloride, 0.336 mg sodium DL-lactate, and water for injection. pH may have been adjusted with sodium hydroxide or hydrochloric acid. Dosage : See prescribing information. Do not add supplemental medication or additives. Rx only Store refrigerated (2°C to 8°C [36°F to 46°F]). If needed, product may be stored at room temperature up to 25°C (77°F) for up to 6 months. Discard after 6 months if stored at room temperature. The drug product must be stored in its light protective carton during storage. Protect from freezing. Baxter Healthcare Corporation Deerfield, IL 60015 USA 07-01-00-1916 Vasopressin in 0.9% Sodium Chloride Injection 20 units per 100 mL (0.2 units/mL) Vasopressin in 0.9% Sodium Chloride Injection 20 units per 100 mL (0.2 units/mL) NDC 0338-9640-12 Vasopressin in 0.9% Sodium Chloride Injection 20 units per 100 mL (0.2 units/mL) For Intravenous Infusion Only The drug product must be stored in its light protective carton during storage. Protect from freezing. Code 2G3498 Rx only 1 Single-Dose bag Discard unused portion Baxter logo Carton Label Vasopressin in 0.9% Sodium Chloride Injection 40 units per 100 mL (0.4 units/mL) Vasopressin in 0.9% Sodium Chloride Injection 40 units per 100 mL (0.4 units/mL) NDC 0338-9647-12 Vasopressin in 0.9% Sodium Chloride Injection 40 units per 100 mL (0.4 units/mL) UNVARNISHED AREA FOR ON-LINE PRINTING OF LOT & EXP Bar Code 303389647126 For Intravenous Infusion only Each mL of the 0.4 units/mL strength also contains 9 mg sodium chloride, 0.336 mg sodium DL-lactate, and water for injection. pH may have been adjusted with sodium hydroxide or hydrochloric acid. Dosage : See prescribing information. Do not add supplemental medication or additives. Rx only Store refrigerated (2°C to 8°C [36°F to 46°F]). If needed, product may be stored at room temperature up to 25°C (77°F) for up to 6 months. Discard after 6 months if stored at room temperature. The drug product must be stored in its light protective carton during storage. Protect from freezing. Baxter Healthcare Corporation Deerfield, IL 60015 USA 07-01-00-1917 Vasopressin in 0.9% Sodium Chloride Injection 40 units per 100 mL (0.4 units/mL) Vasopressin in 0.9% Sodium Chloride Injection 40 units per 100 mL (0.4 units/mL) NDC 0338-9647-12 Vasopressin in 0.9% Sodium Chloride Injection 40 units per 100 mL (0.4 units/mL) For Intravenous Infusion Only The drug product must be stored in its light protective carton during storage. Protect from freezing. Code 2G3499 Rx only 1 Single-Dose bag Discard unused portion Baxter logo Vasopressin 20 9640-12 Representative Container Label (1 of 2) Vasopressin 20 9640-12 Representative Container Label (2 of 2) Vasopressin 40 9647-12 Representative Container Label (1 of 2) Vasopressin 40 9647-12 Representative Container Label (2 of 2) Vasopressin 20 9640-12 Representative Carton Label (1 of 2) Vasopressin 20 9640-12 Representative Carton Label (2 of 2) Vasopressin 40 9647-12 Representative Carton Label (1 of 2) Vasopressin 40 9647-12 Representative Carton Label (2 of 2)
- 16 HOW SUPPLIED/STORAGE AND HANDLING Vasopressin in Sodium Chloride Injection is supplied as a clear, practically colorless solution for intravenous administration in single-dose 100 mL ready-to-use containers available as: Product Code Product Description NDC Number 2G3498 20 units vasopressin (0.2 units/mL) Supplied as 12 bags per carton 0338-9640-12 2G3499 40 units vasopressin (0.4 units/mL) Supplied as 12 bags per carton 0338-9647-12 Store in the refrigerator (2°C to 8°C [36°F to 46°F]). Protect from freezing. If needed, Vasopressin in Sodium Chloride Injection may be stored at room temperature up to 25°C (77°F) for up to 6 months. Discard after 6 months if stored at room temperature or until the expiration date printed on the carton and container label, whichever is earlier. Once stored at room temperature, do not place back in the refrigerator. The drug product must be stored in its light protective carton during storage. Manufactured by, Packed by, Distributed by: Baxter Healthcare Corporation Deerfield, IL 60015 USA Printed in USA 07-19-06-884 Baxter and Galaxy are trademarks of Baxter International Inc.
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label NDC 0338-9640-12 Vasopressin in 0.9% Sodium Chloride Injection 20 units per 100 mL ( 0.2 units/mL) For Intravenous Infusion Only 100 mL Single-Dose Container Discard Unused Portion Rx only Sterile Each mL of the 0.2 units/mL strength also contains 9 mg sodium chloride, 0.336 mg sodium DL-lactate, and water for injection. pH may have been adjusted with sodium hydroxide or hydrochloric acid. Dosage: See prescribing information. Store refrigerated (2°C to 8°C [36°F to 46°F]). If needed, product may be stored at room temperature up to 25°C (77°F) for up to 6 months. Discard after 6 months if stored at room temperature. Protect from light. Protect from freezing. Do not add supplemental medication or additives. Code 2G3498 Baxter Logo Baxter Healthcare Corporation, Deerfield, IL 60015 USA Product of USA 07-34-00-2342 BAR CODE 303389640127 Container Label NDC 0338-9647-12 Vasopressin in 0.9% Sodium Chloride Injection 40 units per 100 mL ( 0.4 units/mL) For Intravenous Infusion Only 100 mL Single-Dose Container Discard Unused Portion Rx only Sterile Each mL of the 0.4 units/mL strength also contains 9 mg sodium chloride, 0.336 mg sodium DL-lactate, and water for injection. pH may have been adjusted with sodium hydroxide or hydrochloric acid. Dosage: See prescribing information. Store refrigerated (2°C to 8°C [36°F to 46°F]). If needed, product may be stored at room temperature up to 25°C (77°F) for up to 6 months. Discard after 6 months if stored at room temperature. Protect from light. Protect from freezing. Do not add supplemental medication or additives. Code 2G3499 Baxter Logo Baxter Healthcare Corporation, Deerfield, IL 60015 USA Product of USA 07-34-00-2343 BAR CODE 303389647126 Carton Label Vasopressin in 0.9% Sodium Chloride Injection 20 units per 100 mL (0.2 units/mL) Vasopressin in 0.9% Sodium Chloride Injection 20 units per 100 mL (0.2 units/mL) NDC 0338-9640-12 Vasopressin in 0.9% Sodium Chloride Injection 20 units per 100 mL (0.2 units/mL) UNVARNISHED AREA FOR ON-LINE PRINTING OF LOT & EXP Bar Code 303389640127 For Intravenous Infusion only Each mL of the 0.2 units/mL strength also contains 9 mg sodium chloride, 0.336 mg sodium DL-lactate, and water for injection. pH may have been adjusted with sodium hydroxide or hydrochloric acid. Dosage : See prescribing information. Do not add supplemental medication or additives. Rx only Store refrigerated (2°C to 8°C [36°F to 46°F]). If needed, product may be stored at room temperature up to 25°C (77°F) for up to 6 months. Discard after 6 months if stored at room temperature. The drug product must be stored in its light protective carton during storage. Protect from freezing. Baxter Healthcare Corporation Deerfield, IL 60015 USA 07-01-00-1916 Vasopressin in 0.9% Sodium Chloride Injection 20 units per 100 mL (0.2 units/mL) Vasopressin in 0.9% Sodium Chloride Injection 20 units per 100 mL (0.2 units/mL) NDC 0338-9640-12 Vasopressin in 0.9% Sodium Chloride Injection 20 units per 100 mL (0.2 units/mL) For Intravenous Infusion Only The drug product must be stored in its light protective carton during storage. Protect from freezing. Code 2G3498 Rx only 1 Single-Dose bag Discard unused portion Baxter logo Carton Label Vasopressin in 0.9% Sodium Chloride Injection 40 units per 100 mL (0.4 units/mL) Vasopressin in 0.9% Sodium Chloride Injection 40 units per 100 mL (0.4 units/mL) NDC 0338-9647-12 Vasopressin in 0.9% Sodium Chloride Injection 40 units per 100 mL (0.4 units/mL) UNVARNISHED AREA FOR ON-LINE PRINTING OF LOT & EXP Bar Code 303389647126 For Intravenous Infusion only Each mL of the 0.4 units/mL strength also contains 9 mg sodium chloride, 0.336 mg sodium DL-lactate, and water for injection. pH may have been adjusted with sodium hydroxide or hydrochloric acid. Dosage : See prescribing information. Do not add supplemental medication or additives. Rx only Store refrigerated (2°C to 8°C [36°F to 46°F]). If needed, product may be stored at room temperature up to 25°C (77°F) for up to 6 months. Discard after 6 months if stored at room temperature. The drug product must be stored in its light protective carton during storage. Protect from freezing. Baxter Healthcare Corporation Deerfield, IL 60015 USA 07-01-00-1917 Vasopressin in 0.9% Sodium Chloride Injection 40 units per 100 mL (0.4 units/mL) Vasopressin in 0.9% Sodium Chloride Injection 40 units per 100 mL (0.4 units/mL) NDC 0338-9647-12 Vasopressin in 0.9% Sodium Chloride Injection 40 units per 100 mL (0.4 units/mL) For Intravenous Infusion Only The drug product must be stored in its light protective carton during storage. Protect from freezing. Code 2G3499 Rx only 1 Single-Dose bag Discard unused portion Baxter logo Vasopressin 20 9640-12 Representative Container Label (1 of 2) Vasopressin 20 9640-12 Representative Container Label (2 of 2) Vasopressin 40 9647-12 Representative Container Label (1 of 2) Vasopressin 40 9647-12 Representative Container Label (2 of 2) Vasopressin 20 9640-12 Representative Carton Label (1 of 2) Vasopressin 20 9640-12 Representative Carton Label (2 of 2) Vasopressin 40 9647-12 Representative Carton Label (1 of 2) Vasopressin 40 9647-12 Representative Carton Label (2 of 2)
Overview
Vasopressin in Sodium Chloride Injection contains vasopressin, a polypeptide hormone. The chemical name of vasopressin is Cyclo (1-6) L-Cysteinyl-L-Tyrosyl-L-Phenylalanyl-L-Glutaminyl-L-Asparaginyl-L-Cysteinyl-L-Prolyl-L-Arginyl-L-Glycinamide. It is a white to off-white amorphous powder, freely soluble in water. The structural formula is: Molecular Formula: C 46 H 65 N 15 O 12 S 2 Molecular Weight: 1084.23 Vasopressin in Sodium Chloride Injection is a sterile, aqueous solution of synthetic arginine vasopressin for intravenous administration. Each 100 mL contains 20 units (0.2 units/mL) or 40 units (0.4 units/mL) of vasopressin. Each 100mL also contains 900 mg Sodium Chloride, 33.6 mg Sodium DL-Lactate, and Water for Injection. pH may have been adjusted with sodium hydroxide and/or hydrochloric acid. It has a pH of 3.6 – 4.0. Vasopressin Structural Formula
Indications & Usage
Vasopressin in Sodium Chloride Injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. Vasopressin in Sodium Chloride Injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. ( 1 )
Dosage & Administration
• Post-cardiotomy shock: 0.03 units/minute to 0.1 units/minute by intravenous infusion. ( 2.1 ) • Septic shock: 0.01 units/minute to 0.07 units/minute by intravenous infusion. ( 2.1 ) 2.1 Administration This product does not require dilution prior to administration. In general, titrate to the lowest dose compatible with a clinically acceptable response. The recommended starting dose is: Post-cardiotomy shock: 0.03 units/minute by intravenous infusion Septic Shock: 0.01 units/minute by intravenous infusion Titrate up by 0.005 units/minute at 10- to 15-minute intervals until the target blood pressure is reached. There are limited data for doses above 0.1 units/minute for post-cardiotomy shock and 0.07 units/minute for septic shock. Adverse reactions are expected to increase with higher doses. After target blood pressure has been maintained for 8 hours without the use of catecholamines, taper vasopressin injection by 0.005 units/minute every hour as tolerated to maintain target blood pressure. Inspect visually for any particulate matter and discoloration prior to administration. Discard Unused Portion Do not add supplemental medication or additive
Warnings & Precautions
• Can worsen cardiac function ( 5.1 ) • Reversible diabetes insipidus ( 5.2 ) 5.1 Worsening Cardiac Function A decrease in cardiac index may be observed with the use of vasopressin. 5.2 Reversible Diabetes Insipidus Patients may experience reversible diabetes insipidus, manifested by the development of polyuria, a dilute urine, and hypernatremia, after cessation of treatment with vasopressin. Monitor serum electrolytes, fluid status and urine output after vasopressin discontinuation. Some patients may require readministration of vasopressin or administration of desmopressin to correct fluid and electrolyte shifts.
Contraindications
Vasopressin in Sodium Chloride Injection is contraindicated in patients with a known allergy or hypersensitivity to 8-L-arginine vasopressin. • Vasopressin in Sodium Chloride Injection is contraindicated in patients with known allergy or hypersensitivity to 8-L-arginine vasopressin. ( 4 )
Adverse Reactions
The following adverse reactions associated with the use of vasopressin were identified in the literature. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to estimate reliably their frequency or establish a causal relationship to drug exposure. Bleeding/lymphatic system disorders: Hemorrhagic shock, decreased platelets, intractable bleeding Cardiac disorders: Right heart failure, atrial fibrillation, bradycardia, myocardial ischemia Gastrointestinal disorders: Mesenteric ischemia Hepatobiliary: Increased bilirubin levels Renal/urinary disorders: Acute renal insufficiency Vascular disorders: Distal limb ischemia Metabolic: Hyponatremia Skin: Ischemic lesions Postmarketing Experience Reversible diabetes insipidus [ see Warnings and Precautions (5.2) ] The most common adverse reactions include decreased cardiac output, bradycardia, tachyarrhythmias, hyponatremia and ischemia (coronary, mesenteric, skin, digital). ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug Interactions
• Pressor effects of catecholamines and Vasopressin in Sodium Chloride Injection are expected to be additive. ( 7.1 ) • Indomethacin may prolong effects of Vasopressin in Sodium Chloride Injection. ( 7.2 ) • Co-administration of ganglionic blockers or drugs causing SIADH (syndrome of inappropriate antiduretic hormone secretion) may increase the pressor response. ( 7.3 , 7.4 ) • Co-administration of drugs causing diabetes insipidus may decrease the pressor response. ( 7.5 ) 7.1 Catecholamines Use with catecholamines is expected to result in an additive effect on mean arterial blood pressure and other hemodynamic parameters. Hemodynamic monitoring is recommended; adjust the dose of vasopressin as needed. 7.2 Indomethacin Use with indomethacin may prolong the effect of Vasopressin in Sodium Chloride Injection on cardiac index and systemic vascular resistance. Hemodynamic monitoring is recommended; adjust the dose of vasopressin as needed [ see Clinical Pharmacology (12.3) ] . 7.3 Ganglionic Blocking Agents Use with ganglionic blocking agents may increase the effect of Vasopressin in Sodium Chloride Injection on mean arterial blood pressure. Hemodynamic monitoring is recommended; adjust the dose of vasopressin as needed [ see Clinical Pharmacology (12.3) ] . 7.4 Drugs Suspected of Causing SIADH Use with drugs suspected of causing SIADH (e.g., SSRIs, tricyclic antidepressants, haloperidol, chlorpropamide, enalapril, methyldopa, pentamidine, vincristine, cyclophosphamide, ifosfamide, felbamate) may increase the pressor effect in addition to the antidiuretic effect of Vasopressin in Sodium Chloride Injection. Hemodynamic monitoring is recommended; adjust the dose of vasopressin as needed. 7.5 Drugs Suspected of Causing Diabetes Insipidus Use with drugs suspected of causing diabetes insipidus (e.g., demeclocycline, lithium, foscarnet, clozapine) may decrease the pressor effect in addition to the antidiuretic effect of Vasopressin in Sodium Chloride Injection. Hemodynamic monitoring is recommended; adjust the dose of vasopressin as needed.
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