VASOPRESSIN IN 0.9% SODIUM CHLORIDE injection

Vasopressin in 0.9% Sodium Chloride by

Drug Labeling and Warnings

Vasopressin in 0.9% Sodium Chloride by is a Prescription medication manufactured, distributed, or labeled by Baxter Healthcare Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • 1 INDICATIONS AND USAGE

    Vasopressin in Sodium Chloride Injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines.

  • 2 DOSAGE AND ADMINISTRATION

    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

  • 3 DOSAGE FORMS AND STRENGTHS

    Injection: a clear, practically colorless solution for intravenous infusion, supplied in 100-mL single dose ready-to-use containers as:

    • 20 units vasopressin (0.2 units/mL) in 0.9% sodium chloride
    • 40 units vasopressin (0.4 units/mL) in 0.9% sodium chloride
  • 4 CONTRAINDICATIONS

    Vasopressin in Sodium Chloride Injection is contraindicated in patients with a known allergy or hypersensitivity to 8-L-arginine vasopressin.

  • 5 WARNINGS AND PRECAUTIONS

    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.

  • 6 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)]

  • 7 DRUG INTERACTIONS

    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.

  • 8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    Risk Summary

    There are no available data on Vasopressin in Sodium Chloride Injection use in pregnant women to inform a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted.

    Clinical Considerations

    •   Dose Adjustments During Pregnancy and the Postpartum Period: Because of increased clearance of vasopressin in the second and third trimester, the dose of Vasopressin in Sodium Chloride Injection may need to be increased [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3)].
    •   Maternal Adverse Reactions: Vasopressin in Sodium Chloride Injection may produce tonic uterine contractions that could threaten the continuation of pregnancy.

    8.2 Lactation

    There are no data on the presence of vasopressin injection in either human or animal milk, the effects on the breastfed infant, or the effects on milk production.

    8.4 Pediatric Use

    Safety and effectiveness of Vasopressin in Sodium Chloride Injection in pediatric patients with vasodilatory shock have not been established.

    8.5 Geriatric Use

    Clinical studies of vasopressin did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy [see Warnings and Precautions (5), Adverse Reactions (6), and Clinical Pharmacology (12.3)].

  • 10 OVERDOSAGE

    Overdosage with Vasopressin in Sodium Chloride Injection can be expected to manifest as consequences of vasoconstriction of various vascular beds (peripheral, mesenteric, and coronary) and as hyponatremia. In addition, overdosage may lead less commonly to ventricular tachyarrhythmias (including Torsade de Pointes), rhabdomyolysis, and non-specific gastrointestinal symptoms.

    Direct effects will resolve within minutes of withdrawal of treatment.

  • 11 DESCRIPTION

    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:

    Vasopressin Structural Formula

    Molecular Formula: C46H65N15O12S2 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.

  • 12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action

    Vasopressin causes vasoconstriction by binding to V1 receptors on vascular smooth muscle coupled to the Gq/11-phospholipase C-phosphatidyl-inositol-triphosphate pathway, resulting in the release of intracellular calcium. In addition, vasopressin stimulates antidiuresis via stimulation of V2 receptors which are coupled to adenyl cyclase.

    12.2 Pharmacodynamics

    At therapeutic doses exogenous vasopressin elicits a vasoconstrictive effect in most vascular beds including the splanchnic, renal and cutaneous circulation. In addition, vasopressin at pressor doses triggers contractions of smooth muscles in the gastrointestinal tract mediated by muscular V1-receptors and release of prolactin and ACTH via V3 receptors. At lower concentrations typical for the antidiuretic hormone vasopressin inhibits water diuresis via renal V2 receptors. In addition, vasopressin has been demonstrated to cause vasodilation in numerous vascular beds that are mediated by V2, V3, oxytocin and purinergic P2 receptors.

    In patients with vasodilatory shock vasopressin in therapeutic doses increases systemic vascular resistance and mean arterial blood pressure and reduces the dose requirements for norepinephrine. Vasopressin tends to decrease heart rate and cardiac output. The pressor effect is proportional to the infusion rate of exogenous vasopressin. The pressor effect reaches its peak within 15 minutes. After stopping the infusion the pressor effect fades within 20 minutes. There is no evidence for tachyphylaxis or tolerance to the pressor effect of vasopressin in patients.

    12.3 Pharmacokinetics

    Vasopressin plasma concentrations increase linearly with increasing infusion rates from 10 to 200 μU/kg/min. Steady state plasma concentrations are achieved after 30 minutes of continuous intravenous infusion.

    Distribution

    Vasopressin does not appear to bind plasma protein. The volume of distribution is 140 mL/kg.

    Elimination

    At infusion rates used in vasodilatory shock (0.01 to 0.1 units/minute), the clearance of vasopressin is 9 to 25 mL/min/kg in patients with vasodilatory shock. The apparent t1/2 of vasopressin at these levels is ≤10 minutes.

    Metabolism

    Serine protease, carboxipeptidase and disulfide oxido-reductase cleave vasopressin at sites relevant for the pharmacological activity of the hormone. Thus, the generated metabolites are not expected to retain important pharmacological activity.

    Excretion

    Vasopressin is predominantly metabolized and only about 6% of the dose is excreted unchanged into urine.

    Specific Populations

    •   Pregnancy: Because of a spillover into blood of placental vasopressinase, the clearance of exogenous and endogenous vasopressin increases gradually over the course of a pregnancy. During the first trimester of pregnancy, the clearance is only slightly increased. However, by the third trimester the clearance of vasopressin is increased about 4-fold and at term up to 5-fold. After delivery, the clearance of vasopressin returns to pre-conception baseline within two weeks.

    Drug Interaction Studies

    •   Indomethacin more than doubles the time to offset for vasopressin’s effect on peripheral vascular resistance and cardiac output in healthy subjects [see Drug Interactions (7.2)].
    •   The ganglionic blocking agent tetra-ethylammonium increases the pressor effect of vasopressin by 20% in healthy subjects [see Drug Interactions (7.3)].
    •   Halothane, morphine, fentanyl, alfentanyl and sufentanyl do not impact exposure to endogenous vasopressin.
  • 13 NONCLINICAL TOXICOLOGY

    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

    No formal carcinogenicity or fertility studies with vasopressin have been conducted in animals. Vasopressin was found to be negative in the in vitro bacterial mutagenicity (Ames) test and the in vitro Chinese hamster ovary (CHO) cell chromosome aberration test. In mice, vasopressin has been reported to have an effect on function and fertilizing ability of spermatozoa.

    13.2 Animal Toxicology and/or Pharmacology

    No toxicology studies were conducted with vasopressin.

  • 14 CLINICAL STUDIES

    Increases in systolic and mean blood pressure following administration of vasopressin were observed in 7 studies in septic shock and 8 in post-cardiotomy vasodilatory shock.

  • 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

    Vasopressin 20 9640-12 Representative Container Label (1 of 2)
    Vasopressin 20 9640-12 Representative Container Label (2 of 2)

    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

    BaxterLogo
    Baxter Healthcare Corporation, Deerfield, IL 60015 USA

    Product of USA
    07-34-00-2342

    BAR CODE
    POSITION ONLY UPCA-A

    303389640127

    Vasopressin 40 9647-12 Representative Container Label (1 of 2)
    Vasopressin 40 9647-12 Representative Container Label (2 of 2)

    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
    POSITION ONLY UPCA-A

    303389647126

    Vasopressin 20 9640-12 Representative Carton Label (1 of 2)
    Vasopressin 20 9640-12 Representative Carton Label (2 of 2)

    Carton Label

    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.

    Do not add supplemental medication or additives.

    Vasopressin
    in 0.9% Sodium Chloride Injection
    20 units per 100 mL    (0.2 units/mL)

    Contains: 6 x 100 mL Single-Dose bags.
    Each bag contains 100 mL.

    BaxterLogo

    Rx only

    NDC: 0338-9640-12
    Code 2G3498

    *FOR BAR CODE POSITION ONLY

    (01) 20303389640121

    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 and/or hydrochloric acid.
    Dosage: See prescribing information.

    Baxter Healthcare Corporation,Deerfield, IL 60015 USA

    07-04-00-1385

    Vasopressin 40 9647-12 Representative Carton Label (1 of 2)
    Vasopressin 40 9647-12 Representative Carton Label (2 of 2)

    Carton Label

    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.

    Do not add supplemental medication or additives.

    Vasopressin
    in 0.9% Sodium Chloride Injection
    40 units per 100 mL
    (0.4 units/mL)

    Contains: 6 x 100 mL Single-Dose bags.
    Each bag contains 100 mL.

    BaxterLogo

    Rx only

    NDC: 0338-9647-12
    Code 2G3499

    *FOR BAR CODE POSITION ONLY

    (01) 20303389647120

    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 and/or hydrochloric acid.
    Dosage: See prescribing information.

    Baxter Healthcare Corporation,Deerfield, IL 60015 USA

    07-04-00-1401

  • INGREDIENTS AND APPEARANCE
    VASOPRESSIN IN 0.9% SODIUM CHLORIDE 
    vasopressin in 0.9% sodium chloride injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 0338-9640
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VASOPRESSIN (UNII: Y4907O6MFD) (VASOPRESSIN - UNII:Y4907O6MFD) VASOPRESSIN20 [USP'U]  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 900 mg  in 100 mL
    SODIUM LACTATE (UNII: TU7HW0W0QT) 33.6 mg  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 0338-9640-1212 in 1 CARTON09/29/2023
    1100 mL in 1 BAG; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA21756909/29/2023
    VASOPRESSIN IN 0.9% SODIUM CHLORIDE 
    vasopressin in 0.9% sodium chloride injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 0338-9647
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VASOPRESSIN (UNII: Y4907O6MFD) (VASOPRESSIN - UNII:Y4907O6MFD) VASOPRESSIN40 [USP'U]  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 900 mg  in 100 mL
    SODIUM LACTATE (UNII: TU7HW0W0QT) 33.6 mg  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 0338-9647-1212 in 1 CARTON09/29/2023
    1100 mL in 1 BAG; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA21756909/29/2023
    Labeler - Baxter Healthcare Corporation (005083209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Baxter Healthcare Corporation194684502ANALYSIS(0338-9640, 0338-9647) , MANUFACTURE(0338-9640, 0338-9647) , PACK(0338-9640, 0338-9647) , STERILIZE(0338-9640, 0338-9647) , LABEL(0338-9640, 0338-9647)
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