VASOPRESSIN IN 0.9% SODIUM CHLORIDE- vasopressin solution

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 Long Grove Pharmaceuticals, LLC. 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 Preparation of Solution

    Inspect parenteral drug products for particulate matter and discoloration prior to use, whenever solution and container permit.

    This product does not require further dilution prior to administration.

    2.2 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 postcardiotomy 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 in Sodium Chloride Injection by 0.005 units/minute every hour as tolerated to maintain target blood pressure.

  • 3 DOSAGE FORMS AND STRENGTHS

    Vasopressin in Sodium Chloride Injection is a clear, colorless premixed solution for intravenous administration in a single-dose, ready to use vial available as:

    • 20 units/100 mL (0.2 units/mL) in 0.9% sodium chloride
    • 40 units/100 mL (0.4 units/mL) in 0.9% sodium chloride
    • 50 units/50 mL (1 unit/mL) in 0.9% sodium chloride
  • 4 CONTRAINDICATIONS

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

  • 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 their frequency reliably or to 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 (2.2) 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 in Sodium Chloride 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 is a polypeptide hormone. Vasopressin in Sodium Chloride Injection is a sterile, aqueous solution of synthetic arginine vasopressin for intravenous administration.

    Each mL of the 0.2 unit/mL strength contains 0.2 units vasopressin, 0.0672 mg aspartic acid, 0.0180 mg boric acid, 0.05 mg chlorobutanol, 9 mg sodium chloride and Water for Injection, USP. Each mL of the 0.4 unit/mL strength contains 0.4 units vasopressin, 0.0672 mg aspartic acid, 0.0180 mg boric acid, 0.10 mg chlorobutanol, 9 mg sodium chloride and Water for Injection, USP. Each mL of the 1 unit/mL strength contains 1 unit vasopressin, 0.0672 mg aspartic acid, 0.0180 mg boric acid, 0.25 mg chlorobutanol, 9 mg sodium chloride and Water for Injection, USP.

    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:

    Structural Formula

    Molecular Formula: C46H65N15O12S2 Molecular Weight: 1084.23

  • 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 preconception baseline within two weeks.

    Drug Interactions

    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.

  • 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 a clear, colorless solution for intravenous administration available as:

    NDC: 81298-8552-3: A carton of 10 single dose vials. Each vial contains vasopressin 100 mL at 20 units/100 mL (0.2 units/mL).

    NDC: 81298-8554-3: A carton of 10 single dose vials. Each vial contains vasopressin 100 mL at 40 units/100 mL (0.4 units/mL).

    NDC: 81298-8550-3: A carton of 10 single dose vials. Each vial contains vasopressin 50 mL at 50 units/50 mL (1 unit/mL).

    Store unopened vials refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. Keep vials in original carton to protect from light.

    Vials may be held up to three (3) months for 0.2 units/mL and one (1) month for 0.4 units/mL and 1 unit/mL upon removal from refrigeration to room temperature storage conditions (20°C to 25°C [68°F to 77°F], USP Controlled Room Temperature), anytime within the labeled shelf life. Once removed from refrigeration, unopened vial should be marked to indicate the revised three (3) months expiration date for 0.2 units/mL and one (1) month expiration date for 0.4 units/mL and 1 unit/mL. If the manufacturer's original expiration date is shorter than the revised expiration date, then the shorter date must be used. Do not use Vasopressin in Sodium Chloride Injection beyond the manufacturer's expiration date stamped on the vial.

    Manufactured for:
    Long Grove Pharmaceuticals, LLC
    Rosemont, IL 60018

    Made in India

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – 20 Units per 100 mL Carton Label

    Vasopressin
    in 0.9% Sodium Chloride Injection

    20 Units per 100 mL (0.2 units per mL)

    For intravenous infusion

    Ready to use
    10 x 100 mL Single-Dose Vials
    Discard Unused Portion

    NDC: 81298-8552-3

    Rx only

    Recommended Dosage: See
    Prescribing Information.

    LONG GROVE™
    PHARMACEUTICALS

    Principal Display Panel – 20 Units per 100 mL Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – 40 Units per 100 mL Carton Label

    Vasopressin
    in 0.9% Sodium Chloride Injection

    40 Units per 100 mL (0.4 units per mL)

    For intravenous infusion

    Ready to use
    10 x 100 mL Single-Dose Vials
    Discard Unused Portion

    NDC: 81298-8554-3

    Rx only

    Recommended Dosage: See
    Prescribing Information.

    LONG GROVE™
    PHARMACEUTICALS

    Principal Display Panel – 40 Units per 100 mL Carton Label
  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – 50 Units per 50 mL Carton Label

    Vasopressin
    in 0.9% Sodium Chloride Injection

    50 Units per 50 mL (1 units per mL)

    For intravenous infusion

    Ready to use
    10 x 50 mL Single-Dose Vials
    Discard Unused Portion

    NDC: 81298-8550-3

    Rx only

    Recommended Dosage: See
    Prescribing Information.

    LONG GROVE™
    PHARMACEUTICALS

    Principal Display Panel – 50 Units per 50 mL Carton Label
  • INGREDIENTS AND APPEARANCE
    VASOPRESSIN IN 0.9% SODIUM CHLORIDE 
    vasopressin solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 81298-8552
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VASOPRESSIN (UNII: Y4907O6MFD) (VASOPRESSIN - UNII:Y4907O6MFD) VASOPRESSIN0.2 [USP'U]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CHLOROBUTANOL (UNII: HM4YQM8WRC) 0.05 mg  in 1 mL
    ASPARTIC ACID (UNII: 30KYC7MIAI) 0.0672 mg  in 1 mL
    BORIC ACID (UNII: R57ZHV85D4) 0.0180 mg  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 9 mg  in 1 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 81298-8552-310 in 1 CARTON07/12/2024
    1NDC: 81298-8552-1100 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA21776607/12/2024
    VASOPRESSIN IN 0.9% SODIUM CHLORIDE 
    vasopressin solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 81298-8554
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VASOPRESSIN (UNII: Y4907O6MFD) (VASOPRESSIN - UNII:Y4907O6MFD) VASOPRESSIN0.4 [USP'U]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CHLOROBUTANOL (UNII: HM4YQM8WRC) 0.10 mg  in 1 mL
    ASPARTIC ACID (UNII: 30KYC7MIAI) 0.0672 mg  in 1 mL
    BORIC ACID (UNII: R57ZHV85D4) 0.0180 mg  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 9 mg  in 1 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 81298-8554-310 in 1 CARTON07/12/2024
    1NDC: 81298-8554-1100 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA21776607/12/2024
    VASOPRESSIN IN 0.9% SODIUM CHLORIDE 
    vasopressin solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 81298-8550
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VASOPRESSIN (UNII: Y4907O6MFD) (VASOPRESSIN - UNII:Y4907O6MFD) VASOPRESSIN1.0 [USP'U]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CHLOROBUTANOL (UNII: HM4YQM8WRC) 0.25 mg  in 1 mL
    ASPARTIC ACID (UNII: 30KYC7MIAI) 0.0672 mg  in 1 mL
    BORIC ACID (UNII: R57ZHV85D4) 0.0180 mg  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 9 mg  in 1 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 81298-8550-310 in 1 CARTON07/12/2024
    1NDC: 81298-8550-150 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA21776607/12/2024
    Labeler - Long Grove Pharmaceuticals, LLC (081134465)
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