Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDELING VASOSTRICT(TM) (VASOPRESSIN INJECTION, USP) is supplied in the following dosage forms. NDC 51662-1314-1 VASOSTRICT(TM) (VASOPRESSIN INJECTION, USP) 20 UNITS PER mL 1mL VIAL NDC 51662-1314-2 VASOSTRICT(TM) (VASOPRESSIN INJECTION, USP) 20 UNITS PER mL 1mL VIAL in 1 pouch HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Vasostrict® (vasopressin injection, USP) is a clear, practically colorless solution for intravenous administration available as: NDC 42023-164-25: A carton of 25 single dose vials each containing vasopressin 1 mL at 20 units/mL. NDC 42023-190-01: A carton of 1 multiple dose vial containing vasopressin 10 mL at 200 units/10 mL (20 units/mL). Store between 2°C and 8°C (36°F and 46°F). Do not freeze. Vials may be held up to 12 months 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 12 month expiration date. If the manufacturer’s original expiration date is shorter than the revised expiration date, then the shorter date must be used. Do not use Vasostrict® beyond the manufacturer’s expiration date stamped on the vial. After initial entry into the 10 mL vial, the remaining contents must be refrigerated. Discard the refrigerated 10 mL vial after 30 days after first puncture. The storage conditions and expiration periods are summarized in the following table. HOW SUPPLIED-STORAGE; PRINCIPAL DISPLAY PANEL, VIAL FRONT VIAL FRONT; PRINCIPAL DISPLAY PANEL, VIAL BACK VIAL BACK; PRINCIPAL DISPLAY PANEL, SERIALIZED VIAL SERIALIZED VIAL; PRINCIPAL DISPLAY PANEL, SERIALIZED LABEL ONLY SERIALIZED LABEL; PRINCIPAL DISPLAY PANEL - SERIALIZED POUCH 51662-1314-2 SERIALIZED POUCH SERIALIZED RFID LABELING
- 16 HOW SUPPLIED/STORAGE AND HANDELING VASOSTRICT(TM) (VASOPRESSIN INJECTION, USP) is supplied in the following dosage forms. NDC 51662-1314-1 VASOSTRICT(TM) (VASOPRESSIN INJECTION, USP) 20 UNITS PER mL 1mL VIAL NDC 51662-1314-2 VASOSTRICT(TM) (VASOPRESSIN INJECTION, USP) 20 UNITS PER mL 1mL VIAL in 1 pouch HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms Vasostrict® (vasopressin injection, USP) is a clear, practically colorless solution for intravenous administration available as: NDC 42023-164-25: A carton of 25 single dose vials each containing vasopressin 1 mL at 20 units/mL. NDC 42023-190-01: A carton of 1 multiple dose vial containing vasopressin 10 mL at 200 units/10 mL (20 units/mL). Store between 2°C and 8°C (36°F and 46°F). Do not freeze. Vials may be held up to 12 months 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 12 month expiration date. If the manufacturer’s original expiration date is shorter than the revised expiration date, then the shorter date must be used. Do not use Vasostrict® beyond the manufacturer’s expiration date stamped on the vial. After initial entry into the 10 mL vial, the remaining contents must be refrigerated. Discard the refrigerated 10 mL vial after 30 days after first puncture. The storage conditions and expiration periods are summarized in the following table. HOW SUPPLIED-STORAGE
- PRINCIPAL DISPLAY PANEL, VIAL FRONT VIAL FRONT
- PRINCIPAL DISPLAY PANEL, VIAL BACK VIAL BACK
- PRINCIPAL DISPLAY PANEL, SERIALIZED VIAL SERIALIZED VIAL
- PRINCIPAL DISPLAY PANEL, SERIALIZED LABEL ONLY SERIALIZED LABEL
- PRINCIPAL DISPLAY PANEL - SERIALIZED POUCH 51662-1314-2 SERIALIZED POUCH SERIALIZED RFID LABELING
Overview
Vasopressin is a polypeptide hormone that causes contraction of vascular and other smooth muscles and antidiuresis. Vasostrict® is a sterile, aqueous solution of synthetic arginine vasopressin for intravenous administration. The 1 mL solution contains vasopressin 20 units/mL, Water for Injection, USP, and sodium acetate buffer adjusted to a pH of 3.8. The 10 mL solution contains vasopressin 20 units/mL, chlorobutanol, NF 0.5% as a preservative, and Water for Injection, USP and, sodium acetate buffer adjusted to a pH of 3.8. 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: C46H65N15O12S2 Molecular Weight: 1084.23 One mg is equivalent to 530 units. STRUCTURE
Indications & Usage
INDICATIONS & USAGE Vasostrict® is indicated to increase blood pressure in adults with vasodilatory shock (e.g., post-cardiotomy or sepsis) who remain hypotensive despite fluids and catecholamines.
Dosage & Administration
DOSAGE & ADMINISTRATION 2.1 Preparation of Diluted Solutions Dilute Vasostrict® in normal saline (0.9% sodium chloride) or 5% dextrose in water (D5W) prior to use for intravenous administration. Discard unused diluted solution after 18 hours at room temperature or 24 hours under refrigeration. Table 1 Preparation of diluted solutions Fluid restriction? Final concentration Mix Vasostrict® Diluent No 0.1 units/mL 2.5 mL (50 units) 500 mL Yes 1 unit/mL 5 mL (100 units) 100 mL Inspect parenteral drug products for particulate matter and discoloration prior to use, whenever solution and container permit. 2.2 Administration The goal of treatment is optimization of perfusion to critical organs, but aggressive treatment can compromise perfusion of organs, like the gastrointestinal tract, whose function is difficult to monitor. The following advice is empirical. In general, titrate to the lowest dose compatible with a clinically acceptable response. For post-cardiotomy shock, start with a dose of 0.03 units/minute. For septic shock, start with a dose of 0.01 units/minute. If the target blood pressure response is not achieved, titrate up by 0.005 units/minute at 10- to 15-minute intervals. The maximum dose for post-cardiotomy shock is 0.1 units/minute and for septic shock 0.07 units/minute. After target blood pressure has been maintained for 8 hours without the use of catecholamines, taper Vasostrict® by 0.005 units/minute every hour as tolerated to maintain target blood pressure.
Warnings & Precautions
5.1 Worsening Cardiac Function Use in patients with impaired cardiac response may worsen cardiac output.
Contraindications
Vasostrict® is contraindicated in patients with known allergy or hypersensitivity to 8-L-arginine vasopressin or chlorobutanol.
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
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. 7.2 Indomethacin Use with indomethacin may prolong the effect of Vasostrict® on cardiac index and systemic vascular resistance [see Clinical Pharmacology ( 12- 12.3)]. 7.3 Ganglionic Blocking Agents Use with ganglionic blocking agents may increase the effect of Vasostrict® on mean arterial blood pressure [see Clinical Pharmacology ( 12- 12.3)]. 7.4 Furosemide Use with furosemide increases the effect of Vasostrict® on osmolar clearance and urine flow [see Clinical Pharmacology ( 12- 12.3)]. 7.5 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 Vasostrict®. 7.6 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 Vasostrict®.
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