Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
VASOPRESSIN (UNII: Y4907O6MFD) (VASOPRESSIN - UNII:Y4907O6MFD)
Eagle Pharmaceuticals, Inc.
PARENTERAL
PRESCRIPTION DRUG
Vasopressin Injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. Vasopressin Injection is contraindicated in patients with known allergy or hypersensitivity to 8-L-arginine vasopressin or chlorobutanol. Risk Summary There are no available data on Vasopressin 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 Injection may need to be increased [see Dosage and Administration (2.2) and see Clinical Pharmacology (12.3) ]. Maternal adverse reactions: Vasopressin Injection may produce tonic uterine contractions that could threaten the continuation of pregnancy. There are no data on the pres
Vasopressin Injection, USP is a clear, colorless to practically colorless solution for intravenous administration available as: NDC 42367-570-87: A carton containing 25 x 1 mL multiple dose vials. Each vial contains vasopressin 1 mL at 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 Vasopressin Injection beyond the manufacturer’s expiration date stamped on the vial. Discard vial after 48 hours after first puncture. The storage conditions and expiration periods are summarized in the following table.
Abbreviated New Drug Application
VASOPRESSIN - VASOPRESSIN INJECTION EAGLE PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE VASOPRESSIN INJECTION, SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VASOPRESSIN INJECTION. VASOPRESSIN INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 2014 INDICATIONS AND USAGE Vasopressin Injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. (1) DOSAGE AND ADMINISTRATION Dilute 20 units/mL multiple dose vial content with normal saline (0.9% sodium chloride) or 5% dextrose in water (D5W) to either 0.1 units per mL or 1 unit per mL for intravenous administration. Discard unused diluted solution after 18 hours at room temperature or 24 hours under refrigeration. (2.1) Post-cardiotomy shock: 0.03 to 0.1 units/minute (2.2) Septic shock: 0.01 to 0.07 units/minute (2.2) DOSAGE FORMS AND STRENGTHS Injection: 20 units per mL in a multiple dose vial. To be used after dilution. (3) CONTRAINDICATIONS Vasopressin Injection is contraindicated in patients with known allergy or hypersensitivity to 8-L-arginine vasopressin or chlorobutanol. (4) WARNINGS AND PRECAUTIONS Can worsen cardiac function. (5.1) Reversible diabetes insipidus. (5.2) ADVERSE REACTIONS 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 EAGLE PHARMACEUTICALS, INC. AT 1-855- 318-2170 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH DRUG INTERACTIONS Pressor effects of catecholamines and Vasopressin Injection are expected to be additive. (7.1) Indomethacin may prolong effects of Vasopressin Injection. (7.2) Co-administration of ganglionic blockers or drugs causing SIADH may increase the pressor response. (7.3, 7.4) Co-administration of drugs causing diabetes insipidus may decrease the pressor response. (7.5) USE IN Đọc toàn bộ tài liệu