VASOPRESSIN injection, solution

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

VASOPRESSIN (UNII: Y4907O6MFD) (VASOPRESSIN - UNII:Y4907O6MFD)

Sẵn có từ:

American Regent, Inc.

Tuyến hành chính:

INTRAVENOUS

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Vasopressin injection is indicated to increase blood pressure in adults with vasodilatory shock who remain hypotensive despite fluids and catecholamines. Vasopressin injection 1 mL single-dose vial and 10 mL multiple-dose vial are 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 with vasopressin. 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 Clinical Pharmacology (12.3)].  Maternal adverse reactions Vasopressin injection may produce tonic uterine contractions. Vasopressin receptors are

Tóm tắt sản phẩm:

Vasopressin injection, USP is a clear, practically colorless solution for intravenous administration available as: NDC 0517-1020-25: A carton of 25 single-dose vials each containing vasopressin 1 mL at 20 units/mL. NDC 0517-1030-01: A carton of one multiple-dose vial containing vasopressin 10 mL at 20 units/mL. Store between 2°C and 8°C (36°F and 46°F). Do not freeze. Storage is permitted for up to 12 months at controlled room temperature (USP) 20°C to 25°C (68°F to 77°F) within the expiry date. Once removed from refrigeration, mark the unopened vial with the revised 12-month expiration date. Do not return Vasopressin to the refrigerator after it has been stored at room temperature. Discard the product after 12 months at room temperature or at the expiry date, whichever is earlier. The storage conditions and expiration periods are summarized in the following table. Unopened Refrigerated 2°C to 8°C (36°F to 46°F) Unopened Room Temperature 20°C to 25°C (68°F to 77°F) Do not store above 25°C (77°F) Opened (After First Puncture) 1 mL Vial Until manufacturer expiration date 12 months or until manufacturer expiration date, whichever is earlier N/A 30 days

Tình trạng ủy quyền:

New Drug Application

Đặc tính sản phẩm

VASOPRESSIN- VASOPRESSIN INJECTION, SOLUTION
AMERICAN REGENT, 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 vasopressin injection with normal saline (0.9% sodium chloride)
or 5% dextrose in water (D5W) to
either 0.1 units/mL or 1 unit/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/ mL in a single-dose vial and 200 units/10 mL (20
units/mL) in a multiple-dose vial. (3)
CONTRAINDICATIONS
Vasopressin injection 1 mL single-dose vial and 10 mL multiple-dose
vial are 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 AMERICAN REGENT, INC.
AT 1-800-734-
9236 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
(syndrome of inappropriate
antidiuretic hormone secretion) may increase the pressor response.
(7