Angiotensin Ii
Generic Name: angiotensin ii
Brand Names:
Angiotensin Ii
11 DESCRIPTION Angiotensin II is a naturally occurring peptide hormone of the renin-angiotensin-aldosterone system (RAAS) that causes vasoconstriction and an increase in blood pressure. Angiotensin II Injection is a sterile, aqueous solution of synthetic human angiotensin II for intravenous administration by infusion.
Overview
11 DESCRIPTION Angiotensin II is a naturally occurring peptide hormone of the renin-angiotensin-aldosterone system (RAAS) that causes vasoconstriction and an increase in blood pressure. Angiotensin II Injection is a sterile, aqueous solution of synthetic human angiotensin II for intravenous administration by infusion.
Uses
1 INDICATIONS AND USAGE Angiotensin II Injection increases blood pressure in adults with septic or other distributive shock. Angiotensin II Injection is a vasoconstrictor to increase blood pressure in adults with septic or other distributive shock. (1)
Dosage
2 DOSAGE AND ADMINISTRATION Dilute Angiotensin II Injection in 0.9% sodium chloride prior to use. See Full Prescribing Information for instructions on preparation and administration of injection. Diluted solution may be stored at room temperature or under refrigeration and should be discarded after 24 hours. Angiotensin II Injection must be administered as an intravenous infusion. ( 2.1 ) • Start Angiotensin II Injection intravenously at 20 nanograms (ng)/kg/min. Titrate as frequently as every 5 minutes by increments of up to 15 ng/kg/min as needed. During the first 3 hours, the maximum dose should not exceed 80 ng/kg/min. Maintenance dose should not exceed 40 ng/kg/min. ( 2.2 ) 2.1.
Side Effects
6 ADVERSE REACTIONS The most common adverse reactions reported in greater than 10% in Angiotensin II treated patients were thromboembolic events. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gland Pharma at (609)-250‐7990 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. ATHOS-3 The safety of Angiotensin II was evaluated in ATHOS-3 [see Warnings and Precautions (5.1) ] .
Interactions
7 DRUG INTERACTIONS • Angiotensin converting enzyme (ACE) inhibitors ACE inhibitors may increase response to Angiotensin II. ( 7.1 ) • Angiotensin II Receptor Blockers (ARB) ARBs may reduce response to Angiotensin II. ( 7.2 ) 7.1. Angiotensin Converting Enzyme (ACE) Inhibitors Concomitant use of angiotensin converting enzyme (ACE) inhibitors may increase the response to Angiotensin II. 7.2. Angiotensin II Receptor Blockers (ARB) Concomitant use of angiotensin II blockers (ARBs) may decrease the response to Angiotensin II.
Warnings
5 WARNINGS AND PRECAUTIONS • There is a potential for venous and arterial thrombotic and thromboembolic events in patients who receive Angiotensin II. Use concurrent venous thromboembolism (VTE) prophylaxis. ( 5.1 , 6.1 ) 5.1 Risk for Thrombosis The safety of Angiotensin II was evaluated in 321 adults with septic or other distributive shock in a randomized, double-blind, placebo-controlled study, ATHOS-3. There was a higher incidence of arterial and venous thrombotic and thromboembolic events in patients who received Angiotensin II compared to placebo-treated patients in the ATHOS-3 study (13% vs. 5%). The major imbalance was in deep venous thromboses. Use concurrent venous thromboembolism (VTE) prophylaxis. 4 CONTRAINDICATIONS None. None (4.1)
Pregnancy
8.1 Pregnancy Risk Summary The published data on angiotensin II use in pregnant women are not sufficient to determine a drug-associated risk of adverse developmental outcomes. Animal reproduction studies have not been conducted with Angiotensin II. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S.
Storage
16.2. Storage and Handling • Angiotensin II Injection vials should be stored in the refrigerator (36-46°F, 2-8°C). • Discard prepared diluted solution after 24 hours at room temperature or under refrigeration. Manufactured by: Gland Pharma Limited Hyderabad -502307, INDIA Revised: September, 2022
Frequently Asked Questions
What is Angiotensin Ii used for?▼
1 INDICATIONS AND USAGE Angiotensin II Injection increases blood pressure in adults with septic or other distributive shock. Angiotensin II Injection is a vasoconstrictor to increase blood pressure in adults with septic or other distributive shock. (1)
What are the side effects of Angiotensin Ii?▼
6 ADVERSE REACTIONS The most common adverse reactions reported in greater than 10% in Angiotensin II treated patients were thromboembolic events. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gland Pharma at (609)-250‐7990 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. ATHOS-3 The safety of Angiotensin II was evaluated in ATHOS-3 [see Warnings and Precautions (5.1) ] .
Can I take Angiotensin Ii during pregnancy?▼
8.1 Pregnancy Risk Summary The published data on angiotensin II use in pregnant women are not sufficient to determine a drug-associated risk of adverse developmental outcomes. Animal reproduction studies have not been conducted with Angiotensin II. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S.
What are the important warnings for Angiotensin Ii?▼
5 WARNINGS AND PRECAUTIONS • There is a potential for venous and arterial thrombotic and thromboembolic events in patients who receive Angiotensin II. Use concurrent venous thromboembolism (VTE) prophylaxis. ( 5.1 , 6.1 ) 5.1 Risk for Thrombosis The safety of Angiotensin II was evaluated in 321 adults with septic or other distributive shock in a randomized, double-blind, placebo-controlled study, ATHOS-3. There was a higher incidence of arterial and venous thrombotic and thromboembolic events in patients who received Angiotensin II compared to placebo-treated patients in the ATHOS-3 study (13% vs. 5%). The major imbalance was in deep venous thromboses. Use concurrent venous thromboembolism (VTE) prophylaxis. 4 CONTRAINDICATIONS None. None (4.1)
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.