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. Each 1 mL of Angiotensin II Injection contains 2.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Angiotensin II raises blood pressure by vasoconstriction and increased aldosterone release. Direct action of angiotensin II on the vessel wall is mediated by binding to the G-protein coupled-angiotensin II receptor type 1 on vascular smooth muscle cells, which stimulates Ca 2+ /calmodulin-dependent phosphorylation of myosin and causes smooth muscle contraction. 12.2 Pharmacodynamics For the 114 (70%) patients in the Angiotensin II arm who reached the target MAP at Hour 3, the median time to reach the target MAP endpoint was approximately 5 minutes. Angiotensin II is titrated to effect for each individual patient. 12.
Indications
- 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)
Common Doses
- 2.5 mg
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.
Contraindications
- 4 CONTRAINDICATIONS None. None (4.1)
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.
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.