Source: FDA, National Drug Code (US) Revision Year: 2020
Angiotensin II is a naturally occurring peptide hormone of the renin-angiotensin-aldosterone system (RAAS) that causes vasoconstriction and an increase in blood pressure. GIAPREZA is a sterile, aqueous solution of synthetic human angiotensin II for intravenous administration by infusion. Each 1 mL of GIAPREZA contains 2.5 mg angiotensin II equivalent to an average of 2.9 mg angiotensin II acetate, 25 mg mannitol, and Water for Injection adjusted with sodium hydroxide and/or hydrochloric acid to pH of 5.5.
The chemical name of the synthetic angiotensin II acetate is L-Aspartyl-L-arginyl-L-valyl-Ltyrosyl-L-isoleucyl-L-histidyl-L-prolyl-L-phenylalanine, acetate salt. The counter ion acetate is present in a non-stoichiometric ratio. It is a white to off-white powder, soluble in water.
The structure of angiotensin II acetate is shown below.
Molecular formula: C50H71N13O12∙ (C2H4O2)n; (n = number of acetate molecules; theoretical n = 3)
Average molecular weight: 1046.2 (as free base).
| Dosage Forms and Strengths |
|---|
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Injection: 2.5 mg/mL angiotensin II in a vial. GIAPREZA is a clear, aqueous solution. |
| How Supplied |
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GIAPREZA (angiotensin II) Injection is a clear, aqueous solution for administration by intravenous infusion supplied as a single-dose vial:
Manufactured for: La Jolla Pharmaceutical Company, San Diego, CA 92121 |
| Drug | Countries | |
|---|---|---|
| GIAPREZA | Austria, Estonia, Finland, France, Croatia, Ireland, Italy, Lithuania, Poland, Romania, United Kingdom, United States |
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