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Brand Name :
Giapreza
Synonyms :
synthetic human angiotensin II
Class :
Angiotensin II Agonists, Vasopressors
Dosage Forms & StrengthsÂ
Intravenous injectable solutionÂ
5mg/2mlÂ
2.5mg/mlÂ
Indicated for Shock
Initial dose: 20ng/Kg/min intravenously by constant infusion
Titration dose: Check the blood pressure levels and titrate every 5 minutes up to 15 ng/kg/min as needed to achieve the desired blood pressure levels. Should not exceed 80 ng/kg/min while the first 3 hours of the treatment
Maintenance dose: dose as low as 1.25 ng/kg/min. Should not exceed 40 ng/kg/min
After the improvement of the Shock condition, titrate downward every 5-15 minutes up to 15 ng/kg/min, depending upon blood pressure levels
Administration through the central venous line is generally recommended
Note:
It is indicated to enhance blood pressure levels in adults with septic or distributive shock
Actions and Spectrum:Â
Angiotensin II is an essential hormone in regulating blood pressure and fluid balance. synthetic human angiotensin II is a laboratory-created version of this hormone that can be used in medical treatments.Â
The action of synthetic human angiotensin II is similar to that of the natural hormone. When administered to the body, it acts on the angiotensin receptors in the blood vessels, causing them to constrict. This leads to increased blood pressure, which can help treat conditions such as hypotension (low blood pressure) or septic shock.Â
In addition to its effects on bp, synthetic human angiotensin II can also stimulate the production of aldosterone, a hormone that regulates salt, water balance in the body. This can help treat conditions such as adrenal insufficiency or salt-wasting syndromes.Â
Overall, the spectrum of synthetic human angiotensin II includes its ability to increase blood pressure and stimulate aldosterone production. It is used in certain medical situations where these effects can be beneficial. Still, it is essential to carefully monitor patients who receive this treatment to avoid potential side effects, such as fluid retention, electrolyte imbalances, and kidney damage.Â
Frequency definedÂ
>10%Â
Thromboembolic events (12.9%)Â
1-10%Â
Fungal infection (6.1%)Â
Thrombocytopenia (9.8%)Â
Acidosis (5.5%)Â
Delirium (5.5%)Â
Tachycardia (8.6%)Â
Hyperglycemia (4.3%)Â
Peripheral ischemia (4.3%)Â
Deep vein thrombosis (4.3%)Â
Black Box Warning:Â
The black box warning for synthetic human angiotensin II relates to its potential to cause blood clots (thromboembolic events) and thrombosis at the site of intravenous catheter insertion.Â
The warning advises healthcare providers to closely monitor patients receiving synthetic human angiotensin II for signs of thromboembolic events, such as DVT (deep vein thrombosis), pulmonary embolism (PE), and arterial thrombosis.
Providers should also take precautions to minimize the risk of catheter-related thrombosis, including using the lowest effective dose of the medication and monitoring the insertion site for signs of thrombosis.Â
It is key to note that the risk of thromboembolic events is more significant in specific patient populations, like as those with a history of blood clots or immobilized for extended periods. Therefore, synthetic human angiotensin II should be used cautiously in these patients, and the treatment’s potential benefits and risks should be carefully weighed.Â
Contraindication/Caution:Â
ContraindicationÂ
synthetic human angiotensin II is contraindicated in patients with a known hypersensitivity to angiotensin II or any of the components of the formulation. It is contraindicated in patients with a prior history of angioedema (swelling of the lips, face, tongue, or throat) associated with previous angiotensin-converting enzyme inhibitor or angiotensin receptor blocker (ARB) therapy.Â
Additionally, synthetic human angiotensin II should not be used in patients with severe aortic or mitral valve stenosis (narrowing of the heart valves) or uncontrolled hypertension. TÂ
Finally, the safety and efficacy of synthetic human angiotensin II have not been established in specific patient populations, such as pregnant/breastfeeding women, pediatric patients, and patients with severe or end-stage renal impairment.Â
CautionÂ
synthetic human angiotensin II should be used with caution in several patient populations, including:Â
Pregnancy consideration:Â Â
US FDA pregnancy category: Not assignedÂ
Lactation:  Â
Excreted into human milk is Not known.Â
Pregnancy category:Â
Pharmacology:Â
synthetic human angiotensin II is a medication miming the effects of the naturally occurring hormone angiotensin II. Angiotensin II is a potent vasoconstrictor that enhances bp and stimulates the release of aldosterone from the adrenal glands, leading to increased sodium reabsorption and potassium excretion by the kidneys.Â
The pharmacology of synthetic human angiotensin II is similar to endogenous angiotensin II. It binds to angiotensin II receptors in vascular smooth muscle cells, causing vasoconstriction and increased blood pressure. synthetic human angiotensin II also stimulates aldosterone secretion, which can increase sodium reabsorption and potassium excretion by the kidneys.Â
Pharmacodynamics:Â
Mechanism of action: The renin-angiotensin-aldosterone system is regulated by angiotensin II, the major bioactive component. It serves as a central regulator of blood pressure in the body. Angiotensin II enhances blood pressure by causing vasoconstriction and increasing the release of aldosterone. Angiotensin II’s direct effect on the vessel wall is facilitated by binding to G-protein-coupled angiotensin II receptors type 1 on the vascular smooth muscle cells. This binding stimulates Ca2+ or calmodulin-dependent phosphorylation of myosin, leading to smooth muscle contraction.Â
Pharmacokinetics:Â
AbsorptionÂ
synthetic human angiotensin II is administered as an intravenous infusion and does not undergo absorption through the gastrointestinal tract.Â
DistributionÂ
Following infusion, the medication rapidly distributes throughout the body, with a volume of distribution of 12 L.Â
MetabolismÂ
synthetic human angiotensin II is primarily metabolized in the liver by angiotensinases, which cleave the molecule into smaller fragments that are excreted in the urine. The half-life of synthetic human angiotensin II is short, with a mean elimination half-life of approximately 1-2 minutes.Â
Elimination and ExcretionÂ
synthetic human angiotensin II excretion occurs primarily through renal clearance, with approximately 30% of the dose excreted unchanged in the urine. The medication is not dialyzable, and there is no evidence of accumulation in patients with renal impairment.Â
Administration:Â
Intravenous administrationÂ
synthetic human angiotensin II is administered intravenously using an infusion pump. The recommended starting dose is 20 ng/kg/min, and the dose can be titrated up to a maximum of 200 ng/kg/min based on the patient’s response and blood pressure goals.Â
The medication is typically given in an intensive care unit (ICU) or hospital setting under the supervision of healthcare providers experienced in managing critically ill patients. Blood pressure, heart rate, and electrolyte levels should be monitored during infusion, and the infusion rate may need to be adjusted depend upon the patient’s response and vital signs.Â
synthetic human angiotensin II should be administered through a central venous catheter (CVC) to minimize the risk of thromboembolic events and catheter-related complications. The CVC should be flushed with saline before and after each infusion to maintain patency and prevent infection.Â
The duration of treatment with synthetic human angiotensin II will depend on the patient’s clinical response and the underlying condition being treated. In general, the medication is used for short-term treatment of hypotension or shock in critically ill patients, with treatment typically lasting no more than 48 hours.Â
In summary, synthetic human angiotensin II is administered as an intravenous infusion using an infusion pump and a central venous catheter. Close monitoring of vital signs and electrolyte levels is necessary during infusion, and the duration of treatment is typically short-term.Â
Patient information leafletÂ
Generic Name: synthetic human angiotensin IIÂ
Pronounced: [ an-jee-oh-TEN-sin-too ]Â
Why do we use synthetic human angiotensin II?Â
synthetic human angiotensin II is a medication used to treat hypotension (low blood pressure) and shock in critically ill adult patients. It works by constricting blood vessels and increasing blood pressure, which can help to restore perfusion to vital organs and improve tissue oxygenation.Â
Specific uses of synthetic human angiotensin II include:Â