Europe — EMA
Glypressin
Glypressin (terlipressin acetate) is an IV vasopressin analog used for acute variceal bleeding, hepatorenal syndrome, and portal hypertension.
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What is Terlipressin Acetate?
Glypressin is an injectable solution that contains terlipressin acetate as its active ingredient. Supplied as a sterile intravenous preparation, it is a vasopressin analog marketed in the European Union. The drug acts as a V1 vasopressin receptor agonist, producing vasoconstriction that helps lower portal venous pressure and control bleeding. Glypressin is prescribed for acute variceal hemorrhage and hepatorenal syndrome in patients with severe liver disease.
What is Terlipressin Acetate used for?
Glypressin is used in clinical practice to manage complications of portal hypertension and related circulatory disturbances, particularly when rapid hemodynamic control is required.
- Acute variceal bleeding in cirrhotic patients. - Hepatorenal syndrome type 1 to improve renal perfusion. - Prevention of re‑bleeding after endoscopic therapy. - Reduction of portal venous pressure during liver transplantation. - Management of severe hypotension associated with septic shock when other vasopressors are insufficient. - Adjunctive therapy in patients with advanced liver disease undergoing large‑volume paracentesis. - Supportive measure to improve renal function in patients with acute kidney injury secondary to cirrhosis.
What are the side effects of Terlipressin Acetate?
The safety profile of Glypressin reflects its vasoconstrictive activity; side effects are reported across a range of frequencies.
Common: - Headache or facial flushing, often mild and transient. - Nausea, vomiting, or abdominal discomfort that usually resolves after infusion. - Transient hypertension or a temporary rise in systolic blood pressure. - Peripheral edema or swelling of the extremities, typically mild.
Serious: - Myocardial ischemia or chest pain suggesting cardiac strain, requiring immediate evaluation. - Severe hyponatremia or other electrolyte disturbances that may need correction. - Ischemic necrosis of the skin or extremities (digital gangrene), a rare but serious complication.
What precautions apply to Terlipressin Acetate?
When prescribing Glypressin, clinicians should evaluate patient history and monitor for conditions that could be worsened by vasoconstriction.
- Cardiovascular disease such as recent myocardial infarction, uncontrolled angina, or severe heart failure. - Pre‑existing hypertension or uncontrolled blood pressure. - Renal impairment, especially in patients with acute kidney injury or chronic kidney disease. - Peripheral vascular disease or risk of ischemia in the limbs. - Pregnancy and lactation, as safety data are limited and the drug is classified as category unknown.
What does Terlipressin Acetate interact with?
Glypressin may interact with other agents that affect vascular tone, renal function, or electrolyte balance.
Avoid: - Other vasopressors (e.g., norepinephrine, phenylephrine) that could cause excessive vasoconstriction. - Vasodilators such as nitroglycerin or hydralazine, which may counteract the intended effect. - Concomitant use with drugs that prolong the QT interval, increasing cardiac risk.
Use with caution: - Diuretics, especially loop diuretics, which may exacerbate electrolyte disturbances. - ACE inhibitors or ARBs, which can influence renal perfusion. - Beta‑blockers, as they may mask tachycardia related to vasoconstriction.
Frequently asked questions
What is the mechanism of action of Glypressin?+
Which clinical conditions is Glypressin indicated for in the European Union?+
How is Glypressin administered to patients?+
What are the most common side effects reported with Glypressin?+
When should Glypressin be avoided in patients with cardiovascular disease?+
Is Glypressin safe to use during pregnancy?+
How does Glypressin affect portal venous pressure?+
What monitoring is recommended during Glypressin therapy?+
Are there any drug interactions between Glypressin and diuretics?+
What should be done if a patient develops severe hypertension while receiving Glypressin?+
How should Glypressin be stored before use?+
Is Glypressin available over the counter?+
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