Urapidil
Regulatory sources consulted
- AEMPS CIMA Ficha Técnica: 76741 (https://cima.aemps.es/cima/dochtml/ft/76741/FT_76741.html)
- AEMPS CIMA · nº registro 76741 ↗
- RxNorm rxcui 39230 ↗
Approved indications
- Hypertensive crises.
- Severe and very severe hypertension. Treatment-resistant hypertension.
- Controlled reduction of blood pressure in hypertensive patients during and/or after surgery.
Contraindications
Absolute
- Hypersensitivity to the active substance or to any of the excipients.
- Stenosis of the aortic isthmus or arteriovenous shunt (except for hemodynamically inactive dialysis shunt).
Clinical warnings
- Major warning · Risk of hypotension: An excessive drop in blood pressure may cause reflex bradycardia. Use with caution in patients with heart failure, aortic/mitral valve stenosis, pulmonary embolism, or impaired cardiac function. — AEMPS CIMA
Drug interactions
- ModerateOther antihypertensive agentsC02, C03, C07, C08, C09
Mechanism: Additive or synergistic antihypertensive effect.
Recommendation: Monitor blood pressure closely. Dose adjustment may be necessary.
AEMPS CIMA
- ModerateCimetidineA02BA01
Mechanism: Cimetidine can increase urapidil serum levels by up to 15% through inhibition of its metabolism.
Recommendation: Monitor clinical response and blood pressure. Consider a dose reduction of urapidil if necessary.
AEMPS CIMA
- LowAlcoholV03AB16
Mechanism: The antihypertensive effect of urapidil may be enhanced.
Recommendation: Advise patients to avoid or limit alcohol consumption during treatment.
AEMPS CIMA
Adverse events
Common (≥1%)
dizziness · headache · nausea
Rare but serious
thrombocytopenia · priapism
Pregnancy and lactation
Pregnancy: Urapidil is not recommended during pregnancy. Lactation: Due to lack of data, breastfeeding is contraindicated.