Last update: May 11, 2019

Urapidil

High Risk for breastfeeding


Poorly safe. Evaluate carefully.
Use safer alternative or interrupt breastfeeding 3 to 7 T½.
Read the Comment.

A centrally and peripherally-acting alpha-1 adrenergic antagonist with vasodilator effect indicated in the treatment of hypertensive crises. Administration via intravenous infusion for a maximum of one week.

Since the last update we have not found any published data on its excretion in breast milk.

Its pharmacokinetic data (Kirsten 1998 and 1988) makes it difficult to accurately predict its possible excretion in breastmilk.

Pharmacokinetics show that after 3 elimination half-lives (T½) 87.5% of the drug is eliminated from the body; after 4 T½ it is 94%, after 5 T½, 96.9%, after 6 T½, 98.4% and after 7 T½ it is 99%. From 7 T½ the plasmatic concentrations of drug in the body are negligible. In general, a period of at least five half-lives can be considered a safe waiting period before breastfeeding again (Anderson 2016).

Taking as reference the longest published T½ (Kirsten 1988) these 5 T½ would correspond to 24 hours.
To further minimize the risk it may be advisable to stop breastfeeding until 35 hours after the last dose (7 T½).

Until there is more published data on this drug in relation to breastfeeding, safer known alternatives may be preferable (Kutlesič 2015, Schaefer 2007 p685), especially during the neonatal period and in cases of prematurity.

Alternatives

Suggestions made at e-lactancia are done by APILAM´s pediatricians and pharmacists, and are based on updated scientific publications.
It is not intended to replace the relationship you have with your doctor but to compound it.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Other names

Urapidil is also known as


Urapidil in other languages or writings:

Tradenames

Main tradenames from several countries containing Urapidil in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 78 %
Molecular weight 388 daltons
Protein Binding 71 - 80 %
VD 0,8 (0,6 - 1,2) l/Kg
pKa 8,1 -
Tmax 6 hours
T1/2 3 (2,2 - 4,4) hours

References

  1. AEMPS-Takeda. Urapidil. Ficha técnica. 2018 Full text (in our servers)
  2. Anderson PO. Cancer Chemotherapy. Breastfeed Med. 2016 May;11:164-5. Abstract Full text (link to original source) Full text (in our servers)
  3. EMA. Urapidil. Drug Summary. 2015 Full text (in our servers)
  4. Kutlesič MS, Kutlesič RM, Koratevič GP. Posterior reversible encephalopathy syndrome in eclamptic patients: neuroradiological manifestation, pathogenesis and management. Med Pregl. 2015 Abstract
  5. Schaefer C, Peters P, Miller RK. Drugs During Pregnancy and Lactation. Treatment options and risk assessment. Elsevier, second edition. London. 2007
  6. Kirsten R, Nelson K, Kirsten D, Heintz B. Clinical pharmacokinetics of vasodilators. Part II. Clin Pharmacokinet. 1998 Abstract
  7. Kirsten R, Nelson K, Steinijans VW, Zech K, Haerlin R. Clinical pharmacokinetics of urapidil. Clin Pharmacokinet. 1988 Abstract

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