- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
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Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
No information
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
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Available formulations
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Dosages
| Keeping the ductus arteriosus open while waiting for an operation |
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Renal impaiment in children > 3 months
No information available on dose adjustment in renal impairment.
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The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here
Side effects in children
Very common (> 10%): apnoea (particularly for birthweights of < 2 kg and in the first hours of the intravenous administration), fever, flushing
Common (1-10%): convulsions, bradycardia, hypotension, tachycardia, cardiac arrest, disseminated intravascular coagulation, diarrhoea, superficial vasodilatation (more often in intra-arterial administration), oedema, septicaemia, hypokalaemia, hypertension. Dizziness, headache.Sepsis. Backpain. Cough, flu-like symptoms, nasal congestion, sinusitis, upper respiratory tract infection.
Occasionally (0,1-1%): Anemia, anuria, bradypnea, cardiac failure, cerebral hemorrhage, gastroesophageal reflux disease, hematuria, hemorrhage, hyperbilirubinemia, hyperemia, hyperirritability, hyperkalemia, hypoglycemia, hypothermia, jitteriness, lethargy, neck hyperextension, peritonitis, second degree atrioventricular block, shock, stiffness, supraventricular tachycardia, thrombocytopenia, ventricular fibrillation, wheezing (bronchial)
Rare (0.01-0.1%): vascular fragility, gastric obstruction, hypertrophy of the gastric mucosa, exostosis.
Also reported: reversible cortical proliferation of the long bones (after long-term use).
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The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here
Contra-indications in children
Spontaneous patent ductus arteriosus botalli as an isolated defect in neonates [SmPC Minprog®]; Do not use in "Respiratory Distress Syndrome" (RDS) due to hyaline membrane disease.
The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here
Warnings & precautions in children
Administer via a central venous catheter, or add a second infusion if peripheral.
Alprostadil must only be used in hospitals where a paediatric intensive care ward is present. Because of the greater risk of apnoea, monitor the respiration; intubate and ventilate if necessary. Treat for as short a time as possible and with the lowest possible dose.
In neonates with reduced pulmonary circulation, the effectiveness of alprostadil is measured by monitoring the increase in oxygenation of the blood; if systemic circulation is reduced, the effectiveness is determined by monitoring the increase in the systemic blood pressure and the pH of the blood.
Check the arterial pressure regularly; reduce the administration rate immediately if there is a significant drop.
Be careful if there is an increased tendency to bleed because prostaglandin E1 inhibits platelet aggregation.
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Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
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| Other cardiac preparations | ||
|---|---|---|
| C01EB16 | ||
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References
- Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
- Pfizer BV, SmPC Prostin VR (RVG 10041) 12-05-2017, www.geneesmiddeleninformatiebank.nl
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Changes
Changes
