DosageTreatment should only be carried out in a neonatal intensive care unit under the supervision of an experienced neonatologist.
A course of therapy is defined as three intravenous doses given at 24-hour intervals. The first injection should be given after the first 6 hours of life. The ibuprofen dose is adjusted to the body weight as follows:
1st injection - 10 mg/kg
2nd and 3rd injections - 5mg/kg
If the ductus arteriosus does not close 48 hours after the last injection or if it re-opens, a second course of 3 doses, as above, may be given. If the condition is unchanged after the second course of therapy, surgery of the patent ductus arteriosus may be necessary.
For intravenous use only.
The dose should be administered as a short infusion over 15 minutes, preferably undiluted. If necessary, the injection volume may be adjusted with either sodium chloride 9 mg/ml (0.9%) solution for injection or glucose 50 mg/ml (5%) solution for injection. Any unused portion of the solution should be discarded.
The total volume of solution injected should take into account the total daily fluid volume administered.
If anuria or manifest oliguria occurs after the first or second dose, the next dose should be withheld until urine output returns to normal levels.
The ampoule should not be treated with chlorhexidine solutions before opening as chlorhexidine is incompatible with ibuprofen injection solution. Ethanol 60% or isopropyl alcohol 70% may be used and the ampoule should be completely dry before it is opened.
Any unused product or waste material should be disposed of in accordance with local requirements.
IncompatibilitiesIbuprofen injection solution is incompatible with with all acidic solutions. If any such solution , such a antibiotics or diuretics, are given through the same infusion line, the line must be flushed over 15 minutes with 1.5 to 2ml of glucose 5% injection or sodium chloride 0.9% injection.
Precautions and Warnings
An adequate echocardiographic examination should be performed prior to treatment in order to detect a haemodynamically significant patent ductus arteriosus and to exclude pulmonary hypertension and ductal-dependant congenital heart disease.
Ibuprofen injection should not be used prophylactically at any gestational age.
Prophylactic use in the first 3 days of life (starting within 6 hours of birth) in preterm newborn infants less than 28 weeks of gestational age was associated with increased pulmonary and renal adverse events. In particular, severe hypoxemia with pulmonary hypertension was reported in 3 infants within one hour of the first infusion and was reversed within 30 minutes after the start of inhaled nitric oxide therapy.
Ibuprofen has been shown in vitro to displace bilirubin from its binding site to albumin. The risk of bilirubin encephalopathy in premature newborn infants may be increased, and therefore ibuprofen should not be used in infants with marked elevated bilirubin concentration.
As a non-steroidal anti-inflammatory drug (NSAID), ibuprofen may mask the usual signs and symptoms of infection. Therefore ibuprofen must be used cautiously in the presence of infection.
Ibuprofen should be administered carefully to avoid extravasation and potential resultant irritation to tissues.
Premature neonates should be monitored for signs of bleeding since ibuprofen may inhibit platelet aggregation.
Monitoring of both renal and gastrointestinal function is recommended.
In preterm newborn infants less than 27 weeks of gestational age, the closure rate of the ductus arteriosus (33-50%) was shown to be low at the recommended dose regimen.
This medicinal product contains less than 1 mmol sodium (15mg) per 2ml, i.e. essentially 'sodium-free'.
Blood creatinine increased
Acute renal failure
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
BNF for Children (2011-2012) Pharmaceutical Press, London.
Summary of Product Characteristics: Pedea 5mg/ml Solution for injection. Orphan Europe. July 2009.
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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