Pedea

Dosage and Administration

Professionals advise the treatment of a hemodynamically significant patent ductus arteriosus in premature newborn infants less than 34 weeks of gestational age.

Dosage description

Professionals defined three intravenous injections of Pedea as a course of therapy given at 24-hour intervals. One should give the first injection after the first 6 hours of life.
The ibuprofen dose is adjusted to the bodyweight as follows:

• 1 st injection: 10 mg/kg,
• 2nd and 3rd injections of strength 5 mg/kg.

If anuria or manifest oliguria occurs in the patient after the first or second ibuprofen dosage, one should withhold the next dose until urine output returns to normal levels. If the ductus arteriosus does not close even after 48 hours of the last injection or re-opens, the second course of 3 doses, as above, may be given. If the condition doesn’t change even after the second course of therapy, the patient may need surgery of the patent ductus arteriosus.

Administration method
One should use it intravenously only.
One should administer Pedea as a short infusion over 15 minutes, preferably undiluted. If necessary, adjust the injection volume with either sodium chloride 9 mg/ml solution for injection or glucose 50 mg/ml solution for ibuprofen injection. Discard the unused portion of the solution. One should consider the total volume of solution injected and the administration of the total daily fluid volume.

Overdose
There is no case of overdosage yet in preterm newborn infants. If an overdose occurs, one should consult the doctor for further signs and worsening symptoms.

Side effects

There are numerous side effects of this medicine, and their classification is as:

Very Common
Thrombocytopenia, neutropenia, bronchopulmonary dysplasia, blood creatinine increased, and blood sodium decreased are pervasive side effects.

Common
Intraventricular haemorrhage, Periventricular leukomalacia, Pulmonary haemorrhage, Necrotizing enterocolitis, Intestinal perforation, Oliguria, Fluid retention and Haematuria are common side effects of this medicine.

Uncommon
Hypoxemia, gastrointestinal haemorrhage, and acute renal failure are known uncommon side effects of ibuprofen injection.

Precautions and Warnings

• Before administration, one should perform an adequate echocardiographic examination of ibuprofen injection to detect a hemodynamically significant patent ductus arteriosus and remove pulmonary hypertension and ductal-dependent congenital cardiac problems.
• Since one should use prophylactic in the first 3 days of life (starting within 6 hours of birth) in premature newborn infants less than 28 weeks of gestational age was associated with increased pulmonary and renal adverse events. One should not use ibuprofen injection prophylactically at any gestational age. In particular, there are reports about severe hypoxemia with pulmonary hypertension in 3 infants within one hour of the first infusion, and professionals reversed it within 30 min after the start of inhaled nitric oxide therapy. If hypoxaemia occurs during or after ibuprofen infusion, pay close attention to pulmonary pressure.
• As a nonsteroidal anti-inflammatory drug (NSAID), ibuprofen may mask the usual symptoms of infection. Therefore one should use Pedea cautiously in the presence of an infection.
• Administer Pedea carefully to avoid extravasation and potential resultant irritation to tissues.
• As ibuprofen may inhibit platelet aggregation, one should monitor the premature neonates for signs of bleeding.
• Professionals recommend that ibuprofen decrease aminoglycosides’ clearance and they also recommend strict surveillance of their serum levels during co-administration with ibuprofen.
• Professionals recommend careful monitoring of both renal and gastrointestinal function.
• In premature newborn infants less than 27 weeks of gestational age, at the recommendation of a dosing regimen, professionals observed that the closure rate of the ductus arteriosus (33 to 50%) was low.
• This medication contains less than 1 mmol sodium per 2 ml, essentially ‘sodium free’

Handling and storage

• Keep ibuprofen injection out of reach and sight of children.
• Experts recommend that the mentioned expiry date on the carton and label after Exp one should not use Pedea after the expiry date. The expiry date means the last day of that month.
• This medication does not require any special storage conditions.
• After opening, one should administer Pedea immediately.
• One should not throw medicines through wastewater or household waste. Ask the pharmacist how to throw medicines no longer required.