Medicinal Products

PEDEA 5 mg / mL

Generic drug of the therapeutic class: Cardiology and angiology
active ingredients: Ibuprofen
laboratory: Orphan Europe

Injectable solution
Box of 4 ampoules of 2 ml
All forms

Indication

Treatment of persistent hemodynamically significant arterial duct in preterm infants less than 34 weeks of gestational age.

Dosage PEDEA 5 mg / mL Solution for injection Box of 4 ampoules of 2 ml

Treatment with Pedea must be given in a neonatal intensive care unit under the responsibility of an experienced neonatologist.

Dosage

A cure is three injections of Pedea administered intravenously at 24 hours intervals. The first injection should be administered from the 6th hour of life. The dose of ibuprofen is adjusted according to body weight, as follows:

- 1st injection: 10 mg / kg,

- 2nd and 3rd injections: 5 mg / kg.

In case of significant anuria or oliguria after the first or second dose, wait until diuresis returns to normal before administering the next dose.

If the arterial duct has not closed 48 hours after the last injection or if it opens again, a second course of 3 doses can be administered, as indicated above. If the condition of the newborn remains unchanged after the second series of three doses, surgical treatment of the persistence of the arterial duct may be considered.

Administration mode :

Intravenous use only.

Pedea will be given as a short infusion of 15 minutes, preferably undiluted. If appropriate, the injection volume will be adjusted using either sodium chloride 9 mg / ml (0.9%) injectable solution or 50 mg / ml (5%) glucose injectable solution. Any part of the unused solution will have to be removed.

The total volume of solution injected should take into account the total volume of liquid administered per day.

Against indications

- Hypersensitivity to the active substance or to any of the excipients;

- life-threatening infection;

- Haemorrhage, especially intracranial or gastrointestinal haemorrhage;

- Thrombocytopenia or coagulation disorders;

- significant renal insufficiency;

- Congenital heart disease when the opening of the arterial duct is necessary to ensure satisfactory pulmonary or systemic blood flow (eg pulmonary atresia, severe tetralogy of Fallot, coarctation of the severe aorta);

- Necrotizing enterocolitis known or suspected.

Pedea adverse effects

Data from both the ibuprofen literature and clinical trials conducted with Pedea are currently available from approximately 1000 premature newborns. It is difficult to establish the causality of adverse effects reported in preterm infants as they may be related to both the haemodynamic consequences of the persistent ductus arteriosus and the direct effects of ibuprofen. The undesirable effects that have been reported are listed below, by organ systems and frequency. Frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100, <1/10), and uncommon (≥ 1 / 1, 000, <1/100). Within each frequency group, adverse effects are presented in descending order of severity.

Blood and lymphatic system disorders

Very common: Thrombocytopenia, Neutropenia

Nervous system disorders

Common: Intraventricular hemorrhage, Periventricular leukomalacia

Respiratory, thoracic and mediastinal disorders

Very common: Bronchopulmonary Dysplasia *

Common: Pulmonary hemorrhage

Uncommon: Hypoxemia *

Gastrointestinal disorders

Common: Necrotizing enterocolitis, Intestinal perforation

Uncommon: Gastrointestinal haemorrhage

Renal and urinary disorders

Common: Oliguria, Fluid retention, Hematuria

Uncommon: Acute renal failure

investigations

Very common: Elevated serum creatinine, decreased serum sodium

* see below

In a clinical trial on the healing effect of Pedea in 175 newborns less than 35 weeks of gestational age, the incidence of bronchopulmonary dysplasias at the 36-week post-conceptional age was 13/81. (16%) for indomethacin and 23/94 (24%) for ibuprofen. In a clinical trial on the prophylactic effect of Pedea administered during the first 6 hours of life, severe hypoxemia with pulmonary hypertension was described in 3 infants less than 28 weeks of gestational age, in the hour after the first injection. A return to normal was achieved within 30 minutes of inhaling nitric oxide.

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