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Ibuprofen Gen.Orph is a brand name for Ibuprofen. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of a haemodynamically significant patent ductus arteriosus in preterm newborn infants less than 34 weeks of gestational age.
Verbatim from this product's EMA label. Tap a section to expand.
Orph should only be carried out in a neonatal intensive care unit under the supervision of an experienced neonatologist. Orph 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: 5 mg/kg.
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. 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 then be necessary. Method of administration For intravenous use only. Orph should be administered as a short infusion over 15 minutes, preferably undiluted.
3 The total volume of solution injected should take into account the total daily fluid volume administered. 6.
Data are currently available on approximately 1 000 preterm newborn from both the literature and clinical trials with ibuprofen. Causality of adverse events reported in the preterm newborn is difficult to assess since they may be related to the haemodynamic consequences of the patent ductus arteriosus as well as to direct effects of ibuprofen.
Tabulated list of adverse reactions - Reported adverse reactions are listed in the table below according to MedDRA system organ class and frequency. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1 000, < 1/100), rare (≥ 1/10 000, < 1/1 000), very rare (< 1/10 000), and not known (cannot be estimated from the available data).
. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Table 1. Tabulated list of adverse reactions System organ class (SOC) Frequency Adverse reaction Blood and lymphatic system disorders Very common Thrombocytopenia, Neutropenia 5 Nervous system disorders Common Intraventricular haemorrhage, Periventricular leukomalacia Respiratory, thoracic and mediastinal disorders Very common Bronchopulmonary dysplasia* Common Pulmonary haemorrhage Uncommon Hypoxemia* Gastrointestinal disorders Common Necrotizing enterocolitis, Intestinal perforation Uncommon Gastrointestinal haemorrhage Not known Gastric perforation Skin and subcutaneous tissue disorders Not known Acute generalised exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) Renal and urinary disorders Common Oliguria, Fluid retention, Haematuria Uncommon Acute renal failure Investigations Very common Blood creatinine increased, Blood sodium decreased * see below In a clinical curative trial involving 175 preterm newborn infants less than 35 weeks of gestational age, the incidence of bronchopulmonary dysplasia at 36 weeks post-conceptional age was 13/81 (16%) for indomethacin versus 23/94 (24%) for ibuprofen.
Orph an adequate echocardiographic examination should be performed in order to detect a haemodynamically significant patent ductus arteriosus and to exclude pulmonary hypertension and ductal-dependent congenital heart disease. 1). In particular, severe hypoxemia with pulmonary hypertension was reported in 3 infants within one hour of the first infusion and was reversed within 30 min after start of inhaled nitric oxide therapy.
Orph infusion, close attention should be paid to pulmonary pressure. 2). 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.
3). Orph should be administered carefully to avoid extravasation and potential resultant irritation to tissues. As ibuprofen may inhibit platelet aggregation, premature neonates should be monitored for signs of bleeding. As ibuprofen may decrease the clearance of aminoglycosides, strict surveillance of their serum levels is recommended during co-administration with ibuprofen.
Careful monitoring of both renal and gastrointestinal function is recommended. 8). Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment.
Acute generalised exanthematous pustulosis (AGEP) and drug reaction with eosinophilia 4 and systemic symptoms (DRESS syndrome) have been reported in relation to ibuprofen-containing products. Ibuprofen should be discontinued, at the first appearance of signs and symptoms of severe skin reactions, such as skin rash, mucosal lesions, or any other sign of hypersensitivity.
1). Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per 2 mL, that is to say essentially 'sodium-free'.
1. - Life-threatening infection. - Active bleeding, especially intracranial or gastrointestinal haemorrhage. - Thrombocytopenia or coagulation defects. - Significant impairment of renal function. g. pulmonary atresia, severe tetralogy of Fallot, severe coarctation of the aorta).
- Known or suspected necrotising enterocolitis.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Ibuprofen in European Union.
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In a clinical trial where ibuprofen was administered prophylactically during the first 6 hours of life, severe hypoxemia with pulmonary hypertension was reported in 3 newborn infants less than 28 weeks of gestational age. This occurred within one hour of the first infusion and was reversed within 30 minutes after the inhalation of nitric oxide.
There have also been post-marketing reports of pulmonary hypertension where ibuprofen was administered to premature neonates in the therapeutic setting. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.