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Drug | Timing | Dose | Route | Duration | Benefits | Limitations | Recommendations |
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Indomethacin | Prophylactic (within 48 hours of life) | 0.1 mg/kg per dose | Intravenous | 3 to 5 doses every 24 hours | (1) Reduce symptomatic PDA (2) Reduce the need for duct ligation (3) Decrease severe IVH | (1) Decrease cerebral perfusion (2) Worsen the short-term respiratory outcomes (3) No evidence of benefit on neurodevelopmental outcome | Evidence does not recommend prophylactic therapy (Grade 1B) |
Therapeutic (1) early presymptomatic (before 7 days), (2) late symptomatic (after 7 days) | 0.2 mg/kg/dose | Intravenous | 3 to 5 doses every 12 hours | (1) Reduce the need for duct ligation (2) Reduce duct-related morbidities (BPD)
| (1) Hyponatremia (2) Oliguria (3) Active bleeding (4) Transient impairment of renal function (5) NEC (stage II and III) (6) IVH (7) Focal gastrointestinal perforation | (1) Evidence does not recommend early presymptomatic therapy (2) Evidence supports late symptomatic therapy for HS-PDA in mechanical ventilation dependent infants (Grade 2B) |
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Ibuprofen | Prophylactic (within 48 hours of life) | 10 mg/kg followed by two additional doses of 5 mg/kg given at 24-hour intervals | (1) Intravenous (2) Oral | 3 doses every 24 hours | (1) Decrease the incidence of PDA on day three (2) Decreased the need for rescue treatment with indomethacin (3) Decreased the need for surgical ligation | (1) Transient impairment of renal function (2) Increase the risk for hyperbilirubinemia with high doses (3) Inhibit platelet adhesiveness (4) Oral ibuprofen increases the risk of GIT bleeding and NEC (5) No significant differences in mortality, IVH, or BPD | Evidence does not recommend prophylactic therapy (Grade 1B) |
Therapeutic (1) early presymptomatic (before 7 days), (2) late symptomatic (after 7 days) | 10 mg/kg followed by two additional doses of 5 mg/kg given at 24-hour intervals | (1) Intravenous (2) Oral | 3 doses every 24 hours | (1) Reduce the need for duct ligation (2) Reduce duct-related morbidities (BPD)
| (1) Transient impairment of renal function (2) Increase the risk for hyperbilirubinemia with high doses (3) Inhibit platelet adhesiveness (4) Oral ibuprofen increases the risk of GIT bleeding (5) No significant differences in mortality, IVH, or BPD | (1) Evidence does not recommend early therapy (2) Evidence supports late therapy for HS-PDA in mechanical ventilation dependent infants (Grade 2B) |
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Paracetamol | Prophylactic | No available data | No available data | No available data | No available data | No available data | No available evidence |
Therapeutic | 15 mg/kg per dose | (1) Oral (2) Intravenous | 12 doses every 6 hours for 3 days | (1) Close HS-PDA | No available data | Evidence from small case series supports its use. |
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