Basic Drug Info
Drug Name:NeoProfen
Manufacturer:Ovation Pharmaceuticals
Other Info:Rx only

Clinical Trials:

Indications and Usage

NeoProfen is indicated to close a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management (e.g., fluid restriction, diuretics, respiratory support, etc.) is ineffective.

The clinical trial was conducted among infants with an asymptomatic PDA.

However, the consequences beyond 8 weeks after treatment have not been evaluated; therefore, treatment should be reserved for infants with clear evidence of a clinically significant PDA.
NeoProfen is contraindicated in:Preterm infants with proven or suspected infection that is untreated;Preterm infants with congenital heart disease in whom patency of the PDA is necessary for satisfactory pulmonary or systemic blood flow (e.g., pulmonary atresia, severe tetralogy of Fallot, severe coarctation of the aorta);Preterm infants who are bleeding, especially those with active intracranial hemorrhage or gastrointestinal bleeding;Preterm infants with thrombocytopenia;Preterm infants with coagulation defects;Preterm infants with or who are suspected of having necrotizing enterocolitis;Preterm infants with significant impairment of renal function.
Prematurity of fetus --

Communicable Diseases -- broad class of diseases whose causative agents may be passed between individuals in many different ways.

Infection -- Invasion of the host organism by microorganisms that can cause pathological conditions or diseases.

Congenital heart disease -- imperfections or malformations of the heart, existing at, and usually before, birth regardless of their causation.

INTRACRANIAL HEMORRHAGE -- Bleeding within the cranium.

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