Prostin VR Pediatric (Alprostadil) Drug Information: Side Effects and Drug Interactions

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May 27, 2012

Prostin VR Pediatric

Congenital Heart Defects »

What are congenital heart defects?

Congenital (kon-JEN-i-tal) heart defects are problems with the heart's structure that are present at birth. These defects can involve the interior walls of the heart, valves inside the heart, or the arteries and veins that carry blood to the heart or out to the body. Congenital heart defects change the normal flow of blood through the heart.

There are many different types of congenital heart defects. They range from simple defects with no symptoms to complex defects with severe, life-threatening symptoms.

Congenital heart defects are the most common type of birth defect, affecting 8 of every 1,000 newborns. Each year, more than 35,000 babies in the United States are born with congenital heart defects. Most of these defects are simple conditions that are easily fixed or need no treatment.

A small number of babies are born with complex congenital heart defects that need special medical attention soon afte...

Read the Congenital Heart Defects article »

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Prostin VR Pediatric

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SIDE EFFECTS

Prostin VR Pediatric (alprostadil) Sterile Solution

Central Nervous System Apnea has been reported in about 12% of the neonates treated. (See BOXED WARNING.) Other common adverse reactions reported have been fever in about 14% of the patients treated and seizures in about 4%. The following reactions have been reported in less than 1% of the patients: cerebral bleeding, hyperextension of the neck, hyperirritability, hypothermia, jitteriness, lethargy, and stiffness.

Cardiovascular System: The most common adverse reactions reported have been flushing in about 10% of patients (more common after intraarterial dosing), bradycardia in about 7%, hypotension in about 4%, tachycardia in about 3%, cardiac arrest in about 1%, and edema in about 1%. The following reactions have been reported in less than 1% of the patients: congestive heart failure, hyperemia, second degree heart block, shock, spasm of the right ventricle infundibulum, supraventricular tachycardia, and ventricular fibrillation.

Respiratory System: The following reactions have been reported in less than 1% of the patients: bradypnea, bronchial wheezing, hypercapnia, respiratory depression, respiratory distress, and tachypnea.

Gastrointestinal System: See WARNINGS. The most common adverse reaction reported has been diarrhea in about 2% of the patients. The following reactions have been reported in less than 1% of the patients: gastric regurgitation, and hyperbilirubinemia.

Hematologic System: The most common hematologic event reported has been disseminated intravascular coagulation in about 1% of the patients. The following events have been reported in less than 1% of the patients: anemia, bleeding, and thrombocytopenia.

Excretory System: Anuria and hematuria have been reported in less than 1% of the patients.

Skeletal System: Cortical proliferation of the long bones has been reported. See PRECAUTIONS.

Miscellaneous: Sepsis has been reported in about 2% of the patients. Peritonitis has been reported in less than 1% of the patients. Hypokalemia has been reported in about 1% and hypoglycemia and hyperkalemia have been reported in less than 1% of the patients.

DRUG INTERACTIONS

Prostin VR Pediatric (alprostadil) Sterile Solution

No drug interactions have been reported between Prostin VR Pediatric (alprostadil) and the therapy standard in neonates with restricted pulmonary or systemic blood flow. Standard therapy includes antibiotics, such as penicillin and gentamicin; vasopressors, such as dopamine and isoproterenol; cardiac glycosides; and diuretics, such as furosemide.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.