Prostin VR Pediatric

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using alprostadil and call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• bleeding after an injection;
• a painful erection that lasts 4 hours or longer;
• new or worsening pain in your penis; or
• redness, swelling, tenderness, lumps, unusual shape or curving of the erect penis.

Common side effects may include:

• mild pain in your penis, urethra, or testicles;
• redness of the penis; or
• warmth or burning in your urethra.

Your sex partner may have side effects such as burning, itching, or irritation of body areas that come into contact with your penis.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Prostin VR Pediatric (Alprostadil)

Prostin VR Pediatric Professional Information

SIDE EFFECTS

Central Nervous System

Apnea has been reported in about 12% of the neonates treated. (See WARNING BOX.) 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.

Read the entire FDA prescribing information for Prostin VR Pediatric (Alprostadil)

&Copy; Prostin VR Pediatric Patient Information is supplied by Cerner Multum, Inc. and Prostin VR Pediatric Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.