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Prostin VR Pediatric

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Prostin VR Pediatric

Prostin VR Pediatric Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Prostin VR Pediatric (alprostadil) Injection is a prostaglandin used to improve blood flow in newborn babies with congenital heart defects. It is available in generic form. Common side effects of Prostin VR Pediatric include fever, wheezing, and diarrhea.

The recommended dose of Prostin VR Pediatric is 0.05 to 0.1 micrograms per kilogram of body weight per minute. Prostin VR Pediatric must be administered under a doctor's supervision. Other drugs may interact with Prostin VR Pediatric. Tell your doctor all medications your baby has been given. Tell your doctor if your baby has respiratory distress syndrome. Prostin VR Pediatric is not indicated for women of childbearing age. Do not take Prostin VR Pediatric if you are pregnant or breastfeeding.

Our Prostin VR Pediatric (alprostadil) Injection, USP Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Prostin VR Pediatric in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these 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 serious side effect such as:

  • feeling light-headed, fainting;
  • trouble urinating, blood in your urine;
  • bleeding, bruising, or swelling where you injected the medication;
  • a painful erection that lasts 4 hours or longer;
  • severe pain or irritation of your penis or urethra; or
  • redness, lumps, tenderness, unusual shape or curving of the erect penis.

Less serious side effects may include:

  • unusual discharge from your penis; or
  • mild pain in your penis, urethra, or testicles;
  • headache, dizziness;
  • back pain;
  • a rash on the skin of your penis;
  • itching, warmth, or numbness of your penis;
  • cough, stuffy nose, cold symptoms, flu symptoms.

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.

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

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

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Prostin VR Pediatric FDA Prescribing Information: Side Effects
(Adverse Reactions)

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.

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

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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