prostin vr pediatric
Pharmaranks rates Prostin Vr Pediatric 3.2/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Prostin Vr Pediatric (Alprostadil) is a prostaglandin analog used to treat Aortic Arch Syndromes, Aortic Coarctation, Patent Ductus Arteriosus, Pulmonary Hypertension.
Alprostadil · by Pfizer
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Alprostadil
- Drug class
- Prostaglandin Analog
- Form
- Injectable
- Strength
- Alprostadil 0.5MG/ML
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Pfizer
- FDA application
- NDA018484
- FDA boxed warning
- Yes — see the boxed warning
What is Prostin Vr Pediatric?
From the FDA label:Sterile Solution for intravascular infusion contains 500 micrograms alprostadil, more commonly known as prostaglandin E 1 , in 1.0 mL dehydrated alcohol. The chemical name for alprostadil is (11α,13E,15S)-11,15 dihydroxy-9-oxo-prost-13-en-1-oic acid, and the molecular weight is 354.49. Alprostadil is a white to off-white crystalline powder with a melting point between 110° and 116°C. Its solubility at 35°C is 8000 micrograms per 100 mL double distilled water. Structural Formula Chemical Structure
How to use
The preferred route of administration for PROSTIN VR PEDIATRIC Sterile Solution is continuous intravenous infusion into a large vein. Alternatively, PROSTIN VR PEDIATRIC may be administered through an umbilical artery catheter placed at the ductal opening. Increases in blood pO 2 (torr) have been the same in neonates who received the drug by either route of administration. Begin infusion with 0.05 to 0.1 micrograms alprostadil per kilogram of body weight per minute. A starting dose of 0.1 micrograms per kilogram of body weight per minute is the recommended starting dose based on clinical studies; however, adequate clinical response has been reported using a starting dose of 0.05 micrograms per kilogram of body weight per minute. After a therapeutic response is achieved (increased pO 2 in infants with restricted pulmonary blood flow or increased systemic blood pressure and blood pH in infants with restricted systemic blood flow), reduce the infusion rate to provide the lowest possible dosage that maintains the response. This may be accomplished by reducing the dosage from 0.1 to 0.05 to 0.025 to 0.01 micrograms per kilogram of body weight per minute. If response to 0.05 micrograms per kilogram of body weight per minute is inadequate, dosage can be increased up to 0.4 micrograms per kilogram of body weight per minute although, in general, higher infusion rates do not produce…
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.…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
Apnea is experienced by about 10 to 12% of neonates with congenital heart defects treated with PROSTIN VR PEDIATRIC Sterile Solution. Apnea is most often seen in neonates weighing less than 2 kg at birth and usually appears during the first hour of drug infusion. Therefore, respiratory status should be monitored throughout treatment, and PROSTIN VR PEDIATRIC should be used where ventilatory assistance is immediately available.
Warnings
Important safety information
See WARNING box. NOTE: PROSTIN VR PEDIATRIC Sterile Solution must be diluted before it is administered. See dilution instructions in DOSAGE AND ADMINISTRATION section. The administration of PROSTIN VR PEDIATRIC to neonates may result in gastric outlet obstruction secondary to antral hyperplasia. This effect appears to be related to duration of therapy and cumulative dose of the drug. Neonates receiving PROSTIN VR PEDIATRIC at recommended doses for more than 120 hours should be closely monitored for evidence of antral hyperplasia and gastric outlet obstruction. PROSTIN VR PEDIATRIC should be infused for the shortest time and at the lowest dose that will produce the desired effects. The risks of long-term infusion of PROSTIN VR PEDIATRIC should be weighed against the possible benefits that critically ill infants may derive from its administration.
Who should not take Prostin Vr Pediatric
None.
Overdose — what happens if you take too much
Apnea, bradycardia, pyrexia, hypotension, and flushing may be signs of drug overdosage. If apnea or bradycardia occurs, discontinue the infusion, and provide appropriate medical treatment. Caution should be used in restarting the infusion. If pyrexia or hypotension occurs, reduce the infusion rate until these symptoms subside. Flushing is usually a result of incorrect intraarterial catheter placement, and the catheter should be repositioned.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
No drug interactions have been reported between PROSTIN VR PEDIATRIC 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.
Drug class
- Prostaglandin Analog
- Prostaglandin E1 Agonist
How this class works, per Latanoprost - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
- aortic arch syndromes
- aortic coarctation
- patent ductus arteriosus
- pulmonary hypertension
- pulmonary valve stenosis
- tetralogy of fallot
See how Prostin Vr Pediatric ranks — best-rated prostaglandin analog for:
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Prostin Vr Pediatric treat?
- Prostin Vr Pediatric (Alprostadil) may be used to treat aortic arch syndromes, aortic coarctation, patent ductus arteriosus, pulmonary hypertension, pulmonary valve stenosis, tetralogy of fallot, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Prostin Vr Pediatric work?
- Prostin Vr Pediatric is a prostaglandin analog. Prostaglandin analogs (used as eye drops for glaucoma) activate FP receptors that relax the eye's drainage tissues, helping fluid flow out more easily. This lowers the pressure inside the eye and protects the optic nerve.
- How is Prostin Vr Pediatric rated?
- pharmaranks gives Prostin Vr Pediatric a composite score of 3.2 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Prostin Vr Pediatric?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Prostin Vr Pediatric. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Prostin Vr Pediatric?
- Prostin Vr Pediatric is marketed by Pfizer. You can see Pfizer's full profile, rating, and other products on pharmaranks.
- Is Prostin Vr Pediatric a brand-name or generic drug?
- Prostin Vr Pediatric is a brand-name product with the active ingredient Alprostadil.
- Is Prostin Vr Pediatric available over the counter?
- No. Prostin Vr Pediatric is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Prostin Vr Pediatric come in?
- Prostin Vr Pediatric is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Prostin Vr Pediatric?
- Prostin Vr Pediatric is classified as prostaglandin analog, prostaglandin e1 agonist, per the FDA's Established Pharmacologic Class.
- Is Prostin Vr Pediatric FDA-registered?
- Prostin Vr Pediatric is on record with the U.S. FDA under application number NDA018484. You can verify this on its official FDA label.
- Has Prostin Vr Pediatric been recalled by the FDA?
- Prostin Vr Pediatric has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Prostin Vr Pediatric safe?
- There's no single safe-or-not verdict. pharmaranks gives Prostin Vr Pediatric a recall-safety score of 64/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Prostin Vr Pediatric?
- Prostin Vr Pediatric's side effects are taken directly from its FDA label. From the label: 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%.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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prostin vr pediatric
64/100