Neupedix
Neupedix uses alprostadil to open small blood vessels, which improves blood flow and helps keep a blood vessel (ductus arteriosus) open in newborns with certain heart defects until surgery can be performed.
Form
infuusiokonsentraatti, liuosta varten
Strength
0.5 mg/ml
Active Ingredient
Alprostadil
Manufacturer
Oresund Pharma ApS (Øresund Pharma)
How to Use
Dosage
Start with 0.05-0.1 microgram per kg per minute. Once stable, reduce to the lowest effective dose, usually 0.01-0.025 microgram per kg per minute.
Method
Given as a continuous infusion into a large vein, diluted with normal saline (0.9%) or glucose solution (5%).
Important
The maximum dose is 0.4 microgram per kg per minute. Treatment typically lasts 2-3 days before surgery, but can be extended up to 3 weeks if needed.
Possible Side Effects
COMMON
- •Increased alkaline phosphatase (an enzyme related to bones, liver, and bile ducts) with long-term use.
- •Increased body temperature.
- •Breathing pauses (apnea).
- •Increased bone formation in long bones, mineralization disorders in covering bones (skull, facial bones) with long-term use.
- •Temporary fever.
- •Excessive blood clotting leading to bleeding tendency.
- •Seizures (epilepsy), convulsive muscle twitching, headache.
- •Low blood pressure, slow or fast heart rate, cardiac arrest.
- •Low potassium levels in the blood.
- •Diarrhea, thickening of the stomach lining with stomach emptying obstruction in long-term use.
- •Redness, swelling.
- •Skin redness, blood poisoning (sepsis).
- •Shock, congestive heart failure, heart rhythm disorders, fluid accumulation in the lungs due to heart failure, chest pain, palpitations, dizziness.
- •Fragile blood vessels: damage to the ductus arteriosus, pulmonary artery, or aorta (weakening of the wall with swelling, ruptures, and/or aneurysm formation) with long-term treatment.
- •Sudden fluid accumulation in the lungs, slow or fast breathing, wheezing, shortness of breath including shallow breathing.
- •Esophageal inflammatory disease due to abnormal stomach acid reflux (heartburn), peritonitis, necrotizing enterocolitis (inflammation of small and large intestine with destruction of intestinal lining).
- •Elevated liver enzyme levels (bilirubin and transaminases).
- •Joint problems.
- •Kidney failure, greatly reduced or no urine output, blood in urine.
- •Infection, low body temperature, hives, developing tolerance, warmth, swelling, pain, local swelling at the administration site, redness and inflammation in the infusion vein, vascular pain, inflammation in blood vessels.
RARE
- •Anemia, increased blood volume, decreased platelet count, bleeding, increased C-reactive protein (marker of inflammation).
- •Increased blood carbon dioxide, increased blood potassium, decreased blood calcium, decreased or increased blood sugar, increased ketone bodies (substances like acetone and acetoacetic acid from fat breakdown).
- •Neck hyperextension, over-irritability, nervousness, extreme tiredness, dizziness, abnormal sensations (e.g., tingling) in hands and feet.
- •Changes in white blood cell count, increased platelets.
- •Confusion.
- •Allergic reactions (e.g., rash, itching, fever, redness, chills, sweating).
- •Blood clots (thrombosis) at the catheter tip and local bleeding.
- •Severe allergic reactions (hypersensitivity reactions) with possible drop in blood pressure, dizziness, and nausea.
Important Warnings
- Do not use if your child is allergic to alprostadil, has breathing difficulties (respiratory distress syndrome), very low blood pressure, or a naturally open ductus arteriosus.
- This medicine should only be given in a hospital with intensive care facilities for children.
- Breathing pauses (apnea) can occur, especially in newborns weighing less than 2 kg, usually within the first hour of infusion. Equipment for immediate intubation and ventilation must be available.
- For long-term treatment (over 5 days), monitor for thickening of the stomach lining or stomach outlet blockage.
- Long-term use may cause abnormal bone growth (hyperostosis) and bone mineralization issues, which usually resolve after stopping the medicine.
Show 6 more warnings
- Pathological studies show vessel wall weakening (swelling, ruptures, aneurysms) in the ductus arteriosus, pulmonary artery, or aorta with long-term, dose-dependent treatment.
- Monitor bleeding carefully in newborns with a history of bleeding, as alprostadil can reduce blood clotting.
- Blood pressure must be closely monitored; if it drops significantly, the infusion rate should be reduced immediately.
- Antibiotics are recommended to prevent infections during Neupedix treatment.
- Many side effects, like breathing pauses, skin redness, fever, slow heart rate, or low blood pressure, depend on the dose; the dose should be lowered if these occur.
- This medicine contains alcohol (ethanol). Discuss with your doctor if your child has epilepsy or liver problems.