Patient Medication Information: uses, side effects, how to take - Alprostadil Injection USP
ABOUT THIS MEDICATION
What the medication is used for:
Alprostadil Injection USP is used for temporary treatment of patent ductus arteriosus, a heart defect in infants, until surgery can be done.
What it does:
Alprostadil Injection USP is used to keep a blood vessel (ductus arteriosis) open temporarily after the child is born. Normally this blood vessel closes soon after birth. In some children who are born with heart defects, this blood vessel needs to be kept open for a longer time so that enough blood can reach the rest of the body.
When it should not be used:
Alprostadil Injection USP should not be given to patients with:
- A blue appearance of the lips, skin and nails due to poor flow through the lungs;
- Abnormal or unusual blood flow between the lungs and the heart.
What the medicinal ingredient is:
Alprostadil.
What the important nonmedicinal ingredient is:
Ethyl alcohol anhydrous.
What dosage forms it comes in:
Alprostadil Injection USP is available in 1 mL fill in 2 mL vials, boxes of 1.
Each mL contains alprostadil 500 mcg in intravascular injection.
WARNINGS AND PRECAUTIONS
This medication is for use in infants only.
Since alprostadil appears most effective within 96 hours after birth due to a decreasing responsiveness of the ductus arteriosus with time after birth, every effort should be made to start infusion of the drug during this period.
- Blood pressure should be monitored by appropriate methods.
- Administration may result in gastric outlet obstruction and should be monitored for evidence of enlargement of gastric chamber.
- Care should be taken to avoid the use of alprostadil in neonates with respiratory distress syndrome and restricted pulmonary blood flow.
- Neonates may experience interrupted breathing (apnea).
INTERACTIONS WITH THIS MEDICATION
Interactions with other drugs, foods or herbal products have not been established.
PROPER USE OF THIS MEDICATION
Usual dose:
Your child's doctor will decide what dose will be given.
Overdose:
Symptoms of overdose may include interrupted breathing, slow heartbeat, fever, low blood pressure, weakness, or flushing.
Missed dose:
A missed dose is unlikely as treatment will follow hospital protocol and be given by trained medical personnel.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
The patient will be watched closely since seizures, a rapid or slow heart rate and breathing trouble can occur while using this medication.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY | |||
| HAPPEN AND WHAT TO DO ABOUT THEM | |||
| Symptom/effect | Advise your doctor | ||
| Only if severe | In all cases | ||
| Common | |||
Cardiovascular (flushing 10.1%; slow heartbeat 6.7%; low blood pressure 3.9%; accelerated heartbeat 2.8%; cardiac arrest 1.1%; edema 1.1%).
| ✓ |
Central Nervous System (fever 13.8%; seizures 4.1%).
| ✓ |
Respiratory (interrupted breathing 11.5%).
| ✓ |
Alprostadil Injection USP Page 16 of 16
Gastrointestinal (diarrhea 2.6%).
| ✓ |
Hematologic (coagulation of the blood 1.1%).
| ✓ | ||
| ✓ |
Metabolic (low
concentration of potassium ions in the blood 1.1%).
Infection (toxins in the blood 1.6%).
| ✓ | |||
| Uncommon | Cardiovascular (congestive heart failure; increased blood flow to body parts; shock; rapid heart rate; etc). Central Nervous System (intracranial bleeding; hyperextension of neck; jitteriness; stiffness; unconsciousness). Respiratory (slowness of respiration; wheezing; hyperventilation; respiratory depression; distress). Gastrointestinal (gastric regurgitation; inflammation of the peritoneum). Hematologic (anemia; bleeding). Urinary Track (absence of urine formation, presence of blood in urine, renal failure). Metabolic (low level of sugar in blood). Infection (inflammation of the tonsils). | ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ | |
This is not a complete list of side effects. For any unexpected effects after your child has been administered Alprostadil Injection USP, advise your doctor.
HOW TO STORE IT
Alprostadil Injection USP should be refrigerated between 2 and 8°C and should be protected from light and freezing. Unused portions should be discarded. Keep out of reach of children.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:
Toll-free telephone: 1-866-234-2345
Toll-free fax: 1-866-678-6789
By email: cadrmp@hc-sc.gc.ca
By regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness Information Division
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.
MORE INFORMATION
This document, plus the full product monograph prepared for health professionals, can be obtained by contacting the distributor:
SteriMax Inc.
Oakville, ON L6H 6R4
or by telephone at: 1-800-881-3550
Advanced Dosage Forms Inc.
Imported and Distributed by SteriMax Inc. Oakville ON L6H 6R4