Patient Medication Information: uses, side effects, how to take - Dilaudid (Purdue Pharma, 250 mg, 20 mg, 50 mg)
ABOUT THIS MEDICATION
What the medication is used for:
DILAUDID is an injection containing HYDROmorphone (an opioid analgesic) used to control pain.
What it does:
DILAUDID contains the medicine HYDROmorphone. HYDROmorphone is used to treat severe pain in patients who require opioids administered by injection under the skin or into the muscle or vein in doses or concentrations higher than those usually needed.
HYDROmorphone belongs to a class of drugs which is commonly referred to as opiates, opioids or narcotics, and also includes codeine, fentanyl, morphine and oxycodone.
Your pain may increase or decrease occasionally and your doctor may need to change the amount of HYDROmorphone you take daily (daily dosage).
When it should not be used:
DILAUDID should not be used if:
- Your doctor did not prescribe it for you;
- You are not already receiving high doses or high concentrations of opioids;
- You are allergic to HYDROmorphone, opioids or any other ingredient in the injection (see What the non-medicinal ingredients are:);
- Your pain is mild;
- Your pain can be controlled by non-opioid painkillers;
- You have severe asthma or severe lung problems;
- You have an irregular heartbeat;
You suffer from alcoholism;
- You have a head injury;
- You have a brain tumour;
- You suffer from seizures;
You have a condition where the small bowel does
not work properly (paralytic ileus) or you have severe pain in your abdomen;
You are taking, or have taken within the past 2
weeks, monoamine oxidase inhibitor medications (e.g., phenelzine sulphate, tranylcypromine sulphate, moclobemide or selegiline);
You are pregnant, planning to become pregnant, in
labour or delivery or breast-feeding.
Individuals under 18 years of age should not take DILAUDID.
What the medicinal ingredient is:
HYDROmorphone Hydrochloride
What the non-medicinal ingredients are: DILAUDID-HP: citric acid, sodium citrate
DILAUDID-HP-PLUS: citric acid, sodium citrate
DILAUDID-XP: citric acid, sodium citrate
DILAUDID Sterile Powder (when prepared for injection): sterile water for injection or 0.9% sodium chloride or 5% dextrose
What dosage forms it comes in:
DILAUDID-HP: 10 mg/mL, 1 mL and 5 mL
ampoules, 50 mL single-use vial
DILAUDID-HP-PLUS: 20 mg/mL, 50 mL single-
use vial
DILAUDID-XP: 50 mg/mL, 50 mL single-use vial
DILAUDID Sterile Powder: 250 mg/vial
WARNINGS AND PRECAUTIONS
Keep DILAUDID out of the reach of children. You should not give DILAUDID to anyone as inappropriate use may have severe medical consequences, including death.
BEFORE using DILAUDID, talk to your doctor or
pharmacist if you have, or had in the past any other medical conditions, especially the following ones: trouble breathing or lung problems, head injury, liver or kidney problems, gastrointestinal problems, low blood pressure, prostate problems, unusual narrowing of the urethra, adrenal gland problems, such as Addison’s disease, convulsions or seizures, alcoholism, hallucinations or other severe mental problems, past or present substance abuse or drug addiction.
DILAUDID should be used with caution before and during surgery and within the first 24 hours post-surgery.
Tell your doctor or pharmacist if you are pregnant, plan to become pregnant, or are breast-feeding. DILAUDID will pass through the milk and may harm the baby. DILAUDID should not be used in patients who are pregnant or lactating, in labour or delivery.
You should take the following precautions while taking DILAUDID:
You must not consume alcohol while taking
DILAUDID, as it may increase the chance of experiencing dangerous side effects;
- Driving or other tasks requiring full alertness should not be attempted until you are sure that taking DILAUDID does not make you drowsy;
- You must tell your doctor and pharmacist if you are taking any other prescription medications, over-the-counter drugs or any herbal remedies - they will tell you what you should do.
Abuse, Addiction and Physical Dependence
There is a risk of abuse or addiction with all opioids. Some patients, particularly those who have abused drugs in the past, may have a higher risk of abusing or developing an addiction while taking opioids, such as DILAUDID. Patients who have taken DILAUDID for a period of time may develop physical dependence, and should not abruptly stop taking it. See ‘Discontinuation:’ section of this leaflet.
While there are important differences between physical dependence and addiction, each is a reason for close medical supervision and honest discussions with your doctor. If you have questions or concerns about abuse, addiction or physical dependence, please tell your doctor.
INTERACTIONS WITH THIS MEDICATION
You should not use DILAUDID if you are currently taking (or recently stopped taking) one of the medicines known as monoamine oxidase inhibitor medications (e.g., phenelzine sulphate, tranyl-cypromine sulphate, moclobemide or selegiline).
Drugs that may interact with DILAUDID include:
Alcohol or other sedative drugs may enhance the
drowsiness caused by HYDROmorphone;
Other opioids, anaesthetics (e.g., barbiturates),
sedatives, hypnotics, tranquilizers, neuroleptics, antidepressants, some heart medication (e.g. beta-blockers), some antimetics (medication to stop vomiting or nausea), and chloral hydrate;
Antihistamines or sleep aids (these medicines could
make you drowsy and depress your breathing);
Any nonprescription (over-the-counter)
medications;
- Any herbal remedies.
PROPER USE OF THIS MEDICATION
Usual dose:
The proper dose is determined by your doctor.
Your dose of DILAUDID will be clearly labelled on the packaging of the medication. Be sure to follow the directions on the label exactly; this is very important. Do not increase or decrease your dose without consulting your doctor. If your dosage is changed by your doctor, be sure to write it down at the time your doctor calls or sees you, and follow the new directions exactly. Review your pain regularly with your doctor to determine if you still need DILAUDID. Be sure to use DILAUDID only for the condition for which it was prescribed.
Discontinuation:
After you stop taking DILAUDID, you should take the unused medication to your pharmacist to be destroyed.
Consult your doctor for instructions on how to stop this medicine slowly to avoid uncomfortable symptoms such as body aches, diarrhea, gooseflesh, loss of appetite, nausea, nervousness or restlessness, runny nose, sneezing, tremors or shivering, stomach cramps, tachycardia, trouble with sleeping, unusual increase in sweating, unexplained fever, weakness and yawning.
You should not stop taking DILAUDID all at once if you have been taking it for more than a few days.
Reordering DILAUDID:
A new written prescription is required from your doctor each time you need more DILAUDID. Therefore, it is important that you contact your doctor at least three working days before your current supply runs out.
Overdose:
The most important signs of overdose are decreased breathing (abnormally slow or weak breathing), dizziness, confusion or extreme drowsiness. If you accidentally use DILAUDID at a dose greater than prescribed, call your doctor and/or your local emergency number and/or Regional Poison Control DILAUDID-HP®, DILAUDID-HP-Plus®, DILAUDID-XP® and Reconstituted DILAUDID® Sterile Powder are highly concentrated solutions of hydromorphone hydrochloride. They should be used only in opioid tolerant patients requiring high doses or high concentrations of opioid agonists. Do not confuse DILAUDID-HP®, DILAUDID-HP-Plus®, DILAUDID-XP® and Reconstituted DILAUDID® Sterile Powder with the lower concentration of the DILAUDID® 2 mg/mL Sterile Solution for Injection since overdosage and death could result.
Centre immediately or go to a hospital emergency and take any remaining medication with you, even though you may not feel sick.
Do not seek additional prescriptions for this medicine from any other doctor - unless responsibility for your pain management has been transferred to another doctor.
Should your pain increase or any other complaint develop as a result of taking DILAUDID, tell your doctor immediately.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
The most common side effects you may experience are constipation, light-headedness, dizziness, drowsiness, nausea, vomiting and sweating. Tell your doctor about these problems if they arise. Your doctor may order a laxative and stool softener to help relieve your constipation while you are taking DILAUDID.
If you experience any symptoms related to difficulty in breathing, such as tight chest or wheezing, fainting, or rapid heartbeat, seek immediate emergency medical assistance.
Physical dependence, abuse and withdrawal reactions have been reported. See withdrawal reactions listed within the “Discontinuation:” section of this leaflet.
This is not a complete list of side effects. For any unexpected effects while taking DILAUDID, contact your doctor or pharmacist.
HOW TO STORE IT
Store ampoules and vials at room temperature (15˚-25˚C). Protect ampoules from light. Do not use beyond the expiry date indicated on the label.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Keep DILAUDID in a secure place to prevent theft and misuse.
Do not give any DILAUDID to anyone other than the person for whom it was prescribed, since it may seriously harm them, including death.
Keep DILAUDID under lock and out of sight and out of reach of children. Accidental ingestion by a child is dangerous and may result in death.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
Complete a Canada Vigilance Reporting
Form and:
- Fax toll-free to 1-866-678-6789, or
Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701C
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available in the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of the side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
This leaflet summarized important information about DILAUDID. If you would like more information, talk with your doctor and/or pharmacist.
This document plus the full product monograph, prepared for health professionals can be found at:
http://www.purdue.ca or by contacting the manufacturer, Purdue Pharma, at: 1-800-387-5349.
Last revised: April 5, 2012
®Purdue Pharma, owner of the registered trademarks DILAUDID, DILAUDID-HP, DILAUDID-HP-PLUS and DILAUDID-XP