hydromorphone

Generic Name: hydromorphone (injection) (hy dro MOR fone)
Brand Name: Dilaudid, Dilaudid-HP

What is hydromorphone injection?

Hydromorphone is an opioid pain medication. An opioid is sometimes called a narcotic.

Hydromorphone injection is used to treat moderate to severe pain.

Hydromorphone injection may also be used for purposes not listed in this medication guide.

What is the most important information I should know about hydromorphone injection?

You should not use this medication if you have ever had an allergic reaction to a narcotic medicine, if you have paralytic ileus (a bowel obstruction), or if you are having an asthma attack.

Hydromorphone may be habit-forming and should be used only by the person for whom it was prescribed. Keep the medication in a secure place where others cannot get to it.

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Do not drink alcohol while you are receiving hydromorphone. Dangerous side effects or death can occur when alcohol is combined with a narcotic pain medicine.

Avoid driving or operating machinery until you know how hydromorphone will affect you.

Do not stop using hydromorphone suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using hydromorphone.

What should I discuss with my healthcare provider before receiving hydromorphone injection?

You should not use this medication if you have ever had an allergic reaction to a narcotic medicine (examples include codeine, methadone, morphine, Lortab, OxyContin, Percocet, Vicodin, and many others).

You should also not use hydromorphone injection if you have:

• a bowel obstruction called paralytic ileus; or

• if you are having an asthma attack.

Do not use hydromorphone if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

You may not be able to use hydromorphone injection unless you are already being treated with a similar opioid pain medicine and your body is tolerant to it. Opioid medicines include fentanyl (Actiq, Duragesic), methadone (Methadose, Dolophine), morphine (Kadian, MS Contin, Oramorph), oxycodone (Oxycontin), oxymorphone (Opana), and many others. Talk with your doctor if you are not sure you are opioid-tolerant.

To make sure you can safely use hydromorphone, tell your doctor if you have any of these other conditions:

• asthma, COPD, sleep apnea, or other breathing disorders;

• sulfite allergy;

• liver or kidney disease;

• underactive thyroid;

• curvature of the spine;

• a history of head injury or brain tumor;

• epilepsy or other seizure disorder;

• low blood pressure;

• gallbladder disease or pancreatitis;

• Addison's disease or other adrenal gland disorders;

• enlarged prostate, urination problems;

• mental illness;

• a history of alcoholism or drug addiction; or

• if you have recently used alcohol, sedatives, tranquilizers, or other narcotic medications.

Hydromorphone may be habit forming and should be used only by the person for whom it was prescribed. Never share hydromorphone with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

FDA pregnancy category C. It is not known whether hydromorphone will harm an unborn baby. Hydromorphone may cause addiction or withdrawal symptoms in a newborn if the mother uses the medication during pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using hydromorphone.

Hydromorphone can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using hydromorphone.

Serious side effects may be more likely in older adults and those who are ill or debilitated.

How is hydromorphone injection given?

Use exactly as prescribed. Never use hydromorphone in larger amounts, or for longer than recommended by your doctor. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Hydromorphone is injected under the skin or into a muscle, or into a vein through an IV. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

Hydromorphone injected into a vein must be given slowly, and the IV infusion should take at least 2 to 3 minutes to complete.

Your doctor may occasionally change your dose to make sure you get the best results. Your dose needs may be different if you have recently used an opioid pain medicine and your body is tolerant to it.

You may need to mix hydromorphone with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

Do not use hydromorphone if it has changed colors or has particles in it. Call your doctor for a new prescription.

If you need surgery, tell the surgeon ahead of time that you are using hydromorphone. You may need to stop using the medicine for a short time.

Do not stop using hydromorphone suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using hydromorphone.

Store at room temperature away from moisture, heat, and light.

Keep track of the amount of medicine used from each new bottle. Hydromorphone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription. After you have stopped using this medication, flush any unused medicine down the toilet.

What happens if I miss a dose?

Since hydromorphone is used on an as needed basis, you are not likely to miss a dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of hydromorphone can be fatal.

Overdose symptoms may include extreme drowsiness, pinpoint pupils, cold and clammy skin, slow heart rate, weak pulse, shallow breathing, fainting, or breathing that stops.

What should I avoid while receiving hydromorphone injection?

Do not drink alcohol while you are using this medication. Dangerous side effects or death can occur when alcohol is combined with hydromorphone. Check your food and medicine labels to be sure these products do not contain alcohol.

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how hydromorphone will affect you.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Hydromorphone injection side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• weak or shallow breathing, feeling like you might pass out.;

• pounding heartbeats or fluttering in your chest;

• wheezing, chest tightness, trouble breathing;

• seizure (convulsions); or

• confusion, severe weakness or drowsiness.

Less serious side effects may include:

• blurred vision, double vision;

• flushing (warmth, redness, or tingly feeling);

• nausea, vomiting, constipation, diarrhea, stomach pain;

• dizziness, drowsiness;

• pain where the injection was given;

• dry mouth;

• sweating, itching; or;

• sleep problems (insomnia), or strange dreams.

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.

See also: hydromorphone side effects (in more detail)

Hydromorphone Dosing Information

Usual Adult Dose for Pain:

Doses should be titrated to appropriate analgesic effects while minimizing adverse effects. When changing routes of administration, it should be noted that oral doses are less than one-half as effective as parenteral doses. Oral doses may be only one fifth as effective as parenteral doses.

Recommended dose:
Oral liquid: 2.5 to 10 mL every 3 to 6 hours, increasing gradually
Oral tablets: 2 to 4 mg every 4 to 6 hours, increasing gradually

Chronic pain: Oral: Patients taking opioids chronically may become tolerant and require doses higher than the usual dosage range to maintain the desired effect. Tolerance can be managed by appropriate dose titration. There is no optimal or maximal dose for hydromorphone in chronic pain. The appropriate dose is one that relieves pain throughout its dosing interval without causing unmanageable side effects.

IV: Care should be taken to avoid dosing errors due to confusion between the different concentrations and between mg and mL. Hydromorphone HP injection should never be administered to opioid-naïve patients.

Subcutaneous or IM initial dose: 0.2 to 1 mg given slowly every 2 to 3 hours as needed (Lower doses may be used in opioid-naïve patients)

IV initial dose: 0.2 to 1 mg every 2 to 3 hours (given slowly over at least 2 to 3 minutes). The initial dose should be reduced in the elderly or debilitated and may be lowered to 0.2 mg.

Hydromorphone extended release tablets:
Hydromorphone extended release tablets are indicated for opioid tolerant patients only. Patient must not be started on hydromorphone extended release tablets as their first opioid.

Hydromorphone extended release tablets should be swallowed whole and should not be broken, crushed, dissolved, or chewed before swallowing. The tablets are to be administered every 24 hours with or without food.

The dose range of hydromorphone extended release tablets studied in clinical trials is 8 mg to 64 mg.

Patients receiving oral immediate-release hydromorphone may be converted to hydromorphone extended release tablets by administering a starting dose equivalent to the patient's total daily oral hydromorphone dose, taken once daily. The dose of hydromorphone extended release tablets can be titrated every 3 to 4 days until adequate pain relief with tolerable side effects has been achieved.

It is critical to accurately initiate the dosing regimen individually for each patient. Overestimating the hydromorphone extended release tablets dose when converting patients from another opioid medication can result in fatal overdose with the first dose. In the selection of the initial dose of hydromorphone extended release tablets, the following should be noted:
-the daily dose, potency, and specific characteristics of the opioid the patient has been taking previously;
-the reliability of the relative potency estimate used to calculate the equivalent hydromorphone dose needed;
-the patient's degree of opioid tolerance;
-the age, general condition, and medical status of the patient;
-concurrent non-opioid analgesics and other medications, such as those with central nervous system activity;
-the type and severity of the patient pain;
-the balance between pain control and adverse effects;
-risk factors for abuse, addiction, or diversion, including a prior history of abuse, addiction, or diversion.

Dosing recommendations, therefore, can only be considered as suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.

Conversion from oral opioids to hydromorphone extended release tablets:
For conversion from other opioids to hydromorphone extended release tablets, physicians and other healthcare professionals are advised to refer to published relative potency data, keeping in mind that conversion ratios are only approximate. In general, therapy with hydromorphone extended release tablets should be started by administering 50% of the calculated total daily dose of hydromorphone extended release tablets every 24 hours. The initial dose of hydromorphone extended release tablets can be titrated until adequate pain relief with tolerable side effects has been achieved.

Conversion from transdermal fentanyl to hydromorphone extended release tablets:
Eighteen hours following the removal of the transdermal fentanyl patch, hydromorphone extended release tablets treatment can be initiated. For each 25 mcg/hr fentanyl transdermal dose the equianalgesic dose of hydromorphone extended release tablets is 12 mg every 24 hours. An appropriate starting dose of hydromorphone extended release tablets is 50% of the calculated total daily dose every 24 hours.

Individualization of Dosage:
Once therapy is initiated, assess pain relief and other opioid adverse reactions frequently.

Titrate patients to adequate analgesia with dose increases not more often than every 3 to 4 days, in order to attain steady-state plasma concentrations of hydromorphone at each dose.

As a guideline, consider dosage increases of 25% to 50% of the current daily dose of hydromorphone extended release tablets for each titration step.

If more than two doses of rescue medication are needed within a 24 hour period for two consecutive days, the dose of hydromorphone extended release tablets may need to be titrated upward.

Administer hydromorphone extended release tablets no more frequently than every 24 hours.

During periods of changing analgesic requirements, including initial titration, maintain frequent contact between physician, other members of the healthcare team, the patient and the caregiver/family.

Maintenance of Therapy:
During chronic therapy with hydromorphone extended release tablets, assess the continued need for around-the-clock opioid therapy periodically. Continue to assess patients for their clinical risks for opioid abuse, addiction, or diversion particularly with high-dose formulations. If patients need to titrate while on maintenance therapy, follow the same method outlined above to reestablish pain control.

What other drugs will affect hydromorphone injection?

Do not use hydromorphone with any other narcotic pain medications, sedatives, tranquilizers, sleeping pills, muscle relaxers, or other medicines that can make you sleepy or slow your breathing. Dangerous side effects may result.

Tell your doctor about all other medicines you use, especially:

• buprenorphine (Buprenex, Subutex);

• butorphanol (Stadol);

• nalbuphine (Nubain);

• pentazocine (Talwin);

• atropine (Atreza, Sal-Tropine), belladonna (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm Scop);

• bladder or urinary medicines such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);

• bronchodilators such as ipratropium (Atrovent) or tiotropium (Spiriva);

• irritable bowel medicines such as dicyclomine (Bentyl), hyoscyamine (Hyomax), or propantheline (Pro Banthine); or

• ulcer medications such as glycopyrrolate (Robinul) or mepenzolate (Cantil).

This list is not complete and other drugs may interact with hydromorphone. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your doctor or pharmacist can provide more information about hydromorphone injection.