Dilaudid-HP

DILAUDID INJECTION is indicated for the management of pain in patients where an opioid analgesic is appropriate.

DILAUDID-HP INJECTION is indicated for the management of moderate-to-severe pain in opioid-tolerant patients who require higher doses of opioids.

• Bronchitis (Acute)
• Common Cold
• Hay Fever (Allergic Rhinitis)
• Sinus Infection (Sinusitis)

In the U.S.

• Dilaudid
• Dilaudid-HP

Available Dosage Forms:

• Solution
• Powder for Solution

Therapeutic Class: Analgesic

Chemical Class: Hydromorphone

This section provides information on the proper use of a number of products that contain hydromorphone. It may not be specific to Dilaudid-HP. Please read with care.

A nurse or other trained health professional will give you this medicine in a hospital. This medicine may be given as a shot under the skin, as a shot into one of your muscles, or through a needle placed in one of your veins.

Hydromorphone injection may sometimes be given at home to patients who do not need to be in the hospital. If you are using this medicine at home, your doctor will teach you how to prepare and inject the medicine. Be sure you understand the instructions before giving yourself an injection.

You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas.

Use a new needle and syringe each time you inject the medicine.

If the medicine in the vial has changed color, or if you see particles in it, do not use it.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection (intramuscular or subcutaneous) dosage forms:
  • For moderate to severe pain:
    • For patients who are not taking opioid medicines (not opioid-tolerant):
      • Adults—At first, 1 to 2 milligrams (mg) injected under the skin or into one of your muscles every 2 to 3 hours as needed. Your doctor may adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.
    • For patients who are already taking opioid medicines (opioid-tolerant):
      • Adults—Your dose is based on the narcotic pain medicine you are already receiving. Your doctor may adjust your dose as needed.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

• Abdominal or stomach pain
• blurred vision
• change in consciousness
• change in the ability to see colors, especially blue or yellow
• chest pain or discomfort
• cold, clammy skin
• confusion
• cough
• difficult or troubled breathing
• dizziness
• fast, pounding, or irregular heartbeat or pulse
• headache
• irregular, fast, slow, or shallow breathing
• lightheadedness, dizziness, or fainting
• loss of appetite
• noisy breathing
• pale or blue lips, fingernails, or skin
• severe constipation
• severe vomiting
• slow or irregular heartbeat
• sweating
• tightness in the chest
• trouble with sleeping
• unusual tiredness
• very slow heartbeat or pulse
• vomiting

Get emergency help immediately if any of the following symptoms of overdose occur:

• Change in consciousness
• cold and clammy skin
• convulsions (seizures)
• drowsiness that is so severe you are not able to answer when spoken to or, if asleep, cannot be awakened
• pale or blue lips, fingernails, or skin
• pinpoint (small) pupils in the eyes
• sleepiness or unusual drowsiness
• slow heartbeat
• unable to speak
• very slow or troubled breathing
• weak muscle tone

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Anxiety
• bad, unusual, or unpleasant (after) taste
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in taste
• chills
• constricted, pinpoint, or small pupils (black part of the eye)
• decrease in the frequency or amount of urination
• diarrhea
• difficulty having a bowel movement (stool)
• difficulty in passing urine (dribbling)
• double vision
• dry mouth
• false or unusual sense of well-being
• fast or rapid breathing
• feeling of warmth
• hives or welts
• irritability
• itching
• loss of appetite
• muscle stiffness or tightness
• nausea
• painful urination
• redness, pain, or swelling at the injection site
• redness of the face, neck, arms, and occasionally, upper chest
• relaxed or calm feeling
• seeing, hearing, or feeling things that are not there
• seeing double
• shaking
• sleepiness
• uncontrolled eye movements
• upper stomach pain
• weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Serious adverse reactions associated with DILAUDID INJECTION and Dilaudid-HP INJECTION include respiratory depression and apnea and, to a lesser degree, circulatory depression, respiratory arrest, shock, and cardiac arrest.

The following serious adverse reactions described elsewhere in the labeling include:

The most common adverse effects are lightheadedness, dizziness, sedation, nausea, vomiting, sweating, flushing, dysphoria, euphoria, dry mouth, and pruritus. These effects seem to be more prominent in ambulatory patients and in those not experiencing severe pain.

Less Frequently Observed Adverse Reactions

Cardiac disorders: tachycardia, bradycardia, palpitations

Eye disorders: vision blurred, diplopia, miosis, visual impairment

Gastrointestinal disorders: constipation, ileus, diarrhea, abdominal pain

General disorders and administration site conditions: weakness, feeling abnormal, chills, injection site urticaria

Hepatobiliary disorders: biliary colic

Metabolism and nutrition disorders: decreased appetite

Musculoskeletal and connective tissue disorders: muscle rigidity

Nervous system disorders: headache, tremor, paraesthesia, nystagmus, increased intracranial pressure, syncope, taste alteration, involuntary muscle contractions, presyncope

Psychiatric disorders: agitation, mood altered, nervousness, anxiety, depression, hallucination, disorientation, insomnia, abnormal dreams

Renal and urinary disorders: urinary retention, urinary hesitation, antidiuretic effects

Respiratory, thoracic, and mediastinal disorders: bronchospasm, laryngospasm

Skin and subcutaneous tissue disorders: injection site pain, urticaria, rash, hyperhidrosis

Vascular disorders: flushing, hypotension, hypertension

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of hydromorphone. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: anaphylactic reactions, confusional state, convulsions, drowsiness, dyskinesia, dyspnea, erectile dysfunction, fatigue, hepatic enzymes increased, hyperalgesia, hypersensitivity reaction, injection site reactions, lethargy, myoclonus, oropharyngeal swelling, peripheral edema, and somnolence.

  Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Long term studies in animals to evaluate the carcinogenic potential of hydromorphone have not been conducted.

Mutagenesis

Hydromorphone was not mutagenic in the in vitro bacterial reverse mutation assay (Ames assay). Hydromorphone was not clastogenic in either the in vitro human lymphocyte chromosome aberration assay or the in vivo mouse micronucleus assay.

Impairment of Fertility

No effects on fertility, reproductive performance, or reproductive organ morphology were observed in male or female rats given oral doses up to 7 mg/kg/day which is 3-fold higher than the human dose of 24 mg DILAUDID INJECTION (4 mg every 4 hours), on a body surface area basis.

Analgesic effects of single doses of DILAUDID ORAL LIQUID administered to patients with post-surgical pain have been studied in double-blind controlled trials. In one study, both 5 mg and 10 mg of DILAUDID ORAL LIQUID provided significantly more analgesia than placebo.

You should not use this medicine if you have severe asthma or breathing problems, or a bowel obstruction called paralytic ileus.

Do not use this medicine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Hydromorphone can slow or stop your breathing, and may be habit-forming. MISUSE OF THIS MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Using this medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

You should not use this medicine if you have ever had an allergic reaction to a narcotic medicine, or if you have:

• severe asthma or breathing problems; or

• a bowel obstruction called paralytic ileus.

Do not use hydromorphone if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

You may not be able to use hydromorphone if you are NOT already being treated with a similar opioid (narcotic) pain medicine and are tolerant to it. Talk with your doctor if you are not sure you are opioid-tolerant.

Some medicines can interact with hydromorphone and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

To make sure hydromorphone is safe for you, tell your doctor if you have:

• any type of breathing problem or lung disease;

• a history of head injury, brain tumor, or seizures;

• a history of drug abuse, alcohol addiction, or mental illness;

• urination problems;

• liver or kidney disease;

• sulfite allergy;

• Addison's disease or other adrenal gland disorders;

• problems with your gallbladder, pancreas, or thyroid; or

• if you use a sedative like Valium (diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others).

Hydromorphone is more likely to cause breathing problems in older adults and people who are severely ill, malnourished, or otherwise debilitated.

It is not known whether this medicine will harm an unborn baby. If you use hydromorphone while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

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