Hydromorphone Injection

IMPORTANT WARNING:

Hydromorphone injection may be habit forming, especially with prolonged use. Inject hydromorphone injection exactly as directed. Do not use more of it or use it more often than prescribed by your doctor, While using hydromorphone injection, discuss with your health care provider your pain treatment goals, length of treatment, and other ways to manage your pain. Tell your doctor if you or anyone in your family drinks or has ever drunk large amounts of alcohol, uses or has ever used street drugs, or has overused prescription medications, or has had an overdose, or if you have or have ever had depression or another mental illness. There is a greater risk that you will overuse hydromorphone if you have or have ever had any of these conditions. Talk to your health care provider immediately and ask for guidance if you think that you have an opioid addiction or call the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) National Helpline at 1-800-662-HELP.

Hydromorphone injection may cause serious or life-threatening breathing problems, especially during the first 24 to 72 hours of your treatment and any time your dose is increased. Your doctor will monitor you carefully during your treatment. Tell your doctor if you have slowed breathing or have or have ever had asthma. Your doctor will probably tell you not to use hydromorphone injection. Also tell your doctor if you have or have ever had lung disease such as chronic obstructive pulmonary disease (a group of diseases that affect the lungs and airways), a head injury, a brain tumor, or any condition that increases the pressure in your brain. The risk that you will develop breathing problems may be higher if you are an older adult, or are weakened or malnourished due to disease. If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment: slowed breathing, long pauses between breaths, or shortness of breath.

Taking certain medications during your treatment with hydromorphone injection may increase the risk that you will develop serious or life-threatening breathing problems, sedation, or coma. Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Your doctor may need to change the doses of your medications and will monitor you carefully. If you use hydromorphone injection with other medications and you develop any of the following symptoms, call your doctor immediately or seek emergency medical care: unusual dizziness, lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. Be sure that your caregiver or family members know which symptoms may be serious so they can call the doctor or emergency medical care if you are unable to seek treatment on your own.

Drinking alcohol, taking prescription or nonprescription medications that contain alcohol, or using street drugs during your treatment with hydromorphone injection increases the risk that you will experience serious, life-threatening side effects. Do not drink alcohol, take prescription or nonprescription medications that contain alcohol, or use street drugs during your treatment.

Do not allow anyone else to use your medication. Hydromorphone injection may harm or cause death to other people who use your medication, especially children. Store hydromorphone injection in a safe place so that no one else can use it accidentally or on purpose. Be especially careful to keep hydromorphone out of the reach of children. Keep track of how much medication is left so you will know if any is missing.

Tell your doctor if you are pregnant or plan to become pregnant. If you use hydromorphone injection regularly during your pregnancy, your baby may experience life-threatening withdrawal symptoms after birth. Tell your baby's doctor right away if your baby experiences any of the following symptoms: irritability, hyperactivity, abnormal sleep, high-pitched cry, uncontrollable shaking of a part of the body, vomiting, diarrhea, or failure to gain weight.

Talk to your doctor about the risks of receiving hydromorphone injection.

WHY is this medicine prescribed?

Hydromorphone injection is used as a short-term treatment to relieve severe, acute pain (pain that begins suddenly, has a specific cause, and is expected to go away when the cause of the pain is healed) in people who are expected to need an opioid pain medication and who cannot be controlled by the use of alternative pain medications. Hydromorphone injection is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Hydromorphone injection comes as a solution (liquid) to inject subcutaneously (under the skin), intravenously (into a vein), or intramuscularly (into a muscle). It is usually injected once every 2 to 3 hours as needed. Use hydromorphone injection exactly as directed.

Your doctor may adjust your dose of hydromorphone injection during your treatment, depending on how well your pain is controlled and on the side effects that you experience. Talk to your doctor about how you are feeling during your treatment with hydromorphone injection. If you feel that your pain is not controlled or if your pain increases, becomes worse, or if you have new pain or an increased sensitivity to pain while you are using hydromorphone injection, call your doctor. Do not use more of it or use it more often than prescribed by your doctor.

If you have used hydromorphone injection for longer than a few days, do not stop using it suddenly. If you suddenly stop using hydromorphone injection, you may experience withdrawal symptoms including restlessness; teary eyes; runny nose; yawning; sweating; chills; muscle, back or joint pain; widening of the pupils; irritability; anxiety; weakness; stomach cramps; difficulty falling asleep or staying asleep; nausea; loss of appetite; vomiting; diarrhea; fast breathing; or fast heartbeat. Your doctor will probably decrease your dose gradually.

What SPECIAL PRECAUTIONS should I follow?

Before using hydromorphone injection,

• tell your doctor and pharmacist if you are allergic to hydromorphone injection, any other medications, sulfites, or any of the ingredients in hydromorphone injection solution. Ask your pharmacist for a list of the ingredients.

• tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Emsam, Zelapar), or tranylcypromine (Parnate).

• tell your doctor if you have any of the conditions listed in the IMPORTANT WARNING section or a blockage in your stomach or intestines or paralytic ileus (condition in which digested food does not move through the intestines). Your doctor may tell you not to use hydromorphone injection.

• tell your doctor if you have or have ever had low blood pressure; adrenal insufficiency (condition in which the adrenal glands do not produce enough of certain hormones needed for important body functions); seizures; diabetes; any condition that causes difficulty urinating, such as urethral stricture (blockage of the tube that allows urine to leave the body)or an enlarged prostate (a male reproductive gland); or gallbladder, pancreas, thyroid; liver, or kidney disease.

• tell your doctor if you are breastfeeding. You should not breastfeed while you are using hydromorphone injection. Hydromorphone injection can cause shallow breathing, difficulty or noisy breathing, confusion, more than usual sleepiness, trouble breastfeeding, or limpness in breastfed infants.

• you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of using hydromorphone injection.

• you should know that hydromorphone injection may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.

• you should know that hydromorphone injection may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

• you should know that hydromorphone injection may cause constipation. Talk to your doctor about changing your diet or using other medications to prevent or treat constipation while you are using hydromorphone injection.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Hydromorphone injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• constipation
• dry mouth
• lightheadedness
• drowsiness
• flushing
• itching
• mood changes
• increased sweating
• pain or redness at injection site

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• agitation, hallucinations (seeing things or hearing voices that do not exist), fever, sweating, confusion, fast heartbeat, shivering, severe muscle stiffness or twitching, loss of coordination, or diarrhea
• nausea, vomiting, loss of appetite, weakness, or dizziness
• rash; hives; hoarseness; difficulty breathing or swallowing; or swelling of the face, mouth, tongue or throat
• seizures
• fainting
• inability to get or keep an erection
• irregular menstruation
• decreased sexual desire

Hydromorphone injection may cause other side effects. Call your doctor if you have any unusual problems while you are using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, out of reach of children, and in a location that is not easily accessible by others, including visitors to the home. Store it at room temperature and away from excess heat and moisture (not in the bathroom). You must immediately dispose of any medication that is outdated or no longer needed through a medicine take-back program. If you do not have a take-back program nearby or one that you can access promptly, flush any hydromorphone injection solution that is outdated or no longer needed down the toilet. Talk to your pharmacist about the proper disposal of your medication.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

While using hydromorphone, you should talk to your doctor about having a rescue medication called naloxone readily available (e.g., home, office). Naloxone is used to reverse the life-threatening effects of an overdose. It works by blocking the effects of opiates to relieve dangerous symptoms caused by high levels of opiates in the blood. Your doctor may also prescribe you naloxone if you are living in a household where there are small children or someone who has abused street or prescription drugs. You should make sure that you and your family members, caregivers, or the people who spend time with you know how to recognize an overdose, how to use naloxone, and what to do until emergency medical help arrives. Ask your doctor about other ways that you can obtain naloxone (directly from a pharmacy or as part of a community based program). Your doctor or pharmacist will show you and your family members how to use the medication. Ask your pharmacist for the instructions or visit the manufacturer's website to get the instructions. If symptoms of an overdose occur, a friend or family member should give the first dose of naloxone, call 911 immediately, and stay with you and watch you closely until emergency medical help arrives. Your symptoms may return within a few minutes after you receive naloxone. If your symptoms return, the person should give you another dose of naloxone. Additional doses may be given every 2 to 3 minutes, if symptoms return before medical help arrives.

Symptoms of overdose may include the following:

• slow or shallow breathing
• difficulty breathing
• sleepiness
• unable to respond or wake up
• muscle weakness
• cold, clammy skin
• narrowing or widening of the pupils (dark circle in the middle of the eye)
• slowed heartbeat
• dizziness
• fainting
• unusual snoring

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Before having any laboratory test (especially those that involve methylene blue), tell your doctor and the laboratory personnel that you are using hydromorphone injection.

This prescription is not refillable. If you continue to have pain after you finish your treatment with hydromorphone injection, call your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

^¶ This branded product is no longer on the market. Generic alternatives may be available.