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.

Do not drink alcohol. Dangerous side effects or death could occur.

This medicine may impair your thinking or reactions. Avoid driving or operating machinery until you know how hydromorphone will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

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

Like other narcotic medicines, hydromorphone can slow your breathing. Death may occur if breathing becomes too weak.

Call your doctor at once if you have:

• weak or shallow breathing;

• severe drowsiness;

• a light-headed feeling, like you might pass out;

• infertility, missed menstrual periods;

• impotence, sexual problems, loss of interest in sex; or

• low cortisol levels-- nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common side effects may include:

• constipation, nausea, vomiting;

• dizziness, drowsiness;

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

• sweating, itching;

• dry mouth;

• mood changes; or

• skin irritation or a hard lump where the injection was given.

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.

A nurse or other trained health professional will give you hydromorphone in a hospital. hydromorphone 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 hydromorphone 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 hydromorphone that your doctor prescribed. Different brands may not work the same way.

Dosing

The dose of hydromorphone 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 hydromorphone. 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.

• Tell all of your health care providers that you take hydromorphone injection. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
• Do not take hydromorphone injection with other strong pain drugs or if you are using a pain patch without talking to your doctor first.
• Have your blood work checked if you are on this medicine for a long time. Talk with your doctor.
• If you are allergic to sulfites, talk with your doctor. Some products have sulfites.
• This medicine may raise the chance of seizures in some people, including people who have had seizures in the past. Talk to your doctor to see if you have a greater chance of seizures while taking hydromorphone injection.
• Long-term use of an opioid drug like this medicine may lead to lower sex hormone levels. This may lead to signs like change in sex ability in men, no menstrual period in women, lowered interest in sex, or fertility problems. Call your doctor if you have any of these signs.
• If you have been taking hydromorphone injection on a regular basis and you stop it all of a sudden, you may have signs of withdrawal. Do not stop taking this medicine all of a sudden without calling your doctor. Tell your doctor if you have any bad effects.
• If you have been taking hydromorphone injection for a long time or at high doses, it may not work as well and you may need higher doses to get the same effect. This is known as tolerance. Call your doctor if this medicine stops working well. Do not take more than ordered.
• If you are 65 or older, use hydromorphone injection with care. You could have more side effects.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this medicine, call your doctor right away.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Controlled Substance

Hydromorphone Hydrochloride Injection, USP (HIGH POTENCY) contains hydromorphone, which is a Schedule II controlled substance.

Abuse

Hydromorphone Hydrochloride Injection, USP (HIGH POTENCY) contains hydromorphone hydrochloride, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, methadone, morphine, oxycodone, oxymorphone, and tapentadol. Hydromorphone Hydrochloride Injection, USP (HIGH POTENCY) can be abused and is subject to misuse, addiction, and criminal diversion [see Warnings and Precautions (5.2)].

All patients treated with opioids require careful monitoring for signs of abuse and addiction, because use of opioid analgesic products carries the risk of addiction even under appropriate medical use.

Prescription drug abuse is the intentional non-therapeutic use of a prescription drug, even once, for its rewarding psychological or physiological effects.

Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that develop after repeated substance use and includes a strong desire to take the drug, difficulties in controlling its use, persisting in its use despite harmful consequences, a higher priority given to drug use than to other activities and obligations, increased tolerance, and sometimes a physical withdrawal. "Drug-seeking" behavior is very common in persons with substance use disorders. Drug-seeking tactics include, emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated "loss" of prescriptions, tampering of prescriptions, and reluctance to provide prior medical records or contact information for other treating healthcare providers. "Doctor shopping" (visiting multiple prescribers to obtain additional prescriptions) is common among drug abusers and people suffering from untreated addiction. Preoccupation with achieving adequate pain relief can be appropriate behavior in a patient with poor pain control.

Abuse and addiction are separate and distinct from physical dependence and tolerance. Healthcare providers should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of true addiction.

Hydromorphone Hydrochloride Injection, USP (HIGH POTENCY), like other opioids, can be diverted for non-medical use into illicit channels of distribution. Careful record-keeping of prescribing information, including quantity, frequency, and renewal requests as required by state and federal law, is strongly advised.

Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.

Risks Specific to Abuse of Hydromorphone Hydrochloride Injection, USP (HIGH POTENCY)

Abuse of Hydromorphone Hydrochloride Injection, USP (HIGH POTENCY) poses a risk of overdose and death. The risk is increased with concurrent use of Hydromorphone Hydrochloride Injection, USP (HIGH POTENCY) with alcohol and other central nervous system depressants.

Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV.

Dependence

Both tolerance and physical dependence can develop during chronic opioid therapy. Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Tolerance may occur to both the desired and undesired effects of drugs, and may develop at different rates for different effects.

Physical dependence results in withdrawal symptoms after abrupt discontinuation of a significant dosage reduction of a drug. Withdrawal also may be precipitated through the administration of drugs with opioid antagonist activity (e.g., naloxone, nalmefene), mixed agonist/antagonist analgesics (e.g., pentazocine, butorphanol, nalbuphine), or partial agonists (e.g., buprenorphine). Physical dependence may not occur to a clinically significant degree until after several days to weeks of continued opioid usage.

Hydromorphone Hydrochloride Injection, USP (HIGH POTENCY) should not be abruptly discontinued in a physically-dependent patient [see Dosage and Administration (2.6)]. If Hydromorphone Hydrochloride Injection, USP (HIGH POTENCY) is abruptly discontinued in a physically-dependent patient, a withdrawal syndrome may occur. Some or all of the following can characterize this syndrome: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other signs and symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.

Infants born to mothers physically dependent on opioids will also be physically dependent and may exhibit respiratory difficulties and withdrawal signs [see Use in Specific Populations (8.1)].

1 mL Single-dose Vial
NDC 0703-0110-01

HIGH POTENCY FORMULATION
Rx only

Hydromorphone
Hydrochloride Injection, USP
CII

10 mg/mL

Mfd For: TEVA PHARMACEUTICALS USA, INC.
North Wales, PA 19454

Rev. A 8/2015

NDC 0703-0018-01

1 X 50 mL Single-dose Vial
Rx only

HIGH POTENCY FORMULATION

Hydromorphone
Hydrochloride
Injection, USP
CII

500 mg/ 50 mL
(10 mg/mL)

FOR USE IN THE
PREPARATION OF
LARGE-VOLUME
PARENTERAL SOLUTIONS

RETAIN IN THE CARTON
UNTIL TIME OF USE.

TEVA

This medication is used to relieve moderate to severe pain. Hydromorphone is an opioid (narcotic) pain reliever. It acts on certain centers in the brain to give you pain relief.

How to use Hydromorphone HCL Syringe

Depending on your specific product, this medication is given by injection under the skin, into a muscle, or slowly into a vein. Use exactly as directed by your doctor. Learn the proper way to give injections. If you have any questions about using this medication properly, consult your doctor or pharmacist.

Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the injection site with rubbing alcohol. If this medication is given into a muscle or under the skin, it is important to change the location of the injection site with each dose to avoid problem areas under the skin.

Use needles and syringes only once. Learn how to discard needles and medical supplies safely. Some brands of this medication contain more than 1 dose. Some brands contain only 1 dose. Review the use of the product you have been prescribed with your pharmacist. If your doctor has directed you to use a single-dose brand, use it for only 1 dose. Do not save any medication remaining in the package. Consult your pharmacist for more information.

The dosage is based on your medical condition and response to treatment. Pain medications work best if they are used when the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well. Do not increase your dose, use the medication more frequently, or use it for a longer time than prescribed. Properly stop the medication when so directed.

If nausea occurs, ask your doctor or pharmacist for ways to decrease it (such as lying down for 1 to 2 hours with as little head movement as possible).

If you have ongoing pain (such as due to cancer), your doctor may direct you to also take long-acting opioid medications. In that case, this medication might be used for sudden (breakthrough) pain only as needed. Other pain relievers (such as acetaminophen, ibuprofen) may also be prescribed. Ask your doctor or pharmacist about using hydromorphone safely with other drugs.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as mental/mood changes, fast breathing, yawning, sweating, watering eyes, goosebumps, muscle twitching) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away.

Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Use this medication exactly as prescribed to lower the risk of addiction. Ask your doctor or pharmacist for more details.

When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.

Tell your doctor if your pain persists or worsens.