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Another way to learn about EXALGO.

Want to know more about your EXALGO prescription? Watch this short video for information about using EXALGO safely.

You may be wondering…

How to take EXALGO. What to expect. Possible side effects. You may have other questions. Please call your doctor or pharmacist for answers. You can also check the topics below for important information.



Only take EXALGO if…

  • You have moderate to severe chronic pain
  • You were already taking an opioid medicine when your doctor prescribed EXALGO
  • You are used to taking opioid medicines. Ask your doctor if you are unsure you are used to taking opioid medicines
  • You need to take a pain relief medicine for a long time

Don't take EXALGO if you have…

  • Mild or temporary pain
  • Trouble breathing, or certain other lung problems
  • A bowel blockage
  • Allergies to any ingredients in EXALGO, including hydromorphone or sulfites, or if you have taken a monoamine oxidase inhibitor (MAOI) medicine within 14 days
  • Severe asthma or during an asthma attack
  • Narrowing of the stomach or intestines
  • Had surgery in your stomach or intestines

Before taking EXALGO, tell your doctor if you…

  • Have trouble breathing or lung problems such as asthma, wheezing, or shortness of breath
  • Have had a head injury or brain problem
  • Have liver or kidney problems
  • Have an adrenal gland problem, such as Addison's disease
  • Have thyroid problems
  • Have seizures (convulsions or fits)
  • Have problems with your pancreas or gallbladder
  • Have constipation
  • Have had stomach or intestinal surgery, or a blockage in your stomach or intestine
  • Have prostate enlargement or problems urinating
  • Have low blood pressure
  • Have mental problems including depression, anxiety, or hallucinations (seeing or hearing things that are not there)
  • Have or had a drinking problem or alcoholism, or a family history of this problem
  • Have or had a drug abuse or addiction problem in the past, or a family history of this problem
  • Have any other medical conditions
  • Are pregnant or planning to become pregnant. If you take EXALGO regularly before your baby is born, your newborn baby may have withdrawal symptoms because his or her body has become used to the medicine. Symptoms of withdrawal in a newborn baby may include:
    • - irritability
    • - crying more than usual
    • - shaking (tremors)
    • - jitteriness
    • - breathing faster than normal
    • - diarrhea or more stools than normal
    • - vomiting
    • - fever
    If you take EXALGO right before your baby is born, your baby could have breathing problems
  • Are breastfeeding. Do not breastfeed while taking EXALGO. Some EXALGO passes into breast milk. A nursing baby could become drowsy or have difficulty breathing or feeding well. If you stop breastfeeding or suddenly stop taking EXALGO while breastfeeding, your baby may have withdrawal symptoms. See the list of withdrawal symptoms above

Follow these directions when taking EXALGO:

  • Take EXALGO exactly as prescribed
  • Take EXALGO once a day at the same time every day
  • Swallow EXALGO tablets whole
  • Do not take more than one dose a day. In some cases, your dose may be more than one tablet to add up to the right dose. Your doctor will tell you
  • Do not change your dose unless your doctor tells you to. Talk to your doctor if you still have chronic pain or side effects. Your doctor may decide to change your dose
  • If you are not sure if you have taken your dose, do not take another dose
  • If you stop taking EXALGO for 3 or more days, talk to your doctor before taking it again

CALL YOUR DOCTOR IMMEDIATELY OR GET EMERGENCY MEDICAL HELP IF YOU:

  • Take too much EXALGO
  • Have trouble breathing
  • Have extreme drowsiness with slowed breathing
  • Have shallow breathing (little chest movement with breathing)
  • Feel faint, dizzy, or confused
  • Have other unusual symptoms

Do not stop taking EXALGO without…

Talking to your doctor. If your doctor decides to take you off EXALGO, your doctor will most likely begin to slowly reduce your dose so that you do not have withdrawal symptoms.

If you miss a dose, contact your doctor.

If you forget to take EXALGO, talk to your doctor or pharmacist. Do not take extra tablets to make up for the missed dose.

Do not chew, break, crush, or inject EXALGO.

It is very dangerous. You might receive the full daily dose too quickly. This may result in an overdose.

While taking EXALGO, do not…

  • Drive, operate heavy machinery, or do other dangerous things until you know how EXALGO affects you. EXALGO can make you sleepy. Ask your doctor when it is okay to do these activities
  • Drink alcohol. Drinking alcohol while taking EXALGO may lead to an overdose. An overdose can cause death
  • Take other medicines without talking to your doctor. Your doctor will tell you if it is safe to use other medicines. Other medicines include prescription and nonprescription drugs, vitamins, and herbal supplements
  • Combine EXALGO with other pain medicines unless your doctor tells you it is safe
  • Combine EXALGO with medicines that make you sleepy, especially sleeping pills or tranquilizers. Combining EXALGO with other medicines may result in serious medical problems
  • Do not breast-feed while using EXALGO. EXALGO can pass to your baby through your milk. It may cause serious harm to your baby. You and your doctor should decide whether you should take EXALGO or breast-feed but not both

Safe storage of EXALGO.

  • Keep EXALGO in a safe and secure place away from children and from anyone for whom it was not prescribed. Use by a child is a medical emergency and can cause death. If a child takes EXALGO, get emergency help right away
  • Keep EXALGO from being stolen by people who abuse drugs or prescription medicines
  • Do not give your EXALGO to anyone. It may harm them or cause death
  • Do not remove EXALGO from its container to store in a temporary container
  • Never leave EXALGO in an unlocked cabinet, common area, purse, etc
  • Store EXALGO away from heat, moisture, and light
  • Limit access to EXALGO to yourself or a caregiver
  • Always keep EXALGO in a secure place to prevent theft
  • Store EXALGO at room temperature, 59°F-86°F (15°C-30°C)
  • Flush unused or out-of-date EXALGO down the toilet

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.

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INDICATION

EXALGO® is a strong opioid pain medicine. EXALGO is used in people who are opioid tolerant. EXALGO is used to manage moderate to severe pain that is continuous and is expected to last for a long time.

IMPORTANT RISK INFORMATION

IMPORTANT WARNINGS

Abuse Potential

EXALGO contains hydromorphone, a strong pain medication and a Schedule II controlled substance with the potential for abuse like other strong pain medications, legal or illegal. Medication prescribers should assess each patient for the potential to abuse strong pain medications or become addicted to them before they give EXALGO. The risk for strong pain medication abuse is higher in patients who have abused strong pain medications before or who have family members that have (this includes both strong pain medication or alcohol) or mental illness (like depression). Medication prescribers should regularly monitor all patients they give EXALGO for signs they are not using the medication correctly.

Life-threatening Respiratory Depression

Slowed breathing may occur with EXALGO and could cause death. Death could occur even if used exactly as the medication prescriber said. EXALGO should only be used if patients have been taking strong pain medicines for a long time. The right dose is important and EXALGO should only be prescribed by healthcare professionals who have experience with strong pain medications for treating pain that will last for a long time. Watch for slowed breathing especially when first started or if the dose is increased. Swallow the tablet whole. Do not crush or chew as this can cause death.

Do not use EXALGO if you are NOT opioid tolerant. Use of EXALGO by people who are not opioid tolerant can cause life-threatening breathing problems that can cause death.

Accidental Exposure

Accidentally taking EXALGO, especially in children, can cause death.

  • Do not take EXALGO if:
    • - You have not been taking strong pain medications for a long period of time. Slowed breathing could occur and cause death.
    • - You have bad slowed breathing
    • - You have bad asthma, unless you are in the hospital and being observed by a medical professional
    • - You have any type of block in your intestines
    • - You have had surgery on your intestines
    • - You are allergic to hydromorphone or sulfites
  • EXALGO should not be used if:
    • - The pain is only occurring occasionally
    • - The pain is mild or not going to last for a long time
    • - The pain just started
    • - The pain is after surgery
  • Patients considered to have taken strong pain medications for a long period of time are those who are taking at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day or an equianalgesic dose of another opioid, for a week or longer.
  • Do not drive or operate heavy machinery or other dangerous activities until you know how EXALGO affects you. EXALGO can make you sleepy and cause you to feel dizzy or lightheaded. This may affect your ability to think and react.
  • Do not drink alcohol or use prescription or non-prescription medicines that contain alcohol while taking EXALGO. Using alcohol while taking EXALGO may cause overdose and death.
  • Do not take EXALGO if you already take a monoamine oxidase inhibitor medicine (MAOI). Do not take EXALGO within 14 days after you stop taking an MAOI medicine.
  • Tell your healthcare provider about all your medicines. This includes prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may cause serious or life-threatening medical problems when taken with EXALGO.
  • Breathing problems, which occur more often in older people or weakened patients, is the chief hazard with EXALGO. Call your doctor or get emergency medical help if you have any symptoms listed below. It can mean that you have taken too much (overdose) EXALGO. You have trouble breathing. You have extreme drowsiness with slowed breathing. You have shallow breathing (little chest movement with breathing). You feel faint, dizzy, or confused. You have other unusual symptoms.
  • Common side effects of EXALGO include constipation, nausea, vomiting, drowsiness or sleepiness, headache and dizziness. Serious events can include drop in blood pressure, symptoms of stomach or intestinal blockage, allergic reactions, and physical dependence symptoms from stopping EXALGO all at once.

Please see Medication Guide for Important Risk Information and Full Prescribing Information.

IMPORTANT RISK INFORMATION

WARNING:ABUSE POTENTIAL, LIFE-THREATENING RESPIRATORY DEPRESSION, and ACCIDENTAL EXPOSURE

Abuse Potential

EXALGO® contains hydromorphone, an opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid agonists,
legal or illicit. Click here for more Important Risk Information, including full boxed warning