Exalgo

Exalgo is a prescription medication used to relieve pain severe enough to require daily, around-the-clock, long-term opioid treatment. Exalgo belongs to a group of drugs called narcotic analgesics. These work by changing the way that the brain and nervous system respond to pain.

This medication comes as extended release tablets and is taken once a day. Do not chew, divide, or break Exalgo extended release tablets. Swallow these tablets whole.

Common side effects of Exalgo include nausea, vomiting, constipation, and headache.

Exalgo can also cause drowsiness and dizziness. Do not drive or operate heavy machinery until you know how Exalgo affects you.

Exalgo is a prescription medication used to manage pain severe enough to require daily around-the-clock, long-term treatment with an opioid, in people who are already regularly using opioid pain medicine, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them.

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

Take Exalgo exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The Exalgo dose your doctor recommends will be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The recommended dose range of Exalgo (hydromorphone) tablets for the treatment of pain is 8 to 64 mg once daily.

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; AND NEONATAL OPIOID WITHDRAWAL SYNDROME

• EXALGO exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk before prescribing, and monitor regularly for development of these behaviors or conditions. 
• Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Instruct patients to swallow EXALGO tablets whole to avoid exposure to a potentially fatal dose of hydromorphone. 
• Accidental ingestion of EXALGO, especially in children, can result in fatal overdose of hydromorphone. 
• Prolonged use of EXALGO during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.

Serious side effects have been reported with Exalgo including the following:

• Rash
• Hives
• Swelling of the eyes, face, lips, tongue, mouth, throat, arms, hands, feet, ankles, or lower legs
• Difficulty breathing or swallowing
• Hoarseness
• Seizures
• Chest pain
• Extreme drowsiness
• Fainting

Exalgo can cause dizziness and drowsiness. Do not drive or operate heavy machinery until you know how Exalgo affects you. Do not drink alcohol or use prescription or over-the-counter medicines containing alcohol while taking Exalgo. Using products containing alcohol during treatment with Exalgo may cause you to overdose and end in death.

Do not take Exalgo if you:

• are allergic to Exalgo or to any of its ingredients
• have respiratory depression
• have acute, severe, or uncontrolled asthma
• have a bowel blockage or have narrowing of the stomach or intestines

Exalgo may only be used in patients who are opioid-tolerant.

• Exalgo is a long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.
• Exalgo is NOT for use to treat pain that is not around-the-clock.

Serious side effects have been reported with Exalgo. See the “Exalgo Precautions” section.

Common side effects of Exalgo include the following:

• Nausea
• Vomiting
• Headache
• Constipation
• Sleepiness
• Feeling tired
• Stomach pain
• Dry mouth
• Heavy sweating
• Muscle, back, or joint pain
• Itching

This is not a complete list of Exalgo side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Buprenorphine (Buprenex, Butrans, in Suboxone)
• Butorphanol (Stadol)
• Anticholinergics such as Ipratropium (Atrovent)
• Medications for glaucoma, irritable bowel disease, Parkinson's disease, ulcers, and urinary problems
• Pentazocine (Talwin)
• Nalbuphine

Also tell your doctor or pharmacist if you are taking any of the following medications or have stopped taking them within the past 2 weeks:

• Isocarboxazid (Marplan)
• Phenelzine (Nardil)
• Selegiline (Eldepryl, Emsam, Zelapar)
• Tranylcypromine (Parnate)

This is not a complete list of Exalgo drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Exalgo falls into category C. There are no well-controlled studies that have been done in pregnant women. Exalgo should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Prolonged use of Exalgo during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Exalgo has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Exalgo, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Hydromorphone has the potential for addiction, abuse, and misuse. Use this medication only as prescribed.

Seek immediate medical attention if you have difficulty breathing.

Do not abruptly discontinue using extended release hydrocodone. Discuss a tapering regimen with your health care provider before you stop taking extended release hydrocodone.