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.

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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.

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.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Exalgo, there are no specific foods that you must exclude from your diet when receiving this medication.

Do not drink alcohol or take products containing alcohol while taking Exalgo.

Before taking Exalgo, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Exalgo or to any of its ingredients
• are allergic to sulfites or latex
• have ever had a head injury or condition that damaged the brain
• seizures
• problems urinating
• abuse of street or prescription drugs, alcohol addiction, or mental health problems.
• hypothyroidism (condition in which the thyroid gland produces less hormone than normal)
• gallbladder disease
• pancreatic disease
• liver disease
• kidney disease
• pregnant or plan on becoming pregnant
• breastfeeding or plan to breastfeed

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

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.

Take Exalgo exactly as prescribed.

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.

Get emergency help right away if you take too much Exalgo (overdose).

When you first start taking Exalgo, when your dose is changed, or if you take too much (overdose), serious or life threatening breathing problems that can lead to death may occur.

When taking Exalgo:

• Do not change your dose. Take Exalgo exactly as prescribed by your healthcare provider.
• Take your prescribed dose every 24 hours, at the same time every day. Do not take more than your prescribed dose in 24 hours. If you miss a dose, take your next dose at your usual time the next day.
• Swallow Exalgo whole. Do not cut, break, chew, crush, dissolve, snort, or inject Exalgo because this may cause you to overdose and die. 
• Call your healthcare provider if the dose you are taking does not control your pain.
• Do not stop taking Exalgo without talking to your healthcare provider. 
• Exalgo is contained in a hard tablet shell that you may see in your bowel movement; this is normal. 

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.

If you take too much Exalgo, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Get emergency medical help if you have:

• trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue or throat, extreme drowsiness, light-headedness when changing positions, or you are feeling faint.

If Exalgo is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Exalgo at 25ºC (77ºF).
• Keep this and all medicines out of the reach of children.

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.