Xtampza ER

Xtampza ER is a prescription medication used to manage pain that is severe enough to require daily pain medication and for pain that requires around the clock management. It is indicated for pain that has not been managed with other treatment options.

Xtampza ER belongs to a group of drugs called opioids. These work to stop pain signals made in the brain.

This medication is available as extended release capsules and is typically taken twice a day, with food. Swallow Xtampza ER capsules whole. Do not crush capsules. 

Common side effects of Xtampza ER include nausea, headache, and constipation.

Xtampza ER may cause drowsiness and dizziness. Do not drive or operate heavy machinery until you know how this medication affects you.  

Xtampza ER is a prescription medication used to manage pain that is severe enough to require daily pain medication and for pain that requires around the clock management. It is indicated for pain that has not been managed with other treatment options. Xtampza ER is not to be given for as-needed pain. 

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

Serious side effects have been reported. See "Xtampza ER Drug Precautions" section.

Common side effects of Xtampza ER include:

• nausea
• headache
• constipation
• feeling tired
• itching
• vomiting
• dizziness

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

Tell your healthcare provider if you have any side effect that bothers you or 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 healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Be especially careful about taking other medicines that make you sleepy such as:

• pain medicines
• sleeping pills
• anxiety medicines
• antihistamines
• anti-depressants
• tranquilizers
• anti-nausea medicine
• alcohol

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

Xtampza ER can cause serious side effects such as:

• Serious breathing problems. Xtampza ER can cause serious breathing problems that can become life-threatening, especially if Xtampza ER is used the wrong way. Call your healthcare provider or get medical help right away if:
  • your breathing slows down
  • you have shallow breathing (little chest movement with breathing)
  • you feel faint, dizzy, confused, or
  • you have any other unusual symptoms
• Low blood pressure. Xtampza ER can cause your blood pressure to drop. This can make you feel dizzy and faint if you get up too fast from sitting or lying down. Low blood pressure is also more likely to happen if you take other medicines that can also lower your blood pressure. Severe low blood pressure can happen if you lost blood or take certain other medicines.
• Risk for addiction. There is a chance of abuse or addiction with Xtampza ER. The chance is higher if you are or have been addicted to or abused other medicines, street drugs, or alcohol, or if you have a history of mental problems.
• Adrenal Insufficiency. Tell your doctor if you notice symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure.  

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, lightheadedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.

Never give anyone else your medication. They could die from taking it. Store this medication away from children and in a safe place to prevent stealing or abuse. Selling or giving away Xtampza ER is against the law. 

Do not drive, operate heavy machinery, or participate in any other possibly dangerous activities until you know how you react to this medicine. This medication can make you sleepy.

Do not drink alcohol while using Xtampza ER. It may increase the chance of getting dangerous side effects.

Do not take other medicines without your doctor’s approval. Other medicines include prescription and non-prescription medicines, vitamins, and supplements. Be especially careful about products that make you sleepy.

Do not take Xtampza ER if:

• your doctor did not prescribe it for you
• are allergic to any of its ingredients
• have had a severe allergic reaction to a medicine that contains oxycodone. Ask your healthcare provider if you are not sure.
• are having an asthma attack or have severe asthma, trouble breathing, or any lung problems
• have a bowel blockage called paralytic ileus
• have narrowing of the stomach or intestines
• have recently had a head injury
• you have a history of drug or alcohol dependence
• you have had a severe allergic reaction to codeine or hydrocodone. A severe allergic reaction includes a severe rash, hives, breathing problems, or dizziness.

Grapefruit and grapefruit juice may interact with Xtampza ER and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Tell your doctor if you:

• are allergic to Xtampza ER or to any of its ingredients
• have trouble breathing or lung problems
• have had a head injury
• have liver or kidney problems
• have problems urinating
• have adrenal gland problems, such as Addison's disease
• have severe scoliosis that affects your breathing
• pancreas or gallbladder problems
• have thyroid problems
• have or had convulsions or seizures
• have a past or present drinking problem or alcoholism
• have hallucinations or other severe mental problems
• have past or present substance abuse or drug addiction
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your healthcare provider 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.

There are no well-done studies that have been done in humans with Xtampza ER. Prolonged use of Xtampza ER 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. 

Xtampza ER has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Xtampza ER, a choice should be made whether to stop nursing or to stop the use of this medication. It is recommended not to breastfeed while taking this medication. 

Take Xtampza ER exactly as prescribed. 

Do not change your dose. Use the lowest dose possible for the shortest time needed.

Xtampza ER is available in extended release capsule form and is typically taken every 12 hours, at the same time every day.

• Swallow capsules whole. Do not snort, or inject this medication because this may cause you to overdose and die
• Do not take more than your prescribed dose.
• Always take this medication with approximately the same amount of food to ensure enough medicine is absorbed.

If you miss a dose, take your next dose at your usual time.

If you cannot swallow Xtampza ER capsules, then 

• The contents of the capsules may be sprinkled on soft food, sprinkled into a cup and then put directly into the mouth, or given through a nasogastric or gastrostomy tube.

Tell your healthcare provider if the dose you are taking does not control your pain.

Do not stop taking this medication without talking to your healthcare provider.

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

The dose will depend on if you were taking an opioid already, which one, and at what dose. Your dose will also depend on how well it has been controlling your pain. 

Your doctor will determine the best dose for you. The dosage of Xtampza ER must be individualized.

If you take more Xtampza ER than prescribed, or overdose, call your local emergency number (such as 911) or your local Poison Control Center right away, or get emergency help.

• Keep Xtampza ER out of the reach of children. Accidental overdose by a child is dangerous and can lead to death.
• Store Xtampza ER at 25°C (77°F). 
• Keep Xtampza ER in the container it comes in.
• Keep the container tightly closed and away from light.

Xtampza ER is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep this medication in a safe place to prevent misuse and abuse. Selling or giving away this medication may harm others, and is against the law.

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and CYTOCHROME P450 3A4 INTERACTION

• XTAMPZA ER 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 and conditions.
• Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase.
• Accidental ingestion of XTAMPZA ER, especially by children, can result in fatal overdose of oxycodone.
• Prolonged maternal use of XTAMPZA ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be lifethreatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
• Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of oxycodone from XTAMPZA ER.