Oxycodone Extended-Release Capsules

What is this medication?

OXYCODONE (ox i KOE done) treats severe, chronic pain. It is prescribed when other pain medications do not work well enough or cannot be tolerated. It works by blocking pain signals in the brain. It belongs to a group of medications called opioids. It is a long-acting medication. Do not use it to treat sudden pain.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): XTAMPZA

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Addison's disease
• Brain tumor
• Drug abuse or addiction
• Gallbladder disease
• Head injury
• Heart disease
• History of pancreatitis
• If you often drink alcohol
• Kidney disease
• Liver disease
• Low adrenal gland function
• Lung disease, asthma, or breathing problem
• Mental health disease
• Seizures
• Taken an MAOI like Marplan, Nardil, or Parnate in the last 14 days
• Thyroid disease
• An unusual or allergic reaction to oxycodone, other medications, foods, dyes or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Do not cut, crush or chew this medication. Swallow the capsules whole. You can take this medication with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. Special care may be needed.

Patients over 65 years of age may have a stronger reaction and need a smaller dose.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

• Alcohol
• Antihistamines for allergy, cough and cold
• Antiviral medications for HIV or AIDS
• Atropine
• Certain antibiotics like clarithromycin, erythromycin, linezolid, rifampin
• Certain medications for anxiety or sleep
• Certain medications for bladder problems like oxybutynin, tolterodine
• Certain medications for depression like amitriptyline, fluoxetine, sertraline
• Certain medications for fungal infections like ketoconazole, itraconazole, voriconazole
• Certain medications for migraine headache like almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan
• Certain medications for nausea or vomiting like dolasetron, ondansetron, palonosetron
• Certain medications for Parkinson's disease like benztropine, trihexyphenidyl
• Certain medications for seizures like phenobarbital, phenytoin, primidone
• Certain medications for stomach problems like dicyclomine, hyoscyamine
• Certain medications for travel sickness like scopolamine
• Diuretics
• General anesthetics like halothane, isoflurane, methoxyflurane, propofol
• Ipratropium
• Local anesthetics like lidocaine, pramoxine, tetracaine
• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
• Medications that relax muscles for surgery
• Methylene blue
• Nilotinib
• Other narcotic medications for pain or cough
• Phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Tell your care team if your pain does not go away, if it gets worse, or if you have new or a different type of pain. You may develop tolerance to this medication. Tolerance means that you will need a higher dose of the medication for pain relief. Tolerance is normal and is expected if you take this medication for a long time.

There are different types of narcotic medications (opioids) for pain. If you take more than one type at the same time, you may have more side effects. Give your care team a list of all medications you use. They will tell you how much medication to take. Do not take more medication than directed. Get emergency help right away if you have trouble breathing.

Do not suddenly stop taking your medication because you may develop a severe reaction. Your body becomes used to the medication. This does NOT mean you are addicted. Addiction is a behavior related to getting and using a medication for a nonmedical reason. If you have pain, you have a medical reason to take pain medication. Your care team will tell you how much medication to take. If your care team wants you to stop the medication, the dose will be slowly lowered over time to avoid any side effects.

Talk to your care team about naloxone and how to get it. Naloxone is an emergency medication used for an opioid overdose. An overdose can happen if you take too much opioid. It can also happen if an opioid is taken with some other medications or substances, like alcohol. Know the symptoms of an overdose, like trouble breathing, unusually tired or sleepy, or not being able to respond or wake up. Make sure to tell caregivers and close contacts where it is stored. Make sure they know how to use it. After naloxone is given, you must get emergency help right away. Naloxone is a temporary treatment. Repeat doses may be needed.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medication affects you. Do not stand up or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medication. Avoid alcoholic drinks.

This medication will cause constipation. If you do not have a bowel movement for 3 days, call your care team.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy and drinking plenty of water may help. Contact your care team if the problem does not go away or is severe.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• CNS depression—slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, difficulty staying awake
• Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness
• Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Constipation
• Dizziness
• Drowsiness
• Dry mouth
• Headache
• Nausea
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets. This medication can be abused. Keep it in a safe place to protect it from theft. Do not share it with anyone. It is only for you. Selling or giving away this medication is dangerous and against the law.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Protect from light. Keep the container tightly closed.

This medication may cause harm and death if it is taken by other adults, children, or pets. Return medication that has not been used to an official disposal site. Contact the DEA at 1-800-882-9539 or your city/county government to find a site. If you cannot return the medication, flush it down the toilet. Do not use the medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.