Avinza

Avinza is used for:

Managing moderate to severe pain for more than a few days. It may also be used for other conditions as determined by your doctor.

Avinza is a narcotic pain reliever. It works by dulling the pain perception center in the brain. It may also affect other body systems (eg, breathing and circulatory systems) at higher doses.

Do NOT use Avinza if:

• you are allergic to any ingredient in Avinza
• you have known or suspected paralysis of the intestines or antibiotic associated colitis
• you are taking cimetidine, sodium oxybate (GHB), or a tricyclic antidepressant (eg, amitriptyline), or you drink alcohol
• you are taking or have taken a monoamine oxidase (MAO) inhibitor (eg, phenelzine) within the past 14 days
• you have slowed breathing or severe asthma or you are having an asthma attack

Contact your doctor or health care provider right away if any of these apply to you.

Before using Avinza :

Some medical conditions may interact with Avinza . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines or other substances
• if you have asthma, chronic obstructive pulmonary disease (COPD), or other lung or breathing problems, or you have a history of drug abuse or dependence
• if you have increased pressure in the head, a recent head injury, or lesions in the head
• if you have difficulty urinating; heart, liver, or thyroid disease; hypercapnia (abnormally increased carbon dioxide tension in your arteries); curvature of the spine; seizures; or a history of suicidal thoughts or behaviors
• if you have low blood volume, a stomach blockage or inflammatory bowel disease, have had stomach tract surgery, or are in shock

Some MEDICINES MAY INTERACT with Avinza . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Fluoxetine, naltrexone, narcotic agonists/antagonists (eg, pentazocine), rifampin, or risperidone because the effectiveness of Avinza may be decreased
• Barbiturate anesthetics (eg, thiopental), cimetidine, ethanol, ketorolac, MAO inhibitors (eg, phenelzine) sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because side effects (eg, disorientation, respiratory depression, seizures) may occur
• Barbiturate anesthetics (eg, thiopental) or sodium oxybate (GHB) because the actions and side effects of these medicines may be increased
• Mexiletine or trovafloxacin because the effectiveness of these medicines may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Avinza may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Avinza :

Use Avinza as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Avinza may be taken with or without food.
• Swallow Avinza whole. Do not crush, chew, or dissolve Avinza .
• If capsules cannot be swallowed whole, you may open the capsule and sprinkle the contents on a small amount of applesauce right before taking. Do not chew, crush, or dissolve the pellets. Rinse your mouth with water to make sure you swallow the pellets. Do not mix the pellets and store for future use.
• Take Avinza regularly to receive the most benefit from it.
• Taking Avinza at the same time each day will help you remember to take it.
• If you are taking trovafloxacin, do not take Avinza within 4 hours of trovafloxacin.
• If you miss a dose of Avinza , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Avinza .

Important safety information:

• Avinza may cause dizziness or drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Avinza . Using Avinza alone, with other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Avinza . Avinza will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
• Do not drink alcohol or take any prescription or nonprescription medicines that contain alcohol while you are using Avinza . Ask your pharmacist if you have questions about if any of your medicines contain alcohol.
• Excessive drowsiness usually disappears in 3 to 5 days. Consult your doctor if it continues or is accompanied by unsteadiness or confusion.
• Avinza may cause constipation. Constipation may be avoided by using a stool softener or fiber laxative.
• Do not take more of Avinza or take it more often than recommended by your doctor. Exceeding the recommended dose or taking the medicine for longer than prescribed may be habit-forming.
• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Avinza .
• Do not take Avinza if you have had a severe allergic reaction to morphine or hydromorphone (eg, MS Contin, Roxanol, Dilaudid). If you have a question about whether you are allergic to Avinza or if a certain medicine contains morphine or hydromorphone, contact your doctor or pharmacist.
• LAB TESTS, including liver function, kidney function, lung function, and complete blood cell counts, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Use Avinza with caution in the ELDERLY because they may be more sensitive to its effects.
• Avinza is not recommended for use in CHILDREN; safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Avinza during pregnancy. Avinza is excreted in breast milk. Do not breast-feed while taking Avinza .

When used for long periods of time or at high doses, Avinza may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Avinza stops working well. Do not take more than prescribed.

When used for long periods of time or at high doses, some people develop a need to continue taking Avinza . This is known as DEPENDENCE or addiction. If you suddenly stop taking Avinza , you may experience WITHDRAWAL symptoms, including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Avinza :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; headache; lightheadedness; mood changes; nausea; vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); excessive drowsiness; face or throat swelling; fast, irregular, or slow heartbeat; hallucinations; itching; pounding in the chest; seizures; shock; shortness of breath; sudden chest pain; sweating.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include cold and clammy skin; convulsions; deep sleep; dizziness; drowsiness; lightheadedness; loss of consciousness; low body temperature; slowed breathing; slowed heartbeat.

Store Avinza at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Protect from heat, moisture, and light. Do not store in the bathroom. Keep Avinza out of the reach of children and away from pets.

General information:

• If you have any questions about Avinza , please talk with your doctor, pharmacist, or other health care provider.
• Avinza is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Avinza . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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