Avinza extended-release capsules

Pronunciation

Generic Name: morphine (MOR-feen)
Brand Name: Avinza

Avinza extended-release capsules is a narcotic pain medicine that may become habit-forming. Misuse or abuse can lead to overdose and death. Do NOT take more than the recommended dose, take for longer than prescribed, or take more often than prescribed without checking with your doctor.

Avinza extended-release capsules may cause severe and sometimes fatal breathing problems. The risk may be greater when you first start this drug or with any increase in dose. Contact your doctor right away if you experience slow, shallow, or difficult breathing.

Be sure to swallow Avinza extended-release capsules whole. Do NOT break, crush, cut, dissolve, or chew Avinza extended-release capsules before swallowing it. Do NOT inject or snort Avinza extended-release capsules. Doing any of these things could result in very serious side effects, including severe trouble breathing and death from overdose. If you cannot swallow Avinza extended-release capsules whole, you may open it and sprinkle the contents over a spoonful of applesauce. Swallow the mixture right away, followed by a glass of water. Do NOT crush or chew the medicine before swallowing. Do not store the mixture for future use.

Accidental swallowing of even one dose of Avinza extended-release capsules may be fatal, especially in children. Keep Avinza extended-release capsules out of the reach of children. Seek emergency medical care right away if another person swallows Avinza extended-release capsules.

Do NOT drink alcohol or take medicines (prescription or nonprescription) that contain alcohol while you are taking Avinza extended-release capsules. This could cause a fatal overdose. If you are unsure if any of your medicines contain alcohol, check with your doctor or pharmacist.

Long-term use of Avinza extended-release capsules during pregnancy may cause dependence in the unborn baby. This can lead to withdrawal in the newborn, which can be life-threatening. Discuss any questions or concerns with your doctor.


Avinza extended-release capsules is used for:

Managing severe pain. Avinza extended-release capsules is only for use when continuous (around-the-clock) treatment is needed for a long time. It is also only for use when other pain treatments do not treat your pain well enough or you cannot take them. It is NOT for use right after surgery if you have not already been using narcotic pain medicines, if you need only occasional or as-needed pain relief, or if the pain is mild or is not expected to last for a long time.

Certain strengths of Avinza extended-release capsules should only be used by patients who have already been taking other narcotic pain medicine on a regular schedule and are tolerant to its effects. The use of these strengths by people who are not used to taking narcotic pain medicine may cause severe and sometimes fatal breathing problems.

Avinza extended-release capsules is a narcotic (opioid) pain medicine. It works in the brain and the nervous system to decrease pain.

Do NOT use Avinza extended-release capsules if:

  • you are allergic to any ingredient in Avinza extended-release capsules
  • you have narrowing of the stomach or bowels or known or suspected stomach or bowel blockage (eg, paralytic ileus)
  • you have slow, shallow, or difficult breathing
  • you have severe lung problems (eg, severe asthma), or you are having an asthma attack
  • you are taking buprenorphine, a mixed agonist/antagonist pain medicine (eg, butorphanol, nalbuphine, pentazocine), or sodium oxybate (GHB)
  • you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine), or you have taken one within the past 14 days

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

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Before using Avinza extended-release capsules:

Some medical conditions may interact with Avinza extended-release capsules. 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, especially other narcotic pain relievers (eg, codeine, hydromorphone); foods; or other substances
  • if you have a history of chronic obstructive pulmonary disease (COPD) or other lung or breathing problems (eg, asthma, bronchitis, emphysema), sleep apnea, curvature of the spine (scoliosis), a certain heart problem (cor pulmonale), high levels of carbon dioxide in the blood (hypercapnia or hypercarbia), or low levels of oxygen in the blood (hypoxia)
  • if you have severe drowsiness, increased pressure in the brain, a recent head injury, growths in the brain (eg, tumors, lesions), or a history of seizures (eg, epilepsy)
  • if you have a history of liver or kidney problems, thyroid problems, stomach or bowel problems (eg, blockage, inflammation), gallbladder problems, pancreas problems (eg, pancreatitis), an enlarged prostate, or urinary blockage or trouble urinating
  • if you have low blood pressure, dehydration, low blood volume, constipation, stomach pain, or poor health
  • if you drink alcohol, have symptoms of alcohol withdrawal, or have a history of suicidal thoughts or attempts
  • if you or a member of your family has a history of mental or mood problems (eg, depression), hallucinations, suicidal thoughts or actions, or alcohol or other substance abuse or dependence
  • if you are very overweight, or have recently had or will be having surgery (eg, stomach or bowel surgery)
  • if you have a gastric or nasogastric (NG) tube (stomach tube)
  • if you have never taken a narcotic pain medicine before

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

  • Phenothiazines (eg, chlorpromazine) because the risk of low blood pressure may be increased
  • Cimetidine or sodium oxybate (GHB) because the risk of severe drowsiness, coma, confusion, or slowed or difficult breathing may be increased
  • Anticholinergics (eg, scopolamine, benztropine) because the risk of constipation and trouble urinating may be increased
  • MAOIs (eg, phenelzine) because the risk of a severe reaction, including fever, seizures, and coma, may be increased
  • Other narcotic pain medicines (eg, morphine, oxycodone) or quinidine because they may increase the risk of Avinza extended-release capsules's side effects
  • Buprenorphine, mixed agonist/antagonist pain medicines (eg, butorphanol, nalbuphine, pentazocine), or naltrexone because they may decrease Avinza extended-release capsules's effectiveness and withdrawal symptoms may occur
  • Rifamycins (eg, rifampin) because they may decrease Avinza extended-release capsules's effectiveness
  • Muscle relaxants (eg, cyclobenzaprine) because the risk of their side effects may be increased
  • Diuretics (eg, furosemide, hydrochlorothiazide) because their effectiveness may be decreased by Avinza extended-release capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Avinza extended-release capsules 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 extended-release capsules:

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

  • Avinza extended-release capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Avinza extended-release capsules refilled.
  • Take Avinza extended-release capsules by mouth with or without food. It stomach upset occurs, take with food to reduce stomach irritation.
  • Avinza extended-release capsules must only be taken by mouth. Do not inject or snort Avinza extended-release capsules. Do not take Avinza extended-release capsules through a gastric or nasogastric (NG) tube (stomach tube).
  • Swallow Avinza extended-release capsules whole. Do not break, cut, dissolve, crush, or chew before swallowing.
  • If you cannot swallow the capsule whole, you may open it and sprinkle the contents over a spoonful of applesauce. Swallow the mixture right away, followed by a glass of water. Do not crush or chew the medicine before swallowing. Do not store the mixture for future use. Flush the empty capsule down the toilet right away.
  • Do not suddenly stop taking Avinza extended-release capsules. You may have an increased risk of withdrawal symptoms (eg, nausea, vomiting, diarrhea, anxiety, shivering). If you need to stop Avinza extended-release capsules, your doctor will gradually lower your dose.
  • Avinza extended-release capsules works best if it is taken at the same time each day. Do not miss any doses.
  • If you miss a dose of Avinza extended-release capsules, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Do not take more than 1 dose in 24 hours.

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

Important safety information:

  • Avinza extended-release capsules may cause dizziness, drowsiness, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Avinza extended-release capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol or take medicines (prescription or nonprescription) that have alcohol in them while you are taking Avinza extended-release capsules. Check with your pharmacist if you have questions about whether any of your medicines contain alcohol.
  • Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking Avinza extended-release capsules; the risk of severe drowsiness or breathing problems may be increased. Ask your pharmacist if you have questions about which medicines may increase the risk of these effects.
  • Avinza extended-release capsules may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
  • Avinza extended-release capsules may cause constipation. Talk with your doctor or pharmacist about using a stool softener or laxative to prevent constipation. It is also important to maintain a diet adequate in fiber, drink plenty of water, and exercise to prevent constipation. If you become constipated while taking Avinza extended-release capsules, talk with your doctor or pharmacist.
  • Do NOT take more than the recommended dose, take for longer than prescribed, or take more often than prescribed without checking with your doctor.
  • If your pain continues or becomes worse or if you have side effects that concern you, contact your doctor.
  • Tell your doctor or dentist that you take Avinza extended-release capsules before you receive any medical or dental care, emergency care, or surgery.
  • Seek emergency medical care right away if another person swallows Avinza extended-release capsules. Accidental swallowing of Avinza extended-release capsules may be fatal, especially in children.
  • Use Avinza extended-release capsules with caution in the ELDERLY; they may be more sensitive to its effects, especially breathing problems.
  • Avinza extended-release capsules should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Avinza extended-release capsules while you are pregnant. Long-term use of Avinza extended-release capsules during pregnancy may cause dependence in the fetus or newborn. Discuss any questions or concerns with your doctor. Avinza extended-release capsules is found in breast milk. Do not breast-feed while taking Avinza extended-release capsules.

When used for long periods of time or at high doses, Avinza extended-release capsules 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 extended-release capsules stops working well. Do not take more than prescribed.

Some people who use Avinza extended-release capsules for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you stop taking Avinza extended-release capsules suddenly, you may have WITHDRAWAL symptoms. These may include 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 extended-release capsules:

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:

Back pain; constipation; decreased appetite; diarrhea; dizziness; drowsiness; dry mouth; headache; mild stomach pain; nausea; sweating; tiredness; trouble sleeping; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue); abnormal sighing; burning, numbness, or tingling; chest pain; confusion; difficult or painful urination; fainting; fast, irregular, or slow heartbeat; fever, chills, or persistent sore throat; hallucinations; memory problems; mental or mood changes (eg, agitation, depression); seizures; severe or persistent constipation, stomach pain, or vomiting; severe or persistent dizziness, drowsiness, headache, or light-headedness; shortness of breath; slow, shallow, or difficult breathing; swelling of the hands, ankles, or feet; tremor; trouble talking, thinking, or walking; trouble urinating; unusual bruising or bleeding; unusual tiredness or weakness; vision changes (eg, blurred vision).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include bluish skin or nails; cold and clammy skin; coma; difficult, shallow, or slow breathing; fainting; limp muscles; pinpoint or enlarged pupils; severe drowsiness, dizziness, or light-headedness; shortness of breath; slow or irregular heartbeat.

Proper storage of Avinza extended-release capsules:

Store Avinza extended-release capsules 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 extended-release capsules out of the reach of children and away from pets.

General information:

  • If you have any questions about Avinza extended-release capsules, please talk with your doctor, pharmacist, or other health care provider.
  • Avinza extended-release capsules 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.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Avinza extended-release capsules or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Avinza extended-release capsules. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Avinza extended-release capsules. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Avinza extended-release capsules.

Issue Date: November 5, 2014
Database Edition 14.4.1.002
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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