Avinza

DRUG DESCRIPTION

AVINZA (morphine sulfate extended-release capsules) 30, 45, 60, 75, 90, and 120 mg contain both immediate release and extended release beads of morphine sulfate for once daily oral administration.

Chemically, morphine sulfate is 7,8-didehydro-4,5 alpha-epoxy-17-methylmorphinan-3,6 alpha-diol sulfate (2:1) (salt) pentahydrate with a molecular weight of 758. Morphine sulfate occurs as white, feathery, silky crystals; cubical masses of crystal; or white crystalline powder. It is soluble in water and slightly soluble in alcohol, but is practically insoluble in chloroform or ether. The octanol:water partition coefficient of morphine is 1.42 at physiologic pH and the pKa is 7.9 for the tertiary nitrogen (the majority is ionized at pH 7.4).

Each AVINZA (morphine sulfate) Capsule contains either 30, 45, 60, 75, 90, or 120 mg of morphine sulfate, USP and the following inactive ingredients: ammoniomethacrylate copolymers, NF, fumaric acid, NF, povidone, USP, sodium lauryl sulfate, NF, sugar starch spheres, NF, and talc, USP. The capsule shell contains black ink, gelatin, titanium dioxide, D&C yellow No. 10 (30 mg), FD&C blue No. 2 (45 mg), FD&C green No. 3 (60 mg), FDA iron oxide and FDA yellow iron oxide (75 mg), FD&C red No. 40 (90 mg), FD&C red No. 3 (120 mg), and FD&C blue No. 1 (120 mg).

Structure:

 AVINZA® (morphine sulfate) Structural Formula Illustration

AVINZA (morphine sulfate) uses the proprietary SODAS® (Spheroidal Oral Drug Absorption System) technology to produce the extended release component of AVINZA (morphine sulfate) , which combined with an immediate release component achieves the desired release profile characteristics of AVINZA (morphine sulfate) capsules. Within the gastrointestinal tract, due to the permeability of the ammoni-omethacrylate copolymers of the beads, fluid enters the beads and solubilizes the drug. This is mediated by fumaric acid, which acts as an osmotic agent and a local pH modifier. The resultant solution then diffuses out in a predetermined manner which prolongs the in vivo dissolution and absorption phases. (See Pharmacokinetics)

What are the possible side effects of morphine?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • shallow breathing, slow heartbeat;
  • seizure (convulsions);
  • cold, clammy skin;
  • confusion;
  • severe weakness or dizziness; or
  • feeling light-headed, fainting.

Less serious side effects are more likely to occur, such as:

    ...

Read All Potential Side Effects and See Pictures of Avinza »

What are the precautions when taking morphine sulfate (Avinza)?

Before taking morphine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), kidney disease, liver disease, mental/mood disorders (such as confusion, depression), personal or family history of regular use/abuse of drugs/alcohol, stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus), difficulty urinating...

Read All Potential Precautions of Avinza »


Avinza Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, constipation, lightheadedness, dizziness, or drowsiness may occur. Some of these side effects may decrease after you have been using this medication for a while. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Ask your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as agitation, confusion, hallucinations), severe stomach/abdominal pain, difficulty urinating.

Seek immediate medical attention if any of these rare but serious side effects occur: fainting, seizure, slow/shallow breathing, unusual drowsiness/difficulty waking up.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking morphine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain disorders (such as head injury, tumor, seizures), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), kidney disease, liver disease, mental/mood disorders (such as confusion, depression), personal or family history of regular use/abuse of drugs/alcohol, stomach/intestinal problems (such as blockage, constipation, diarrhea due to infection, paralytic ileus), difficulty urinating (such as due to enlarged prostate).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the effects of this drug, especially dizziness, drowsiness, or urinary problems.

During pregnancy, this medication should be used only when clearly needed. Using it for long periods or in high doses near the expected delivery date is not recommended because of the potential for harm to the unborn baby. Discuss the risks and benefits with your doctor. Babies born to mothers who have used this medication for an extended time may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, or diarrhea. If you notice any of these symptoms in your newborn, tell the doctor promptly.

This drug passes into breast milk and may rarely have undesirable effects on a nursing infant. Tell the doctor immediately if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breast-feeding.


Avinza Patient Information Including Side Effects

Brand Names: Avinza, Kadian, Morphine IR, MS Contin, MSIR, Oramorph SR, Roxanol

Generic Name: morphine (Pronunciation: MOR feen)

  • What is morphine (Avinza)?
  • What are the possible side effects of morphine?
  • What is the most important information I should know about morphine?
  • What should I discuss with my healthcare provider before using morphine?
  • How should I use morphine?
  • What happens if I miss a dose?
  • What happens if I overdose?
  • What should I avoid while using morphine?
  • What other drugs will affect morphine?
  • Where can I get more information?

What is morphine (Avinza)?

Morphine is in a group of drugs called narcotic pain relievers.

Morphine is used to treat moderate to severe pain. Short-acting morphine is taken as needed for pain. Extended-release morphine is for use when around-the-clock pain relief is needed.

Morphine is not for treating pain just after surgery unless you were already taking morphine before the surgery.

Morphine may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of morphine?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • shallow breathing, slow heartbeat;
  • seizure (convulsions);
  • cold, clammy skin;
  • confusion;
  • severe weakness or dizziness; or
  • feeling light-headed, fainting.

Less serious side effects are more likely to occur, such as:

  • constipation;
  • warmth, tingling, or redness under your skin;
  • nausea, vomiting, stomach pain, diarrhea, loss of appetite;
  • dizziness, headache, anxiety;
  • memory problems; or
  • sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about morphine?

You may not be able to take this medicine unless you are already being treated with a similar opioid pain medicine and your body is tolerant to it. Talk with your doctor if you are not sure you are opioid-tolerant.

Morphine may be habit-forming and should be used only by the person it was prescribed for. Morphine should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Do not drink alcohol while you are using morphine. Dangerous side effects or death can occur when alcohol is combined with morphine. Check your food and medicine labels to be sure these products do not contain alcohol.

Never take more than your prescribed dose of morphine. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Do not stop taking morphine suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

Related Drug Centers
  • Avinza
  • Roxanol
  • MS-Contin
  • Kadian


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