Avinza
Name: Avinza
- Avinza dosage
- Avinza drug
- Avinza side effects
- Avinza tablet
- Avinza used to treat
- Avinza avinza side effects
- Avinza usual dose
- Avinza action
- Avinza 30 mg
- Avinza serious side effects
- Avinza side effects of avinza
- Avinza effects of avinza
How to use
Manufacturer
King Pharmaceuticals, Inc.
Avinza Precautions
Avinza may be habit-forming. Take this medication as prescribed. Do not take more of it, or take it more often than as directed by your doctor. There is a greater risk that you will overuse Avinza if you have or have ever had depression or another mental illness, or if you have abused alcohol, used street drugs, or overused prescription medications.
Do not allow anyone else to take your medication. Keep this medication out of the reach of children and in a safe place so that no one else can take it as Avinza may harm or cause death to other people who take your medication, especially children.
Avinza may cause slowed or stopped breathing, especially when you begin your treatment and any time your dose is increased. Tell your doctor if you have slowed breathing and if you have or have ever had lung disease such as asthma, chronic obstructive pulmonary disease (COPD; a group of diseases including chronic bronchitis and emphysema that cause difficulty breathing), or other breathing problems. If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment: slowed breathing, long pauses between breaths, or shortness of breath.
Taking certain other medications during your treatment with Avinza may increase the risk that you will experience breathing problems or other serious, life-threatening side effects.
Important information about Avinza:
- Get emergency help right away if you take too much Avinza (overdose). Avinza overdose can cause life threatening breathing problems that can lead to death.
- Never give anyone else your Avinza. They could die from taking it. Store Avinza away from children and in a safe place to prevent stealing or abuse.
- Selling or giving away Avinza is against the law. Avinza is a federally controlled substance (CII) because it can be abused or lead to dependence.
Do not take Avinza if you have:
- severe asthma, trouble breathing, or other lung problems.
- a bowel blockage or have narrowing of the stomach or intestines.
While taking Avinza do not:
- Drive or operate heavy machinery, until you know how Avinza affects you. Avinza can make you sleepy, dizzy, or lightheaded.
- Drink alcohol or use prescription or over-the-counter medicines that contain alcohol.
Avinza and Pregnancy
Tell your doctor if you are pregnant or plan to become pregnant.
The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.
This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.
Uses For Avinza
Morphine is used to relieve moderate to severe pain. It belongs to the group of medicines called narcotic analgesics (pain medicines). Morphine acts on the central nervous system (CNS) to relieve pain.
Morphine extended-release capsules or tablets should not be used if you need pain medicine for just a short time, such as when recovering from surgery. Do not use this medicine to relieve mild pain, or in situations when non-narcotic medication is effective. This medicine should not be used to treat pain that you only have once in a while or "as needed".
When morphine is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.
This medicine is available only with your doctor's prescription.
Avinza Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Less common- Abdominal or stomach pain
- blurred vision
- bulging soft spot on the head of an infant
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- change in the ability to see colors, especially blue or yellow
- chest pain or discomfort
- confusion
- cough
- decreased urination
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fainting
- fast, pounding, or irregular heartbeat or pulse
- headache
- hives, itching, or skin rash
- increased sweating
- loss of appetite
- nausea or vomiting
- nervousness
- pounding in the ears
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- severe constipation
- severe vomiting
- shakiness in the legs, arms, hands, or feet
- slow heartbeat
- sweating or chills
- Black, tarry stools
- cold, clammy skin
- feeling of warmth or heat
- flushing or redness of the skin, especially on the face and neck
- irregular, fast or slow, or shallow breathing
- lightheadedness
- loss of consciousness
- low blood pressure or pulse
- painful urination
- pale or blue lips, fingernails, or skin
- pale skin
- pinpoint red spots on the skin
- pounding in the ears
- shakiness and unsteady walk
- unsteadiness, trembling, or other problems with muscle control or coordination
- unusual bleeding or bruising
- very slow heartbeat
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose- Constricted, pinpoint, or small pupils (black part of the eye)
- decreased awareness or responsiveness
- extreme drowsiness
- fever
- increased blood pressure
- increased thirst
- lower back or side pain
- muscle cramps or spasms
- muscle pain or stiffness
- no muscle tone or movement
- severe sleepiness
- swelling of the face, fingers, or lower legs
- weight gain
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common- Cramps
- difficulty having a bowel movement (stool)
- drowsiness
- false or unusual sense of well-being
- relaxed and calm feeling
- sleepiness or unusual drowsiness
- weight loss
- Absent, missed, or irregular menstrual periods
- agitation
- bad, unusual, or unpleasant (after) taste
- change in vision
- depression
- dry mouth
- face is warm or hot to touch
- floating feeling
- halos around lights
- heartburn or indigestion
- loss in sexual ability, desire, drive, or performance
- muscle stiffness or tightness
- night blindness
- overbright appearance of lights
- problems with muscle control
- redness of the skin
- skin rash
- stomach discomfort or upset
- trouble sleeping
- uncontrolled eye movements
- Abnormal dreams
- change in walking and balance
- change or problem with discharge of semen
- clumsiness or unsteadiness
- confusion as to time, place, or person
- delusions
- dementia
- feeling of constant movement of self or surroundings
- general feeling of discomfort or illness
- holding false beliefs that cannot be changed by fact
- problems with memory
- seeing, hearing, or feeling things that are not there
- sensation of spinning
- unusual excitement, nervousness, or restlessness
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Overdosage
Clinical Presentation
Acute overdosage with morphine is manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, and death. Marked mydriasis rather than miosis may be seen due to severe hypoxia in overdose situations.
Treatment of Overdose
In case of overdose, priorities are the re-establishment of a patent and protected airway and institution of assisted or controlled ventilation if needed. Employ other supportive measures (including oxygen, vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life support techniques.
The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to morphine overdose. Such agents should be administered cautiously to persons who are known, or suspected to be physically dependent on Avinza. In such cases, an abrupt or complete reversal of opioid effects may precipitate an acute withdrawal syndrome.
Because the duration of reversal would be expected to be less than the duration of action of morphine in Avinza, carefully monitor the patient until spontaneous respiration is reliably re-established. Avinza will continue to release morphine and add to the morphine load for 36 to 48 hours or longer following ingestion necessitating prolonged monitoring. If the response to opioid antagonists is suboptimal or not sustained, additional antagonist should be administered as directed in the product's prescribing information.
In an individual physically dependent on opioids, administration of the usual dose of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be begun with care and by titration with smaller than usual doses of the antagonist.
Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
Addiction, Abuse, and Misuse
Inform patients that the use of Avinza, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose or death [see Warnings and Precautions (5.1)]. Instruct patients not to share Avinza with others and to take steps to protect Avinza from theft or misuse.
Life-threatening Respiratory Depression
Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting Avinza or when the dose is increased, and that it can occur even at recommended doses [see Warnings and Precautions (5.2)]. Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop.
Accidental Ingestion
Inform patients that accidental ingestion, especially in children, may result in respiratory depression or death [see Warnings and Precautions (5.2)]. Instruct patients to take steps to store Avinza securely and to dispose of unused Avinza by flushing the capsules down the toilet.
Neonatal Opioid Withdrawal Syndrome
Inform female patients of reproductive potential that prolonged use of Avinza during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated [see Warnings and Precautions (5.3)].
Interactions with Alcohol and other CNS Depressants
Instruct patients not to consume alcoholic beverages, as well as prescription and over-the-counter products that contain alcohol, during treatment with Avinza. The co-ingestion of alcohol with Avinza may result in increased plasma levels and a potentially fatal overdose of morphine [see Warnings and Precautions (5.4)].
Inform patients that potentially serious additive effects may occur if Avinza is used with alcohol or other CNS depressants, and not to use such drugs unless supervised by a healthcare provider.
Important Administration Instructions
Instruct patients how to properly take Avinza, including the following:
- Swallowing Avinza capsules whole or sprinkling the capsule contents on applesauce and then swallowing immediately without chewing
- Not crushing, chewing, or dissolving the pellets in the capsules
- Using Avinza exactly as prescribed to reduce the risk of life-threatening adverse reactions (e.g., respiratory depression)
- Not discontinuing Avinza without first discussing the need for a tapering regimen with the prescriber
Hypotension
Inform patients that Avinza may cause orthostatic hypotension and syncope. Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur (e.g., sit or lie down, carefully rise from a sitting or lying position).
Driving or Operating Heavy Machinery
Inform patients that Avinza may impair the ability to perform potentially hazardous activities such as driving a car or operating heavy machinery. Advise patients not to perform such tasks until they know how they will react to the medication.
Constipation
Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention.
Anaphylaxis
Inform patients that anaphylaxis has been reported with ingredients contained in Avinza. Advise patients how to recognize such a reaction and when to seek medical attention.
Pregnancy
Advise female patients that Avinza can cause fetal harm and to inform the prescriber if they are pregnant or plan to become pregnant.
Disposal of Unused Avinza
Advise patients to flush the unused capsules down the toilet when Avinza is no longer needed.
Manufactured by:
Alkermes Gainesville LLC
Gainesville, GA 30504
Utilizing SODAS® Technology Developed by:
Alkermes Pharma Ireland Limited
Dublin, Ireland
U.S. Patent 6,066,339
SODAS® is a registered trademark of Alkermes Pharma Ireland Limited.
This product's label may have been updated. For current full prescribing information please visit www.pfizer.com.
LAB-0600-3.0
Medication Guide
Avinza® (ah-ven-zah) (morphine sulfate) extended-release capsules, CII
Avinza is:
- A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily around-the-clock, long-term treatment with an opioid, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them.
- A long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.
- Not for use to treat pain that is not around-the-clock.
Important information about Avinza:
- Get emergency help right away if you take too much Avinza (overdose). When you first start taking Avinza, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.
- Never give anyone your Avinza. They could die from taking it. Store Avinza away from children and in a safe place to prevent stealing or abuse. Selling or giving away Avinza is against the law.
Do not take Avinza if you have:
- severe asthma, trouble breathing, or other lung problems.
- a bowel blockage or have narrowing of the stomach or intestines.
| Before taking Avinza, tell your healthcare provider if you have a history of: | |
| • head injury, seizures | • liver, kidney, thyroid problems |
| • problems urinating | • pancreas or gallbladder problems |
| • abuse of street or prescription drugs, alcohol addiction, or mental health problems. | |
Tell your healthcare provider if you are:
- pregnant or planning to become pregnant. Prolonged use of Avinza during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
- breastfeeding. Avinza passes into breast milk and may harm your baby.
- taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking Avinza with certain other medicines can cause serious side effects.
When taking Avinza:
- Do not change your dose. Take Avinza exactly as prescribed by your healthcare provider.
- Take your prescribed dose every 24 hours, at the same time every day. Do not take more than your prescribed dose in 24 hours. If you miss a dose, take your next dose at your usual time the next day.
- Swallow Avinza whole. Do not cut, break, chew, crush, dissolve, snort, or inject Avinza because this may cause you to overdose and die.
- If you cannot swallow Avinza capsules, see the detailed Instructions for Use.
- Call your healthcare provider if the dose you are taking does not control your pain.
- Do not stop taking Avinza without talking to your healthcare provider.
- After you stop taking Avinza, flush any unused capsules down the toilet.
While taking Avinza DO NOT:
- Drive or operate heavy machinery, until you know how Avinza affects you. Avinza can make you sleepy, dizzy, or lightheaded.
- Drink alcohol, or use prescription or over-the-counter medicines containing alcohol. Using products containing alcohol during treatment with Avinza may cause you to overdose and die.
The possible side effects of Avinza are:
- constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.
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, light-headedness when changing positions, or you are feeling faint.
These are not all the possible side effects of Avinza. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov
Manufactured for: Pfizer Inc, New York, NY 10017 by: Alkermes Gainesville LLC, Gainesville, GA, www.Avinza.com or call 1-800-438-1985
This Medication Guide has been approved by the U.S. Food and Drug Administration
LAB-0630-2.0
April 2014
Instructions For Use
Avinza ® (ah-ven-zah)
(morphine sulfate) extended-release Capsules, CII
- If you cannot swallow Avinza ® capsules, tell your healthcare provider. There may be another way to take Avinza that may be right for you. If your healthcare provider tells you that you can take Avinza using this other way, follow these steps:
Avinza can be opened and the pellets inside the capsule can be sprinkled over applesauce, as follows:Figure 1 - Open the Avinza capsule and sprinkle the pellets over approximately one tablespoon of applesauce (See Figure 1).
Figure 2 - Swallow all of the applesauce and pellets right away. Do not save any of the applesauce and pellets for another dose (See Figure 2).
Figure 3 - Rinse your mouth to make sure you have swallowed all of the pellets. Do not chew the pellets (See Figure 3).
Figure 4 - Flush the empty capsule down the toilet right away (See Figure 4).
You should not receive Avinza through a nasogastric tube or gastric tube (stomach tube).
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured for: Pfizer Inc, New York, NY 10017
by: Alkermes Gainesville LLC, Gainesville, GA
LAB-0642-1.0
April 2014
PRINCIPAL DISPLAY PANEL - 30 mg Capsule Bottle Label
ALWAYS DISPENSE WITH MEDICATION GUIDE
NDC 60793-605-01
30 mg
Avinza®
(morphine sulfate extended-
release capsules)
CII
King
Pharmaceuticals
Rx Only
100 capsules
PRINCIPAL DISPLAY PANEL - 45 mg Capsule Bottle Label
ALWAYS DISPENSE WITH MEDICATION GUIDE
NDC 60793-603-01
45 mg
Avinza®
(morphine sulfate extended-
release capsules)
CII
King
Pharmaceuticals
Rx Only
100 capsules
PRINCIPAL DISPLAY PANEL - 60 mg Capsule Bottle Label
ALWAYS DISPENSE WITH MEDICATION GUIDE
NDC 60793-606-01
60 mg
Avinza®
(morphine sulfate extended-
release capsules)
CII
King
Pharmaceuticals
Rx Only
100 capsules
PRINCIPAL DISPLAY PANEL - 75 mg Capsule Bottle Label
ALWAYS DISPENSE WITH MEDICATION GUIDE
NDC 60793-604-01
75 mg
Avinza®
(morphine sulfate extended-
release capsules)
CII
King
Pharmaceuticals
Rx Only
100 capsules
PRINCIPAL DISPLAY PANEL - 90 mg Capsule Bottle Label
ALWAYS DISPENSE WITH MEDICATION GUIDE
NDC 60793-607-01
90 mg
Avinza®
(morphine sulfate extended-
release capsules)
CII
For use in opioid-tolerant patients only
King
Pharmaceuticals
Rx Only
100 capsules
PRINCIPAL DISPLAY PANEL - 120 mg Capsule Bottle Label
ALWAYS DISPENSE WITH MEDICATION GUIDE
NDC 60793-608-01
120 mg
Avinza®
(morphine sulfate extended-
release capsules)
CII
For use in opioid-tolerant patients only
King
Pharmaceuticals
Rx Only
100 capsules
| Avinza morphine sulfate capsule, extended release | ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| Avinza morphine sulfate capsule, extended release | ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| Avinza morphine sulfate capsule, extended release | ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| Avinza morphine sulfate capsule, extended release | ||||||||||||||||||||||
| ||||||||||||||||||||||
| ||||||||||||||||||||||
| ||||||||||||||||||||||
| ||||||||||||||||||||||
| ||||||||||||||||||||||
| ||||||||||||||||||||||
| Avinza morphine sulfate capsule, extended release | ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| Avinza morphine sulfate capsule, extended release | ||||||||||||||||||||||
| ||||||||||||||||||||||
| ||||||||||||||||||||||
| ||||||||||||||||||||||
| ||||||||||||||||||||||
| ||||||||||||||||||||||
| ||||||||||||||||||||||
| Labeler - Pfizer Laboratories Div Pfizer Inc (134489525) |
How should I use Avinza?
Take Avinza exactly as prescribed by your doctor. Follow all directions on your prescription label. Morphine can slow or stop your breathing, especially when you start using this medicine or whenever your dose is changed. Never use Avinza in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.
Morphine may be habit-forming. Never share Avinza with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away Avinza is against the law.
Stop taking all other around-the-clock narcotic pain medications when you start taking Avinza.
To make swallowing easier, you may open the extended-release capsule and sprinkle the medicine into a spoonful of applesauce. Swallow right away without chewing. Do not save the mixture for later use.
Do not stop using Avinza suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.
Never crush or break open an Avinza capsule to inhale the powder or mix it into a liquid to inject the drug into your vein. This practice has resulted in death with the misuse of morphine and similar prescription drugs.
Store at room temperature, away from heat, moisture, and light. Keep track of your medicine. Morphine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.
Do not keep leftover Avinza capsules. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush any unused capsules down the toilet.
Avinza side effects
Get emergency medical help if you have signs of an allergic reaction to Avinza: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Like other opioid medicines, morphine can slow your breathing. Death may occur if breathing becomes too weak. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.
Call your doctor at once if you have:
-
slow heart rate, sighing, weak or shallow breathing;
-
chest pain, fast or pounding heartbeats;
-
extreme drowsiness, feeling like you might pass out; or
-
low cortisol levels - nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.
Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.
Morphine is more likely to cause breathing problems in older adults and people who are severely ill, malnourished, or otherwise debilitated.
Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.
Common Avinza side effects may include:
-
drowsiness, dizziness;
-
constipation, stomach pain, nausea, vomiting;
-
headache, tired feeling;
-
anxiety; or
-
mild itching.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Avinza?
Narcotic (opioid) medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:
-
other narcotic medications - opioid pain medicine or prescription cough medicine;
-
drugs that make you sleepy or slow your breathing - a sleeping pill, muscle relaxer, sedative, tranquilizer, or antipsychotic medicine; or
-
drugs that affect serotonin levels in your body - medicine for depression, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting.
This list is not complete. Other drugs may interact with morphine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.