"Young children have died or become seriously ill from accidental exposure to a skin patch containing fentanyl, a powerful pain reliever. As a result of this, the Food and Drug Administration (FDA) is issuing a Drug Safety Communication to warn pa"...
Included as part of the PRECAUTIONS section.
(morphine sulfate) Extended-release Capsules CII
ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and INTERACTION WITH ALCOHOL
Addiction, Abuse, and Misuse
AVINZA® exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing AVINZA, and monitor all patients regularly for the development of these behaviors or conditions [see WARNINGS AND PRECAUTIONS].
Life-threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of AVINZA. Monitor for respiratory depression, especially during initiation of AVINZA or following a dose increase. Instruct patients to swallow AVINZA capsules whole or to sprinkle the contents of the capsule on applesauce and swallow immediately without chewing. Crushing, chewing, or dissolving AVINZA can cause rapid release and absorption of a potentially fatal dose of morphine [see WARNINGS AND PRECAUTIONS].
Accidental ingestion of even one dose of AVINZA, especially by children, can result in a fatal overdose of morphine [see WARNINGS AND PRECAUTIONS].
Neonatal Opioid Withdrawal Syndrome
Prolonged use of AVINZA during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see WARNINGS AND PRECAUTIONS].
Interaction with Alcohol
Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while taking 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].
AVINZA extended-release capsules are for oral use and contain pellets of morphine sulfate. Morphine sulfate is an agonist at the mu-opioid receptor.
Each AVINZA extended-release 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).
The chemical name of 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. The empirical formula is (C17H19NO3)2•H2SO4•5H2O.
Morphine sulfate is an odorless, 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). Its structural formula is:
What are the possible side effects of morphine (Avinza, Kadian, MS Contin, MSIR, Oramorph SR)?
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 a serious side effect such as:
- shallow breathing, slow heartbeat;
- stiff muscles, seizure (convulsions);
- cold, clammy skin;
- confusion, unusual thoughts or behavior;
- severe weakness, feeling like you might pass out;
- trouble swallowing;
- urinating less than usual or not at all;
- pale skin,...
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...
Last reviewed on RxList: 5/1/2014
This monograph has been modified to include the generic and brand name in many instances.
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