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Kadian

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Kadian

KADIAN®
(morphine sulfate) Capsules

Kadian

WARNING

ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and INTERACTION WITH ALCOHOL

Addiction, Abuse, and Misuse

KADIAN 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 KADIAN, 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 KADIAN. Monitor for respiratory depression, especially during initiation of KADIAN or following a dose increase. Instruct patients to swallow KADIAN capsules whole; crushing, chewing, or dissolving KADIAN capsules can cause rapid release and absorption of a potentially fatal dose of morphine [see WARNINGS AND PRECAUTIONS].

Accidental Ingestion

Accidental ingestion of even one dose of KADIAN, especially by children, can result in a fatal overdose of morphine [see WARNINGS AND PRECAUTIONS].

Neonatal Opioid Withdrawal Syndrome

Prolonged use of KADIAN 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 nonprescription products that contain alcohol while taking KADIAN. The co-ingestion of alcohol with KADIAN may result in increased plasma levels and a potentially fatal overdose of morphine [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION

KADIAN (morphine sulfate) extended-release capsules are for oral use and contain pellets of morphine sulfate. Morphine sulfate is an agonist at the mu-opioid receptor.

Each KADIAN extended-release capsule contains either 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, 70 mg, 80 mg, 100 mg, 130 mg, 150 mg, or 200 mg of Morphine Sulfate USP and the following inactive ingredients common to all strengths: hypromellose, ethylcellulose, methacrylic acid copolymer, polyethylene glycol, diethyl phthalate, talc, corn starch, and sucrose.

The capsule shells contain gelatin, silicon dioxide, sodium lauryl sulfate, titanium dioxide, and black ink, D&C red #28, FD&C blue #1 (10 mg), D&C yellow #10 (20 mg), FD&C red #3, FD&C blue #1 (30 mg), D&C yellow #10, FD&C blue #1, FD&C red #3 (40 mg), D&C red #28, FD&C red #40, FD&C blue #1 (50 mg), D&C red #28, FD&C red #40, FD&C blue #1 (60 mg), D&C red #28, FD&C blue #1, FD&C red #3 (70 mg), FD&C blue #1, FD&C red #40, FD&C yellow #6 (80 mg), D&C yellow #10, FD&C blue #1 (100 mg), FD&C red #40, FD&C blue #1, FD&C yellow #6, black iron oxide, red iron oxide, yellow iron oxide (130 mg), FD&C blue #1, D&C yellow #10, black iron oxide, red iron oxide, yellow iron oxide (150 mg), black iron oxide, yellow iron oxide, red iron oxide (200 mg). The imprint ink contains black iron oxide, potassium hydroxide, propylene glycol, and shellac.

The chemical name of morphine sulfate is 7,8-didehydro-4,5 α-epoxy-17-methyl-morphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate. The empirical formula is (C17H19NO3)2•H2SO4•5H2O and its molecular weight is 758.85.

Morphine sulfate is an odorless, white, crystalline powder with a bitter taste. It has a solubility of 1 in 21 parts of water and 1 in 1000 parts of alcohol, but is practically insoluble in chloroform or ether. The octanol: water partition coefficient of morphine is 1.42 at physiologic pH and the pKb is 7.9 for the tertiary nitrogen (mostly ionized at pH 7.4). Its structural formula is:

KADIAN® (morphine sulfate) Structural Formula Illustration

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...

Read All Potential Side Effects and See Pictures of Kadian »

What are the precautions when taking morphine sulfate extended-release (Kadian)?

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 Kadian »

Last reviewed on RxList: 4/30/2014
This monograph has been modified to include the generic and brand name in many instances.

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Kadian - User Reviews

Kadian User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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