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What is the indication for KADIAN® use?
KADIAN® Capsules are an extended-release capsule taken by mouth of morphine sulfate that is used to manage moderate to severe pain that continues around-the-clock and is expected to last for an extended period of time.
KADIAN® is NOT for use to treat pain that occurs once in a while (“as needed”).
KADIAN® is not indicated for pain in the immediate post-operative period (12-24 hours following surgery) for patients who have not taken drugs called opioids before.
KADIAN® is not indicated for pain in the post-operative period if the pain is mild or not expected to persist for an extended period of time.
Risk and safety information about KADIAN®
The BOXED WARNING in the prescribing information for Healthcare Providers states:
WARNING
KADIAN® contains morphine sulfate, an opioid agonist and a Schedule II controlled substance, with an abuse liability similar to other opioid analgesics. KADIAN® can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing KADIAN® in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion.
KADIAN® capsules are an extended-release oral formulation of morphine sulfate indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
KADIAN® Capsules are NOT for use as a prn analgesic.
KADIAN® 100 mg and 200 mg Capsules ARE FOR USE IN OPIOID-TOLERANT PATIENTS ONLY. Ingestion of these capsules or of the pellets within the capsules may cause fatal respiratory depression when administered to patients not already tolerant to high doses of opioids.
KADIAN® CAPSULES ARE TO BE SWALLOWED WHOLE OR THE CONTENTS OF THE CAPSULES SPRINKLED ON APPLE SAUCE. THE PELLETS IN THE CAPSULES ARE NOT TO BE CHEWED, CRUSHED, OR DISSOLVED DUE TO THE RISK OF RAPID RELEASE AND ABSORPTION OF A POTENTIALLY FATAL DOSE OF MORPHINE.
WHAT DOES THIS INFORMATION MEAN FOR YOU?
Information to Know About KADIAN®
• KADIAN® which is a federally controlled substance (CII), can be abused by people who abuse prescription medicines or street drugs. To prevent theft, misuse, or abuse of KADIAN®, keep it in a safe place. Do not give KADIAN® to anyone else. It may harm them or even cause death. After you stop taking KADIAN®, flush any unused capsules down the toilet.
• Do not crush, dissolve, or chew KADIAN® capsules or the capsule contents before swallowing. Abuse of KADIAN® by crushing, chewing, snorting or injecting the dissolved product will result in the uncontrolled delivery of morphine and pose a significant risk to the abuser that could result in overdose or death.
• KADIAN® is NOT for use to treat pain that occurs once in a while (“as needed”).
• KADIAN®100 mg and 200 mg capsules are for use only in opioid tolerant patients. “Opioid tolerant” means that you regularly use another opioid medicine for constant pain and that your body is used to it. Ingesting KADIAN® 100 mg and 200 mg capsules when you are not opioid tolerant may cause serious breathing problems and death.
Do Not Take KADIAN® If:
• You have a known hypersensitivity (allergy) to morphine, morphine salts, or any of the ingredients in KADIAN® (See the accompanying Prescribing Information for a complete list of ingredients in KADIAN®).
• You are having an asthma attack or have severe asthma, trouble breathing, or lung problems.
• You have a bowel blockage called paralytic ileus.
• Do not take KADIAN® with alcohol, other opioids, or illicit drugs because dangerous additive effects may occur resulting in serious injury or death. In addition, alcohol can cause very high levels of morphine in your blood and you can die due to an overdose of morphine.
What are the Possible Side Effects of KADIAN®?
Breathing Problems
• KADIAN® can cause serious breathing problems that may be life-threatening, especially if KADIAN® is used in the wrong way. Call your healthcare professional or get medical help right away if your breathing slows down, you have shallow breathing, you feel faint, dizzy, confused, or have any unusual symptoms. These can be symptoms that you have taken too much KADIAN® or that the dose is too high for you. These symptoms may lead to serious problems or death if not treated right away.
• There is a chance of abuse or addiction with KADIAN®.
• Serious allergic reactions, while extremely rare, have been reported with use of KADIAN®. Get medical help right away if you experience any symptoms of a severe allergic reactions, such as: feeling dizzy or faint, trouble breathing, chest pain, or swelling of the face, throat, or tongue.
• Do not drive or operate machinery or perform other potentially hazardous activities until you know how you react to this medicine or to a change in the dose.
• Serious side effects that may be associated with KADIAN® therapy are those observed with other opioid analgesics and include: respiratory depression, respiratory arrest, apnea, circulatory depression, cardiac arrest, hypotension, and/or shock.
• The less severe side effects seen on initiation of therapy with KADIAN® are also typical opioid side effects. The most frequent of these include drowsiness, dizziness, constipation, and nausea.
• Severe constipation could occur as a result of taking KADIAN® and appropriate laxatives, stool softeners, and other appropriate treatments should be started at the beginning of therapy.
WHAT ARE SOME OF THE OTHER RISKS ASSOCIATED WITH KADIAN®?
Warnings
• Impaired Respiration: Respiratory depression is the chief hazard of all morphine preparations. Respiratory depression occurs more frequently in elderly and debilitated patients, and those suffering from conditions accompanied by hypoxia, hypercapnia, or upper airway obstruction (when even moderate therapeutic doses may significantly decrease pulmonary ventilation).
KADIAN® should be used with extreme caution in patients with chronic obstructive pulmonary disease or cor pulmonale, and in patients having a substantially decreased respiratory reserve (e.g. severe kyphoscoliosis), hypoxia, hypercapnia, or pre-existing respiratory depression. In such patients, even usual therapeutic doses of morphine may increase airway resistance and decrease respiratory drive to the point of apnea. In these patients, alternative non-opioid analgesics should be considered, and opioids should be employed only under careful medical supervision at the lowest effective dose.
• Head Injury and Increased Intracranial Pressure: The respiratory depressant effects of morphine may be markedly exaggerated in the presence of head injury, other intracranial lesions, or a pre-existing increase in intracranial pressure. KADIAN® produces effects which may hide neurologic signs of further increases in pressure in patients with head injuries. Morphine should only be administered under such circumstances when considered essential and then with extreme care.
• Hypotensive Effect: KADIAN® may cause severe hypotension (low blood pressure). There is an added risk to patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume, or a concurrent administration of drugs such as phenothiazines or general anesthetics. KADIAN® may produce orthostatic hypotension and fainting in ambulatory patients. KADIAN®, like all opioid analgesics, should be administered with caution to patients in circulatory shock, as vasodilation produced by the drug may further reduce cardiac output and blood pressure.
• Interactions with CNS Depressants: KADIAN® should be used with great caution and in reduced dosage in patients who are concurrently receiving other central nervous system depressants including sedatives or sleep aids, general anesthetics, phenothiazines, other tranquilizers, and alcohol because respiratory depression, low blood pressure, and profound sedation or coma may result.
• Gastrointestinal Obstruction: KADIAN® should not be given to patients with gastrointestinal obstruction (bowel blockage), particularly a type called paralytic ileus, as there is a risk of the product remaining in the stomach for an extended period and the subsequent release of a bolus of morphine when normal gut motility is restored. As with other solid morphine formulations diarrhea may reduce morphine absorption.
Precautions:
• General: Opioid analgesics have a narrow therapeutic index in certain patient populations, especially when combined with CNS depressant drugs, and should be reserved for cases where the benefits of opioid pain medication outweigh the known risks of respiratory depression, altered mental state, and postural hypotension.
The administration of KADIAN® may obscure the diagnosis or clinical course in patients with acute abdominal conditions.
KADIAN® may aggravate pre-existing convulsions in patients with convulsive disorders.
• Cordotomy: Patients taking KADIAN® who are scheduled for cordotomy or other interruption of pain transmission pathways should have KADIAN® ceased 24 hours prior to the procedure and the pain controlled by parenteral short-acting opioids. In addition, the post-procedure titration of analgesics for such patients should be individualized to avoid either over sedation or withdrawal syndromes.
• Use in Pancreatic/Biliary Tract Disease: KADIAN® may cause spasm of the sphincter of Oddi and should be used with caution in patients with biliary tract disease, including acute pancreatitis. Opioids may cause increases in the serum amylase level.
• Tolerance and Physical Dependence: Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Physical dependence is manifested by withdrawal symptoms after abrupt discontinuation of a drug or upon administration of an antagonist. Physical dependence and tolerance are not unusual during chronic opioid therapy.
SPECIAL RISK GROUPS
• KADIAN® should be administered with caution, and in reduced dosages in elderly or debilitated patients; patients with severe kidney or liver insufficiency; patients with Addison's disease; myxedema; hypothyroidism; prostatic hypertrophy or urethral stricture.
Caution should also be exercised in the administration of KADIAN® to patients with CNS depression, toxic psychosis, acute alcoholism and delirium tremens, and convulsive disorders.
DRUG INTERACTIONS
• There is a potential for combined effects when KADIAN® is used by patients who are also taking other drugs that have central nervous system depressant effects, including sedatives, sleep aids, anti-nausea agents, other pain relievers, tranquilizers, muscle relaxants, alcohol, diuretics, and cimetidine.
• KADIAN® should not be used by patients who take Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of stopping the MAOI.
DOSAGE AND ADMINISTRATION – HOW TO USE KADIAN®
• Do not crush, dissolve, or chew KADIAN® capsules or the capsule contents before swallowing. Abuse of KADIAN® by crushing, chewing, snorting or injecting the dissolved product will result in the uncontrolled delivery of morphine and pose a significant risk to the abuser that could result in overdose or death.
• Do not stop taking KADIAN® or any other opioid without talking to your healthcare professional. KADIAN® can cause physical dependence. This means you could become sick with uncomfortable withdrawal symptoms because your body has become used to these medicines. Physical dependence is not the same as drug addiction. Your doctor can tell you more about the differences between physical dependence and drug addiction.
IT IS IMPORTANT TO REMEMBER THAT:
• These are not all the risks and side effects associated with KADIAN®. For more information, please contact your doctor.
• Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.