Kadian

Tell your doctor about all the medications you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven)
• antidepressants such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil)
• antihistamines (found in cold and allergy medications)
• beta blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal)
• buprenorphine (Butrans, Subutex, in Suboxone)
• butorphanol (Stadol)
• cimetidine (Tagamet)
• diuretics ('water pills')
• medications for anxiety, seizures, depression, mental illness, or nausea
• monoamine oxidase (MAO) inhibitors, including isocarboxazid (Marplan), phenelzine (Nardil), procarbazine (Matulane), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate)
• muscle relaxants
• nalbuphine (Nubain)
• other narcotic pain medications
• pentazocine (Talwin)
• quinidine  
• sedatives, sleeping pills, or tranquilizers

This is not a complete list of Kadian drug interactions. Ask your doctor or pharmacist for more information.

Kadian 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 Kadian 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 Kadian may harm or cause death to other people who take your medication, especially children. 

Kadian 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 Kadian may increase the risk that you will experience breathing problems or other serious, life-threatening side effects.

Important information about Kadian:

• Get emergency help right away if you take too much Kadian (overdose). Kadian overdose can cause life threatening breathing problems that can lead to death.
• Never give anyone else your Kadian. They could die from taking it. Store Kadian away from children and in a safe place to prevent stealing or abuse.
• Selling or giving away Kadian is against the law. Kadian is a federally controlled substance (CII) because it can be abused or lead to dependence.

Do not take Kadian if you have:

• severe asthma, trouble breathing, or other lung problems.
• a bowel blockage or have narrowing of the stomach or intestines.

While taking Kadian do not:

• Drive or operate heavy machinery, until you know how Kadian affects you. Kadian can make you sleepy, dizzy, or lightheaded.
• Drink alcohol or use prescription or over-the-counter medicines that contain alcohol.

Tell your healthcare provider if you are breastfeeding. Kadian passes into human breast milk and may harm your baby.

The following serious adverse reactions are discussed elsewhere in the labeling:

• Addiction, Abuse, and Misuse [see WARNINGS AND PRECAUTIONS]
• Life Threatening Respiratory Depression [see WARNINGS AND PRECAUTIONS]
• Neonatal Opioid Withdrawal Syndrome [see WARNINGS AND PRECAUTIONS]
• Interactions with Other CNS Depressants [see WARNINGS AND PRECAUTIONS]
• Hypotensive Effect [see WARNINGS AND PRECAUTIONS]
• Gastrointestinal Effects [see WARNINGS AND PRECAUTIONS]
• Seizures [see WARNINGS AND PRECAUTIONS]

In the randomized study, the most common adverse reactions with KADIAN therapy were drowsiness, constipation, nausea, dizziness, and anxiety. The most common adverse reactions leading to study discontinuation were nausea, constipation (may be severe), vomiting, fatigue, dizziness, pruritus, and somnolence.

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In clinical trials in patients with chronic cancer pain, the most common adverse events reported by patients at least once during therapy were drowsiness (9%), constipation (9%), nausea (7%), dizziness (6%), and anxiety (6%). Other less common side effects expected from KADIAN or seen in less than 2% of patients in the clinical trials were:

• Body as a Whole: Headache, chills, flu syndrome, back pain, malaise, withdrawal syndrome
• Cardiovascular: Tachycardia, atrial fibrillation, hypotension, hypertension, pallor, facial flushing, palpitations, bradycardia, syncope
• Central Nervous System: Confusion, anxiety, abnormal thinking, abnormal dreams, lethargy, depression, loss of concentration, insomnia, amnesia, paresthesia, agitation, vertigo, foot drop, ataxia, hypesthesia, slurred speech, hallucinations, vasodilation, euphoria, apathy, seizures, myoclonus
• Endocrine: Hyponatremia due to inappropriate ADH secretion, gynecomastia
• Gastrointestinal: Dysphagia, dyspepsia, stomach atony disorder, gastro-esophageal reflux, delayed gastric emptying, biliary colic
• Hemic and Lymphatic: Thrombocytopenia
• Metabolic and Nutritional: Hyponatremia, edema
• Musculoskeletal: Back pain, bone pain, arthralgia
• Respiratory: Hiccup, rhinitis, atelectasis, asthma, hypoxia, respiratory insufficiency, voice alteration, depressed cough reflex, non-cardiogenic pulmonary edema
• Skin and Appendages: Decubitus ulcer, pruritus, skin flush
• Special Senses: Amblyopia, conjunctivitis, miosis, blurred vision, nystagmus, diplopia
• Urogenital: Urinary abnormality, amenorrhea, urinary retention, urinary hesitancy, reduced libido, reduced potency, prolonged labor

In the open-label, 4-week safety study, 1418 patients ages 18 to 85 with chronic, non-malignant pain (e.g., back pain, osteoarthritis, neuropathic pain) were enrolled. The most common adverse events reported at least once during therapy were constipation (12%), nausea (9%), and somnolence (3%). Other less common side effects occurring in less than 3% of patients were vomiting, pruritus, dizziness, sedation, dry mouth, headache, fatigue, and rash.

Post-Marketing Experience

Anaphylaxis has been reported with ingredients contained in KADIAN. Advise patients how to recognize such a reaction and when to seek medical attention.

Read the entire FDA prescribing information for Kadian (Morphine Sulfate Extended-Release)

• Tell all of your health care providers that you take Kadian. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Do not take Kadian with other strong pain drugs or if you are using a pain patch without talking to your doctor first.
• Have your blood work checked if you are on this medicine for a long time. Talk with your doctor.
• Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
• If you have been taking Kadian for a long time or at high doses, it may not work as well and you may need higher doses to get the same effect. This is known as tolerance. Call your doctor if this medicine stops working well. Do not take more than ordered.
• Do not stop taking Kadian all of a sudden without calling your doctor. You may have a greater risk of signs of withdrawal. If you need to stop this medicine, you will want to slowly stop it as ordered by your doctor.
• Long-term use of an opioid drug like Kadian may lead to lower sex hormone levels. This may lead to signs like change in sex ability in men, no menstrual period in women, lowered interest in sex, or fertility problems. Call your doctor if you have any of these signs.
• This medicine may raise the chance of seizures in some people, including people who have had seizures in the past. Talk to your doctor to see if you have a greater chance of seizures while taking this medicine.
• If you are 65 or older, use Kadian with care. You could have more side effects.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this medicine, call your doctor right away.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine is refilled. If you have any questions about Kadian, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Kadian. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Kadian (morphine extended-release capsules).

Review Date: October 4, 2017

12.1       Mechanism of Action

Morphine is a full opioid agonist and is relatively selective for the mu-opioid receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of morphine is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with morphine. Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression.

The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.

12.2       Pharmacodynamics

CNS Depressant/Alcohol Interaction 

Additive pharmacodynamic effects may be expected when Kadian is used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression. 

Effects on the Central Nervous System

Morphine produces respiratory depression by direct action on brainstem respiratory centers.  The respiratory depression involves a reduction in the responsiveness of the brainstem respiratory centers to both increases in carbon dioxide tension and to electrical stimulation.  

Morphine causes miosis, even in total darkness.  Pinpoint pupils are a sign of opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or ischemic origins may produce similar findings).  Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations.

Effects on the Gastrointestinal Tract and Other Smooth Muscle

Morphine causes a reduction in motility associated with an increase in smooth muscle tone in the antrum of the stomach and duodenum. Digestion of food in the small intestine is delayed and propulsive contractions are decreased. Propulsive peristaltic waves in the colon are decreased, while tone may be increased to the point of spasm, resulting in constipation. Other opioid-induced effects may include a reduction in biliary and pancreatic secretions, spasm of sphincter of Oddi, and transient elevations in serum amylase.

Effects on the Cardiovascular System

Morphine produces peripheral vasodilation, which may result in orthostatic hypotension or syncope. Manifestations of histamine release or peripheral vasodilation may include pruritus, flushing, red eyes, sweating, and/or orthostatic hypotension.

Effects on the Endocrine System

Opioids inhibit the secretion of adrenocorticotropic hormone (ACTH), cortisol, and luteinizing hormone (LH) in humans [see Adverse Reactions (6.2)]. They also stimulate prolactin, growth hormone (GH) secretion, and pancreatic secretion of insulin and glucagon.

Chronic use of opioids may influence the hypothalamic-pituitary-gonadal axis, leading to androgen deficiency that may manifest as low libido, impotence, erectile dysfunction, amenorrhea, or infertility. The causal role of opioids in the clinical syndrome of hypogonadism is unknown because the various medical, physical, lifestyle, and psychological stressors that may influence gonadal hormone levels have not been adequately controlled for in studies conducted to date [see Adverse Reactions (6.2)].

Effects on the Immune System 

Opioids have been shown to have a variety of effects on components of the immune system in in vitro and animal models.  The clinical significance of these findings is unknown.  Overall, the effects of opioids appear to be modestly immunosuppressive. 

Concentration-Efficacy Relationships

The minimum effective analgesic concentration will vary widely among patients, especially among patients who have been previously treated with potent agonist opioids. The minimum effective analgesic concentration of morphine for any individual patient may increase over time due to an increase in pain, the development of a new pain syndrome, and/or the development of analgesic tolerance [see Dosage and Administration (2.1, 2.2)].

Concentration–Adverse Reaction Relationships

There is a relationship between increasing morphine plasma concentration and increasing frequency of dose-related opioid adverse reactions such as nausea, vomiting, CNS effects, and respiratory depression. In opioid-tolerant patients, the situation may be altered by the development of tolerance to opioid-related adverse reactions [see Dosage and Administration (2.1, 2.2, 2.3)].

12.3       Pharmacokinetics

Absorption

Kadian capsules contain polymer coated extended-release pellets of morphine sulfate that release morphine significantly more slowly than oral morphine solution. Following the administration of oral morphine solution, approximately 50% of the morphine absorbed reaches the systemic circulation within 30 minutes compared to 8 hours with an equal amount of Kadian. Because of pre-systemic elimination, only about 20 to 40% of the administered dose reaches the systemic circulation.

Both dose-normalized Cmax and dose-normalized AUC0-48hr values of morphine after a single dose administration of Kadian in healthy volunteers are less than those for morphine oral solution or an extended-release tablet formulation (Table 1). 

When Kadian was given twice daily to 24 patients with chronic pain due to malignancy, steady-state was achieved in about two days.  At steady-state, Kadian has a significantly lower Cmax and a higher Cmin than equivalent doses of oral morphine solution given every 4 hrs and an extended-release tablet given twice daily. When given once daily to 24 patients with malignancy, Kadian had a similar Cmax and higher Cmin at steady-state when compared to an extended-release morphine tablets, given twice daily at an equivalent total daily dosage (see Table 1).

The single-dose pharmacokinetics of Kadian are linear over the dosage range of 30 to 100 mg.

# For single dose AUC = AUC0-48h, for multiple dose AUC = AUC0-24h at steady-state

+ For single dose parameter normalized to 100 mg, for multiple dose parameter normalized to 100 mg per 24 hours

* Steady-state fluctuation in plasma concentrations = Cmax-Cmin/Cmin

^ Not applicable

Food Effect:  

While concurrent administration of food slows the rate of absorption of Kadian, the extent of absorption is not affected and Kadian can be administered without regard to meals.  

Distribution

Once absorbed, morphine is distributed to skeletal muscle, kidneys, liver, intestinal tract, lungs, spleen and brain.  The volume of distribution of morphine is approximately 3 to 4 L/kg. Morphine is 30 to 35% reversibly bound to plasma proteins.  Although the primary site of action of morphine is in the CNS, only small quantities pass the blood-brain barrier.  Morphine also crosses the placental membranes [see Use in Specific Populations (8.1)] and has been found in breast milk [see Use in Specific Populations (8.4)].

Elimination

Metabolism

Major pathways of morphine metabolism include glucuronidation in the liver to produce metabolites including morphine-3-glucuronide, M3G (about 50%) and morphine-6-glucuronide, M6G (about 5 to 15%) and sulfation in the liver to produce morphine-3-etheral sulfate. A small fraction (less than 5%) of morphine is demethylated. M3G has no significant contribution to the analgesic activity. Although M6G does not readily cross the blood-brain barrier, it has been shown to have opioid agonist and analgesic activity in humans.

Studies in healthy subjects and cancer patients have shown that the glucuronide metabolite to morphine mean molar ratios (based on AUC) are similar after both single doses and at steady-state for Kadian, 12-hour extended-release morphine sulfate tablets and morphine sulfate solution.

Excretion

Approximately 10% of a morphine dose is excreted unchanged in the urine.  Most of the dose is excreted in the urine as M3G and M6G which are then renally excreted.  A small amount of the glucuronide metabolites is excreted in the bile and there is some minor enterohepatic cycling.  Seven to 10% of administered morphine is excreted in the feces.

The mean adult plasma clearance of morphine is about 20 to 30 mL/minute/kg. The effective terminal half-life of morphine after IV administration is reported to be approximately 2 hours.  The terminal elimination half-life of morphine following a single dose of Kadian administration is approximately 11 to 13 hours.

Specific Populations

Sex:  No meaningful differences between male and female patients were demonstrated in the analysis of the pharmacokinetic data from clinical studies.

Race/Ethnicity: Chinese subjects given intravenous morphine in one study had a higher clearance when compared to Caucasian subjects (1852 + 116 mL/min versus 1495 + 80 mL/min).

Hepatic Impairment  

Morphine pharmacokinetics are altered in patients with alcoholic cirrhosis. Clearance was found to decrease with a corresponding increase in half-life. The M3G and M6G to morphine AUC ratios also decreased in these patients, indicating a decrease in metabolic activity.  Adequate studies of the pharmacokinetics of morphine in patients with severe hepatic impairment have not been conducted.

Renal Impairment 

 Morphine pharmacokinetics are altered in patients with renal failure. The AUC is increased and clearance is decreased and the metabolites, M3G and M6G, may accumulate to much higher plasma levels in patients with renal failure as compared to patients with normal renal function.  Adequate studies of the pharmacokinetics of morphine in patients with severe renal impairment have not been conducted.

Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instruction for use). 

Addiction, Abuse, and Misuse

Inform patients that the use of Kadian, even when taken as recommended, can result in addiction, abuse, and misuse, which can lead to overdose and death [see Warnings and Precautions (5.1)]. Instruct patients not to share Kadian with others and to take steps to protect Kadian 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 Kadian or when the dosage 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 by children, may result in respiratory depression or death [see Warnings and Precautions (5.2)]. Instruct patients to take steps to store Kadian securely and to dispose of unused Kadian by flushing the unused capsules down the toilet.

Interactions with Alcohol

Instruct patients not to consume alcoholic beverages, or prescription and non-prescription products that contain alcohol, during treatment with Kadian. The co-ingestion of alcohol with Kadian may result in increased plasma levels and a potentially fatal overdose of morphine [see Drug Interactions (7)].

Interactions with Benzodiazepines 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 Kadian. The co-ingestion of alcohol with Kadian may result in increased plasma levels and a potentially fatal overdose of (active opioid) [see Warnings and Precautions (5.4)].

Serotonin Syndrome

Inform patients that opioids could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs. Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. Instruct patients to inform their physicians if they are taking, or plan to take serotonergic medications [see Drug Interactions 7].

MAOI Interaction

Inform patients not to take Kadian while using any drugs that inhibit monoamine oxidase. Patients should not start MAOIs while taking Kadian [see Warnings and Precautions (5.6), Drug Interactions (7)].

Adrenal Insufficiency

Inform patients that opioids could cause adrenal insufficiency, a potentially life-threatening condition. Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Advise patients to seek medical attention if they experience a constellation of these symptoms [see Warnings and Precautions (5.6)].

Important Administration Instructions

Instruct patients how to properly take Kadian, including the following:

• Swallow Kadian capsules whole or sprinkling the capsule contents on applesauce and then swallow immediately without chewing [see Dosage and Administration (2.1, 2.5)]
  
• DO not crush, chew, or dissolve the pellets contained in the capsules due to a risk of fatal morphine overdose [see Dosage and Administration (2.1)]
  
• Use Kadian exactly as prescribed to reduce the risk of life-threatening adverse reactions (e.g., respiratory depression) [see Warnings and Precautions (5.2)]
  
• Do not discontinue Kadian without first discussing the need for a tapering regimen with the prescriber [see Dosage and Administration (2.4)]

Hypotension

Inform patients that Kadian 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) [see Warnings and Precautions (5.8)]. 

Anaphylaxis

Inform patients that anaphylaxis has been reported with Kadian.  Advise patients how to recognize such a reaction and when to seek medical attention [see Contraindications (4), Adverse Reactions (6)].

Pregnancy

Neonatal Opioid Withdrawal Syndrome

Inform female patients of reproductive potential that prolonged use of Kadian 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), Use in Specific Populations (8.1)]].

Embryo-Fetal Toxicity 

Inform female patients of reproductive potential that Kadian can cause fetal harm and to inform their healthcare provider of a known or suspected pregnancy [see Use in Specific Populations (8.1)]. 

Lactation

Advise patients that breastfeeding is not recommended during treatment with Kadian[see Use in Specific Populations (8.2)].

Infertility

Inform patients that chronic use of opioids may cause reduced fertility. It is not known whether these effects on fertility are reversible [see Adverse Reactions (6.2)].

Driving or Operating Heavy Machinery

Inform patients that Kadian 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 [see Warnings and Precautions (5.13)].

Constipation

Advise patients of the potential for severe constipation, including management instructions and when to seek medical attention [see Adverse Reactions (6), Clinical Pharmacology (12.2)].

Disposal of Unused Kadian

Advise patients to flush the unused capsules down the toilet when Kadian is no longer needed.

For all medical inquiries contact:
Allergan USA, Inc.
Medical Communications
1-800-678-1605

Distributed By:  Allergan USA, Inc.
Irvine, CA 92612

© 2016 Allergan. All rights reserved.

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 12/2016

Instructions For Use

Kadian® (key-dee-uhn)

(morphine sulfate) extended-release Capsules, CII

If you cannot swallow Kadian capsules, tell your healthcare provider. There may be another way to take Kadian that may be right for you. If your healthcare provider tells you that you can take Kadian using this other way, follow these steps:

Kadian can be opened and the pellets inside the capsule can be sprinkled over applesauce, as follows:

You should not receive Kadian through a nasogastric tube.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Distributed By: Allergan USA, Inc.

Irvine, CA 92612

Revised: 12/2016

PRINCIPAL DISPLAY PANEL

NDC 0023-6011-60
Kadian
Morphine Sulfate
Extended- Release Capsules
10 mg
60 Capsules
Rx Only

PRINCIPAL DISPLAY PANEL

NDC 0023-6012-60
Kadian
Morphine Sulfate
Extended- Release Capsules
20 mg
60 Capsules
Rx Only

PRINCIPAL DISPLAY PANEL

NDC 0023-6013-60
Kadian
Morphine Sulfate
Extended- Release Capsules
30 mg
60 Capsules
Rx Only

PRINCIPAL DISPLAY PANEL

NDC 0023-6014-60
Kadian
Morphine Sulfate
Extended- Release Capsules
40 mg
60 Capsules
Rx Only

PRINCIPAL DISPLAY PANEL

NDC 0023-6015-60
Kadian
Morphine Sulfate
Extended- Release Capsules
50 mg
60 Capsules
Rx Only

PRINCIPAL DISPLAY PANEL

NDC 0023-6016-60
Kadian
Morphine Sulfate
Extended- Release Capsules
60 mg
60 Capsules
Rx Only

PRINCIPAL DISPLAY PANEL

NDC 0023-6017-60
Kadian
Morphine Sulfate
Extended- Release Capsules
80 mg
60 Capsules
Rx Only

PRINCIPAL DISPLAY PANEL

NDC 0023-6018-60
Kadian
Morphine Sulfate
Extended- Release Capsules
100 mg
60 Capsules
Rx Only

PRINCIPAL DISPLAY PANEL

NDC 0023-6019-60
Kadian
Morphine Sulfate
Extended- Release Capsules
200 mg
60 Capsules
Rx Only

You should not take Kadian if you have ever had an allergic reaction to morphine or other narcotic medicines, or if you have:

• severe asthma or breathing problems; or

• a blockage in your stomach or intestines.

Do not use Kadian if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

To make sure Kadian is safe for you, tell your doctor if you have ever had:

• any type of breathing problem or lung disease;

• a head injury, brain tumor, or seizures;

• a drug or alcohol addiction, or mental illness;

• urination problems;

• liver or kidney disease;

• problems with your gallbladder, pancreas, or thyroid; or

• if you use a sedative like Valium (diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others).

Some medicines can interact with morphine and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

If you use Kadian while you are pregnant your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

Do not breast-feed while taking Kadian. This medicine can pass into breast milk and cause drowsiness, breathing problems, or death in a nursing baby.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A morphine overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, and fainting.