Kadian

Kadian

Kadian Recall

Get an alert when a recall is issued.

Questions & Answers

Side Effects & Adverse Reactions

KADIAN® Capsules are to be swallowed whole and are not to be chewed, crushed, or dissolved.  Taking chewed, crushed, or dissolved KADIAN® Capsules leads to rapid release and absorption of a potentially fatal dose of morphine.

KADIAN® 100 mg and 200 mg Capsules ARE FOR USE IN OPIOID-TOLERANT PATIENTS ONLY.  This capsule strength may cause fatal respiratory depression when ingested or administered to patients who are not previously exposed to opioids. 

Care should be taken in the prescribing of this capsule strength.  Patients should be instructed against use by individuals other than the patient for whom it was prescribed, as such inappropriate use may have severe medical consequences, including death.

Misuse, Abuse and Diversion of Opioids

KADIAN® contains morphine an opioid agonist and a Schedule II controlled substance.  Opioid agonists have the potential for being abused and are sought by drug abusers and people with addiction disorders and are subject to criminal diversion.

Morphine 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.

Abuse of KADIAN® by crushing, chewing, snorting or injecting the dissolved product will result in the uncontrolled delivery of the opioid and pose a significant risk to the abuser that could result in overdose and death (see WARNINGS and DRUG ABUSE AND DEPENDENCE)

Concerns about abuse, addiction, and diversion should not prevent the proper management of pain.  Healthcare professionals should contact their State Professional Licensing Board, or State Controlled Substances Authority for information on how to prevent and detect abuse or diversion of this product.

Interactions with Alcohol and Drugs of Abuse

KADIAN® may be expected to have additive effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression because respiratory depression, hypotension, and profound sedation or coma may result.

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 with carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure 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 obscure 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.  There is an added risk to individuals 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. (See also PRECAUTIONS-Drug Interactions.) KADIAN® may produce orthostatic hypotension and syncope 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 other 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 hypnotics, general anesthetics, phenothiazines, other tranquilizers, and alcohol because respiratory depression, hypotension, and profound sedation or coma may result.

Gastrointestinal Obstruction

KADIAN® should not be given to patients with gastrointestinal obstruction, particularly 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.

Other

Although extremely rare, cases of anaphylaxis have been reported.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

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 (see CLINICAL PHARMACOLOGY).

KADIAN® Capsules are NOT intended for use as a prn analgesic.

KADIAN® is not indicated for pain in the immediate postoperative period (the first 12-24 hours following surgery), or if the pain is mild or not expected to persist for an extended period of time. KADIAN® is only indicated for postoperative use if the patient is already receiving the drug prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate. (See American Pain Society guidelines.)

History

There is currently no drug history available for this drug.

Other Information

KADIAN® (morphine sulfate) capsules are an opioid analgesic supplied in 10 mg, 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, 100 mg, and 200 mg strengths for oral administration.

Chemically, morphine sulfate is 7,8-didehydro-4,5 α-epoxy-17-methyl-morphinan-3,6 α-diol sulfate (2:1) (salt) pentahydrate and has the following structural formula:

image of chemical structure

Morphine sulfate is an odorless, white, crystalline powder with a bitter taste and a molecular weight of 758 (as the sulfate).  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).

Each KADIAN® extended-release capsule contains either 10 mg, 20 mg, 30 mg, 50 mg, 60 mg, 80 mg, 100 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 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), FD&C blue #1, FD&C red #40, FD&C yellow #6 (80 mg), D&C yellow #10, FD&C blue #1 (100 mg), black iron oxide, yellow iron oxide, red iron oxide (200 mg).

Kadian Manufacturers


  • Physicians Total Care, Inc.
    Kadian (Morphine Sulfate) Capsule, Extended Release [Physicians Total Care, Inc.]
  • Stat Rx Usa Llc
    Kadian (Morphine Sulfate) Capsule, Extended Release [Stat Rx Usa Llc]
  • Bryant Ranch Prepack
    Kadian (Morphine Sulfate) Capsule, Extended Release [Bryant Ranch Prepack]
  • Lake Erie Medical Dba Quality Care Products Llc
    Kadian (Morphine Sulfate) Capsule, Extended Release [Lake Erie Medical Dba Quality Care Products Llc]
  • Lake Erie Medical Dba Quality Care Products Llc
    Kadian (Morphine Sulfate) Capsule, Extended Release [Lake Erie Medical Dba Quality Care Products Llc]
  • Bryant Ranch Prepack
    Kadian (Morphine Sulfate) Capsule, Extended Release [Bryant Ranch Prepack]
  • Bryant Ranch Prepack
    Kadian (Morphine Sulfate) Capsule, Extended Release [Bryant Ranch Prepack]
  • Actavis Kadian Llc
    Kadian (Morphine Sulfate) Capsule, Extended Release [Actavis Kadian Llc]
  • Actavis Pharma, Inc.
    Kadian (Morphine Sulfate) Capsule, Extended Release [Actavis Pharma, Inc.]

Login To Your Free Account