KADIAN PACKAGE INSERT PDF

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Medically reviewed by Drugs. Last updated on Dec 28, Excipient information presented when available limited, particularly for generics ; consult specific product labeling. Generic: 0. Binds to opioid receptors in the CNS, causing inhibition of ascending pain pathways, altering the perception of and response to pain; produces generalized CNS depression.

Distributes to skeletal muscle, liver, kidneys, lungs, intestinal tract, spleen and brain; V d :. Cancer patients Children age 1. Hepatic via conjugation with glucuronic acid primarily to morphineglucuronide M6G active analgesic and morphineglucuronide M3G inactive as analgesic; may contribute to CNS stimulation [Lugo ] ; minor metabolites include morphinediglucuronide; other minor metabolites include normorphine active and morphine 3-ethereal sulfate.

It has been suggested that accumulation of morphineglucuronide might cause toxicity with renal insufficiency. All of the metabolites ie, morphineglucuronide, morphineglucuronide, and normorphine have been suggested as possible causes of neurotoxicity eg, myoclonus. Clearance: Note: In pediatric patients, adult values are reached by 6 months to 2. Infants 1 to 3 months: Median: Infants 3 to 6 months: Median: Infants 6 months to Children 2.

Cancer patients Children age: 1. Injection: Management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Duramorph: Epidural or intrathecal management of pain without attendant loss of motor, sensory, or sympathetic function. Note: Not for use in continuous microinfusion devices. Infumorph, Mitigo: Used in continuous microinfusion devices for intrathecal or epidural administration in management of intractable chronic pain severe enough to require an opioid analgesic and for which less invasive means of controlling pain are inadequate.

Extended release: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Immediate release: Management of acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Rectal: Management of acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations of use: Reserve morphine for use in patients for whom alternative treatment options eg, nonopioid analgesics, opioid combination products are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

ER formulations are not indicated as as-needed analgesics. Based on Cancer Care Ontario's symptom management guide-to-practice: dyspnea , morphine is an effective and recommended agent for the management of dyspnea in palliative care patients. Hypersensitivity eg, anaphylaxis to morphine or any component of the formulation; significant respiratory depression; acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment; concurrent use of monoamine oxidase inhibitors MAOIs or use of MAOIs within the last 14 days; GI obstruction, including paralytic ileus known or suspected.

Documentation of allergenic cross-reactivity for opioids is limited. Pain management, moderate to severe pain : Note: Opioids may be part of a comprehensive, multimodal, patient-specific treatment plan for pain. Maximize nonopioid analgesia, if appropriate, prior to initiation of opioid analgesia CDC [Dowell ]; Hill Dosing provided is based on typical doses and some patients may require higher or lower doses.

Use the lowest effective dose for the shortest period of time. Before starting opioid therapy for chronic pain, establish realistic goals for pain and function, and consider how therapy will be discontinued if benefits do not outweigh risks CDC [Dowell ]. General dosing: Note: Dosing presented in this section is for opioid-naive patients. Patients who are opioid-tolerant will likely require higher dosing; adjust doses accordingly Arnold Note: Consider the use of other more commonly prescribed oral opioids eg, oxycodone instead of morphine Pino Initial: 10 mg every 4 hours as needed; if pain is not relieved, may increase dose as tolerated.

Intermittent: Initial: 1 to 4 mg every 1 to 4 hours as needed; if pain is not relieved, may increase dose as tolerated. May give up to 10 mg every 4 hours as needed for severe, acute pain in hospitalized patients at low risk for respiratory depression APS ; Herzig ; Mariano ; SCCM [Barr ]; manufacturer's labeling.

For some severe acute pain episodes eg, trauma , may initially give more frequently eg, every 5 to 15 minutes if needed and titrate to pain relief; once pain relief is achieved, reduce frequency eg, every 3 to 4 hours as needed Lvovschi ; Patanwala Note: When IV access is not available, SubQ administration using similar dosing may be considered; however, repeated intermittent SubQ injections cause local tissue irritation, pain, and induration and are not recommended Mariano May adjust dosing and provide rescue bolus doses eg, 0.

In general, a continuous basal infusion is not recommended in an opioid-naive patient ISMP b. IM not recommended for routine use : Opioid-naive patients: Initial: 5 to 10 mg every 3 to 4 hours as needed; if pain is not relieved, may increase dose as tolerated. Note: IM administration is generally not recommended due to pain associated with injection, variable absorption, and delayed time to peak effect APS ; Mariano Rectal may be used as an alternative to IV or oral administration : Opioid-naive patients: Initial: 10 mg every 4 hours scheduled or as needed; may increase or decrease the dose as tolerated following the same precautions as oral dosing up to 30 mg every 4 hours scheduled or as needed.

Routine use in patients with acute coronary syndrome has been associated with worse clinical outcomes and concomitant use with oral P2Y12 inhibitors may diminish antiplatelet effects Duarte ; Kubica ; Meine Note: Multimodal approaches eg, a combination of analgesics and techniques should typically be employed for pain control in this setting.

Pain should be monitored using validated scales eg, behavioral pain scale, critical-care observation tool in medical, postoperative, or trauma excluding brain injury ICU patients who are unable to self-report SCCM [Devlin ]. Loading dose: 2 to 10 mg, followed by maintenance dosing Tietze Note: More than 1 loading dose may be needed; onset of action following IV administration is 5 to 10 minutes.

Reduce or omit initial loading dose in select patients eg, older, hypovolemic, at-risk for hemodynamic compromise Tietze Initial pain control in the post-anesthesia care unit: IV: 1 to 3 mg given as frequently as every 5 minutes until adequate pain relief or unwanted side effects eg, respiratory depression, oxygen desaturation, hypotension occur.

Ongoing pain control: IV: 1 to 4 mg every 1 to 4 hours as needed; may give up to 10 mg every 2 to 4 hours as needed for severe, acute pain in patients at low risk for respiratory depression APS ; Casserly ; Mariano ; SCCM [Barr ].

Note: Dosing presented is for patients in emergency department and hospital settings including day hospitals whose previous opioid dose for prior episodes is unknown or who rarely require opioids for pain management. If opioid dose given for a prior episode is known, choose initial dose based on intensity of pain in comparison with previous episode and previous effective dose DeBaun IV: Initial: 0. Evaluate need for long-acting opioid; if patient usually requires a long-acting opioid at home, may convert to oral home regimen once IV dose is roughly equivalent to long-acting opioid dose DeBaun Note: Opioids, including morphine, are not the preferred therapy for chronic noncancer pain due to insufficient evidence of benefit and risk of serious harm; nonpharmacologic treatment and nonopioid analgesics are preferred, with the exception of chronic pain from sickle cell disease and end-of-life care.

Opioids, including morphine, should only be considered in patients who experience clinically meaningful improvement in pain and function that outweighs patient safety risks CDC [Dowell ; Dowell ]. Opioid-naive patients: In general, for noncancer pain, morphine requirement should be established using IR formulations CDC [Dowell ]. With cancer pain, may switch to a long-acting formulation earlier in the course of therapy Portenoy IV, SubQ: Note: Typically reserved for acute exacerbations or those who cannot tolerate oral administration.

For progressive illnesses eg, cancer , a continuous IV or SubQ infusion, with or without a patient-controlled analgesia option, can also be used as pain requirements increase. Noncancer or cancer pain: IV: Initial: 2 to 5 mg every 2 to 4 hours as needed Portenoy Cancer pain or palliative care: SubQ: Initial: 2 to 5 mg every 3 to 4 hours as needed Portenoy If a continuous SubQ infusion is employed, refer to institutional protocols; reported dosing varies greatly and is based on practice and patient needs Anderson ; Koshy ; Portenoy ; Walsh Opioid-tolerant patients also refer to the section Dose conversions for pain management :.

Note: Although manufacturer's labeling contains directions for initiating ER morphine products in opioid-naive patients with chronic pain, these preparations should not be used as initial therapy.

Instead, treatment should be initiated with an IR preparation to more accurately determine the daily opioid requirement and decrease the risk of overdose. Capsules, extended release Kadian : See Dose conversions for pain management : Calculated dose may be administered once daily or in 2 equally divided doses administered every 12 hours; may consider dose reduction with first several doses when converting from IR formulations.

Example initial dose: 30 mg once daily or 15 mg every 12 hours. Dose adjustments may be made as frequently as every 1 to 2 days. Tablets, extended release Arymo ER, MorphaBond ER, MS Contin : See Dose conversions for pain management : Calculated dose may be administered in 2 equally divided doses every 12 hours or 3 equally divided doses every 8 hours ; may consider dose reduction with first several doses when converting from IR formulations.

Example initial dose: 15 mg every 8 or 12 hours. Dose conversions for pain management: Note: Equianalgesic conversions serve only as a general guide to estimate opioid dose equivalents. Multiple factors must be considered for safely individualizing conversion of opioid analgesia.

Kadian: Total daily oral morphine dose administered once daily; in patients experiencing inadequate analgesia with once-daily dosing, total daily dose can be administered in 2 divided doses every 12 hours. Although the bioavailability of rectal morphine is believed to approximate oral morphine ie, , absorption is variable and may be higher or lower than expected. Refer to published equianalgesic opioid conversion data for guidance or refer to institutional protocols.

Provided conversion ratios are only approximations and substantial interpatient variability exists; therefore, it is safer to underestimate a patient's daily oral requirement and provide breakthrough pain relief with IR formulations rather than risk overestimating daily requirements.

When reducing the dose or discontinuing chronic opioid therapy, the dose should be gradually tapered. An optimal tapering schedule has not been established CDC [Dowell ]. Slower tapers may be appropriate after long-term use eg, years , particularly in the final stage of tapering, whereas more rapid tapers may be appropriate in patients experiencing severe adverse effects CDC [Dowell ].

Continue to offer nonopioid analgesics as needed for pain management during the taper; consider nonopioid adjunctive treatments for withdrawal symptoms eg, GI complaints, muscle spasm as needed Berna ; Sevarino Note: Reserve use for severe pain eg, after surgery, cancer pain. Must be administered by health care providers skilled in the care of patients receiving intraspinal opioids APS [Chou ].

Use a preservative-free PF formulation intended for neuraxial use. Single dose using 0. Continuous infusion using 0. May be given alone or usually in combination with local anesthetics eg, bupivacaine, ropivacaine ; when combined with a local anesthetic, analgesic effect is increased due to synergy Bujedo ; Manion Use a PF formulation intended for neuraxial use.

If pain recurs within 24 hours of administration, use of an alternative route of administration is recommended APS ; Mariano Note: Consider lower initial scheduled doses eg, 2. If 2 doses are well tolerated but fail to reduce dyspnea adequately, the dose may be doubled Dudgeon Doses should be titrated to appropriate effect; use lower doses in opioid naive patients; when changing routes of administration in chronically treated patients, please note that oral doses are approximately one-half as effective as parenteral dose.

Acute pain, moderate to severe: Note: Repeated SubQ administration causes local tissue irritation, pain, and induration. The use of IM injections is no longer recommended, especially for repeated administration due to painful administration, variable absorption, and lag time to peak effect; other routes are more reliable and less painful American Pain Society IV or SubQ: 0. Patients should have continuous respiratory monitoring eg, pulse oximetry and be in a setting that permits rapid management of respiratory insufficiency.

KANTHAPURA NOVEL FREE PDF

Novel Drug Delivery Systems.

Glenview, Ill: American Pain Society, American Chronic Pain Association: Partners for understanding pain. Pain fact sheet. Available at www. Accessed December 12,

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Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to. Instruct patients to swallow KADIAN capsules whole or to sprinkle the contents of the capsule on applesauce and swallow immediately without chewing. Crushing, chewing, or dissolving the pellets in KADIAN capsules can cause rapid release and absorption of a potentially fatal dose of morphine [see Warnings and Precautions 5.

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