Durogesic Patch

Durogesic Patch

fentanyl

Manufacturer:

Janssen-Cilag

Distributor:

DKSH
Concise Prescribing Info
Contents
Fentanyl
Indications/Uses
Management of chronic & intractable pain requiring continuous opioid administration for an extended period of time.
Dosage/Direction for Use
Individualized dosage. Assess at regular intervals after application. Initiate dose based on patient’s current opioid use. Replace patch 72 hrly. Increase dose after 3 days if analgesia is insufficient after initial application; or replace patch 48 hrly. Dose titration range: 12- 25 mcg/hr. Adult: Opioid-tolerant patient May titrate dose upward or downward subsequently, in increments of 12 or 25 mcg/hr, depending on response & supplementary analgesic requirements. Opioid-naive patient Titrate w/ low doses of immediate release opioids (eg, morphine, hydromorphone, oxycodone, tramadol, & codeine) to attain equinalgesic dosage to fentanyl release rate 25 mcg/hr. May titrate dose upward or downward subsequently, in 12 or 25 mcg/hr increments to achieve lowest appropriate dose depending on response & supplementary analgesic requirements. Ped: Opioid-tolerant patient (2-16 yr) Recommended dosage based upon daily PO morphine dose: 30-44 mg/day 24-hr PO morphine: 12 mcg/hr fentanyl; 45-134 mg/day 24-hr PO morphine: 25 mcg/hr.
Contraindications
Hypersensitivity. Management of acute or post-op pain.
Special Precautions
Opioid w/drawal symptoms; gradually replace w/ other opioids if discontinuation is necessary, starting at a low dose & increase slowly. Do not cut the patch; immediately remove accidentally transferred patch. Resp depression & fatality when used as initial opioid therapy in opioid-naive & not opioid-tolerant states; potential serious or life-threatening hypoventilation even at lowest dose when used as initial opioid therapy in opioid naive patients. May decrease resp drive & increase airway resistance in patients w/ chronic pulmonary disease. Drug tolerance, physical & psychological dependence may develop; may result in overdosage &/or death if abused or intentionally misused; monitor for signs of misuse, abuse & addiction in patients w/ increased risk for opioid abuse. Patients particularly susceptible to intracranial effects of CO2 retention (eg, w/ evident increased intracranial pressure, impaired consciousness & coma); w/ brain tumor. Bradyarrhythmias; may product bradycardia. Monitor for opioid AR if fever increased to 40°C; avoid exposure to external heat sources. Conduct measures to prevent constipation; discontinue if paralytic ileus is present or suspected. Concomitant use of CNS-active drugs; drugs affecting serotonergic neurotransmitter systems eg, SSRIs, serotonin norepinephrine re-uptake inhibitors (SNRIs) & MAOIs (do not use w/in 14 days of MAOI-discontinuation). May impair ability to drive & use machines. Hepatic & renal impairment. May result in resp depression in newborns; pregnancy; not recommended during lactation. Elderly. Childn <2 yr.
Adverse Reactions
Anorexia; insomnia, depression; somnolence, dizziness; vertigo; palpitation; nausea, vomiting, constipation, upper abdominal pain, dry mouth; hyperhidrosis, pruritus, rash; muscle spasms; fatigue, feeling cold, malaise, asthenia, peripheral oedema. Hypersensitivity; anxiety, confusional state; hallucination; headache, tremor, paraesthesia; diarrhea, abdominal pain; erythema; urinary retention. Hypoaesthesia; resp depression; muscles spasm; application site reaction.
Drug Interactions
May produce additive depressant effects & hypoventilation, profound sedation, coma or death may occur w/ CNS depressants including opioids, sedatives, hypnotics, general anesth, phenothiazines, tranquilizers, skeletal muscle relaxants, sedating antihistamines, alcohol. May result in decreased plasma conc & therapeutic effect w/ CYP3A4 inducers. May increase plasma conc w/ CYP3A4 inhibitors. Potentiation of opiate or serotoninergic effects w/ MAOIs. Increased risk of potentially life-threatening serotonin syndrome w/ SSRIs, SNRIs & MAOIs.
MIMS Class
ATC Classification
N02AB03 - fentanyl ; Belongs to the class of phenylpiperidine derivative opioids. Used to relieve pain.
Presentation/Packing
Form
Durogesic Patch transdermal patch 25 mcg/hr (4.2 mg)
Packing/Price
1 × 5's
Form
Durogesic Patch transdermal patch 12 mcg/hr (2.1 mg)
Packing/Price
1 × 5's
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