Fentanyl


Generic Medicine Info
Contraindications
Transdermal patch/buccal tab/nasal spray/lozenge/SL spray: Significant respiratory depression, acute or severe bronchial asthma in unmonitored setting or in the absence of resuscitative equipment; gastrointestinal obstruction including paralytic ileus, management of acute pain; mild, or post-operative pain; non-opioid tolerant patient. Nasal spray: Previous facial radiotherapy, recurrent episodes of epistaxis.
Special Precautions
Patient with risk factors for sleep-disordered breathing (e.g. heart failure, obesity); hypovolaemia, hypotension, CV disease, acute MI, previous/pre-existing bradycardia, bradyarrhythmia, non-severe COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, acute abdominal conditions, chronic constipation, thyroid dysfunction, adrenal insufficiency, Addison's disease, biliary tract dysfunction, acute pancreatitis; impaired consciousness or coma, head injury, intracranial lesion, brain tumour, increased intracranial pressure, delirium tremens, mental health conditions (e.g. depression, anxiety disorders, post-traumatic stress disorder), toxic psychosis, history of seizure disorders, myasthenia gravis, prostatic hyperplasia, urinary stricture, history of drug abuse or acute alcoholism; mouth wounds, oral mucositis (sublingual); fever (patch). Cachectic or debilitated patients. Avoid abrupt withdrawal. Renal and hepatic impairment. Children and elderly. Pregnancy and lactation. Patient Counselling This drug may cause dizziness, somnolence, and blurred vision, if affected, do not drive or operate machinery. Do not switch between brands or dosage forms unless instructed by your doctor. Transdermal patch: Avoid exposing the application site and surrounding area to direct external heat sources (e.g. heating pad, tanning lamp, hot tub, sauna). Monitoring Parameters Monitor blood pressure, heart rate, respiratory and mental status, pain relief; LFTs at baseline and as clinically indicated; respiratory depression within the 1st 24-72 hours after treatment initiation and dose increases. Assess for signs and symptoms of misuse, abuse or addiction, hypogonadism, hypoadrenalism.
Adverse Reactions
Significant: Severe hypotension, including orthostatic hypotension and syncope; secondary hypogonadism (long-term use), bradycardia, CNS depression, seizures, non-epileptic (myo)clonic movements, constriction of sphincter of Oddi, elevated intracranial pressure, hyperalgesia (high doses), increased sleep-related disorders (e.g. central sleep apnoea, hypoxaemia), decreased bowel motility, tolerance, physical or psychological dependence, withdrawal symptoms, anaphylaxis, hypersensitivity; muscular rigidity, including thoracic muscles (rapid IV infusion). Blood and lymphatic system disorders: Anaemia, neutropenia. Cardiac disorders: Tachycardia, palpitation, arrhythmia, dyspnoea. Ear and labyrinth disorders: Vertigo. Eye disorders: Blurred or double vision. Gastrointestinal disorders: Nausea, vomiting, throat irritation, constipation, dysgeusia, abdominal pain, stomatitis, dry mouth, diarrhoea, dyspepsia, toothache, oral candidiasis. General disorders and administration site conditions: Pyrexia, asthenia, fatigue, chills, lethargy, application site reactions (e.g. pain, erythema, irritation, ulcer, bleeding). Injury, poisoning and procedural complications: Fall, postoperative confusion. Investigations: Weight decreased. Metabolism and nutrition disorders: Anorexia, peripheral oedema, dehydration. Musculoskeletal and connective tissue disorders: Myalgia, backpain, muscle spasms. Nervous system disorders: Headache, dizziness, tremor, sedation, paraesthesia. Psychiatric disorders: Somnolence, depression, anxiety, insomnia, confusional state, hallucination. Renal and urinary disorders: Urinary retention. Respiratory, thoracic and mediastinal disorders: Pharyngolaryngeal pain, laryngospasm, bronchospasm. Skin and subcutaneous tissue disorders: Hyperhidrosis, rash, pruritus, allergic dermatitis. Vascular disorders: Flushing, hypertension; venous pain (IM/IV).
Potentially Fatal: Respiratory depression, serotonin syndrome, neonatal withdrawal syndrome (long-term use during pregnancy), adrenal insufficiency.
ROUTE(S) : Epidural / IM / IV / Nasal / PO / SC: C
ROUTE(S) : Buccal / Parenteral / Transdermal: C D if prolonged use/high doses at term.
Drug Interactions
Enhanced CNS depressants effects with Na oxybate. Reduced analgesic effects and induce withdrawal symptoms with partial opioid agonists/antagonists (e.g. buprenorphine, nalbuphine, pentazocine). Reduced plasma levels and efficacy with CYP3A4 inducers (e.g. rifampicin, carbamazepine, phenytoin), and oxymetazoline. May reduce the efficacy of diuretics. Increased risk of urinary retention and severe constipation with anticholinergics. May increase the terminal half-life and reduce the clearance of midazolam. May increase the plasma concentrations of etomidate. Induced extrapyramidal symptoms with neuroleptics.
CIMS Class
Analgesics (Opioid)
ATC Classification
N02AB03 - fentanyl ; Belongs to the class of phenylpiperidine derivative opioids. Used to relieve pain.
N01AH01 - fentanyl ; Belongs to the class of opioid anesthetics. Used as general anesthetics.
Disclaimer: This information is independently developed by CIMS based on fentanyl from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 CIMS. All rights reserved. Powered by CIMSAsia.com
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