A. Menarini


Zuellig Pharma
Concise Prescribing Info
Fentanyl citrate
Management of breakthrough pain in adult patients using opioid therapy for chronic cancer pain.
Dosage/Direction for Use
Initially 100 mcg. If adequate analgesia is not obtained w/in 15-30 min, supplemental dose of 100 mcg may be administered. If adequate analgesia is not obtained w/in 15-30 min of the 1st dose, increase dose to next highest tab strength for the next episode of breakthrough pain. Dose strength for supplemental dose may be increased from 100-200 mcg at doses ≥400 mcg. Not >2 doses should be administered for single episode of breakthrough pain during titration phase. Max: 4 doses daily.
May be taken with or without food: Place tab under the tongue & allow to dissolve completely in the sublingual cavity, do not chew/suck/swallow. Do not eat or drink anything until tab is completely dissolved. For patients w/ dry mouth, use water to moisten the buccal mucosa before administration.
Hypersensitivity. Patients w/o maintenance opioid therapy (increased risk of resp depression). Severe resp depression or obstructive lung conditions. Treatment of acute pain other than breakthrough pain.
Special Precautions
Tolerance & physical &/or psychological dependence may develop. Discontinue use if serotonin syndrome is suspected. Patients w/ COPD or other medical conditions predisposing to resp depression (eg, myasthenia gravis); susceptible to intracranial effects of hypercapnia eg, showing evidence of raised intracranial pressure, reduced consciousness, coma or brain tumours; previous or preexisting bradyarrythmias; hypovolaemia & hypotension; mouth wounds or mucositis. Avoid abrupt w/drawal. May affect ability to drive & use machines. Renal or hepatic impairment. Pregnancy. Not to be used during labour, delivery & lactation. Childn & adolescents <18 yr. Elderly.
Adverse Reactions
Nausea. Dizziness, headache, somnolence; dyspnoea; stomatitis, vomiting, constipation, dry mouth; hyperhidrosis; fatigue.
Drug Interactions
Reduced efficacy w/ CYP3A4 inducers. Increased bioavailability w/ macrolide antibiotics (eg, erythromycin), azole antifungal agents (eg, ketoconazole, itraconazole) or certain PIs (eg, ritonavir), grapefruit juice. Increased CNS depressant effects w/ other morphine derivatives (eg, analgesics & antitussives), general anaesth, skeletal muscle relaxants, sedative antidepressants, sedative H1-antihistamines, barbiturates, anxiolytics (eg, benzodiazepines), hypnotics, antipsychotics, clonidine. Potentiated sedative effects w/ alcohol. Severe & unpredictable potentiation by MAOIs. Partially antagonised analgesic effect & induced w/drawal symptoms w/ partial opioid agonists/antagonists (eg, buprenorphine, nalbuphine, pentazocine). Increased risk of serotonin syndrome w/ serotonergic agent (eg, SSRI, SNRI or MAOI).
MIMS Class
ATC Classification
N02AB03 - fentanyl ; Belongs to the class of phenylpiperidine derivative opioids. Used to relieve pain.
Abstral SL tab 400 mcg
Abstral SL tab 100 mcg
Abstral SL tab 200 mcg
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