Fendermal

Fendermal

fentanyl

Manufacturer:

Sandoz

Distributor:

Sandoz
Concise Prescribing Info
Contents
Fentanyl
Indications/Uses
Severe chronic pain which can be adequately treated only w/ opioid analgesics in adult. Long-term management of severe chronic pain in childn from 2 yr who are receiving opioid therapy.
Dosage/Direction for Use
Individualized dosage. Opioid-tolerant patient May subsequently titrated upwards or downwards, if required, in increments of either 12.5 or 25 mcg/hr. Opioid-naive patient Consider starting only w/ the lowest dose (ie, 12.5 mcg/hr). Childn ≥16 yr Follow adult dose. Childn 2-16 yr Switching from oral morphine (or its equiv) to fentanyl 12.5 mcg/hr (for 30-44 mg/day oral 24-hr morphine) or 25 mcg/hr (for 45-134 mg/day oral 24-hr morphine).
Contraindications
Hypersensitivity. Acute or post-op pain. Severe resp depression.
Special Precautions
Opioid-naive patients & not opioid-tolerant states. Resp depression. Concomitant use w/ sedative medicines eg, benzodiazepines or related medicinal products. Patients w/ COPD or other pulmonary disease. Patients w/ history of drug dependence/alcohol abuse. Monitor patients for signs of misuse, abuse or addiction. CNS conditions including increased intracranial pressure, patients w/ brain tumours. Cardiac disease, patients w/ bradyarrhythmias. Hypotension in patients w/ acute hypovolaemia. Correct underlying, symptomatic hypotension &/or hypovolaemia before initiating treatment. Patients w/ fever or external heat, myasthenia gravis. Avoid exposing patch application site to direct external heat sources eg, sauna. Discontinue treatment if serotonin syndrome is suspected; paralytic ileus is present or suspected. Concomitant use w/ SSRIs, serotonin norepinephrine re-uptake inhibitors & MAOIs; CYP3A4 inhibitors; mixed opioid agonist/antagonists. Accidental exposure by patch transfer. Patients w/ chronic constipation. Advise patients on measures to prevent constipation & consider prophylactic laxative use. May cause +ve reaction to anti-doping tests. Hepatic & renal impairment. May impair mental &/or physical ability required for the performance of potentially hazardous tasks eg, driving or operating machinery. Pregnancy & lactation. Elderly. Not for childn <2 yr.
Adverse Reactions
Somnolence, dizziness, headache; nausea, vomiting, constipation. Hypersensitivity; anorexia; insomnia, depression, anxiety, confusional state, hallucination; tremor, paraesthesia; vertigo; palpitations, tachycardia; HTN; dyspnoea; diarrhoea, dry mouth, abdominal pain, upper abdominal pain, dyspepsia; hyperhidrosis, pruritus, rash, erythema; muscle spasms; urinary retention; fatigue, peripheral oedema, asthenia, malaise, cold feeling.
Drug Interactions
Increased risk of sedation, resp depression, coma & death because of additive CNS depressant effect w/ sedative medicines eg, benzodiazepines or related medicinal products, other CNS depressants (including other opioids, hypnotics, general anaesth, phenothiazines, tranquilisers, sedating antihistamines, alcohol & CNS depressant narcotic drugs) & skeletal muscle relaxants. Potentiation of opiate effects or potentiation of serotoninergic effects w/ MAOIs. May increase risk of serotonin syndrome w/ SSRI or serotonin norepinephrine re-uptake inhibitor or MAOI. Partially antagonise analgesic effect & may induce w/drawal symptoms in opioid dependent patients w/ buprenorphine, nalbuphine or pentazocine. Increased plasma conc w/ CYP3A4 inhibitors (eg, amiodarone, cimetidine, clarithromycin, diltiazem, erythromycin, fluconazole, itraconazole, ketoconazole, nefazodone, ritonavir, verapamil & voriconazole). Decreased plasma conc & therapeutic effect w/ CYP3A4 inducers (eg, carbamazepine, phenobarb, phenytoin & rifampicin).
MIMS Class
Analgesics (Opioid)
ATC Classification
N02AB03 - fentanyl ; Belongs to the class of phenylpiperidine derivative opioids. Used to relieve pain.
Presentation/Packing
Form
Fendermal transdermal patch 12.5 mcg/hr
Packing/Price
5's
Form
Fendermal transdermal patch 25 mcg/hr
Packing/Price
5's
Form
Fendermal transdermal patch 50 mcg/hr
Packing/Price
5's
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