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Fendermal

Fendermal

fentanyl

Manufacturer:

Sandoz

Distributor:

Sandoz
Concise Prescribing Info
Contents
Fentanyl
Indications/Uses
Severe chronic pain in adults which can be adequately managed only w/ opioid analgesics. Long-term management of severe chronic pain in childn from 2 yr who are receiving opioid therapy.
Dosage/Direction for Use
Individualized dosage. Fentanyl patch should be replaced every 72 hr. Opioid-tolerant adult Initiate dose based on daily dose of the prior opioid. May subsequently be titrated upwards or downwards, if required, in increments of either 12.5 or 25 mcg/hr. Opioid-naïve adult If commencing w/ oral opioid is not possible, initiate therapy w/ patch at the lowest dose (ie, 12.5 mcg/hr). Childn ≥16 yr Follow adult dose. Opioid-tolerant childn 2-16 yr who are already receiving at least 30 mg oral morphine equiv daily Switching from oral morphine (or its equiv) to fentanyl patch 12.5 mcg/hr (for oral 24-hr morphine 30-44 mg daily) or 25 mcg/hr (for oral 24-hr morphine 45-134 mg daily).
Contraindications
Hypersensitivity. Acute or post-op pain. Severe resp depression.
Special Precautions
Generally not recommended in opioid-naïve patients. Potential for serious or life-threatening hypoventilation in opioid-naïve patients & not opioid-tolerant states. Risk of resp depression. May have more severe adverse effects in patients w/ COPD, or other pulmonary disease. Tolerance, physical dependence, & psychological dependence may develop upon repeated administration of opioids. Re-evaluate appropriateness of continued fentanyl use at the time of prescription renewals. Gradually down-titrate to address w/drawal symptoms when there is no benefit for continuing therapy. Do not abruptly discontinue, especially in patients physically dependent on opioids. Monitor patients at increased risk of opioid abuse for signs of misuse, abuse, or addiction. Caution in patients who are susceptible to intracranial effects of CO2 retention eg, ICP, w/ impaired consciousness, or coma; patients w/ brain tumours. May produce bradycardia. Risk of hypotension, especially in patients w/ acute hypovolaemia. Correct underlying, symptomatic hypotension &/or hypovolaemia before initiating treatment. Potential increase in fentanyl conc if skin temp increases. Avoid exposing patch application site to direct external heat sources. Caution w/ concomitant use of sedative medicines eg, benzodiazepines or related medicinal products; alcohol; SSRIs, SNRIs & MAOIs. Not recommended w/ CYP3A4 inhibitors; mixed opioid agonist/antagonists (eg, buprenorphine, nalbuphine or pentazocine). In case of accidental patch transfer, immediately remove patch from the skin of the non-patch wearer. Reduce or taper off opioid dose when opioid induced hyperalgesia is suspected. May cause +ve reaction to anti-doping tests. May impair mental &/or physical ability required for the performance of potentially hazardous tasks eg, driving or operating machinery. Patients w/ hepatic or renal impairment & the elderly should be carefully observed for signs of fentanyl toxicity; reduce dose if necessary. Should not be used during pregnancy unless clearly necessary. Discontinue breastfeeding during treatment & for at least 72 hr after removal of patch. Not to be used in 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 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 & gabapentinoids (gabapentin & pregabalin). Potentiation of opiate effects or potentiation of serotoninergic effects w/ MAOIs. Increased risk of serotonin syndrome w/ SSRI or SNRI or MAOI. Partially antagonised analgesic effect & induction of w/drawal symptoms in opioid-dependent patients w/ mixed opioid agonists/antagonists eg, 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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