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  • Fenta
    / Rafa

    Active Ingredient
    Fentanyl 12.5, 25, 50, 75, 100 mcg/hour

    Status in Israel

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Transdermal Patch

    5 X 12 mcg

    partial basket chart 14813 6469, 6408

    Transdermal Patch

    5 X 25 mcg

    partial basket chart 71213 6397

    Transdermal Patch

    5 X 50 mcg

    partial basket chart 71214 6398

    Transdermal Patch

    5 X 75 mcg

    partial basket chart 71215 6399

    Transdermal Patch

    5 X 100 mcg

    partial basket chart 71216 6400

    Related information


    Initial dose selection: The appropriate initiating dose of Fenta should be based on the patient’s current opioid use. Fenta should be used in patients who have demonstrated opioid tolerance. Other factors to be considered are the current general condition and medical status of the patient, including body size, age, and extent of debilitation as well as degree of opioid tolerance.
    Opioid-tolerant patients: To convert opioid-tolerant patients from oral or parenteral opioids to Fenta refer to Equianalgesic potency conversion below. The dosage may subsequently be titrated upwards or downwards, if required, in increments of either 12.5 or 25 mcg/hr to achieve the lowest appropriate dose of Fenta depending on response and supplementary analgesic requirements.
    Use in elderly patients: Data from intravenous studies with fentanyl suggest that elderly patients may have reduced clearance, a prolonged half-life and they may be more sensitive to the drug than younger patients. Elderly, cachectic, or debilitated patients should be observed carefully for signs of fentanyl toxicity and the dose reduced if necessary.
    Paediatric population
    Children aged 16 years and above: follow adult dosage Children aged 2 to16 years old: Fenta should be administered only to opioid-tolerant paediatric patients (ages 2 to 16 years) who are already receiving at least 30 mg oral morphine equivalents per day.
    For full details see prescribing information.


    Management of chronic and intractable pain requiring opioid analgesia in patients who are already receiving opioid therapy, who have demonstrated opioid tolerance.


    Patients who are not opioid tolerant. Post operative pain, acute pain, mild to moderate pain. Concurrently with MAO inhibitors. Breastfeeding. Known hypersensitivity to fentanyl or any components of the product. Illnesses related to the respiratory system (e.g., severe asthma, respiratory depression or severe COPD). Suspected intestinal obstruction. Not for use on non-intact skin.

    Special Precautions

    – Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death.
    – Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.
    – Limit dosages and durations to the minimum required.
    – Follow patients for signs and symptoms of respiratory depression and sedation.

    It is not possible to ensure the interchangeability of different makes of fentanyl transdermal patches in individual patients. Therefore, it should be emphasised that patients should not be changed from one make of fentanyl transdermal patches to another without specific counselling on the change from their healthcare professionals. Fenta should be kept out of reach and sight of children at all times before and after use. Do not cut Fenta patches. A patch that has been divided, cut or damaged in any way should not be used. Use of fentanyl transdermal patch in opioid-naïve patients has been associated with very rare cases of significant respiratory depression and/or fatality when used as initial opioid therapy. The potential for serious or life-threatening hypoventilation exists even if the lowest dose of Fenta is used in initiating therapy in opioid-naïve patients. Therefore, Fenta should only be used in patients who have demonstrated opioid tolerance. When Fenta is administered for chronic intractable pain that will require prolonged treatment, it is strongly recommended that the physician defines treatment outcomes with regards to pain relief and functional improvement in accordance with locally defined pain management guidelines. Physician and patient should agree to discontinue treatment if these objectives are not met.
    Respiratory depression: As with all potent opioids, some patients may experience significant respiratory depression with Fenta; patients must be observed for these effects. Respiratory depression may persist beyond the removal of the Fenta patch. The incidence of respiratory depression increases as the Fenta dose is increased. CNS active drugs may increase the respiratory depression.
    Serotonin Syndrome: Caution is advised when Fenta is coadministered with drugs that affect the serotonergic neurotransmitter systems. The development of a potentially life-threatening serotonin syndrome may occur with the concomitant use of serotonergic drugs such as Selective Serotonin Re-uptake Inhibitors (SSRIs) and Serotonin Norepinephrine Re-uptake Inhibitors (SNRIs), and with drugs which impair metabolism of serotonin (including Monoamine Oxidase Inhibitors [MAOIs]). This may occur within the recommended dose. Serotonin syndrome may include mental-status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g, tachycardia, labile blood pressure, hyperthermia), neuromuscular abnormalities (e.g. hyper-reflexia, incoordination, rigidity), and/or gastrointestinal symptoms (e.g, nausea, vomiting, diarrhoea). If serotonin syndrome is suspected, rapid discontinuation of Fenta should be considered.
    Interactions with other Medicinal Products
    Interactions with CYP3A4 Inhibitors
    The concomitant use of Fenta with cytochrome P450 3A4 inhibitors (e.g. ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, erythromycin, nelfinavir, nefazodone, verapamil, diltiazem and amiodarone) may result in an increase in fentanyl plasma concentrations, which could increase or prolong both the therapeutic and adverse effects, and may cause serious respiratory depression. In this situation special patient care and observation are appropriate. Therefore the concomitant use of transdermal fentanyl and cytochrome P450 3A4 inhibitors is not recommended unless the patient is closely monitored. Patients, especially those who are receiving Fenta and CYP3A4 inhibitors, should be monitored for signs of respiratory depression and dosage adjustments should be made if warranted.
    Concomitant use of mixed agonists/antagonists: The concomitant use of buprenorphine, nalbuphine or pentazocine is not recommended.
    Chronic pulmonary disease: Fentanyl, like other opioids, may have more severe adverse effects in patients with chronic obstructive or other pulmonary disease. In such patients, opioids may decrease respiratory drive and increase airway resistance.
    Drug dependence and potential for abuse: Tolerance, physical dependence and psychological dependence may develop upon repeated administration of opioids such as fentanyl. Iatrogenic addiction following opioid administration is rare. Patients with a prior history of drug dependence/alcohol abuse are more at risk to develop dependence and abuse in opioid treatment. Patients at increased risk of opioid abuse may still be appropriately treated with modified-release opioid formulations; however, these patients will require monitoring for signs of misuse, abuse, or addiction. Fentanyl can be abused in a manner similar to other opioid agonists. Abuse or intentional misuse of Fenta may result in overdose and/or death.
    For full details see prescribing information.

    Side Effects

    The safety of fentanyl transdermal patch was evaluated in 1854 adult and paediatric subjects who participated in 11 clinical trials (double-blind fentanyl transdermal patch [placebo or active control] and/or open label fentanyl transdermal patch [no control or active control]) used for the management of chronic malignant or non-malignant pain. These subjects took at least one dose of fentanyl transdermal patch and provided safety data. Based on pooled safety data from these clinical trials, the most commonly reported (ie ≥10% incidence) Adverse Drug Reactions (ADRs) were (with % incidence): nausea (35.7%), vomiting (23.2%), constipation (23.1%), somnolence (15.0%), dizziness (13.1%), headache (11.8%) and insomnia (10.2%).
    For full details see prescribing information.

    Drug interactions

    The concomitant use of other Central Nervous System depressants, including opioids, sedatives, anxiolytics, hypnotics, general anaesthetics, phenothiazines, tranquilizers, antipsychotics, skeletal muscle relaxants, sedating antihistamines and alcoholic beverages may produce additive depressant effects; hypoventilation, hypotension and profound sedation, coma or death may occur. Therefore, the use of any of the above mentioned concomitant drugs requires special care and observation. Fentanyl, a high clearance drug, is rapidly and extensively metabolised mainly by CYP3A4. The concomitant use of transdermal fentanyl with cytochrome P450 3A4 (CYP3A4) inhibitors (e.g. ritonavir, ketoconazole, itraconazole, fluconazole, voriconazole, troleandomycin, clarithromycin, nelfinavir, nefazodone, verapamil, diltiazem, and amiodarone) may result in an increase in fentanyl plasma concentrations, which could increase or prolong both the therapeutic and adverse effects, and may cause serious respiratory depression. In this situation, special patient care and observation are appropriate. The concomitant use of CYP3A4 inhibitors and transdermal fentanyl is not recommended, unless the patient is closely monitored. The concomitant use with CYP3A4 inducers (e.g. rifampicin, carbamazepine, phenobarbital, phenytoin) could result in a decrease in fentanyl plasma concentrations and a decreased therapeutic effect. This may require a dose adjustment of transdermal fentanyl. After stopping the treatment of a CYP3A4 inducer, the effects of the inducer decline gradually and may result in a fentanyl plasma increase concentration which could increase or prolong both the therapeutic and adverse effects, and may cause serious respiratory depression. In this situation, careful monitoring and dose adjustment should be made if warranted.
    Monoamine Oxidase Inhibitors (MAOI): Fenta is not recommended for use in patients who require the concomitant administration of an MAOI. Severe and unpredictable interactions with MAOIs, involving the potentiation of opiate effects or the potentiation of serotoninergic effects, have been reported. Therefore, Fenta should not be used within 14 days after discontinuation of treatment with MAOIs.
    Serotonergic Drugs: Coadministration of transdermal fentanyl with a serotonergic agent, such as a Selective Serotonin Reuptake Inhibitor (SSRI) or a Serotonin Norepinephrine Re-uptake Inhibitor (SNRI) or a Monoamine Oxidase Inhibitor (MAOI), may increase the risk of serotonin syndrome, a potentially life-threatening condition.
    Concomitant use of mixed agonists/antagonists: The concomitant use of buprenorphine, nalbuphine or pentazocine is not recommended. They have high affinity to opioid receptors with relatively low intrinsic activity and therefore partially antagonise the analgesic effect of fentanyl and may induce withdrawal symptoms in opioid dependent patients.
    For full details see prescribing information.

    Pregnancy and Lactation

    There are no adequate data from the use of fentanyl transdermal patch in pregnant women. Studies in animals have shown some reproductive toxicity. The potential risk for humans is unknown, although in other formulations, fentanyl as an IV anaesthetic has been found to cross the placenta in early human pregnancies. Neonatal withdrawal syndrome has been reported in newborn infants with chronic maternal use of Fenta during pregnancy. Fenta should not be used during pregnancy unless clearly necessary. Use of Fenta during childbirth is not recommended because it should not be used in the management of acute or postoperative pain. Moreover, because fentanyl passes through the placenta, the use of Fenta during childbirth might result in respiratory depression in the newborn infant. Fentanyl is excreted into breast milk and may cause sedation and respiratory depression in the breastfed infant. Breastfeeding should therefore be discontinued during treatment with Fenta and for at least 72 hours after removal of the patch.


    Symptoms: The manifestations of fentanyl overdose are an extension of its pharmacological actions, the most serious effect being respiratory depression.
    Treatment: For management of respiratory depression, immediate countermeasures include removing Fenta and physically or verbally stimulating the patient. These actions can be followed by administration of a specific opioid antagonist such as naloxone. Respiratory depression following an overdose may outlast the duration of action of the opioid antagonist. The interval between IV antagonist doses should be carefully chosen because of the possibility of re-narcotization after the patch is removed; repeated administration or a continuous infusion of naloxone may be necessary. Reversal of the narcotic effect may result in acute onset of pain and release of catecholamines. If the clinical situation warrants, a patent airway should be established and maintained, possibly with an oropharyngeal airway or endotracheal tube and oxygen should be administered and respiration assisted or controlled, as appropriate. Adequate body temperature and fluid intake should be maintained. If severe or persistent hypotension occurs, hypovolaemia should be considered, and the condition should be managed with appropriate parenteral fluid therapy.

    Labtec GmbH