Fentyn

Fentyn

fentanyl

Manufacturer:

HEXAL

Distributor:

UNILAB, Inc
Full Prescribing Info
Contents
Fentanyl.
Description
Fentanyl 25 μg/hr: Each transdermal patch releases 25 micrograms fentanyl per hour. Each transdermal patch of 10.5 cm2 absorption area contains 5.78 mg fentanyl.
Fentanyl 50 μg/hr: Each transdermal patch releases 50 micrograms fentanyl per hour. Each transdermal patch of 21 cm2 absorption area contains 11.56 mg fentanyl.
Action
Pharmacotherapeutic group: Analgesics, opioids, phenylpiperidine derivative.
Pharmacology: Pharmacodynamics: Fentanyl is an opioid analgesic which interacts predominantly with the μ-receptor. Its principal therapeutic effects are analgesia and sedation. The serum concentrations of fentanyl that cause a minimal analgesic effect in opioid-naive patients fluctuate between 0.3-1.5 ng/mL; an increased incidence of adverse reactions is observed if serum levels exceed 2 ng/mL. Both the lowest effective fentanyl concentration and the concentration causing adverse reactions will increase with the development of increasing tolerance. The tendency to develop tolerance varies considerably between individuals.
Paediatric population: The safety of transdermal fentanyl was evaluated in three open-label trials in 293 paediatric patients with chronic pain, 2 years of age through to 18 years of age, of which 66 children were aged to 2 to 6 years. In these studies, 30 mg to 44 mg oral morphine per day was replaced by one fentanyl 12.5 μg/h transdermal patch. Starting dose of 25 μg/h and higher were used by 181 patients who had been on prior daily opioid doses of at least 45 mg of oral morphine.
Pharmacokinetics: Following administration of fentanyl patch, fentanyl is continuously absorbed through the skin over a period of 72 hours. Due to the polymer matrix and the diffusion of fentanyl through the skin layers, the release rate remains relatively constant.
Absorption: After the first application of fentanyl patch, serum fentanyl concentrations increase gradually, generally leveling off between 12 and 24 hours, and remaining relatively constant for the remainder of the 72-hour application period. The serum fentanyl concentrations attained are dependent on the fentanyl patch size. For all practical purposes by the second 72-hour application, a steady sate serum concentration is reached and is maintained during subsequent applications of a patch of the same size.
Distribution: The plasma protein binding for fentanyl is 84%.
Biotransformation: Fentanyl is metabolised primarily in the liver via CYP3A4. The major metabolite, norfentanyl, is inactive.
Elimination: When treatment with fentanyl patches is withdrawn, serum fentanyl concentrations decline gradually, falling approximately 50% in 13-22 hours in adults or 22-25 hours in children, respectively. Continued absorption of fentanyl from the skin accounts for a slower reduction in serum concentration than is seen after an intravenous infusion.
Around 75% of fentanyl is excreted into the urine, mostly as metabolites, with less than 10% as unchanged active substance. About 9% of the dose is recovered in the faeces, primarily as metabolites.
Pharmacokinetics in special populations: Adjusting for body weight, clearance (L/hour/kg) in paediatric patients appears to be 82% higher in children 2 to 5 years old and 25% higher in children 6 to 10 years old when compared to children 11 to 16 years old, who are likely to have the same clearance as adults. These findings have been taken into consideration in determining the dosing recommendations for paediatric patients.
Elderly and debilitated patients may have reduced clearance of fentanyl leading to prolonged terminal half-life. In patients with renal or hepatic impairment, clearance of fentanyl may be altered because of changes of plasma proteins and metabolic clearance resulting in increased serum concentrations.
Toxicology: Preclinical Safety Data: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenicity.
Animal studies have shown reduced fertility and increased mortality in rat foetuses. Teratogenic effects have, however, not been demonstrated.
Long-term carcinogenicity studies have not been performed.
Indications/Uses
Adults: Severe chronic pain which can be adequately managed only with opioid analgesics.
Dosage/Direction for Use
Fentanyl patch release fentanyl over 72 hours.
The dosing is individual and based on the patient's opioid history and takes into account: the possible development of tolerance, the current general condition, the medical status of the patient, and the degree of severity of the disorder.
The required fentanyl dose is adjusted individually and should be assessed regularly after each administration.
Adults: Patients receiving opioid treatment for the first time: In patients who have not previously received strong opioids, the initial dose should not exceed 12.5-25 μg/h.
In older or weak patients, it is not recommended to initiate an opioid treatment with fentanyl patches, due to their known susceptibility to opioid treatments. In these cases, it would be preferable to initiate a treatment with low doses of immediate release morphine and to prescribe fentanyl patches after determination of the optimal doses.
Switching from other opioids: When changing over from oral or parenteral opioids to fentanyl treatment, the initial dose should be calculated as follows: 1. The quantity of analgesics required over the last 24 hours should be determined.
2. The obtained sum should be converted to the corresponding oral morphine dose using Table 1.
3. The corresponding fentanyl dose should be determined as follows: a) using Table 2 for patients who have a need for opioid rotation (conversion ratio of oral morphine to transdermal fentanyl equal to 150:1); b) using Table 3 for patients on stable and well tolerated opioid therapy (conversion ratio of oral morphine to transdermal fentanyl equal to 100:1).
See Table 1:

Click on icon to see table/diagram/image

See Table 2:

Click on icon to see table/diagram/image

See Table 3:

Click on icon to see table/diagram/image

By combining several transdermal patches, a fentanyl release rate of over 100 μg/h can be achieved.
The initial evaluation of the maximum analgesic effect of fentanyl patch should not be made before the patch has been worn for 24 hours. This is due to the gradual increase in serum fentanyl concentrations during the first 24 hours after application of the patch.
In the first 12 hours after changing to fentanyl patch the patient continues to receive the previous analgesic at the previous dose; over the next 12 hours this analgesic is administered according to need.
Dose titration and maintenance therapy: The patch should be replaced every 72 hours. The dose should be titrated individually until analgesic efficacy is attained. In patients who experience a marked decrease in the period 48-72 hours after application, replacement of fentanyl patch after 48 hours may be necessary. The dose 12.5 μg/h is appropriate for dose titration in the lower dose area. If analgesia is insufficient at the end of the initial application, the dose may be increased after 3 days, until the desired effect is obtained for each patient. Additional dose adjustment should normally be performed in 12.5 μg/h or 25 μg/h increments, although the supplementary analgesic requirements and pain status of the patient should be taken into account. Patients may require periodic supplemental doses of a short-acting analgesic for breakthrough pain (e.g. morphine). Additional or alternative methods of analgesia or alternative administration of opioids should be considered when the transdermal fentanyl dose exceeds 300 μg/h.
Withdrawal symptoms have been reported when changing from long-term treatment with morphine to transdermal fentanyl despite adequate analgesic efficacy. In case of withdrawal symptoms it is recommended to treat those with short-acting morphine in low doses.
Changing or ending therapy: If discontinuation of the patch is necessary, any replacement with other opioids should be gradual, starting at a low dose and increasing slowly. This is because fentanyl levels fall gradually after the patch is removed; it takes at least 17 hours for the fentanyl serum concentration to decrease by 50% (see Pharmacology: Pharmacokinetics under Actions). As a general rule, the discontinuation of opioid analgesia should be gradual, in order to prevent withdrawal symptoms (such as nausea, vomiting, diarrhoea, anxiety and muscular tremor). Tables 2 and 3 should not be used to switch form transdermal fentanyl to a morphine treatment.
Elderly patients: Elderly patients should be observed carefully for sings of toxicity and the dose reduced if necessary (Pharmacology: Pharmacokinetics under Actions and Precautions).
Paediatric population: Fentanyl patch should not be used in children under 2 years of age.
Children aged 16 years and above: follow adult dosage.
Children aged 2 to 16 years old: Fentanyl patch 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. To convert paediatric patients from oral or parenteral opioids to fentanyl patch, refer to Table 1 and Table 2.
For children who receive more than 90 mg oral morphine a day, only limited information is currently available from clinical trials. In the paediatric studies, the required fentanyl patch dose was calculated conservatively: 30 mg to 44 mg oral morphine per day or its equivalent opioid dose was replaced by one fentanyl patch 12.5 μg/h. It should be noted that this conversion schedule for children only applies to the switch from oral morphine (or its equivalent) to fentanyl patches. The conversion schedule could not be used to convert from fentanyl patches into other opioids, as overdose could then occur.
The analgesic effect of the first dose of fentanyl patch will not be optimal within the first 24 hours. Therefore, during the first 12 hours after switching to fentanyl patch, the patient should be given the previous regular dose of analgesics. In the next 12 hours, these analgesics should be provided based on clinical need.
Since peak fentanyl level occur after 12 to 24 hours of treatment, monitoring of the paediatric patient for adverse events, which may include hypoventilation, is recommended for at least 48 hours after initiation of fentanyl patch therapy or up-titration of the dose (see also Precautions).
Dose titration and maintenance therapy: If the analgesic effect of fentanyl patch is insufficient, supplementary morphine or another short-duration opioid should be administered. Depending on the additional analgesic needs and the pain status of the child, it may be decided to use more patches. Dose adjustments should be done in 12.5 μg/h steps.
Hepatic and renal impairment: Patients with hepatic or renal impairment should be observed carefully and the dose reduced if necessary (see Precautions).
Method of administration: For transdermal use.
Directly after removal from the pack and the release liner, the patch is applied to a non-hairy area of skin on the upper body (chest, back, upper arm).
For use in children: There are no safety and pharmacokinetic data available for other application sites.
In young children, the upper back is the preferred location to apply the patch, to minimise the potential of the child removing the patch.
To remove hair, scissors should be used instead of razors.
Prior to application, the skin should be carefully washed with clean water (no cleaning agents) and thoroughly dried. The transdermal patch is then applied using slight pressure with the palm of the hand for approximately 30 seconds. The skin area to which the patch is applied should be free of microlesions (e.g. due to irradiation or shaving) and skin irritation.
As the transdermal patch is protected by an outer waterproof backing film, it can also be worn while showering.
If progressive dose increases are made, the active surface area required may reach a point where no further increase is possible.
Duration of administration: The patch should be changed after 72 hours. If an earlier change becomes necessary in individual cases, no change should be made before 48 hours have elapsed, otherwise a rise in mean fentanyl concentrations may occur. A new skin area must be selected for each application. A period of 7 days should be allowed to elapse before applying a new patch to the same area of skin. The analgesic effect may persist for some time after removal of the transdermal patch.
If traces of the transdermal patch remain on the skin after removal of the patch, these can be cleaned off using copius amounts of soap and water. No alcohol or other solvents must be used for cleaning, as these may penetrate the skin due to the effect of the patch.
Overdosage
Symptoms: The manifestations of fentanyl overdose are an extension of its pharmacologic actions, the most serious effect being respiratory depression.
Treatment: For management of respiratory depression, immediate countermeasures include removing the fentanyl patch 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-narcotisation 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, possible 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.
Contraindications
Fentanyl patches are contraindicated in patients with known hypersensitivity to fentanyl or to the excipients present in the patch.
Acute or postoperative pain, since dose titration is not possible during short-term use and because serious and life-threatening hypoventilation could result.
Severe impairment of the central nervous system.
Severe respiratory depression.
Special Precautions
Patients who have experienced serious adverse events should be monitored for at least 24 hours after fentanyl patch removal or more as clinical symptoms dictate because serum fentanyl concentrations decline gradually and are reduced by about 50% 17 (range 13-22) hours later.
Fentanyl patch should be kept out of reach of children before and after use.
Do not cut fentanyl patches. A patch that has been divided, cut or damaged in any way should not be used.
It is not possible to ensure the interchangeability of different makes of fentanyl patches in individual patients. Therefore, it should be emphasized that patients should not be changed from one make of fentanyl patches to another without specific counseling on the change from their healthcare professionals.
Respiratory depression: As with all potent opioids, some patients may experience significant respiratory depression with fentanyl patch; patients must be observed for these effects. Respiratory depression may persist beyond the removal of the fentanyl patch. The incidence of respiratory depression increases as the fentanyl dose is increased (See Overdosage, concerning respiratory depression). CNS active medicinal products may increase the respiratory depression.
Chronic pulmonary disease: Fentanyl 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. Iatrogenic addiction following opioid administration is rare. Fentanyl can be abused in a manner similar to other opioid agonists. Abuse or intentional misuse of fentanyl patch may result in overdose and/or death.
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.
Increased intracranial pressure: Fentanyl patch should be used with caution in patients who may be particularly susceptible to the intracranial effects of CO2 retention such as those with evidence of increased intracranial pressure, impaired consciousness, or coma. Fentanyl patch should be used with caution in patients with brain tumours.
Cardiac disease: Fentanyl may produce bradycardia and should therefore be administered with caution to patients with bradyarrhythmias.
Opioids may cause hypotension, especially in patients with acute hypovolaemia. Underlying, symptomatic hypotension and/or hypovolaemia should be corrected before treatment with fentanyl patches is initiated.
Hepatic impairment: Because fentanyl is metabolised to inactive metabolites in the liver, hepatic impairment might delay its elimination. If patients with hepatic impairment receive fentanyl patch, they should be observed carefully for signs of fentanyl toxicity and the dose of fentanyl patch is reduced if necessary.
Renal impairment: Less than 10% of fentanyl is excreted unchanged by the kidney and, unlike morphine, there are no known active metabolites eliminated by the kidney. If patients with renal impairment receive fentanyl patch, they should be observed carefully for signs of fentanyl toxicity and the dose reduced if necessary.
Fever/external heat application: A pharmacokinetic model suggests that serum fentanyl concentrations may increase by about one-third if the skin temperature increases to 40°C. Therefore, patients with fever should be monitored for opioid side effects and the fentanyl patch dose should be adjusted if necessary. There is a potential for temperature-dependent increases in fentanyl released from the system resulting in possible overdose and death. A clinical pharmacology trial conducted in healthy adult subjects has shown that the application of heat over the fentanyl patch system increased mean fentanyl AUC values by 120% and mean Cmax values by 61%.
All patients should be advised to avoid exposing the fentanyl patch application site to direct external heat sources such as heating pads, electric blankets, heater water beds, heat or tanning lamps, intensive sunbathing, hot water bottles, prolonged hot baths, saunas and hot whirlpool spa baths.
Serotonin syndrome: Caution is advised when fentanyl is used together with medicinal products that affect the serotonergic neurotransmitter systems.
The development of a potentially life-threatening serotonin syndrome may occur with the concomitant use of serotonergic medicinal products such as selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) and with medicinal products which impair the metabolism of serotonin (including monoamine oxidase inhibitors (MAOIs)). This may occur within the recommended dose.
The serotonin syndrome may cause changes in consciousness (e.g. agitation, hallucinations, coma), autonomic instability (e.g. tachycardia, unstable blood pressure, hyperthermia), neuromuscular changes (e.g. hyperreflexia, incoordination, rigidity) and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea).
If a serotonin syndrome is suspected, treatment with fentanyl should be discontinued.
Accidental Exposure by Patch Transfer: Accidental transfer of a fentanyl patch to the skin of a non-patch wearer (particularly a child), while sharing a bed or being in close physical contact with a patch wearer, may result in an opioid overdose for the non-patch wearer. Patients should be advised that if accidental patch transfer occurs, the transferred patch must be removed immediately from the skin of the non-patch wearer (see Overdosage).
Gastrointestinal tract: Opioids increase the tone and decrease the propulsive contractions of the smooth muscle of the gastrointestinal tract. The resultant prolongation in gastrointestinal transit time may be responsible for the constipating effect of fentanyl. Patients should be advised on measures to prevent constipation and prophylactic laxative use should be considered. Extra caution should be used in patients with chronic constipation. If paralytic ileus is present or suspected, treatment with fentanyl should be stopped.
Patients with myasthenia gravis: Non-epileptic (myo)clonic reactions can occur. Caution should be exercised when treating patients with myasthenia gravis.
Athletes must be aware that this medicine may cause a positive reaction to 'anti-doping' tests.
Effects on ability to drive and use machines: Fentanyl may impair mental and/or physical ability required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Patients stabilised on a specific dose without further interference from other medicinal products will not necessarily be restricted. Caution is required especially at the beginning of treatment, at dose increases as well as in connection with other medicinal products since the ability to drive and use machines may be impaired.
Use in Children: Fentanyl patch should not be administered to opioid naive paediatric patients. The potential for serious or life-threatening hypoventilation exists regardless of the dose of fentanyl system administered.
Fentanyl patch was not studied in children under 2 years of age. Fentanyl patch should be administered only to opioid-tolerant children 2 years or older. Fentanyl patch should not be used in children under 2 years of age.
To guard against accidental ingestion by children, use caution when choosing the application site for fentanyl patch and monitor adhesion of the patch closely.
Use in Elderly: 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 medicinal product than younger patients. If elderly patients receive fentanyl patch, they should be observed carefully for signs of fentanyl toxicity and the dose reduced if necessary (see Pharmacology: Pharmacokinetics under Actions).
Use In Pregnancy & Lactation
Pregnancy: There are no adequate data from the use of fentanyl patch in pregnant women. Studies in animals have shown some reproductive toxicity. The potential risk for humans is unknown. Fentanyl crosses the placenta. Neonatal withdrawal syndrome has been reported in newborn infants with chronic maternal use of fentanyl patch during pregnancy. Fentanyl patch should not be used during pregnancy unless clearly necessary.
Use of fentanyl patch during childbirth is not recommended because it should not be used in the management of acute or postoperative pain (see Contraindications). Moreover, because fentanyl passes through the placenta, the use of fentanyl patch during childbirth might result in respiratory depression in the newborn infant.
Lactation: 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 fentanyl patch and for at least 72 hours after removal of the patch.
Adverse Reactions
The safety of fentanyl patch was evaluated in 1,854 adult and paediatric subjects who participated in 11 clinical trials (double-blind fentanyl patch [placebo or active control] and/or open label patch [no control or active control]) used for the management of chronic malignant or non-malignant pain. These subjects took at least 1 dose of fentanyl patch and provided safety data.
Based on pooled safety data from these clinical trials, the most commonly reported adverse drug reactions (ADRs) were (with % incidence): nausea (35.7%), vomiting (23.2%), constipation (23.1%), somnolence (15.0%), dizziness (13.1%), and headache (11.8%).
The most serious side effect of fentanyl is respiratory depression.
The ADRs reported with the use of fentanyl patch from these clinical trials, including the previously-mentioned ADRs, and from post-marketing experiences are listed as follows.
The displayed frequency categories use the following convention: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), not known (cannot be estimated from the available data). (See Table 4.)

Click on icon to see table/diagram/image

Description of selected adverse reactions: As with other opioid analgesics, tolerance, physical dependence, and psychological dependence can develop on repeated use of fentanyl patch (see Precautions).
Opioid withdrawal symptoms (such as nausea, vomiting, diarrhoea, anxiety, and shivering) are possible in some patients after conversion from their previous opioid analgesic to fentanyl patch or if therapy is stopped suddenly (see Dosage & Administration).
There have been very rare reports of newborn infants experiencing neonatal withdrawal syndrome when mothers chronically used fentanyl patch during pregnancy (see Use in Pregnancy & Lactation).
Paediatric subjects: The adverse event profile in children and adolescents treated with fentanyl patch was similar to that observed in adults. No risk was identified in the paediatric population beyond that expected with the use of opioids for the relief of pain associated with serious illness and there does not appear to be any paediatric-specific risk associated with fentanyl patch use in children as young as 2 years old when used as directed. Very common adverse events reported in paediatric clinical trials were fever, headache, vomiting, nausea, constipation, diarrhoea and pruritus.
In very rare cases, soya-bean oil, refined can cause allergic reactions.
Drug Interactions
The concomitant use of other central nervous system depressants, including opioids, sedatives, hypnotics, general anaesthetics, phenothiazines, tranquilizers, 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 these medicinal products concomitantly with fentanyl patch requires special patient care and observation. Dose reduction of one or both medicinal products should be taken into consideration.
CYP3A4 Inhibitors: Fentanyl, a high clearance medicinal product, 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.
CYP3A4 Inducer: The concomitant use with CYP3A4 inducers (e.g. rifampicin, carbamazepine, phenobarbital, phenytoin) could result in a decrease in fentanyl plasma concentrations and a decrease 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 my 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): Fentanyl patch is not recommended for use in patients who required the concomitant administration of a MAOI. Severe and unpredictable interactions with MAOIs, involving the potentiation of opiate effects or the potentiation of serotoninergic effects, have been reported.
Therefore, fentanyl patch should not be used within 14 days after discontinuation of treatment with MAOIs.
Serotonergic medicinal products: The concomitant use of fentanyl with a serotonergic agent, such as a selective serotonin reuptake inhibitor (SSRI), a serotonin-noradrenaline reuptake inhibitor (SNRI) or a monoamine oxidase inhibitors (MAOIs) 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.
Caution For Usage
Incompatibilities: Not applicable.
Instructions for use and handling: Significant quantities of fentanyl remain in the transdermal patches even after use. Used transdermal patches should be folded with the adhesive surfaces inwards and due to safety and environmental reasons, discarded safely or whenever possible returned to the pharmacy. Any unused medicinal products should be discarded safely or returned to the pharmacy.
Storage
Store at temperatures not exceeding 25°C.
MIMS Class
ATC Classification
N02AB03 - fentanyl ; Belongs to the class of phenylpiperidine derivative opioids. Used to relieve pain.
Presentation/Packing
Transdermal patch 25 mcg/hr (milky-white rectangular with rounded corners on release liner, and imprint "fentanyl 25 μg/h") x 5's. 50 mcg/hr (milky-white rectangular with rounded corners on release liner, and imprint "fentanyl 50 μg/h") x 5's.
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