Fentanyl transdermal
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Transdermal patches containing fentanyl.
Drugs List
Therapeutic Indications
Uses
Pain - chronic intractable caused by carcinoma
Prolonged relief of severe and intractable pain
Dosage
The lowest effective dose should be used.
Adults
Initial dose selection
The initial dose should be based on the patients opioid history, including the degree of opioid tolerance, if any, as well as the current general condition and medical status of the patient including body size, age and extent of debilitation.
The initial evaluation of the analgesic effect of fentanyl should not be made before the patch has been worn for 24 hours due to the gradual increase in serum fentanyl concentrations up to this time. Previous analgesic therapy should therefore be phased out gradually from the time of the first patch application until analgesic efficacy with fentanyl is attained.
In opioid-naive patients
Fentanyl patches are not recommended in opioid-naive patients, consider alternative routes of administration. In circumstances where oral administration of fentanyl is not possible, and transdermal fentanyl is the only appropriate treatment, the initial dosage should not exceed 12micrograms/hr.
If therapy is considered appropriate, it is recommended that these patients are titrated with low doses of short-acting oral opioids initially, and then converted to fentanyl patch 12micrograms/hr or 25micrograms/hr. This dose may be subsequently titrated up or down in 12 or 25microgram/hr increments as required, in order to achieve the lowest appropriate dose depending on response and supplementary analgesic requirements. Opioid-naive patients must be closely monitored for potential serious or life-threatening adverse reactions.
In opioid-tolerant patients
The initial dose should be based on the previous 24 hour opioid analgesic requirement. A recommended conversion scheme from oral morphine to fentanyl patches for patients who have need for opioid rotation (conversion ratio of oral morphine to transdermal fentanyl equal to 150:1) is shown below:
Oral 24 hour morphine less than 90mg/day: convert to fentanyl patch 12micrograms/hr
Oral 24 hour morphine 90 to 134mg/day: convert to fentanyl patch 25micrograms/hr
Oral 24 hour morphine 135 to 224mg/day: convert to fentanyl patch 50micrograms/hr
Oral 24 hour morphine 225 to 314mg/day: convert to fentanyl patch 75micrograms/hr
Oral 24 hour morphine 315 to 404mg/day: convert to fentanyl patch 100micrograms/hr
Oral 24 hour morphine 405 to 494mg/day: convert to fentanyl patch 125micrograms/hr
Oral 24 hour morphine 495 to 584mg/day: convert to fentanyl patch 150micrograms/hr
Oral 24 hour morphine 585 to 674mg/day: convert to fentanyl patch 175micrograms/hr
Oral 24 hour morphine 675 to 764mg/day: convert to fentanyl patch 200micrograms/hr
Oral 24 hour morphine 765 to 854mg/day: convert to fentanyl patch 225micrograms/hr
Oral 24 hour morphine 855 to 944mg/day: convert to fentanyl patch 250micrograms/hr
Oral 24 hour morphine 945 to 1034mg/day: convert to fentanyl patch 275micrograms/hr
Oral 24 hour morphine 1035 to 1124mg/day: convert to fentanyl patch 300micrograms/hr
Alternatively, the following conversion scheme is recommended by some manufacturers for patients on stable and well tolerated opioid therapy (conversion ratio of oral morphine to transdermal fentanyl equal to 100:1):
Oral 24 hour morphine less than or equal to 44mg/day: convert to fentanyl patch 12micrograms/hr
Oral 24 hour morphine 45 to 89mg/day: convert to fentanyl patch 25micrograms/hr
Oral 24 hour morphine 90 to 149mg/day: convert to fentanyl patch 50micrograms/hr
Oral 24 hour morphine 150 to 209mg/day: convert to fentanyl patch 75micrograms/hr
Oral 24 hour morphine 210 to 269mg/day: convert to fentanyl patch 100micrograms/hr
Oral 24 hour morphine 270 to 329mg/day: convert to fentanyl patch 125micrograms/hr
Oral 24 hour morphine 330 to 389mg/day: convert to fentanyl patch 150micrograms/hr
Oral 24 hour morphine 390 to 449mg/day: convert to fentanyl patch 175micrograms/hr
Oral 24 hour morphine 450 to 509mg/day: convert to fentanyl patch 200micrograms/hr
Oral 24 hour morphine 510 to 569mg/day: convert to fentanyl patch 225micrograms/hr
Oral 24 hour morphine 570 to 629mg/day: convert to fentanyl patch 250micrograms/hr
Oral 24 hour morphine 630 to 689mg/day: convert to fentanyl patch 275micrograms/hr
Oral 24 hour morphine 690 to 749mg/day: convert to fentanyl patch 300micrograms/hr
Dose titration and maintenance therapy
The patch should be replaced every 72 hours. The dose should be titrated individually until a balance between analgesic efficacy and tolerability is attained. If analgesia is insufficient at the end of the initial application period, the dose may be increased. Dose adjustment, when necessary, should normally be performed in 12 to 25micrograms/hour increments, although the supplementary analgesic requirements (oral morphine 90mg/day approximately equivalent to fentanyl 25micrograms/hour) and the pain status of the patient should be taken into account. More than one patch may be used to achieve the desired dose but they should be applied at the same time to avoid confusion. Patients may require periodic supplemental doses of short-acting analgesic for "breakthrough" pain. Additional or alternative methods of analgesia should be considered when the fentanyl dose exceeds 300micrograms/hour.
If the patch needs to be replaced before 72 hours, a patch of the same strength may be replaced after 48 hours with a patch of the same strength should be applied to a different skin site. Monitor the patient for changes in serum concentrations.
Discontinuation
If discontinuation of fentanyl is necessary, replacement with other opioids should be gradual, starting at a low dose and increasing slowly. This is because fentanyl levels fall gradually after removal of a patch, it may take 20 hours for the fentanyl serum concentrations to decrease by 50%.
Elderly
Elderly patients should be observed carefully and the dose should be individualised to the status of the patient. In opioid naive patients, treatment should only be used if the benefits outweigh the risks. In such cases, only fentanyl 12micrograms/hour patches should be used for initial treatment.
Children
Children aged 16 to 18 years old (Not all brands are licensed for this age group)
See Dosage; Adult.
Children aged 2 to 16 years old (Not all brands are licensed for this age group)
Administer only to opioid-tolerant patients who are already receiving at least 30mg oral morphine equivalents per day.
Recommended dosages of fentanyl patches, based upon the oral daily morphine dosage are stated below:
Oral 24 hour morphine 30 to 44mg/day: convert to fentanyl patch 12micrograms/hr
Oral 24 hour morphine 45 to 134mg/day: convert to fentanyl patch 25micrograms/hr or two 12microgram/hr patches
Please note that this conversion schedule should not be used to convert dosages from fentanyl patches to other opioids, as overestimation could occur.
An application site should be chosen which is difficult for young children to reach and tamper with the patch e.g. the upper back. Conversion to fentanyl patch doses above 25micrograms/hr is the same for adult and paediatric patients.
The analgesic effect of the first dose of transdermal fentanyl will not be optimal within the first 24 hours. Therefore, during the first 12 hours after switching to transdermal fentanyl, 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.
Patients should be monitored for adverse effects including hypoventilation for at least 48 hours after initiation of therapy, since peak fentanyl levels occur after 12 to 24 hours of treatment.
Dose adjustments are made in 12microgram/hr steps over at least 72-hour intervals although the supplementary analgesic requirements and the pain status of the patient should be taken into account.
Patients with Renal Impairment
Adjust dose based off the individualised status of the patient. In opioid naive patients with renal impairment, only consider the 12mcg/h fentanyl patch for initial treatment. Patients with renal impairment should be observed carefully for fentanyl toxicity and dose reduced if necessary.
The Renal Drug Handbook (2019) recommends initiating with 50% of normal dose if GFR under 10ml/minute, or 75% of normal dose if GFR between 10 and 50ml/minute and then titrating to response.
Patients with Hepatic Impairment
Adjust dose based off the individualised status of the patient. In opioid naive patients with hepatic impairment, only consider the 12mcg/h fentanyl patch for initial treatment.
Patients with hepatic impairment should be observed carefully for signs of fentanyl toxicity and the dose reduced if necessary. Opioids may precipitate coma in patients with hepatic impairment.
Administration
Fentanyl patches should be applied immediately upon removal from a sealed package.
Apply patches to a dry, non-hairy, flat area of skin on the torso or upper arm. Application to the upper back is preferred in children. Application sites should be rotated allowing at least 7 days before re-applying a patch to the same site. If necessary, hair may be removed from the application site using clippers but must not be shaved. If the application site requires cleansing prior to application, this should be done with water, ensuring the area is completely dry prior to application. Soaps, oils, lotions or other agents which may irritate the skin or alter its characteristics should not be used.
During application, care should be taken to avoid contact with the adhesive side of the patch. Users must wash their hands following application. Patches must not be cut. Patches should be worn continuously for 72 hours. Old patches must be removed before application of a new patch.
Contraindications
Children under 2 years
Opioid-naive patients
Risk of paralytic ileus
Within 2 weeks of discontinuing MAOIs
Acute asthma
Breastfeeding
Central nervous system disorder
Chronic obstructive pulmonary disease
Head trauma
Raised intracranial pressure
Severe respiratory depression
Precautions and Warnings
Children aged 2 to 16 years
Debilitation
Elderly
Impaired consciousness
Shock
Asthma
Biliary tract disorder
Bradyarrhythmia
Brain neoplasm
Central nervous system neoplasm
Cerebral oedema
Chronic constipation
Coma
Hepatic impairment
History of alcohol abuse
History of drug misuse
Hypotension
Hypovolaemia
Inflammatory bowel disease
Myasthenia gravis
Pregnancy
Psychiatric disorder
Renal impairment
Respiratory disease
Urethral stricture
Correct hypotension before initiating treatment
Not suitable for acute pain relief
Advise patient ability to drive or operate machinery may be impaired
Advise patient not to drive until they know how the medicine affects them
Advise patient this medicine may be subject to driving restrictions
Correct hypovolaemia prior to administration
Not all available brands are licensed for all age groups
Some products contain arachis (peanut) oil, soya or soya derivative
Some products contain colophony which may cause allergic reactions
Different brands may not be interchangeable
Advise patients and caregivers on the correct administration of patches
Avoid exposing application site to direct external heat
Cleanse and dry skin before application
Discard used patches safely - fold with adhesive edges together
Remove metal containing patch prior to MRI scan
Rotate application sites. Allow 7 days before applying patch to same site
Fever: Monitor patient for opiate side effects and adjust dose as required
Monitor patient for signs and symptoms of respiratory depression
Monitor patients for signs and symptoms of Serotonin Syndrome
Monitor patients with a history of alcoholism and drug abuse
Monitor patients with hepatic impairment for toxic effects
Monitor patients with renal impairment for toxic effects
Potential for drug abuse
Reassess need for continued treatment at regular intervals
Tolerance and dependence may occur
When used with SSRIs, risk of Serotonin syndrome
Advise patient that increased temperature increases delivery rate
Advise patient to stop medication & contact GP if signs of opioid toxicity
Potential for withdrawal symptoms
Avoid abrupt withdrawal
Discontinue if paralytic ileus is suspected
Discontinue if serotonin syndrome develops
Consider dose reduction in hepatic impairment
Consider dose reduction in renal impairment
Consider dose reduction or alternative opioid in cases of hyperalgesia
Consider reducing dose in elderly
Advise patient not to take St John's wort concurrently
Advise that effects are potentiated by CNS depressants (including alcohol)
The use of fentanyl patches in opioid naive patients is contraindicated as the use of fentanyl patches in opioid-naive patients has been associated with very rare cases of respiratory depression and/or fatality when used as initial opioid therapy, even with the lowest dose. It is recommended that fentanyl patches should be used in patients who have demonstrated opioid tolerance.
Some patients may experience significant respiratory depression which may persist beyond the removal of the fentanyl patch. Patients who have experienced serious adverse events should be monitored for up to 24 hours after removal of the patch since serum fentanyl concentrations decline gradually with mean terminal half life ranging from 17 to 25 hours.
Fentanyl exhibits an additive effect with other CNS depressants. Prescribe at lowest dose and monitor for signs of respiratory depression and sedation.
Hyperalgesia may occur in patients on long-term opiod therapy, this may be distinct from disease-related pain progression or to breakthrough pain due to opioid tolerance. Hyperalgesia symptoms may be resolved by reducing opioid dose.
Pregnancy and Lactation
Pregnancy
Use fentanyl patches with caution during pregnancy.
The manufacturer does not recommend using fentanyl patches during pregnancy unless clearly necessary. Animal studies have shown reproductive toxicity. Human data is limited and as such potential risk cannot be ruled out. Fentanyl as an IV anaesthetic has been found to cross the placenta in humans. Withdrawal syndrome has been reported in newborn infants following chronic maternal use of fentanyl patches.
Lactation
Fentanyl patches are contraindicated during breastfeeding.
Use of fentanyl patches when breastfeeding is contraindicated by the manufacturer. Breastfeeding should be discontinued during treatment and for 72 hours after the removal of the patch. Fentanyl is present in human breast milk and may cause sedation/respiratory depression in the exposed infant.
Counselling
Advise patients to avoid exposure of the application site to direct external heat sources such as prolonged hot baths, hot water bottles, heating pads, electric blankets, heated water beds, heat or tanning lamps, electric blankets, sunbathing, saunas, or hot whirlpool spa baths. Increases in temperature will increase the delivery rate of fentanyl.
Advise patients that transfer of the fentanyl patch to the skin of a non-patch wearer (through close physical contact) may result in an opioid overdose for the non-wearer. If patch transfer occurs, the patch should be removed immediately. Urgent medical attention should be sought for anyone accidentally exposed to fentanyl patches.
Advise patients that when removing patches they should fold the used patch in half so the adhesive edges adhere to themselves, return it to the original sachet and dispose of it safely.
Advise patients to keep patches out of the reach and sight of children. This includes used patches as they may contain residual amounts of fentanyl which could cause serious harm following accidental exposure.
Advise patients that the use of alcohol may increase the risk of serious side effects.
Advise patients not to take St. John's Wort concurrently.
Advise patients of the symptoms and signs of opioid overdosage. Patches should be removed immediately in case of breathing difficulties, marked drowsiness, confusion, dizziness, feeling faint or difficulty thinking, walking or talking, and prompt medical attention sought. Patients who experience serious adverse events should be monitored closely for up to 24 hours.
Advise patients that their ability to perform potentially hazardous tasks, such as driving or operating machinery, may be impaired. This medicine may be subject to driving restrictions.
Side Effects
Abdominal pain
Agitation
Allergic dermatitis
Altered temperature sensation
Amblyopia
Amnesia
Anaphylactic reaction
Anaphylactic shock
Anaphylactoid reaction
Anorexia
Anxiety
Apnoea
Application site reaction
Arrhythmias
Asthenia
Ataxia
Biliary spasm
Bladder pain
Bradycardia
Bradypnoea
Confusion
Conjunctivitis
Constipation
Contact dermatitis
Convulsions
Cyanosis
Delusions
Dependence
Depression
Dermatitis
Disorientation
Disturbances of appetite
Dizziness
Dry mouth
Dyspepsia
Dyspnoea
Eczema
Erectile dysfunction
Erythema
Euphoria
Exanthema
Excitement
Fatigue
Fever
Flatulence
Gastrointestinal disorder
Haemoptysis
Hallucinations
Headache
Hiccups
Hyperhidrosis
Hypersensitivity reactions
Hypertension
Hypoaesthesia
Hypotension
Hypoventilation
Ileus
Impaired co-ordination
Influenza-like symptoms
Insomnia
Involuntary muscle contractions
Malaise
Miosis
Muscle spasm
Myoclonic movements
Nausea
Nervousness
Oedema
Oliguria
Palpitations
Paraesthesia
Peripheral oedema
Pharyngitis
Pruritus
Rash
Respiratory depression
Respiratory distress
Rhinitis
Sedation
Sensation of cold
Sexual dysfunction
Shivering
Skin discomfort
Skin disorder
Somnolence
Speech disturbances
Sweating
Tachycardia
Tolerance
Tremor
Ureteric spasm
Urinary retention
Vasodilatation
Vertigo
Visual disturbances
Vomiting
Withdrawal symptoms
Xerostomia
Yawning
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: November 2019
Reference Sources
Summary of Product Characteristics: Durogesic D Trans. Janssen-Cilag Ltd. Revised June 2019.
Summary of Product Characteristics: Fencino. Dallas Burston Ashbourne Ltd. Revised June 2019.
Summary of Product Characteristics: Fentalis. Sandoz Ltd. Revised October 2018.
Summary of Product Characteristics: Matrifen. Teva UK Ltd. Revised October 2019.
Summary of Product Characteristics: Mezolar Matrix. Sandoz Ltd. Revised June 2019.
Summary of Product Characteristics: Opiodur. Rx Farma. Revised June 2017.
Summary of Product Characteristics: Opiodur. Zentiva. Revised November 2019.
Summary of Product Characteristics: Osmanil 12micrograms/hr. Winthrop Pharmaceuticals Ltd. Revised June 2011.
Summary of Product Characteristics: Victanyl. Accord UK Ltd. Revised May 2020.
Summary of Product Characteristics: Yemex. Sandoz. Revised June 2019.
The Renal Drug Handbook. Fifth Edition (2019) ed. Ashley, C. and Dunleavy, A. Radcliffe Publishing Ltd, London.
MHRA Drug Safety Update September 2020
Available at: https://www.mhra.gov.uk
Last accessed: 12 November 2020
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 11 November 2019
Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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