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IREMIA is a brand name for Fentanyl. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Fentanyl is indicated for the treatment of breakthrough pain (BTP) in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain. BTP is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. Patients receiving maintenance opioid…
Verbatim from this product's MHRA label. Tap a section to expand.
4). Treatment should be initiated by and remain under the guidance of a physician experienced in the management of opioid therapy in cancer patients. Physicians should keep in mind the potential of abuse of fentanyl. Patients should be instructed not to use two different formulations of fentanyl concurrently for the treatment of breakthrough pain, and to dispose of any fentanyl product prescribed for BTP when switching to Fentanyl.
The number of tablet strengths available to the patients at any time should be minimised to prevent confusion and potential overdose. Fentanyl should be administered directly under the tongue at the deepest part. Fentanyl should not be swallowed, but allowed to completely dissolve in the sublingual cavity without chewing or sucking.
Patients should be advised not to eat or drink anything until the sublingual tablet is completely dissolved. After 30 minutes, if remnants from the Fentanyl tablet remain, they may be swallowed. In patients who have a dry mouth, water may be used to moisten the buccal mucosa before taking Fentanyl.
4 for warnings in children). Patients should be advised to keep Fentanyl in a locked storage space. Dose Titration Before patients are titrated with Fentanyl, it is expected that their background persistent pain will be controlled by use of opioid therapy and that they are typically experiencing no more than 4 episodes of breakthrough pain per day.
The object of dose titration is to identify an optimal maintenance dose for ongoing treatment of breakthrough pain episodes. This optimal dose should provide adequate analgesia with an acceptable level of adverse reactions. The optimal dose of Fentanyl will be determined by upward titration, on an individual patient basis.
Several doses are available for use during the dose titration phase. The initial dose of Fentanyl used should be 133 micrograms, titrating upwards as necessary through the range of available dosage strengths. Patients should be carefully monitored until an optimal dose is reached.
4). Switching from other fentanyl containing products to Fentanyl must not occur at a 1:1 ratio because of different absorption profiles. If patients are switched from another fentanyl containing product, a new dose titration with Fentanyl is required.
The following dose regimen is recommended for titration, although in all cases the physicianshould take into account the clinical need of the patient, age and concomitant illness. All patients must start therapy with a single 133 micrograms sublingual tablet.
Typical opioid side effects are to be expected with Fentanyl. Frequently, these will cease or decrease in intensity with continued use of the product, as the patient is titrated to the most appropriate dose. However, the most serious adverse reactions are respiratory depression (potentially leading to apnoea or respiratory arrest), circulatory depression, hypotension and shock and all patients should be closely monitored for these.
Application site reactions, including gum bleeding, irritation, pain and ulcer have been reported in post-marketing use. Because the clinical trials of fentanyl were designed to evaluate safety and efficacy in treating breakthrough pain, all patients were also taking concomitant opioids, such as sustained-release morphine or transdermal fentanyl, for their persistent pain.
Thus it is not possible to definitively separate the effects of fentanyl alone. The following adverse reactions have been reported with Fentanyl and/or other fentanyl-containing compounds during clinical studies and post marketing experience.
6), Withdrawal CCRF21093 0009 syndrome*, pyrexia Investigations Weight decreased Injury, poisoning and procedural complications accidental injury (for example, falls) *opioid withdrawal symptoms, such as nausea, vomiting, diarrhoea, anxiety, chills, tremor andsweating have been observed with transmucosal fentanyl.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme.
uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Accidental use in children Patients and their carers must be instructed that Fentanyl contains an active substance in an amount that can be fatal to a child. Death has been reported in children who have accidentally ingested Fentanyl.
Patients and their carers must be instructed to keep all units out of the sight and reach of children and to discard open and unopened units appropriately. An evaluation of each out-patient concerning possible accidental child exposures should be undertaken.
Maintenance opioid therapy The product must not be given to patients without maintenance opioid therapy as there is an increased risk of respiratory depression and death. It is important that the long acting opioid treatment used to treat the patient’s persistent pain has been stabilised before Fentanyl therapy begins and that the patient continues to be treated with the long acting opioid treatment whilst taking Fentanyl.
Drug dependence, tolerance and potential for abuse For all patients, prolonged use of this product may lead to drug dependence (addiction), even at therapeutic doses. , major depression). Additional support and monitoring may be necessary when prescribing for patients at risk of opioid misuse.
A comprehensive patient history should be taken to document concomitant medications, including over-the-counter medicines and medicines obtained on-line, and past and present medical and psychiatric conditions. Patients may find that treatment is less effective with chronic use and express a need to increase the dose to obtain the same level of pain control as initially experienced.
Patients may also supplement their treatment with additional pain relievers. These could be signs that the patient is developing tolerance. The risks of developing tolerance should be explained to the patient. Overuse or misuse may result in overdose and/or death.
It is important that patients only use medicines that are prescribed for them at the dose they have been prescribed and do not give this medicine to anyone else. Patients should be closely monitored for signs of misuse, abuse, or addiction.
1. 1) as there is an increasedrisk of respiratory depression. 5). • Severe respiratory depression or severe obstructive lung conditions. • Treatment of acute pain other than breakthrough pain. • Patients being treated with medicinal products containing sodium oxybate.
• Contraindicated in opioid naive patients
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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If adequate analgesia is not obtained within 15-30 minutes of administration of a single tablet, a supplemental (second) 133 micrograms tablet may be administered. If treatment of a breakthrough pain episode requires more than one dosage unit, an increase in dose to the next higher available strength should be considered (Refer to figure below).
Dose escalation should continue in a stepwise manner until adequate analgesia is achieved. The dose strength for the supplemental (second) tablet should be increased from 133 to 267 micrograms at doses of 533 micrograms. This is illustrated in the schedule below.
No more than two (2) tablets should be administered for a single episode of breakthrough pain during this titration phase. FENTANYL TITRATION PROCESS Strength (micrograms) of first tablet per episode of breakthrough pain Strength (micrograms) of supplemental (second) tablet to be taken 15-30 minutes after first tablet, if required 133 133 267 133 400 133 533 267 800 - If adequate analgesia is achieved at the higher dose, but undesirable effects are considered unacceptable, an intermediate dose may be administered (using the 67 micrograms or 133 micrograms tablet).
Doses higher than 800 micrograms have not been evaluated in clinical studies. In order to minimise the risk of opioid–related adverse reactions and to identify the appropriate dose, it is imperative that patients be monitored closely by health professionals during the titration process.
Maintenance therapy Once an appropriate dose has been established, which may be more than one tablet, patients should be maintained on this dose and should limit consumption to a maximum of four Fentanyl doses per day. Dose re-adjustment If the response (analgesia or adverse reactions) to the titrated Fentanyl dose markedly changes, an adjustment of dose may be necessary to ensure that an optimal dose is maintained.
If more than four episodes of breakthrough pain are consistently experienced per day, then the dose of the long acting opioid used for persistent pain should be re-evaluated. If the long acting opioid or dose of long acting opioid is changed, the Fentanyl dose should be re- evaluated and re-titrated as necessary to ensure the patient is on an optimal dose.
It is imperative that any dose re-titration of any analgesic is monitored by a health professional. Discontinuation of therapy Fentanyl should be discontinued immediately if the patient no longer experiences breakthrough pain episodes.
The treatment for the persistent background pain should be kept as prescribed. If discontinuation of all opioid therapy is required, the patient must be closely followed by the doctor in order to manage the risk of abrupt withdrawal effects.
Use in elderly patients Dose titration needs to be approached with particular care and patients observed carefully for signs of fentanyl toxicity (see […]
The clinical need for analgesic treatment should be reviewed regularly. Tolerance, physical and psychological dependence may develop upon repeated administration of opioids such as fentanyl. However, iatrogenic addiction following therapeutic use of opioids is known to occur.
Fentanyl can be abused in a manner similar to other opioids and all patients treated with opioids require monitoring for signs of abuse and addiction. Patients at increased risk of opioid abuse may still be appropriately treated with opioids; however, these patients will require additional monitoring for signs of misuse, abuse or addiction.
Repeated use of fentanyl-containing product may lead to Opioid Use Disorder (OUD). Abuse or intentional misuse of fentanyl-containing product may result in overdose and/or death. , major depression, anxiety and personality disorders).
, too early requests for refills). This includes the review of concomitant opioids and psycho-active drugs (like benzodiazepines). For patients with signs and symptoms of OUD, consultation with an addiction specialist should be considered.
Drug withdrawal syndrome Prior to starting treatment with any opioids, a discussion should be held with patients to put in place a withdrawal strategy for ending treatment with fentanyl. Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction.
When a patient no longer requires therapy, it is advisable to taper the dose gradually to minimise symptoms of withdrawal. Tapering from a high dose may take weeks to months. The opioid drug withdrawal syndrome is characterised by some or all of the following: restlessness, lacrimation, rhinorrhoea, yawning, perspiration, chills, myalgia, mydriasis and palpitations.
Other symptoms may also develop including irritability, agitation, anxiety, hyperkinesia, tremor, weakness, insomnia, anorexia, abdominal cramps, nausea, vomiting, diarrhoea, increased blood pressure, increased respiratory rate or heart rate.
If women take this drug during pregnancy, there is a risk that their newborn infants will experience neonatal withdrawal syndrome. Hyperalgesia Hyperalgesia may be diagnosed if the patient on long-term opioid therapy presents with increased pain.
This might be qualitatively and anatomically distinct from pain related to disease progression or to breakthrough pain resulting from development of opioid tolerance. Pain associated with hyperalgesia tends to be more diffuse than the pre-existing pain and less defined in quality.
Symptoms of hyperalgesia may resolve with a reduction of opioid dose. Endocrine effects Opioids may influence the hypothalamic-pituitary-adrenal or gonadal axes. Some changes that can be seen include an increase in serum prolactin and decrease in plasma cortisol and testosterone.
Clinical signs and symptoms may manifest from these hormonal changes. Cases of adrenal insufficiency have been reported with opioid use including fentanyl, more often following greater than one month of use. 8). Respiratory depression As with all opioids, there is a risk of clinically significant respiratory depression associated with the use of fentanyl, patients should be monitored accordingly.
Particular caution should be used when […]