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CYNRIL is a brand name for Fentanyl. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Cynril is indicated for management of breakthrough pain in patients already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of persistent pain controlled by other means. Patients receiving maintenance opioid therapy are…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology In order to minimise the risks of opioid-related side-effects and to identify the “successful” dose, it is imperative that patients be monitored closely by health professionals during the titration process or dose adjustment.
Cynril is not interchangeable on a mcg to mcg basis with other short-acting fentanyl products that are indicated for the use of breakthrough cancer pain, as the pharmacokinetic profiles and/or dosing schedules of these products are significantly different.
Patients should be instructed not to use more than one short-acting fentanyl product concurrently for the treatment of breakthrough cancer pain, and to dispose of any fentanyl product prescribed for breakthrough pain (BTP) when switching to Cynril.
The number of Cynril strengths available to the patient at any time should be minimised to prevent confusion and potential overdose. Any unused Cynril units that the patient no longer requires must be disposed of properly. Patients must be reminded of the requirements to keep Cynril stored in a location away from children.
Adults Dose titration and maintenance therapy Cynril should be individually titrated to a “successful” dose that provides adequate analgesia and minimises adverse reaction. In clinical trials the successful dose of Cynril for breakthrough pain was not predicted from the daily maintenance dose of opioid.
a) Titration Before patients are titrated with Cynril, 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 initial dose of Cynril used should be 200 micrograms, titrating upwards as necessary through the range of available dosage strengths (200, 400, 600, 800, 1200 and 1600 micrograms). Patients should be carefully monitored until a dose is reached that provides adequate analgesia with acceptable adverse reaction using a single dosage unit per episode of breakthrough pain.
This is defined as the successful dose. , 15 minutes after the patient completes consumption of a single Cynril unit), a second Cynril unit of the same strength may be consumed. No more than two Cynril units should be used to treat any individual pain episode.
At 1600 micrograms, a second dose is only likely to be required by a minority of patients. If treatment of consecutive breakthrough pain episodes requires more than one dosage unit per episode, an increase in dose to the next higher available strength should be considered.
Typical opioid side effects are to be expected with Cynril. 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 events 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 Cynril 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 Cynril alone. The following adverse reactions have been reported with Cynril during clinical studies and post marketing experience. 4), delirium Nervous system disorders somnolence, dizziness, headache loss of consciousness, convulsion, vertigo, myoclonus, sedation, parathesia (including hyperaesthesia/ circu moral parathesia), abnormal gait/ incoordination, taste perversion coma, slurred speech Eye disorders abnormal vision (blurred, double vision) Vascular disorders vasodilatation flushing, hot flush Respiratory, thoracic and mediastinal disorders dyspnoea pharyangeal oedema, respiratory depression, sleep apnoea syndrome System organ class Very common Common Uncommon Not known Gastrointestinal disorders nausea, vomiting, constipation, abdominal pain dry mouth, dyspepsia, stomatitis, tongue disorder (for example, burning sensation, ulcers), flatulence, abdomen enlarged ileus, mouth ulcers, dental caries, gingival bleeding tooth loss, gingival recession, gingivitis, diarrhoea Skin and subcutaneous tissue disorders pruritis, sweating, rash urticaria Renal and urinary disorders urinary retention General disorders and administration site conditions asthenia application site reactions including irritation, pain and ulcer, malaise fatigue, peripheral oedema, pyrexia, withdrawal syndrome*, neonatal withdrawal syndrome, drug dependence (addiction), drug abuse, drug tolerance, bleeding at the site of application Investigations weight decreased Injury, poisoning and procedural complications accidental injury (for example, falls) *opioid withdrawal symptoms such as nausea, vomiting, diarrhoea, anxiety, chills, tremor and sweating have been observed with transmucosal fentanyl.
Because of the risks, including fatal outcome, associated with accidental exposure, misuse, and abuse, patients and their carers must be advised to keep Cynril in a safe and secure place, not accessible by others. Accidental use in children Patients and their carers must be instructed that Cynril contains an active substance in an amount that can be fatal to a child.
Death has been reported in children who have accidentally ingested Cynril. Patients and their carers must be instructed to keep all units out of the reach and sight of children and to discard open and unopened units appropriately. An evaluation of each outpatient concerning possible accidental child exposures should be undertaken.
Maintenance opioid therapy The product should 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 maintenance opioid therapy used to treat the patient’s persistent pain has been stabilized before Cynril therapy begins and that the patient continues to be treated with the maintenance opioid therapy whilst taking Cynril.
Tolerance and Opioid Use Disorder (abuse and dependence) Tolerance and physical and/or psychological dependence may develop upon repeated administration of opioids such as fentanyl. 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 Cynril may lead to Opioid Use Disorder (OUD).
A higher dose and longer duration of opioid treatment, can increase the risk of developing OUD. Abuse or intentional misuse of Cynril may result in overdose and/or death. , major depression, anxiety and personality disorders). 2). Before and during treatment the patient should also be informed about the risks and signs of OUD.
1. 4) as there is an increased risk of respiratory depression. 5). - Severe respiratory depression or severe obstructive lung conditions. - Patients being treated with medicinal products containing sodium oxybate.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Fentanyl in United Kingdom.
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Cynril Titration process Did the patient achieve adequate pain relief with a one Cynril unit? Yes No *Dose concentrations available are 200, 400, 600, 800, 1200 and 1600 micrograms. , on average, an episode is effectively treated with a single unit), patients should be maintained on this dose and should limit consumption to a maximum of four Cynril units per day.
Patients should be monitored by a health professional to ensure that the maximum consumption of four units of Cynril per day is not exceeded. Dose re-adjustment The maintenance dose of Cynril should be increased when an episode is not effectively treated with a single unit for several consecutive BTP episodes.
For dose-readjustment the same principles apply as outlined for dose titration (see above). If more than four episodes of breakthrough pain are experienced per day the dose of the long-acting opioid used for persistent pain should be re-evaluated.
If the dose of the long- acting opioid is increased, the dose of Cynril to treat breakthrough pain may need to be reviewed. 1. Patient consumes Cynril over 15 minutes. 2. Patient waits 15 minutes. If inadequate analgesia, patient consumes a second Cynril unit of the same strength.
3. Patient tries this Cynril dose for consecutive episodes of breakthrough pain. 4). It is imperative that any dose re-titration of any analgesic is monitored by a health professional. Treatment duration and goals Before initiating treatment with Cynril, a treatment strategy including treatment duration and treatment goals, and a plan for end of the treatment, should be agreed together with the patient, in accordance with pain management guidelines.
During treatment, there should be frequent contact between the physician and the patient to evaluate the need for continued treatment, consider discontinuation and to adjust dosages if needed. 4). Cynril should not be used longer than necessary.
Discontinuation of therapy Cynril 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 as gradual downward opioid titration is necessary in order to avoid the possibility of abrupt withdrawal effects.
Use in the elderly Elderly patients have been shown to be more sensitive to the effects of fentanyl when administered intravenously. Therefore, dose titration needs to be approached with particular care. In the elderly, elimination of fentanyl is slower, and the terminal elimination half-life is longer, which may result in accumulation of the active substance and to a greater risk of undesirable effects.
Formal clinical trials with Cynril have not been conducted in the elderly population. It has been observed, however, in clinical trials that patients […]
Descriptions of selected adverse reactions Tolerance Tolerance can develop on repeated use. Drug dependence Repeated use of Cynril can lead to drug dependence, even at therapeutic doses. 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Patients should be advised to contact their physician if these signs occur. , 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.
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 lozenges, 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 Cynril.
Cynril patients should be monitored accordingly. Particular caution should be used when titrating Cynril in patients with non-severe chronic obstructive pulmonary disease or other medical conditions predisposing them to respiratory depression, as even normally therapeutic doses of Cynril may further decrease respiratory drive to the point of respiratory failure.
Sleep-related breathing disorders Opioids can cause sleep-related breathing disorders including central sleep apnoea (CSA) and sleep-related hypoxemia. Opioid use increases the risk of CSA in a dose-dependent fashion. In patients who present with CSA, consider decreasing the total opioid dosage.
5). Risks of concomitant administration with benzodiazepines Concomitant use of opioids, including Cynril, with benzodiazepines may result in profound sedation, respiratory depression, coma, and death. Because of these risks, concomitant prescribing of opioids and benzodiazepines should be made only in patients for whom alternative treatment options are inadequate.
If a decision is made to prescribe Cynril concomitantly with benzodiazepines, the lowest effective dosages and minimum durations of concomitant use should be chosen. 5). Intracranial effects of CO2 retention, impaired consciousness, head injury Cynril should only be administered with extreme caution in patients who may be particularly susceptible to the intracranial effects of CO2 retention, such as those with evidence of increased intracranial pressure, or impaired consciousness.
Opioids may obscure the clinical course of a patient with a head injury and should be used only if clinically warranted. Bradyarrhythmias Intravenous fentanyl may produce bradycardia. Therefore, Cynril should be used with caution in patients with previous or pre-existing bradyarrhythmias.
Hepatic or renal impairment In addition, Cynril should be administered with caution to patients with liver or kidney dysfunction. The influence of liver and renal impairment on the pharmacokinetics of the medicinal product has not been evaluated; however, when administered intravenously the clearance of fentanyl has been shown to be […]