Loading…
Instanyl is a brand name for Fentanyl. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Instanyl is indicated for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. Patients receiving maintenance opioid therapy are…
Verbatim from this product's EMA label. Tap a section to expand.
Treatment should be initiated by and remain under the supervision of a physician experienced in the management of opioid therapy in cancer patients. 4). Posology Patients should be individually titrated to a dose that provides adequate analgesia with tolerable adverse drug reactions.
Patients must be carefully monitored during the titration process. Titration to a higher dose necessitates contact with the health care professional. 4). 1).
Maximum daily dose:
Treatment of up to four breakthrough pain episodes, each with no more than two doses separated by at least 10 minutes. Patients should wait 4 hours before treating another breakthrough pain episode with Instanyl during both titration and maintenance therapy.
On exceptional occasions where a new episode occurs earlier, patients can use Instanyl to treat it but they must wait at least 2 hours before doing so. Dose adjustment of the background opioid therapy following pain reassessment should be considered if the patient frequently presents with breakthrough pain episodes that are less than 4 hours apart or with more than four breakthrough pain episodes per 24 hours.
Dose titration Before patients are titrated with Instanyl, it is expected that their background persistent pain is controlled by use of chronic opioid therapy and that they are experiencing no more than four episodes of breakthrough pain per day.
Method of titration The initial strength should be one dose of 50 micrograms in one nostril, titrating upwards as necessary through the range of available strengths (50, 100, and 200 micrograms). If adequate analgesia is not achieved, redosing of the same strength may be administered at the earliest after 10 minutes.
Each titration step (dose strength) should be evaluated in several episodes. Maintenance therapy Once the dose has been established according to the steps described above, the patient should be maintained on this strength of Instanyl.
If the patient has insufficient pain relief, redosing with same strength can be undertaken at the earliest after 10 minutes. Dose adjustment Generally, the maintenance strength of Instanyl should be increased when a patient requires more than one dose per breakthrough pain episode for several consecutive episodes.
Summary of the safety profile Typical opioid adverse reactions are to be expected with Instanyl. Frequently, most of these will cease or decrease in intensity with continued use of the medicinal product. 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.
The adverse reactions considered to be at least possibly related to treatment in the clinical trials of Instanyl are included in the table below. 9 Tabulated list of adverse reactions The following categories are used to rank the undesirable effects by frequency of occurrence: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); and very rare (< 1/10,000), not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. The following adverse reactions have been reported with Instanyl and/or other fentanyl-containing compounds during clinical studies and post marketing experience: System organ class Common Uncommon Not known Immune system disorders Anaphylactic shock, anaphylactic reaction, hypersensitivity Psychiatric disorders Insomnia Hallucination, delirium, drug dependence (addiction), drug abuse Nervous system disorders Somnolence, dizziness, headache Sedation, myoclonus, paraesthesia, dysaesthesia, dysgeusia Convulsions, loss of consciousness Ear and Labyrinth disorders Vertigo Motion sickness Cardiac disorders Hypotension Vascular disorders Flushing, hot flush Respiratory, thoracic and mediastinal disorders Throat irritation Respiratory depression, epistaxis, nasal ulcer, rhinorrhea Nasal septum perforation, dyspnoea Gastrointestinal disorders Nausea, vomiting Constipation, stomatitis, dry mouth Diarrhoea Skin and subcutaneous tissue disorders Hyperhidrosis Pain of skin, pruritus General disorders and administration site conditions Pyrexia Fatigue, malaise peripheral oedema, withdrawal syndrome*, neonatal withdrawal syndrome, Drug tolerance Injury, poisoning and procedural complications Fall *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 Instanyl in a safe and secure place, not accessible by others. Respiratory depression Clinically significant respiratory depression may occur with fentanyl, and patients must be observed for these effects.
Patients with pain who receive chronic opioid therapy develop tolerance to respiratory depression and hence the risk of respiratory depression in these patients may be reduced. 5). Chronic pulmonary disease In patients with chronic obstructive pulmonary diseases, fentanyl may have more severe adverse reactions.
In these patients, opioids may decrease respiratory drive. Risk from concomitant use of sedative medicines such as benzodiazepines or related drugs Concomitant use of Instanyl and sedative medicines such as benzodiazepines or related drugs may result in sedation, respiratory depression, coma and death.
Because of these risks, concomitant prescribing with these sedative medicines should be reserved for patients for whom alternative treatment options are not possible. If a decision is made to prescribe Instanyl concomitantly with sedative medicines, the lowest effective dose should be used, and the duration of treatment should be as short as possible.
The patients should be followed closely for signs and symptoms of respiratory depression and sedation. 5). Impaired renal or hepatic function Fentanyl should be administered with caution to patients with moderate to severe hepatic or renal impairment.
The influence of hepatic and renal impairment on the pharmacokinetics of Instanyl have not been evaluated; however, when administered intravenously the clearance of fentanyl has shown to be altered due to hepatic and renal impairment caused by alterations in metabolic clearance and plasma proteins.
1. Patients without maintenance opioid therapy as there is an increased risk of respiratory depression. Treatment of acute pain other than breakthrough pain. Patients being treated with medicinal products containing sodium oxybate. Severe respiratory depression or severe obstructive lung conditions.
Previous facial radiotherapy. 4).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Fentanyl in European Union.
Know a brand we are missing in European Union? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Dose adjustment of the background opioid therapy following pain reassessment should be considered if the patient frequently presents with breakthrough pain episodes that are less than 4 hours apart or with more than four breakthrough pain episodes per 24 hours.
Start at 50 micrograms - Use one dose of Instanyl - Wait 10 minutes Dose obtained Adequate pain relief with one dose of Instanyl Yes No Redose with same strength. Consider next higher strength for next episode 4 If adverse reactions are intolerable or persistent, the strength should be reduced or treatment with Instanyl be replaced by other analgesics.
Treatment duration and goals Before initiating treatment with Instanyl, 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). Instanyl should not be used longer than necessary.
Discontinuation of therapy Instanyl 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 physician as gradual downward opioid titration is necessary in order to avoid the possibility of abrupt withdrawal effects.
Special populations Elderly and Cachectic population Limited data on pharmacokinetics, efficacy and safety are available for the use of Instanyl in patients above 65 years of age. Elderly patients may have a reduced clearance, a prolonged half-life and higher sensitivity to fentanyl than younger patients.
Limited data on pharmacokinetics are available for the use of fentanyl in cachectic (debilitated) patients. Cachectic patients may have reduced clearance of fentanyl. Caution should therefore be taken in treatment of elderly, cachectic or debilitated patients.
In clinical trials elderly patients tend to titrate to a lower effective strength than patients less than 65 years of age. Particular caution should be exercised when titrating Instanyl in elderly patients. 4). 4). Paediatric population The safety and efficacy of Instanyl in children aged below 18 years have not yet been established.
No data are available. Method of administration Instanyl is intended for nasal use only. It is recommended that the patient sit or stand in upright position when administrating Instanyl. Cleaning of the nasal spray tip is required after each use.
Precautions to be taken before handling or administering the medicinal product Before using Instanyl for the first time, the nasal spray must be primed until a fine mist appears; 3 to […]
Description of selected adverse reactions Tolerance Tolerance can develop on repeated use. 10 Drug dependence Repeated use of Instanyl 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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Increased intracranial pressure Fentanyl should be used with caution in patients with evidence of increased intracranial pressure, impaired consciousness or coma. Instanyl should be used with caution in patients with cerebral tumour or head injury.
6 Cardiac disease Fentanyl use may be associated with bradycardia. Fentanyl should therefore be used with caution in patients with previous or pre-existing bradyarrhythmias. Opioids may cause hypotension, especially in patients with hypovolaemia.
Instanyl should therefore be used with caution in patients with hypotension and/or hypovolaemia. Serotonin syndrome Caution is advised when Instanyl is coadministered with medicinal products that affect the serotoninergic 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 Re-uptake Inhibitors (SSRIs) and Serotonin Norepinephrine Re-uptake Inhibitors (SNRIs), and with medicinal products which impair metabolism of serotonin (including Monoamine Oxidase Inhibitors [MAOIs]).
This may occur within the recommended dose. , nausea, vomiting, diarrhoea). If serotonin syndrome is suspected, treatment with Instanyl should be discontinued. Hyperalgesia As with other opioids, in case of insufficient pain control in response to an increased dose of fentanyl, the possibility of opioid-induced hyperalgesia should be considered.
A fentanyl dose reduction or discontinuation of fentanyl treatment or treatment review may be indicated. Nasal conditions If the patient experiences recurrent episodes of epistaxis or nasal discomfort while taking Instanyl, an alternative administration form for treatment of breakthrough pain should be considered.
Common cold The overall extent of fentanyl exposure in subjects with common cold without prior treatment with nasal vasoconstrictor is comparable to that in healthy subjects. For concomitant use of nasal vasoconstrictor see section