Generic Name and Formulations:
Fentanyl 40mcg; per activation on-demand; iontophoretic transdermal system (provides up to 80 doses).
The Medicines Company
Indications for IONSYS:
Short-term management of acute post-operative pain severe enough to require an opioid analgesic in the hospital and for which alternative treatments are inadequate.
Limitations Of use:
Only for use in patients who are alert enough and have adequate cognitive ability to understand directions for use. Not for home use; discontinue treatment before patients leave hospital. Use after patients have been titrated to an acceptable level of analgesia using alternate opioids.
For hospital use only. Use one system at a time for up to 24hrs or 80 doses, whichever comes first. Only patients should activate dosing. Cleanse application site with alcohol. Apply one to intact, non-irritated, non-irradiated skin on chest or upper arm only; hold in place for 15 secs. Max 6 doses/hr. May use for max 3 days of therapy, with each subsequent system applied to a different skin site. Conversion to other analgesics: titrate dose and monitor. Provide supplement analgesics or replace with alternatives if inadequate response. Concomitant use or discontinuation of CYP3A4 inhibitors or inducers: monitor closely and consider dose adjustments (see full labeling).
<18yrs: not established.
Significant respiratory depression. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment. Known or suspected GI obstruction, including paralytic ileus. Allergy to cetylpyridinium chloride.
Life-threatening respiratory depression. Ionsys REMS program. Addiction, abuse, and misuse. Cytochrome P450 3A4 interaction. Risks from concomitant use with benzodiazepines or other CNS depressants.
Life-threatening respiratory depression; monitor within first 24–72hrs of initiating therapy and following dose increases. Accidental exposure may cause fatal overdose (esp. in children). COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression; monitor and consider non-opioid analgesics. Abuse potential (monitor). Discontinue if severe skin reactions occur. Remove and dispose system prior to MRI, cardioversion, defribrillation, X-ray, CT, or diathermy. Avoid contact with synthetic materials (eg, carpet), electronic security systems, radio frequency ID transmitters. Adrenal insufficiency. Head injury. Increased intracranial pressure, brain tumors; monitor. Seizure disorders. CNS depression. Impaired consciousness, coma, shock; avoid. Biliary tract disease. Acute pancreatitis. Bradyarrhythmias. Drug abusers. Renal or hepatic impairment. Reevaluate periodically. Avoid abrupt cessation. Elderly. Cachectic. Debilitated. Pregnancy; potential neonatal opioid withdrawal syndrome during prolonged use. Labor & delivery: not recommended. Nursing mothers: monitor infants.
Increased risk of hypotension, respiratory depression, sedation with benzodiazepines or other CNS depressants (eg, non-benzodiazepine sedatives/hypnotics, anxiolytics, general anesthetics, phenothiazines, tranquilizers, muscle relaxants, antipsychotics, alcohol, other opioids); reserve concomitant use in those for whom alternative options are inadequate; limit dosages/durations to minimum required; monitor. During or within 14 days of MAOIs: not recommended. Risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, 5-HT3 antagonists, mirtazapine, trazodone, tramadol, MAOIs, linezolid, IV methylene blue); monitor and discontinue if suspected. Avoid concomitant mixed agonist/antagonist opioids (eg, butorphanol, nalbuphine, pentazocine) or partial agonist (eg, buprenorphine); may reduce effects and precipitate withdrawal symptoms. Potentiated by CYP3A4 inhibitors (eg, macrolides, azole antifungals, protease inhibitors, grapefruit juice). Antagonized by CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin). May antagonize diuretics; monitor. Paralytic ileus may occur with anticholinergics.
Headache, hypotension (may be severe), nausea, vomiting, anemia, dizziness, application site reaction, erythema, pruritus, urinary retention; respiratory depression, syncope.
Transdermal systems—6 (w. Controller, Drug Unit)
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