Instanyl

Company: Nycomed Products Ltd.
Legal category: Controlled Drug. GMS. Sport Prohibited.
Active ingredient: Fentanyl (as citrate) 50μg, 100μg, 200μg/dose nasal spray.
Description: Nasal spray, solution.
Presentation: For all strengths: 10, €91.70; 20, €183.40.
Indications: Management of breakthrough pain in adult patients using opioid therapy for chronic cancer pain (i.e. those taking at least 60mg of oral morphine daily, at least 25μg of transdermal fentanyl per hour, at least 30mg oxycodone daily, at least 8mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer). Breakthrough pain is a transient exacerbation of otherwise controlled chronic background pain.

Pharmacology: Fentanyl is a potent μ-opioid analgesic (approximately 100-fold more potent than morphine) with rapid onset of analgesia and short duration of action.
Dosage: Adult: Initially, 50μg in one nostril. If adequate analgesia not obtained administer same strength at the earliest after 10 minutes. If adequate analgesia still not obtained, consider next higher strength for the next episode (each dose strength should be evaluated in several episodes). Maximum daily dose: Treatment of up to four breakthrough pain episodes, each with no more than two doses separated by at least 10 minutes. Once adequate dose established, maintain patient at this dose. Patient should wait at least 4 hours before treating another breakthrough pain episode with Instanyl during both titration and maintenance therapy. Elderly: Approach dose titration with particular care. Children: Under 18 years, not recommended.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. Use in opioid-naïve patients. Severe respiratory depression or severe obstructive lung conditions. Previous facial radiotherapy. Recurrent episodes of epistaxis. Lactation, pregnancy (unless clearly necessary).
Special precautions: Respiratory depression, circulatory depression, hypotension and shock may occur (monitor closely for these). Caution: Elderly, cachectic, or debilitated patients, moderate to severe renal/hepatic impairment, chronic obstructive pulmonary diseases, increased intracranial pressure, impaired consciousness or coma, cerebral tumour, head injury, bradyarrhythmias, hypotonia, hypovolaemia. Driving/using machines.
Drug interactions: Not recommended: MAOIs (within 14 days), nasal decongestants, partial opioid agonists/antagonists (e.g. buprenorphine, nalbuphine, pentazocine). Caution: Moderate and strong CYP3A4 inhibitors, CYP3A4 inducers (see Appendix I). Concomitant use of other CNS depressants, including other opioids, sedatives or hypnotics, general anaesthetics, phenothiazines, tranquillisers, skeletal muscle relaxants, sedating antihistamines and alcohol may produce additive depressant effects.
Adverse drug reactions: Dizziness, somnolence, headache, vertigo, flushing, hot flush, throat irritation, nausea, vomiting, hyperhidrosis.
Full prescribing information and references available from Nycomed Products Ltd. Telephone: (01) 6420021.