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| Drug class description : | Opiates (opioids). |
| Generic Name : | Fentanyl |
| Drug description : | Lozenges with integral oromucosal applicator. The oral transmucosal delivery system is formulated as a white to off-white compressed powder drug matrix attached using edible glue to a fracture resistant radio opaque plastic handle marked with the dosage strength. The lozenge itself is printed with the name Actiq and the dosage strength. |
| Presentation : | Lozenges, fentanyl (as citrate) 200 micrograms , 400 micrograms , 600 micrograms , 800 micrograms , 1200 micrograms , 1600 micrograms . |
| Indications : | For the management of breakthrough pain in patients already receiving maintenance opioid therapy for chronic pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. |
| Adult Dosage : | Before patients are titrated to a "successful" dose that provides adequate analgesia and minimises adequate analgesia and minimises side effects, their background pain will be controlled by use of opioid therapy and typically, they will be experiencing no more than four episodes of breakthrough pain per day. Initially, 200 micrograms, titrating upwards as necessary through the range of available dosage strengths. During titration, if adequate analgesia is not obtained within 15 minutes after the patient completes consumption of a single Actiq unit, a second Actiq unit of the same strength may be consumed. No more than two Actiq units should be used to treat any individual pain episode. If treatment of several 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. Once a successful dose has been established, maintain patient on this dose and limit consumption to a maximum of four units per day. Refer to Summary of Product Characteristics. Actiq should be placed in the mouth against the cheek and should be moved around the mouth using the handle, with the aim of maximising the amount of mucosal exposure to the product. The Actiq unit should be sucked, not chewed. Water may be used to moisten the buccal mucosa in patients with a dry mouth. The Actiq unit should be consumed over a 15-minute period. If signs of excessive opioid effects appear before the Actiq unit is fully consumed it should be immediately removed, and consideration given to decreasing future dosages. |
| Child Dosage : | Not recommended. |
| Contra Indications : | Known intolerance or hypersensitivity to fentanyl or any of the excipients contained in the formulation. Lactation. |
| Special Precautions : | Tolerance and physical and/or psychological dependence may administration. Chronic obstructive pulmonary disease or other pre-existing medical conditions predisposing patients to respiratory depression. Actiq should not be given to opioid naive patients. Use with extreme caution in patients with increased intracranial pressure or impaired consciousness. Head injury. Bradyarrhythmias. Renal or hepatic dysfunction. Not recommended for use within 14 days of receiving MAOIs. Pregnancy. |
| Interactions : | Other CNS depressants, including other opioids, sedatives or hypnotics, general anaesthetics, phenothiazines, tranquillisers, skeletal muscle relaxants, sedating antihistamines and alcohol. Potent inhibitors of cytochrome P450 3A4 (eg, erythromycin, ketoconazole, certain protease inhibitors). Grapefruit juice. MAOIs. Opioid antagonists such as naloxone or drugs with mixed opioid agonist/ antagonist activity (eg, pentazocine, buprenorphine, nalbuphine). |
| Adverse Reactions : | Respiratory depression, circulatory depression, hypotension and shock. Sedation. Also, nausea, somnolence, dizziness, asthenia, constipation, confusion, headache, abdominal pain, dyspepsia, mouth ulceration, dry mouth, vasodilation, hallucinations, vertigo, dyspnoea, pruritus, sweating. |
| Manufacturer : | Elan |
| Drug Availability : | (CD) |
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