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ACTIQ 400 micrograms compressed lozenge with integral oromucosal applicator.
One lozenge contains 400 micrograms fentanyl (as citrate).
Excipient(s) with known effect:
Each lozenge contains dextrates (equivalent to approximately 2 grams of glucose), sucrose (approximately30 milligrams confectioner’s sugar) and propylene glycol (part of the artificial berry flavour and imprinting ink) as excipients.
For the full list of excipients, see section 6.1.
Compressed lozenge with integral oromucosal applicator.
ACTIQ is formulated as a white to off-white compressed powder medicinal product matrix attached using edible glue to a fracture resistant radio opaque plastic applicator. The dosage strength is marked on the lozenge and on the plastic applicator.
ACTIQ is indicated for the 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 otherwise controlled persistent pain.
Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
In order to minimise the risks of opioid-related adverse reactions and to identify the “successful” dose, it is imperative that patients be monitored closely by health professionals during the titration process. Buy Actiq online 1200mcg
ACTIQ 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 ACTIQ. The number of ACTIQ strengths available to the patient at any time should be minimised to prevent confusion and potential overdose.
Any unused ACTIQ units that the patient no longer requires must be disposed of properly. Patients must be reminded of the requirements to keep ACTIQ stored in a location away from children.
Dose titration and maintenance therapy
ACTIQ should be individually titrated to a “successful” dose that provides adequate analgesia and minimises adverse reactions. In clinical trials the successful dose of ACTIQ for breakthrough pain was not predicted from the daily maintenance dose of opioid.
Before patients are titrated with ACTIQ, 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 ACTIQ used should be 200 micrograms, titrating upwards as necessary through the range of available dosage strengths (200, 400, 600, 800, 1,200 and 1,600 micrograms). Patients should be carefully monitored until a dose is reached that provides adequate analgesia with acceptable adverse reactions using a single dosage unit per episode of breakthrough pain. This is defined as the successful dose.
During titration, if adequate analgesia is not obtained within 30 minutes after starting the first unit (i.e. 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. 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.
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