Active Ingredient: Sufentanil
Sufentanil is indicated for the management of acute moderate to severe pain in adult patients.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Sublingual, 30 micrograms sufentanil, 1 to 24 doses in total, over the duration of at least 1 hour.
Sufentanil is to be administered by a healthcare professional in a medically monitored setting only. A medically monitored setting must have equipment and personnel trained to detect and manage hypoventilation, and availability of supplemental oxygen and opioid antagonists, such as naloxone. Sufentanil should only be prescribed and administered by healthcare professionals who are experienced in the management of opioid therapy; particularly opioid adverse reactions, such as respiratory depression.
Sufentanil is provided in a disposable single-dose applicator, to be administered by a healthcare provider as needed by the individual patient, but no more than once every hour, resulting in a maximum dose of 720 micrograms/day. Patients with a higher pain intensity at one hour after sufentanil treatment was initiated required more frequent redosing compared to patients with lower pain intensity scores at one hour.
Sufentanil should not be used beyond 48 hours.
No specific dose adjustment is required in elderly patients. However, elderly patients should be observed closely for adverse reactions of sufentanil.
The dispensed sublingual tablet should dissolve under the tongue and should not be chewed or swallowed. If swallowed, the oral bioavailability of sufentanil is only 9% which would result in a sub-therapeutic dose. Patients should not eat or drink and should minimise talking for 10 minutes after each dose of sufentanil. In the case of an excessive dry mouth, patients may be given ice cubes.
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