Mitigo Prescribing & Dosing Schedule

Dosage & Administration Drug label Prior authorization Patient education People also ask

Mitigo (morphine sulfate)

MITIGO 200 MG in 20 ML Injection

Dosage & Administration

* MITIGO ® should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks. ( 2.1)
* Should be administered by or under the direction of a physician experienced in the techniques of epidural or intrathecal administration. ( 2.1)
* Patients should be observed in a fully equipped and staffed environment for at least 24 hours after each test dose and, as indicated, for the first several days after surgery. ( 2.1)
* Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals. Reserve titration to higher doses of MITIGO ® for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks. ( 2.1, 5)
* Initiate the dosing regimen for each patient individually, taking into account the patient’s underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse. ( 2.1, 5.2)
* Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with MITIGO ® . Consider this risk when selecting an initial dose and when making dose adjustments. ( 2.1, 5.3)
* Initial Dosage: Must be individualized, based upon in-hospital evaluation of the response to serial singledose epidural bolus injections of regular morphine sulfate injection, USP 0.5 mg/mL or 1 mg/mL, with close observation for analgesic efficacy and adverse effects prior to surgery involving the continuous microinfusion device. ( 2.2)
* Dosage for Epidural Administration: Initial dose range of 3.5 to 7.5 mg/day for patients with no tolerance to opioids. The usual starting dose for continuous epidural infusion in patients with some degree of opioid tolerance is 4.5 to 10 mg/day and may increase significantly during treatment to 20-30 mg/day. ( 2.3)
* Dosage for Intrathecal Administration: Initial dose range of 0.2 to 1 mg/day for patients with no tolerance to opioids. The range of doses for patients with some degree of opioid tolerance varies from 1 to 10 mg/day. Doses above 20 mg/day should be employed with caution. ( 2.4)
* Do not abruptly discontinue MITIGO ® in a physically- dependent patient. ( 2.6)