Active Ingredient: Zuranolone
Zuranolone is indicated for the treatment of postpartum depression (PPD) in adults following childbirth.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 50 milligrams zuranolone, once daily to dinner, over the duration of 14 days.
The recommended dose is 50 mg zuranolone taken orally once daily for 14 days as a single course of treatment. No data on additional treatment in case of a relapse or an insufficient response to zuranolone are available.
The dose may be reduced to 40 mg taken orally once daily for 14 days if the patient does not tolerate 50 mg. If required, dosing may be stopped without down-titration.
Zuranolone may be used alone or with stable background oral antidepressant therapy.
Zuranolone should be taken in the evening. If an evening dose is missed, the patient should be instructed to take the next dose at their regular time in the evening of the next day. The patient should not take additional dose on the same day to make up for the missed dose. The patient should continue taking zuranolone once daily until the full treatment course (14 days) is completed.
The recommended dose is 30 mg taken orally once daily during the 14 day treatment period when used with strong CYP3A inhibitors.
Zuranolone should be taken orally once daily in the evening with fat-containing food as either a meal or snack (e.g. fat-containing dairy products, meats and oily fish, avocado, hummus, soy-based products, nuts, peanut butter, chocolate, or fat-containing nutritional bars or drinks).
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