APO MI45 Pill — WHITE OVAL, 13mm — Mirtazapine

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ImprintAPO / MI45
ColourWHITE
ShapeOVAL
Size13
StrengthMIRTAZAPINE 45 mg
Dosage formTablet, Film Coated
ManufacturerPreferred Pharmaceuticals, Inc.
NDC68788-7172
Schedule—
Availability—
IngredientsMIRTAZAPINE[MIRTAZAPINE]

What does this imprint mean?

The imprint "APO MI45" is a code stamped or printed on the tablet or capsule by the manufacturer, used to identify the drug, its strength and the maker.

Active ingredient

Mirtazapine

Uses and warnings

BOXED WARNING: "Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults," and prescribers are instructed to "balance this risk with the clinical need," with close monitoring advised, especially early in treatment and after dose changes. Concomitant use with a monoamine oxidase inhibitor "is contraindicated," as is starting mirtazapine within 14 days of stopping an MAOI. Other major warnings include agranulocytosis/severe neutropenia, serotonin syndrome risk with other serotonergic or dopaminergic drugs, activation of mania/hypomania, seizures, and hyponatremia.

"REMERON (mirtazapine) Tablets are indicated for the treatment of major depressive disorder," with efficacy established in placebo-controlled trials of outpatients meeting DSM criteria for a major depressive episode.

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Official references

Source: FDA Structured Product Label via NLM Pillbox archive (retired 2021); source file 4d19c77e-77d5-472d-8b77-27cbbf37daf0.xml