DULOXETIN HYDROCHLORIDE

Electrolyte / Mineral

Brand names: Duloxetine hydrochloride

Pregnancy: Category COral

Mechanism of Action

12.1 Mechanism of Action Although the exact mechanisms of the antidepressant, central pain inhibitory and anxiolytic actions of duloxetine in humans are unknown, these actions are believed to be related to its potentiation of serotonergic and noradrenergic activity in the CNS.

Indications

1. INDICATIONS AND USAGE Duloxetine delayed-release capsules

USP are indicated for the treatment of major depressive disorder (MDD). The efficacy of duloxetine delayed-release capsules

and includes at least 5 of the following 9 symptoms: depressed mood

loss of interest in usual activities

significant change in weight and/or appetite

insomnia or hypersomnia

FDA Warnings

WARNINGS AND PRECAUTIONS • Suicidality: Monitor for clinical worsening and suicide risk (5
1) • Hepatotoxicity: Hepatic failure, sometimes fatal, has been reported in patients treated with duloxetine delayed-release capsules
If concomitant use of duloxetine delayed-release capsules with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases (5
4) • Abnormal Bleeding: Duloxetine delayed-release capsules may increase the risk of bleeding events

Known Side Effects

0 documented side effects by frequency

No structured side effect data available.

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Compare With

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Formulations

Dosage Forms

Tablet

Route

Oral