API

Duloxetine (20mg)

Drug classification

Antidepressant; serotonin-norepinephrine reuptake inhibitor (SNRI).

Dosage form

Film-coated oral tablet containing 20 mg duloxetine.

API strength per dosage

Dose

Duloxetine is typically initiated at 30–60 mg once daily for adults, depending on indication, with adjustments as needed; maximum recommended dose is usually 60 mg/day. Not recommended in severe hepatic or severe renal impairment (CrCl <30 mL/min). Safety and efficacy in pediatric patients vary by indication; consult specific guidelines. Always individualize dosing.

Mechanism of action

Duloxetine inhibits the reuptake of serotonin and norepinephrine by blocking the serotonin transporter (SERT) and norepinephrine transporter (NET) in the central nervous system, increasing synaptic concentrations of these neurotransmitters, which enhances mood and modulates pain perception.

Indications

Treatment of DepressionTreatment of Anxiety disorderTreatment of Diabetic nerve painTreatment of FibromyalgiaTreatment of Neuropathic painTreatment of Stress urinary incontinence

Side effects

Nausea Headache Dryness in mouth Sleepiness Dizziness

Pregnancy category

Duloxetine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus; consult a healthcare provider before use.

Precautions

Monitor for suicidal thoughts, serotonin syndrome, blood pressure changes, liver function, hyponatremia, worsening depression, glaucoma, orthostatic hypotension, withdrawal symptoms on discontinuation, drug interactions, especially with MAOIs and CNS depressants, caution in hepatic or severe renal impairment, avoid abrupt cessation.

Contraindications

Hypersensitivity to duloxetine, concomitant use with MAO inhibitors or uncontrolled hypertension, severe hepatic impairment, end-stage renal disease, use with thioridazine, uncontrolled narrow-angle glaucoma.