Indications

Duloxetine is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for- Major Depressive Disorder (MDD) Generalized Anxiety Disorder (GAD) Diabetic Peripheral Neuropathic Pain (DPNP) Fibromyalgia and Chronic Musculoskeletal Pain.

Composition

Pharmacology

Duloxetine Hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Duloxetine is a less potent inhibitor of dopamine reuptake. Duloxetine has no significant affinity for dopaminergic, adrenergic, cholinergic, histaminergic, opioid, glutamate, and GABA receptors in vitro. Duloxetine does not inhibit monoamine oxidase (MAO). Orally administered Duloxetine hydrochloride is well absorbed. Elimination of Duloxetine is mainly through hepatic metabolism.

Dosage & Administration

Major Depressive Disorder (MDD)- Starting Dose : 40 mg/day to 60 mg/day Target Dose : Acute: 40 mg/day (20 mg twice daily) to 60 mg/day (once daily or as 30 mg twice daily); Maintenance: 60 mg/day Maximum Dose : 120 mg/day Generalized Anxiety Disorder (GAD)- Starting Dose : 60 mg/day Target Dose : 60 mg/day (once daily) Maximum Dose : 120 mg/day Diabetic Peripheral Neuropathic Pain (DPNP)- Starting Dose : 60 mg/day Target Dose : 60 mg/day (once daily) Maximum Dose : 60 mg/day Fibromyalgia- Starting Dose : 30 mg/day Target Dose : 60 mg/day (once daily) Maximum Dose : 60 mg/day Chronic Musculoskeletal Pain- Starting Dose : 30 mg/day Target Dose : 60 mg/day (once daily) Maximum Dose : 60 mg/day Some patients may benefit from starting at 30 mg once daily. There is no evidence that doses greater than 60 mg/day confers an additional benefit, while some adverse reactions were observed to be dose-dependent. A gradual dose reduction is recommended to avoid discontinuation symptoms.

Contraindications

Duloxetine is contraindicated in patients with a known hypersensitivity to this drug or any of the inactive ingredients. Duloxetine is not approved for use in treating bipolar depression. Duloxetine should not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease. In clinical trials, Duloxetine was associated with an increased risk of mydriasis; therefore, it should be used cautiously in patients with controlled narrow-angle glaucoma.

Side Effects

The most commonly observed adverse events in Duloxetine hydrochloride treated patients were nausea, dizziness, dry mouth, constipation, decreased appetite, fatigue, somnolence, increased sweating, hyperhidrosis and asthenia. It may slightly increase blood pressure. No clinically significant differences were observed for QT, PR, and QRS intervals between Duloxetine-treated and placebo-treated patients.

Pregnancy & Lactation

Pregnancy : Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women; therefore, Duloxetine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Labor and Delivery : The effect of Duloxetine on labor and delivery in humans is unknown. Duloxetine should be used during labor and delivery only if the potential benefit justifies the potential risk to the fetus. Lactation : It is unknown whether or not Duloxetine and/or it's metabolites are excreted into human milk, but nursing while on Duloxetine is not recommended

Precautions & Warnings

All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes. Blood pressure should be measured prior to initiating treatment and periodically measured throughout treatment. Patients should be cautioned about the risk of bleeding associated with the concomitant use of Duloxetine and NSAIDs, aspirin, or other drugs that affect coagulation. Duloxetine should be used cautiously in patients with a history of mania. Duloxetine should be prescribed with care in patients with a history of a seizure disorder.

Therapeutic Class

Serotonin-norepinephrine reuptake inhibitor (SNRI)

Storage Conditions

Do not store above 30°C. Keep away from light and out of the reach of children.