Duloxetine

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, Chronic Musculoskeletal Pain, and Stress Urinary Incontinence. It increases serotonin and noradrenaline levels in the brain. Common side effects include nausea, headache, dry mouth, somnolence, and dizziness. Contraindicated in uncontrolled narrow-angle glaucoma, with MAOIs, and in severe renal/hepatic impairment.

• Major Depressive Disorder (MDD)
• Generalized Anxiety Disorder (GAD)
• Diabetic Peripheral Neuropathic Pain (DPNP)
• Fibromyalgia
• Chronic Musculoskeletal Pain
• Stress Urinary Incontinence

Duloxetine Hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). It is a less potent inhibitor of dopamine reuptake. Duloxetine has no significant affinity for dopaminergic, adrenergic, cholinergic, histaminergic, opioid, glutamate, and GABA receptors. It does not inhibit monoamine oxidase (MAO).

Duloxetine is a potent inhibitor of neuronal reuptake of serotonin, norepinephrine and to a lesser extent dopamine. It has no significant affinity for adrenergic, muscarinic, cholinergic, histaminergic, opioid, glutamate and GABA receptors.

Adult Dose (Oral):

• MDD: Initial: 20-30 mg BID or 60 mg once daily; Max: 120 mg/day.
• DPNP: 60 mg once daily; Max: 120 mg/day in divided doses.
• GAD: 30 or 60 mg once daily; Max: 120 mg/day.
• Fibromyalgia: Initial: 30 mg once daily for 1 week, then 60 mg once daily.
• Chronic Musculoskeletal Pain: Initial: 30 mg once daily, Target: 60 mg once daily.

Elderly Dose: MDD: initiate at 20 mg daily or divided; GAD: 30 mg daily initially, increase to 60 mg after 2 weeks.

Oral capsule/tablet. Take in the dose and duration as advised by your doctor. Swallow whole. Do not chew, crush or break. May be taken with or without food, but better to take at a fixed time.

If you miss a dose of Duloxetine, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not double the dose.

Common Side Effects:

• Nausea
• Headache
• Dry mouth
• Somnolence
• Dizziness
• Constipation
• Decreased appetite
• Fatigue
• Increased sweating
• Asthenia

• Duloxetine helps treat depression, anxiety and nerve pain.
• May take 2-4 weeks to start working.
• May cause dizziness and sleepiness; do not drive or do anything requiring concentration.
• Avoid alcohol consumption (may cause excessive drowsiness and liver damage).
• May increase blood pressure, especially during first month. Monitor blood pressure regularly.
• Inform doctor if sudden mood changes or suicidal thoughts occur.
• Do not stop medication suddenly.

• Hypersensitivity to Duloxetine or any inactive ingredients
• Uncontrolled narrow-angle glaucoma
• Concomitant use or within 2 weeks of MAOIs
• Renal and hepatic impairment
• Severe liver disease or cirrhosis
• Severe renal impairment (GFR <30 mL/min)

Increased risk of serotonin syndrome with TCA, SSRI, SNRI, lithium. May increase bleeding risk with aspirin, NSAIDs, warfarin and other anticoagulants. Potentially fatal with MAOIs, linezolid and methylene blue. Increased serum levels with potent CYP1A2 inhibitors (e.g., ciprofloxacin, enoxacin).

It is unsafe to consume alcohol with Duloxetine.

Duloxetine may be unsafe during pregnancy. Animal studies have shown harmful effects. Doctor will weigh benefits and risks.

Duloxetine is probably unsafe during breastfeeding. Limited human data suggests drug may pass into breastmilk and harm the baby.

Safety and efficacy in pediatric patients have not been established.

Lower initial dose and adjust gradually in elderly patients.

Renal impairment: Avoid use in severe renal impairment (GFR <30 mL/min). No dose adjustment needed in mild and moderate disease.

Hepatic impairment: Avoid use in liver disease. Do not use in severe liver disease or cirrhosis.

Overdose may cause nausea, vomiting, dizziness, somnolence, serotonin syndrome. No specific antidote. Gastric lavage and activated charcoal may be helpful.

Store below 30°C, away from light. Keep out of reach of children.

Duloxetine