INCEPTA PHARMACEUTICALS LTD.
Duloxetine Hydrochloride is indicated for the- Treatment of Major Depressive Disorder (MDD) Management of neuropathic pain associated with diabetic peripheral neuropathy. Chronic Musculoskeletal Pain Urinary stress incontinence.
Serotonin-norepinephrine reuptake inhibitor (SNRI)
Duloxetine is a combined serotonin (5-HT) and noradrenaline (NE) reuptake inhibitor. It weakly inhibits dopamine reuptake with no significant affinity for histaminergic, dopaminergic, cholinergic and adrenergic receptors. Duloxetine dose-dependently increases extracellular levels of serotonin and noradrenaline in various brain areas of animals.
Major Depressive Disorder (MDD): Starting dose- 20-30 mg b.i.d or 60 mg once daily, Target dose- 60 mg once daily, max. dose- 60 mg once daily Diabetic peripheral neuropathy: Starting dose- 60 mg/day (once daily), Target dose- 60 mg once daily, max. dose- 60 mg once daily Chronic Musculoskeletal Pain: Starting dose- 30 mg/day, Target dose- 60 mg once daily, max. dose- 60 mg once daily Urinary stress incontinence: Starting dose- 40 mg /day, Target dose- 80 mg/day (twice daily, max. dose- 80 mg/day (twice daily).
Monoamine oxidase inhibitors (MAOIs): Due to the risk of serotonin syndrome, Duloxetine should not be used in combination with non selective, irreversible monoamine oxidase inhibitors (MAOIs), or within at least 14 days of discontinuing treatment with an MAOI. Inhibitors of CYP1A2: Because CYP1A2 is involved in Duloxetine metabolism, concomitant use with potent inhibitors of CYP1A2 is likely to result in higher concentrations of Duloxetine. Therefore, Duloxetine should not be administered in combination with potent inhibitors of CYP1A2 like fluvoxamine. CNS medicinal products: Caution is advised when Duloxetine is taken in combination with other centrally acting medicinal products or substances, including alcohol and sedative medicinal products (e.g., benzodiazepines, morphinomimetics, antipsychotics, phenobarbital, sedative antihistamines).
Duloxetine is contraindicated in patients with a known hypersensitivity to this drug or any of the inactive ingredients. Concomitant use in patients taking monoamine oxidase inhibitors (MAOIs) is contraindicated. It should be avoided in patients with uncontrolled narrow-angle glaucoma.
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: 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.
There is limited clinical experience with Duloxetine overdose in humans. There is no specific antidote to Duloxetine. In case of acute overdose, treatment should consist of those general measures employed in the management of overdose with any drug. An adequate airway, oxygenation, and ventilation should be assured, and cardiac rhythm and vital signs should be monitored. Induction of emesis is not recommended. Gastric lavage with a large-bore orogastric tube with appropriate airway protection, if needed, may be indicated if performed soon after ingestion or in symptomatic patients. Activated charcoal may be useful in limiting absorption of Duloxetine from the gastrointestinal tract.
Duloxetine hydrochloride should ordinarily not be prescribed to patients with substantial alcohol use. Blood pressure should be measured prior to initiating treatment and periodically measured throughout treatment. It should be used cautiously in patients with a history of mania, seizure disorder and controlled narrow-angle glaucoma.
Store in a cool and dry place, protected from light and moisture.