Depression, Anxiety Diabetic Peripheral Neuropathic Pain, Osteoarthritis pain, Fibromyalgia.
Serotonin-Noreprnephrine Inhibitor; Antidepressant
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.
30-60 mg/day (given either once a day or as 30 mg BID) without regard to meals.
Both CYP1A2 and CYP2D6 isozymes are responsible for Duloxetine metabolism. When Duloxetine was co-administered with fluvoxamine, a potent CYP1A2 inhibitor, the AUC, Cmax and t of Duloxetine was increased. Other drugs that inhibit CYP1A2 metabolism include cimetidine and quinolone antimicrobials such as ciprofloxacin and enoxacin would be expected to have similar effects and these combinations should be avoided. Because CYP2D6 is involved in Duloxetine metabolism, concomitant use of Duloxetine with potent inhibitors of CYP2D6 may result in higher concentrations of Duloxetine.
Known hypersensitivity to Duloxetine. Concomitant use in patients taking Monoamine Oxidase Inhibitors (MAOIs) is contraindicated. Duloxetine use should be avoided in patients nwith uncontrolled narrow-angle glaucoma.
In Duloxetine-treated MDD patients: nausea; dry mouth; constipation; decreased appetite; fatigue; somnolence; & increased sweating. In Duloxetine-treated DPN patients: nausea; somnolence; dizziness; constipation; dry mouth; decreased appetite; & asthenia.
The drug should be used during pregnancy only when the potential benefits justify the possible risk to the fetus. Women receiving the drug should not breastfeed their infants.
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 the absorption of Duloxetine from the gastrointestinal tract.
Do not store above 30°C. Keep away from light and out of the reach of children.
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