Duloxetine


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Depression Initial: 20-30 mg bid or 60 mg once daily, then increase dose in increments of 30 mg/day over 1 wk. Max: 120 mg/day. Anxiety 30 or 60 mg once daily. Max: 120 mg/day. Diabetic neuropathy 60 mg once daily. Max: 120 mg/day in divided doses. Fibromyalgia Initial: 30 mg once daily for 1 wk, then increase to 60 mg once daily.
Dosage Details
Oral
Anxiety
Adult: 30 or 60 mg once daily. Max: 120 mg/day.

Oral
Diabetic neuropathy
Adult: 60 mg once daily. Max: 120 mg/day in divided doses.

Oral
Depression
Adult: Initially, 20-30 mg bid or 60 mg once daily, then increase dose in increments of 30 mg/day over 1 wk as tolerated. Max: 120 mg/day.

Oral
Fibromyalgia
Adult: Initially, 30 mg once daily for 1 wk, then increase to 60 mg once daily.
Renal Impairment
Mild to moderate: Consider lower starting dose and titrate dose gradually. Severe: Avoid use.
Hepatic Impairment
Avoid use.
Administration
May be taken with or without food. Swallow whole, do not chew/crush.
Contraindications
Hepatic impairment, severe renal impairment, uncontrolled HTN or narrow-angle glaucoma. Concomitant use w/ MAOIs or w/in 14 days of discontinuing the MAOI. Use w/ linezolid or IV methylene blue. Concomitant use w/ potent CYP1A2 inhibitors (e.g. ciprofloxacin, enoxacin).
Special Precautions
Patient w/ HTN, gastroparesis, mania or hypomania, increased intraocular pressure or at risk of acute narrow-angle glaucoma, seizure, bleeding disorders, mild to moderate renal impairment. Smokers. Gradual dose reduction is recommended rather than abrupt withdrawal. Pregnancy and lactation.
Adverse Reactions
Changes in behaviour, suicidal ideation, HTN, headache, somnolence, fatigue, dizziness, insomnia, agitation, tremor, anxiety, insomnia, lethargy, abnormal dreams, nausea, xerostomia, palpitation, hyperhydrosis, decreased libido, hot flushes, sexual dysfunction, vomiting, constipation, diarrhoea, dyspepsia, abdominal pain, wt gain, decreased appetite, erectile dysfunction, increased hepatic enzymes, muscle spasms, paraesthesia, tinnitus, blurred vision, mydriasis, nasopharyngitis, hyponatraemia, may impair platelet aggregation. Stevens-Johnson syndrome and erythema multiforme.
Potentially Fatal: Hepatic failure w/ or w/o jaundice.
Patient Counseling Information
May impair ability to drive or operate machinery.
MonitoringParameters
Monitor BP and mental status for depression. Closely observe for clinical worsening, suicidality and unusual changes in behaviour.
Overdosage
Symptoms: Somnolence, coma, serotonin syndrome, seizures, vomiting and tachycardia. Management: Ensure adequate airway, oxygenation and ventilation. Initiate gastric lavage immediately after ingestion. Admin activated charcoal to reduce absorption. Monitor cardiac rhythm and vital signs.
Drug Interactions
Increased risk of serotonin syndrome w/ TCA, SSRI, SNRI, lithium. May increase bleeding risk w/ aspirin, NSAIDs, warfarin and other anticoagulants.
Potentially Fatal: Increased risk of serotonin syndrome w/ MAOIs, linezolid and methylene blue. Increased serum levels and risk of toxicity w/ potent CYP1A2 inhibitors (e.g. ciprofloxacin, enoxacin).
Food Interaction
Increased risk of serotonin syndrome w/ St John’s wort. Increased risk of hepatic injury w/ alcohol.
Action
Description: 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. It also does not inhibit monoamine oxidase.
Pharmacokinetics:
Absorption: Well absorbed from GI tract. Bioavailability: Between 32-80%. Time to peak plasma concentration: Approx 6 hr.
Distribution: - Distributed into breast milk. Plasma protein binding: Approx 96% mainly to albumin and α1-acid glycoprotein.
Metabolism: Extensively metabolised by CYP1A2 and CYP2D6 isoenzymes.
Excretion: Via urine and faeces (approx 20%). Elimination half-life: 8-17 hr.
Storage
Store below 30°C.
References
Anon. Duloxetine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 24/07/2014.

Buckingham R (ed). Duloxetine Hydrochloride. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 24/07/2014.

Duloxetine Capsule, Delayed Release (Remedyrepack Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 24/07/2014.

McEvoy GK, Snow EK, Miller J et al (eds). Duloxetine Hydrochloride. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 24/07/2014.

Disclaimer: This information is independently developed by MIMS based on Duloxetine from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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