Duloxetine

DEA Class;  Rx

Common Brand Names; Cymbalta, Irenka, Drizalma Sprinkle

Concomitant use of duloxetine with MAOIs intended to treat psychiatric disorders

Use of duloxetine within 14 days of MAOI discontinuation

Initiating duloxetine in patients who are being treated with linezolid or IV methylene blue

• Nausea (23-25%)
• Dry mouth (13-15%)
• Headache (13-14%)
• Somnolence (10-12%)
• Fatigue (9-11%)
• Constipation (9-10%)
• Dizziness (9-10%)
• Insomnia (9-10%)
• Diarrhea (9-10%)
• Anorexia (8%)
• Decreased appetite (7-8%)
• Abdominal pain (4-6%)
• Hyperhidrosis (6%)
• Agitation (5%)
• Nasopharyngitis (5%)
• Vomiting (3-5%)
• Male sexual dysfunction (2-5%)
• Erectile dysfunction (4%)
• Decreased libido (4%)
• Musculoskeletal pain (4%)
• Upper respiratory tract infection (URTI) (4%)
• Decreased libido (3-4%)
• Musculoskeletal pain (3-4%)
• Abnormal orgasm (2-3%)
• Agitation (3%)
• Anxiety (3%)
• Blurred vision (3%)
• Cough (3%)
• Influenza (3%)
• Muscle spasms (2-3%)
• Tremor (3%)
• Abnormal dreams (2%)
• Dyspepsia (2%)
• Hot flushes (2%)
• Oropharyngeal pain (2%)
• Palpitations (2%)
• Paresthesia (2%)
• Weight loss (2%)
• Yawning (2%)
• Blood pressure increase (2%)
• Ejaculation delayed (2%)
• Dysuria (>1%)
• Gastritis (>1%)
• Rash (>1%)

Prior to initiating treatment with, screen patients for any personal or family history of bipolar disorder, mania, or hypomania

Suicidality; monitor for clinical worsening and suicide risk, especially in children, adolescents and young adults (18-24 years) during early phases of treatment and alterations in dosage (see Black Box Warnings)

Serotonin syndrome or neuroleptic malignant syndrome-like reactions may occur; discontinue and initiate supportive therapy; closely monitor patients concomitantly receiving triptans, antipsychotics and serotonin precursors

Neonates exposed to serotonin-norepinephrine reuptake inhibitors (SNRIs) or selective serotonin reuptake inhibitors (SSRIs) late in 3rd trimester of pregnancy have developed complications necessitating prolonged hospitalization, respiratory support, and tube feeding

Increased risk of hepatotoxicity, sometimes fatal; monitor for abdominal pain, hepatomegaly, elevated AST/ALT exceeding 20x ULN, and jaundice; cholestatic jaundice with minimal elevations of hepatic transaminases have also been reported; not recommended in patients with substantial alcohol use or chronic liver disease

SSRIs and SNRIs may impair platelet aggregation and increase the risk of bleeding events, ranging from ecchymoses, hematomas, epistaxis, petechiae, and GI hemorrhage to life-threatening hemorrhage; concomitant use of aspirin, NSAIDs, warfarin, other anticoagulants, or other drugs known to affect platelet function may add to this risk

Severe skin reactions (eg, erythema multiforme and Stevens-Johnson syndrome); discontinue at first appearance of blisters, peeling rash, mucosal erosions, or any other sign of hypersensitivity if no other etiology can be identified

Orthostatic hypotension and syncope, especially during week 1 of therapy; monitor patients taking drugs that increase risk of orthostatic hypotension; consider dose reduction or discontinue therapy in patients who experience symptomatic orthostatic hypotension, falls and/or syncope

Data from a postmarketing retrospective cohort study indicate that use in the month before delivery may be associated with an increased risk of postpartum hemorrhage

Drug present in human milk in a published study, lactating women who were weaning their infants were given duloxetine