Eli Lilly


Concise Prescribing Info
Duloxetine HCl
Major depressive disorder, diabetic neuropathic pain, generalized anxiety disorder, fibromyalgia w/ or w/o depression; chronic pain states associated w/ diabetic peripheral neuropathic pain, fibromyalgia, chronic lower back pain, OA.
Dosage/Direction for Use
60 mg once daily. Max: 120 mg/day in evenly divided doses.
May be taken with or without food.
Hypersensitivity. Concomitant use w/ non-selective irreversible MAOIs; fluvoxamine, ciprofloxacin or enoxacine (ie, potent CYP1A2 inhibitors). Liver disease resulting in hepatic impairment. Severe renal impairment (CrCl <30 mL/min).
Special Precautions
History of mania or diagnosis of bipolar disorder &/or seizures. Raised IOP or those at risk of acute narrow-angle glaucoma. Fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency. Monitor BP in patients w/ known HTN &/or other cardiac disease. Substantial alcohol use or pre-existing liver disease. Concomitant use w/ antidepressants particularly selective reversible MAOIs; herbal prep containing St. John's wort; anticoagulants &/or medicinal products known to affect platelet function (eg, NSAIDs, aspirin). Suicidal ideations/behaviors. Patients w/ known bleeding tendencies. Hyponatremia. Avoid abrupt discontinuation. Severe renal impairment on hemodialysis (CrCl <30 mL/min). May affect ability to drive & use machines. Pregnancy. Not recommended during lactation. Adolescents <18 yr. Childn. Elderly.
Adverse Reactions
Constipation, dry mouth, nausea; fatigue; headache. Palpitations; blurred vision; diarrhea, vomiting, dyspepsia, abdominal pain, flatulence; decreased wt, increased BP; decreased appetite; musculoskeletal pain, muscle spasm; dizziness, lethargy, somnolence, tremor, dysgeusia, paraesthesia; insomnia, abnormal orgasm, decreased libido, anxiety, sleep disorder, agitation, abnormal dreams; oropharyngeal pain, yawning; hyperhidrosis, pruritus; flushing.
Drug Interactions
Risk of serotonin syndrome w/ non-selective irreversible MAOIs (concomitant or w/in at least 14 days of discontinuation); selective reversible MAOIs (eg, moclobemide); SSRIs (eg, paroxetine, fluoxetine), tricyclics (eg, clomipramine or amitriptyline), St. John's wort, venlafaxine or triptans, tramadol, pethidine & tryptophan. Higher conc w/ potent CYP1A2 (eg, fluvoxamine) & CYP2D6 inhibitor. Lower plasma conc w/ smokers. Increased AUC of desipramine & steady state AUC of tolterodine. Medications that are predominantly metabolized by CYP2D6 & w/ narrow therapeutic index. Decreased apparent plasma clearance w/ paroxetine, CYP2D6 inhibitors (eg, SSRIs). Other centrally acting medicinal products & substances including alcohol & sedative medicinal products (eg, benzodiazepines, morphinomimetics, antipsychotics, phenobarb, sedative antihistamines). Serotonin syndrome w/ other drugs w/ serotonergic activity (eg, SNRIs, SSRIs, triptans or tramadol). Increased in free conc w/ highly protein bound drugs.
MIMS Class
Antidepressants / Drugs for Neuropathic Pain
ATC Classification
N06AX21 - duloxetine ; Belongs to the class of other antidepressants.
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