Eli Lilly


Agencia Lei Va Hong
Concise Prescribing Info
Duloxetine HCl
Major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathic pain, fibromyalgia, chronic musculoskeletal pain.
Dosage/Direction for Use
Major depressive disorder Adult 40-60 mg daily. Generalized anxiety disorder Adult 60 mg once daily. Elderly Initially 30 mg once daily for 2 wk, may be increased to target dose of 60 mg thereafter. Max dose: 120 mg/day. Diabetic peripheral neuropathic pain Adult 60 mg once daily. Fibromyalgia & chronic musculoskeletal pain Adult Initially 30 mg once daily for 1 wk, increasing to target & max dose of 60 mg once daily thereafter.
May be taken with or without food: Swallow whole, do not chew/crush. Do not open the cap or sprinkle its contents on food or mix w/ liqd.
Concomitant use w/ MAOIs (including linezolid or IV methylene blue). Use of MAOI w/in 5 days of stopping treatment w/ Cymbalta. Use of Cymbalta w/in 14 days of stopping MAOI.
Special Precautions
Appropriately monitor & closely observe patients for clinical worsening, suicidality, & unusual changes in behavior, especially during the initial course of therapy, or at times of dose changes. Not approved for use in treating bipolar depression. Patients w/ depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder. Risk of hepatic failure or aggravating pre-existing liver disease; orthostatic hypotension, falls & syncope; serotonin syndrome (particularly w/ other serotonergic drugs); severe skin reactions (eg, erythema multiforme & SJS); hyponatremia; urinary hesitation & retention. Increased risk of bleeding events. Risk of activation of mania or hypomania in patients w/ major depressive disorder. Risk of angle closure attack in patients w/ anatomically narrow angles who do not have a patent iridectomy. Caution in patients w/ history of seizure disorder; conditions that may slow gastric emptying (eg, DM); recent history of MI or unstable coronary artery disease. Gradual reduction in dose when discontinuing treatment is recommended. Measure BP prior to, & periodically throughout therapy. Glycemic control may worsen in some DM patients. Carefully evaluate patients for history of drug abuse & closely observe such patients for signs of misuse or abuse of Cymbalta. Concomitant use w/ other serotonergic drugs & drugs that impair metabolism of serotonin; potent CYP1A2 or CYP2D6 inhibitors; CYP2D6 substrates w/ narrow therapeutic index; alcohol; CNS-acting drugs. Avoid use in patients w/ chronic liver disease or cirrhosis, & in patients w/ severe renal impairment (GFR <30 mL/min). May cause symptoms of sexual dysfunction (ejaculatory delay or failure, decreased libido, erectile dysfunction in males; decreased libido & delayed or absent orgasm in females). Pregnancy & lactation. Elderly. Safety & effectiveness have not been established in ped patients for the treatment of major depressive disorder.
Adverse Reactions
Nausea, dry mouth, somnolence, constipation, decreased appetite, hyperhidrosis, agitation, insomnia, dizziness, fatigue.
Drug Interactions
Increased AUC, Cmax & t½ w/ CYP1A2 inhibitors (eg, fluvoxamine, cimetidine, quinolone antimicrobials eg, ciprofloxacin & enoxacin). Increased AUC w/ paroxetine & other potent CYP2D6 inhibitors (eg, fluoxetine, quinidine). Potentiated risk of GI bleeding w/ NSAIDs or aspirin. Altered anticoagulant effects of warfarin. Premature drug release w/ GI pH-increasing drugs. Increased AUC of theophylline (CYP1A2 substrate) & desipramine (CYP2D6 substrate). Increased risk of serotonin syndrome w/ MAOIs (including linezolid or IV methylene blue) & serotonergic drugs. Increased risk of liver injury w/ alcohol. Additive CNS effects w/ other CNS-acting drugs. Increased free conc of co-administered drugs highly bound to plasma protein.
MIMS Class
Antidepressants / Drugs for Neuropathic Pain / Other Drugs Acting on Musculo-Skeletal System
ATC Classification
N06AX21 - duloxetine ; Belongs to the class of other antidepressants.
Cymbalta cap 30 mg
Cymbalta cap 60 mg
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