Cymbalta欣百達

Cymbalta

duloxetine

Manufacturer:

Eli Lilly

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Duloxetine HCl
Indications/Uses
Major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathy, fibromyalgia, chronic musculoskeletal pain.
Dosage/Direction for Use
Major depressive disorder 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 60 mg once daily. Fibromyalgia & chronic musculoskeletal pain Initially 30 mg once daily for 1 wk, increasing to target & max dose of 60 mg once daily thereafter.
Administration
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.
Contraindications
Concomitant use w/ MAOIs (eg, 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; orthostatic hypotension, falls & syncope; serotonin syndrome (particularly w/ other serotonergic drugs); severe skin reactions (eg, erythema multiforme & Stevens-Johnson Syndrome); 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. Patients w/ history of seizure disorder. Gradual reduction in dose when discontinuing treatment is recommended. Measure BP prior to, & periodically throughout therapy. Patients w/ conditions that may slow gastric emptying (eg, DM); recent history of MI or unstable coronary artery disease. Glycemic control may worsen in some DM patients. 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). Pregnancy & lactation. Elderly. Childn & adolescents.
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 (eg, 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.
Presentation/Packing
Form
Cymbalta cap 30 mg
Packing/Price
28's
Form
Cymbalta cap 60 mg
Packing/Price
28's
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