Cymbalta

Duloxetine HCl

Adults w/ major depressive episodes; diabetic peripheral neuropathic pain; generalized anxiety disorder (GAD); fibromyalgia w/ depression. Chronic pain states associated w/ diabetic peripheral neuropathic pain, fibromyalgia, chronic lower back pain & OA.

Adult Major depressive episodes Initial & maintenance dose: 60 mg once daily. Diabetic peripheral neuropathic pain Initial & maintenance dose: 60 mg once daily. Evaluate response after 2 mth. GAD, fibromyalgia w/ depression, chronic pain Initial & maintenance dose: 60 mg once daily. Max: 120 mg/day. Elderly GAD Initially 30 mg once daily for 2 wk before increasing to target dose of 60 mg. Max: 120 mg/day.

May be taken with or without food: Swallow whole, do not chew/crush.

Hypersensitivity. Concomitant use w/ nonselective, irreversible MAOIs & potent CYP1A2 inhibitors (eg, fluvoxamine, ciprofloxacin or enoxacin). Liver disease resulting in hepatic impairment. Severe renal impairment (CrCl <30 mL/min).

Increase risk of elevation of serum transaminase levels. Patients w/ substantial alcohol use or preexisting liver disease; increased IOP, or those at risk of narrow-angle glaucoma; conditions that could be compromised by an increased heart rate or BP. History of mania or diagnosis of bipolar disorder &/seizures. Monitor BP in patients w/ known HTN &/or cardiac disease at initiation of treatment. Concomitant use w/ antidepressants & herbal prep containing St. John's wort. Increased risk of suicidal thoughts, self-harm & suicide; hyponatremia in elderly, cirrhotic, dehydrated patients & those treated w/ diuretics. Closely monitor patients for the emergence of suicidal ideation/behavior during therapy. Fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency. Patients taking anticoagulants or drugs known to affect platelet function & those w/ known bleeding tendencies. Gradually taper when discontinuing treatment over a period of not <2 wk. Akathisia/psychomotor restlessness. Severe renal impairment. May affect ability to drive or operate machinery. Pregnancy & lactation. Childn & adolescents <18 yr. Elderly (w/ max dose).

Nausea, dry mouth, headache. Musculoskeletal pain, muscle spasm; dizziness, lethargy, somnolence, tremor, dysgeusia, paraesthesia; insomnia, abnormal orgasm, decreased libido, anxiety, sleep disorder, agitation, abnormal dreams, urinary frequency; ejaculation disorder, erectile dysfunction, delayed ejaculation; oropharyngeal pain, yawning; hyperhidrosis, pruritus; flushing.

Concomitant use w/ other centrally acting medicinal products & substances including alcohol & sedative medicinal products (eg, benzodiazepine, morphinomimetics, antipsychotics, phenobarb, sedative, antihistamines), & CYP2D6 substrates w/ narrow therapeutic index. Risk of serotonin syndrome w/ nonselective irreversible MAOIs & selective, reversible MAOIs (eg, moclobemide). Serotonin syndrome w/ serotonergic antidepressants eg, SSRIs (eg, paroxetine, fluoxetine), TCAs (eg, clomipramine or amitriptyline), St. John's wort (Hypericum perforatum), venlafaxine or triptans, tramadol, pethidine & tryptophan. Increased conc may occur w/ potent CYP1A2 inhibitors (eg, fluvoxamine). Decreased plasma conc w/ CYP1A2 inducers (eg, smoking). Increased INR w/ warfarin.

Drugs for Neuropathic Pain / Antidepressants

N06AX21 - duloxetine ; Belongs to the class of other antidepressants.

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