Monograph Details
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Pain & Pyrexia
> Nonnarcotic analgesics
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CYMBALTA |
| Manufacturer |
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Lilly, Eli and Company |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Serotonin and norepinephrine reuptake inhibitor. |
| Generic Name |
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Duloxetine (as HCl) 20mg, 30mg, 60mg; e-c pellets in caps. |
| Indications |
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Diabetic peripheral neuropathic pain. Fibromyalgia. |
| Children |
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Not recommended. |
| Adults |
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Swallow whole. Neuropathic pain: 60mg once daily (may start at lower dose if 60mg not tolerated); renal impairment: consider lower starting dose and slow titration. Fibromyalgia: Initially 30mg once daily for 1 week, then increase to 60mg once daily. |
| Contraindications |
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Allow at least 14 days after MAOI discontinuance before starting duloxetine; allow at least 5 days after duloxetine discontinuance before starting an MAOI. Uncontrolled narrow-angle glaucoma. |
| Precautions |
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Severe renal impairment (CrCl<30mL/min), end stage renal disease, hepatic insufficiency, evidence of chronic liver disease, or substantial alcohol use: not recommended. History of seizure or mania/hypomania. Controlled narrow-angle glaucoma. Decreased GI motility. Cardiac disease. Monitor BP prior to and during therapy. Diabetes. Suicidal tendencies (monitor). Avoid abrupt cessation. Reevaluate periodically. Elderly. Labor & delivery. Pregnancy (Cat.C) (avoid 3rd trimester; consider tapering, see literature for effects on neonate). Nursing mothers: not recommended. |
| Interactions |
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See Contraindications. Concomitant tryptophan, other SSRIs, SNRIs: not recommended. Concomitant thioridazine (may cause arrhythmias): not recommended. Potentiated by CYP1A2 inhibitors; avoid (eg, cimetidine, fluvoxamine, quinolones). May potentiate or be potentiated by CYP2D6 inhibitors (eg, paroxetine, fluoxetine, quinidine) or substrates (eg, tricyclics, phenothiazines, type 1C antiarrhythmics) or other highly protein-bound drugs; caution with CYP2D6 substrates with narrow therapeutic indexes. Caution with potent CYP1A2 inhibitors, antihypertensives, other drugs that induce orthostatic hypotension. Caution with triptans, linezolid, lithium, tramadol, St. John's wort; may cause serotonin syndrome. Monitor concomitant CNS-acting drugs, and with those that affect gastric pH (eg, acid pump inhibitors). Increased bleeding risk with aspirin, anticoagulants, NSAIDs. |
| Adverse Reactions |
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Nausea, dry mouth, constipation, somnolence, hyperhidrosis, decreased appetite, weight changes, GI disturbances, fatigue, dizziness, increased sweating, mania/hypomania, tremor, blurred vision, insomnia, hot flushes, urinary hesitation/retention, abnormal ejaculation, genital disorders, decreased libido, increased BP, orthostatic hypotension, syncope, hepatotoxicity (eg, elevated liver transaminases, cholestatic jaundice); discontinue if occurs, hyponatremia, asthenia, others; rare: seizure. |
| How Supplied |
Caps 20mg—60
30mg, 60mg—30, 90, 1000 |
| Additional Resources |
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• Related Prescribing Note |
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