Cymbalta

Cymbalta Special Precautions

duloxetine

Manufacturer:

Eli Lilly

Distributor:

Zuellig
Full Prescribing Info
Special Precautions
As with similar CNS active drugs, duloxetine should be used cautiously in patients with a history of mania or a diagnosis of bipolar disorder, and/or seizures.
Mydriasis has been reported in association with duloxetine, therefore, caution should be used when prescribing duloxetine in patients with raised intraocular pressure, or those at risk of acute narrow-angle glaucoma.
Duloxetine (Cymbalta) hard gastro-resistant capsules contain sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Renal Impairment: Increased plasma concentrations of duloxetine occur in patients with severe renal impairment on hemodialysis (creatinine clearance of less than 30 mL/min). For patients with severe renal impairment, see Contraindications. See Dosage & Administration for information on patients with mild or moderate renal dysfunction.
Increased blood pressure: Duloxetine is associated with an increase in blood pressure in some patients. In patients with known hypertension and/or other cardiac disease, blood pressure monitoring is recommended as appropriate.
Elevated liver enzymes: Elevations in liver enzymes were seen in some patients treated with duloxetine in clinical trials. These were usually transient and self-limiting, or resolved upon discontinuation of duloxetine. Severe elevations of liver enzymes (>10 times the upper limit of normal) or liver injury with a cholestatic or mixed pattern have been rarely reported, in some cases associated with excessive alcohol use or pre-existing liver disease. Duloxetine should be used with caution in patients with substantial alcohol use or pre-existing liver disease.
Use with antidepressants: Cautions should be exercised when using duloxetine in combination with antidepressants. In particular the combination with selective reversible MAOIs is not recommended.
St. John's wort: Undesirable effects may be more common during concomitant use of duloxetine and herbal preparations containing St. John's wort (Hypericum perforatum).
Suicide: The possibility of a suicide attempt is inherent in depression and other psychiatric disorders and may persist until significant remission occurs. Close supervision of high-risk patients should accompany drug therapy.
As with other drugs with similar pharmacological action (inhibitor of serotonin reuptake [SSRI] or inhibitor of serotonin and norepinephrine reuptake [SNRI]), isolated cases of suicidal ideation and suicidal behaviors have been reported during duloxetine therapy or early after treatment discontinuation.
Duloxetine hydrochloride has not been studied in patients under the age of 18 and is not intended for use in this age group. Although a causal role for duloxetine in inducing such events has not been established some analyses from pooled studies of antidepressants in psychiatric disorders found an increased risk for suicidal ideation and/or suicidal behaviors in pediatric and young adult (<25 years of age) patients compared to placebo. Physicians should encourage patients to report any distressing thoughts or feelings at any time.
Hemorrhage: There have been reports of cutaneous bleeding abnormalities, such as ecchymoses and purpura with selective serotonin reuptake inhibitors (SSRIs). Caution is advised in patients taking anticoagulants and/or medicinal products known to affect platelet function, and in patients with known bleeding tendencies.
Hyponatremia: Cases of hyponatremia (some with serum sodium lower than 110 mmol/Liter) have been reported very rarely. The majority of these cases occurred in elderly patients, especially when coupled with a recent history of altered fluid balance or conditions pre-disposing to altered fluid balance. Hyponatremia may present with nonspecific signs and symptoms (such as dizziness, weakness, nausea, vomiting, confusion, somnolence, and lethargy). Signs and symptoms associated with more severe cases have included syncopal episodes, falls, and seizure.
Abnormal Bleeding: SSRIs and SNRIs, including duloxetine, may increase the risk of bleeding events, including gastrointestinal bleeding. Therefore, caution is advised in patients taking duloxetine concomitantly with anticoagulants and/or medicinal products known to affect platelet function (e.g., NSAIDs, aspirin) and in patients with known bleeding tendencies.
Discontinuation of Treatment: Some patients may experience symptoms on discontinuation of duloxetine, particularly if treatment is stopped abruptly (see Dosage & Administration and Adverse Reactions).
Effects on ability to drive and use machines: Duloxetine may be associated with undesirable effects, such as sedation and dizziness. Therefore, patients should be cautioned about operating hazardous machinery, including automobiles, while taking duloxetine.
Use in the Elderly: Only limited clinical data on the use of duloxetine in elderly patients with major depressive disorders is available. Therefore, caution should be exercised when treating the elderly (see Dosage & Administration and Pharmacology: Pharmacokinetics under Actions).
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