Cymbalta (duloxetine hydrochloride) is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) for oral administration.
Indications and Usage:
Cymbalta is indicated for the treatment of major depressive disorder. The effectiveness of Cymbalta for longer-term (more than 9 weeks) use has not been systematically evaluated in clinical trials. It is also indicated for management of diabetic peripheral neuropathic pain.
Cymbalta is contraindicated in anyone who has shown a sensitivity to duloxetine or any of Cymbalta's inactive ingredients. It should not be used concommitantly with an MAOI. In clinical trials, Cymbalta was associated with increased mydriasis in patients with uncontrolled narrow-angle glaucoma and should not be used by patients with this condition.
Cymbalta increases the risk of elevated serum transaminase. It has been associated with an increase in blood pressure. Blood pressure should be monitored throughout treatment. Cymbalta should be used with caution in patients with a history of mania or seizures. It should not be used in those with Uncontrolled Narrow-Angle Glaucoma. It should be discontinuated gradually to avoid symptoms. Experience with Cymbalta and concommitant illness is limited. See Cymbalta.com for details.
Patients should be observed closely for clinical worsening and suicidality, especially at the beginning of therapy or when dose changes are made. Patients should also be monitored for the emergence of symptoms such as anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia, hypomania and mania. If such symptoms are severe, abrupt in onset or not a part of the patient's presenting symptoms, consideration should be given to changing the therapeutic regimen.
Information about drug interactions is too lengthy to summarize here. Please visit Cymbalta.com for complete information.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
In female mice receiving an equivalent of 11 times the maximum recommended human dose (MRHD), there was an increase in hepatocellular adenomas and carninomas. The no-effect dose was 4 times the MRHD. Tumor incidence was not increased in male mice at doses up to 8 times the MRHD. It was not mutagenic in studies performed nor did it affect fertility.
Pregnancy and Lactation:
Cymbalta is a Class C drug. There are no adequat and well-controlled studies in pregnant women; therefore, duloxetine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
The most common adverse events (reported by greater than 5%) were: nausea, dry mouth, constipation, decreased appetite, fatigue, somnolence, and increased sweating. Adverse events occuring to at least 2% of patients included: diarrhea, vomiting, weightloss, dizziness, tremor, hot flushes, blurred vision, insomnia, anxiety and sexual side-effects.
Drug Abuse and Dependence:
Duloxetine is not a controlled substance. In animal studies, it did not demonstrate barbiturate-like abuse potential. In drug dependence studies, it did not demonstrate dependence-producing potential in rats. While Cymbalta has not been systematically studied in humans for it's potential for abuse, there were no indications of drug-seeking behavior in the clinical trials.
Dosage and Administration:Cymbalta should be administered at a total dose of 40 mg/day (given as 20 mg BID) to 60 mg/day (given either once a day or as 30 mg BID) without regard to meals. There is no evidence that doses greater than 60 mg/day confer any additional benefits.
Summarized from: htttp://www.cymbalta.com/