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Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see Warnings and Precautions (5.1)]. In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions (5.1)]. Swallow Cymbalta whole. Do not chew or crush. Do not open the capsule and sprinkle its contents on food or mix with liquids. All of these might affect the enteric coating. Cymbalta can be given without regard to meals. If a dose of Cymbalta is missed, take the missed dose as soon as it is remembered. If it is almost time for the next dose, skip the missed dose and take the next dose at the regular time. Do not take two doses of Cymbalta at the same time. Elderly — Initiate Cymbalta at a dose of 30 mg once daily for 2 weeks before considering an increase to the target dose of 60 mg. Thereafter, patients may benefit from doses above 60 mg once daily. If a decision is made to increase the dose beyond 60 mg once daily, increase dose in increments of 30 mg once daily. The maximum dose studied was 120 mg per day. Safety of doses above 120 mg once daily has not been adequately evaluated [see Clinical Studies (14.2)]. Dosage for Treatment of Fibromyalgia Administer Cymbalta 60 mg once daily. Begin treatment at 30 mg once daily for 1 week, to allow patients to adjust to the medication before increasing to 60 mg once daily. Some patients may respond to the starting dose. There is no evidence that doses greater than 60 mg/day confer additional benefit, even in patients who do not respond to a 60 mg dose, and higher doses are associated with a higher rate of adverse reactions [see Clinical Studies (14.4)]. Effects on Male and Female Sexual Function in Adults Changes in sexual desire, sexual performance and sexual satisfaction often occur as manifestations of psychiatric disorders or diabetes, but they may also be a consequence of pharmacologic treatment. Because adverse sexual reactions are presumed to be voluntarily underreported, the Arizona Sexual Experience Scale (ASEX), a validated measure designed to identify sexual side effects, was used prospectively in 4 MDD placebo-controlled trials. In these trials, as shown in Table 5 below, patients treated with Cymbalta experienced significantly more sexual dysfunction, as measured by the total score on the ASEX, than did patients treated with placebo. Gender analysis showed that this difference occurred only in males. Males treated with Cymbalta experienced more difficulty with ability to reach orgasm (ASEX Item 4) than males treated with placebo. Females did not experience more sexual dysfunction on Cymbalta than on placebo as measured by ASEX total score. Negative numbers signify an improvement from a baseline level of dysfunction, which is commonly seen in depressed patients. Physicians should routinely inquire about possible sexual side effects. Cymbalta is present in human milk. In a published study, lactating women who were weaning their infants were given Cymbalta. At steady state, the concentration of Cymbalta in breast milk was approximately 25% that of maternal plasma. The estimated daily infant dose was approximately 0.14% of the maternal dose. The developmental and health benefits of human milk feeding should be considered along with the mother's clinical need for Cymbalta and any potential adverse effects on the milk-fed child from the drug or from the underlying maternal condition. Exercise caution when Cymbalta is administered to a nursing woman. Medication Guide Cymbalta® [sim-BALL-tah] (duloxetine delayed-release capsules) Read this Medication Guide before you start taking Cymbalta® and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk to your healthcare provider about: People who take Cymbalta close in time to an MAOI may have a serious problem called Serotonin Syndrome (see “What are the possible side effects of Cymbalta?”). What should I tell my healthcare provider before taking Cymbalta? Before starting Cymbalta, tell your healthcare provider if you: Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Cymbalta and some medicines may interact with each other, may not work as well, or may cause serious side effects. Especially tell your healthcare provider if you take: Take Cymbalta exactly as your healthcare provider tells you to take it. Your healthcare provider may need to change the dose of Cymbalta until it is the right dose for you. Swallow Cymbalta whole. Do not chew or crush Cymbalta. Do not open the capsule and sprinkle on food or mix with liquids. Opening the capsule may affect how well Cymbalta works. Cymbalta may be taken with or without food. If you miss a dose of Cymbalta, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Cymbalta at the same time. If you take too much Cymbalta, call your healthcare provider or poison control center at 1-800-222-1222 right away, or get emergency treatment. When switching from another antidepressant to Cymbalta your healthcare provider may want to lower the dose of the initial antidepressant first to potentially avoid side effects. What are the possible side effects of Cymbalta? Cymbalta may cause serious side effects, including: See “What is the most important information I should know about Cymbalta? ” Common possible side effects in people who take Cymbalta include: 1. liver damage. Symptoms may include: Side effects in adults may also occur in children and adolescents who take Cymbalta. Children and adolescents should have height and weight monitored during treatment. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Cymbalta. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to 1-800-FDA-1088. How should I store Cymbalta? Store Cymbalta at room temperature between 68°F to 77°F (20°C to 25°C). Keep Cymbalta and all medicines out of the reach of children. General information about the safe and effective use of Cymbalta. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Cymbalta for a condition for which it was not prescribed. Do not give Cymbalta to other people, even if they have the same symptoms that you have. It may harm them. This Medication Guide summarizes the most important information about Cymbalta. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about Cymbalta that is written for healthcare professionals. For more information, call 1-800-545-5979. What are the ingredients in Cymbalta? Active ingredient: duloxetine hydrochloride Inactive ingredients: FD&C Blue No. 2, gelatin, hypromellose, hydroxypropyl methylcellulose acetate succinate, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, and triethyl citrate. The 20 and 60 mg capsules also contain iron oxide yellow. This Medication Guide has been approved by the U.S. Food and Drug Administration. Coumadin, Jantoven, and Mellaril are trademarks of their respective owners and not trademarks of Eli Lilly and Company. Medication Guide revised: November 2014 Marketed by: Lilly USA, LLC Indianapolis, IN 46285, USA Cymbalta is a registered trademark of Eli Lilly and Company. Copyright © 2009, 2014, Eli Lilly and Company. All rights reserved. CYM-0003-MG-20141125','url':'http://www.drugs.com/pro/cymbalta.html','og_descr':'Cymbalta official prescribing information for healthcare professionals. Includes: indications, dosage, adverse reactions, pharmacology and more.
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Cymbalta official prescribing information for healthcare professionals. Includes: indications, dosage, adverse reactions, pharmacology and more.
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