Cymbalta Indications

Cymbalta is the brand name for duloxetine, an antidepressant prescribed to treat the symptoms of depression. It is in a class of medications called serotonin-norepinephrine reuptake inhibitors (SNRIs). It works by increasing the levels of the neurotransmitters serotonin and norepinephrine, which help regulate mood and may block pain signals traveling through the brain.

The Food and Drug Administration (FDA) approved duloxetine in 2004 under the brand name Cymbalta for the Lilly drug company. The FDA announced that it had also approved generic versions of duloxetine for several drug companies in 2013. Cymbalta could also help ease pain associated with osteoarthritis. This is according to a study published in the International Journal of Clinical Practice in 2012. The researchers noted that the use of this medication could result in fewer side effects than the drugs traditionally used for the condition. Traditionally used drugs, such as non-steroidal anti-inflammatory drugs, or NSAIDs can lead to gastrointestinal bleeding. Opioids like morphine often lead to constipation. They concluded that doctors may consider adding antidepressants, such as Cymbalta to the treatment regimens for patients with osteoarthritis. The FDA requires that Cymbalta carry a black-box warning about the risk of suicide among people who use the antidepressant.

Doctors can prescribe Cymbalta to treat anxiety that lasts for at least six months, pain from diabetic nerve damage, fibromyalgia, and long-term muscle or bone pain.

Getting Worse Before Getting Better

This antidepressant may increase the risk of suicidal thoughts or behaviors if you are 24 years old or younger. Doctors usually do not prescribe this antidepressant for anyone younger than 18. The risk is greatest when first starting treatment or increasing the dose of Cymbalta. Your depression may get worse before it gets better when you start taking this drug. Let your doctor know if you have thoughts of suicide, symptoms of aggression, irritability, panic attacks, extreme worry, restlessness, acting without thinking, and abnormal excitement. Your doctor will monitor you carefully for any of these symptoms when you start this medication. You should also let friends and family members know about these symptoms. If you have any thoughts of suicide or if a friend or family member thinks you are acting strange, call your doctor right away.

CYMBALTA WEIGHT GAIN

Cymbalta 60 mgResearchers have found that Cymbalta (like many antidepressants) can cause fluctuations in weight among people taking the drug. A 2011 study, published in the International Journal of Clinical Practice, found that some Cymbalta users reported weight loss at the start of their Cymbalta therapy. This may be explained by a loss of appetite, a common side effect of the drug. Some long-term users of Cymbalta, however, reported weight gain up to 16 percent over their initial weight (especially people who were taking Cymbalta for low-back pain or fibromyalgia). These findings, the study authors wrote, were consistent with earlier studies that had focused on weight changes among people taking Cymbalta for depression.

PRECAUTIONS

  • You should also know that you cannot take Cymbalta if you have a condition called uncontrolled narrow-angle glaucoma.
  • This medication can worsen glaucoma symptoms. Tell your doctor if you have any eye conditions.
  • Cymbalta may cause liver damage. You may not be able to take this drug if you have liver disease or if you abuse alcohol.
  • Alcohol may increase some serious side effects of Cymbalta.
  • Cymbalta may make you feel drowsy. Until you know how the drug will affect you, do not drive or operate machinery.
  • This medication may cause high blood pressure, dizziness or lightheadedness, especially when you get up too quickly after sitting or lying down.
  • Cymbalta has many side effects and can interfere with many medications and can cause problems.

Always tell your doctor if you have allergies to any medications, including antidepressants. You will need to discuss all the risks and benefits of Cymbalta with your doctor. Let your doctor know if you are taking a type of drug called a monoamine oxidase inhibitor (MAOI). Brand names for MAOIs include Marplan, Nardil, Eldepryl, Emsam, Zelapar, and Parnate. Use this drug with caution if you have certain medical conditions. Tell your doctor about any history of these conditions:

  • liver problems,
  • eye problems,
  • frequent use of alcohol,
  • heart problems,
  • high blood pressure,
  • seizures,
  • drug abuse,
  • bipolar disorder,
  • kidney disease,
  • abnormal bleeding,
  • and family history of suicide.

SIDE EFFECTS OF CYMBALTA

Cymbalta side effects

The Cymbalta side effects have three different levels of severity. These include very severe effects such as fainting, severe vomiting and nausea and mood swing, agitation, mania, suicidal thoughts, urinating difficulty, jaundice, seizures, muscle weakness or cramping. Seek immediate medical advice.

Severe side effects include allergic reaction such as difficulty breathing, swelling in the throat, hives, irregular pulses, low blood pressure with dizziness, high blood pressure with severe headache, blurred vision, chills or fever, unusual bleeding. Get immediate medical advice.

Mild side effects include headache, nervousness, tremor, constipation, nausea, dry mouth, insomnia, sexual issues or changes in appetite.

In general, the most common side effects of Cymbalta are nausea, dry mouth, sleepiness, fatigue, constipation, loss of appetite, sweating. Other possible side effects include headache, muscle ache, diarrhea, vomiting, heartburn, stomach ache, loss of interest in sex, increased urination, dizziness, weakness, and tremor. Serious side effects can occur.

If you have any of these side effects as well, call your doctor right away:

  • unusual bruising or bleeding,
  • loss of appetite,
  • abdominal pain,
  • yellowing of the eyes or skin,
  • dark-colored urine,
  • fever with sweating,
  • confusion,
  • racing heart,
  • and muscle stiffness,
  • extreme weakness,
  • swelling of the face, lips, or tongue,
  • swelling in other parts of the body,
  • trouble breathing or swallowing,
  • a blistering or peeling rash,
  • chest pain,
  • difficulty breathing,
  • worsening depression,
  • and panic attack.

CYMBALTA WITHDRAWAL SYMPTOMS

Take Cymbalta as directed by your doctor. Don’t stop taking this medication on your own, because suddenly stopping can cause severe withdrawal symptoms. Symptoms of Cymbalta withdrawal may include nausea and vomiting, anxiety, dizziness, headache, tingling and numbness, insomnia, difficulty sleeping, sweating, and nightmares.

TAKING DULOXETINE

This medication comes in a delayed-release capsule and taken orally. For the treatment of depression, doctors will usually instruct you to take it at most twice per day. For GAD and pain, it is usually prescribed once a day. Make sure you take this medication at the same time each day. Follow whatever directions are included in the prescription. If you are not sure how to take this drug, you can always ask your pharmacist or even call your doctor to clarify.

When taking Duloxetine, you should not expect to feel its full effects immediately. It could take at least one week. Do not adjust the dosage on your own even if you are already feeling well. Your doctor will most likely decrease the dosage after a routine check-up. Bear in mind that if you stop taking this medication suddenly, you could experience symptoms of withdrawal. These include nausea, anxiety, tiredness, pain, irritability, sweating and headaches. If you experience any of these when your dose was reduced, be sure to tell the doctor. Just like any medication, there is a risk of experiencing side effects. While taking Duloxetine, you might feel any of the following: nausea, constipation, heartburn, decreased appetite, dry mouth, difficulty urinating, dizziness and headache. Signs of overdose include fast heartbeat, loss of coordination, drowsiness, seizures, and fainting.

ADVERSE REACTIONS

Cymbalta antidepressant

Clinical trials are conducted under widely varying conditions. For this reason, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse reaction of the type listed. A reaction was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation. The therapy did not necessarily cause the reactions reported during the studies. The frequencies do not reflect investigator impression (assessment) of causality.

Adults

The data described below reflect exposure to CYMBALTA in placebo-controlled trials for MDD (N=3779), GAD (N=1018), OA (N=503), CLBP (N=600), DPNP (N=906), and FM (N=1294). The population studied was 17 to 89 years of age; 65.7%, 60.8%, 60.6%, 42.9%, and 94.4% female; and 81.8%, 72.6%, 85.3%, 74.0%, and 85.7% Caucasian for MDD, GAD, OA and CLBP, DPNP, and FM, respectively. Most patients received doses of a total of 60 to 120 mg per day. The data below do not include results of the trial examining the efficacy of CYMBALTA in patients > 65 years old for the treatment of generalized anxiety disorder. However, the adverse reactions observed in this geriatric sample were generally similar to adverse reactions in the overall adult population.

Children And Adolescents

The data described below reflect exposure to CYMBALTA in pediatric, 10-week, placebo-controlled trials for MDD (N=341) and GAD (N=135). The population studied (N=476) was 7 to 17 years of age with 42.4% children age 7 to 11 years of age, 50.6% female, and 68.6% white. Patients received 30-120 mg per day during placebo-controlled acute treatment studies. Additional data come from the overall total of 822 pediatric patients (age 7 to 17 years of age) with 41.7% children age 7 to 11 years of age and 51.8% female exposed to CYMBALTA in MDD and GAD clinical trials up to 36weeks in length, in which most patients received 30-120 mg per day.

Major Depressive Disorder

Approximately 8.4% (319/3779) of the patients who received CYMBALTA in placebo-controlled trials for MDD discontinued treatment due to an adverse reaction, compared with 4.6% (117/2536) of the patients receiving placebo. Nausea (CYMBALTA 1.1%, placebo 0.4%) was the only common adverse reaction reported as a reason for discontinuation and considered to be drug-related (i.e., discontinuation occurring in at least 1% of the CYMBALTA-treated patients and at a rate of at least twice that of placebo).

Generalized Anxiety Disorder

Approximately 13.7% (139/1018) of the patients who received CYMBALTA in placebo-controlled trials for GAD discontinued treatment due to an adverse reaction, compared with 5.0% (38/767) for placebo. Common adverse reactions reported as a reason for discontinuation and considered to be drug-related (as defined above) included nausea (CYMBALTA 3.3%, placebo 0.4%), and dizziness (CYMBALTA 1.3%, placebo 0.4%).

Diabetic Peripheral Neuropathic Pain

Approximately 12.9% (117/906) of the patients who received CYMBALTA in placebo-controlled trials for DPNP discontinued treatment due to an adverse reaction, compared with 5.1% (23/448) for placebo. Common adverse reactions reported as a reason for discontinuation and considered to be drug-related (as defined above) included nausea (CYMBALTA 3.5%, placebo 0.7%), dizziness (CYMBALTA 1.2%, placebo 0.4%), and somnolence (CYMBALTA 1.1%, placebo 0.0%).

Fibromyalgia

Approximately 17.5% (227/1294) of the patients who received CYMBALTA in 3 to 6 month placebo-controlled trials for FM discontinued treatment due to an adverse reaction, compared with 10.1% (96/955) for placebo. Common adverse reactions reported as a reason for discontinuation and considered to be drug-related (as defined above) included nausea (CYMBALTA 2.0%, placebo 0.5%), headache (CYMBALTA 1.2%, placebo 0.3%), somnolence (CYMBALTA 1.1%, placebo 0.0%), and fatigue (CYMBALTA 1.1%, placebo 0.1%).