Duloxetine hydrochloride

Brand names: Cymbalta

Why is Duloxetine hydrochloride prescribed?

Cymbalta is used to treat major depression—a disorder marked by continuing, serious, and overwhelming feelings of depression that interfere with daily functioning. Symptoms may include major changes in appetite or sleep habits; lack of interest in social or work life; feelings of sadness, guilt, or worthlessness; fatigue; difficulty concentrating or making decisions; and suicidal thoughts or attempted suicide.

Cymbalta is also used to treat diabetic peripheral neuropathy, a painful nerve disorder associated with diabetes that affects the hands, legs, and feet.

Cymbalta is thought to work by correcting an imbalance of two brain chemicals known to influence mood—serotonin and norepinephrine. It belongs to a class of antidepressants called selective serotonin and norepinephrine reuptake inhibitors (SNRIs).

Most important fact about Duloxetine hydrochloride

Serious, sometimes fatal reactions can occur if Cymbalta is taken with antidepressants known as MAO inhibitors, including the antidepressants phenelzine and tranylcypromine. Never combine Cymbalta with one of these drugs, and wait at least 14 days after stopping an MAO inhibitor before starting treatment with Cymbalta. Likewise, after stopping therapy with Cymbalta, allow at least 5 days before starting treatment with an MAO inhibitor.

How should you take Duloxetine hydrochloride?

Take Cymbalta at about the same time each day. Swallow the capsule whole; do not chew it or break it open. Cymbalta may be taken with or without food.

It may take several weeks before the drug begins to work. Continue taking Cymbalta even if you begin to feel better. Do not stop taking Duloxetine hydrochloride without your doctor's approval. Abruptly stopping treatment may cause severe side effects.

  • If you miss a dose...Take the forgotten dose as soon as you remember. However, if it is almost time for your next dose, skip the one you missed and return to your regular schedule. Do not take two doses at once.
  • Storage instructions...Store at room temperature.

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe to continue using Cymbalta.

  • Side effects may include:Appetite changes, constipation, diarrhea, dizziness, dry mouth, fatigue, headache, insomnia, nausea, sexual difficulties, sleepiness, sweating, tremor, urinary difficulties, vomiting, weakness

Why should Duloxetine hydrochloride not be prescribed?

You will not be able to use Cymbalta if it causes an allergic reaction. In addition, you should not take Cymbalta if you have uncontrolled narrow-angle glaucoma, a disease that causes increased pressure in the eyes.

Never combine Cymbalta with an MAO inhibitor (see "Most important fact about Duloxetine hydrochloride").

Do not take the drug thioridazine with Cymbalta, as it could cause fatal heartbeat irregularities.

Special warnings about Duloxetine hydrochloride

In clinical studies, antidepressants increased the risk of suicidal thinking and behavior in children and adolescents with depression and other psychiatric disorders. Anyone considering the use of Cymbalta or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Cymbalta has not been studied in children or adolescents and is not approved for treating anyone less than 18 years old.

Additionally, the progression of major depression is associated with a worsening of symptoms and/or the emergence of suicidal thinking or behavior in both adults and children, whether or not they are taking antidepressants. Individuals being treated with Cymbalta and their caregivers should watch for any change in symptoms or any new symptoms that appear suddenly—especially agitation, anxiety, hostility, panic, restlessness, extreme hyperactivity, and suicidal thinking or behavior—and report them to the doctor immediately. Be especially observant at the beginning of treatment or whenever there is a change in dose.

Some medical conditions require careful monitoring during treatment with Cymbalta. Be sure to tell the doctor if you have diabetes, glaucoma, high blood pressure, or a seizure disorder. Cymbalta can cause episodes of mania (abnormally high feelings of excitement and energy), so be sure the doctor is aware if you have this condition.

Using Cymbalta is not recommended if you have liver problems or severe kidney disease.

Like other antidepressants, Cymbalta can cause drowsiness and affect judgment or motor skills. Use caution when driving, operating dangerous machinery, or participating in hazardous activities until you know how the drug affects you.

Possible food and drug interactions when taking Duloxetine hydrochloride

Never take Cymbalta with MAO inhibitors (see "Most important fact about Duloxetine hydrochloride) or the drug thioridazine. Consult your doctor first before taking drugs that act on the central nervous system, such as antipsychotics, narcotic painkillers, sleep inducers, or tranquilizers.

Due to the possibility of liver damage, do not take Cymbalta if you use alcohol more than occasionally.

If Cymbalta is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Cymbalta with the following:

Antibiotics known as quinolones, such as ciprofloxacinAntidepressants known as tricyclics, such as amitriptylineAntidepressants that raise serotonin levelsAntipsychotic medication known as phenothiazinesFlecainideFluvoxaminePropafenoneQuinidine

Special information if you are pregnant or breastfeeding

Cymbalta had negative effects during pregnancy when given to animals. There have been no adequate studies in pregnant women. Cymbalta should be used during pregnancy only if the benefits outweigh the potential risks.

Cymbalta appears in the breast milk of animals. It is unknown whether the drug appears in human breast milk. Therefore, it's recommended that you avoid breastfeeding while taking Cymbalta.

Recommended dosage for Duloxetine hydrochloride

ADULTS 18 YEARS AND OLDER

Major DepressionThe total daily dose ranges from 40 milligrams (taken as one 20-milligram capsule twice a day) to 60 milligrams (taken as a 60-milligram capsule once a day or as a 30-milligram capsule twice a day).

Diabetic Peripheral NeuropathyThe recommended dose is 60 milligrams taken once daily.

Overdosage

Any medication taken in excess can have serious consequences. If you suspect an overdose, seek emergency treatment immediately.