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|Cymbalta

DULOXETINE (Systemic)†

Some commonly used brand names are:

In the U.S.—

• Cymbalta

† Not commercially available in Canada.

Category

• Antidepressant
• antineuralgic

Description

Duloxetine (du-LOX-uh-teen) is used to treat mental depression. It is also used for pain caused by nerve damage associated with diabetes.

Duloxetine belongs to a group of medicines known as selective serotonin and norepinephrine reuptake inhibitors (SSNRIs). These medicines are thought to work by increasing the activity of chemicals called serotonin and norepinephrine in the brain.

This medicine is available only with your doctor"s prescription, in the following dosage forms:

• Oral
• Delayed-release capsules (U.S.)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For duloxetine, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to duloxetine. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Duloxetine has not been studied in pregnant women. Duloxetine should only be used during pregnancy if the potential benefit outweighs the potential risk to the baby. Before taking this medicine, make sure your doctor knows if you are pregnant (especially if it is the third trimester) or if you may become pregnant.

Breast-feeding—Duloxetine passes into the milk of rats. It is not known whether it passes into human milk. Because the effects of this medicine in nursing babies is not known and because of the risks, duloxetine is not recommended if you are breast-feeding.

Children—Children should not usually take duloxetine. However, if your doctor prescribes duloxetine for your child to treat depression, caution must be used. Studies have shown occurrences of children thinking about suicide or attempting suicide in clinical trials for this medicine. More study is needed to be sure duloxetine is safe and effective in children.

Older adults—This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults. However, elderly patients are more likely to be sensitive than younger adults to the effects of duloxetine.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking duloxetine, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Antidepressants (fluoxetine [e.g., Prozac], paroxetine [e.g., Paxil])—Taking certain medicines for depression with duloxetine may increase your chance for side effects.

• Antiarrhythmics (flecainide [e.g., Tambocor], propafenone [e.g., Rythmol], Quinidine [e.g., Quinaglute, Quinidex])—Taking certain medicines for an uneven heartbeat together with duloxetine may increase the chance of getting serious side effects.

• Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate])—Do not take duloxetine while you are taking or within 2 weeks of taking an MAO inhibitor , or you may develop serious side effects. At least 14 days should be allowed between stopping treatment with one medicine (duloxetine or the MAO inhibitor) and starting treatment with the other

• Phenothiazines (e.g., Compazine, Phenergan, Thorazine)—Taking phenothiazines together with duloxetine may increase the risk of side effects.

• Tricyclic antidepressants (amitriptyline [e.g., Elavil], desipramine [e.g., Norpramin], imipramine [e.g., Tofranil], nortriptyline [e.g., Aventyl])—Taking certain tricyclic antidepressants together with duloxetine may increase the risk of side effects.

• Thioridazine (e.g., Mellaril)—Taking thioridazine with duloxetine may cause serious heart problems.

Other medical problems—The presence of other medical problems may affect the use of duloxetine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bipolar disorder (mood disorder with alternating episodes of mania and depression) or risk of—May make condition worse. Your doctor will check you for this condition.

• Diabetes mellitus (sugar diabetes)—May increase your blood sugar

• Kidney disease, severe—Higher blood levels of duloxetine may occur, increasing the chance of side effects.

• Liver disease, severe—You should not take this medicine because it may make your liver disease worse.

• Mania (history of)—The condition may be activated.

• Narrow-angle glaucoma—May increase your chance of getting blurred vision

• Seizures (history of)—The risk of seizures may be increased.

Proper Use of This Medicine

Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

Swallow the capsule whole. Do not chew, crush or sprinkle the contents on food or mix with liquids before swallowing.

Dosing—The dose of duloxetine will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of duloxetine. If your dose is different, do not change it unless your doctor tells you to do so.

The number of capsules that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are taking duloxetine

• For oral dosage form (capsule):
  • For treatment of depression:
    • Adults—40 milligrams (mg) a day (given as 20 mg twice a day) to 60 mg a day (given either once a day or as 30 mg twice a day) with or without meals.
    • Children—Use and dose must be determined by your doctor.
  • For treatment of pain associated with diabetic peripheral neuropathy
    • Adults—60 milligrams (mg) a day with or without meals.
    • Children—Dose must be determined by your doctor.

Missed dose—If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is important that your doctor check your progress at regular visits, to allow for changes in your dose and to help reduce any side effects.

Duloxetine has not been shown to add to the effects of alcohol. However, use of alcohol is not recommended in patients who are taking duloxetine.

Duloxetine may cause some people to be agitated, irritable or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these adverse effects, tell your doctor right away.

This medicine can cause serious liver problems. If you experience symptoms such as dark urine, general tiredness and weakness, light-colored stools, nausea and vomiting, upper right abdominal pain, or yellow eyes and skin, contact your doctor immediately.

Four weeks of duloxetine may be required before your symptoms improve. It is important to continue duloxetine after symptoms of depression are relieved.

Do not suddenly stop taking your duloxetine . If you have been instructed to stop taking duloxetine, ask your healthcare professional how to slowly decrease the dose. This is to decrease the chance of having discontinuation symptoms such as dizziness, nausea, headache, vomiting, irritability, nightmares, prickling or tingling feelings.

Do not take duloxetine if you have taken a monoamine oxidase (MAO) inhibitor (furazolidone, phenelzine, procarbazine, selegiline, tranylcypromine) in the past 2 weeks. Do not start taking an MAO inhibitor within 5 days of stopping duloxetine . If you do, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, sudden high body temperature, extremely high blood pressure, severe convulsions, or the serotonin syndrome.

For diabetic patients :

• This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

Duloxetine may cause some people to become drowsy or have blurred vision. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to see clearly .

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 09/22/2004
Revised: 10/31/2005

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