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• Do not keep outdated medicine or medicine no longer needed.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.

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 Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of duloxetine in children with use in other age groups.

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.

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

• 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.