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Drug information for
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DULOXETINE (Systemic)†
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Some commonly used brand names are:
In the U.S.—
Cymbalta
† Not commercially available in Canada.
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Category
Antidepressant
antineuralgic
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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.)
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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—Duloxetine must be used with caution
in children with depression. 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, 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.
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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.
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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.
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 you 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 .
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Side Effects of This Medicine
Along with its needed effects, a medicine may cause some unwanted
effects.
Other side effects may occur that usually do not need medical
attention. These side effects may go away during treatment
as your body adjusts to the medicine. However, check with
your doctor if any of the following side effects continue
or are bothersome.
More Common
Cough; diarrhea; difficulty having a bowel movement (stool);
dizziness; dry mouth; fever; frequent urination; headache;
lack or loss of strength; loss of appetite; muscle aches;
nausea; sleepiness or unusual drowsiness; sleeplessness; sore
throat; stuffy or runny nose; sweating increased; trouble
sleeping; unable to sleep; unusual tiredness or weakness;
vomiting; weight loss
Less common
Abnormal orgasm; acid or sour stomach; belching; change or
problem with discharge of semen; decreased interest in sexual
intercourse; difficulty in moving; erectile dysfunction; fear;
feeling of warmth redness of the face, neck, arms and occasionally,
upper chest; heartburn; inability to have or keep an erection;
indigestion; joint pain; longer than usual time to ejaculation
of semen; loose stools; loss in sexual ability, desire, drive,
or performance; muscle aching or cramping; muscle pains or
stiffness; nervousness; shakiness in legs, arms, hands, feet;
stomach discomfort upset or pain; sudden sweating; swollen
joints; trembling or shaking of hands or feet; vision blurred
Other side effects not listed above may also occur in some
patients. If you notice any other effects, check with your
doctor.
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