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|Symbyax Symbyax

Symbyax

Generic name: Olanzapine and Fluoxetine hydrochloride
Brand names: Symbyax

Why is Symbyax prescribed?

Symbyax is used to treat depressive episodes associated with bipolar disorder. Bipolar disorder, sometimes called manic-depressive illness, is a condition in which a person"s mood swings from depression to excessive excitement.

Symbyax is a combination of the active ingredients in Prozac (fluoxetine), used to treat depression and other conditions; and Zyprexa (olanzapine), used to treat the manic phase of bipolar disorder as well as other conditions.

Most important fact about Symbyax

If you have bipolar disorder, you may think about, or try to commit, suicide. You also may think about harming others. If you have any of these thoughts, tell your doctor immediately or go to an emergency center. If your doctor feels that you are at risk for these symptoms, he or she will monitor you closely while you are taking Symbyax.

Serious, sometimes fatal reactions have been known to occur when fluoxetine, one of the ingredients in Symbyax, is taken with other antidepressant drugs called MAO inhibitors, including Nardil and Parnate. Such reactions have also occurred when fluoxetine is discontinued and an MAO inhibitor is started. Never take Symbyax with an MAO inhibitor, or within 14 days of discontinuing therapy with an MAO inhibitor. Allow 5 weeks or more between stopping Symbyax and starting an MAO inhibitor. Be especially careful if you have been taking Symbyax in high doses or for a long time.

If you are taking any prescription or nonprescription medications, notify your doctor before taking Symbyax (see "Possible food and drug interactions when taking Symbyax").

How should you take Symbyax?

Symbyax can be taken with or without food. It is best to take it in the evening. Take Symbyax exactly as prescribed. Keep taking the medication even if your mood improves. Never change your dosage or stop taking Symbyax without consulting your doctor.

--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. Keep the container tightly closed and protect the drug from moisture.

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 Symbyax.

• More common side effects may include:
  Abnormal thinking, increased appetite, lack of coordination, sleepiness, sore throat, tremor, water retention (especially in the arms and legs), weakness, weight gain

Why should Symbyax not be prescribed?

Symbyax is a combination of the ingredients in Prozac and Zyprexa. You cannot use Symbyax if you have experienced an allergic reaction to any of its ingredients, or to Prozac or Zyprexa. Make sure that your doctor is aware of any drug reaction that you have experienced.

Do not take Symbyax with an MAO inhibitor (see "Most important fact about Symbyax") or with thioridazine (Mellaril) (see "Possible food and drug interactions while taking Symbyax").

Special warnings about Symbyax

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 Symbyax or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Symbyax is not approved for use in children.

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 Symbyax 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.

Certain antipsychotic drugs--including olanzapine, one of the ingredients in Symbyax--are associated with an increased risk of developing high blood sugar, which on rare occasions has led to coma or death. See your doctor right away if you develop signs of high blood sugar, including dry mouth, unusual thirst, increased urination, and tiredness. If you have diabetes or have a high risk of developing it, see your doctor regularly for blood sugar testing.

Use Symbyax with caution if you have a history of heart disease, heart rhythm problems, stroke, seizures, or liver problems. Also be cautious if you"re at risk of developing low blood pressure (for example, when you"re dehydrated).

Symbyax has not been studied in people with certain diseases. However, the individual ingredients in Symbyax have been known to cause problems in people with specific illnesses. Be sure to tell the doctor if you"ve ever had any of the following: heart attack, heart disease, an enlarged prostate, high or low blood pressure, abnormal bleeding, narrow-angle glaucoma, paralysis of the intestines, trouble swallowing, Alzheimer"s disease, or dementia (if you"re older than 65).

Symbyax can cause dizziness and even fainting when getting up from sitting or lying down. If you experience this, notify your doctor.

The ingredients in Symbyax could cause an allergic reaction. Tell your doctor immediately if you develop a skin rash or hives.

Olanzapine and other antipsychotic drugs can cause a condition called Neuroleptic Malignant Syndrome (NMS). Symptoms include high fever, muscle rigidity, irregular pulse or blood pressure, rapid or irregular heartbeat, and excessive sweating. If these symptoms appear, contact your doctor immediately.

Symbyax could increase the risk of developing tardive dyskinesia, a condition marked by slow, rhythmic, involuntary movements. This problem is more likely to surface in older adults, especially women. If it does, your doctor may have you stop taking Symbyax.

Symbyax could trigger a manic episode. Your doctor will watch you closely for symptoms of mania.

Medications such as Symbyax can interfere with the regulation of body temperature. Do not get overheated or become dehydrated while taking Symbyax. Avoid extreme heat and drink plenty of fluids.

Symbyax sometimes causes drowsiness. It can impair your judgment, thinking, and motor skills. Use caution while driving, and don"t operate dangerous machinery until you know how the drug affects you.

Serotonin-boosting antidepressants such as fluoxetine, one of the ingredients in Symbyax, could potentially cause stomach bleeding. This is especially likely when serotonin-boosters are combined with nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), and ketoprofen (Orudis KT). Consult your doctor before combining Symbyax with NSAIDs or blood-thinning medications.

Animal studies suggest that olanzapine, one of the ingredients in Symbyax, may increase the risk of breast cancer, although human studies have not confirmed such a risk. If you have a history of breast cancer, see your doctor regularly for checkups.

Prolonged seizures have occurred in people receiving electroconvulsive therapy (ECT) while taking fluoxetine, one of the ingredients in Symbyax. To date, there are no clinical studies establishing the benefit of combined treatment with fluoxetine and ECT.

Possible food and drug interactions when taking Symbyax

Avoid alcohol while taking Symbyax. The combination can cause a sudden drop in blood pressure.

Never combine Symbyax with MAO inhibitors (see "Most important fact about Symbyax").

Do not take Symbyax with thioridazine (Mellaril). Wait at least 5 weeks between stopping Symbyax and starting thioridazine.

Be careful using Symbyax with Zyprexa, Zyprexa Zydis, Prozac, Prozac Weekly, or Sarafem. Symbyax contains the same active ingredients as these medications.

Be careful about combining Symbyax with aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, or with other drugs that affect blood clotting. The combination may increase the risk of bleeding.

If Symbyax is taken with certain other drugs, the effects of either can be increased, decreased, or altered. Ask your doctor before taking any other prescription or over-the-counter medication. It is especially important to check before combining Symbyax with the following:

Antidepressants known as tricyclics, such as Elavil
Blood pressure medications
Carbamazepine (Tegretol)
Clozapine (Clozaril)
Diazepam (Valium)
Drugs that boost the effect of dopamine, such as the Parkinson"s medications Mirapex, Parlodel, Permax, and Requip
Fluvoxamine
Haloperidol (Haldol)
Levodopa (Larodopa)
Lithium (Eskalith)
Phenytoin (Dilantin)
Pimozide (Orap)
Sumatriptan (Imitrex)
Tryptophan
Warfarin (Coumadin)

Let the doctor know if you smoke cigarettes, since this could affect how your body processes Symbyax.

Special information if you are pregnant or breastfeeding

If you are pregnant or plan to become pregnant, notify your doctor immediately. Symbyax should be used during pregnancy only if absolutely necessary.

You should not breastfeed while taking Symbyax. The drug may pass into breast milk and harm your baby.

Recommended dosage

ADULTS

The usual starting dose is one capsule containing 6 milligrams of olanzapine and 25 milligrams of fluoxetine, taken once a day in the evening. If needed, the doctor may gradually increase the dose. The usual dosage range is 6 to 12 milligrams of olanzapine and 25 to 50 milligrams of fluoxetine.

The doctor may adjust your dosage if you have liver problems, a high risk of low blood pressure, or a combination of factors that may slow your body"s processing of Symbyax (female, older age, nonsmoker).

CHILDREN

The safety and effectiveness of Symbyax have not been studied in children.

Overdosage

Overdose with fluoxetine, one of the ingredients in Symbyax, can be fatal. There have been reports of patients dying after overdosing on fluoxetine and olanzapine taken as separate drugs at the same time. If you suspect an overdose, seek emergency treatment immediately.

• Symptoms of overdose may include:
  Aggressive behavior, agitation, coma, confusion, convulsions, heart problems, irregular or fast heartbeat, loss of consciousness, problems with muscle coordination, problems with speech, sleepiness, sluggishness