Symbyax

1 What is Symbyax?

Brand: Symbyax

Generic: Olanzapine and Fluoxetine

Symbyax is used for the treatment of depression that is a part of bipolar disorder, and depression in patients who received other antidepressants that did not work well.

This drug combination works by increasing the activity of certain chemicals that relieve depression such as serotonin, norepinephrine, and dopamine in the brain. This drug combination requires a prescription.

2 What to Know Before Using

Before using Symbyax, you must know all about the risks and complications associated with it.

Inform your healthcare provider for any allergic reactions to these drugs or any other drugs, foods, dyes, preservatives, or animals. Carefully read the label of non-prescription drugs for any possible allergic reaction or contraindications.

Studies in children younger than 10 years of age and in children with treatment-resistant depression regarding the correlation of age to the effects of olanzapine and fluoxetine combination to treat bipolar I depression have not been performed while safety and efficacy have not been established in these groups.

Studies in the elderly have not demonstrated any geriatric-specific problems that would limit the utility of olanzapine and fluoxetine combination.

Adjustments in the dose of the elderly may be required since they are more likely to have dementia or age-related liver, kidney, or heart problems.

Adverse effects have been reported in animal studies but studies in pregnant women or animals are still inadequate. Infant risk is still undetermined when using this drug during breastfeeding.

Discuss with your healthcare professional about the potential risks and benefits of taking this drug while breastfeeding.

Drugs should not be taken together to prevent any interactions but in necessary cases inquire your healthcare provider regarding the adjustments in dosage or any other necessary precautions to prevent any unwanted side effects.

Inform your healthcare professional if you are taking any other drugs such as:

  • Benzodiazepines
  • Inducers of 1A2
  • Alcohol
  • Inhibitors of CYP1A2
  • Pimozide
  • Carbamazepine
  • Thioridazine
  • Tricyclic Antidepressants
  • Antihypertensive Agents
  • Levodopa and Dopamine Agonists
  • Benzodiazepines
  • Clozapine
  • Haloperidol
  • Phenytoin
  • Drugs metabolized by CYP2D6 Drugs
  • Metabolized by CYP3A
  • Lithium
  • Drugs tightly bound to plasma proteins
  • Valproate
  • Biperiden
  • Theophylline
  • Drugs that prolong the QT Interval

Intake of specific food or using alcohol or tobacco with this drug is associated with an increased risk of certain side effects.

Your healthcare professional can give you special instructions about the use of food, alcohol, or tobacco.

Inform your healthcare professional if you have any other medical problems such as:

3 Proper Usage

To use Symbyax properly, you must follow all instructions given by your doctor. This drug can be taken with or without food.

The dose of this drug will be variable for different patients. The directions on the label or the prescription by your healthcare professional should be followed.

The dosage of this drug you take depends on the medical problem for which you are using this drug. Adults with bipolar I depression are initially given one capsule containing 6 milligrams of olanzapine and 25 mg of fluoxetine once a day in the evening.

Your healthcare professional may adjust your dose as needed. The dose must not exceed 18 mg of olanzapine and 75 mg of fluoxetine per day.

Children 10 to 17 years of age are initially given one capsule containing 3 milligrams of olanzapine and 25 mg of fluoxetine once a day in the evening.

Your healthcare professional may adjust your dose as needed. The dose must not exceed 12 mg of olanzapine and 50 mg of fluoxetine per day.

Use and dose in children younger than 10 years of age must be determined by your healthcare professional. Adults with resistant depression are initially given one capsule containing 6 milligrams of olanzapine and 25 mg of fluoxetine once a day in the evening.

Your healthcare professional may adjust your dose as needed. The dose must not exceed 12 mg of olanzapine and 50 mg of fluoxetine per day.

Use and dose in children must be determined by your healthcare professional. A missed dose should be taken as soon as possible.

However, skip the missed dose and go back to your regular dosing schedule if it is almost time for your next dose.

Store the drug in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children.

Dispose any outdated or expired drugs and ask your healthcare professional for the proper disposal of the drugs.

4 Precautions to Take

Before using Symbyax, there are some precautions you must take. Regular visits should be made to your healthcare provider to track your progress and to monitor the effectiveness of the drug. Unwanted effects can be screened using blood tests.

It is not recommended to take this drug with a monoamine oxidase (MAO) inhibitor (eg, isocarboxazid [MarplanВ®], linezolid [ZyvoxВ®], methylene blue injection, phenelzine [NardilВ®], selegiline [EldeprylВ®], tranylcypromine [ParnateВ®]).

Taking this drug during the 2 weeks after you stop a MAO inhibitor is not recommended and it is advised to wait 5 weeks after stopping this drug before you start taking an MAO inhibitor.

Confusion, agitation, restlessness, stomach or intestinal symptoms, a sudden high body temperature, an extremely high blood pressure, or severe convulsions may develop if you take them together or do not wait for the proper amount of time.

Taking thioridazine (MellarilВ®) is not recommended with this drug, and it is advised to wait 5 weeks after stopping this drug before you start taking thioridazine.

Pimozide (OrapВ®) is contraindicated with this drug as these drugs together can cause very serious heart problems.

This drug may cause a serious condition called serotonin syndrome if taken together with some drugs such as buspirone (BusparВ®), fentanyl (AbstralВ®, DuragesicВ®), lithium (EskalithВ®, LithobidВ®), tryptophan, St. John's wort, or some pain or migraine drugs (eg, rizatriptan, sumatriptan, tramadol, FrovaВ®, ImitrexВ®, MaxaltВ®, RelpaxВ®, UltramВ®, ZomigВ®).

This drug can increase suicidal thoughts in some children, teenagers, and young adults. Inform your healthcare professional immediately if you start to feel more depressed and have thoughts about hurting yourself, or any unusual thoughts or behaviors that trouble you.

Inform your healthcare professional if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act recklessly. Inform your healthcare professional if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared.

Notify your healthcare professional if you or anyone in your family has bipolar disorder or has tried to commit suicide.

Check with your healthcare professional immediately if you are having symptoms of a neuroleptic malignant syndrome such as:

  • convulsions
  • difficulty with breathing
  • fast heartbeat
  • high fever
  • high or low blood pressure
  • increased sweating
  • loss of bladder control
  • severe muscle stiffness
  • unusually pale skin
  • tiredness

The cholesterol and fats levels in your blood may be increased by this drug. You will be given drugs that can lower the amount of cholesterol and fats in the blood if this happens.

Your healthcare professional will monitor your weight regularly during treatment with this drug, as weight changes have been reported with the use of this drug.

This drug may increase the amount of sugar in your blood. Check with your healthcare professional immediately if you have increased thirst or increased urination.

If you have diabetes, you may notice a change in the results of your urine or blood sugar tests.

Check with your healthcare professional immediately if you have any symptoms of a neuroleptic malignant syndrome such as:

  • convulsions
  • difficulty with breathing
  • a fast heartbeat
  • a high fever
  • high or low blood pressure
  • increased sweating
  • loss of bladder control
  • severe muscle stiffness
  • unusually pale skin
  • tiredness

Check with your healthcare professional immediately if you have any symptoms of tardive dyskinesia such as lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

Olanzapine injection may cause drowsiness, trouble with thinking, trouble with controlling body movements, or trouble with your vision.

Be careful in taking this drug before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help.

This drug may cause post-injection delirium/sedation syndrome which can manifest as convulsions, dizziness, drowsiness, sleepiness, or confusion as to time, place, or person after receiving the injection.

This drug can temporarily cause leukopenia which can increase the chance of getting an infection. It is recommended to avoid people with infections.

Check with your healthcare professional immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination. This drug may increase your risk for bleeding problems.

Inform your healthcare professional if you are also taking other drugs that thin the blood, such as aspirin, nonsteroidal antiinflammatory agents, also called NSAIDs (eg, diclofenac, ibuprofen, naproxen, AdvilВ®, AleveВ®, CelebrexВ®, VoltarenВ®), or warfarin (CoumadinВ®, JantovenВ®).

Check with your healthcare professional immediately if you have symptoms of hyponatremia such as confusion, difficulty concentrating, headaches, memory problems, weakness, and unsteadiness.

This drug may make it harder for your body to cool itself down. Prevent yourself from being overheated during exercise or hot weather since overheating may result in heat stroke.

Contact your healthcare professional right away if you have dizziness, fainting, or a fast, pounding, or uneven heartbeat.

Inform your healthcare professional if you have ever had a heart rhythm problem, such as QT prolongation, or if you or a family member has had a heart attack, heart failure, low blood pressure, or a stroke. This drug may cause drowsiness, trouble in thinking, trouble in controlling movements, or trouble in seeing clearly.

Make sure you know how you react to this drug before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well.

Check with your healthcare professional before you suddenly stop taking this drug. If you have been instructed to stop taking this drug, ask your healthcare professional how to slowly decrease the dose.

This is to decrease the chance of having symptoms such as agitation, breathing problems, chest pain, confusion, diarrhea, dizziness or lightheadedness, fast heartbeat, headache, increased sweating, muscle pain, nausea, restlessness, runny nose, trouble in sleeping, trembling or shaking, unusual tiredness or weakness, vision changes, or vomiting.

The use of alcohol is not recommended in patients who are using this drug. Consult with your healthcare professional before taking any other prescription or nonprescription drugs, and herbal or vitamin supplements.

5 Potential Side Effects

As with many medications, there are several potential side effects associated with Symbyax. Seek advice from your healthcare professional immediately if you experience any unusual symptoms.

Some side effects may occur that usually do not need medical attention. As your body adjusts to the medicine, the side effects will slowly disappear. Ask your healthcare professional about ways to prevent or reduce some of these side effects.

If any of the following side effects persists or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional. Report any side effects to the FDA hotline at 1-800-FDA-1088.

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