Symbyax

DRUG DESCRIPTION

SYMBYAX (olanzapine and fluoxetine HC1 capsules) combines an atypical antipsychotic and a selective serotonin reuptake inhibitor, olanzapine (the active ingredient in Zyprexa, and Zyprexa Zydis) and fluoxetine hydrochloride (the active ingredient in Prozac, Prozac Weekly, and Sarafem).

Olanzapine belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b] [1,5]benzodiazepine. The molecular formula is C17H20N4S, which corresponds to a molecular weight of 312.44.

Fluoxetine hydrochloride is a selective serotonin reuptake inhibitor (SSRI). The chemical designation is (±)-N-methyl-3phenyl-3-[(?,?,?-trifluoro-p-tolyloxy]propylamine hydrochloride. The molecular formula is C17H18F3NO•HCl, which corresponds to a molecular weight of 345.79.

The chemical structures are:

SYMBYAX
  (olanzapine and fluoxetine hydrochloride) capsule  Structural Formula Illustration

Olanzapine is a yellow crystalline solid, which is practically insoluble in water.

Fluoxetine hydrochloride is a white to off-white crystalline solid with a solubility of 14 mg/mL in water.

SYMBYAX capsules are available for oral administration in the following strength combinations:

  3 mg/25 mg 6 mg/25 mg 6 mg/50 mg 12 mg/25 mg 12 mg/50 mg
olanzapine equivalent 3 6 6 12 12
fluoxetine base equivalent 25 25 50 25 50

Each capsule also contains pregelatinized starch, gelatin, dimethicone, titanium dioxide, sodium lauryl sulfate, edible black ink, red iron oxide, yellow iron oxide, and/or black iron oxide.

What are the possible side effects of fluoxetine and olanzapine (Symbyax)?

Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once...

Read All Potential Side Effects and See Pictures of Symbyax »

What are the precautions when taking olanzapine and fluoxetine (Symbyax)?

Before taking olanzapine/fluoxetine, tell your doctor or pharmacist if you are allergic to olanzapine or fluoxetine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: personal or family history of suicide attempts, breast cancer, diabetes or family history of diabetes, heart disease (e.g., chest pain, heart attack, heart failure, irregular heartbeat), intestinal problems (e.g., paralytic ileus, chronic constipation), kidney disease, liver problems, low blood pressure, neuroleptic malignant syndrome, narrow-angle glaucoma, prostate problems, seizures,...

Read All Potential Precautions of Symbyax »


Symbyax Consumer (continued)

SIDE EFFECTS: See also the Warning section.

Dizziness, drowsiness, diarrhea, dry mouth, constipation, increased appetite, weight gain, or trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, unusual or severe mental/mood changes (e.g., nervousness, trouble concentrating, rare thoughts of suicide), swelling hands/ankles/feet, restlessness, shaking (tremor), inability to keep still, decreased interest in sex, changes in sexual ability.

Tell your doctor immediately if any of these rare but very serious side effects occur: black stools, vomit that looks like coffee grounds, easy bruising/bleeding, muscle spasm, change in the amount of urine, yellowing eyes/skin, dark urine, severe stomach/abdominal pain, slow/irregular/fast heartbeat, signs of infection (such as fever, persistent sore throat).

Seek immediate medical attention if any of these rare but very serious side effects occur: weakness on one side of body, sudden vision changes, severe headache, seizures.

This drug may infrequently make your blood sugar level rise, an effect that may cause or worsen diabetes. This high blood sugar can rarely cause serious conditions such as diabetic coma. Tell your doctor immediately if you develop symptoms of high blood sugar, such as increased thirst/urination or unexplained weakness. If you already have diabetes, be sure to check your blood sugars regularly and share the results with your doctor. Your doctor may need to adjust your medication, diet, and exercise program when you start or stop this medication.

This drug may also cause significant weight gain and a rise in your blood cholesterol (or triglyceride) levels, especially in teenagers. These effects, along with diabetes, may increase your risk for developing heart disease. Discuss the risks and benefits of treatment with your doctor. (See also Notes section.)

This medication may rarely cause a very serious condition called serotonin syndrome. The risk increases when this medication is used with certain other drugs such as "triptans" used to treat migraine headaches (e.g., sumatriptan, eletriptan), certain antidepressants including other SSRIs (e.g., citalopram, paroxetine) and SNRIs (e.g., duloxetine, venlafaxine), lithium, tramadol, tryptophan, or a certain drug to treat obesity (sibutramine). See also Drug Interactions section. Before taking this drug, tell your doctor if you take any of these medications. Serotonin syndrome may be more likely when you start or increase the dose of any of these medications. Seek immediate medical attention if you develop any of the following symptoms: hallucinations, unusual restlessness, severe dizziness, unexplained fever, loss of coordination, severe nausea/vomiting/diarrhea, twitchy muscles.

This medication may rarely cause a serious condition called neuroleptic malignant syndrome (NMS). Seek immediate medical attention if you develop the following: confusion, high fever, muscle stiffness, severe sweating, fast or irregular heartbeat.

Olanzapine may rarely cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor immediately if you develop any unusual/uncontrolled movements (especially of the face/lips/tongue).

In rare cases, this medication may increase your blood level of a certain hormone (prolactin). For females, this rare increase in prolactin levels may result in unwanted breast milk, irregular/stopped menstrual periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor immediately.

For males, in the very unlikely event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and seek immediate medical attention, or permanent problems could occur.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking olanzapine/fluoxetine, tell your doctor or pharmacist if you are allergic to olanzapine or fluoxetine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: personal or family history of suicide attempts, breast cancer, diabetes or family history of diabetes, heart disease (e.g., chest pain, heart attack, heart failure, irregular heartbeat), intestinal problems (e.g., paralytic ileus, chronic constipation), kidney disease, liver problems, low blood pressure, neuroleptic malignant syndrome, narrow-angle glaucoma, prostate problems, seizures, stomach/intestinal ulcers, brain problems (e.g., dementia, stroke), severe loss of body water (dehydration), low white blood cell count.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

To reduce dizziness and lightheadedness, get up slowly when rising from a sitting or lying position, especially when you first start taking this medication.

This medication can make it harder to control your body temperature. Avoid activities that might cause you to overheat (e.g., doing strenuous work, exercising in hot weather, or using hot tubs). Drink plenty of fluids to avoid becoming dehydrated.

Teenagers may be more sensitive to the side effects of this drug, especially weight gain, and also increased amounts of cholesterol, triglycerides and prolactin. See also Side Effects section for more details.

Older adults may be more sensitive to the side effects of this drug, especially a type of mineral imbalance (hyponatremia) that is more common when taking "water pills" or diuretics with this medication.

During pregnancy, this medication should be used only when clearly needed. Babies born to mothers who have used this drug during the last 3 months of pregnancy may infrequently develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn anytime during their first month, tell the doctor right away.

Since untreated depression can be a serious condition, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss the benefits and risks of using this medication during pregnancy with your doctor.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Symbyax Patient Information Including Side Effects

Brand Names: Symbyax

Generic Name: fluoxetine and olanzapine (Pronunciation: floo OX eh teen and oh LAN za peen)

  • What is fluoxetine and olanzapine (Symbyax)?
  • What are the possible side effects of fluoxetine and olanzapine (Symbyax)?
  • What is the most important information I should know about fluoxetine and olanzapine (Symbyax)?
  • What should I discuss with my healthcare provider before taking fluoxetine and olanzapine (Symbyax)?
  • How should I take fluoxetine and olanzapine (Symbyax)?
  • What happens if I miss a dose (Symbyax)?
  • What happens if I overdose (Symbyax)?
  • What should I avoid while taking fluoxetine and olanzapine (Symbyax)?
  • What other drugs will affect fluoxetine and olanzapine (Symbyax)?
  • Where can I get more information?

What is fluoxetine and olanzapine (Symbyax)?

Fluoxetine is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs).

Olanzapine is an antipsychotic medication. These drugs affect chemicals in the brain.

The combination of fluoxetine and olanzapine is used to treat depression caused by bipolar disorder (manic depression). Fluoxetine and olanzapine is also used to treat depression after at least 2 other medications have been tried without successful treatment of symptoms.

Fluoxetine and olanzapine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of fluoxetine and olanzapine (Symbyax)?

Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

  • sudden and severe headache, blurred vision, confusion, chest pain, numbness, and problems with vision, speech, or balance;
  • increased thirst, frequent urination, excessive hunger, or weakness;
  • fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, trouble breathing;
  • jerky muscle movements you cannot control;
  • seizure (convulsions);
  • feeling like you might pass out;
  • easy bruising or bleeding; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • trouble swallowing, runny nose, sore throat;
  • weight gain, swelling in your hands of feet;
  • drowsiness, trouble concentrating, sleep problems (insomnia);
  • dry mouth, diarrhea, changes in appetite; or
  • decreased sex drive, impotence, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about fluoxetine and olanzapine (Symbyax)?

This medication is not for use in psychotic conditions related to dementia. Olanzapine may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.

Do not take fluoxetine and olanzapine together with pimozide (Orap), thioridazine (Mellaril), or a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), rasagiline (Azilect), phenelzine (Nardil), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate).

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Olanzapine can cause high blood sugar (hyperglycemia). If you are diabetic, check your blood sugar levels on a regular basis while you are taking olanzapine.

SSRI antidepressants may cause serious or life-threatening lung problems in newborn babies whose mothers take the medication during pregnancy. However, you may have a relapse of depression if you stop taking your antidepressant during pregnancy. If you are planning a pregnancy, or if you become pregnant while taking fluoxetine and olanzapine, do not stop taking the medication without first talking to your doctor.

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