OLANZAPINE-FLUOXETINE

Antidepressant medications are used to treat a variety of conditions, including depression and other mental/mood disorders. These medications can help prevent suicidal thoughts/attempts and provide other important benefits. However, studies have shown that a small number of people (especially people younger than 25) who take antidepressants for any condition may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. Therefore, it is very important to talk with the doctor about the risks and benefits of antidepressant medication (especially for people younger than 25), even if treatment is not for a mental/mood condition.

Tell the doctor right away if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed.

There may be a slightly increased risk of serious, possibly fatal side effects (such as stroke, heart failure, fast/irregular heartbeat, pneumonia) when this medication is used by older adults with dementia. This medication is not approved for the treatment of dementia-related behavior problems. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for dementia-related behavior problems, with the doctor.

Minor side effects (if these symptoms persist or worsen, inform your doctor)

• Dizziness, lightheadedness, drowsiness, diarrhea, dry mouth, constipation, increased appetite, weight gain, or trouble sleeping

Serious side effects (inform your doctor immediately)

• unusual or severe mental/mood changes (e.g., confusion, 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, trouble urinating, black stools, vomit that looks like coffee grounds, easy bruising/bleeding, muscle spasm, yellowing eyes/skin, severe stomach/abdominal pain, slow heartbeat, signs of infection (such as fever, persistent sore throat), fainting, severe headache, seizures, eye pain/swelling/redness, vision changes (such as seeing rainbows around lights at night, blurred vision)
• May rarely cause a very serious condition called neuroleptic malignant syndrome (NMS)
• fever, muscle stiffness/pain/tenderness/weakness, severe tiredness, severe confusion, sweating, fast/irregular heartbeat, dark urine, change in the amount of urine.

• May rarely cause a condition known as tardive dyskinesia
  • unusual/uncontrolled movements (especially of the face/lips/tongue)
• For males it may cause a very unlikely event you have a painful or prolonged erection lasting 4 or more hours

May rarely cause changes in blood sugar, especially if you have diabetes

• Symptoms of high blood sugar include increased thirst and urination
• Symptoms of low blood sugar include nervousness, shakiness, sweating, fast heartbeat, and hunger

May also cause significant weight gain and a rise in your blood cholesterol (or triglyceride) levels, especially in teenager.

May increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity.

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 right away.

Severe allergic reactions are rare. Get immediate medical help if you notice the following:

• Rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Precautions

• Inform your doctor.
  • Allergy to the medication or any allergies.
  • Medical History of personal or family history of suicide attempts, breast cancer, intestinal problems (e.g., paralytic ileus, chronic constipation), kidney disease, liver problems, low blood pressure, neuroleptic malignant syndrome, personal or family history of glaucoma (angle-closure type), prostate problems, seizures, stomach/intestinal ulcers, brain problems (e.g., dementia, stroke), severe loss of body water (dehydration), low white blood cell count, personal or family history of diabetes, heart disease, high cholesterol/triglyceride levels.

• May cause dizziness or drowsiness. Limit alcohol intake.

• May cause QT prolongation, a condition that affects the heart rhythm.
  • Risk increases if you have the following conditions:
    • Heart problems, family history of certain heart problems.
    • Low levels of potassium or magnesium.
      • Usage of such as diuretics/”water pills” or presence of conditions such as severe sweating, diarrhea, or vomiting.

• May 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.

• Should only be used when there is a clear need during pregnancy as it may harm an unborn baby. If you are planning to be pregnant or think you may be pregnant, discuss the risks and benefits of use with your doctor.

• Consult your doctor before breast-feeding as this medication passes into breast milk and may cause unwanted effects on your baby.

Interactions

Taking multiple drugs may affect how medications work and/or cause unwanted side effects. List down all the medications you are taking and inform your physician and pharmacist. Do not take, discontinue, or alter any dose of medications without prior approval of your physician.

• Products that may interact with this medication include:
  • drugs removed from your body by certain liver enzymes (e.g., carbamazepine, cimetidine, phenytoin, vinblastine, drugs for anxiety such as alprazolam and diazepam, antipsychotics such as aripiprazole/clozapine/haloperidol/perphenazine, antiarrhythmics such as propafenone/flecainide, TCA antidepressants such as desipramine/imipramine), fosamprenavir/ritonavir, metoprolol, “water pills” (diuretics such as furosemide), drugs that can cause bleeding/bruising (e.g., aspirin, antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen, “blood thinners” such as heparin, warfarin), drugs for high blood pressure, medicines for Parkinson’s disease (e.g., cabergoline).
  • Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for 2 weeks before and at least 5 weeks after treatment with this medication. Ask your doctor when to start or stop taking this medication.
  • Aspirin can increase the risk of bleeding when used with this medication (see above). If your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Discuss the risks and benefits with your doctor.
  • Risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Examples include street drugs such as MDMA/”ecstasy” St. John’s wort, certain antidepressants (including other SSRIs such as citalopram/paroxetine, SNRIs such as duloxetine/venlafaxine), tryptophan, among others. The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs.
• Double check the labels on all medications you are currently taking especially cough-and-cold products since they may contain drowsiness-causing components.

• Cigarette smoking may decrease blood levels of this medication.

• Laboratory tests that may be affected:
  • Brain scan for Parkinson’s disease.

• If overdose is suspected, contact a poison control center or emergency room immediately.
  • irregular heartbeat, seizures, loss of consciousness.

Missed Dose: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and as soon as you remember, take a regular dose or if the time of the next dose is near, wait for it before taking another dose and resume your usual schedule. Do not increase the dose to compensate for the missed dose.

Storage:

• Room temperature 25 degrees C
• Brief storage between 59-86 degrees F (15-30 degrees C) is allowed
• Do not expose to light and moisture
• Do not store in the bathroom
• Keep all medications away from pets and children