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Symbyax Warnings and Precautions

Specific Symbyax Warnings and Precautions

Warnings and precautions to be aware of prior to taking Symbyax include the following:
 
  • Antidepressants, including fluoxetine (Prozac®) -- one of the components of Symbyax -- may increase the risk of suicidal thoughts or behavior (see Depression and Suicide). Therefore, if you notice any changes in symptoms or develop new symptoms, talk to your healthcare provider immediately. Some of these symptoms can include:
 
    • Anxiety
    • Hostility
    • Agitation
    • Panic
    • Restlessness
    • Hallucinations
    • Extreme hyperactivity
 
  • The U.S. Food and Drug Administration (FDA) has issued a special warning (a "black box warning") about the use of Symbyax in elderly people with dementia (a condition involving confusion; disorientation; and a loss of memory, intellect, and judgment) or psychosis.
Elderly people with dementia (Alzheimer's disease is the most common form) who are treated with antipsychotics -- including Symbyax -- are more likely to die of various causes than those who were not treated with those medications. Symbyax is not approved to treat dementia or dementia-related psychosis, and caution should be used before prescribing Symbyax to such people.  
  • Symbyax can cause a life-threatening condition called neuroleptic malignant syndrome (NMS). Some symptoms of NMS include:

 

    • A high fever
    • Stiff muscles
    • Confusion
    • An irregular pulse or blood pressure
    • A fast heart rate (tachycardia)
    • Sweating
    • An irregular heart rhythm (arrhythmia).
Tell your healthcare provider right away if think you might have NMS.
  • Symbyax can cause tardive dyskinesia, a condition involving unusual and uncontrollable body or facial movements. The condition can become permanent even if Symbyax is stopped. The best way to prevent it from becoming permanent is to tell your healthcare provider right away if you notice any abnormal movements (including abnormal movements of the tongue) while taking the drug.
     
  • There is an increased risk of strokes in elderly people who take Symbyax for dementia. The medication is not approved for the treatment of dementia in the elderly.
     
  • Symbyax can cause an increase in blood sugar levels and can increase the risk of developing diabetes. Tell your healthcare provider if you develop signs of diabetes while taking the drug. Possible signs include increases in thirst, urination, or hunger. If you have diabetes, your blood sugar should be monitored carefully and regularly during treatment with Symbyax to make sure that it is not becoming more severe (see Symbyax and Diabetes).
     
  • Symbyax can cause a drop in blood pressure when going from a sitting or lying-down position to standing (known medically as orthostatic hypotension). This can cause a person to have lightheadedness, dizziness, or fainting spells. Tell your healthcare provider if you have any of these symptoms when standing.
     
  • Taking Symbyax with other medications that affect serotonin can increase your risk of a dangerous group of symptoms called serotonin syndrome. These other medications include other antidepressants, triptans (migraine medications), and several other medications (see Symbyax Drug Interactions). Contact your healthcare provider immediately if you have any possible symptoms of serotonin syndrome, including:

 

    • Confusion
    • Seeing or hearing things that are not really there (hallucinations)
    • A fast heartbeat (tachycardia)
    • Feeling faint
    • Fever
    • Sweating
    • Muscle spasms
    • Difficulty walking
    • Diarrhea

 

  • Symbyax may increase the risk of seizures. Before starting the drug, tell your healthcare provider if you have epilepsy or a history of seizures.
 
  • Symbyax may cause a change in the heart rhythm known as QT prolongation. In some cases, QT prolongation can turn into a life-threatening arrhythmia known as torsade de pointes. People taking other QT-prolonging medications or people with long QT syndrome, heart problems, low magnesium or potassium in the blood, or liver problems might be at a higher risk for this problem.
 
  • Symbyax can cause difficulty swallowing, which can lead to inhalation of food and possibly pneumonia. Tell your healthcare provider if you notice any problems swallowing.

 

 

  • Symbyax can increase the level of a certain hormone (prolactin) in the blood. Increased prolactin can cause breast enlargement in men and women, impotence (erectile dysfunction or ED) in men, unusual breast discharge in women, and menstrual changes in women. Tell your healthcare provider if you have any of these side effects. High prolactin levels may increase the risk of osteoporosis (see High Prolactin Levels and Osteoporosis) and may stimulate the growth of certain breast cancers.
     
  • Symbyax can cause an increase in liver enzymes. Usually, this increase is harmless, although liver damage could occur. Talk with your healthcare provider before taking Symbyax if you have liver problems.
     
  • The medication may cause bleeding in the stomach or intestines. This risk is increased in those taking aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen. Symptoms of gastrointestinal bleeding may include:

 

    • Bright red blood coating the stool
    • Dark blood mixed with the stool
    • Black or tarry stool
    • Bright red blood in vomit
    • Vomit that has the appearance of coffee grounds.
If you experience any of these symptoms, call your healthcare provider.
  • If you are elderly or taking a diuretic, Symbyax could cause low salt levels in the blood (hyponatremia). This generally returns to "normal" levels when Symbyax is discontinued.
     
  • Symbyax may affect your ability to perform complex tasks requiring mental and motor skills. Therefore, it is recommended that you become accustomed to its effects on you before becoming involved in activities requiring mental or motor concentration (such as driving a car or operating machinery).
     
  • Symbyax is considered a pregnancy Category C medication. This means that it may not be safe to take during pregnancy. Be sure to talk with your healthcare provider about the risks and benefits of using the drug while pregnant (see Symbyax and Pregnancy).
     
  • Symbyax passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to taking the drug (see Symbyax and Breastfeeding).
     
  • Symbyax can make certain medical conditions worse, including glaucoma (a condition of the eye), bowel blockages or bowel obstruction, and an enlarged prostate (benign prostatic hyperplasia or BPH). Talk with your healthcare provider if you have any of these conditions.
     
  • Symbyax has not been fully studied in people with liver, kidney, or heart problems. Talk with your healthcare provider if you have any of these conditions.
     
  • In general, alcohol should be avoided while taking the drug (see Alcohol and Symbyax).
     
  • Symbyax can interact with certain other medications (see Symbyax Drug Interactions).
 
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