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(ven-luh-FAX-een)

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

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Effexor XR

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 children/teenagers) 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 children/teenagers), even if treatment is not for a mental/mood condition.

Tell the doctor immediately 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.

Venlafaxine is an antidepressant (serotonin-norepinephrine reuptake inhibitor type-SNRI) used in the treatment of depression, anxiety, and panic attacks. It works by restoring the balance of natural substances (neurotransmitters such as serotonin and norepinephrine) in the brain. Venlafaxine may improve your mood, feelings of well-being, and energy level and decrease nervousness and the number of panic attacks you may have.

Read the Medication Guide provided by your pharmacist before you start using venlafaxine and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Take this medication with food, usually once daily or as directed by your doctor. Dosage is based on your medical condition and response to treatment.

Swallow the medication whole. Do not crush, break, or chew the capsule or place it in water. If you have difficulty swallowing this medication whole, you may open the capsule, sprinkle the contents onto a spoonful of applesauce, and swallow immediately. Do not chew the food/medication mixture. Follow each dose with a glass of water.

To reduce your risk of side effects, your doctor may direct you to start taking this drug at a low dose and gradually increase your dose. Follow your doctor's instructions carefully. Do not take more or less medication or take it more frequently than prescribed. Your condition will not improve any faster, and your risk of side effects will increase. Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time each day.

It is important to continue taking this medication even if you feel well. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased.

This medication may cause dependence, especially if it has been used regularly for an extended time or if it has been used in high doses. In such cases, withdrawal reactions (e.g., nausea, vomiting, headache, numbness, tingling, nightmares) may occur if you suddenly stop this drug. To prevent withdrawal when stopping extended/regular treatment with this drug, gradually reduce the dosage as directed. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.

It may take several weeks to feel the full benefit of this medication. Tell your doctor if your condition persists or worsens.

Before taking venlafaxine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

personal or family history of psychiatric disorders (e.g., bipolar/manic-depressive disorder)
personal or family history of suicide attempts
bleeding problems
severe loss of body water (dehydration)
glaucoma
high blood pressure
heart problems (chest pain, irregular heartbeat, heart failure, heart attack)
high cholesterol
kidney disease
liver disease
seizure disorder
thyroid problems
low sodium in the blood (e.g., hyponatremia)

This drug may make you dizzy or drowsy. Use caution while driving, using machinery, or doing any other activity that requires alertness. Avoid alcoholic beverages.

Caution is advised when using this medication in the elderly because they may be more sensitive to its effects. The elderly are more likely to lose too much salt (hyponatremia), especially if they are also taking "water pills" (diuretics) with this medication.

Caution is advised when using this drug in children because it may affect weight, growth rate, and final height. Consult your doctor or pharmacist for more details.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Also, babies born to mothers who have used this drug during the last 3 months of pregnancy may infrequently develop withdrawal symptoms such as feeding/breathing difficulties, seizures, muscle stiffness, or constant crying. If you notice any of these symptoms in your newborn, tell the doctor promptly.

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 is not recommended while using this drug. Consult your doctor before breast-feeding.

See also Warning section.

Headache, drowsiness, dizziness, nausea, weakness, dry mouth, constipation, loss of appetite, weight loss, blurred vision, tiredness, nervousness, trouble sleeping, sweating, or yawning may occur. If any of these effects persist or worsen, tell your doctor promptly.

Venlafaxine may increase blood pressure. Your blood pressure should be checked regularly while you are taking this medication.

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
severe/pounding headache
unusual or severe mental/mood changes (e.g., extreme anxiety, unusual high energy/excitement, rare thoughts of suicide)
shakiness (tremor)
decreased interest in sex
changes in sexual ability
difficulty urinating
change in the amount of urine

Tell your doctor immediately if any of these rare but very serious side effects occur:

stomach/abdominal pain
chest pain
persistent cough
shortness of breath
bloody/black/tarry stools
vomit that looks like coffee grounds
easy bruising/bleeding
fast/irregular/pounding heartbeat
muscle weakness/cramps
yellowing eyes/skin
dark urine
seizures
unusual tiredness

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 SSRIs (e.g., citalopram, paroxetine) and other SNRIs (e.g., duloxetine), 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 some of the following symptoms:

hallucinations
restlessness
loss of coordination
fast heartbeat
severe dizziness
unexplained fever
severe nausea/vomiting/diarrhea
twitchy muscles

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
severe dizziness
trouble breathing

If you notice other effects not listed above, contact your doctor or pharmacist.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Taking certain medications with this product could result in serious (rarely fatal) drug interactions. Avoid taking MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) with venlafaxine for 2 weeks before treatment, during treatment, and at least 7 days after your last dose of venlafaxine. Consult your doctor or pharmacist for more information.

This drug should also not be used with the following medications because very serious (possibly fatal) interactions may occur:

weight loss drugs (e.g., sibutramine, phentermine)
tryptophan

If you are currently using any of these medications, tell your doctor or pharmacist before starting venlafaxine.

Certain drugs that may affect the heart rhythm (QTc prolongation in the EKG) include amiodarone, dofetilide, pimozide, quinidine, sotalol, procainamide, thioridazine, and erythromycin, among others. Venlafaxine may increase the risk of this effect. QTc prolongation can infrequently result in a serious (rarely fatal) irregular heartbeat. Consult your doctor or pharmacist for more details and for instructions on how you may reduce this risk of this effect.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of:

drugs removed from your body by certain liver enzymes (e.g., antipsychotics such as clozapine/ haloperidol, HIV medications such as indinavir, tricyclic antidepressants-TCAs such as desipramine)
drugs affecting liver enzymes that remove venlafaxine from your body (e.g., cimetidine, azole antifungals such as ketoconazole, itraconazole)
"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)

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.

Also tell your doctor if you take any other drugs that increase serotonin, such as buspirone, dextromethorphan, lithium, meperidine, propoxyphene, SSRIs, other SNRIs, St. John's wort, drugs used to treat migraines such as "triptans" and dihydroergotamine, street drugs such as MDMA/"ecstasy," amphetamine. (See also Side Effects section.)

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, amitriptyline, trazodone). Check the labels on all your medicines (e.g., allergy, cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using these products safely.

Cimetidine is a nonprescription drug that is commonly used to treat extra stomach acid. Because it may cause undesirable interactions when used with venlafaxine, ask your pharmacist about other products to treat stomach acid.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness, seizures, fast/irregular heartbeat.

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 resume your usual dosing schedule. Do not double the dose to catch up.

Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Do not share this medication with others.

Psychiatric/medical check-ups or lab tests (e.g., blood pressure, cholesterol, growth monitoring in children) should be done periodically to monitor your progress or check for side effects. Consult your doctor for more details.

The information contained in the First DataBank databases is intended to supplement the knowledge of physicians, pharmacists, and other healthcare professionals regarding drug therapy problems and patient counselling information. This information is advisory only and is not intended to replace sound clinical judgment in the delivery of healthcare services.

First DataBank disclaims all warranties, whether expressed or implied, including any warranty as to the quality, accuracy, and suitability of this information for any purpose.

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