EFFEXOR (Venlafaxine)

What is Effexor XR?

Effexor XR (venlafaxine) is an antidepressant belonging to a group of drugs called selective serotonin and norepinephrine reuptake inhibitors (SSNRIs). Venlafaxine affects chemicals in the brain that may be unbalanced in people with depression.

Effexor XR is a prescription medicine used in adults to treat major depressive disorder, generalized anxiety disorder (GAD), social anxiety disorder (SAD), and panic disorder.

Talk to your healthcare provider if you do not think that your condition is getting better with Effexor XR treatment.

Warnings

You should not take Effexor if you have uncontrolled narrow-angle glaucoma, or if you are being treated with methylene blue injection.

Do not use Effexor XR within 7 days before or 14 days after you have used an MAO inhibitor, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, or tranylcypromine.

Some young people have thoughts about suicide when first taking an antidepressant. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor, 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.

Do not stop using Effexor XR without first talking to your doctor.

Do not give this medicine to anyone younger than 18 years old without the advice of a doctor. Effexor XR is not approved for use in children.

Do not stop using Effexor XR without first asking your doctor.

Before taking this medicine

You should not take Effexor XR if you are allergic to venlafaxine or desvenlafaxine (Pristiq), or if you have uncontrolled narrow-angle glaucoma.

Do not use Effexor XR within 7 days before or 14 days after you have used an MAO inhibitor, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, or tranylcypromine. A dangerous drug interaction could occur.

Tell your doctor if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson’s disease, migraine headaches, serious infections, or prevention of nausea and vomiting. An interaction with Effexor XR could cause a serious condition called serotonin syndrome.

To make sure Effexor XR is safe for you, tell your doctor if you have ever had:

• bipolar disorder (manic depression);
• liver disease;
• kidney disease;
• heart disease, high blood pressure, high cholesterol;
• diabetes;
• glaucoma;
• a thyroid disorder;
• a seizure;
• sexual problems;
• bleeding problems; or
• low blood levels of sodium.

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Effexor XR is not approved for use by anyone younger than 18 years old.

Taking this medicine during pregnancy could harm the baby, but stopping the medicine may not be safe for you. Do not start or stop Effexor XR without asking your doctor.

Venlafaxine can pass into breast milk and may harm a nursing baby. If venlafaxine was used successfully during your pregnancy, speak to your doctor about the risks and benefits of continuing it while breastfeeding.

How should I take Effexor XR?

Take Effexor XR exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Take Effexor XR with food at the same time each day.

Do not chew an extended-release capsule. To make the extended-release Effexor XR capsule easier to swallow, you may open the capsule and sprinkle the medicine into a small amount of applesauce. Swallow all of the mixture without chewing, and do not save any for later use.

Tell your doctor if you have any changes in sexual function, such as loss of interest in sex, trouble having an orgasm, or (in men) problems with erections or ejaculation. Some sexual problems can be treated.

Do not stop using Effexor XR suddenly, or you could have unpleasant symptoms (such as agitation, confusion, tingling or electric shock feelings). Ask your doctor how to safely stop using this medicine.

Your symptoms may not improve for several weeks.

Your blood pressure will need to be checked often.

This medicine may cause false results on a drug-screening urine test. Tell the laboratory staff that you use Effexor XR.

Store at room temperature away from moisture and heat.

Dosing information

Usual Adult Dose for Depression:

Extended release:
-Initial dose: 75 mg orally once a day
-Maintenance dose: 75 to 225 mg orally once a day
-Maximum dose:
—Moderately depressed outpatients: 225 mg/day
—Severely depressed inpatients: 375 mg/day

Comments:
Healthcare providers should consider initial extended release doses of 37.5 mg orally once a day for 4 to 7 days (before increasing the dose to 75 mg/day) in patients who may require additional time to adjust to the drug.
-Doses may be increased in daily increments of up to 75 mg orally at intervals of no less than 4 days.
-Patients should be periodically reassessed for the continued need of maintenance treatment and for the appropriate dose of treatment.
-Use of doses exceeding 225 mg/day is limited.

Usual Adult Dose of for Generalized Anxiety Disorder:

Extended release:
-Initial dose: 75 mg orally once a day
-Maintenance dose: 75 to 225 mg orally once a day
-Maximum dose: 225 mg/day

Comments:
-Healthcare providers should consider initial extended release doses of 37.5 mg orally once a day for 4 to 7 days (before increasing the dose to 75 mg/day) in patients who may require additional time to adjust to the drug.
-Doses may be increased in daily increments of up to 75 mg orally at intervals of no less than 4 days.

Usual Adult Dose of for Social Anxiety Disorder:

Extended release: 75 mg orally once a day

Comment: There is no evidence that doses greater than 75 mg/day confer additional benefit.

Usual Adult Dose for Panic Disorder:

Extended release:
-Initial dose: 37.5 mg orally once a day for 7 days, then 75 mg orally once a day thereafter
-Maintenance dose: 75 to 225 mg orally once a day
-Maximum dose: 225 mg/day

Comment: Doses may be increased in daily increments of 75 mg orally at intervals of no less than 7 days.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What should I avoid while taking Effexor XR?

Do not drink alcohol.

Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin, ibuprofen, naproxen, Advil, Aleve, Motrin, and others. Using an NSAID with Effexor XR may cause you to bruise or bleed easily.

Avoid driving or hazardous activity until you know how Effexor XR will affect you. Your reactions could be impaired.

Effexor XR side effects

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

Report any new or worsening symptoms to your doctor, 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:

• blurred vision, eye pain or redness, seeing halos around lights;
• cough, chest tightness, trouble breathing;
• a seizure (convulsions);
• unusual bleeding nose bleeds, bleeding gums, abnormal vaginal bleeding, any bleeding that will not stop;
• low blood sodium – headache, confusion, problems with thinking or memory, weakness, feeling unsteady; or
• severe nervous system reaction – very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea

Common Effexor XR side effects may include:

• headache, dizziness, drowsiness, tiredness;
• feeling anxious, nervous, or jittery;
• sleep problems, unusual dreams;
• tremors;
• fast heartbeats;
• blurred vision;
• nausea, vomiting, diarrhea, constipation;
• changes in weight or appetite;
• dry mouth, yawning;
• increased sweating; or
• sexual problems.

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 other drugs will affect Effexor XR?

Using Effexor XR with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Tell your doctor about all your current medicines. Many drugs can interact with venlafaxine, especially:

• any other antidepressant;
• cimetidine;
• tramadol;
• St. John’s wort, tryptophan (sometimes called L-tryptophan);
• diet pills, weight loss medicine (such as phentermine);
• a blood thinner – warfarin, Coumadin, Jantoven;
• medicine to treat mood disorders, thought disorders, or mental illness – buspirone, lithium, and many others; or
• migraine headache medicine – sumatriptan, zolmitriptan, and others.