Effexor XR

Generic name: venlafaxine
Drug class: Serotonin-norepinephrine reuptake inhibitors

Medically reviewed by A Ras MD.

What is Effexor XR?

Effexor XR is a prescription medicine used to treat depression. It is important to talk with your healthcare provider about the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider. Effexor XR is also used to treat Generalized Anxiety Disorder (GAD), Social Anxiety Disorder (SAD), Panic Disorder (PD).

Description

Effexor XR is an extended-release capsule for once-a-day oral administration that contains venlafaxine hydrochloride, a SNRI.

Venlafaxine is designated (R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl] cyclohexanol hydrochloride or (±)-1-[α- [(dimethylamino)methyl]-p-methoxybenzyl] cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.86. The structural formula is shown as follows:

Venlafaxine hydrochloride is a white to off-white crystalline solid, with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol:water (0.2 M sodium chloride) partition coefficient is 0.43.

Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH-dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.

Mechanism of Action

The exact mechanism of the antidepressant action of venlafaxine in humans is unknown, but is thought to be related to the potentiation of serotonin and norepinephrine in the central nervous system, through inhibition of their reuptake. Non- clinical studies have demonstrated that venlafaxine and its active metabolite, ODV, are potent and selective inhibitors of neuronal serotonin and norepinephrine reuptake and weak inhibitors of dopamine reuptake.

What is the most important information I should know about Effexor XR?

Effexor XR and other antidepressant medicines may cause serious side effects, including:

1. Suicidal thoughts or actions:

Effexor XR and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed.
Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.
Watch for these changes and call your healthcare provider right away if you notice:
- New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.
- Pay particular attention to such changes when Effexor XR is started or when the dose is changed.

Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.

Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you:

attempts to commit suicide
acting on dangerous impulses
acting aggressive or violent
thoughts about suicide or dying
new or worse depression
new or worse anxiety or panic attacks
feeling agitated, restless, angry or irritable
trouble sleeping
an increase in activity or talking more than what is normal for you
other unusual changes in behavior or mood
visual problems. Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are. Visual problems include:
- eye pain
- changes in vision
- swelling or redness in or around the eye

Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. Effexor XR may be associated with these serious side effects :

2. Serotonin syndrome

This condition can be life-threatening and may include:

agitation, hallucinations, coma or other changes in mental status
coordination problems or muscle twitching (overactive reflexes)
racing heartbeat, high or low blood pressure
sweating or fever
nausea, vomiting, or diarrhea
muscle rigidity

3. Changes in blood pressure. Effexor XR may:

increase your blood pressure. Control high blood pressure before starting treatment and monitor blood pressure regularly

4. Enlarged pupils (mydriasis).

5. Anxiety and insomnia.

6. Changes in appetite or weight.

7. Manic/hypomanic episodes:

greatly increased energy
severe trouble sleeping
racing thoughts
reckless behavior
unusually grand ideas
excessive happiness or irritability
talking more or faster than usual

8. Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include:

headache
weakness or feeling unsteady
confusion, problems concentrating or thinking or memory problems

9. Seizures or convulsions.

10. Abnormal bleeding : Effexor XR and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin, Jantoven), a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin.

11. Elevated cholesterol.

12. Lung disease and pneumonia: Effexor XR may cause rare lung problems. Symptoms include:

worsening shortness of breath
cough
chest discomfort

13. Severe allergic reactions:

trouble breathing
swelling of the face, tongue, eyes or mouth
rash, itchy welts (hives) or blisters, alone or with fever or joint pain.

Do not stop Effexor XR without first talking to your healthcare provider. Stopping Effexor XR too quickly or changing from another antidepressant too quickly may cause serious symptoms including:

anxiety, irritability
feeling tired, restless or problems sleeping
headache, sweating, dizziness
electric shock-like sensations, shaking, confusion, nightmares
vomiting, nausea, diarrhea

Who should not take Effexor XR?

Do not take Effexor XR if you:

are allergic to Effexor XR or any of the ingredients in Effexor XR . See below for a complete list of ingredients in Effexor XR.
have uncontrolled angle-closure glaucoma
take a Monoamine Oxidase Inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
Do not take an MAOI within 7 days of stopping Effexor XR unless directed to do so by your physician.
Do not start Effexor XR if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.
- People who take Effexor XR close in time to an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms:
  - high fever
  - uncontrolled muscle spasms
  - stiff muscles
  - rapid changes in heart rate or blood pressure
  - confusion
  - loss of consciousness (pass out)

What should I tell my healthcare provider before taking Effexor XR?

Ask if you are not sure.

Before starting Effexor XR, tell your healthcare provider if you:

Are taking certain drugs such as:

Amphetamines
Medicines used to treat migraine headaches such as:
- triptans
Medicines used to treat mood, anxiety, psychotic or thought disorders, such as:
- tricyclic antidepressants
- lithium
- SSRIs
- SNRIs
- antipsychotic drugs
Medicines used to treat pain such as:
- tramadol
Medicines used to thin your blood such as:
- warfarin
Medicines used to treat heartburn such as:
- Cimetidine
Over-the-counter medicines or supplements such as:
- Aspirin or other NSAIDs
- Tryptophan
- St. John’s Wort

Before starting Effexor XR, also tell your healthcare provider if you:

have heart problems
have diabetes
have liver problems
have kidney problems
have thyroid problems
have or had seizures or convulsions
have bipolar disorder or mania
have low sodium levels in your blood
have high blood pressure
have high cholesterol
have or had bleeding problems
are pregnant or plan to become pregnant. It is not known if Effexor XR will harm your unborn baby. Talk to your healthcare provider about the benefits and risks of treating depression during pregnancy
are breast-feeding or plan to breast-feed. Some Effexor XR may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking Effexor XR .

Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Effexor XR and some medicines may interact with each other, may not work as well, or may cause serious side effects.

Your healthcare provider or pharmacist can tell you if it is safe to take Effexor XR with your other medicines. Do not start or stop any medicine while taking Effexor XR without talking to your healthcare provider first.

If you take Effexor XR, you should not take any other medicines that contain (venlafaxine) including: venlafaxine HCl.

How should I take Effexor XR?

Take Effexor XR exactly as prescribed. Your healthcare provider may need to change the dose of Effexor XR until it is the right dose for you.
Effexor XR is to be taken with food.
If you miss a dose of Effexor XR, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Effexor XR at the same time.
If you take too much Effexor XR, call your healthcare provider or poison control center right away, or get emergency treatment.
When switching from another antidepressant to Effexor XR your doctor may want to lower the dose of the initial antidepressant first to avoid side effects

What should I avoid while taking Effexor XR?

Effexor XR can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how Effexor XR affects you. Do not drink alcohol while using Effexor XR.

What are the possible side effects of Effexor XR?

Effexor XR may cause serious side effects, including:

See “What is the most important information I should know about Effexor XR?” above
Increased cholesterol- have your cholesterol checked regularly
Newborns whose mothers take Effexor XR in the third trimester may have problems right after birth including:
- problems feeding and breathing
- seizures
- shaking, jitteriness or constant crying
Angle-closure glaucoma

Common possible side effects in people who take Effexor XR include :

unusual dreams
sexual problems
loss of appetite, constipation, diarrhea, nausea or vomiting, or dry mouth
feeling tired, fatigued or overly sleepy
change in sleep habits, problems sleeping
yawning
tremor or shaking
dizziness, blurred vision
sweating
feeling anxious, nervous or jittery
headache
increase in heart rate

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Effexor XR . For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. you may report side effects to the FDA AT 1-800-FDA-1088.

General information about the safe and effective use of Effexor XR

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Effexor XR for a condition for which it was not prescribed. Do not give Effexor XR to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about Effexor XR . If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about Effexor XR that is written for healthcare professionals.

For more information about Effexor XR call 1-800-438-1985 or go to www.EffexorXR.com