Effexor-XR

It is also used to treat certain anxiety disorders or to relieve the symptoms of anxiety . However, it generally is not used for anxiety or tension caused by the stress of everyday life. Venlafaxine is also used to treat panic disorders .

This medicine is available only with your doctor`s prescription .

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems . Although this use is not included in product labeling, venlafaxine is used in certain patients with the following medical condition:

• Hot flashes

This product is available in the following dosage forms:

• Capsule, Extended Release


• Tablet, Extended Release


• Tablet

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated any benefit to using venlafaxine in children with depression. Studies have shown that some children, teenagers, and young adults think about suicide or attempt suicide when taking the medicine. Because of this toxicity, use in children is not recommended .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of venlafaxine in the elderly. However, elderly patients are more likely to have age-related liver or kidney problems, which may require an adjustment in the dose for patients receiving venlafaxine .

Pregnancy

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Using this medicine with any of the following medicines is not recommended . Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Furazolidone


• Iproniazid


• Isocarboxazid


• Linezolid


• Metoclopramide


• Moclobemide


• Nialamide


• Pargyline


• Phenelzine


• Procarbazine


• Selegiline


• Toloxatone


• Tranylcypromine


• Trifluoperazine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol


• Almotriptan


• Amitriptyline


• Amoxapine


• Amoxicillin


• Anagrelide


• Ancrod


• Anisindione


• Antithrombin III Human


• Aspirin


• Atazanavir


• Bivalirudin


• Cilostazol


• Clarithromycin


• Clomipramine


• Clopidogrel


• Danaparoid


• Defibrotide


• Dermatan Sulfate


• Desipramine


• Desirudin


• Desvenlafaxine


• Dexfenfluramine


• Dextroamphetamine


• Dibenzepin


• Dicumarol


• Dipyridamole


• Dothiepin


• Doxepin


• Duloxetine


• Entacapone


• Epoprostenol


• Eptifibatide


• Fenfluramine


• Fluoxetine


• Fondaparinux


• Frovatriptan


• Haloperidol


• Heparin


• Iloprost


• Imipramine


• Itraconazole


• Jujube


• Lamifiban


• Lexipafant


• Metoprolol


• Milnacipran


• Mirtazapine


• Naratriptan


• Nefazodone


• Nelfinavir


• Nortriptyline


• Oxycodone


• Pentosan Polysulfate Sodium


• Phenindione


• Phenprocoumon


• Protriptyline


• Rasagiline


• Ritonavir


• Rizatriptan


• Saquinavir


• Sibrafiban


• Sibutramine


• Sulfinpyrazone


• Sulodexide


• Sumatriptan


• Tapentadol


• Telithromycin


• Ticlopidine


• Tirofiban


• Tramadol


• Trazodone


• Trimipramine


• Vasopressin


• Warfarin


• Xemilofiban


• Zolmitriptan


• Zolpidem

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aceclofenac


• Acemetacin


• Alclofenac


• Benoxaprofen


• Bromfenac


• Bufexamac


• Carprofen


• Celecoxib


• Clonixin


• Clozapine


• Dexketoprofen


• Diclofenac


• Diflunisal


• Dipyrone


• Droxicam


• Etodolac


• Etofenamate


• Etoricoxib


• Felbinac


• Fenbufen


• Fenoprofen


• Fentiazac


• Floctafenine


• Flufenamic Acid


• Flurbiprofen


• Ginkgo


• Ibuprofen


• Indomethacin


• Indoprofen


• Isoxicam


• Ketoprofen


• Ketorolac


• Lornoxicam


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Morniflumate


• Nabumetone


• Naproxen


• Niflumic Acid


• Nimesulide


• Oxaprozin


• Parecoxib


• Phenylbutazone


• Pirazolac


• Piroxicam


• Pirprofen


• Propyphenazone


• Proquazone


• Rofecoxib


• St John`s Wort


• Sulindac


• Suprofen


• Tenidap


• Tenoxicam


• Tiaprofenic Acid


• Tolmetin


• Valdecoxib


• Zolpidem


• Zomepirac

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bipolar disorder (mental disease with cycles of elation and depression), history of, or


• Bleeding problems or


• Glaucoma (e.g., acute narrow-angle) or


• High blood pressure or


• Hypercholesterolemia (high cholesterol in the blood) or


• Hyponatremia (low sodium in the blood) or


• Seizures (convulsions), history ofa€”May make these conditions worse .

• Heart attack, recent or


• Heart failure or


• Hyperthyroidism (overactive thyroid)a€”Use with caution. May cause an increase in heart rate .

• Kidney disease or


• Liver disease (e.g., liver cirrhosis)a€”Use with caution. The effects may be increased because of slower removal of the medicine from the body .

• Mania or hypomania (history of)a€”Use of venlafaxine may activate these conditions .

Proper Use

Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered .

You may have to take venlafaxine for 4 weeks or longer before you begin to feel better. Also, you will probably need to keep taking this medicine for at least 6 months, even if you feel better, to help prevent your depression from returning. Your doctor should check your progress at regular visits during this time .

Venlafaxine should be taken with food or on a full stomach to lessen the chance of stomach upset. However, if your doctor tells you to take the medicine a certain way, take it exactly as directed .

If you are taking the extended-release capsule form, take it with food and swallow the capsule whole with fluid . Do not open, crush, chew, or place the capsule in a liquid .

Dosing

The dose of this medicine will be different for different patients. Follow your doctor`s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For mental depression:
  
  
  
  • For oral dosage form (extended-release capsules):
    
    
    
    • Adultsa€”At first, 75 milligrams (mg) a day, taken as one dose in the morning or evening. Your doctor may adjust your dose if needed. However, the dose is usually not more than 225 mg a day.
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  • For oral dosage form (tablets):
    
    
    
    • Adultsa€”At first, a total of 75 milligrams (mg) a day, taken in smaller doses two or three times during the day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 375 mg a day.
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  

• For anxiety:
  
  
  
  • For oral dosage form (extended-release capsules):
    
    
    
    • Adultsa€”At first, 75 milligrams (mg) a day, taken as one dose in the morning or evening. Your doctor may adjust your dose if needed. However, the dose is usually not more than 225 mg a day.
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  


• For panic disorder:
  
  
  
  • For oral dosage form (extended-release capsules):
    
    
    
    • Adultsa€”At first, 37.5 milligrams (mg) a day, taken as one dose in the morning or evening for 7 days. Your doctor may adjust your dose if needed. However, the dose is usually not more than 225 mg a day.
    
    
    • Childrena€”Use and dose must be determined by your doctor .
    
    
    
    
  
  
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is important that your doctor check your progress at regular visits, to allow for changes in your dose and to help reduce any side effects .

Venlafaxine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed . If you, your child, or your caregiver notice any of these side effects, tell your doctor or your child`s doctor right away .

Do not stop taking this medicine without first checking with your doctor . Your doctor may want you to gradually reduce the amount you are taking before stopping completely. This is to decrease the chance of side effects .

Do not take venlafaxine within 2 weeks (14 days) of taking a monoamine oxidase (MAO) inhibitor (e.g., isocarboxazid [MarplanA®], phenelzine [NardilA®], selegiline [EldeprylA®], or tranylcypromine [ParnateA®]), and do not take an MAO inhibitor for at least 7 days after taking venlafaxine. If you do, you may develop serious side effects such as seizures .

Make sure your doctor knows about all the other medicines you are using. Venlafaxine may cause a serious condition called serotonin syndrome when taken with certain medicines such as linezolid [e.g., ZyvoxA®], lithium, tryptophan, St. John`s Wort, or some pain or migraine medicines (e.g., tramadol [UltramA®], sumatriptan [ImitrexA®], zolmitriptan [ZomigA®], or rizatriptan [MaxaltA®]). Check with your doctor first before taking any other medicines .

It is not known how venlafaxine will interact with alcohol and other central nervous system (CNS) depressants (medicines that may make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these medicines while you are using venlafaxine .

Venlafaxine may cause some people to become drowsy or have blurred vision . Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or able to see clearly .

Dizziness, light-headedness, or fainting may occur with this medicine, especially when you get up quickly from a lying or sitting position . Getting up slowly may help. If this problem continues or gets worse, check with your doctor .

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention .

Check with your doctor immediately if any of the following side effects occur:

More common

• Changes in vision, such as blurred vision


• Headache


• High blood pressure

Less common

• Chest pain


• Fast or irregular heartbeat


• Mood or mental changes


• Ringing or buzzing in the ears

Rare

• Convulsions (seizures)


• Itching or skin rash


• Light-headedness or fainting, especially when getting up suddenly from a sitting or lying position


• Menstrual changes


• Problems in urinating or in holding urine


• Swelling


• Talking, feeling, and acting with excitement that you cannot control


• Trouble with breathing

Incidence not known

• Abdominal or stomach pain


• Agitation


• Black, tarry stools


• Bleeding gums


• Blistering, peeling, loosening of skin


• Bloating of the abdomen


• Blood in eye


• Bloody urine


• Bloody, black, or tarry stools


• Blue-green to black skin


• Chest pain or discomfort


• Confusion


• Confusion as to time, place, or person


• Cough or hoarseness


• Coughing up blood


• Dark urine


• Decreased awareness or responsiveness


• Decreased frequency or amount of urine


• Depression


• Difficulty with breathing or swallowing


• Doing the opposite of what one is requested to do


• Dry cough


• Extra heartbeats


• Eye pain


• Fast, pounding, slow, or irregular heartbeat or pulse


• Fever with or without chills


• General feeling of tiredness or weakness


• Hallucinations


• Hearing loss


• High fever


• Hives


• Holding false beliefs that can not be changed by fact


• Hostility


• Increased menstrual flow or vaginal bleeding


• Increased thirst


• Indigestion


• Involuntary movements


• Irregular heartbeats


• Irritability


• Joint or muscle pain


• Lethargy


• Light-colored stools


• Lip smacking or puckering


• Loss of consciousness or coma


• Low blood pressure


• Lower back or side pain


• Mimicry of speech or movements


• Muscle cramps or spasms


• Muscle pain or stiffness


• Muscle twitching


• Nosebleeds


• Overactive reflexes


• Pain, redness, or swelling in the arm or leg


• Painful or difficult urination


• Pains in stomach, side, or abdomen, possibly radiating to the back


• Palpitations


• Panic


• Paralysis


• Peculiar postures or movements, mannerisms, or grimacing


• Poor coordination


• Pounding or rapid pulse


• Prolonged bleeding from cuts


• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• Puffing of cheeks


• Rapid breathing


• Rapid or worm-like movements of the tongue


• Rapid weight gain


• Rash


• Recurrent fainting


• Red or dark brown urine


• Red skin lesions, often with a purple center


• Red, irritated eyes


• Redness in the whites of the eyes


• Restlessness


• Severe muscle stiffness


• Severe sleepiness


• Shivering


• Shock-like electrical sensations


• Sore throat


• Sores, ulcers, or white spots in the mouth or on the lips


• Stupor


• Sweating


• Swelling of the face, lower legs, ankles, hands, or fingers


• Swollen or painful glands


• Tightness in the chest


• Tiredness


• Twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs


• Unable or unwilling to speak


• Uncontrolled chewing movements


• Uncontrolled movements of the arms and legs


• Unexplained bleeding or bruising


• Unpleasant breath odor


• Unusual excitement, nervousness, or restlessness


• Unusually pale skin


• Vomiting of blood or material that looks like coffee grounds


• Weight gain


• Wheezing


• Yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Agitation


• Convulsions (seizures)


• Drowsiness


• Extreme tiredness or weakness


• Fast heartbeat


• Tingling, burning, or prickling sensations


• Trembling or shaking

Some side effects may occur that usually do not need medical attention . These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abnormal dreams


• Anxiety or nervousness


• Chills


• Constipation


• Decrease in sexual desire or ability


• Diarrhea


• Dizziness


• Drowsiness


• Dry mouth


• Heartburn


• Increased sweating


• Loss of appetite


• Nausea


• Stomach pain or gas


• Stuffy or runny nose


• Tingling, burning, or prickly sensations


• Trembling or shaking


• Trouble with sleeping


• Unusual tiredness or weakness


• Vomiting


• Weight loss

Less common

• Change in sense of taste


• Muscle tension


• Yawning

Incidence not known

• Night sweats

After you stop using this medicine, it may still produce some side effects that need attention . During this period of time, check with your doctor immediately if you notice the following side effects:

• Actions that are out of control


• Anxiety


• Changes in dreaming


• Continuing ringing or buzzing or other unexplained noise in the ears


• Convulsions (seizures)


• Crying


• Depersonalization


• Diarrhea


• Difficulty with coordination


• Dizziness


• Dry mouth


• Dysphoria


• Euphoria


• Fear


• Feeling of constant movement of self or surroundings


• Feeling unwell or unhappy


• Headache


• Hearing loss


• Hyperventilation


• Increased sweating


• Irregular heartbeats


• Irritability


• Light-headedness


• Loss of appetite


• Loss of bladder control


• Mental depression


• Mood or mental changes


• Muscle spasm or jerking of all extremities


• Nausea


• Nervousness


• Nightmares


• Paranoia


• Quick to react or overreact emotionally


• Rapidly changing moods


• Restlessness


• Sensation of spinning


• Sensory disturbances (including shock-like electrical sensations)


• Shakiness in legs, arms, hands, or feet


• Shaking


• Shortness of breath


• Sleeping or unusual drowsiness


• Sudden loss of consciousness


• Talking, feeling, and acting with excitement


• Trembling or shaking of hands or feet


• Trouble with sleeping


• Twitches of the muscles under the skin


• Unusual drowsiness, dullness, or the feeling of sluggishness


• Unusual tiredness or weakness


• Vomiting


• Weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional .

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