Venlafaxine (oral route)


    Brand Name

    US Brand Name

    Effexor

    Effexor-XR


    Description

    Venlafaxine is used to treat depression. It is also used to treat general anxiety disorder, social anxiety disorder, and panic disorder. Venlafaxine belongs to a group of medicines known as serotonin and norepinephrine reuptake inhibitors (SNRI). These medicines are thought to work by increasing the activity of a chemical called serotonin in the brain.

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

    This product is available in the following dosage forms:

    • Tablet, Extended Release
    • Tablet
    • Capsule, Extended Release

    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. 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 geriatric-specific problems that would limit the usefulness of venlafaxine in the elderly. However, elderly patients might be more sensitive to the effects of this medicine which may cause hyponatremia (low levels of sodium in the blood), or age-related liver or kidney problems, which may require caution and an adjustment in the dose for patients taking venlafaxine.

    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

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    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.

    • Bepridil
    • Bromopride
    • Cisapride
    • Dronedarone
    • Furazolidone
    • Iproniazid
    • Isocarboxazid
    • Levoketoconazole
    • Linezolid
    • Mavorixafor
    • Mesoridazine
    • Methylene Blue
    • Metoclopramide
    • Ozanimod
    • Phenelzine
    • Pimozide
    • Piperaquine
    • Procarbazine
    • Rasagiline
    • Safinamide
    • Saquinavir
    • Selegiline
    • Sparfloxacin
    • Terfenadine
    • Thioridazine
    • Tranylcypromine
    • Trifluoperazine
    • Ziprasidone

    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.

    • Abciximab
    • Abiraterone Acetate
    • Abiraterone Acetate, Micronized
    • Aceclofenac
    • Acemetacin
    • Acenocoumarol
    • Adagrasib
    • Alfentanil
    • Alfuzosin
    • Almotriptan
    • Amineptine
    • Amiodarone
    • Amisulpride
    • Amitriptyline
    • Amitriptylinoxide
    • Amoxapine
    • Amoxicillin
    • Amphetamine
    • Amprenavir
    • Amtolmetin Guacil
    • Anagrelide
    • Anileridine
    • Apixaban
    • Apomorphine
    • Aprepitant
    • Ardeparin
    • Argatroban
    • Aripiprazole
    • Aripiprazole Lauroxil
    • Arsenic Trioxide
    • Asenapine
    • Aspirin
    • Astemizole
    • Atazanavir
    • Atomoxetine
    • Azithromycin
    • Bedaquiline
    • Bemiparin
    • Benzhydrocodone
    • Benzphetamine

    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.

    • Ginkgo
    • St John's Wort

    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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

    • Ethanol
    • Grapefruit Juice

    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 (mood disorder with mania and depression), or risk of or
    • Bleeding problems or
    • Glaucoma, angle-closure or
    • Heart attack, recent or history of or
    • Hypercholesterolemia (high cholesterol in the blood) or
    • Hypertension (high blood pressure) or
    • Hyponatremia (low sodium in the blood) or
    • Interstitial lung disease, history of or
    • Mania, history of or
    • Seizures, history of or
    • Stroke, history of or
    • Tachycardia (fast heart rate)—Use with caution. May make these conditions worse.
    • Kidney disease or
    • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

    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.

    This medicine should come with a Medication Guide. Follow the instructions carefully. Ask your doctor if you have any questions.

    Take the extended-release capsule or tablet with food either in the morning or evening at about the same time each day. If your doctor tells you to take the medicine a certain way, take it exactly as directed.

    Swallow the extended-release capsule whole with fluid. Do not crush, chew, divide, or place the capsule in a liquid.

    If you are unable to swallow the extended-release capsule, open it and pour the medicine on a spoonful of applesauce. Swallow the mixture of applesauce and medicine right away without chewing. Drink a glass of water so all of the medicine is swallowed.

    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 oral dosage forms (extended-release capsules, extended-release tablets):
      • For depression:
        • Adults—At first, 75 milligrams (mg) per day, taken as one dose in the morning or evening. Some patients may need a starting dose of 37.5 mg per day, taken for 4 to 7 days. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 225 mg per day.
        • Children—Use and dose must be determined by your doctor.
      • For generalized anxiety disorder:
        • Adults—At first, 75 milligrams (mg) per day, taken as one dose in the morning or evening. Some patients may need a starting dose of 37.5 mg per day, taken for 4 to 7 days. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 225 mg per day.
        • Children—Use and dose must be determined by your doctor.
      • For panic disorder:
        • Adults—At first, 37.5 milligrams (mg) per day, taken for 7 days, taken as one dose in the morning or evening. Your doctor may adjust your dose as needed and tolerated. However, the dose is usually not more than 225 mg per day.
        • Children—Use and dose must be determined by your doctor.
      • For social anxiety disorder:
        • Adults—75 milligrams (mg) per day, taken as one dose in the morning or evening.
        • Children—Use and dose must be determined by your doctor.
    • For oral dosage form (tablets):
      • For depression:
        • Adults—At first, a total of 75 milligrams (mg) per day, divided and taken 2 or 3 times during the day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 225 mg per day.
        • Children—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

    If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

    Do not take venlafaxine with a monoamine oxidase (MAO) inhibitor (eg, isocarboxazid (Marplan®), phenelzine (Nardil®)], selegiline (Eldepryl®), tranylcypromine (Parnate®)). Do not start taking venlafaxine during the 14 days after you stop a MAO inhibitor and wait 7 days after stopping venlafaxine before you start taking a MAO inhibitor. If you take them together or do not wait the proper amount of time, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, a sudden high body temperature, an extremely high blood pressure, or severe seizures.

    Venlafaxine may cause a serious condition called serotonin syndrome if taken together with certain medicines. Do not use venlafaxine with buspirone (Buspar®), fentanyl (Abstral®, Duragesic®), linezolid (Zyvox®), lithium (Eskalith®, Lithobid®), methylene blue injection, tryptophan, St John's wort, amphetamines, or some pain or migraine medicines (eg, meperidine, methadone, rizatriptan, sumatriptan, tramadol, Demerol®, Frova®, Imitrex®, Maxalt®, Methadose®, Relpax®, Ultram®, Zomig®). Check with your doctor first before taking any other medicines with venlafaxine.

    This medicine may cause some teenagers and young adults 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. Some people may have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. If you or your caregiver notice any of these unwanted effects, tell your doctor right away. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.

    Do not suddenly stop taking this medicine without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely. This will decrease the chance of side effects, including agitation, anxiety, blurred vision, confusion, diarrhea, dizziness, fast or irregular heartbeat, headache, irritability, nausea or vomiting, numbness or tingling feeling, restlessness, seizures, sweating, thoughts of hurting yourself or others, trouble sleeping, unusual dreams, or unusual drowsiness, tiredness, or weakness.

    This medicine may cause hyponatremia (low sodium in the blood). This is more common in elderly patients, those who take diuretic medicines, or those who have a low amount of fluid in the body due to severe diarrhea or vomiting. Check with your doctor right away if you have a headache, trouble concentrating, memory problems, confusion, weakness, or feel unsteady when standing.

    Venlafaxine may increase your risk for bleeding problems. Make sure your doctor knows if you are also using other medicines that thin the blood, including NSAIDs (eg, aspirin, diclofenac, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, Voltaren®) or warfarin (Coumadin®, Jantoven®).

    Tell your doctor right away if you are having chest pain or discomfort, dry cough, fever, general feeling of tiredness or weakness, skin rash, or trouble breathing with this medicine. These might be symptoms of a serious lung problem, including interstitial lung disease and eosinophilic pneumonia.

    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. It is best to avoid alcohol with venlafaxine.

    Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

    Check with your doctor right away if you have decreased interest in sexual intercourse, delayed or inability to have and orgasm in women, inability to have or keep an erection in men, or loss in sexual ability, desire, drive, or performance. These could be symptoms of sexual dysfunction.

    Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


    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

    • Change or problem with discharge of semen
    • decreased interest in sexual intercourse
    • inability to have or keep an erection
    • lack or loss of strength
    • loss in sexual ability, desire, drive, or performance
    • severe headache
    • sweating

    Less common

    • Blurred vision
    • chest pain
    • delayed or inability to have an orgasm
    • fast or irregular heartbeat
    • mood or mental changes
    • ringing or buzzing in the ears
    • suicidal thoughts

    Rare

    • Actions that are out of control
    • high fever
    • irritability
    • itching or skin rash
    • lightheadedness or fainting, especially when getting up suddenly from a sitting or lying position
    • menstrual changes
    • nervousness
    • problems with urinating or holding urine
    • seizures
    • severe muscle stiffness
    • talking, feeling, and acting with excitement that you cannot control
    • trouble breathing
    • unusually pale skin

    Incidence not known

    • Agitation
    • bloody, black, or tarry stools
    • bloody stool or urine
    • dark urine
    • decreased frequency or amount of urine
    • diarrhea
    • drowsiness
    • fever
    • general feeling of tiredness or weakness
    • headache
    • increased thirst
    • light-colored stools
    • muscle cramps, spasms, or pain
    • nausea or vomiting
    • nosebleeds
    • overactive reflexes
    • poor coordination
    • red or purple spots on the skin
    • restlessness
    • shivering
    • stomach pain on the upper right side
    • swelling of the face, lower legs, ankles, hands, or fingers
    • trembling or shaking that is hard to control
    • twitching
    • unusual bruising
    • unusual tiredness or weakness
    • vomiting of blood or material that looks like coffee grounds
    • yellow eyes or skin

    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
    • chills
    • constipation
    • decrease in sexual desire or ability
    • diarrhea
    • dry mouth
    • heartburn
    • increased sweating
    • loss of appetite
    • nausea
    • stomach pain or gas
    • stuffy or runny nose
    • tingling, burning, or prickly sensations
    • trouble sleeping
    • vomiting
    • weight loss

    Less common

    • Change in taste
    • muscle tension
    • yawning

    Incidence not known

    • Decrease in smell
    • loss of sense of smell
    • night sweats

    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.






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