Description
Vilazodone is used to treat depression in adults. It is an antidepressant and belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). Vilazodone works 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
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 have not been performed on the relationship of age to the effects of vilazodone in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of vilazodone in the elderly. However, elderly patients are more likely to have hyponatremia (low sodium in the blood) and age-related liver, kidney, or heart problems which may require caution in patients receiving vilazodone.
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.
- Isocarboxazid
- Linezolid
- Methylene Blue
- Metoclopramide
- Ozanimod
- Phenelzine
- Procarbazine
- Rasagiline
- Safinamide
- Selegiline
- Tranylcypromine
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
- Aceclofenac
- Acemetacin
- Acenocoumarol
- Alfentanil
- Almotriptan
- Amineptine
- Amitriptyline
- Amitriptylinoxide
- Amoxapine
- Amphetamine
- Amtolmetin Guacil
- Anagrelide
- Anileridine
- Apalutamide
- Apixaban
- Ardeparin
- Argatroban
- Aspirin
- Avacopan
- Bemiparin
- Benzhydrocodone
- Benzphetamine
- Betrixaban
- Bivalirudin
- Boceprevir
- Bromfenac
- Brompheniramine
- Bufexamac
- Buprenorphine
- Buspirone
- Butorphanol
- Cangrelor
- Carbamazepine
- Celecoxib
- Ceritinib
- Certoparin
- Chlorpheniramine
- Choline Salicylate
- Cilostazol
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.
- 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
- Hyponatremia (low sodium in the blood) or
- Mania or hypomania, history of or
- Seizures, history of or
- Sexual problems—Use with caution. May make these conditions worse.
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 comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.
It is best to take this medicine with food.
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 form (tablets):
- For treatment of depression:
- Adults—At first, 10 milligrams (mg) as a single dose once a day for 7 days. Then, your doctor may adjust your dose as needed. However, the dose is usually not more than 40 mg per day.
- Children—Use is not recommended.
- For treatment of depression:
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 prevent any unwanted effects. Blood tests may be needed to check for unwanted effects.
Do not take vilazodone with a monoamine oxidase (MAO) inhibitor (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], methylene blue injection, phenelzine [Nardil®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]). Do not start taking vilazodone during the 2 weeks after you stop a MAO inhibitor and wait 2 weeks after stopping vilazodone before you start taking a MAO inhibitor. If you take them together or do not wait 2 weeks, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, a sudden high body temperature, an extremely high blood pressure, or severe seizures.
Vilazodone may cause you 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.
Vilazodone may cause a serious condition called serotonin syndrome if taken together with some medicines. Do not use vilazodone with buspirone (Buspar®), fentanyl (Abstral®, Duragesic®), lithium (Eskalith®, Lithobid®), tryptophan, St. John's wort, amphetamines, or some pain or migraine medicines (eg, meperidine, methadone, rizatriptan, sumatriptan, tramadol, Demerol®, Methadose®, Frova®, Imitrex®, Maxalt®, Relpax®, Ultram®, Check with your doctor first before taking any other medicines with vilazodone.
This medicine may increase your risk for bleeding problems. Make sure your doctor knows if you are also taking other medicines that thin the blood, including aspirin, nonsteroidal antiinflammatory agents, also called NSAIDs (eg, diclofenac, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, Voltaren®), or warfarin (Coumadin®, Jantoven®).
Do not suddenly stop taking this medicine without checking first with your doctor. If you have been instructed to stop taking vilazodone, ask your doctor how to slowly decrease the dose. This will decrease your chance of having withdrawal symptoms, including dizziness, nausea, headaches, vomiting, increased sweating, irritability, nightmares, seizures, or prickling or tingling feelings.
Hyponatremia (low sodium in the blood) may occur with this medicine. This is more common in elderly patients, those who are taking diuretic medicines for high blood pressure, or those who have decreased amounts of fluid in the body due to severe diarrhea or vomiting. Check with your doctor right away if you have confusion, difficulty concentrating, headaches, memory problems, weakness, and unsteadiness.
The use of alcohol is not recommended in patients who are taking this medicine.
Vilazodone may cause some people to become dizzy or drowsy. 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 dizzy or not alert.
Check with your doctor right away if you have decreased interest in sexual intercourse, delayed or inability to have an orgasm, inability to have or keep an erection, 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 (eg, St. John's wort) 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:
Less common
- Actions that are out of control
- anxiety
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain or discomfort
- decreased interest in sexual intercourse
- delayed or inability to have an orgasm
- extra heartbeat
- fast, irregular, pounding, or racing heartbeat or pulse
- inability to have or keep an erection
- irritability
- loss in sexual ability, desire, drive, or performance
- shakiness in the legs, arms, hands, or feet
- sweating
- talking, feeling, and acting with excitement
- trembling or shaking of the hands or feet
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
- Diarrhea
- dizziness
- dry mouth
- nausea
- trouble sleeping
Less common
- Abnormal dreams
- aching or discomfort in the lower legs or sensation of crawling in the legs
- acid or sour stomach
- belching
- blindness
- bloated or full feeling
- blurred vision
- change in taste
- decreased vision
- difficulty with moving
- drowsiness
- dry eyes
- excess air or gas in the stomach or intestines
- feeling jittery
- headache, severe and throbbing
- heartburn
- increased or decreased appetite
- increased sweating
- indigestion
- loss of appetite
- loss of taste
- muscle pain or stiffness
- night sweats
- pain in the joints
- passing gas
- relaxed and calm
- restlessness
- sleepiness or unusual drowsiness
- stomach pain, discomfort, or upset
- unusual tiredness or weakness
- vomiting
- weakness
Incidence not known
- Decrease in smell
- eye pain
- loss of sense of smell
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.
DRG-20074798
