Viibryd Titration Pack (Oral)

Vilazodone is used to treat depression in adults. It is an antidepressant and is part of a group of medicines called selective serotonin reuptake inhibitors (SSRIs). Vilazodone works by boosting the activity of a chemical called serotonin in the brain.

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

It is important for your doctor to check your progress at regular visits. This allows for dose adjustments and helps prevent unwanted effects. Blood tests may be necessary to check for these effects.

Do not take vilazodone with a monoamine oxidase (MAO) inhibitor (for example, isocarboxazid [Marplan®], linezolid [Zyvox®], methylene blue injection, phenelzine [Nardil®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]). Do not start vilazodone within 2 weeks after stopping a MAO inhibitor, and wait 2 weeks after stopping vilazodone before starting a MAO inhibitor. Taking them together or not waiting 2 weeks may cause confusion, agitation, restlessness, stomach or intestinal symptoms, a sudden high body temperature, very high blood pressure, or severe seizures.

Vilazodone may cause some teenagers and young adults to feel agitated, irritable, or show other unusual behaviors. It may also lead some people to have suicidal thoughts or to feel more depressed. Some individuals may have trouble sleeping, become easily upset, experience a significant increase in energy, or act recklessly. If you or your caregiver notice any of these effects, contact your doctor immediately. Inform your doctor if you or anyone in your family has bipolar disorder (manic-depressive) or has attempted suicide.

Vilazodone may lead to a serious condition called serotonin syndrome if taken with certain 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 medications (for example, meperidine, methadone, rizatriptan, sumatriptan, tramadol, Demerol®, Methadose®, Frova®, Imitrex®, Maxalt®, Relpax®, Ultram®). Check with your doctor before taking any other medicines with vilazodone.

This medicine may increase your risk of bleeding problems. Make sure your doctor knows if you are also taking other medications that thin the blood, including aspirin, nonsteroidal antiinflammatory agents (NSAIDs) (for example, diclofenac, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, Voltaren®), or warfarin (Coumadin®, Jantoven®).

Do not suddenly stop taking this medicine without first checking with your doctor. If you need to stop vilazodone, ask your doctor how to gradually decrease the dose. This will lower your chances of experiencing withdrawal symptoms, which may include dizziness, nausea, headaches, vomiting, increased sweating, irritability, nightmares, seizures, or prickling or tingling sensations.

Hyponatremia (low sodium in the blood) may occur with this medicine. This is more common in elderly patients, those taking diuretic medicines for high blood pressure, or those who have low fluid levels due to severe diarrhea or vomiting. Contact your doctor immediately if you experience confusion, trouble concentrating, headaches, memory issues, weakness, or unsteadiness.

The use of alcohol is not recommended for patients taking this medicine.

Vilazodone may cause some people to feel dizzy or drowsy. Be sure to know how you react to this medicine before driving, using machines, or doing anything else that could be dangerous if you feel dizzy or alert.

Contact your doctor right away if you notice a decreased interest in sexual intercourse, delays or inability to have an orgasm in women, inability to achieve or maintain an erection in men, or loss of sexual ability, desire, drive, or performance. These may be signs of sexual dysfunction.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines, and herbal (for example, St. John's wort) or vitamin supplements.

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

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other drugs. As well 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. Nevertheless, 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.

Breast Feeding

There are no adequate studies in women for determining infant chance when using this medicine during breastfeeding. Weigh the potential benefits against the potential chances prior to taking this medication while breastfeeding.

Interactions with Medications

Although certain medicines should not be used together at all, in other cases two different medications may be used together even if an interaction might occur. In these cases, your clinician may want to change the dose, or other precautions may be necessary. When you are taking this medication, it is especially important that your healthcare professional know if you are using 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 medication with any of the following drugs is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medications you take.

• Isocarboxazid
• Linezolid
• Methylene Blue
• Metoclopramide
• Ozanimod
• Phenelzine
• Procarbazine
• Rasagiline
• Safinamide
• Selegiline
• Tranylcypromine

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

• Abciximab
• Aceclofenac
• Acemetacin
• Acenocoumarol
• Alfentanil
• Almotriptan
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amphetamine
• Amtolmetin Guacil
• Anagrelide
• Anileridine
• Apalutamide
• Apixaban
• Ardeparin
• Argatroban
• Aspirin
• Bemiparin
• Benzhydrocodone
• Benzphetamine
• Betrixaban
• Bivalirudin
• Boceprevir
• Bromfenac
• Brompheniramine
• Bufexamac
• Buprenorphine
• Buspirone
• Butorphanol
• Cangrelor
• Carbamazepine
• Celecoxib
• Ceritinib
• Certoparin
• Chlorpheniramine
• Choline Salicylate
• Cilostazol
• Citalopram
• Clarithromycin
• Clomipramine
• Clonixin
• Clopidogrel
• Cobicistat
• Cocaine
• Codeine
• Colchicine
• Conivaptan
• Cyclobenzaprine
• Cyclosporine
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Darunavir
• Desipramine
• Desirudin
• Desmopressin
• Desvenlafaxine
• Dexibuprofen
• Dexketoprofen
• Dextroamphetamine
• Dextromethorphan
• Dibenzepin
• Diclofenac
• Difenoxin
• Diflunisal
• Digoxin
• Dihydrocodeine
• Diphenoxylate
• Dipyridamole
• Dipyrone
• Dolasetron
• Doxepin
• Drotrecogin Alfa
• Droxicam
• Duloxetine
• Edoxaban
• Eletriptan
• Enoxaparin
• Enzalutamide
• Epoprostenol
• Eptifibatide
• Escitalopram
• Ethylmorphine
• Etodolac
• Etofenamate
• Etoricoxib
• Everolimus
• Felbinac
• Fenfluramine
• Fenoprofen
• Fentanyl
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Fondaparinux
• Fosphenytoin
• Frovatriptan
• Gepirone
• Granisetron
• Heparin
• Hydrocodone
• Hydromorphone
• Hydroxyamphetamine
• Hydroxytryptophan
• Ibuprofen
• Idelalisib
• Iloprost
• Imipramine
• Indinavir
• Indomethacin
• Iobenguane I 131
• Itraconazole
• Ivosidenib
• Josamycin
• Ketobemidone
• Ketoconazole
• Ketoprofen
• Ketorolac
• Lasmiditan
• Lepirudin
• Levomilnacipran
• Levorphanol
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lonafarnib
• Lopinavir
• Lorcaserin
• Lornoxicam
• Loxoprofen
• Lumacaftor
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Melitracen
• Meloxicam
• Meperidine
• Metaxalone
• Methadone
• Methamphetamine
• Methylphenidate
• Mibefradil
• Mifepristone
• Milnacipran
• Mirtazapine
• Mitotane
• Morniflumate
• Morphine
• Morphine Sulfate Liposome
• Nabumetone
• Nadroparin
• Nalbuphine
• Naproxen
• Naratriptan
• Nefazodone
• Nelfinavir
• Nepafenac
• Nicomorphine
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nortriptyline
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Oxaprozin
• Oxycodone
• Oxymorphone
• Oxyphenbutazone
• Palonosetron
• Papaveretum
• Parecoxib
• Paregoric
• Parnaparin
• Paroxetine
• Pentazocine
• Phenprocoumon
• Phenylbutazone
• Phenytoin
• Piketoprofen
• Piritramide
• Piroxicam
• Posaconazole
• Pranoprofen
• Prasugrel
• Proglumetacin
• Propyphenazone
• Proquazone
• Protein C
• Protriptyline
• Remifentanil
• Reviparin
• Ribociclib
• Rifampin
• Rifapentine
• Ritonavir
• Rivaroxaban
• Rizatriptan
• Rofecoxib
• Salicylic Acid
• Salsalate
• Saquinavir
• Selexipag
• Sertraline
• Sibutramine
• Sirolimus
• Sodium Salicylate
• St John's Wort
• Sufentanil
• Sulfinpyrazone
• Sulindac
• Sulodexide
• Sumatriptan
• Tacrolimus
• Tapentadol
• Telaprevir
• Telithromycin
• Tenoxicam
• Tianeptine
• Tiaprofenic Acid
• Ticagrelor
• Ticlopidine
• Tilidine
• Tinzaparin
• Tirofiban
• Tolfenamic Acid
• Tolmetin
• Tolvaptan
• Tramadol
• Trazodone
• Treprostinil
• Trimipramine
• Troleandomycin
• Tryptophan
• Tucatinib
• Valdecoxib
• Venlafaxine
• Vorapaxar
• Voriconazole
• Vortioxetine
• Warfarin
• Ziprasidone
• Zolmitriptan

Interactions with Food/Tobacco/Alcohol

Certain drugs 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 drugs may additionally 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 drug with any of the following is typically not advised, but may be unavoidable in some cases. If used together, your clinician 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 issues may affect the use of this drug. Make sure you inform your doctor if you have any other medical problems, especially:

• Bipolar disorder (mood disorder with mania and depression), or risk of or
• Bleeding issues or
• Glaucoma, angle-closure or
• Hyponatremia (low sodium in the blood) or
• Mania or hypomania, history of or
• Seizures, history of—Use with caution. May make these conditions worse.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor right away if any of the following side effects happen:

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 happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you how to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, 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 happen 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.

In the U.S.

• Viibryd
• Viibryd Titration Pack

Available Dosage Forms:

• Tablet

Therapeutic Class: Antidepressant

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.

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.

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