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Fight against Depression with Viibryd

By Jemima Faith

What is Viibryd?

Viibryd (vilazodone) is an antidepressant, a medicine which fights against depression, and placed in a group of drugs called selective serotonin reuptake inhibitors (SSRIs).

Viibryd uses (uses of Viibryd)

Due to specificity, just one of the uses of viibryd has been listed here which is that;

Viibryd is used to treat a number of mental health issues that have been placed under major depressive disorder (MDD).

There are other viibryd uses that have not been included here as explained above.

Important information

Before taking this medicine

You should not use Viibryd at all if you are being treated with a methylene blue injection.

Please do not use Viibryd if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, phenelzine, methylene blue injection, linezolid, rasagiline, selegiline, or tranylcypromine. An extremely dangerous drug interaction could occur.

Some young people have thoughts about suicide when first taking antidepressant drugs like this. Stay alert to changes in your mood or the symptoms. Report any new or worsening conditions to your doctor.

Viibryd has not been approved for use in children.

Some medicines can interact with vilazodone and cause a very serious condition called serotonin syndrome. You should be sure your doctor knows about all other medications that you use. Ask your doctor before making any changes in how and/or when you take your medications.

To make sure that Viibryd is safe for you, inform your doctor if you have:

  • A liver or kidney disease;
  • some bleeding or blood clotting disorders;
  • narrow-angle glaucoma;
  • seizures and/or epilepsy;
  • bipolar disorder (manic depression);
  • a history of drug abuse or occasional thoughts of suicide; or
  • if you drink alcohol.

As a reminder some young people have thoughts about suicide when first taking an antidepressant. Your doctor should check your progress level at regular visits. All your family or other caregivers should also be very alert to changes in your mood or symptoms.

Taking an SSRI antidepressant during pregnancy may cause some serious lung problems or other complications in the newborn baby. However, you may have a sort of relapse of depression if you stop taking your antidepressant drug. Tell your doctor right away if you become pregnant and do not start or stop taking this medicine during pregnancy without your doctor's advice.

It is not yet known whether vilazodone passes into breast milk or if it could harm a nursing baby but it is important that you tell your doctor if you are breastfeeding a baby.

Do not give Viibryd to anyone under the age of 18 years without medical advice. Viibryd has not been approved for use in children.

How should I take Viibryd?

It is very dangerous to formulate your own dosage of viibryd hence you should take Viibryd exactly as prescribed by your doctor. Follow all the directions given on your prescription label. Your doctor may or may not occasionally change your dose to make sure you get the best results. For your own safety do not take this medicine in larger or smaller amounts or for longer than recommended by your health care provider.

Viibryd will work at its best if you take it with food.

It may take several days, weeks or a few months before your symptoms start improving so keep using the medication as you have been directed and tell your doctor if your symptoms do not improve or if they get worse.

You should not stop using Viibryd suddenly, else you could have unpleasant withdrawal symptoms. Ask your doctor how you can safely stop using this medicine in case you wish to.

Store viibryd at normal room temperature away from moisture and heat.

 

Viibryd dosing information (Dosage of Viibryd)

Usual Adult Dose for Depression:

Initial dose: 10 mg orally once a day for a period of 7 days, followed by 20 mg orally one time a day for an additional 7 days
Maintenance dose: 40 mg orally once in a day


Emphasis: This drug should always be taken with food.



Use: Major Depressive Disorder (MDD)

What happens if I miss a dose?

It is important to strictly follow the routine dosage of Viibryd. You should do your best to take the missed dose as soon as you remember. However, skip the missed dose if it is almost the time for your next scheduled dose because it is not proper to take extra medicine to make up the missed dose.

What happens if I overdose?

In order to avoid some adverse Viibryd side effects please seek immediate emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of vilazodone can be fatal, so you are advised to be careful.

What should I avoid while using Viibryd?

Drinking alcohol while you are taking this drug can cause Viibryd side effects.

Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) for arthritis, fever, pain, or swelling. This includes aspirin, ibuprofen (Advil, Motrin), celecoxib (Celebrex), diclofenac, naproxen (Aleve), meloxicam, indomethacin, and others. Also, using an NSAID with vilazodone may cause you to easily bruise or bleed easily.

This medication may go as far as impairing your thinking or reactions. Be careful if you have to drive or do anything that requires you in an alert state.

Viibryd side effects (Side effects of Viibryd)

The side effects of viibryd may be severe or minute so you should get emergency medical help if you have some signs of an allergic reaction to Viibryd:skin rash or hives; difficulty breathing; swelling of your face, lips, tongue and/or throat.

Report any new or persisting symptoms to your doctor immediately, such as: mood or behavior changes, panic attacks, anxiety, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about committing suicide or hurting yourself.

Call your doctor at once if you have:

  • a seizure (convulsions);
  • tunnel vision, blurred vision, pain in the eyes or swelling, or seeing halos around lights;
  • easy bruising, unusual bleeding (nose, vagina, mouth, or rectum), blood traces in your urine or stools, red or purple pinpoint spots under your skin;
  • racing thoughts, decreased inhibitions, unusual risk-taking behavior, feelings of extreme happiness or sadness; or
  • relatively high levels of serotonin in the body - agitation, fever, hallucinations, fast heart rate, overactive reflexes, feeling of nausea, vomiting, diarrhea, fainting; or
  • relatively low levels of sodium in the body - headache, severe weakness, confusion, slurred speech, loss of coordination, feeling unsteady.

Common Viibryd side effects may include the following:

  • vision changes;
  • diarrhea, mild nausea; or
  • sleep problems (insomnia).

This is not a complete list of the side effects of Viibryd and others may occur. Call your doctor for some medical advice about side effects. You may also report all side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Viibryd?

A combination of Viibryd with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or even death. Ask your doctor before taking a narcotic pain medication, prescription cough medicine, a muscle relaxer, or medicine for anxiety, sleeping pill, depression, or seizures.

Many drugs can also interact with vilazodone. Not all the possible interactions are listed here so you are urged to tell your doctor about all your current medicines and any you start and/or stop using, especially:

  • any other antidepressant (s);
  • a diuretic or "water pill";
  • mephenytoin;
  • St. John's wort;
  • a blood thinner - Coumadin, warfarin, Jantoven;
  • medicines to treat anxiety, thought disorders, mood disorders, or mental illness - amitriptyline, lithium, buspirone, desipramine, nortriptyline, and many others;
  • medicine used to treat ADHD or narcolepsy - Adderall, Ritalin, Concerta, Vyvanse, Zenzedi, and some others;
  • migraine headache medicine - rizatriptan, zolmitriptan, sumatriptan, and others; or
  • narcotic pain medicine – fentanyl and tramadol.

The list above is not complete and many other drugs can interact with vilazodone. This includes many prescription and over-the-counter medicines, vitamins, and other herbal products. Give a complete list of all your medicines to any of your healthcare provider who treats you.

Viibryd Dosage and Administration

Dosage for Treatment of the Major Depressive Disorder

The recommended target dosage for the one of the uses of Viibryd is 20 mg to 40 mg orally once daily with food. To achieve the targeted dosage, titrate your Viibryd as follows:

  • Start with an initial (preliminary)  dosage of 10 mg once daily with food for 7 days,
  • Then gradually increase to 20 mg once daily with food.
  • The dose may be increased to up to 40 mg once daily with food after a minimum of 7 days between dosage increases.

Screen for a Bipolar Disorder Prior to Starting Viibryd

Prior to initiation of treatment with Viibryd or another antidepressant, medical experts should screen patients for a personal or family history of bipolar disorder, mania, or hypomania.

Switching over to or from a Monoamine Oxidase Inhibitor Antidepressant

At least 14 days must always elapse between discontinuation of a monoamine oxidase inhibitor (MAOI) antidepressant and initiation of Viibryd. In addition, at least 14 days must also elapse after stopping Viibryd before starting an MAOI antidepressant.

Dosage Adjustments with CYP3A4 Inhibitors or Inducers

Patients receiving the concomitant CYP3A4 inhibitors:

During the concomitant use of a strong CYP3A4 inhibitor (e.g., itraconazole, voriconazole, clarithromycin), the Viibryd dose should never exceed 20 mg once daily. The original dosage of Viibryd can be resumed when the CYP3A4 inhibitor is discontinued.

Patients receiving the concomitant CYP3A4 inducers:

Based on clinical response (s), you may consider increasing the dosage of Viibryd by 2-fold, up to a maximum of 80 mg once daily, over 1 to 2 weeks in the patients who are taking strong CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin) for greater than 14 days. If CYP3A4 inducers are eventually discontinued, then gradually reduce the Viibryd dosage to its original level over 1 to 2 weeks.

Discontinuing Treatment with Viibryd

Some adverse reactions may occur upon discontinuation of Viibryd. A preferably gradual reduction in dosage rather than abrupt cessation is recommended whenever possible. Viibryd should also be down tapered from the normal 40 mg once daily dose to 20 mg once daily for 4 days, followed by a 10 mg once daily for 3 days. All the patients taking Viibryd 20 mg once daily should be also be tapered to 10 mg once daily for 7 days.

Dosage Forms and Strengths

Viibryd Tablets are available in forms of 10 mg, 20 mg and 40 mg film-coated tablets.

  • 10 mg is pink, oval tablet, debossed with 10 on one side
  • 20 mg is orange, oval tablet, debossed with 20 on one side
  • 40 mg is blue, oval tablet, debossed with 40 on one side

Contraindications

Viibryd has been contraindicated in:

  • Patients that are taking, or are within 14 days of stopping the use of monoamine oxidase inhibitors (MAOIs), including MAOIs such as the linezolid or intravenous methylene blue, because of an increased risk of the serotonin syndrome.

Warnings and Precautions

There will be Suicidal Thoughts and Behavior in all little Children, Adolescents and Young Adults

In some pooled analyses of placebo-controlled trials of the antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients, and way over 4,400 pediatric patients (children), the incidence or occurence of suicidal thoughts and behaviors in patients age 24 years and younger was greater in antidepressant-treated patients than in placebo-treated patients.

Increased Risk of Bleeding

Drugs that interfere with the serotonin reuptake inhibition, including this Viibryd, increase the risk of bleeding events in patients. Concomitant usage of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDS), warfarin, other antiplatelet drugs, and other anticoagulants may add to this risk. Case reports and some epidemiological studies (case-control and cohort design) have demonstrated that there is an association between use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding. Bleeding events which are related to drugs that interfere with serotonin reuptake have ranged from ecchymosis, epistaxis, hematoma, and petechiae to life-threatening hemorrhages.

Inform all patients about the risk of bleeding associated with the concomitant uses of Viibryd and antiplatelet agents or anticoagulants. For patients who are taking warfarin, carefully monitor the coagulation indices when titrating, initiating, or discontinuing Viibryd.

Activation of Mania or Hypomania

In patients with some bipolar disorders, treating a depressive episode with Viibryd or some other antidepressant may precipitate a mixed/manic episode. In some controlled clinical trials, patients with the bipolar disorders were excluded; however, some symptoms of mania or hypomania were reported in 0.1% of the undiagnosed patients treated with Viibryd. Prior to initiating the treatment with Viibryd, experts should screen patients for any personal or family history of bipolar disorder, mania, or hypomania.

Discontinuation Syndrome

Adverse reactions after the discontinuation of serotonergic antidepressants, particularly after an abrupt discontinuation, include: nausea, agitation, sweating, dysphoric mood, irritability, dizziness, sensory disturbances (e.g., paresthesia, such as an electric shock sensation), tremor, anxiety, confusion, headache, insomnia, lethargy, emotional lability, hypomania, tinnitus, and a series of seizures. A gradual reduction in the dosage rather than abrupt cessation is the ideal recommendation whenever possible.

Seizures

Viibryd has not yet been systematically evaluated in patients with a seizure disorder. Patients with some history of seizures were excluded from clinical studies. Viibryd should be prescribed with a lot of caution in patients with a seizure disorder.

Angle-Closure Glaucoma

The pupillary dilation that occurs following the use of many antidepressant drugs including your Viibryd may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy. Avoid the usage of antidepressants, including Viibryd, in patients who have untreated anatomically narrow angles.

Hyponatremia

Hyponatremia may also occur as a result of treatment with SNRIs and SSRIs, including Viibryd. Cases of the serum sodium lower than 110 mmol/L have been reported so far. Signs and symptoms of hyponatremia may include headache, difficulty concentrating, weakness, memory impairment, confusion, and unsteadiness, which may lead to falls. Signs and symptoms associated with more severe and/or acute cases of this condition have included hallucination, seizure, syncope, coma, respiratory arrest, and death. In several cases, this hyponatremia appears to come as the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH).

In patients who have symptomatic hyponatremia, stop taking Viibryd and institute appropriate medical intervention at once. Elderly patients, patients who are taking diuretics, and those who are mostly volume-depleted may be at a greater risk of developing hyponatremia with SSRIs and SNRIs.

Clinical Trials Experience

Because many clinical trials are conducted under some widely varying conditions and varying lengths of time, adverse reaction rates that are observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect rates observed in actual practice.

The most commonly observed or witnessed adverse reactions in Viibryd-treated patients with major depressive disorder (MDD) in placebo-controlled studies (incidence ≥ 5% and at least twice the rate of placebo) were diarrhea, vomiting, nausea, and insomnia.

Patient Exposure

The safety of Viibryd was evaluated in some 3,007 patients (18-70 years of age) diagnosed with the MDD who participated in clinical studies, showing 676 patient-years of exposure. In an open-label a 52 week study at 40 mg daily, about 599 patients were exposed to Viibryd for a total period of 348 patient-years.

The adverse reaction information given below was derived from studies of Viibryd 20 mg and 40 mg daily in patients with MDD including:

  • Four placebo-controlled 8 to 10-week studies in 2,233 patients, including over 1,265 Viibryd-treated patients; and
  • An open-label 52-week study of over 598 Viibryd-treated patients.

These studies have included a titration period of 10 mg daily for 7 days, followed by the 20 mg daily for 7 days or to 40 mg daily over 2 weeks. In all these clinical trials, Viibryd was always administered with food.

Some Adverse reactions reported as reasons for discontinuation of the treatment

In these studies, 7.3% of the Viibryd-treated patients discontinued treatment because of some adverse reaction, compared with 3.5% of placebo-treated patients. The most common adverse (dangerous)) reactions leading to the discontinuation in at least 1% of the Viibryd-treated patients in the placebo-controlled studies was nausea (1.4%).

Vilazodone Pregnancy Warnings

Vilazodone caused some developmental toxicity in tested rats, but was not teratogenic in rats or rabbits as well. There are yet no controlled data in human pregnancy. Additionally, exposed of neonates to vilazodone and other selective serotonin reuptake inhibitors (SSRIs) or serotonin and norepinephrine reuptake inhibitors (SNRIs), late in the third trimester of pregnancy have developed complications requiring prolonged hospitalization periods, respiratory support, and tube feeding. Signs and symptoms have included some respiratory distress, apnea, cyanosis, seizures, temperature fluctuatioins, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These clinical findings are very consistent with either a direct toxic effect of SSRIs and SNRIs or a drug discontinuation syndrome. In some other cases, this clinical picture is also consistent with serotonin syndrome. Infants who are exposed to SSRIs in pregnancy may also have an increased risk for a condition known as persistent pulmonary hypertension of the newborn (PPHN). The US FDA pregnancy category C: Animal reproduction studies have also shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but some potential benefits may warrant use of the drug in pregnant women despite all potential risks.

This drug should be used during pregnancy only if the benefit overtakes or outweighs the risk.

Vilazodone Breastfeeding Warnings

This drug should be put in use only if the potential benefits of the drug overtakes or outweighs the potential risk to the child. Excreted into human breast milk: Data not available yet Excreted into animal milk: Yes Noteworthy: The effects in the nursing infant are not yet known.

Looking keenly at viibryd uses, we see that it has a purpose to correct some very delicate mental conditions. Viibryd uses vilazodone as the active ingredient to give wonderful results if all details are strictly respected as have been given by the medical experts who are in charge. It is very important to note that negative side effects of viibryd may occur which are as severe as death hence this drug should be sold to patients respecting strict and valid prescription documents.

A Disclaimer: This write-up has the singular purpose which is guidance of patients who have doubts or medical personnel who are undergoing a series of trainings. In this light, no part of this document or the entire document should be used to replace the medical expertise of a doctor, pharmacist or any other health care provider or health care providing institutions.

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