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VIIBRYD
Overview
What is VIIBRYD?
VIIBRYD tablets for oral administration contain polymorph Form IV vilazodone hydrochloride (HCl), a selective serotonin reuptake inhibitor and a 5HT receptor partial agonist.
Vilazodone HCl is 2-benzofurancarboxamide, 5-[4-[4-(5-cyano-1-indol-3-yl)butyl]-1-piperazinyl]-, hydrochloride (1:1). Its molecular weight is 477.99. The structural formula is:
In addition to the active ingredient, VIIBRYD tablets contain the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, magnesium stearate, colloidal silicon dioxide, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, FD&C Blue #1 (40 mg only), FD&C Yellow #6 (20 mg only) and FD&C Red #40 (10 mg only).
What does VIIBRYD look like?
What are the available doses of VIIBRYD?
Tablets: 10 mg, 20 mg, and 40 mg ()
What should I talk to my health care provider before I take VIIBRYD?
How should I use VIIBRYD?
VIIBRYD is indicated for the treatment of major depressive disorder (MDD)
The recommended target dosage for VIIBRYD is 20 mg to 40 mg orally once daily with food . To achieve the target dosage, titrate VIIBRYD as follows:
If a dose is missed, it should be taken as soon as the patient remembers. If it is almost time for the next dose, the patient should skip the missed dose and take the next dose at the regular time. Two doses should not be taken at the same time.
What interacts with VIIBRYD?
Sorry No Records found
What are the warnings of VIIBRYD?
Sorry No Records found
What are the precautions of VIIBRYD?
Sorry No Records found
What are the side effects of VIIBRYD?
Sorry No records found
What should I look out for while using VIIBRYD?
VIIBRYD is contraindicated in:
What might happen if I take too much VIIBRYD?
There is limited clinical trial experience regarding human overdose with VIIBRYD. The adverse reactions associated with overdose of VIIBRYD at doses of 200-280 mg (5 to 7 times the recommended dosage) as observed in clinical trials included serotonin syndrome, lethargy, restlessness, hallucinations, and disorientation.
For current information on the management of poisoning or overdose, contact a poison control center at 1-800-222-1222.
No specific antidotes for vilazodone are known. Removal of vilazodone by dialysis has not been studied; however, the high volume of distribution of vilazodone suggests that dialysis will not be effective in reducing vilazodone plasma concentrations.
How should I store and handle VIIBRYD?
Keep out of reach of children.Protect from light, moisture, and excessive heat.Dispense in tight, light-resistant container with child-resistant closure.Keep out of reach of children.Protect from light, moisture, and excessive heat.Dispense in tight, light-resistant container with child-resistant closure.Keep out of reach of children.Protect from light, moisture, and excessive heat.Dispense in tight, light-resistant container with child-resistant closure.VIIBRYD (vilazodone HCl) tablets are supplied in the following configurations: Viibryd (vilazodone HCl) 20 mg are available in bottles of approximately 2520 tablets, NDC 55154-4627-8.Viibryd (vilazodone HCl) 40 mg are available in bottles of approximately 960 tablets, NDC 55154-4624-2.Viibryd (vilazodone HCl) 40 mg are available in bottles of approximately 1920 tablets, NDC 55154-4624-8.Store tablets at 25°C (77°F). Excursions permitted to 15°C - 30°C (59°F - 86°F) []. VIIBRYD (vilazodone HCl) tablets are supplied in the following configurations: Viibryd (vilazodone HCl) 20 mg are available in bottles of approximately 2520 tablets, NDC 55154-4627-8.Viibryd (vilazodone HCl) 40 mg are available in bottles of approximately 960 tablets, NDC 55154-4624-2.Viibryd (vilazodone HCl) 40 mg are available in bottles of approximately 1920 tablets, NDC 55154-4624-8.Store tablets at 25°C (77°F). Excursions permitted to 15°C - 30°C (59°F - 86°F) []. VIIBRYD (vilazodone HCl) tablets are supplied in the following configurations: Viibryd (vilazodone HCl) 20 mg are available in bottles of approximately 2520 tablets, NDC 55154-4627-8.Viibryd (vilazodone HCl) 40 mg are available in bottles of approximately 960 tablets, NDC 55154-4624-2.Viibryd (vilazodone HCl) 40 mg are available in bottles of approximately 1920 tablets, NDC 55154-4624-8.Store tablets at 25°C (77°F). Excursions permitted to 15°C - 30°C (59°F - 86°F) []. VIIBRYD (vilazodone HCl) tablets are supplied in the following configurations: Viibryd (vilazodone HCl) 20 mg are available in bottles of approximately 2520 tablets, NDC 55154-4627-8.Viibryd (vilazodone HCl) 40 mg are available in bottles of approximately 960 tablets, NDC 55154-4624-2.Viibryd (vilazodone HCl) 40 mg are available in bottles of approximately 1920 tablets, NDC 55154-4624-8.Store tablets at 25°C (77°F). Excursions permitted to 15°C - 30°C (59°F - 86°F) []. VIIBRYD (vilazodone HCl) tablets are supplied in the following configurations: Viibryd (vilazodone HCl) 20 mg are available in bottles of approximately 2520 tablets, NDC 55154-4627-8.Viibryd (vilazodone HCl) 40 mg are available in bottles of approximately 960 tablets, NDC 55154-4624-2.Viibryd (vilazodone HCl) 40 mg are available in bottles of approximately 1920 tablets, NDC 55154-4624-8.Store tablets at 25°C (77°F). Excursions permitted to 15°C - 30°C (59°F - 86°F) [].
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The mechanism of the antidepressant effect of vilazodone is not fully understood but is thought to be related to its enhancement of serotonergic activity in the CNS through selective inhibition of serotonin reuptake. Vilazodone is also a partial agonist at serotonergic 5-HT receptors; however, the net result of this action on serotonergic transmission and its role in vilazodone's antidepressant effect are unknown.
Non-Clinical Toxicology
VIIBRYD is contraindicated in:HMG-CoA reductase inhibitors:
Coadministration of multiple doses of 10 mg of verapamil with 80 mg simvastatin resulted in exposure to simvastatin 2.5-fold that following simvastatin alone. Limit the dose of simvastatin in patients on verapamil to 10 mg daily. Limit the daily dose of lovastatin to 40 mg. Lower starting and maintenance doses of other CYP3A4 substrates (e.g., atorvastatin) may be required as verapamil may increase the plasma concentration of these drugs.
Aspirin:
Grapefruit juice:
Alcohol:
Beta-blockers:
In one study involving 15 patients treated with high doses of propranolol (median dose: 480 mg/day; range: 160 to 1,280 mg/day) for severe angina, with preserved left ventricular function (ejection fraction greater than 35%), the hemodynamic effects of additional therapy with verapamil hydrochloride were assessed using invasive methods. The addition of verapamil to high-dose beta-blockers induced modest negative inotropic and chronotropic effects that were not severe enough to limit short-term (48 hours) combination therapy in this study. These modest cardiodepressant effects persisted for greater than 6 but less than 30 hours after abrupt withdrawal of beta-blockers and were closely related to plasma levels of propranolol. The primary verapamil/beta-blocker interaction in this study appeared to be hemodynamic rather than electrophysiologic.
In other studies, verapamil did not generally induce significant negative inotropic, chronotropic, or dromotropic effects in patients with preserved left ventricular function receiving low or moderate doses of propranolol (less than or equal to 320 mg/day); in some patients, however, combined therapy did produce such effects. Therefore, if combined therapy is used, close surveillance of clinical status should be carried out. Combined therapy should usually be avoided in patients with atrioventricular conduction abnormalities and those with depressed left ventricular function.
Asymptomatic bradycardia (36 beats/min) with a wandering atrial pacemaker has been observed in a patient receiving concomitant timolol (a beta-adrenergic blocker) eyedrops and oral verapamil.
A decrease in metoprolol and propranolol clearance has been observed when either drug is administered concomitantly with verapamil. A variable effect has been seen when verapamil and atenolol were given together.
Digitalis:
Antihypertensive agents:
The electrophysiologic effects of quinidine and verapamil on AV conduction were studied in 8 patients. Verapamil significantly counteracted the effects of quinidine on AV conduction. There has been a report of increased quinidine levels during verapamil therapy.
In pooled analyses of placebo-controlled trials of antidepressant drugs (SSRIs and other antidepressant classes) that included approximately 77,000 adult patients, and over 4,400 pediatric patients, the incidence of suicidal thoughts and behaviors in patients age 24 years and younger was greater in antidepressant-treated patients than in placebo-treated patients. The drug-placebo differences in the number of cases of suicidal thoughts and behaviors per 1000 patients treated are provided in .
No suicides occurred in any of the pediatric studies. There were suicides in the adult studies, but the number was not sufficient to reach any conclusion about antidepressant drug effect on suicide.
It is unknown whether the risk of suicidal thoughts and behaviors in children, adolescents, and young adults extends to longer-term use, i.e., beyond four months. However, there is substantial evidence from placebo-controlled maintenance studies in adults with MDD that antidepressants delay the recurrence of depression.
Monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during the initial few months of drug therapy and at times of dosage changes. Counsel family members or caregivers of patients to monitor for changes in behavior and to alert the healthcare provider. Consider changing the therapeutic regimen, including possibly discontinuing VIIBRYD, in patients whose depression is persistently worse, or who are experiencing emergent suicidal thoughts or behaviors.
The following adverse reactions are discussed in greater detail in other sections of the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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