VIIBRYD*
Manufacturer DetailsGENERIC*
USA AND CANADA
Compositions:
Vilazodone hydrochloride -mg,
Vilazodone hydrochloride -mg,
| Strength | Rate | Packing Style |
|---|---|---|
| mg | 0.00 | unit |
List of Related Indications:
- Treat major depressive disorder in adults
List Of Drugs:
- Vilazodone hydrochloride- Viibryd- @- Antidepressant (Jan 2011)
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Drug Interaction:
MAOIs:
Do not use VIIBRYD concomitantly with an MAOI or within 14 days
of stopping or starting an MAOI
CYP3A4 inhibitors:
The VIIBRYD dose should be reduced to 20 mg when co-administered
with CYP3A4 strong inhibitors
CYP3A4 inducers:
Based on clinical response, consider increasing the dose of VIIBRYD
up to 2-fold when used concomitantly with strong CYP3A4 inducers
(e.g., carbamazepine) for greater than 14 days.
The maximum daily dose should not exceed 80 mg.
Indication:
VIIBRYD (vilazodone HCl) Tablets for oral administration
Initial U.S. Approval: 2011
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
See full prescribing information for complete boxed warning.
Increased risk of suicidal thinking and behavior in children, adolescents, and
young adults taking antidepressants
Monitor for worsening and emergence of suicidal thoughts and behaviors
VIIBRYD is not approved for use in pediatric patients
RECENT MAJOR CHANGE
Boxed Warning 12/2013 Dosage and Administration 12/2013
Warnings and Precautions 04/2014
Drug Name- Viibryd*
Active Ingredient - Viladone hydrochloride
Treat major depressive disorder in adults
Indication-
Treat major depressive disorder in adults
Approved by FDA on 21-1-2011 (Ref- FDA approved List- 2011)
LIST OF APPROVED DRUG FROM 01-01-2015 To 31-12-2015
ISSUED BY NEW DRUG DIVISION - DRUG CONTROLLER GENERAL- INDIA
Sr.No Name of Drug Indication Date of Issue
10. Vilazodone Hydrochloride 19-08-2015
20mg/40mg and Bulk
For the treatment of Major depressive disorders
in adults
Approved by DCG INDIA (Ref- DCGI approved List- 01-01-2015 To 31-12-3015)
Adverse Reaction:
The most common adverse reactions (incidence . 5% and at least twice
the rate of placebo) are: diarrhea, nausea, vomiting, and insomnia
Contra-Indications:
CONTRAINDICATIONS
Serotonin Syndrome and MAOIs:
Do not use MAOIs intended to treat psychiatric disorders with VIIBRYD
or within 14 days of stopping treatment with VIIBRYD.
Do not use VIIBRYD within 14 days of stopping an MAOI intended to treat
psychiatric disorders. In addition, do not start VIIBRYD in a patient who is
being treated with linezolid or intravenous methylene blue
WARNINGS AND PRECAUTIONS
Suicidal Thoughts and Behaviors in Children, Adolescents and Young Adults:
Monitor patients for clinical worsening and suicidal thinking or behavior
Serotonin Syndrome: Serotonin syndrome has been reported with SSRIs
and SNRIs, including VIIBRYD, both when taken alone, but especially
when co-administered with other serotonergic agents (including triptans,
tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan,
buspirone and St. John¡¦s Wort).
If such symptoms occur, discontinue VIIBRYD and initiate supportive treatment.
If concomitant use of VIIBRYD with other serotonergic drugs is clinically
warranted, patients should be made aware of a potential increased risk
for serotonin syndrome, particularly during treatment initiation and dose increases
Seizures: Can occur with treatment. Use with caution in patients with a seizure disorder
Abnormal Bleeding: Treatment can increase the risk of bleeding. Use with caution
in association with nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin,
or other drugs that affect coagulation
Activation of Mania/Hypomania: Can occur with treatment. Screen patients
for bipolar disorder
Discontinuation of Treatment with VIIBRYD: A gradual reduction in dose is
recommended rather than an abrupt cessation
Hyponatremia: Can occur in association with the syndrome of inappropriate
antidiuretic hormone secretion (SIADH)
Dosages/ Overdosage Etc:
Indication-
Treat major depressive disorder in adults
INDICATIONS AND USAGE
VIIBRYD is indicated for the treatment of major depressive disorder (MDD).
The efficacy of VIIBRYD was established in two 8-week, placebo-controlled
trials in adult patients with MDD
DOSAGE AND ADMINISTRATION
The recommended dose for VIIBRYD is 40 mg once daily
VIIBRYD should be titrated to the 40 mg dose, starting with an initial dose of
10 mg once daily for 7 days, followed by 20 mg once daily for an additional 7 days,
and then increased to 40 mg once daily
VIIBRYD should be taken with food. Administration without food can result
in inadequate drug concentrations and may diminish effectiveness
When discontinuing treatment, reduce the dose gradually
When discontinuing treatment, reduce the dose gradually
DOSAGE FORMS AND STRENGTHS
VIIBRYD is available as 10 mg, 20 mg and 40 mg tablets
When discontinuing treatment, reduce the dose gradually
DOSAGE FORMS AND STRENGTHS
VIIBRYD is available as 10 mg, 20 mg and 40 mg tablets
Patient Information:
PATIENT COUNSELING INFORMATION
1. Information for Patients
Advise patients and their caregivers about the benefits and risks associated with
treatment with VIIBRYD and counsel them in its appropriate use.
2.Suicidal Thoughts and Behaviors
Advise patients and caregivers to monitor for the emergence of suicidal thoughts
or behaviors, especially early during treatment and when the dose is adjusted
up or down. Advise them to notify their healthcare provider if these occur
3.Dosing and Administration
Instruct patients to take VIIBRYD with food. When initiating treatment with VIIBRYD
the dose should be titrated, starting with a dose of 10 mg once daily for 7 days,
followed by 20 mg once daily for an additional 7 days, and then increased
to 40 mg once daily
4.Concomitant Medication
Instruct patients not to take VIIBRYD with an MAOI or within 14 days of stopping an
MAOI and to allow 14 days after stopping VIIBRYD before starting an MAOI
5.Serotonin Syndrome
Caution patients about the risk of serotonin syndrome, particularly with the
concomitant use of VIIBRYD with other serotonergic drugs including triptans,
tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone,
St. John’s Wort, and with drugs that impair metabolism of serotonin
(in particular, MAOIs, both those intended to treat psychiatric disorders
and also others, such as linezolid)
6.Seizures
Caution patients about using VIIBRYD if they have a history of a seizure disorder
Patients with a history of seizures were excluded from clinical studies.
Pharmacology/ Pharmacokinetics:
1. Mechanism of action
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-HT1A receptors; however, the net result
of this action on serotonergic transmission and its role in vilazodone’s
antidepressant effect are unknown
2. Pharmacokinetics
Vilazodone activity is due primarily to the parent drug. The pharmacokinetics
of vilazodone (5 mg / 80 mg) are dose-proportional. Accumulation of vilazodone
is predictable from single dose data, does not vary with dose, and steady-state
is achieved in about 3 days.
Elimination of vilazodone is primarily by hepatic metabolism with a terminal
half-life of approximately 25 hours. At steady-state, after daily dosing of VIIBRYD
40 mg under fed conditions, the mean Cmax value is 156 ng/mL, and the mean
AUC (0-24 hours) value is 1645 ng·h/mL.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
Pregnancy:
There are no controlled human data regarding VIIBRYD use during pregnancy.
Use only if the potential benefits outweigh the potential risks
.Nursing Mothers:
There are no human data regarding VIIBRYD concentrations in breast milk.
Women should breast feed only if the potential benefits outweigh
the potential risks (
Pediatric Use:
The safety and efficacy of VIIBRYD in pediatric patients
have not been studied
. Geriatric Use:
No dose adjustment is recommended on the basis of age
