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Image 0 of Viibryd 20 Mg Tabs 30 By Allergan Inc. Image 1 of Viibryd 20 Mg Tabs 30 By Allergan Inc.

Viibryd 20 Mg Tabs 30 By Allergan Inc.

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Viibryd 20 Mg Tabs 30 By Allergan Inc. This Item Requires A Valid Order From A Physician Licensed in USA. Item Number.:RXD4441655/RXB10097195/RXa581207/RXA312540
Size : 30
ABC Selling UoM : EA

NDC: 00456-1120-30
UPC Barcode :
Supplier: 0050001063 ALLERGAN USA, INC.
Supplier Material : 112030
Generic Code : 067377 VILAZODONE HYDROCHLORIDE ORAL TABLET 20
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
Product Type : BRX Branded RX

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Product Description.:

20
tablet , orange , oval oblong
Debossed

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 (1, 14).
------------ DOSAGE AND ADMINISTRATION--------
? The recommended dose for VIIBRYD is 40 mg once
daily (2.1).
? 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 (2.1).
? VIIBRYD should be taken with food. Administration
without food can result in inadequate drug concentrations
and may diminish effectiveness (2.1, 12.3).
? When discontinuing treatment, reduce the dose
gradually (2.4).
------------ DOSAGE FORMS AND STRENGTHS ------
VIIBRYD is available as 10 mg, 20 mg and 40 mg
tablets (3).
-----------------CONTRAINDICATIONS--------------
? Monoamine Oxidase Inhibitors: Do not use VIIBRYD
concomitantly with an MAOI or within 14 days of
stopping or starting an MAOI (4.1).
------------WARNINGS AND PRECAUTIONS----------
Clinical Worsening/Suicide Risk: Monitor patients
for clinical worsening and suicidal thinking or
behavior (5.1).
Serotonin Syndrome or Neuroleptic Malignant (NMS)-
like Syndrome: Can occur with treatment. Discontinue
and initiate supportive treatment (5.2).
Seizures: Can occur with treatment. Use with caution in
patients with a seizure disorder (5.3).
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 (5.4).
Activation of Mania/Hypomania: Can occur with
treatment. Screen patients for bipolar disorder (5.5).
Discontinuation of Treatment with VIIBRYD: A gradual
reduction in dose is recommended rather than an abrupt
cessation (5.6).
Hyponatremia: Can occur in association with the syndrome
of inappropriate antidiuretic hormone secretion
(SIADH) (5.7).
------------------ADVERSE REACTIONS---------------
The most common adverse reactions (incidence ��%
and at least twice the rate of placebo) are: diarrhea,
nausea, vomiting, and insomnia (6).
To report SUSPECTED ADVERSE REACTIONS, contact
Forest Laboratories, Inc. at 1-800-678-1605 or FDA at
1-800-FDA-1088 or www.fda.gov/medwatch.
----------------- DRUG INTERACTIONS---------------
MAOIs: Do not use VIIBRYD concomitantly with
an MAOI or within 14 days of stopping or starting an
MAOI (4.1, 7.1).
CYP3A4 inhibitors: The VIIBRYD dose should be
reduced to 20 mg when co-administered with CYP3A4
strong inhibitors (7.3).
CYP3A4 inducers: Concomitant use of VIIBRYD with
inducers of CYP3A4 can result in inadequate drug concentrations
and may diminish effectiveness. The effect
of CYP3A4 inducers on systemic exposure of vilazodone
has not been evaluated (7.3).
-----------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 (2.3, 8.1).
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 (8.3, 2.3).
Pediatric Use: The safety and efficacy of VIIBRYD in
pediatric patients have not been studied (2.3, 8.4).
Geriatric Use: No dose adjustment is recommended on
the basis of age (8.5).
Hepatic Impairment: No dose adjustment is recommended
in patients with mild or moderate hepatic
impairment. VIIBRYD has not been studied in patients
with severe hepatic impairment (2.3, 8.6).
Renal Impairment: No dose adjustment is recommended
in patients with mild, moderate, or severe renal
impairment. (2.3, 8.7).
See 17 for PATIENT COUNSELING INFORMATION
and Medication Guide.