Drugplain

Vilazodone Hydrochloride 40 mg/1

Vilazodone Hydrochloride · TABLET · Accord Healthcare Inc.

No Recall History
Plain English

Vilazodone Hydrochloride is a tablet containing vilazodone hydrochloride at 40 mg/1, taken oral. Manufactured by Accord Healthcare Inc..

Key Facts

Brand Name
Vilazodone Hydrochloride
Generic Name
Vilazodone Hydrochloride
NDC Code (Product)
16729-354
Manufacturer
Accord Healthcare Inc.
Strength
40 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA208209
Marketing Start
06/04/2022

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

anxiety29 reports
drug ineffective29 reports
depression26 reports
nausea19 reports
product substitution issue19 reports
fatigue17 reports
headache17 reports
pruritus16 reports
product dose omission issue15 reports
dizziness14 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Vilazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)]. Vilazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults (1).

Dosage & Administration

2 DOSAGE AND ADMINISTRATION • Recommended target dosage: 20 mg to 40 mg once daily with food (2.1, 12.3). • To titrate: start with initial dosage of 10 mg once daily for 7 days, followed by 20 mg once daily. The dose may be increased up to 40 mg once daily after a minimum of 7 days between dosage increases (2.1). • Prior to initiating vilazodone hydrochloride tablets, screen for bipolar disorder (2.2, 5.4). • When discontinuing vilazodone hydrochloride tablets, reduce the dosage gradually (2.4, 5.5). 2.1 Dosage for Treatment of Major Depressive Disorder The recommended target dosage for vilazodone hydrochloride tablet is 20 mg to 40 mg orally once daily with food [see Clinical Pharmacology (12.3), Clinical Studies (14)]. To achieve the target dosage, titrate vilazodone hydrochloride tablet as follows: • Start with an initial dosage of 10 mg once daily with food for 7 days, • Then increase to 20 mg once daily with food. • The dose may be increased up to 40 mg once daily with food after a minimum of 7 days between dosage increases. 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 …

Contraindications

4 CONTRAINDICATIONS Vilazodone hydrochloride tablets are contraindicated in: • Patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (MAOIs), including MAOIs such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see Warnings and Precautions (5.2), Drug Interactions (7)]. • Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within 14 days of stopping MAOIs (4).

Drug Interactions

7 DRUG INTERACTIONS •CYP3A4 Inhibitors: The vilazodone hydrochloride tablet dose should not exceed 20 mg once daily when co-administered with strong CYP3A4 inhibitors (2.4, 7). •CYP3A4 Inducers: Consider increasing vilazodone hydrochloride tablets dosage by 2-fold, up to 80 mg once-daily over 1 to 2 weeks when used concomitantly with strong CYP3A4 inducers for greater than 14 days (2.4, 7). 7.1 Drugs Having Clinically Important Interactions With Vilazodone Hydrochloride Tablets Table 4: Clinically Important Drug Interactions with Vilazodone Hydrochloride Tablets Concomitant Drug Name or Drug Class Clinical Rationale Clinical Recommendation Monoamine Oxidase Inhibitors (MAOIs) The concomitant use of MAOIs and serotonergic drugs including vilazodone hydrochloride tablets increases the risk of serotonin syndrome. Vilazodone hydrochloride tablets are contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [see Contraindications (4), Dosage and Administration (2.3), and Warnings and Precautions (5.2)]. Other Serotonergic Drugs The concomitant use of serotonergic drugs including vilazodone hydrochloride tablets and other serotonergic drug…

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: • Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see Warnings and Precautions (5.1)]. • Serotonin Syndrome [see Warnings and Precautions (5.2)]. • Increased Risk of Bleeding [see Warnings and Precautions (5.3)]. • Activation of Mania or Hypomania [see Warnings and Precautions (5.4)]. • Discontinuation Syndrome [see Warnings and Precautions (5.5)]. • Seizures [see Warnings and Precautions (5.6)]. • Angle-Closure Glaucoma [see Warnings and Precautions (5.7)]. • Hyponatremia [see Warnings and Precautions (5.8)]. • Sexual Dysfunction [see Warnings and Precautions (5.9)]. Most common adverse reactions (incidence ≥ 5% and at least twice the rate of placebo): diarrhea, nausea, vomiting, and insomnia (6). To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions and varying lengths of time, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of an…

Frequently Asked Questions

What is Vilazodone Hydrochloride used for?

Vilazodone Hydrochloride contains Vilazodone Hydrochloride. It is a tablet taken oral. Consult your doctor for specific uses.

Is Vilazodone Hydrochloride a controlled substance?

Vilazodone Hydrochloride is not classified as a controlled substance by the DEA.

What is the generic name for Vilazodone Hydrochloride?

The generic name for Vilazodone Hydrochloride is Vilazodone Hydrochloride. There are 8 other brand versions of Vilazodone Hydrochloride.

What is the NDC code for Vilazodone Hydrochloride 40 mg/1?

The NDC (National Drug Code) for Vilazodone Hydrochloride 40 mg/1 is 16729-354, listed by Accord Healthcare Inc..

Product NDC

16729-354

Package NDC

16729-354-10

Other Vilazodone Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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