vilazodone

BEERS REMS

Major depressive disorder.

Contraindicated in:

Concurrent use of MAO inhibitors or MAO-inhibitor-like drugs (linezolid or methylene blue).

Use Cautiously in:

May ↑ risk of suicide attempt/ideation especially during early treatment or dose adjustment; this risk appears to be greater in adolescents or children;
Bipolar disorder (may ↑ risk of mania/hypomania);
Angle-closure glaucoma;
OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Safety and effectiveness not established in children;
Geri: Appears on Beers list. May worsen or cause syndrome of inappropriate antidiuretic hormone (SIADH) secretion and/or hyponatremia in older adults. Use with caution in older adults and closely monitor sodium concentrations when starting therapy or ↑ dose.

Endo: SIADH

F and E: hyponatremia

GI: diarrhea, nausea, dry mouth, PANCREATITIS, vomiting

GU: ↓libido, delayed/absent orgasm, ejaculatory delay/failure, erectile dysfunction

Hemat: BLEEDING

Neuro: insomnia, abnormal dreams, dizziness, NEUROLEPTIC MALIGNANT-LIKE SYNDROME, restlessness, SEIZURES, sleep paralysis, SUICIDAL THOUGHTS/BEHAVIORS

Misc: SEROTONIN SYNDROME

Drug-drug:

Concurrent use with, or use within 14 days of starting or stopping, MAO inhibitors may ↑ risk of neuroleptic malignant syndrome or serotonin syndrome and should be avoided.
MAO-inhibitor-like drugs, such as linezolid or methylene blue, may ↑ risk of serotonin syndrome; concurrent use contraindicated; do not start therapy in patients receiving linezolid or methylene blue; if linezolid or methylene blue need to be started in a patient receiving vilazodone, immediately discontinue vilazodone and monitor for signs/symptoms of serotonin syndrome for 2 wk or until 24 hr after last dose of linezolid or methylene blue, whichever comes first (may resume vilazodone therapy 24 hr after last dose of linezolid or methylene blue).
Drugs that affect serotonergic neurotransmitter systems, including tricyclic antidepressants, SNRIs, fentanyl, lithium, buspirone, tramadol, meperidine, methadone, amphetamines, and triptans, may ↑ risk of serotonin syndrome.
↑risk of bleeding with NSAIDs, aspirin, clopidogrel, prasugrel, ticagrelor, dabigatran, apixaban, edoxaban, rivaroxaban, or warfarin.
Strong CYP3A4 inhibitors, including ketoconazole, may ↑ levels and risk of toxicity.
Moderate CYP3A4 inhibitors, including erythromycin, may ↑ levels and risk of toxicity; ↓ dose.
Strong CYP3A4 inducers, including carbamazepine, may ↓ levels and effectiveness.

Drug-Natural Products:

↑risk of serotonin syndrome with St. John’s wort.

(Generic available)

Tablets: 10 mg; 20 mg; 40 mg

PO (Adults ): 10 mg once daily for one wk; then 20 mg once daily for one wk; dose may be ↑ to 40 mg once daily (recommended dose = 20–40 mg/day). Concurrent use of strong CYP3A4 inhibitors: Not to exceed 20 mg/day; Concurrent use of strong CYP3A4 inducers (if used for >14 days): May need to ↑ dose up to twofold (daily dose should not exceed 80 mg).

Increases serotonin activity in the CNS by inhibiting serotonin reuptake. Also binds selectively with high affinity to 5-HT_1A receptors and is a 5-HT_1A receptor partial agonist.

Therapeutic effects:

Improvement in symptoms of depression.

Therapeutic Classification: antidepressants

Pharmacologic Classification: selective serotonin reuptake inhibitors ssris, benzofurans

Absorption: 72% absorbed following oral administration with food.

Distribution: Unknown.

Protein Binding: 96–99%.

Metabolism/Excretion: Mostly metabolized by the liver, primarily by the CYP3A4 isoenzyme; 1% excreted unchanged in urine.

Half-Life: 25 hr.

( plasma concentrations)

ROUTE		ONSET		PEAK		DURATION
PO		unknown		4–5 hr		unknown

Explain purpose and side effects of medication to patient. Advise patient to read Patient Information before starting therapy. Instruct patient to take as directed at the same time each day. Take missed doses as soon as possible unless almost time for next dose. Do not double doses or discontinue abruptly. Gradually ↓ dose before discontinuation. Emphasize the importance of follow-up exams to monitor progress, and encourage patient participation in psychotherapy.
Instruct patient to notify health care provider of all Rx or OTC medications, vitamins, or herbal products being taken and to avoid concurrent use of Rx, OTC, and herbal products, especially NSAIDs, aspirin, and warfarin, without consulting health care provider.
Advise patient, family, and caregivers to look for suicidality, especially during early therapy or dose changes. Notify health care provider immediately if thoughts about suicide or dying, attempts to commit suicide, new or worse depression or anxiety, agitation or restlessness, panic attacks, insomnia, new or worse irritability, aggressiveness, acting on dangerous impulses, mania, or other changes in mood or behavior occur.
Advise patient and caregivers to notify health care provider immediately if symptoms of serotonin syndrome occur.
Caution patient of the risk of serotonin syndrome and neuroleptic malignant syndrome, especially when taking triptans, tramadol, tryptophan supplements, and other serotonergic or antipsychotic agents.
May cause dizziness. Caution patient to avoid driving or other activities requiring alertness until response to the drug is known.
Caution patient to avoid taking alcohol or other CNS-depressant drugs, including opioids, during therapy.
Inform patient that symptoms of sexual dysfunction can occur. Advise men that ejaculatory delay or failure, ↓ libido, and erectile dysfunction may occur. Advise women that ↓ libido and delayed or absent orgasm may occur. Advise patient to notify health care provider if symptoms occur.
Rep: Advise women of reproductive potential to notify health care provider immediately if pregnancy is planned or suspected or if breastfeeding. Use during last month of pregnancy ↑ risk of postpartum hemorrhage. If used during pregnancy, should be tapered during 3rd trimester to avoid neonatal serotonin syndrome. Monitor infants exposed to vilazodone for excess sedation, restlessness, agitation, poor feeding, poor weight gain, or respiratory distress; may ↑ risk of persistent pulmonary hypertension of the newborn. Encourage pregnant patients to enroll in pregnancy exposure registry that monitors outcomes of women exposed to antidepressants during pregnancy by contacting National Pregnancy Registry for Antidepressants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants/.

NDC Code

0456- Allergan, Inc.
- 0456-1110- VIIBRYD
  - 0456-1110-30- 30 TABLET in 1 BOTTLE (0456-1110-30)

0456- Allergan, Inc.
- 0456-1111-
  - 0456-1111-00- 1 BAG in 1 DRUM (0456-1111-00) / 62000 TABLET in 1 BAG

0456- Allergan, Inc.
- 0456-1120- VIIBRYD
  - 0456-1120-30- 30 TABLET in 1 BOTTLE (0456-1120-30)

0456- Allergan, Inc.
- 0456-1121-
  - 0456-1121-00- 1 BAG in 1 DRUM (0456-1121-00) / 60000 TABLET in 1 BAG

0456- Allergan, Inc.
- 0456-1140- VIIBRYD
  - 0456-1140-30- 30 TABLET in 1 BOTTLE (0456-1140-30)

0456- Allergan, Inc.
- 0456-1141-
  - 0456-1141-00- 1 BAG in 1 DRUM (0456-1141-00) / 15000 TABLET in 1 BAG

0480- Teva Pharmaceuticals, Inc.
- 0480-2043- Vilazodone Hydrochloride
  0480-2043-56- 30 TABLET, FILM COATED in 1 BOTTLE (0480-2043-56)

0480- Teva Pharmaceuticals, Inc.
- 0480-2044- Vilazodone Hydrochloride
  - 0480-2044-56- 30 TABLET, FILM COATED in 1 BOTTLE (0480-2044-56)

0480- Teva Pharmaceuticals, Inc.
- 0480-2045- Vilazodone Hydrochloride
  - 0480-2045-56- 30 TABLET, FILM COATED in 1 BOTTLE (0480-2045-56)

16729- Accord Healthcare Inc.
- 16729-352- Vilazodone Hydrochloride
  - 16729-352-10- 30 TABLET in 1 BOTTLE (16729-352-10)

16729- Accord Healthcare Inc.
- 16729-353- Vilazodone Hydrochloride
  - 16729-353-10- 30 TABLET in 1 BOTTLE (16729-353-10)

16729- Accord Healthcare Inc.
- 16729-354- Vilazodone Hydrochloride
  - 16729-354-10- 30 TABLET in 1 BOTTLE (16729-354-10)

42291- AvKARE
- 42291-948- vilazodone
  - 42291-948-30- 30 TABLET in 1 BOTTLE (42291-948-30)

42291- AvKARE
- 42291-949- Vilazodone
  - 42291-949-30- 30 TABLET in 1 BOTTLE (42291-949-30)

42291- AvKARE
- 42291-950- Vilazodone
  - 42291-950-30- 30 TABLET in 1 BOTTLE (42291-950-30)

46708- Alembic Pharmaceuticals Limited
- 46708-232- VILAZODONE HYDROCHLORIDE
  - 46708-232-30- 30 TABLET, FILM COATED in 1 BOTTLE (46708-232-30)

46708- Alembic Pharmaceuticals Limited
- 46708-232- VILAZODONE HYDROCHLORIDE
  - 46708-232-71- 500 TABLET, FILM COATED in 1 BOTTLE (46708-232-71)

46708- Alembic Pharmaceuticals Limited
- 46708-232- VILAZODONE HYDROCHLORIDE
  - 46708-232-90- 90 TABLET, FILM COATED in 1 BOTTLE (46708-232-90)

46708- Alembic Pharmaceuticals Limited
- 46708-232- VILAZODONE HYDROCHLORIDE
  - 46708-232-91- 1000 TABLET, FILM COATED in 1 BOTTLE (46708-232-91)

46708- Alembic Pharmaceuticals Limited
- 46708-233- VILAZODONE HYDROCHLORIDE
  - 46708-233-30- 30 TABLET, FILM COATED in 1 BOTTLE (46708-233-30)

46708- Alembic Pharmaceuticals Limited
- 46708-233- VILAZODONE HYDROCHLORIDE
  - 46708-233-71- 500 TABLET, FILM COATED in 1 BOTTLE (46708-233-71)

46708- Alembic Pharmaceuticals Limited
- 46708-233- VILAZODONE HYDROCHLORIDE
  - 46708-233-90- 90 TABLET, FILM COATED in 1 BOTTLE (46708-233-90)

46708- Alembic Pharmaceuticals Limited
- 46708-233- VILAZODONE HYDROCHLORIDE
  - 46708-233-91- 1000 TABLET, FILM COATED in 1 BOTTLE (46708-233-91)

46708- Alembic Pharmaceuticals Limited
- 46708-234- VILAZODONE HYDROCHLORIDE
  - 46708-234-30- 30 TABLET, FILM COATED in 1 BOTTLE (46708-234-30)

46708- Alembic Pharmaceuticals Limited
- 46708-234- VILAZODONE HYDROCHLORIDE
  - 46708-234-71- 500 TABLET, FILM COATED in 1 BOTTLE (46708-234-71)

46708- Alembic Pharmaceuticals Limited
- 46708-234- VILAZODONE HYDROCHLORIDE
  - 46708-234-90- 90 TABLET, FILM COATED in 1 BOTTLE (46708-234-90)

46708- Alembic Pharmaceuticals Limited
- 46708-234- VILAZODONE HYDROCHLORIDE
  - 46708-234-91- 1000 TABLET, FILM COATED in 1 BOTTLE (46708-234-91)

50370- MSN Pharmachem Private Limited
- 50370-0035-
  - 50370-0035-1- 60 kg in 1 DRUM (50370-0035-1)

51407- Golden State Medical Supply, Inc.
- 51407-915- Vilazodone Hydrochloride
  51407-915-30- 30 TABLET, FILM COATED in 1 BOTTLE (51407-915-30)

51407- Golden State Medical Supply, Inc.
- 51407-916- Vilazodone Hydrochloride
  - 51407-916-30- 30 TABLET, FILM COATED in 1 BOTTLE (51407-916-30)

51407- Golden State Medical Supply, Inc.
- 51407-917- Vilazodone Hydrochloride
  - 51407-917-30- 30 TABLET, FILM COATED in 1 BOTTLE (51407-917-30)

55111- Dr.Reddy's Laboratories Limited
- 55111-955-
  - 55111-955-00- 1 kg in 1 DRUM (55111-955-00)

60505- Apotex Corp.
- 60505-4372- vilazodone hydrochloride
  60505-4372-3- 30 TABLET in 1 BOTTLE (60505-4372-3)

60505- Apotex Corp.
- 60505-4373- vilazodone hydrochloride
  - 60505-4373-3- 30 TABLET in 1 BOTTLE (60505-4373-3)

60505- Apotex Corp.
- 60505-4374- vilazodone hydrochloride
  - 60505-4374-3- 30 TABLET in 1 BOTTLE (60505-4374-3)

60505- Apotex Corp
- 60505-4772- vilazodone
  - 60505-4772-3- 30 TABLET in 1 BOTTLE (60505-4772-3)

60505- Apotex Corp
- 60505-4773- Vilazodone
  - 60505-4773-3- 30 TABLET in 1 BOTTLE (60505-4773-3)

60505- Apotex Corp
- 60505-4774- Vilazodone
  - 60505-4774-3- 30 TABLET in 1 BOTTLE (60505-4774-3)

62332- Alembic Pharmaceuticals Inc.
- 62332-232- VILAZODONE HYDROCHLORIDE
  - 62332-232-30- 30 TABLET, FILM COATED in 1 BOTTLE (62332-232-30)

62332- Alembic Pharmaceuticals Inc.
- 62332-232- VILAZODONE HYDROCHLORIDE
  - 62332-232-71- 500 TABLET, FILM COATED in 1 BOTTLE (62332-232-71)

62332- Alembic Pharmaceuticals Inc.
- 62332-232- VILAZODONE HYDROCHLORIDE
  - 62332-232-90- 90 TABLET, FILM COATED in 1 BOTTLE (62332-232-90)

62332- Alembic Pharmaceuticals Inc.
- 62332-232- VILAZODONE HYDROCHLORIDE
  - 62332-232-91- 1000 TABLET, FILM COATED in 1 BOTTLE (62332-232-91)

62332- Alembic Pharmaceuticals Inc.
- 62332-233- VILAZODONE HYDROCHLORIDE
  - 62332-233-30- 30 TABLET, FILM COATED in 1 BOTTLE (62332-233-30)

62332- Alembic Pharmaceuticals Inc.
- 62332-233- VILAZODONE HYDROCHLORIDE
  - 62332-233-71- 500 TABLET, FILM COATED in 1 BOTTLE (62332-233-71)

62332- Alembic Pharmaceuticals Inc.
- 62332-233- VILAZODONE HYDROCHLORIDE
  - 62332-233-90- 90 TABLET, FILM COATED in 1 BOTTLE (62332-233-90)

62332- Alembic Pharmaceuticals Inc.
- 62332-233- VILAZODONE HYDROCHLORIDE
  - 62332-233-91- 1000 TABLET, FILM COATED in 1 BOTTLE (62332-233-91)

62332- Alembic Pharmaceuticals Inc.
- 62332-234- VILAZODONE HYDROCHLORIDE
  - 62332-234-30- 30 TABLET, FILM COATED in 1 BOTTLE (62332-234-30)

62332- Alembic Pharmaceuticals Inc.
- 62332-234- VILAZODONE HYDROCHLORIDE
  - 62332-234-71- 500 TABLET, FILM COATED in 1 BOTTLE (62332-234-71)

62332- Alembic Pharmaceuticals Inc.
- 62332-234- VILAZODONE HYDROCHLORIDE
  - 62332-234-90- 90 TABLET, FILM COATED in 1 BOTTLE (62332-234-90)

62332- Alembic Pharmaceuticals Inc.
- 62332-234- VILAZODONE HYDROCHLORIDE
  - 62332-234-91- 1000 TABLET, FILM COATED in 1 BOTTLE (62332-234-91)

65015- MYLAN LABORATORIES LIMITED
- 65015-848-
  - 65015-848-61- 100 kg in 1 DRUM (65015-848-61)

65129- ScinoPharm Taiwan Ltd.
- 65129-2248-
  65129-2248-0- 40 kg in 1 BAG (65129-2248-0)

65372- Jubilant Pharmova Limited
- 65372-1203-
  65372-1203-2- 20 kg in 1 DRUM (65372-1203-2)

66039- Glenmark Life Sciences Limited
- 66039-903-
  66039-903-04- 1 kg in 1 DRUM (66039-903-04)

68788- Preferred Pharmaceuticals Inc.
- 68788-8734- vilazodone hydrochloride
  68788-8734-3- 30 TABLET in 1 BOTTLE (68788-8734-3)

68788- Preferred Pharmaceuticals Inc.
- 68788-8735- vilazodone hydrochloride
  - 68788-8735-3- 30 TABLET in 1 BOTTLE (68788-8735-3)

69097- Cipla USA Inc.
- 69097-979- Vilazodone Hydrochloride
  - 69097-979-02- 30 TABLET, FILM COATED in 1 BOTTLE (69097-979-02)

69097- Cipla USA Inc.
- 69097-981- Vilazodone hydrochloride
  - 69097-981-02- 30 TABLET, FILM COATED in 1 BOTTLE (69097-981-02)

69097- Cipla USA Inc.
- 69097-982- Vilazodone hydrochloride
  - 69097-982-02- 30 TABLET, FILM COATED in 1 BOTTLE (69097-982-02)

72205- Novadoz Pharmaceuticals LLC
- 72205-260- vilazodone hydrochloride
  - 72205-260-30- 30 TABLET in 1 BOTTLE (72205-260-30)

72205- Novadoz Pharmaceuticals LLC
- 72205-261- vilazodone hydrochloride
  - 72205-261-30- 30 TABLET in 1 BOTTLE (72205-261-30)

72205- Novadoz Pharmaceuticals LLC
- 72205-262- vilazodone hydrochloride
  - 72205-262-30- 30 TABLET in 1 BOTTLE (72205-262-30)

72603- Northstar Rx LLC
- 72603-813- vilazodone hydrochloride
  - 72603-813-01- 30 TABLET in 1 BOTTLE (72603-813-01)

72603- Northstar Rx LLC
- 72603-814- vilazodone hydrochloride
  - 72603-814-01- 30 TABLET in 1 BOTTLE (72603-814-01)

72603- Northstar Rx LLC
- 72603-815- vilazodone hydrochloride
  - 72603-815-01- 30 TABLET in 1 BOTTLE (72603-815-01)

76282- Exelan Pharmaceuticals Inc.
- 76282-544- Vilazodone Hydrochloride
  - 76282-544-30- 30 TABLET, FILM COATED in 1 BOTTLE (76282-544-30)

76282- Exelan Pharmaceuticals Inc.
- 76282-545- Vilazodone hydrochloride
  - 76282-545-30- 30 TABLET, FILM COATED in 1 BOTTLE (76282-545-30)

76282- Exelan Pharmaceuticals Inc.
- 76282-546- Vilazodone hydrochloride
  - 76282-546-30- 30 TABLET, FILM COATED in 1 BOTTLE (76282-546-30)

82245- Viyash Life Sciences Private Limited
- 82245-0125-
  - 82245-0125-1- 25 kg in 1 CONTAINER (82245-0125-1)

82804- Proficient Rx LP
- 82804-128- vilazodone hydrochloride
  82804-128-30- 30 TABLET in 1 BOTTLE (82804-128-30)

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Indications ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Availability ⬆ ⬇

Route/Dosage ⬆ ⬇

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Classifications ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Pronunciation ⬆ ⬇

Code ⬆