VILAZODONE HYDROCHLORIDE tablet

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

VILAZODONE HYDROCHLORIDE (UNII: U8HTX2GK8J) (Vilazodone - UNII:S239O2OOV3)

Verfügbar ab:

Apotex Corp.

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Vilazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)]. 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)] . Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405- 6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants. Risk Summary Based on data from published observational studies, exposure to SSRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Warnings and Precautions (5.3) and Clinical Considerations]. There are no adequate and well-controlled studies of vilazodone hydrochloride in pregnant women. The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the background risk in the U.S. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies. In animal reproduction studies, oral administration of vilazodone during the period of organogenesis at doses up to 48 and 17 times the maximum recommended human dose (MRHD) in rats and rabbits, respectively, resulted in decreased fetal body weight gain and delayed skeletal ossification but no teratogenic effects were observed. Decreased fetal body weight and delayed skeletal ossification were not observed at doses up to 10 and 4 times the MRHD in rats and rabbits, respectively [see Data] . Clinical Considerations Disease-associated maternal and/or embryo/fetal risk A prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. The women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants. Consider the risks of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. Maternal Adverse Reactions Use of vilazodone hydrochloride in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see Warnings and Precautions (5.3)]. Fetal/Neonatal adverse reactions Exposure to SSRIs and SNRIs, including vilazodone hydrochloride, in late pregnancy may lead to an increased risk for neonatal complications requiring prolonged hospitalization, respiratory support, and tube feeding, and/or persistent pulmonary hypertension of the newborn (PPHN). Monitor neonates who were exposed to vilazodone hydrochloride in the third trimester of pregnancy for PPHN and drug discontinuation syndrome [ see Data)]. Data Human Data Third Trimester Exposure Neonates exposed to SSRIs or SNRIs late in the third trimester, have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. These findings are based on post-marketing reports. Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. These features are consistent with either a direct toxic effect of SSRIs and SNRIs or, possibly, a drug discontinuation syndrome. In some cases, the clinical picture was consistent with serotonin syndrome [ see Warnings and Precautions (5.2)]. Exposure during late pregnancy to SSRIs may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN). PPHN occurs in 1 to 2 per 1,000 live births in the general population and is associated with substantial neonatal morbidity and mortality. In a retrospective case-control study of 377 women whose infants were born with PPHN and 836 women whose infants were born healthy, the risk for developing PPHN was approximately six-fold higher for infants exposed to SSRIs after the 20th week of gestation compared to infants who had not been exposed to antidepressants during pregnancy. A study of 831,324 infants born in Sweden in 1997 to 2005 found a PPHN risk ratio of 2.4 (95% CI 1.2 to 4.3) associated with patient-reported maternal use of SSRIs "in early pregnancy" and a PPHN risk ratio of 3.6 (95% CI 1.2 to 8.3) associated with a combination of patient-reported maternal use of SSRIs "in early pregnancy" and an antenatal SSRI prescription "in later pregnancy." Animal Data No teratogenic effects were observed when vilazodone was given to pregnant rats or rabbits during the period of organogenesis at oral doses up to 200 and 36 mg/kg/day, respectively. These doses are 48 and 17 times, in rats and rabbits, respectively, the maximum recommended human dose (MRHD) of 40 mg on a mg/m2 basis. Fetal body weight gain was reduced, and skeletal ossification was delayed in both rats and rabbits at these doses; these effects were not observed at doses up to 10 times the MRHD in rats or 4 times the MRHD in rabbits. When vilazodone was administered to pregnant rats at an oral dose of 30 times the MRHD during the period of organogenesis and throughout pregnancy and lactation, the number of live born pups was decreased. There was an increase in early postnatal pup mortality, and among surviving pups there was decreased body weight, delayed maturation, and decreased fertility in adulthood. There was some maternal toxicity at this dose. These effects were not seen at 6 times the MRHD. Risk Summary There are no data on the presence of vilazodone in human milk, the effects of vilazodone on the breastfed infant, or the effects of the drug on milk production. However, vilazodone is excreted in rat milk [see Data] . The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for vilazodone hydrochloride and any potential adverse effects on the breastfed child from vilazodone hydrochloride or from the underlying maternal condition. Data Animal Data Administration of vilazodone to lactating rats at an oral dose of 30 times the maximum recommended human dose (MRHD), resulted in early postnatal pup mortality, and among surviving pups there was decreased body weight and delayed maturation. The safety and effectiveness of vilazodone hydrochloride have not been established in pediatric patients for the treatment of MDD. Efficacy was not demonstrated in two adequate and well controlled, 8-week studies including a total of 1,002 pediatric patients ages 7 years to 17 years of age with MDD. The following adverse reactions were reported in at least 5% of pediatric patients treated with vilazodone hydrochloride and occurred at a rate at least twice that for pediatric patients receiving placebo: nausea, vomiting, diarrhea, abdominal pain/discomfort, and dizziness. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric patients [see Boxed Warning, Warnings and Precautions (5.1) , and Adverse Reactions (6.2)]. Juvenile Animal Toxicity Data In a juvenile animal study, male and female rats were treated with vilazodone (10, 50, and 200  mg/kg/day) starting on postnatal day (PND) 21 through 90. A delay in the age of attainment of vaginal patency (i.e. sexual maturation) was observed in females starting at 50 mg/kg/day with a No Observed Adverse Effect Level (NOAEL) of 10 mg/kg/day. This NOAEL was associated with AUC levels similar to those measured at a maximum dose tested in pediatrics (30 mg). Adverse behavioral effects (lack of habituation in an acoustic startle test) were observed in males at 200 mg/kg and females starting at 50 mg/kg both during drug treatment and the recovery periods. The NOAEL for this finding was 50 mg/kg for males and 10 mg/kg for females, which was associated with AUC levels greater than (males) or similar (females), to those observed with the maximum dose tested in pediatric patients. An 8% decrease in femur mineral density was observed in female rats at 200 mg/kg, compared to the control group. The NOAEL for this finding was 50 mg/kg, which was associated with an AUC level greater than those measured at the maximum dose tested in pediatrics. Based on a pharmacokinetic study, no dosage adjustment of vilazodone hydrochloride is recommended on the basis of age (see Figure 3). Results from pharmacokinetic study of a single 20 mg vilazodone hydrochloride dose in geriatric subjects (> 65 years-old) vs. younger subjects (24 to 55 years-old) demonstrated that the pharmacokinetics were generally similar between the two age groups [see Clinical Pharmacology (12.3)]. Clinical studies of vilazodone hydrochloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Of the 3,007 patients in clinical studies with vilazodone hydrochloride, 65 (2.2%) were 65 years of age or older, and 378 (12.6%) were 55 to 64 years of age. In general, dose selection for an elderly patient should be conservative, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Serotonergic antidepressants have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction [see Warnings and Precautions (5.8)] . No other differences in adverse reactions were observed between geriatric and younger patients. No dosage adjustment of vilazodone hydrochloride is necessary on the basis of gender, renal function (mild to severe renal impairment, glomerular filtration rate: 15 to 90 mL/minute), or hepatic function (mild to severe hepatic impairment, Child-Pugh score: 5 to 15 [see Clinical Pharmacology (12.3)] . Vilazodone hydrochloride is not a controlled substance. Vilazodone hydrochloride has been systematically studied in animals and did not demonstrate abuse or dependence potential. While vilazodone hydrochloride has not been systematically studied in humans for its potential for abuse, there was no suggested evidence of drug-seeking behavior in the clinical studies.

Produktbesonderheiten:

Vilazodone hydrochloride tablets are supplied in the following configurations:   10 mg: Pink colored, ellipse shaped, biconvex, film coated tablets, debossed with “MV” on one side and “14” on other side, free from physical defects 60505-4372-3: 30-count bottles 20 mg: Orange colored, ellipse shaped, biconvex, film coated tablets, debossed with “MV” on one side and “15” on other side, free from physical defects 60505-4373-3: 30-count bottles 40 mg: Blue colored, ellipse shaped, biconvex, film coated tablets, debossed with “MV” on one side and “16” on other side, free from physical defects 60505-4374-3: 30-count bottles Blister Package: 10 mg: 100 (10 x 10) Unit-dose tablets NDC 60505-4372-0 20 mg: 100 (10 x 10) Unit-dose tablets NDC 60505-4373-0 40 mg: 100 (10 x 10) Unit-dose tablets NDC 60505-4374-0 Vilazodone hydrochloride tablets should be stored at 25°C (77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Berechtigungsstatus:

Abbreviated New Drug Application

Gebrauchsinformation

VILAZODONE HYDROCHLORIDE- VILAZODONE HYDROCHLORIDE TABLET
Apotex Corp.
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MEDICATION GUIDE
Vilazodone Hydrochloride(vil-AZ-oh-done) Tablets, for oral use
What is the most important information I should know about vilazodone
hydrochloride tablets?
Vilazodone hydrochloride tablets may cause serious side effects,
including:
•
Increased risk of suicidal thoughts or actions in some children,
adolescents, and young adults.
Vilazodone hydrochloride tablets and other antidepressant medicines
may increase suicidal
thoughts or actions in some people 24 years of age and younger,
especially within the first few
months of treatment or when the dose is changed.
Vilazodone hydrochloride tablets are not for use in children.
•
Depression or other serious mental illnesses are the most important
causes of suicidal
thoughts or actions. Some people may have a higher risk of having
suicidal thoughts or
actions. These include people who have (or have a family history of)
depression, bipolar
illness (also called manic-depressive illness) or have a history of
suicidal thoughts or
actions.
How can I watch for and try to prevent suicidal thoughts and actions?
•
Pay close attention to any changes, especially sudden changes in mood,
behavior, thoughts,
or feelings, or if you develop suicidal thoughts or actions. This is
very important when an
antidepressant medicine is started or when the dose is changed.
•
Call your healthcare provider right away to report new or sudden
changes in mood,
behavior, thoughts, or feelings.
•
Keep all follow-up visits with your healthcare provider as scheduled.
Call your healthcare
provider between visits as needed, especially if you have concerns
about symptoms.
Call your healthcare provider or get emergency medical help right away
if you or your family member
have any of the following symptoms, especially if they are new, worse,
or worry you:
attempts to commit suicide
acting on dangerous impulses
acting aggressive, being angry or violent
thoughts about suicide or dying
new or worse depressio

Fachinformation

VILAZODONE HYDROCHLORIDE- VILAZODONE HYDROCHLORIDE TABLET
APOTEX CORP.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VILAZODONE
HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION
FOR VILAZODONE HYDROCHLORIDE TABLETS.
VILAZODONE HYDROCHLORIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2011
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ANTIDEPRESSANTS INCREASE THE RISK OF SUICIDAL THOUGHTS AND BEHAVIORS
IN PEDIATRIC
AND YOUNG ADULT PATIENTS (5.1).
CLOSELY MONITOR ALL ANTIDEPRESSANT-TREATED PATIENTS FOR CLINICAL
WORSENING AND
EMERGENCE OF SUICIDAL THOUGHTS AND BEHAVIORS (5.1).
VILAZODONE HYDROCHLORIDE TABLETS IS NOT APPROVED FOR USE IN PEDIATRIC
PATIENTS (8.4).
RECENT MAJOR CHANGES
Warnings and Precautions (5.2, 5.3) 8/2023
INDICATIONS AND USAGE
Vilazodone hydrochloride tablets are indicated for the treatment of
major depressive disorder (MDD) in
adults (1).
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, screen for bipolar
disorder (2.2, 5.4)
When discontinuing vilazodone hydrochloride, reduce dosage gradually
(2.4, 5.5)
DOSAGE FORMS AND STRENGTHS
Tablets: 10 mg, 20 mg and 40 mg (3)
CONTRAINDICATIONS
Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within
14 days of stopping MAOIs (4)
WARNINGS AND PRECAUTIONS
Serotonin Syndrome: Increased risk when co-administered with other
serotonergic agents, but also
when taken alone. If it occurs, discontinue vilazodone hydrochloride
and serotonergic agents and
initiate supportive treatment (5.2)
Increased Risk of Bleeding: Concomitant use of aspirin, nonsteroidal
anti-inflammatory drugs (NSAIDs),
other anti