FLUVOXAMINE MALEATE capsule, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

FLUVOXAMINE MALEATE (UNII: 5LGN83G74V) (FLUVOXAMINE - UNII:O4L1XPO44W)

Available from:

Par Pharmaceutical, Inc.

INN (International Name):

FLUVOXAMINE MALEATE

Composition:

FLUVOXAMINE MALEATE 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fluvoxamine maleate extended-release capsules are indicated for the treatment of obsessive compulsive disorder (OCD), as defined in the DSM-IV. Obsessive compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. The obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. The efficacy of fluvoxamine maleate extended-release capsules was demonstrated in one 12-week trial in adults with fluvoxamine maleate extended-release capsules as well as in two 10-week trials in adults and in one 10-week trial in children and adolescents (ages 8 to 17 years) with immediate-release fluvoxamine tablets in outpatients with the diagnosis of OCD as defined in DSM-IV or DSM-III-R (see CLINICAL STUDIES [14.1, 14.3] ). The efficacy of fluvoxamine for long-term use was established in one maintenance study in adults with immediate-release fluvoxamine tablets (see CLINICAL STUDIES [14.2] ). The health care provider who elects to prescribe fluvoxamine maleate extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION [2.4] ). Coadministration of thioridazine, tizanidine, pimozide, alosetron, or ramelteon with fluvoxamine maleate extended-release capsules is contraindicated (see WARNINGS AND PRECAUTIONS [5.4-5.8] ). The use of MAOIs intended to treat psychiatric disorders with fluvoxamine maleate extended-release capsules or within 14 days of stopping treatment with fluvoxamine maleate extended-release capsules are contraindicated because of an increased risk of serotonin syndrome. The use of fluvoxamine maleate extended-release capsules within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see DOSAGE AND ADMINISTRATION [2.5] and WARNINGS AND PRECAUTIONS [5.2] ). Starting fluvoxamine maleate extended-release capsules in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see DOSAGE AND ADMINISTRATION [2.6] and WARNINGS AND PRECAUTIONS [5.2]). Teratogenic Effects – Pregnancy Category C: When pregnant rats were given daily doses of fluvoxamine (60, 120, or 240 mg/kg) orally throughout the period of organogenesis, developmental toxicity in the form of increased embryofetal death and increased incidences of fetal eye abnormalities (folded retinas) was observed at doses of 120 mg/kg or greater. Decreased fetal body weight was seen at the high dose. The no effect dose for developmental toxicity in this study was 60 mg/kg (approximately 2 times the maximum recommended human dose [MRHD] on a mg/m2 basis). In a study in which pregnant rabbits were administered doses of up to 40 mg/kg (approximately 2 times the MRHD on a mg/m2 basis) orally during organogenesis, no adverse effects on embryofetal development were observed. In other reproduction studies in which female rats were dosed orally during pregnancy and lactation (5, 20, 80, or 160 mg/kg), increased pup mortality at birth was seen at doses of 80 mg/kg or greater and decreases in pup body weight and survival were observed at all doses (low effect dose approximately 0.1 times the MRHD on a mg/m2 basis). Nonteratogenic Effects: 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 (5.11) and Clinical Considerations ]. Neonates exposed to fluvoxamine maleate tablets and other SSRIs or serotonin and norepinephrine reuptake inhibitors (SNRIs) late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. 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 or SNRIs or, possibly, a drug discontinuation syndrome. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome (see WARNINGS AND PRECAUTIONS-Serotonin Syndrome [5.2] ). Maternal Adverse Reactions: Use of fluvoxamine in the month before delivery may be associated with an increased risk of postpartum hemorrhage (see WARNINGS AND PRECAUTIONS [5.11]). Infants exposed to SSRIs in pregnancy may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN). PPHN occurs in 1-2 per 1000 live births in the general population and is associated with substantial neonatal morbidity and mortality. Several recent epidemiologic studies suggest a positive statistical association between SSRI use (immediate-release fluvoxamine tablets and fluvoxamine maleate extended-release capsules are SSRIs) in pregnancy and PPHN. Other studies do not show a significant statistical association. Physicians should also note the results of a prospective longitudinal study of 201 pregnant women with a history of major depression, who were either on antidepressants or had received antidepressants less than 12 weeks prior to their last menstrual period, and were in remission. Women who discontinued antidepressant medication during pregnancy showed a significant increase in relapse of their major depression compared to those women who remained on antidepressant medication throughout pregnancy. When treating a pregnant woman with fluvoxamine, the physician should carefully consider both the potential risks of taking an SSRI, along with the established benefits of treating depression with an antidepressant. This decision can only be made on a case by case basis (see DOSAGE AND ADMINISTRATION [2.7] ). The effect of fluvoxamine on labor and delivery in humans is unknown. Fluvoxamine is secreted in human breast milk. Because of the potential for serious adverse reactions in nursing infants from fluvoxamine maleate extended-release capsules, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. Fluvoxamine maleate extended-release capsules have not been evaluated in pediatric patients (see BOXED WARNING ). The efficacy of fluvoxamine maleate administered as immediate-release tablets for the treatment of OCD was demonstrated in a 10-week multicenter placebo-controlled study with 120 outpatients ages 8 to 17. In addition, 99 of these outpatients continued open-label fluvoxamine maleate treatment for up to another one to three years, equivalent to 94 patient years. The adverse reaction profile observed in that study was generally similar to that observed in adult studies with immediate-release fluvoxamine maleate tablets (see ADVERSE REACTIONS [6.3]) . Decreased appetite and weight loss have been observed in association with the use of fluvoxamine as well as other SSRIs. Consequently, regular monitoring of weight and growth should be performed in children and adolescents treated with an SSRI such as fluvoxamine maleate extended-release capsules. The risks, if any, that may be associated with fluvoxamine’s extended use in children and adolescents with OCD have not been systematically assessed. The prescriber should be mindful that the evidence relied upon to conclude that fluvoxamine is safe for use in children and adolescents derives from relatively short-term clinical studies and from extrapolation of experience gained with adult patients. In particular, there are no studies that directly evaluate the effects of long-term fluvoxamine use on the growth, cognitive behavioral development, and maturation of children and adolescents. Although there is no affirmative finding to suggest that fluvoxamine possesses a capacity to adversely affect growth, development, or maturation, the absence of such findings is not compelling evidence of the absence of the potential of fluvoxamine to have adverse effects in chronic use (see WARNINGS AND PRECAUTIONS–Clinical Worsening and Suicide Risk [5.1] ). Safety and effectiveness in the pediatric population other than pediatric patients with OCD have not been established (see BOXED WARNING and WARNINGS AND PRECAUTIONS–Clinical Worsening and Suicide Risk [5.1] ). Anyone considering the use of fluvoxamine maleate extended-release capsules in a child or adolescent must balance the potential risks with the clinical need. Approximately 230 patients and 5 patients participating in controlled premarketing studies with immediate-release fluvoxamine maleate tablets and fluvoxamine maleate extended-release capsules, respectively, were 65-years of age or over. No overall differences in safety were observed between these patients and younger patients. Other reported clinical experience has not identified differences in response between the elderly and younger patients. However, SSRIs and SNRIs, including fluvoxamine, have been associated with several cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction (see WARNINGS AND PRECAUTIONS [5.14] ). Furthermore, the clearance of fluvoxamine is decreased by about 50% in elderly compared to younger patients (see CLINICAL PHARMACOLOGY–Elderly [12.3] ), and greater sensitivity of some older individuals also cannot be ruled out. Consequently, a lower starting dose should be considered in elderly patients, and fluvoxamine maleate extended-release capsules should be slowly titrated during initiation of therapy. Fluvoxamine maleate extended-release capsules are not a controlled substance. The potential for abuse, tolerance, and physical dependence with immediate-release fluvoxamine maleate has been studied in a nonhuman primate model. No evidence of dependency phenomena was found. The discontinuation effects of fluvoxamine maleate extended-release capsules were not systematically evaluated in controlled clinical trials. Fluvoxamine maleate extended-release capsules were not systematically studied in clinical trials for potential for abuse, but there was no indication of drug-seeking behavior in clinical trials. It should be noted, however, that patients at risk for drug dependency were systematically excluded from investigational studies of immediate-release fluvoxamine maleate. Generally, it is not possible to predict on the basis of preclinical or premarketing clinical experience the extent to which a CNS active drug will be misused, diverted, and/or abused once marketed. Consequently, health care providers should carefully evaluate patients for a history of drug abuse and follow such patients closely, observing them for signs of fluvoxamine maleate extended-release capsules misuse or abuse (i.e., development of tolerance, incrementation of dose, drug-seeking behavior).

Product summary:

Fluvoxamine Maleate Extended-Release Capsules are available in the following strengths, colors, imprints, and presentations: 100 mg Extended-Release Capsules: Available in a hard gelatin capsule with blue opaque cap imprinted with “A175” in black ink and white opaque body imprinted with“100” in black ink. Bottles of 30 count….. NDC 10370-175-11 Bottles of 1000 count….. NDC 10370-175-10 150 mg Extended-Release Capsules: Available in a hard gelatin capsule with purple opaque cap imprinted with “A176” in black ink and white opaque body imprinted with “150” in black ink. Bottles of 30 count….. NDC 10370-176-11 Bottles of 750 count.. NDC 10370-176-28 Keep out of reach of children. Fluvoxamine maleate extended-release capsules should be protected from high humidity and stored at 20º to 25°C (68º to 77°F) [see USP Controlled Room Temperature]. Avoid exposure to temperatures above 30°C (86°F). Dispense in tight containers.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

FLUVOXAMINE MALEATE- FLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE
Par Pharmaceutical, Inc.
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MEDICATION GUIDE
Fluvoxamine Maleate (floo vox' uh meen mal' ee ate) Extended-Release
Capsules
Read the Medication Guide that comes with fluvoxamine maleate
extended-release capsules before you
start taking it and each time you get a refill. There may be new
information. This Medication Guide does
not take the place of talking to your healthcare provider about your
medical condition or treatment. Talk
to your healthcare provider if there is something you do not
understand or want to learn more about.
What is the most important information I should know about fluvoxamine
maleate extended-release
capsules?
Fluvoxamine maleate extended-release capsules are the same kind of
medicine as those used to treat
depression. These medicines may cause serious side effects, including:
1. Suicidal thoughts or actions:
•
Fluvoxamine maleate extended-release capsules and other antidepressant
medicines may increase
suicidal thoughts or actions in some children, teenagers, or young
adults within the first few
months of treatment or when the dose is changed.
•
Depression or other serious mental illnesses are the most important
causes of suicidal thoughts or
actions.
•
Watch for these changes and call your healthcare provider right away
if you notice:
•
New or sudden changes in mood, behavior, actions, thoughts, or
feelings, especially if severe.
•
Pay particular attention to such changes when fluvoxamine maleate
extended-release capsules is
started or when the dose is changed.
Keep all follow-up visits with your healthcare provider and call
between visits if you are worried about
symptoms.
Call your healthcare provider right away if you have any of the
following symptoms, or call 911 in an
emergency, especially if they are new, worse, or worry you:
•
attempts to commit suicide
•
acting on dangerous impulses
•
acting aggressive or violent
•
thoughts about suicide or dying
•
new or worse depression
•
new or wors

Summary of Product characteristics

FLUVOXAMINE MALEATE- FLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE
PAR PHARMACEUTICAL, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUVOXAMINE MALEATE
EXTENDED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES.
FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES, FOR ORAL ADMINISTRATION
INITIAL U.S. APPROVAL: 2008
WARNING: SUICIDALITY AND ANTIDEPRESSANTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
INCREASED RISK OF SUICIDAL THINKING AND BEHAVIOR IN CHILDREN,
ADOLESCENTS, AND YOUNG
ADULTS TAKING ANTIDEPRESSANTS FOR MAJOR DEPRESSIVE DISORDER AND OTHER
PSYCHIATRIC
DISORDERS (5.1)_._
RECENT MAJOR CHANGES
Warnings and Precautions (5.2,5.11) 06/2023
INDICATIONS AND USAGE
Fluvoxamine maleate extended-release capsules are a selective
serotonin reuptake inhibitor (SSRI)
indicated for the treatment of obsessive compulsive disorder (OCD)
(1). Efficacy was demonstrated in:
One 12-week study with fluvoxamine maleate extended-release capsules
in adults (14.1).
Two 10-week studies with immediate-release (IR) fluvoxamine tablets in
adults and one 10-week study
with IR fluvoxamine tablets in children and adolescents (14.1, 14.3).
One maintenance study with IR fluvoxamine tablets (14.2).
DOSAGE AND ADMINISTRATION
Adults: Recommended starting dose is 100 mg at bedtime, with weekly
increases of 50 mg as tolerated
to maximum effect, not to exceed 300 mg/day (2.1).
Pediatric patients naïve to fluvoxamine maleate: The lowest available
dose of fluvoxamine maleate
extended-release capsules may not be appropriate (2.2).
Hepatically impaired: Decreased clearance may require modified dose
and titration (2.3).
Extended treatment: Adjust dose to maintain lowest effective dose;
reassess patients periodically
(2.4).
Discontinuation: Gradual dose reduction is recommended (2.7, see
WARNINGS AND PRECAUTIONS
[5.10]).
DOSAGE FORMS AND STRENGTHS
100 mg and 150 mg Extended-Release Capsules