Fluvoxamine Maleate Er (fluvoxamine maleate)

Fluvoxamine maleate dosage is expressed in terms of the salt.

Fluvoxamine maleate is administered orally either as immediate-release tablets or extended-release capsules. Since food does not appear to substantially affect GI absorption of fluvoxamine maleate from either formulation, the drug generally can be administered without regard to meals.

Fluvoxamine maleate immediate-release tablets are administered orally once or twice daily. Dosages of 100 mg daily or less in adults or 50 mg daily or less in pediatric patients generally are given as a single daily dose at bedtime; higher dosages generally are given as 2 divided doses, either as equally divided doses or as unequal doses with the larger dose given at bedtime.

Fluvoxamine maleate extended-release capsules are administered once daily at bedtime. The extended-release capsules should not be crushed or chewed.

Commercially available fluvoxamine maleate tablets should be protected from high humidity and stored at 20-25degreesC, but may be exposed to temperatures ranging from 15-30degreesC.

Fluvoxamine maleate extended-release capsules should be protected from high humidity and stored at 25degreesC, but may be exposed to temperature ranging from 15-30degreesC. Avoid exposure to temperatures above 30degreesC.

Although the optimum duration of fluvoxamine therapy has not been established, obsessive-compulsive disorder requires several months or longer of sustained drug therapy. If therapy with the drug is prolonged, the lowest possible dosage should be used and the need for continued therapy should be reassessed periodically.

Symptoms associated with discontinuation of other selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) have been reported. Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Concurrent administration, or within 14 days of stopping, monoamine oxidase inhibitors (MAOIs; including linezolid and IV methylene blue) due to an increased risk of serotonin syndrome.

*Coadministration with tizanidine, thioridazine, alosetron, and pimozide. Coadministration with ramelteon is also contraindicated with fluvoxamine maleate extended-release capsules.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Immediate-release tablets:The most common adverse reactions (>=5% and at least twice placebo) in controlled trials with adult obsessive-compulsive disorder and depression patients include nausea, somnolence, insomnia, asthenia, nervousness, dyspepsia, abnormal ejaculation, sweating, anorexia, tremor, vomiting, anorgasmia, decreased libido, dry mouth, rhinitis, taste perversion, and urinary frequency.

The most common adverse reactions (>=5% and at least twice placebo) in pediatric patients with obsessive-compulsive disorder include agitation, depression, dysmenorrhea, flatulence, hyperkinesia, and rash.

Extended-release capsules:The most common adverse reactions (>=5% and at least twice placebo) in controlled trials in patients with obsessive-compulsive disorder include abnormal ejaculation, anorexia, anorgasmia, asthenia, diarrhea, nausea, somnolence, sweating, tremor, anxiety, decreased libido, myalgia, pharyngitis, vomiting, dyspepsia, dizziness, insomnia, and yawning.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

The efficacy of fluvoxamine maleate tablets for the treatment of obsessive-compulsive disorder was demonstrated in a 10-week, multicenter, placebo-controlled study with 120 outpatients (8 to 17 years of age). In addition, 99 of these outpatients continued open-label fluvoxamine maleate tablets treatment for up to another 1 to 3 years, equivalent to 94 patient-years. The adverse event profile observed was generally similar to that observed in adult studies with fluvoxamine. As with other SSRIs, decreased appetite and weight loss have occurred in association with fluvoxamine therapy. 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.

The risks, if any, that may be associated with fluvoxamine's extended use in children and adolescents with obsessive-compulsive disorder have not been systematically assessed. Safety and effectiveness in the pediatric population other than pediatric patients with obsessive-compulsive disorder have not been established. When considering the use of fluvoxamine maleate in a child or adolescent, balance the potential risk with the clinical need.

Fluvoxamine maleate extended-release capsules have not been evaluated in pediatric patients.

Monitor all patients being treated with antidepressants for clinical worsening, suicidal thoughts, and unusual changes in behavior, especially during the initial few months of treatment, or at times of dose increases or decreases. Monitor weight and growth in pediatric patients.

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.

Prolonged experience with fluvoxamine in pregnant women over decades, based on published observational studies, has not identified a clear drug-associated risk of major birth defects or miscarriage. There are risks associated with untreated depression in pregnancy and risks of persistent pulmonary hypertension of the newborn (PPHN) and poor neonatal adaptation with exposure to SSRIs, including fluvoxamine, during pregnancy. Neonates exposed to fluvoxamine and other SSRIs or 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 and SNRIs or, possibly, a drug discontinuation syndrome. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome.

When pregnant rats were treated orally with fluvoxamine throughout the period of organogenesis, increased embryofetal death and increased incidences of fetal eye abnormalities (folded retinas) were observed at doses >=3 times the maximum recommended human dose (MRHD) of 300 mg/day given to adolescents on a mg/m2 basis. In addition, decreased fetal body weight was seen at a dose 6 times the MRHD given to adolescents on a mg/m2 basis. There were no adverse developmental effects in rabbits treated with fluvoxamine during the period of organogenesis up to a dose 2 times the MRHD given to adolescents on a mg/m2 basis. When fluvoxamine was administered orally to rats during pregnancy and lactation, increased pup mortality at birth was seen at a dose 2 times the MRHD given to adolescents on a mg/m2 basis. In addition, decreases in pup body weight and survival were observed at doses that are >=0.13 times the MRHD given to adolescents.

Women who discontinue antidepressants during pregnancy are more likely to experience a relapse of major depression than women who continue antidepressants. Consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum.

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy (National Pregnancy Registry for Antidepressants: 1-844-405-6185 or online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregi stry/antidepressants/).

Data from published literature report the presence of fluvoxamine in human milk. No adverse effects on the breast-fed infant have been reported in most cases of maternal use of fluvoxamine during breast-feeding. However, there are reports of diarrhea, vomiting, decreased sleep, and agitation. There are no data on the effects of fluvoxamine on milk production. Consider the developmental and health benefits of breast-feeding along with the mother's clinical need for fluvoxamine and any potential adverse effects on the breast-fed child from fluvoxamine or from the underlying maternal condition.

Monitor infants exposed to fluvoxamine through breast milk for diarrhea, vomiting, decreased sleep, and agitation.

A lower initial dose and slower dose titration should be considered due to reduced clearance in geriatric patients.

Approximately 230 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 older. 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. SSRIs and SNRIs, including fluvoxamine, have been associated with several cases of clinically significant hyponatremia in elderly patients. The clearance of fluvoxamine is decreased by about 50% in the elderly compared to younger patients, and greater sensitivity of some older individuals cannot be ruled out.

In a study of fluvoxamine maleate tablets at 50 and 100 mg comparing elderly (ages 66 to 73 years) and young subjects (ages 19 to 35 years), mean maximum plasma concentrations in the elderly were 40% higher. The multiple dose elimination half-life of fluvoxamine was 17.4 and 25.9 hours in the elderly compared to 13.6 and 15.6 hours in young subjects at steady state for 50 and 100 mg doses, respectively. In elderly patients, the clearance of fluvoxamine was reduced by about 50%.

Consider a lower starting dose and slower titration of fluvoxamine in elderly patients.