Fluvoxamine Dosage

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Usual Adult Dose for:

Usual Geriatric Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Obsessive Compulsive Disorder

Initial immediate release tablet dose: 50 mg orally once a day at bedtime.
Maintenance dose: 100 to 300 mg per day. The dose may be increased in 50 mg increments every 4 to 7 days, as tolerated, until maximum therapeutic benefit is achieved.
Maximum Dose: 300 mg per day.
It is advisable that a total daily dose of more than 100 mg should be given in two divided doses. If the doses are not equal, the larger dose should be given at bedtime.

Although the efficacy of fluvoxamine tablets beyond 10 weeks of dosing for OCD has not been documented in controlled trials, OCD is a chronic condition, and it is reasonable to consider continuation for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.

Initial extended release capsule dose: 100 mg once per day.
Fluvoxamine extended release capsules should be administered, with or without food, as a single daily dose at bedtime.

In the controlled clinical trials establishing the effectiveness of fluvoxamine extended release capsules in OCD, patients were titrated in 50 mg increments within a dose range of 100 mg/day to 300 mg/day. Consequently, the dose should be increased in 50 mg increments every week, as tolerated, until maximum therapeutic benefit is achieved, not to exceed 300 mg per day.

Although the efficacy of fluvoxamine extended release capsules beyond 12 weeks of dosing for OCD has not been documented in controlled trials, social anxiety disorder is a chronic condition, and it is reasonable to consider continuation for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.

Usual Adult Dose for Depression

Investigational:
Initial dose: 50 mg orally once a day at bedtime
Maintenance Dose: 100 to 300 mg per day. The dose may be increased in 50 mg increments every 4 to 7 days, as tolerated, until maximum therapeutic benefit is achieved. Total daily doses of more than 100 mg should be given in two divided doses. If the doses are not equal, the larger dose should be given at bedtime.

Usual Adult Dose for Panic Disorder

Investigational:
Initial dose: 50 mg orally once a day at bedtime
Maintenance Dose: 100 to 300 mg per day. The dose may be increased in 50 mg increments every 4 to 7 days, as tolerated, until maximum therapeutic benefit is achieved. Total daily doses of more than 100 mg should be given in two divided doses. If the doses are not equal, the larger dose should be given at bedtime.

Usual Adult Dose for Social Anxiety Disorder

Initial extended release capsule dose: 100 mg once per day.
Fluvoxamine extended release capsules should be administered, with or without food, as a single daily dose at bedtime.

In the controlled clinical trials establishing the effectiveness of fluvoxamine extended release capsules in social anxiety disorder, patients were titrated in 50 mg increments within a dose range of 100 mg/day to 300 mg/day. Consequently, the dose should be increased in 50 mg increments every week, as tolerated, until maximum therapeutic benefit is achieved, not to exceed 300 mg per day.

Although the efficacy of fluvoxamine extended release capsules beyond 12 weeks of dosing for social anxiety disorder has not been documented in controlled trials, social anxiety disorder is a chronic condition, and it is reasonable to consider continuation for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.

Usual Geriatric Dose for Obsessive Compulsive Disorder

Initial tablet dose: Due to greater sensitivity to its effects and slower clearance, lower initial doses (25 mg per day at bedtime) may be advisable.
Maintenance dose: 50 to 300 mg per day. Slower titration may be advisable for elderly patients. Total daily doses of more than 100 mg should be given in two divided doses. If the doses are not equal, the larger dose should be given at bedtime.

Although the efficacy of fluvoxamine tablets beyond 10 weeks of dosing for OCD has not been documented in controlled trials, OCD is a chronic condition, and it is reasonable to consider continuation for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.

Initial extended release capsule dose: 100 mg once per day.
Fluvoxamine extended release capsules should be administered, with or without food, as a single daily dose at bedtime.

In the controlled clinical trials establishing the effectiveness of fluvoxamine extended release capsules in OCD, patients were titrated in 50 mg increments within a dose range of 100 mg/day to 300 mg/day. Consequently, the dose should be increased in 50 mg increments every week, as tolerated, until maximum therapeutic benefit is achieved, not to exceed 300 mg per day. Elderly patients have been observed to have a decreased clearance of fluvoxamine maleate. Consequently, it may be appropriate to titrate slowly following the initial dose of 100 mg.

Although the efficacy of fluvoxamine extended release capsules beyond 12 weeks of dosing for OCD has not been documented in controlled trials, social anxiety disorder is a chronic condition, and it is reasonable to consider continuation for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.

Usual Geriatric Dose for Social Anxiety Disorder

Initial extended release capsule dose: 100 mg once per day.
Fluvoxamine extended release capsules should be administered, with or without food, as a single daily dose at bedtime.

In the controlled clinical trials establishing the effectiveness of fluvoxamine extended release capsules in social anxiety disorder, patients were titrated in 50 mg increments within a dose range of 100 mg/day to 300 mg/day. Consequently, the dose should be increased in 50 mg increments every week, as tolerated, until maximum therapeutic benefit is achieved, not to exceed 300 mg per day. Elderly patients have been observed to have a decreased clearance of fluvoxamine maleate. Consequently, it may be appropriate to titrate slowly following the initial dose of 100 mg.

Although the efficacy of fluvoxamine extended release capsules beyond 12 weeks of dosing for social anxiety disorder has not been documented in controlled trials, social anxiety disorder is a chronic condition, and it is reasonable to consider continuation for a responding patient. Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment.

Usual Pediatric Dose for Obsessive Compulsive Disorder

8 to 11 years:
Initial immediate release dose: 25 mg orally once a day at bedtime.
Maintenance dose: 25 to 100 mg orally twice a day. The dose may be increased in 25 mg increments every 4 to 7 days, as tolerated, up to a maximum dose of 200 mg per day. Total daily doses of more then 50 mg should be given in two divided doses. If the two divided doses are not equal, the larger dose should be given at bedtime.

11 to 17 years:
Initial dose: Immediate release: 25 mg orally once a day at bedtime.
Maintenance dose: 25 to 150 mg orally twice a day. The dose may be increased in 25 mg increments every 4 to 7 days, as tolerated, up to a maximum dose of 300 mg per day. Total daily doses of more then 50 mg should be given in two divided doses. If the two divided doses are not equal, the larger dose should be given at bedtime.

Lower doses may be effective in female versus male patients.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Lower initial tablet doses (25 mg/day) and slower titration may be advisable for patients with hepatic dysfunction.

Extended release capsules: It may be appropriate to titrate slowly following the initial dose of 100 mg.

Dose Adjustments

It may be appropriate to reduce the initial dose and the subsequent dose titration for elderly patients and those with hepatic impairment.

Precautions

Children, adolescents, and young adults (18 to 24 years of age) with major depressive disorder and other psychiatric disorders may be at an increased risk of suicidal thinking and suicidality with antidepressant use, particularly during the first few months of treatment. Medical evidence has not shown this increased risk to exist in adults older than 24 years of age, but adults 65 years of age and older taking antidepressants appear to have a decreased risk of suicidality. The results of a meta-analysis indicate an overall favorable risk-to-benefit profile for the use of antidepressants (i.e., selective serotonin and/or norepinephrine reuptake inhibitors) in the treatment of pediatric patients (less than 19- years- old) with major depressive disorders (MDD), obsessive-compulsive disorder (OCD), or non- OCD anxiety disorders. Although this study also reports an overall increased risk of suicidal ideation/suicide attempt associated with the use of antidepressants in pediatric patients, the risk may be less than originally estimated. Additional prospective studies are warranted in order to confirm these findings.

Worsening of depression and/or increased suicidal thinking or behavior may always be a possibility in patients treated with antidepressant medications, particularly those being treated for depression. Anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia (severe restlessness), hypomania, and mania have been reported in patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. It is unknown if these symptoms are a precursor to either worsening of depression or the emergence of suicidal impulses; however, there is concern that patients who experience one or more of these symptoms may be at increased risk for worsening depression or suicidality. Although the FDA has not concluded that antidepressant drugs cause worsening depression or suicidality, health care providers should be aware that worsening of symptoms could be due to the underlying disease or might be a result of drug therapy.

Health care providers should carefully monitor patients receiving antidepressants for possible and/or persistent worsening of depression or emergent suicidality, especially at the beginning of therapy or when the dose either increases or decreases. If symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms, the health care provider will need to determine what intervention, including discontinuing or modifying the current drug therapy, is indicated. Prescriptions should be written for small quantities of drug to reduce the risk of an attempt to overdose. Health care providers should instruct patients, their families and their caregivers to be alert for the emergence of agitation, irritability, and the other symptoms described above, as well as the emergence of suicidality and worsening depression, and to report such symptoms immediately to their health care provider.

Because antidepressants are believed to have the potential for inducing manic episodes in patients with bipolar disorder, there is a concern about using antidepressants alone in this population. Therefore, patients should be adequately screened to determine if they are at risk for bipolar disorder before initiating antidepressant treatment so that they can be appropriately monitored during treatment. Such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.

The concurrent use of citalopram and MAO inhibitors or thioridazine is not recommended. At least 14 days should elapse between discontinuation of an MAO inhibitor and initiation of fluvoxamine, or vice versa.

Dialysis

Hemodialysis, hemoperfusion and exchange transfusion are not expected to remove fluvoxamine.

Other Comments

The full therapeutic effect may not be seen for 2 to 3 weeks.

Capsules should not be crushed or chewed.

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