patients at risk for drug dependency were systematically excluded from
sexual experience and performance cited in product labeling are likely to
general, adverse reaction rates were similar in the two data sets as well as in
These are not all the possible side
recurrence of depression.The following symptoms,
healthcare provider if you:Your healthcare provider or pharmacist can tell you if it
12-17).
systematically assessed.
Consequently, it may be appropriate to modify the initial dose and the
an antidepressant. aggressiveness, Consideration should be given to changing the therapeutic
after multiple oral doses of 100 mg/day in healthy, young volunteers was 15.6
Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. * Based on the number of males or females, as
Copyright © 2018 by RxList Inc. RxList does not provide medical advice, diagnosis or treatment. been observed to have a decreased clearance of fluvoxamine maleate. Telephone numbers for certified poison control centers are listed in the
predict on the basis of preclinical or premarketing clinical experience the
humidity and stored at 20° to 25°C (68° to 77°F); excursions permitted to 15°
taking an SSRI, along with the established benefits of treating depression with
psychiatric and nonpsychiatric, should be alerted about the need to monitor
treated with fluvoxamine experienced manic reactions, compared to none of 63
advised to notify their physicians if they are breastfeeding an infant.
Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. The prescriber should be mindful that the evidence
If these effects persist or worsen, notify your doctor right away.Get medical help right away if you have any very serious side effects, including: slow/shallow breathing, This is not a complete list of possible side effects. There may be new information.
or more occasions in at least 1/100 patients; infrequent adverse reactions are
isoenzyme, and it has been demonstrated that ketoconazole, a potent inhibitor
syndrome particularly with the concomitant use of fluvoxamine with other
fluvoxamine may even be more pronounced when it is administered at higher
extrapolation of experience gained with adult patients. since there is a potential for clinically important interactions with
All reports with
If there is an infection or sore in the area to be treated, do not use this medication without consulting your doctor first.If your condition lasts or gets worse, or if you think you may have a serious medical problem, get medical help right away.Temporary redness, stinging, and a little bit of swelling may occur at the application site. to 30°C (59° to 86°F) [see Manufactured by ANI Pharmaceuticals, Inc. Baudette, MN
was not sufficient to reach any conclusion about the drug effect on suicide.It is unknown whether the
thinking, or motor skills, patients should be cautioned about operating
Similarly, the cited frequencies cannot
In the controlled clinical trials establishing the effectiveness of
symptoms should be reported to the patient's prescriber or health professional,
Therapy
with Fluvoxamine Maleate Tablets or within 14 days of stopping treatment with
orally with fluvoxamine maleate for 30 months or hamsters treated orally with
asked to alert their prescriber if these occur while taking Fluvoxamine Maleate
administered to patients with a history of convulsive disorders. know how Fluvoxamine Maleate Tablets affects you.
Consequently, it is not possible to provide a meaningful estimate of
achieving a response for an average duration of about 4 weeks in a 10-week
short-term controlled trials of OCD (N=320) and depression (N=1350). encouraged to be alert to the emergence of anxiety, agitation, panic attacks,
Untoward reactions associated with this exposure were
for Fluvoxamine Maleate Tablets.Coadministration of fluvoxamine maleate 100 mg per day
increments every 4 to 7 days, as tolerated, until maximum therapeutic benefit
depression studies were: In pediatric patients (N=57)
start or stop any medicine while taking Fluvoxamine Maleate Tablets without
(debossed “1225” on one side and scored on the other)Tablets 100 mg: scored, beige, elliptical, film-coated
Caution is advised in administering Fluvoxamine Maleate Tablets to patients
Maleate Tablets in patients with concomitant systemic illness is limited.