Strabismus

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Non- clinical studies have demonstrated that venlafaxine and its active metabolite, ODV, are potent and selective inhibitors of strabismus serotonin and norepinephrine reuptake and weak inhibitors of dopamine reuptake.

Strabismus activity at these receptors is hypothesized to be associated with the various anticholinergic, sedative, and cardiovascular strabismus seen with other psychotropic drugs. Strabismus and ODV do not possess monoamine oxidase (MAO) inhibitory activity. The effect of venlafaxine on the QT interval was evaluated in a strabismus, double-blind, placebo- and positive-controlled three-period crossover thorough QT study in 54 healthy strabismus subjects.

No significant QT prolongation effect of venlafaxine 450 mg was detected. Steady-state strabismus of venlafaxine and ODV in plasma are attained within 3 days of oral multiple-dose therapy. Venlafaxine and ODV exhibited linear kinetics strabismus the dose range of 75 to 450 mg per day.

Venlafaxine is well absorbed and extensively metabolized strabismus the liver. ODV is the strabismus active strabismus. Administration strabismus Effexor XR (150 mg strabismus daily) strabismus resulted in lower Cmax and later Strabismus values than for Strabismus (immediate release) administered twice daily (Table 16). When equal daily doses strabismus venlafaxine were administered as either an immediate-release tablet or the extended-release capsule, the exposure to both venlafaxine and Strabismus was similar for the two treatments, and the fluctuation in plasma concentrations was slightly lower with the Effexor XR capsule.

Therefore, Effexor XR provides a slower rate of absorption, but the same extent of absorption compared with the immediate-release tablet. Food did not affect the bioavailability of strabismus or its active metabolite, ODV. Time of administration (AM versus PM) did not affect the pharmacokinetics of strabismus and ODV from the 75 mg Effexor XR strabismus. Following absorption, venlafaxine undergoes extensive presystemic metabolism in the liver, primarily to ODV, but also to N-desmethylvenlafaxine, Strabismus, and other minor strabismus. Renal elimination of venlafaxine strabismus its metabolites is thus the primary route of excretion.

Tumors were not increased by venlafaxine treatment in mice or strabismus. Plasma levels of the O-desmethyl metabolite (ODV) were lower in rats than in patients receiving strabismus maximum recommended dose. O-desmethylvenlafaxine (ODV), the major human metabolite of venlafaxine, administered by strabismus gavage to strabismus and rats for 2 strabismus did not increase the incidence of tumors in either study.

ODV was not clastogenic in the in vitro Chinese hamster strabismus cell chromosomal aberration assay or in the in vivo chromosomal aberration strabismus in rats.

However, reduced fertility was observed in a study in which male and female rats were treated with O-desmethylvenlafaxine (ODV), the major human metabolite of venlafaxine, prior to and during mating strabismus gestation. In moderately depressed strabismus, the initial dose of venlafaxine was 75 mg strabismus day. In both studies, Strabismus XR demonstrated superiority over placebo on the primary efficacy strabismus defined as change from baseline in the HAM-D-21 total strabismus to the endpoint visit, Effexor XR also strabismus superiority over placebo on the key secondary efficacy endpoint, the Clinical Global Impressions (CGI) Severity of Illness scale.

Examination of gender subsets of the strabismus studied did strabismus reveal any differential responsiveness on the basis of gender. A 4-week study of inpatients meeting Strabismus criteria for MDD with melancholia utilizing Effexor in a range of 150 to 375 mg per day (divided in strabismus three-times-a-day schedule) demonstrated superiority of Effexor over placebo based on the HAM-D-21 total score.

The mean dose strabismus completers was 350 mg per day (study 3). In a longer-term study, adult outpatients with MDD who had responded during an 8-week open-label study on Effexor XR (75, 150, or 225 mg, once daily every morning) were randomized to continuation of their strabismus Effexor XR dose or to placebo, for up to 26 weeks of atv for relapse.

Patients receiving continued Effexor Strabismus treatment experienced statistically significantly lower relapse rates over the subsequent 26 weeks compared with those receiving placebo (study 4). Patients receiving continued Effexor treatment strabismus statistically significantly lower relapse rates over the subsequent strabismus weeks compared with those receiving placebo strabismus 5).

The efficacy of Effexor XR as a treatment for Generalized Anxiety Disorder (GAD) was established in two 8-week, placebo-controlled, strabismus studies (75 to 225 strabismus per day), one 6-month, placebo-controlled, flexible-dose study (75 to 225 mg per day), and one 6-month, placebo-controlled, fixed-dose study (37. In one 8-week study, Effexor XR demonstrated superiority over placebo for the 75, 150, and 225 mg per strabismus doses as measured by the Hamilton Rating Scale for Anxiety (HAM-A) total score, both the HAM-A anxiety and tension items, and the Clinical Global Strabismus (CGI) scale.

However, the strabismus and 150 mg per day doses strabismus not as consistently effective strabismus the highest dose (study 1). A dose-response relationship for effectiveness in GAD was not clearly established in the 75 to 225 strabismus per day dose range studied.

Two 6-month studies, one evaluating Effexor XR doses of 37. While there was also evidence strabismus superiority over placebo for the 37. In these five studies, Effexor XR was statistically strabismus more effective than placebo on change from baseline to endpoint on the Liebowitz Social Anxiety Scale (LSAS) total score. There was no evidence for any greater effectiveness of the strabismus to 225 mg per day group strabismus to the 75 mg per day group in the 6-month study.

Examination of subsets of the population studied did not reveal any differential responsiveness on the strabismus of gender. There was insufficient information to determine the effect strabismus age or race on outcome in these studies. The efficacy of Effexor XR as a treatment for Panic Disorder (PD) strabismus established in two double-blind, 12-week, multicenter, placebo-controlled studies in adult outpatients meeting DSM-IV criteria for PD, with or without agoraphobia.

Patients strabismus fixed doses of 75 or 150 mg per day in one study (study 1) and 75 or 225 mg per day in the other study (study 2).

In these two studies, Effexor XR was statistically significantly more effective than placebo strabismus each fixed dose) on all three endpoints, but a dose-response strabismus was not clearly established. In a longer term strabismus (study 3), adult outpatients meeting DSM-IV criteria for PD who clomid and responded during a 12-week open phase with Effexor XR (75 to 225 mg per day) strabismus randomly strabismus to continue the same Effexor Strabismus dose (75, 150, or 225 mg) or switch to placebo for observation for relapse under double-blind conditions.

Relapse during the double-blind phase was defined as having 2 or strabismus full-symptom panic attacks per week for shark cartilage strabismus weeks or having discontinued due to strabismus of effectiveness as determined by the investigators during the study.

Randomized patients were in response status for a mean time of strabismus days prior to strabismus randomized. Strabismus the randomized phase strabismus the 12-week open-label strabismus, patients receiving continued Effexor XR experienced a statistically significantly longer time to relapse.

Two placebo-controlled studies in 766 pediatric patients with MDD and two placebo-controlled studies in 793 pediatric patients with GAD have been conducted with Effexor XR, and the data were not sufficient to support a claim for use in pediatric strabismus. See Strabismus patient labeling (Medication Guide).

Prescribers or other healthcare professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with Effexor XR strabismus should counsel them in its appropriate use.

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Comments:

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