Effexor Xr

INDICATIONS
Major depressive disorder
Effexor XR (venlafaxine hydrochloride) extended-release capsules is indicated for the treatment of major depressive disorders.

effexor xr
The effectiveness of Effexor XR in the treatment of major depressive disorder was established in 8 and 12 weeks of controlled trials of adults hospitalized whose diagnoses corresponds most closely to the DSM-III-R or DSM-IV category of major depressive disorder (see Clinical Trials).

A major depressive episode (DSM-IV) implies a relatively large and persistent (nearly every day for at least 2 weeks) depressed mood or loss of interest or pleasure in almost all activities, which represents a change from functioning precedent, and includes the presence of at least five of the nine following symptoms during the same period of two weeks: depressed mood, decreased interest or pleasure in usual activities, significant changes in weight and / or s appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, Feelings of guilt or worthlessness, slowed thinking or the merger, a suicide attempt or suicidal ideation.

The effectiveness of Effexor (immediate release) in the treatment of major depressive disorders in adults hospitalized meeting diagnostic criteria for major depressive disorder wistfully was established in 4 weeks controlled trial (see CLINICAL TRIALS). The safety and efficacy of Effexor XR in hospitalized depressed patients have not been sufficiently studied.

The effectiveness of Effexor XR in maintaining a response in major depressive disorder for a maximum of 26 weeks after 8 weeks of acute treatment has been demonstrated in a placebo-controlled trial. The effectiveness of Effexor (immediate) to maintain a response in patients with recurrent major depressive disorder who responded and continued to be improved in the first 26 weeks of treatment and were then followed for a maximum period of 52 weeks been demonstrated in a second placebo-controlled trial (see CLINICAL TRIALS). However, the doctor who chooses to use Effexor / Effexor XR for extended periods should periodically re-evaluate long-term usefulness of the drug for each patient (see DOSAGE AND ADMINISTRATION).

Generalized anxiety disorder
Effexor XR is indicated for the treatment of generalized anxiety disorder (AG D), as defined in DSM-IV. Anxiety or tension associated with the stress of daily life in general does not require treatment with an anxiolytic.

The effectiveness of Effexor XR in the treatment of GAD was established in 8 weeks and 6 months placebo-controlled trials in adults hospitalized diagnosis TAG according to the DSM-IV criteria (see CLINICAL TRIALS).

Generalized anxiety (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and the person who finds it difficult to control. It must be associated with at least 3 of 6 following symptoms: restlessness or feeling of attachment or on the periphery of being easily fatigued, difficulty concentrating in progress or the spirit empty, irritability, muscle tension, sleep.

Although the effectiveness of Effexor XR has been demonstrated in 6 months clinical trials in patients with generalized anxiety disorder, the doctor who chooses to use Effexor XR for extended periods should periodically re-evaluate long-term l 'usefulness of the drug for each patient (see DOSAGE AND ADMINISTRATION).

The social phobia
Effexor XR is indicated for the treatment of social phobia, also known as social phobia, as defined in DSM-IV (300.23).

Social Anxiety Disorder (DSM-IV) is characterized by a persistent fear and 1 or more social or performance situations in which the person is exposed to unknown persons or possible consideration by other . Exposure to the feared situation almost always provokes anxiety, May approaching the intensity of a panic attack. The risk situations are avoided or endured with intense anxiety or distress. The avoidance, anxious anticipation, distress or in the risk (s) interferes significantly with the person in the normal routine, professional or academic performance, or social activities or relationships, or there is a distress' have phobias. Lesser degree of performance anxiety or shyness generally do not require psychopharmacological treatment.

The effectiveness of Effexor XR in the treatment of social anxiety has been established in four of 12 weeks and a 6-month placebo-controlled trials in adults hospitalized with social anxiety disorder (DSM-IV) (see clinical trials).

Although the effectiveness of Effexor XR has been demonstrated in a 6-month clinical trials in patients with social anxiety, the doctor who chooses to use Effexor XR for extended periods should periodically re-evaluate long - term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).

Panic disorder
Effexor XR is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the appearance of unexpected panic and concern for further attacks, worry about the consequences or the consequences of the attacks, and / or a significant change in behaviour related to the attacks.

The panic disorder (DSM-IV) is characterized by recurrent, unexpected panic attacks, ie, a discrete period of intense fear or discomfort during which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: 1) palpitations, heart beating, or accelerated heartbeat, 2) sweating; 3) tremors or shaking, 4) sensations of breathlessness or suffocation; 5) feeling of suffocation, 6) chest pain or discomfort, 7) nausea or abdominal pain; 8) feeling dizzy, unsteady, light, low or nonexistent, 9) derealization (feelings of unreality) or depersonalization (being detached from oneself ), 10) fear losing control; 11) afraid of dying; 12) paresthesias (numbness or tingling sensations), 13) chills or hot flashes.

The effectiveness of Effexor XR in the treatment of panic disorder was established in two 12-week placebo-controlled trials in adults hospitalized with panic disorder (DSM-IV). The effectiveness of Effexor XR to extend the time to relapse in the treatment of panic disorder among stakeholders following 12 weeks of open-label acute treatment has been demonstrated in a controlled study against placebo (see CLINICAL PHARMACOLOGY, Clinical Trials) . However, the doctor who chooses to use Effexor XR for long periods ally periodic should reassess the long-term usefulness of the drug for each patient (see DOSAGE AND ADMINISTRATION).

DOSAGE AND ADMINISTRATION
Effexor XR should be administered in a single dose with food either in the morning or evening at the same time every day. Each capsule must be swallowed whole with a fluid and not divided, crushed, chewed or placed in water, May or be administered with care by opening the capsule and layer all content on a spoonful of applesauce. This drug / food mixture should be swallowed with immediate effect, without chewing and followed with a glass of water to swallow the pellets.

STARTING SALARY
Major depressive disorder
For most patients, the recommended starting dose for Effexor XR is 75 mg / day, administered in one dose. In clinical trials proving the effectiveness of Effexor XR in moderately depressed outpatients, the initial dose of venlafaxine was 75 mg / day. For some patients, May it be desirable to begin to 37.5 mg / day for 4 to 7 days, to allow new patients to adapt to this drug before increasing to 75 mg / day. Although the relationship between dose and response to antidepressant Effexor XR has not been sufficiently explored, patients do not respond to the initial dose 75mg/day May benefit from the dose increases to a maximum of about 225 mg / day. Rate increases should be in increments of up to 75 mg / day, as needed, and should be carried out at intervals of at least 4 days, since steady state plasma levels of venlafaxine and its main metabolites are made in most patients by day 4. In clinical trials establishing the effectiveness, increase titration was cleared at intervals of 2 weeks or more, the average doses are approximately 140 to 180 mg / day (see clinical trials under CLINICAL PHARMACOLOGY).

It should be noted that while the maximum dose recommended for moderately depressed outpatients is also 225 mg / day for Effexor (immediate release), more severely depressed patients in a study of the development program for this product meets a average dose of 350 mg / day (range of 150 to 375 mg / day). Whether or not higher doses of Effexor XR are needed for more severely depressed patients is not known, but experience with Effexor XR doses greater than 225 mg / day is very limited. (See PRECAUTIONS-General-Use in patients with concomitant disease.)

Generalized anxiety disorder
For most patients, the recommended starting dose for Effexor XR is 75 mg / day, administered in one dose. In clinical trials proving the effectiveness of Effexor XR ambulatory with generalized anxiety disorder (GAD), the initial dose of venlafaxine was 75 mg / day. For some patients, May it be desirable to begin 37.5mg/day 4 to 7 days, to allow new patients to adapt to this drug before increasing to 75 mg / day. Although a dose-response relationship for efficacy in GAD has not been clearly established in the fixed-dose studies, some patients do not respond to the initial dose 75mg/day May benefit from the dose increases to a maximum of about 225 mg / day. Rate increases should be in increments of up to 75 mg / day, as needed, and should be carried out at intervals of at least 4 days. (See use in patients with concomitant disease of the PRECAUTIONS section.)

The social phobia (social phobia)
The recommended dose is 75 mg / day, administered in one dose. There is no evidence that higher doses confer any additional benefit. (See use in patients with concomitant disease of the PRECAUTIONS section.)

Panic disorder
It is recommended that the first single doses of 37.5 mg / day of Effexor XR be used for 7 days. In clinical trials proving the effectiveness of Effexor XR ambulatory with panic disorder, the first doses of 37.5 mg / day for 7 days were followed by doses of 75 mg / day and increases weekly dose of 75 mg / days to a maximum dose of 225 mg / day. Although a dose-response relationship for efficacy in patients with panic disorder has not been clearly established in the fixed-dose studies, some patients do not respond to 75 mg / day May benefit from the dose increases to a maximum approximately 225 mg / day. Rate increases should be in increments of up to 75 mg / day, as needed, and should be carried out at intervals of at least 7 days. (See use in patients with concomitant disease of the PRECAUTIONS section.)

The passage of patients effects tablets
Patients who are depressed currently treated with a therapeutic dose Effexor (immediate release) May be switched to Effexor XR is the nearest equivalent dose (mg / day), for example, venlafaxine 37.5mg twice a day to 75mg Effexor XR once a day. However, dosage adjustments necessary May.

Special Populations
Treatment of pregnant women during the third quarter
Newborns exposed to Effexor XR, other IRSN, or SSRIs, at the end of the third quarter have developed complications requiring prolonged hospitalization, respiratory support and tube feeding (see PRECAUTIONS). When treating pregnant women with Effexor XR in the third quarter, the physician should consider carefully the potential risks and benefits of treatment. The doctor May consider tapering Effexor XR in the third quarter.

Patients with liver damage
Given the decreased clearance and increasing the half-life disposal for two and venlafaxine ODV that seen in patients with liver cirrhosis and mild and moderate liver failure compared to normal subjects (see CLINICAL PHARMACOLOGY), it is recommended that the total daily dose reduced by 50% in patients with mild to moderate liver failure. Since there were a lot of individual variability in the clearance between subjects with cirrhosis, May it is necessary to reduce the dose even more than 50%, and individualization of treatment May be desirable in some patients.

Patients with kidney failure
Given the decrease in the clearance the venlafaxine and increase the elimination half-life for two and venlafaxine ODV that seen in patients with renal failure (TFG = 10 to 70 ml / min) compared with normal subjects (see CLINICAL PHARMACOLOGY), it is recommended that the total daily dose be reduced by 25% to 50%. In hemodialysis patients, it is recommended that the total daily dose to reduce by 50%. Because there were a lot of individual variability in the clearance between patients with renal insufficiency, the individualization of dosage May be desirable in some patients.

Elderly patients
No dose adjustment is recommended in patients aged solely on the basis of age. As with any medication for the treatment of major depressive disorder, generalized anxiety disorder, social anxiety or panic disorder, however, caution is needed in treating the elderly. When individualize dosage, extra care should be taken by increasing the dose.

Treatment maintenance
There is no data available from controlled trials to indicate how long patients with major depressive disorder, generalized anxiety disorder, social anxiety or panic disorder, should be treated with Effexor XR.

It is generally accepted that acute episodes of major depressive disorder require several months or more sustained beyond therapy pharmacological response to the acute episode. In a study in which patients meet during 8 weeks of acute treatment with Effexor XR were randomly assigned to placebo or the same dose of Effexor XR (75, 150, or 225 mg / day, QAM) during 26 weeks of maintenance treatment as they had received during the acute phase of stabilization, longer-term effectiveness has been demonstrated. A second issue long-term study has demonstrated the effectiveness of Effexor to maintain a response in patients with recurrent major depressive disorder who responded and continued to be improved in the first 26 weeks of treatment and were then assigned at random to Effexor or placebo for a period of up to 52 weeks on the same dose (100 to 200 mg / day, on an offer annex) (see clinical trials under CLINICAL PHARMACOLOGY). Based on these limited data, it is unclear whether or not the dose of Effexor / Effexor XR necessary for the maintenance treatment is identical to the dose required to obtain a first response. Patients should be re-evaluated periodically to determine the need for maintenance treatment and the appropriate dose for such treatment.

In patients with generalized anxiety disorder, Effexor XR has been shown to be effective in 6 months clinical trials. The need for medicines in patients with anxiety that improve with Effexor XR treatment should be reassessed periodically.

In patients with social phobia, Effexor XR has been proven effective in a 6-month clinical trials. The need for medicines in patients with social phobia improve with Effexor XR treatment should be reassessed periodically.

In a study of panic disorder in which patients responding during 12 weeks of acute treatment with Effexor XR were randomly assigned to placebo or the same dose of Effexor XR (75, 150, or 225 mg / day) , Patients continue to Effexor XR experienced a significantly longer to relapse than patients randomized to receive placebo. The need for medicines in patients with panic disorder, which will improve with Effexor XR treatment should be reassessed periodically.

Discontinuing Effexor XR
Symptoms associated with the judgement of Effexor XR, other SNRI s and s SSRIs have been reported (see PRECAUTIONS). Patients should be monitored for these symptoms when stopping treatment. A gradual reduction of the dose rather than the abrupt termination is recommended whenever possible. If symptoms occur after a fall of the dose or stopping treatment, then resume the previously prescribed dose May be taken into consideration. The result, the doctor May continue decreasing the dose, but at a more gradual pace. In clinical trials with Effexor XR, tapering was achieved by reducing the daily dose of 75 mg to 1 week intervals. Individualization of tapering May be necessary.

The move to patients or an inhibitor of monoamine oxidase
At least 14 days must elapse between stopping an MAOI and early treatment with Effexor XR. In addition, at least 7 days must be allowed after stopping Effexor XR before starting an MAOI (see CONTRAINDICATIONS and WARNINGS).

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effexor xr

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