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Effexor XR® (venlafaxine hydrochloride) Extended-Release Capsules Suicidality and Antidepressant Drugs
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Effexor XR or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. 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. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Effexor XR is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: INFORMATION FOR PATIENTS, and PRECAUTIONS: Pediatric Use) DRUG DESCRIPTION
Effexor XR is an extended-release capsule for oral administration that contains venlafaxine hydrochloride, a structurally novel antidepressant. It is designated (R/S)-1-2-(dimethylamino)-1- (4-methoxyphenyl)ethyl cyclohexanol hydrochloride or (±)-1-α- (dimethylamino)methyl-pmethoxybenzyl cyclohexanol hydrochloride and has the empirical formula of C17H27NO2 HCl. Its molecular weight is 313.87. The structural formula is shown below. Effexor® (venlafaxine hydrochloride) Structural Formula Illustration
Venlafaxine hydrochloride is a white to off-white crystalline solid with a solubility of 572 mg/mL in water (adjusted to ionic strength of 0.2 M with sodium chloride). Its octanol : water (0.2 M sodium chloride) partition coefficient is 0.43. Effexor XR is formulated as an extended-release capsule for once-a-day oral administration. Drug release is controlled by diffusion through the coating membrane on the spheroids and is not pH dependent. Capsules contain venlafaxine hydrochloride equivalent to 37.5 mg, 75 mg, or 150 mg venlafaxine. Inactive ingredients consist of cellulose, ethylcellulose, gelatin, hypromellose, iron oxide, and titanium dioxide.
Last updated on RxList: 3/20/2009 INDICATIONS
Major Depressive Disorder Effexor XR (venlafaxine hydrochloride) extended-release capsules is indicated for the treatment of major depressive disorder.
The efficacy of Effexor XR in the treatment of major depressive disorder was established in 8- and 12-week controlled trials of adult outpatients whose diagnoses corresponded 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 prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.
The efficacy of Effexor (immediate release) in the treatment of major depressive disorder in adult inpatients meeting diagnostic criteria for major depressive disorder with melancholia was established in a 4-week controlled trial (see Clinical Trials). The safety and efficacy of Effexor XR in hospitalized depressed patients have not been adequately studied. The efficacy of Effexor XR in maintaining a response in major depressive disorder for up to 26 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial. The efficacy of Effexor (immediate release) in maintaining a response in patients with recurrent major depressive disorder who had responded and continued to be improved during an initial 26 weeks of treatment and were then followed for a period of up to 52 weeks was demonstrated in a second placebo-controlled trial (see Clinical Trials). Nevertheless, the physician who elects to use Effexor/Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Generalized Anxiety Disorder
Effexor XR is indicated for the treatment of Generalized Anxiety Disorder (GAD) as defined in DSM-IV. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of Effexor XR in the treatment of GAD was established in 8-week and 6-month placebo-controlled trials in adult outpatients diagnosed with GAD according to DSM-IV criteria (see Clinical Trials).
Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following 6 symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, sleep disturbance. Although the effectiveness of Effexor XR has been demonstrated in 6-month clinical trials in patients with GAD, the physician who elects to use Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).
Social Anxiety Disorder Effexor XR is indicated for the treatment of Social Anxiety Disorder, also known as Social Phobia, as defined in DSM-IV (300.23).
Social Anxiety Disorder (DSM-IV) is characterized by a marked and persistent fear of 1 or more social or performance situations in which the person is exposed to unfamiliar people or to possible scrutiny by others. Exposure to the feared situation almost invariably provokes anxiety, which may approach the intensity of a panic attack. The feared situations are avoided or endured with intense anxiety or distress. The avoidance, anxious anticipation, or distress in the feared situation(s) interferes significantly with the person's normal routine, occupational or academic functioning, or social activities or relationships, or there is a marked distress about having the phobias. Lesser degrees of performance anxiety or shyness generally do not require psychopharmacological treatment. The efficacy of Effexor XR in the treatment of Social Anxiety Disorder was established in four 12-week and one 6-month placebo-controlled trials in adult outpatients with Social Anxiety Disorder (DSM-IV) (see Clinical Trials).
Although the effectiveness of Effexor XR has been demonstrated in a 6-month clinical trial in patients with Social Anxiety Disorder, the physician who elects to use Effexor XR for extended periods should periodically re-evaluate the 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 occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. Panic disorder (DSM-IV) is characterized by recurrent, unexpected panic attacks, ie, a discrete period of intense fear or discomfort, in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: 1) palpitations, pounding heart, or accelerated heart rate; 2) sweating; 3) trembling or shaking; 4) sensations of shortness of breath or smothering; 5) feeling of choking; 6) chest pain or discomfort; 7) nausea or abdominal distress; 8) feeling dizzy, unsteady, lightheaded, or faint; 9) derealization (feelings of unreality) or depersonalization (being detached from oneself); 10) fear of losing control; 11) fear of dying; 12) paresthesias (numbness or tingling sensations); 13) chills or hot flushes.
The efficacy of Effexor XR in the treatment of panic disorder was established in two 12-week placebo-controlled trials in adult outpatients with panic disorder (DSM-IV). The efficacy of Effexor XR in prolonging time to relapse in panic disorder among responders following 12 weeks of open-label acute treatment was demonstrated in a placebo-controlled study (see CLINICAL PHARMACOLOGY, Clinical Trials). Nevertheless, the physician who elects to use Effexor XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). DOSAGE AND ADMINISTRATION
Effexor XR should be administered in a single dose with food either in the morning or in the evening at approximately the same time each day. Each capsule should be swallowed whole with fluid and not divided, crushed, chewed, or placed in water, or it may be administered by carefully opening the capsule and sprinkling the entire contents on a spoonful of applesauce. This drug/food mixture should be swallowed immediately without chewing and followed with a glass of water to ensure complete swallowing of the pellets. Initial Treatment
Major Depressive Disorder For most patients, the recommended starting dose for Effexor XR is 75 mg/day, administered in a single dose. In the clinical trials establishing the efficacy of Effexor XR in moderately depressed outpatients, the initial dose of venlafaxine was 75 mg/day. For some patients, it may be desirable to start at 37.5 mg/day for 4 to 7 days, to allow new patients to adjust to the medication before increasing to 75 mg/day. While the relationship between dose and antidepressant response for Effexor XR has not been adequately explored, patients not responding to the initial 75 mg/day dose may benefit from dose increases to a maximum of approximately 225 mg/day. Dose increases should be in increments of up to 75 mg/day, as needed, and should be made at intervals of not less than 4 days, since steady state plasma levels of venlafaxine and its major metabolites are achieved in most patients by day 4. In the clinical trials establishing efficacy, upward titration was permitted at intervals of 2 weeks or more; the average doses were about 140 to 180 mg/day (see Clinical Trials under CLINICAL PHARMACOLOGY).
It should be noted that, while the maximum recommended dose for moderately depressed outpatients is also 225 mg/day for Effexor (immediate release), more severely depressed inpatients in one study of the development program for that product responded to a mean 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 unknown; however, the experience with Effexor XR doses higher than 225 mg/day is very limited. (See PRECAUTIONS - General-Use in Patients with Concomitant Illness.) Generalized Anxiety Disorder
For most patients, the recommended starting dose for Effexor XR is 75 mg/day, administered in a single dose. In clinical trials establishing the efficacy of Effexor XR in outpatients with Generalized Anxiety Disorder (GAD), the initial dose of venlafaxine was 75 mg/day. For some patients, it may be desirable to start at 37.5 mg/day for 4 to 7 days, to allow new patients to adjust to the medication before increasing to 75 mg/day. Although a dose-response relationship for effectiveness in GAD was not clearly established in fixed-dose studies, certain patients not responding to the initial 75 mg/day dose may benefit from dose increases to a maximum of approximately 225 mg/day. Dose increases should be in increments of up to 75 mg/day, as needed, and should be made at intervals of not less than 4 days. (See the Use in Patients with Concomitant Illness section of PRECAUTIONS.) Social Anxiety Disorder (Social Phobia)
The recommended dose is 75 mg/day, administered in a single dose. There was no evidence that higher doses confer any additional benefit. (See the Use in Patients with Concomitant Illness section of PRECAUTIONS.) Panic Disorder
It is recommended that initial single doses of 37.5 mg/day of Effexor XR be used for 7 days. In clinical trials establishing the efficacy of Effexor XR in outpatients with panic disorder, initial doses of 37.5 mg/day for 7 days were followed by doses of 75 mg/day and subsequent weekly dose increases of 75 mg/day to a maximum dose of 225 mg/day. Although a dose-response relationship for effectiveness in patients with panic disorder was not clearly established in fixed-dose studies, certain patients not responding to 75 mg/day may benefit from dose increases to a maximum of approximately 225 mg/day. Dose increases should be in increments of up to 75 mg/day, as needed, and should be made at intervals of not less than 7 days. (See the Use in Patients with Concomitant Illness section of PRECAUTIONS.) Switching Patients from Effexor Tablets
Depressed patients who are currently being treated at a therapeutic dose with Effexor (immediate release) may be switched to Effexor XR at the nearest equivalent dose (mg/day), eg, 37.5 mg venlafaxine two-times-a-day to 75 mg Effexor XR once daily. However, individual dosage adjustments may be necessary. Special Populations
Treatment of Pregnant Women During the Third Trimester Neonates exposed to Effexor XR, other SNRIs, or SSRIs, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see PRECAUTIONS). When treating pregnant women with Effexor XR during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. The physician may consider tapering Effexor XR in the third trimester.
Patients with Hepatic Impairment Given the decrease in clearance and increase in elimination half-life for both venlafaxine and ODV that is observed in patients with hepatic cirrhosis and mild and moderate hepatic impairment compared with normal subjects (see CLINICAL PHARMACOLOGY), it is recommended that the total daily dose be reduced by 50% in patients with mild to moderate hepatic impairment. Since there was much individual variability in clearance between subjects with cirrhosis, it may be necessary to reduce the dose even more than 50%, and individualization of dosing may be desirable in some patients.
Patients with Renal Impairment Given the decrease in clearance for venlafaxine and the increase in elimination half-life for both venlafaxine and ODV that is observed in patients with renal impairment (GFR = 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 patients undergoing hemodialysis, it is recommended that the total daily dose be reduced by 50%. Because there was much individual variability in clearance between patients with renal impairment, individualization of dosage may be desirable in some patients.
Elderly Patients No dose adjustment is recommended for elderly patients solely on the basis of age. As with any drug for the treatment of major depressive disorder, Generalized Anxiety Disorder, Social Anxiety Disorder, or panic disorder, however, caution should be exercised in treating the elderly. When individualizing the dosage, extra care should be taken when increasing the dose.
Maintenance Treatment There is no body of evidence available from controlled trials to indicate how long patients with major depressive disorder, Generalized Anxiety Disorder, Social Anxiety Disorder, or panic disorder, should be treated with Effexor XR.
It is generally agreed that acute episodes of major depressive disorder require several months or longer of sustained pharmacological therapy beyond response to the acute episode. In one study, in which patients responding during 8 weeks of acute treatment with Effexor XR were assigned randomly to placebo or to 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 stabilization phase, longer-term efficacy was demonstrated. A second longer-term study has demonstrated the efficacy of Effexor in maintaining a response in patients with recurrent major depressive disorder who had responded and continued to be improved during an initial 26 weeks of treatment and were then randomly assigned to placebo or Effexor for periods of up to 52 weeks on the same dose (100 to 200 mg/day, on a b.i.d. schedule) (see Clinical Trials under CLINICAL PHARMACOLOGY). Based on these limited data, it is not known whether or not the dose of Effexor/Effexor XR needed for maintenance treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed 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-month clinical trials. The need for continuing medication in patients with GAD who improve with Effexor XR treatment should be periodically reassessed.
In patients with Social Anxiety Disorder, Effexor XR has been shown to be effective in a 6-month clinical trial. The need for continuing medication in patients with Social Anxiety Disorder who improve with Effexor XR treatment should be periodically reassessed. In a study of panic disorder in which patients responding during 12 weeks of acute treatment with Effexor XR were assigned randomly to placebo or to the same dose of Effexor XR (75, 150, or 225 mg/day), patients continuing Effexor XR experienced a significantly longer time to relapse than patients randomized to placebo. The need for continuing medication in patients with panic disorder who improve with Effexor XR treatment should be periodically reassessed.
Discontinuing Effexor XR Symptoms associated with discontinuation of Effexor XR, other SNRIs, and SSRIs, have been reported (see PRECAUTIONS). 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. In clinical trials with Effexor XR, tapering was achieved by reducing the daily dose by 75 mg at 1 week intervals. Individualization of tapering may be necessary.
Switching Patients To or From a Monoamine Oxidase Inhibitor At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with Effexor XR. In addition, at least 7 days should be allowed after stopping Effexor XR before starting an MAOI (see CONTRAINDICATIONS and WARNINGS).
HOW SUPPLIED Effexor XR® (venlafaxine hydrochloride) extended-release capsules are available as follows:
37.5 mg, grey cap/peach body with W and “Effexor XR” on the cap and “37.5” on the body. NDC 0008-0837-20, bottle of 15 capsules in unit of use package. NDC 0008-0837-21, bottle of 30 capsules in unit of use package. NDC 0008-0837-22, bottle of 90 capsules in unit of use package. NDC 0008-0837-03, carton of 10 Redipak® blister strips of 10 capsules each.
75 mg, peach cap and body with W and “Effexor XR” on the cap and “75” on the body. NDC 0008-0833-20, bottle of 15 capsules in unit of use package. NDC 0008-0833-21, bottle of 30 capsules in unit of use package. NDC 0008-0833-22, bottle of 90 capsules in unit of use package. NDC 0008-0833-03, carton of 10 Redipak® blister strips of 10 capsules each.
150 mg, dark orange cap and body with W and “Effexor XR” on the cap and “150” on the body. NDC 0008-0836-20, bottle of 15 capsules in unit of use package. NDC 0008-0836-21, bottle of 30 capsules in unit of use package. NDC 0008-0836-22, bottle of 90 capsules in unit of use package. NDC 0008-0836-03, carton of 10 Redipak® blister strips of 10 capsules each.
Store at controlled room temperature, 20° to 25°C (68° to 77°F). The unit of use package is intended to be dispensed as a unit.
The appearance of these capsules is a trademark of Wyeth Pharmaceuticals. Wyeth Pharmaceuticals Inc., Philadelphia, PA 19101. Rev 02/09.
Last updated on RxList: 3/20/2009 SIDE EFFECTS
The information included in the Adverse Findings Observed in Short-Term, Placebo-Controlled Studies with Effexor XR subsection is based on data from a pool of three 8- and 12-week controlled clinical trials in major depressive disorder (includes two U.S. trials and one European trial), on data up to 8 weeks from a pool of five controlled clinical trials in GAD with Effexor XR®, on data up to 12 weeks from a pool of five controlled clinical trials in Social Anxiety Disorder, and on data up to 12 weeks from a pool of four controlled clinical trials in panic disorder. Information on additional adverse events associated with Effexor XR in the entire development program for the formulation and with Effexor (immediate release) is included in the Other Adverse Events Observed During the Premarketing Evaluation of Effexor and Effexor XR subsection (see also WARNINGS and PRECAUTIONS). Adverse Findings Observed in Short-Term, Placebo-Controlled Studies with Effexor XR
Adverse Events Associated with Discontinuation of Treatment Approximately 11% of the 357 patients who received Effexor XR® (venlafaxine hydrochloride) extended-release capsules in placebo-controlled clinical trials for major depressive disorder discontinued treatment due to an adverse experience, compared with 6% of the 285 placebo-treated patients in those studies. Approximately 18% of the 1381 patients who received Effexor XR capsules in placebo-controlled clinical trials for GAD discontinued treatment due to an adverse experience, compared with 12% of the 555 placebo-treated patients in those studies. Approximately 15% of the 819 patients who received Effexor XR capsules in placebo-controlled clinical trials for Social Anxiety Disorder discontinued treatment due to an adverse experience, compared with 5% of the 695 placebo-treated patients in those studies. Approximately 7% of the 1,001 patients who received Effexor XR capsules in placebo-controlled clinical trials for panic disorder discontinued treatment due to an adverse experience, compared with 6% of the 662 placebo-treated patients in those studies. The most common events leading to discontinuation and considered to be drug-related (ie, leading to discontinuation in at least 1% of the Effexor XR-treated patients at a rate at least twice that of placebo for any indication) are shown in Table 6.
Table 6: Common Adverse Events Leading to Discontinuation of Treatment in Placebo-Controlled Trials1 Adverse Event
Percentage of Patients Discontinuing Due to Adverse Event Major Depressive Disorder Indication2
GAD Indication3,4 Social Anxiety Disorder Indication5
Panic Disorder Indication Effexor XR n = 357
Placebo n = 285 Effexor XR n = 1381
Placebo n = 555 Effexor XR n = 819
Placebo n = 695 Effexor XR n = 1001
Placebo n = 662 Body as a Whole
Asthenia --
-- 3%
< 1% 2%
< 1% 1%
0% Headache
-- --
-- --
1% < 1%
-- --
Digestive System Nausea
4% < 1%
8% < 1%
3% < 1%
2% < 1%
Anorexia 1%
< 1% --
-- --
-- --
-- Dry Mouth
1% 0%
2% < 1%
-- --
-- --
Vom iting --
-- 1%
< 1% --
-- --
-- Nervous System
Dizziness 2%
1% --
-- 2%
< 1% --
-- Insomnia
1% < 1%
3% < 1%
2% < 1%
1% < 1%
Somnolence 2%
< 1% 3%
< 1% 2%
< 1% --
-- Nervousness
-- --
2% < 1%
-- --
-- --
Trem or Skin --
-- 1%
0% --
-- --
-- Sweating
-- --
2% < 1%
-- --
-- --
UrogenitalSystem Im potence 6
-- --
-- --
2% 0%
-- --
- Two of the major depressive disorder studies were flexible dose and one was fixed dose. Four of the GAD studies were fixed dose and one was flexible dose. Four of the Social Anxiety Disorder studies were flexible dose and one was fixed/flexible dose. Two of the panic disorder studies were flexible dose and two were fixed dose.
- In U.S. placebo-controlled trials for major depressive disorder, the following were also common events leading to discontinuation and were considered to be drug-related for Effexor XR-treated patients (% Effexor XR n = 192, % Placebo n = 202): hypertension (1%, < 1%); diarrhea (1%, 0%); paresthesia (1%, 0%); tremor (1%, 0%); abnormal vision, mostly blurred vision (1%, 0%); and abnormal, mostly delayed, ejaculation (1%, 0%).
- In two short-term U.S. placebo-controlled trials for GAD, the following were also common events leading to discontinuation and were considered to be drug-related for Effexor XR-treated patients (% Effexor XR n = 476), % Placebo n = 201: headache (4%, < 1%); vasodilatation (1%, 0%); anorexia (2%, < 1%); dizziness (4%, 1%); thinking abnormal (1%, 0%); and abnormal vision (1%, 0%).
- In long-term placebo-controlled trials for GAD, the following was also a common event leading to discontinuation and was considered to be drug-related for Effexor XR-treated patients (% Effexor XR n =
- 35, % Placebo n = 257): decreased libido (1%, 0%).
- In a 6-month placebo-controlled trial for Social Anxiety Disorder, the following was also a common event leading to discontinuation and was considered to be drug-related for Effexor XR-treated patients (% Effexor XR
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