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nostrum laboratories, inc. - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine 150 mg - venlafaxine hydrochloride extended-release tablets are indicated for the treatment of major depressive disorder (mdd). efficacy of venlafaxine in mdd was shown in both short-term trials and a longer-term trial in mdd [see clinical studies (14.1) ]. 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. venlafaxine hydrochloride extended-release tablets are indicated for the treatment of social an

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torrent pharmaceuticals limited - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine 37.5 mg - venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of: • major depressive disorder (mdd) [see clinical studies ( 14.1)] • generalized anxiety disorder (gad) [see clinical studies ( 14.2)] • social anxiety disorder (sad) [see clinical studies ( 14.3)] • panic disorder (pd) [see clinical studies ( 14.4)] venlafaxine hydrochloride extended-release capsules are contraindicated in patients: • with known hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate or to any excipients in the formulation [see adverse reactions (6.2) ] . • taking, or within 14 days of stopping, maois (including the maois linezolid and intravenous methylene blue) because of the risk of serotonin syndrome [see dosage and administration (2.11), warnings and precautions (5.2), and drug interactions (7.1)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants, including effexor xr, duri

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clinical solutions wholesale, llc - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine 37.5 mg - venlafaxine hydrochloride extended-release capsules usp are indicated for the treatment of major depressive disorder (mdd). efficacy was established in three short-term (4, 8, and 12 weeks) and two long-term, maintenance trials. venlafaxine hydrochloride extended-release capsules usp are indicated for the treatment of panic disorder (pd), with or without agoraphobia. efficacy was established in two 12-week placebo-controlled trials. hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate or to any excipients in the formulation the use of maois (intended to treat psychiatric disorders) concomitantly with venlafaxine hydrochloride extended-release capsules or within 7 days of discontinuing treatment with venlafaxine hydrochloride extended-release capsules is contraindicated because of an increased risk of serotonin syndrome. the use of venlafaxine hydrochloride extended-release capsules within 14 days of discontinuing treatment with an maoi (intended to treat psychiatric disorders) is also contr

United States - English - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine 75 mg - venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder (mdd). efficacy was established in three short-term (4, 8, and 12 weeks) and two long-term, maintenance trials. venlafaxine hydrochloride extended-release capsules are indicated for the treatment of generalized anxiety disorder (gad). efficacy was established in two 8-week and two 26-week placebo-controlled trials. venlafaxine hydrochloride extended-release capsules, usp are indicated for the treatment of social anxiety disorder (sad), also known as social phobia. efficacy was established in four 12-week and one 26-week, placebo-controlled trials. venlafaxine hydrochloride extended-release capsules are indicated for the treatment of panic disorder (pd), with or without agoraphobia. efficacy was established in two 12-week placebo-controlled trials. hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate or to any excipients in the formulation the use of maois (intended to treat psych

United States - English - NLM (National Library of Medicine)

physicians total care, inc. - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine hydrochloride 37.5 mg - venlafaxine extended release tablets (venlafaxine hydrochloride) are indicated for the treatment of major depressive disorder (mdd). efficacy of venlafaxine in mdd was shown in both short-term trials and a longer-term trial in mdd [see clinical studies (14.1) ]. 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. venlafaxine extended release tablets are indicated for the treatment of social an

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aphena pharma solutions - tennessee, llc - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine 37.5 mg - venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder (mdd). efficacy was established in three short-term (4, 8, and 12 weeks) and two long-term, maintenance trials. venlafaxine hydrochloride extended-release capsules are indicated for the treatment of social anxiety disorder (sad), also known as social phobia. efficacy was established in four 12-week and one 26-week, placebo-controlled trials. venlafaxine hydrochloride extended-release capsules are indicated for the treatment of panic disorder (pd), with or without agoraphobia. efficacy was established in two 12-week placebo-controlled trials. hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate or to any excipients in the formulation the use of maois (intended to treat psychiatric disorders) concomitantly with venlafaxine hydrochloride extended-release capsules or within 7 days of discontinuing treatment with venlafaxine hydrochloride extended-release capsules are contraindicated

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nucare pharmaceuticals, inc. - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine 37.5 mg - venlafaxine hydrochloride extended-release capsules, usp are indicated for the treatment of major depressive disorder (mdd). efficacy was established in three short-term (4, 8, and 12 weeks) and two long-term, maintenance trials. venlafaxine hydrochloride extended-release capsules, usp are indicated for the treatment of social anxiety disorder (sad), also known as social phobia. efficacy was established in four 12-week and one 26-week, placebo-controlled trials. venlafaxine hydrochloride extended-release capsules, usp are indicated for the treatment of panic disorder (pd), with or without agoraphobia. efficacy was established in two 12-week placebo-controlled trials. hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate or to any excipients in the formulation the use of maois (intended to treat psychiatric disorders) concomitantly with venlafaxine hydrochloride or within 7 days of discontinuing treatment with venlafaxine hydrochloride is contraindicated because of an increased risk of seroto

United States - English - NLM (National Library of Medicine)

major pharmaceuticals - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine 37.5 mg - major depressive disorder venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder. the efficacy of venlafaxine hydrochloride extended-release capsules 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, fe

United States - English - NLM (National Library of Medicine)

aphena pharma solutions - tennessee, llc - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine 37.5 mg - venlafaxine hydrochloride tablets are indicated for the treatment of major depressive disorder. the efficacy of venlafaxine hydrochloride in the treatment of major depressive disorder was established in 6-week controlled trials of adult outpatients whose diagnoses corresponded most closely to the dsm-iii or dsm-iii-r category of major depression and in a 4-week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see clinical trials ). a major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. the effic

United States - English - NLM (National Library of Medicine)

avkare - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine 37.5 mg - 1.1 major depressive disorder venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder (mdd). efficacy was established in three short-term (4, 8, and 12 weeks) and two long-term, maintenance trials. 1.2 generalized anxiety disorder venlafaxine hydrochloride extended-release capsules are indicated for the treatment of generalized anxiety disorder (gad). efficacy was established in two 8-week and two 26-week placebo-controlled trials. 1.3 social anxiety disorder venlafaxine hydrochloride extended-release capsules are indicated for the treatment of social anxiety disorder (sad), also known as social phobia. efficacy was established in four 12-week and one 26- week, placebo-controlled trials. 1.4 panic disorder venlafaxine hydrochloride extended-release capsules are indicated for the treatment of panic disorder (pd), with or without agoraphobia. efficacy was established in two 12-week placebo-controlled trials. venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder (mdd). efficacy was established in three short-term (4, 8, and 12 weeks) and two long-term, maintenance trials. venlafaxine hydrochloride extended-release capsules are indicated for the treatment of generalized anxiety disorder (gad). efficacy was established in two 8-week and two 26-week placebo-controlled trials. venlafaxine hydrochloride extended-release capsules are indicated for the treatment of social anxiety disorder (sad), also known as social phobia. efficacy was established in four 12-week and one 26- week, placebo-controlled trials. venlafaxine hydrochloride extended-release capsules are indicated for the treatment of panic disorder (pd), with or without agoraphobia. efficacy was established in two 12-week placebo-controlled trials. 4.1 hypersensitivity hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate or to any excipients in the formulation 4.2 concomitant use with monoamine oxidase inhibitors (maois) the use of maois (intended to treat psychiatric disorders) concomitantly with venlafaxine hydrochloride extended-release capsules or within 7 days of discontinuing treatment with venlafaxine hydrochloride extended-release capsules is contraindicated because of an increased risk of serotonin syndrome. the use of venlafaxine hydrochloride extended-release capsules within 14 days of discontinuing treatment with an maoi (intended to treat psychiatric disorders) is also contraindicated [see dosage and administration (2.9), warnings and precautions (5.2), and drug interactions (7.2)]. starting venlafaxine hydrochloride extended-release capsules in a patient who is being treated with an maoi such as linezolid or intravenous methylene blue is also contraindicated, because of an increased risk of serotonin syndrome [see dosage and administration (2.9), warnings and precautions (5.2), and drug interactions (7.3)]. hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate or to any excipients in the formulation the use of maois (intended to treat psychiatric disorders) concomitantly with venlafaxine hydrochloride extended-release capsules or within 7 days of discontinuing treatment with venlafaxine hydrochloride extended-release capsules is contraindicated because of an increased risk of serotonin syndrome. the use of venlafaxine hydrochloride extended-release capsules within 14 days of discontinuing treatment with an maoi (intended to treat psychiatric disorders) is also contraindicated [see dosage and administration (2.9), warnings and precautions (5.2), and drug interactions (7.2)]. starting venlafaxine hydrochloride extended-release capsules in a patient who is being treated with an maoi such as linezolid or intravenous methylene blue is also contraindicated, because of an increased risk of serotonin syndrome [see dosage and administration (2.9), warnings and precautions (5.2), and drug interactions (7.3)]. teratogenic effects – pregnancy category c venlafaxine did not cause malformations in offspring of rats or rabbits given doses up to 2.5 times (rat) or 4 times (rabbit) the maximum recommended human daily dose on a mg/m2 basis. however, in rats, there was a decrease in pup weight, an increase in stillborn pups, and an increase in pup deaths during the first 5 days of lactation, when dosing began during pregnancy and continued until weaning. the cause of these deaths is not known. these effects occurred at 2.5 times (mg/m2) the maximum human daily dose. the no effect dose for rat pup mortality was 0.25 times the human dose on a mg/m2 basis. in reproductive developmental studies in rats and rabbits with o-desmethylvenlafaxine (odv), the major human metabolite of venlafaxine, evidence of teratogenicity was not observed at exposure margins of 13 in rats and 0.3 in rabbits. there are no adequate and well-controlled studies in pregnant women. venlafaxine hydrochloride extended-release capsules should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. non-teratogenic effects neonates exposed to venlafaxine hydrochloride extended-release capsules, other snris, or ssris, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. such complications can arise immediately upon delivery. reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. these features are consistent with either a direct toxic effect of ssris and snris, or possibly a drug discontinuation syndrome. it should be noted, that in some cases the clinical picture is consistent with serotonin syndrome [see warnings and precautions (5.2) and drug interactions (7.3)]. when treating a pregnant woman with venlafaxine hydrochloride extended-release capsules during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. the effect of venlafaxine on labor and delivery in humans is unknown. venlafaxine and odv have been reported to be excreted in human milk. because of the potential for serious adverse reactions in nursing infants from venlafaxine hydrochloride extended-release capsules, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. two placebo-controlled trials in 766 pediatric patients with mdd and two placebo-controlled trials in 793 pediatric patients with gad have been conducted with venlafaxine hydrochloride extended-release capsules, and the data were not sufficient to support a claim for use in pediatric patients. anyone considering the use of venlafaxine hydrochloride extended-release capsules in a child or adolescent must balance the potential risks with the clinical need [see boxed warning, warnings and precautions (5.1, 5.10, 5.11) and adverse reactions (6.4)]. although no studies have been designed to primarily assess venlafaxine hydrochloride extended-release capsules’s impact on the growth, development, and maturation of children and adolescents, the studies that have been done suggest that venlafaxine hydrochloride extended-release capsules may adversely affect weight and height [see warnings and precautions (5.10)]. should the decision be made to treat a pediatric patient with venlafaxine hydrochloride extended-release capsules, regular monitoring of weight and height is recommended during treatment, particularly if treatment is to be continued long-term [see warnings and precautions (5.10, 5.11)]. the safety of venlafaxine hydrochloride extended-release capsule treatment for pediatric patients has not been systematically assessed for chronic treatment longer than six months in duration. in the studies conducted in pediatric patients (ages 6 to 17), the occurrence of blood pressure and cholesterol increases considered to be clinically relevant in pediatric patients was similar to that observed in adult patients. consequently, the precautions for adults apply to pediatric patients [see warnings and precautions (5.3, 6.3)]. the percentage of patients in clinical studies for venlafaxine hydrochloride extended-release capsules for mdd, gad, sad, and pd who were 65 years of age or older are shown in table 15. * in addition, in the premarketing assessment of venlafaxine tablets (immediate release), 12% (357/2,897) of patients were   65 years of age. no overall differences in effectiveness or safety were observed between geriatric patients and younger patients, and other reported clinical experience generally has not identified differences in response between the elderly and younger patients. however, greater sensitivity of some older individuals cannot be ruled out. ssris and snris, including venlafaxine hydrochloride extended-release capsules, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event [see warnings and precautions (5.9)]. the pharmacokinetics of venlafaxine and odv are not substantially altered in the elderly [see clinical pharmacology (12.3)] (see figure 3). no dose adjustment is recommended for the elderly on the basis of age alone, although other clinical circumstances, some of which may be more common in the elderly, such as renal or hepatic impairment, may warrant a dose reduction [see dosage and administration (2.6)]. a population pharmacokinetic analysis of 404 venlafaxine-treated patients from two studies involving both twice daily and three times daily regimens showed that dose-normalized trough plasma levels of either venlafaxine or odv were unaltered by age or gender differences. dosage adjustment based on the age or gender of a patient is generally not necessary [see dosage and administration (2.6)] (see table 15). abbreviations: odv, o-desmethylvenlafaxine; auc, area under the curve; cmax, peak plasma concentrations; * similar effect is expected with strong cyp2d6 inhibitors venlafaxine hydrochloride extended-release capsules are not a controlled substance. while venlafaxine has not been systematically studied in clinical studies for its potential for abuse, there was no indication of drug-seeking behavior in the clinical studies. however, it is not possible to predict on the basis of premarketing experience the extent to which a cns-active drug will be misused, diverted, and/or abused once marketed. consequently, physicians should carefully evaluate patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of venlafaxine (e.g., development of tolerance, incrementation of dose, drug-seeking behavior). in vitro studies revealed that venlafaxine has virtually no affinity for opiate, benzodiazepine, phencyclidine (pcp), or n-methyl-d-aspartic acid (nmda) receptors. venlafaxine was not found to have any significant cns stimulant activity in rodents. in primate drug discrimination studies, venlafaxine showed no significant stimulant or depressant abuse liability. discontinuation effects have been reported in patients receiving venlafaxine [see dosage and administration (2.8)].