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

aidarex pharmaceuticals llc - trazodone hydrochloride (unii: 6e8zo8lrnm) (trazodone - unii:ybk48bxk30) - trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (mdd) in adults. the efficacy of trazodone hydrochloride tablets has been established in trials with the immediate release formulation of trazodone [see clinical studies (14)]. none. teratogenic effects pregnancy category c trazodone hydrochloride has been shown to cause increased fetal resorption and other adverse effects on the fetus in two studies using the rat when given at dose levels approximately 30 to 50 times the proposed maximum human dose. there was also an increase in congenital anomalies in one of three rabbit studies at approximately 15 to 50 times the maximum human dose. there are no adequate and well-controlled studies in pregnant women. trazodone hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. trazodone and/or its metabolites have been found in the milk of lactating rats, suggesting that the drug may be secreted in human milk. caut

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

aidarex pharmaceuticals llc - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine tablets, usp is indicated for the treatment of major depressive disorder. the efficacy of venlafaxine tablets, usp 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 efficac

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

aidarex pharmaceuticals llc - naproxen (unii: 57y76r9atq) (naproxen - unii:57y76r9atq) - carefully consider the potential benefits and risks of naproxen tablets and other treatment options before deciding to use naproxen tablets. use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals (see warnings; gastrointestinal bleeding, ulceration, and perforation) . naproxen as naproxen tablets are indicated: - for the relief of the signs and symptoms of rheumatoid arthritis - for the relief of the signs and symptoms of osteoarthritis - for the relief of the signs and symptoms of ankylosing spondylitis - for the relief of the signs and symptoms of juvenile arthritis - for relief of the signs and symptoms of tendonitis - for relief of the signs and symptoms of bursitis - for relief of the signs and symptoms of acute gout - for the management of pain - for the management of primary dysmenorrhea naproxen tablets are contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to naproxen, napr

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

aidarex pharmaceuticals llc - clonazepam (unii: 5pe9fde8gb) (clonazepam - unii:5pe9fde8gb) - clonazepam tablets, usp are useful alone or as an adjunct in the treatment of the lennox-gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. in patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam tablets, usp may be useful. in some studies, up to 30% of patients have shown a loss of anticonvulsant activity, often within 3 months of administration. in some cases, dosage adjustment may reestablish efficacy. clonazepam tablets, usp are indicated for the treatment of panic disorder, with or without agoraphobia, as defined in dsm-v. 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. the efficacy of clonazepam tablets, usp was established in two 6- to 9-week trials in panic disorder patients whose diagnoses corresponded to the dsm-iiir category of

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

aidarex pharmaceuticals llc - buspirone hydrochloride (unii: 207lt9j9oc) (buspirone - unii:tk65wks8hl) - buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. the efficacy of buspirone hydrochloride tablets have been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to generalized anxiety disorder (gad). many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. the patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. generalized anxiety disorder (300.02) is described in the american psychiatric association’s diagnostic and statistical manual, iii1 as follows: generalized, persistent anxiety (of at least 1 month continual d

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

aidarex pharmaceuticals llc - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine tablets, usp is indicated for the treatment of major depressive disorder. the efficacy of venlafaxine tablets, usp 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 efficac

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

aidarex pharmaceuticals llc - alendronate sodium (unii: 2uy4m2u3ra) (alendronic acid - unii:x1j18r4w8p) - alendronate sodium tablets are indicated for the treatment of osteoporosis in postmenopausal women. in postmenopausal women, alendronate sodium tablets increase bone mass and reduces the incidence of fractures, including those of the hip and spine (vertebral compression fractures). [see clinical studies (14.1) .] alendronate sodium tablets are indicated for the prevention of postmenopausal osteoporosis [see clinical studies (14.2) ].   alendronate sodium tablets are indicated for treatment to increase bone mass in men with osteoporosis [see clinical studies (14.3) ].   alendronate sodium tablets are indicated for the treatment of glucocorticoid-induced osteoporosis in men and women receiving glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who have low bone mineral density [see clinical studies (14.4) ].   alendronate sodium tablets are indicated for the treatment of paget’s disease of bone in men and women. treatment is indicated in patients with paget's disease of bone

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

aidarex pharmaceuticals llc - fluoxetine hydrochloride (unii: i9w7n6b1kj) (fluoxetine - unii:01k63sup8d) - fluoxetine capsules, usp are indicated for the acute and maintenance treatment of major depressive disorder in adult patients and in pediatric patients aged 8 to 18 years [see clinical studies (14.1) ]. the usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods, should periodically be re-evaluated [see dosage and administration (2.1) ] . fluoxetine capsules, usp are indicated for the acute and maintenance treatment of obsessions and compulsions in adult patients and in pediatric patients aged 7 to 17 years with obsessive compulsive disorder (ocd) [see clinical studies (14.2) ]. the effectiveness of fluoxetine capsules, usp in long-term use, i.e., for more than 13 weeks, has not been systematically evaluated in placebo-controlled trials. therefore, the physician who elects to use fluoxetine capsules, usp for extended periods, should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see dosage and administration (2.2) ]. fluoxeti

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

aidarex pharmaceuticals llc - warfarin sodium (unii: 6153cwm0cl) (warfarin - unii:5q7zvv76ei) - warfarin sodium 2 mg - warfarin sodium tablets are indicated for: - •prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (pe). - •prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (af) and/or cardiac valve replacement. - •reduction in the risk of death, recurrent myocardial infarction (mi), and thromboembolic events such as stroke or systemic embolization after myocardial infarction. limitations of use warfarin sodium tablets have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and to prevent secondary thromboembolic complications that may result in serious and possibly fatal sequelae. warfarin sodium is contraindicated in: - •pregnancy warfarin sodium is contraindicated in women who are pregnant except in pregnant women with mechanical heart valves, who are at high risk of thromboembolism

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

aidarex pharmaceuticals llc - warfarin sodium (unii: 6153cwm0cl) (warfarin - unii:5q7zvv76ei) - warfarin sodium 3 mg - warfarin sodium tablets are indicated for: - •prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (pe). - •prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (af) and/or cardiac valve replacement. - •reduction in the risk of death, recurrent myocardial infarction (mi), and thromboembolic events such as stroke or systemic embolization after myocardial infarction. limitations of use warfarin sodium tablets have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and to prevent secondary thromboembolic complications that may result in serious and possibly fatal sequelae. warfarin sodium is contraindicated in: - •pregnancy warfarin sodium is contraindicated in women who are pregnant except in pregnant women with mechanical heart valves, who are at high risk of thromboembolism