European Union - English - EMA (European Medicines Agency)

ucb pharma s.a.   - fenfluramine hydrochloride - epilepsies, myoclonic - antiepileptics, - treatment of seizures associated with dravet syndrome as an add-on therapy to other antiepileptic medicines for patients 2 years of age and older.fintepla is indicated for the treatment of seizures associated with dravet syndrome and lennox-gastaut syndrome as an add-on therapy to other anti-epileptic medicines for patients 2 years of age and older.

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

mylan pharmaceuticals inc. - fluoxetine hydrochloride (unii: i9w7n6b1kj) (fluoxetine - unii:01k63sup8d) - fluoxetine 10 mg - fluoxetine capsules, usp are indicated for the treatment of premenstrual dysphoric disorder (pmdd). the efficacy of fluoxetine in the treatment of pmdd was established in three placebo-controlled trials (see clinical trials). the essential features of pmdd, according to the dsm-iv, include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. other features include decreased interest in usual activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. physical symptoms associated with pmdd include breast tenderness, headache, joint and muscle pain, bloating, and weight gain. these symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. in making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated b

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

lake erie medical dba quality care products llc - sertraline hydrochloride (unii: uti8907y6x) (sertraline - unii:quc7nx6wmb) - sertraline 100 mg - major depressive disorder sertraline tablets usp are indicated for the treatment of major depressive disorder in adults. the efficacy of sertraline tablets usp in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the dsm-iii category of major depressive disorder (see clinical trials  under clinical pharmacology ). 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 antidepressant action of sertraline tablets usp in hospital

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

solco healthcare us llc - benzphetamine hydrochloride (unii: 43dwt87qt7) (benzphetamine - unii:0m3s43xk27) - benzphetamine hydrochloride 50 mg - benzphetamine hydrochloride tablets are indicated in the management of exogenous obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (bmi) of 30 kg/m2 or higher who have not responded to appropriate weight reducing regimen (diet and/or exercise) alone. below is a chart of body mass index (bmi) based on various heights and weights. bmi is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. metric conversions are as follows: pounds ÷ 2.2 = kg; inches × 0.0254 = meters. the limited usefulness of agents of this class (see clinical pharmacology ) should be weighed against possible risks inherent in their use such as those described below. benzphetamine hydrochloride tablets are indicated for use as monotherapy only. benzphetamine hydrochloride tablets are contraindicated in patients with advanced arteriosclerosis, symptomatic cardiovascular disease,

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

lake erie medical dba quality care products - phentermine hydrochloride (unii: 0k2i505otv) (phentermine - unii:c045tql4wp) - phentermine hydrochloride 37.5 mg - phentermine hydrochloride, usp 37.5 mg is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30 kg/m2 , or≥27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). below is a chart of body mass index (bmi) based on various heights and weights. bmi is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. the limited usefulness of agents of this class, including phentermine hydrochloride, [see clinical pharmacology ( 12.1 , 12.2 ) ] should be measured against possible risk factors inherent in their use such as those described below. •history of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart fail

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

pd-rx pharmaceuticals, inc. - phentermine hydrochloride (unii: 0k2i505otv) (phentermine - unii:c045tql4wp) - phentermine hydrochloride 37.5 mg - phentermine hydrochloride is indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m 2 , or ≥ 27 kg/m 2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). below is a chart of body mass index (bmi) based on various heights and weights. bmi is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. metric conversions are as follows: pounds ÷ 2.2 = kg; inches × 0.0254 = meters. the limited usefulness of agents of this class, including phentermine hydrochloride tablets, [ see clinical pharmacology (12.1, 12.2) ] should be measured against possible risk factors inherent in their use such as those described below. - history of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart fail

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

proficient rx lp - phentermine hydrochloride (unii: 0k2i505otv) (phentermine - unii:c045tql4wp) - phentermine hydrochloride 30 mg - phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m2 , or ≥ 27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). below is a chart of body mass index (bmi) based on various heights and weights. bmi is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. metric conversions are as follows: pounds ÷ 2.2 = kg; inches × 0.0254 = meters. body mass index (bmi), kg/m2 the limited usefulness of agents of this class, including phentermine, [see clinical pharmacology (12.1, 12.2) ] should be measured against possible risk factors inherent in their use such as those described below. teratogenic effects pregnancy category x phentermine is contraindicated during pregnancy because w

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

remedyrepack inc. - fluoxetine hydrochloride (unii: i9w7n6b1kj) (fluoxetine - unii:01k63sup8d) - fluoxetine 40 mg - fluoxetine capsules, usp are indicated for the treatment of: - acute and maintenance treatment of major depressive disorder [see clinical studies ( 14.1)]. - acute and maintenance treatment of obsessions and compulsions in patients with obsessive compulsive disorder (ocd) [see clinical studies ( 14.2)]. - acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe bulimia nervosa [see clinical studies ( 14.3)]. - acute treatment of panic disorder, with or without agoraphobia [see clinical studies ( 14.4)]. fluoxetine capsules, usp and olanzapine in combination is indicated for the treatment of: - acute treatment of depressive episodes associated with bipolar i disorder. - treatment resistant depression (major depressive disorder in patients, who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode). fluoxetine capsules, usp monotherapy is not indicated for the treatment of depressive episodes associ

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

unit dose services - phentermine hydrochloride (unii: 0k2i505otv) (phentermine - unii:c045tql4wp) - phentermine hydrochloride 30 mg - phentermine hydrochloride capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥30 kg/m2, or ≥27 kg/m2 in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia). below is a chart of body mass index (bmi) based on various heights and weights. bmi is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters. body mass index (bmi), kg/m2 the limited usefulness of agents of this class, including phentermine, [see clinical pharmacology (12.1, 12.2)] should be measured against possible risk factors inherent in their use such as those described below. pregnancy category x phentermine is contraindicated during pregnancy because weight loss offers no po

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

bryant ranch prepack - benzphetamine hydrochloride (unii: 43dwt87qt7) (benzphetamine - unii:0m3s43xk27) - benzphetamine hydrochloride 50 mg - hydrochloride tablets are indicated in the management of exogenous obesity as a short term adjunct (a few weeks) in a regimen of weight reduction based on caloric restriction in patients with an initial body mass index (bmi) of 30 kg/m2 or higher who have not responded to appropriate weight reducing regiment (diet and/or exercise) alone. below is a chart of body mass index (bmi) based on various heights and weights. bmi is calculated by taking the patient's weight, in kilograms (kg), divided by the patient's height, in meters (m), squared. metric conversions are as follows: pounds ÷ 2.2 = kg; inches × 0.0254 = meters.. the limited usefulness of agents of this class (see clinical pharmacology) should be weighed against possible risks inherent in their use. benzphetamine hydrochloride tablets are indicated for use as monotherapy only. benzphetamine hydrochloride tablets are contraindicated in patients with advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension