Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - mirtazapine (unii: a051q2099q) (mirtazapine - unii:a051q2099q) - mirtazapine tablets are indicated for the treatment of major depressive disorder.   the efficacy of mirtazapine tablets in the treatment of major depressive disorder was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the diagnostic and statistical manual of mental disorders – 3rd edition (dsm-iii) category of major depressive disorder (see clinical pharmacology ).  a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest 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 effectiveness of mirtazapine tablets in

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - mirtazapine (unii: a051q2099q) (mirtazapine - unii:a051q2099q) - mirtazapine tablets are indicated for the treatment of major depressive disorder.   the efficacy of mirtazapine tablets in the treatment of major depressive disorder was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the diagnostic and statistical manual of mental disorders – 3rd edition (dsm-iii) category of major depressive disorder (see clinical pharmacology ).  a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest 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 effectiveness of mirtazapine tablets in

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

remedyrepack inc. - olanzapine (unii: n7u69t4szr) (olanzapine - unii:n7u69t4szr) - oral olanzapine is indicated for the treatment of schizophrenia. efficacy was established in three clinical trials in adult patients with schizophrenia: two 6-week trials and one maintenance trial. in adolescent patients with schizophrenia (ages 13 to 17), efficacy was established in one 6-week trial  [ see clinical studies ( 14.1)].    when deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and dyslipidemia. clinicians should consider the potential long-term risks  when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents [see   warnings and precautions ( 5.5) ].  oral olanzapine is indicated for the acute treatment of manic or mixed episodes associated with bipolar i disorder and maintenance treatment of bipolar i disorder. efficacy was established in three clinical trials in adult patients with manic or mixed e

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

remedyrepack inc. - olanzapine (unii: n7u69t4szr) (olanzapine - unii:n7u69t4szr) - oral zyprexa is indicated for the treatment of schizophrenia. efficacy was established in three clinical trials in adult patients with schizophrenia: two 6-week trials and one maintenance trial. in adolescent patients with schizophrenia (ages 13-17), efficacy was established in one 6-week trial [see clinical studies ( 14.1)] . when deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and dyslipidemia. clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents [see warnings and precautions ( 5.5)] . monotherapy — oral zyprexa is indicated for the acute treatment of manic or mixed episodes associated with bipolar i disorder and maintenance treatment of bipolar i disorder. efficacy was established in three clinical trials in adult patients with manic or mixed episo

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

lannett company, inc. - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - attention deficit disorders (previously known as minimal brain dysfunction in children). other terms being used to describe the behavioral syndrome below include: hyperkinetic child syndrome, minimal brain damage, minimal cerebral dysfunction, minor cerebral dysfunction. metadate er is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. the diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. nonlocalizing (soft) neurological signs, learning disability, and abnormal eeg may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. specific etiology of th

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

lannett company, inc. - methylphenidate hydrochloride (unii: 4b3sc438hi) (methylphenidate - unii:207zz9qz49) - attention deficit disorders (previously known as minimal brain dysfunction in children). other terms being used to describe the behavioral syndrome below include: hyperkinetic child syndrome, minimal brain damage, minimal cerebral dysfunction, minor cerebral dysfunction. methylphenidate hydrochloride is indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. the diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. nonlocalizing (soft) neurological signs, learning disability, and abnormal eeg may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. spec

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

remedyrepack inc. - olanzapine (unii: n7u69t4szr) (olanzapine - unii:n7u69t4szr) - oral olanzapine is indicated for the treatment of schizophrenia. efficacy was established in three clinical trials in adult patients with schizophrenia: two 6-week trials and one maintenance trial. in adolescent patients with schizophrenia (ages 13 to 17), efficacy was established in one 6-week trial  [ see clinical studies ( 14.1)].    when deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and dyslipidemia. clinicians should consider the potential long-term risks  when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents [see   warnings and precautions ( 5.5) ].  oral olanzapine is indicated for the acute treatment of manic or mixed episodes associated with bipolar i disorder and maintenance treatment of bipolar i disorder.

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - mirtazapine (unii: a051q2099q) (mirtazapine - unii:a051q2099q) - mirtazapine tablets, usp are indicated for the treatment of major depressive disorder. the efficacy of mirtazapine tablets, usp in the treatment of major depressive disorder was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the diagnostic and statistical manual of mental disorders - 3 rd edition (dsm-iii) category of major depressive disorder (see clinical pharmacology ). a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least 5 of the following 9 symptoms: depressed mood, loss of interest 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 effectiveness of mirtazapine tablets,

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - ketorolac tromethamine (unii: 4eve5946bq) (ketorolac - unii:yzi5105v0l) - carefully consider the potential benefits and risks of ketorolac tromethamine tablets, usp and other treatment options before deciding to use ketorolac tromethamine tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. ketorolac tromethamine tablets are indicated for the short-term (≤ 5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. therapy should always be initiated with ketorolac tromethamine-iv or im and ketorolac tromethamine tablets are to be used only as continuation treatment, if necessary. the total combined duration of use of ketorolac tromethamine-iv/im and ketorolac tromethamine tablets is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see warnings, precautions, dosage and administration and adverse reactions). patients should be switched to alternat

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

remedyrepack inc. - terbinafine hydrochloride (unii: 012c11zu6g) (terbinafine - unii:g7riw8s0xp) - terbinafine tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). prior to initiating treatment, appropriate nail specimens for laboratory testing [potassium hydroxide (koh) preparation, fungal culture, or nail biopsy] should be obtained to confirm the diagnosis of onychomycosis. terbinafine tablets are contraindicated in patients with: - chronic or active liver disease [see warnings and precautions (5.1)] - history of allergic reaction to oral terbinafine because of the risk of anaphylaxis [see adverse reactions (6.2)] risk summary available data from postmarketing cases on the use of terbinafine tablets in pregnant women are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies, terbinafine did not cause malformations or any harm to the fetus when administered to pregnant rabbits and rats during the period of organogenesis at oral doses up to 12 and 23 times the maximum recommended human dose (mrhd) of 250 mg/day, respectively (see data). all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. the background risk of major birth defects and miscarriage for the indicated population is unknown; however, in the u.s. general population, the estimated background risk of major birth defects is 2%-4% and of miscarriage is 15%-20% of clinically recognized pregnancies. data animal data in embryo-fetal development studies in rats and rabbits, pregnant animals received orally (by gavage) doses of terbinafine up to 300 mg/kg/day, during the period of organogenesis. there were no maternal or embryo-fetal effects in either species up to the maximum dose tested. the 300 mg/kg/day dose level in rats and rabbits corresponds to 23 and 12 times the mrhd [based on body surface area (bsa) comparisons], respectively. in a rat peri- and postnatal development study, terbinafine doses of up to 300 mg/kg/day (12 times the mrhd based on bsa comparisons) given by oral gavage during late pregnancy and lactation (day 15 of gestation to day 20 post-partum) had no adverse effects on parturition and lactation. risk summary after oral administration, terbinafine is present in human milk. however, there are no data on the effects on the breastfed child or on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for terbinafine tablets and any potential adverse effects on the breastfed child from terbinafine tablets or from the underlying maternal condition. the safety and efficacy of terbinafine tablets have not been established in pediatric patients with onychomycosis. clinical studies of terbinafine tablets did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. in patients with renal impairment (creatinine clearance less than or equal to 50 ml/min), the use of terbinafine tablets has not been adequately studied. terbinafine tablets are contraindicated for patients with chronic or active liver disease [see contraindications (4)and warnings and precautions (5.1)] . cases of liver failure, some leading to liver transplant or death, have occurred with the use of terbinafine tablets in individuals with and without preexisting liver disease. the severity of hepatic events and/or their outcome may be worse in patients with active or chronic liver disease.