USA - engelska - NLM (National Library of Medicine)

cardinal health - lamotrigine (unii: u3h27498ks) (lamotrigine - unii:u3h27498ks) - lamotrigine tablets, usp are indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older: lamotrigine tablets are indicated for conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (aed). safety and effectiveness of lamotrigine tablets has not been established (1) as initial monotherapy; (2) for conversion to monotherapy from aeds other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from two or more concomitant aeds. lamotrigine tablets, usp are indicated for the maintenance treatment of bipolar i disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy lamotrigine tablets, usp are indicated for the maintenance treatment

USA - engelska - NLM (National Library of Medicine)

cardinal health - paroxetine hydrochloride hemihydrate (unii: x2els050d8) (paroxetine - unii:41vrh5220h) - paroxetine tablets, usp are indicated for the treatment of major depressive disorder. the efficacy of paroxetine tablets, usp in the treatment of a major depressive episode was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the dsm-iii category of major depressive disorder (see clinical pharmacology - 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 effects of paroxetine tablets, usp in hospitalized depressed patients have not been adequately studied. the e

USA - engelska - NLM (National Library of Medicine)

cardinal health - trazodone hydrochloride (unii: 6e8zo8lrnm) (trazodone - unii:ybk48bxk30) - trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (mdd) in adults. trazodone hydrochloride tablets are contraindicated in: pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for antidepressants at 1-844-405- 6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/ risk summary published prospective cohort studies, case series, and case reports over several decades with trazodone use in pregnant women have not identified any drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data). trazodone hydrochloride has been shown to cause increased fetal resorption and other adverse effects on the fetus in the rat when given at dose levels approximately 7.3 to 11

USA - engelska - NLM (National Library of Medicine)

cardinal health 107, llc - amitriptyline hydrochloride (unii: 26lud4jo9k) (amitriptyline - unii:1806d8d52k) - for the relief of symptoms of depression. endogenous depression is more likely to be alleviated than are other depressive states. amitriptyline hydrochloride is contraindicated in patients who have shown prior hypersensitivity to it. it should not be given concomitantly with monoamine oxidase inhibitors. hyperpyretic crises, severe convulsions, and deaths have occurred in patients receiving tricyclic antidepressant and monoamine oxidase inhibiting drugs simultaneously. when it is desired to replace a monoamine oxidase inhibitor with amitriptyline hydrochloride, a minimum of 14 days should be allowed to elapse after the former is discontinued. amitriptyline hydrochloride should then be initiated cautiously with gradual increase in dosage until optimum response is achieved. amitriptyline hydrochloride should not be given with cisapride due to the potential for increased qt interval and increased risk for arrhythmia. this drug is not recommended for use during the acute recovery phase following myocardial infarc

USA - engelska - NLM (National Library of Medicine)

cardinal health 107, llc - paroxetine hydrochloride anhydrous (unii: 3i3t11ud2s) (paroxetine - unii:41vrh5220h) - paroxetine tablets are indicated for the treatment of major depressive disorder. the efficacy of paroxetine in the treatment of a major depressive episode was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the dsm-iii category of major depressive disorder (see clinical pharmacology, 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 effects of paroxetine in hospitalized depressed patients have not been adequately studied. the efficacy of paroxetine in maintaining a

USA - engelska - NLM (National Library of Medicine)

cardinal health - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine tablets usp are indicated for the treatment of schizophrenia. the efficacy of quetiapine tablets usp in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). the effectiveness of quetiapine tablets usp for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see clinical studies ( 14.1 )]. quetiapine tablets usp are indicated for the acute treatment of manic episodes associated with bipolar i disorder, both as monotherapy and as an adjunct to lithium or divalproex. efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [see clinical studies ( 14.2 )]. quetiapine tablets usp are indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. efficacy was established in two 8-week monotherapy trials in adult

USA - engelska - NLM (National Library of Medicine)

cardinal health 107, llc - memantine hydrochloride (unii: jy0wd0ua60) (memantine - unii:w8o17sjf3t) - memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the alzheimer’s type. memantine hydrochloride tablets are contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. risk summary there are no adequate data on the developmental risk associated with the use of memantine hydrochloride in pregnant women. adverse developmental effects (decreased body weight, and skeletal ossification) were observed in the offspring of rats administered memantine during pregnancy at doses associated with minimal maternal toxicity. these doses are higher than those used in humans at the maximum recommended daily dose of memantine hydrochloride [see data].    in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data oral administration of memantine (0, 2, 6, or 18 mg/kg/day) to rats during the period of organogenesis resulted in decreased skeletal ossification in fetuses at the highest dose tested. the higher no-effect dose for adverse developmental effects (6 mg/kg) is 3 times the maximum recommended human daily dose (mrhd) of memantine hydrochloride (20 mg) on a body surface area (mg/m2 ) basis. oral administration of memantine to rabbits (0, 3, 10, or 30 mg/kg/day) during the period of organogenesis resulted in no adverse developmental effects. the highest dose tested is approximately 30 times the mrhd of memantine hydrochloride on a mg/m2 basis. in rats, memantine (0, 2, 6, or 18 mg/kg/day) was administered orally prior to and throughout mating and, in females, through the period of organogenesis or continuing throughout lactation to weaning. decreased skeletal ossification in fetuses and decreased body weight in pups were observed at the highest dose tested. the higher no-effect dose for adverse developmental effects (6 mg/kg/day) is 3 times the mrhd of memantine hydrochloride on a mg/m2 basis. oral administration of memantine (0, 2, 6, or 18 mg/kg/day) to rats from late gestation throughout lactation to weaning, resulted in decreased pup weights at the highest dose tested. the higher no-effect dose (6 mg/kg/day) is approximately 3 times the mrhd of memantine hydrochloride on a mg/m2 basis. risk summary there are no data on the presence of memantine in human milk, the effects on the breastfed infant, or the effects of memantine hydrochloride on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for memantine hydrochloride and any potential adverse effects on the breastfed infant from memantine hydrochloride or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established.  memantine failed to demonstrate efficacy in two 12-week controlled clinical studies of 578 pediatric patients aged 6-12 years with autism spectrum disorders (asd), including autism, asperger’s disorder and pervasive development disorder - not otherwise specified (pdd-nos). memantine has not been studied in pediatric patients under 6 years of age or over 12 years of age. memantine treatment was initiated at 3 mg/day and the dose was escalated to the target dose (weight-based) by week 6. oral doses of memantine 3, 6, 9, or 15 mg extended-release capsules were administered once daily to patients with weights < 20 kg, 20-39 kg, 40-59 kg and ≥ 60 kg, respectively. in a randomized, 12-week double-blind, placebo-controlled parallel study (study a) in patients with autism, there was no statistically significant difference in the social responsiveness scale (srs) total raw score between patients randomized to memantine (n=54) and those randomized to placebo (n=53). in a 12-week responder-enriched randomized withdrawal study (study b) in 471 patients with asd, there was no statistically significant difference in the loss of therapeutic response rates between patients randomized to remain on full-dose memantine (n=153) and those randomized to switch to placebo (n=158). the overall risk profile of memantine in pediatric patients was generally consistent with the known risk profile in adults [see adverse reactions (6.1)] . in study a, the adverse reactions in the memantine group (n=56) that were reported in at least 5% of patients and at least twice the frequency of the placebo group (n=58) are listed in table 2: adverse reaction memantine n=56 placebo n=58 cough 8.9% 3.4% influenza 7.1% 3.4% rhinorrhea 5.4% 0% agitation 5.4% 1.7% discontinuations due to adverse reactionsa aggression 3.6% 1.7% irritability 1.8% 3.4% a reported adverse reactions leading to discontinuation in more than one patient in either treatment group. the adverse reactions that were reported in at least 5% of patients in the 12-48 week open-label study to identify responders to enroll in study b are listed in table 3: adverse reaction memantine n=903 headache 8.0% nasopharyngitis 6.3% pyrexia 5.8% irritability 5.4% discontinuations due to adverse reactionsa irritability 1.2% aggression 1.0% a  at least 1% incidence of adverse reactions leading to premature discontinuation. in the randomized withdrawal study (study b), the adverse reaction in patients randomized to placebo (n=160) and reported in at least 5% of patients and at twice the frequency of the full-dose memantine treatment group (n=157) was irritability (5.0% vs 2.5%). juvenile animal study in a study in which memantine (0, 15, 30 or 45 mg/kg/day) was orally administered to rats during the juvenile period of development (postnatal days [pnd] 14 through 70), delays in sexual maturation were noted in males and females at all but the lowest dose tested, and body weight was reduced at the high dose. in rats orally administered memantine as a single dose (pnd 14) or three daily doses (pnd 14-16), neuronal lesions were observed in several areas of the brain at all but the lowest dose tested. adverse neurobehavioral effects (decreased auditory startle habituation) were observed at the high dose. the no-effect dose for developmental toxicity was the lowest dose tested (15 mg/kg/day). in a second juvenile animal study, memantine (0, 1, 3, 8, 15, 30, and 45 mg/kg/day) was orally administered to male and female rats beginning on pnd 7 and continuing for various periods during postnatal development. because of early memantine-related mortality, the 30 and 45 mg/kg/day groups were terminated without further evaluation. apoptosis or neuronal degeneration in the brain was observed on pnds 8-17 at a dose of 15 mg/kg/day. the no-effect dose for apoptosis and neuronal degeneration was 8 mg/kg/day. in animals in which memantine (0, 1, 3, 8, or 15 mg/kg/day) was orally administered on pnds 7-70, adverse neurobehavioral effects (increased locomotor motor activity, increased auditory startle response and decreased habituation, and deficit in learning and memory) were observed at all but the lowest dose tested. effects on auditory startle persisted after drug discontinuation. the no-effect dose for developmental toxicity was the lowest dose tested (1 mg/kg/day). the majority of people with alzheimer’s disease are 65 years and older. in the clinical studies of memantine hydrochloride the mean age of patients was approximately 76; over 90% of patients were 65 years and older, 60% were 75 years and older, and 12% were at or above 85 years of age. the efficacy and safety data presented in the clinical trial sections were obtained from these patients. there were no clinically meaningful differences in most adverse events reported by patient groups ≥65 years old and <65 years old. no dosage adjustment is needed in patients with mild or moderate renal impairment. a dosage reduction is recommended in patients with severe renal impairment [see dosage and administration (2) and clinical pharmacology (12.3)] .  no dosage adjustment is needed in patients with mild or moderate hepatic impairment. memantine hydrochloride should be administered with caution to patients with severe hepatic impairment [see dosage and administration (2) and clinical pharmacology (12.3)] .

USA - engelska - NLM (National Library of Medicine)

cardinal health - amiodarone hydrochloride (unii: 976728sy6z) (amiodarone - unii:n3rq532iut) - amiodarone hydrochloride 200 mg - because of its life-threatening side effects and the substantial management difficulties associated with its use (see "warnings" below), pacerone® (amiodarone hcl) tablets are indicated only for the treatment of the following documented, life-threatening recurrent ventricular arrhythmias when these have not responded to documented adequate doses of other available antiarrhythmics or when alternative agents could not be tolerated. as is the case for other antiarrhythmic agents, there is no evidence from controlled trials that the use of amiodarone hcl tablets favorably affects survival. pacerone® (amiodarone hcl) tablets should be used only by physicians familiar with and with access to (directly or through referral) the use of all available modalities for treating recurrent life-threatening ventricular arrhythmias, and who have access to appropriate monitoring facilities, including in-hospital and ambulatory continuous electrocardiographic monitoring and electrophysiologic techniques. because of the life-t

USA - engelska - NLM (National Library of Medicine)

cardinal health 107, llc - ibuprofen (unii: wk2xyi10qm) (ibuprofen - unii:wk2xyi10qm) - ibuprofen 400 mg - carefully consider the potential benefits and risks of ibuprofentablets and other treatment options before deciding to use ibuprofen.use the lowest effective dose for the shortest duration consistent withindividual patient treatment goals (see warnings ). ibu tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. ibu tablets are indicated for relief of mild to moderate pain. ibu tablets are also indicated for the treatment of primary dysmenorrhea. controlled clinical trials to establish the safety and effectiveness of ibu tablets in children have not been conducted. ibu tablets are contraindicated in patients with known hypersensitivityto ibuprofen. ibu tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin orother nsaids. severe, rarely fatal, anaphylactic-like reactions to nsaids have been reported in such patients (see warnings, anaphylactoid reactions, and precautions, preexisting asthm

USA - engelska - NLM (National Library of Medicine)

cardinal health 107, llc - vilazodone hydrochloride (unii: u8htx2gk8j) (vilazodone - unii:s239o2oov3) - vilazodone hydrochloride 20 mg - viibryd®  is indicated for the treatment of major depressive disorder (mdd) in adults [see clinical studies (14)]. viibryd is contraindicated in: pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/. risk summary there are no adequate and well-controlled studies of viibryd in pregnant women. the background risk of major birth defects and miscarriage for the indicated population is unknown. however, the background risk in the u.s. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies. in animal reproduction studies, oral administration of vilazodone during the period of organogenesis at doses u