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lannett company, inc. - paroxetine hydrochloride (unii: x2els050d8) (paroxetine - unii:41vrh5220h) - paroxetine 12.5 mg - paroxetine is indicated in adults for the treatment of: - major depressive disorder (mdd) major depressive disorder (mdd) - panic disorder (pd) panic disorder (pd) - social anxiety disorder (sad) social anxiety disorder (sad) - premenstrual dysphoric disorder (pmdd) premenstrual dysphoric disorder (pmdd) paroxetine is contraindicated in patients: - taking, or within 14 days of stopping, maois (including the maois linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see warnings and precautions (5.2 ), drug interactions ( 7 )] . taking, or within 14 days of stopping, maois (including the maois linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see warnings and precautions (5.2 ), drug interactions ( 7 )] . - taking thioridazine because of risk of qt prolongation [see warnings and precautions ( 5.3 ), drug interactions ( 7 )] . taking thioridazine because of risk of qt prolongation [see warnings and precautions ( 5

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lannett company, inc. - clobazam (unii: 2mro291b4u) (clobazam - unii:2mro291b4u) - clobazam oral suspension is indicated for the adjunctive treatment of seizures associated with lennox-gastaut syndrome (lgs) in patients 2 years of age or older. clobazam is contraindicated in patients with a history of hypersensitivity to the drug or its ingredients. hypersensitivity reactions have included serious dermatological reactions [see warnings and precautions (5.6 )] . pregnancy registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to aeds, such as clobazam, during pregnancy. physicians are advised to recommend that pregnant patients taking clobazam enroll in the north american antiepileptic drug (naaed) pregnancy registry. this can be done by calling the toll-free number 1-888-233-2334, and must be done by patients themselves. information on the registry can also be found at the website http://www.aedpregnancyregistry.org. risk summary there are no adequate and well-controlled studies of clobazam in pregnant women. available data suggest that the class o

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lannett company, inc. - aripiprazole (unii: 82vfr53i78) (aripiprazole - unii:82vfr53i78) - aripiprazole 1 mg in 1 ml - aripiprazole oral solution is indicated for the treatment of: - schizophrenia [see clinical studies (14.1 )] - acute treatment of manic and mixed episodes associated with bipolar i disorder [see clinical studies (14.2 )] - adjunctive treatment of major depressive disorder [see clinical studies (14.3 )] - irritability associated with autistic disorder [see clinical studies (14.4 )] - treatment of tourette’s disorder [see clinical studies (14.5 )] aripiprazole oral solution is contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. reactions have ranged from pruritus/urticaria to anaphylaxis [see adverse reactions (6.2)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including aripiprazole, during pregnancy. healthcare providers are encouraged to register patients by contacting the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 or visit http://wome

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lannett company, inc. - escitalopram oxalate (unii: 5u85dbw7lo) (escitalopram - unii:4o4s742any) - escitalopram 5 mg in 5 ml - escitalopram is indicated for the treatment of: - major depressive disorder (mdd) in adults and pediatric patients 12 years of age and older. - generalized anxiety disorder (gad) in adults and pediatric patients 7 years of age and older. escitalopram is contraindicated in patients: - taking maois with escitalopram or within 14 days of stopping treatment with escitalopram because of an increased risk of serotonin syndrome. the use of escitalopram within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [see dosage and administration ( 2.7 ) and warnings and precautions ( 5.2 ) ]. starting escitalopram in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see dosage and administration ( 2.6 ) and warnings and precautions ( 5.2 ) ]. - taking pimozide [see drug interactions ( 7 ) ]. - with a hypersensitivity to escitalopram or citalopram or any of the inact

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lannett company, inc. - lopinavir (unii: 2494g1jf75) (lopinavir - unii:2494g1jf75), ritonavir (unii: o3j8g9o825) (ritonavir - unii:o3j8g9o825) - lopinavir 80 mg in 1 ml - lopinavir and ritonavir is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients 14 days and older. limitations of use: - genotypic or phenotypic testing and/or treatment history should guide the use of lopinavir and ritonavir. the number of baseline lopinavir resistance-associated substitutions affects the virologic response to lopinavir and ritonavir [see microbiology ( 12.4 )] . genotypic or phenotypic testing and/or treatment history should guide the use of lopinavir and ritonavir. the number of baseline lopinavir resistance-associated substitutions affects the virologic response to lopinavir and ritonavir [see microbiology ( 12.4 )] . - lopinavir and ritonavir is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., toxic epidermal necrolysis, stevens-johnson syndrome, erythema multiforme, urticaria, angioedema) to any of its ingredients, including ritonavir. lopinavir and riton

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lannett company, inc. - febuxostat (unii: 101v0r1n2e) (febuxostat - unii:101v0r1n2e) - febuxostat tablet is a xanthine oxidase (xo) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. limitations of use : febuxostat tablets are not recommended for the treatment of asymptomatic hyperuricemia. febuxostat tablets are contraindicated in patients being treated with azathioprine or mercaptopurine [see drug interactions (7)] . risk summary limited available data with febuxostat tablets use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. no adverse developmental effects were observed in embryo-fetal development studies with oral administration of febuxostat to pregnant rats and rabbits during organogenesis at doses that produced maternal exposures up to 40 and 51 times, respectively, the exposure at the maximum recommended human dose (mrhd). no adverse developmental effects were observed in a pre- and postnatal development study with administration of febuxostat to pregnant rats from organogenesis through lactation at an exposure approximately 11 times the mrhd (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the us general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data in an embryo-fetal development study in pregnant rats dosed during the period of organogenesis from gestation days 7 – 17, febuxostat was not teratogenic and did not affect fetal development or survival at exposures up to approximately 40 times the mrhd (on an auc basis at maternal oral doses up to 48 mg/kg/day). in an embryo-fetal development study in pregnant rabbits dosed during the period of organogenesis from gestation days 6 – 18, febuxostat was not teratogenic and did not affect fetal development at exposures up to approximately 51 times the mrhd (on an auc basis at maternal oral doses up to 48 mg/kg/day). in a pre- and postnatal development study in pregnant female rats dosed orally from gestation day 7 through lactation day 20, febuxostat had no effects on delivery or growth and development of offspring at a dose approximately 11 times the mrhd (on an auc basis at a maternal oral dose of 12 mg/kg/day). however, increased neonatal mortality and a reduction in neonatal body weight gain were observed in the presence of maternal toxicity at a dose approximately 40 times the mrhd (on an auc basis at a maternal oral dose of 48 mg/kg/day). febuxostat crossed the placental barrier following oral administration to pregnant rats and was detected in fetal tissues. risk summary there are no data on the presence of febuxostat in human milk, the effects on the breastfed infant, or the effects on milk production. febuxostat is present in rat milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for febuxostat tablets and any potential adverse effects on the breastfed child from febuxostat tablets or from the underlying maternal condition. data animal data orally administered febuxostat was detected in the milk of lactating rats at up to approximately 7 times the plasma concentration. safety and effectiveness of febuxostat tablets in pediatric patients have not been established. no dose adjustment is necessary in elderly patients. of the total number of patients in studies 1, 2, and 3 (clinical studies of febuxostat tablets in the treatment of gout) [see clinical studies (14.1)] , 16% were 65 and over, while 4% were 75 and over. comparing patients in different age groups, no clinically significant differences in safety or effectiveness were observed but greater sensitivity of some older individuals cannot be ruled out. the c max and auc 24 of febuxostat following multiple oral doses of febuxostat tablets in geriatric patients (≥ 65 years) were similar to those in younger patients (18 to 40 years) [see clinical pharmacology (12.3)]. no dose adjustment is necessary in patients with mild to moderate renal impairment (cl cr 30 to 89 ml/min). for patients with severe renal impairment (cl cr 15 to 29 ml/min), the recommended dosage of febuxostat tablets is limited to 40 mg once daily [see dosage and administration (2.2)and clinical pharmacology (12.3)]. no dose adjustment is necessary in patients with mild or moderate hepatic impairment (child-pugh class a or b). no studies have been conducted in patients with severe hepatic impairment (child-pugh class c); therefore, caution should be exercised in these patients [see clinical pharmacology (12.3)]. no studies have been conducted in patients with secondary hyperuricemia (including organ transplant recipients); febuxostat tablets are not recommended for use in patients whom the rate of urate formation is greatly increased (e.g., malignant disease and its treatment, lesch-nyhan syndrome). the concentration of xanthine in urine could, in rare cases, rise sufficiently to allow deposition in the urinary tract.

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lannett company, inc. - valproic acid (unii: 614oi1z5wi) (valproic acid - unii:614oi1z5wi) - valproic acid is indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. valproic acid is indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types which include absence seizures. simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. complex absence is the term used when other signs are also present. see warnings and precautions (5.1) for statement regarding fatal hepatic dysfunction. because of the risk to the fetus of decreased iq, neurodevelopmental disorders, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be used to treat women with epilepsy or bipolar disorder who

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lannett company, inc. - levothyroxine sodium (unii: 9j765s329g) (levothyroxine - unii:q51bo43mg4) - levothyroxine sodium 0.025 mg - levothyroxine sodium is used for the following indications: hypothyroidism - as replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism. primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, or drugs, with or without the presence of goiter. pituitary tsh suppression - in the treatment or prevention of various types of euthyroid goiters (see warnings and precautions ), including thyroid nodules (see warnings and precautions ), subacute or chronic iymphocytic thyroiditis (hashimoto's thyroiditis), multinodular goiter (see warnings and precautions ), and, as an adjunct to surgery and radioiodine therapy in the managem

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lannett company, inc. - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - 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

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

lannett company, inc. - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - 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