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

nucare pharmaceuticals,inc. - fluvoxamine maleate (unii: 5lgn83g74v) (fluvoxamine - unii:o4l1xpo44w) - fluvoxamine maleate tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (ocd), as defined in dsm-iii-r or dsm-iv. the obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. obsessive compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. the efficacy of fluvoxamine maleate tablets was established in four trials in outpatients with ocd: two 10-week trials in adults, one 10-week trial in pediatric patients (ages 8-17), and one maintenance trial in adults [see clinical studies ( 14)] . coadministration coadministration of tizanidine, thioridazine, alosetron, or pimozide with fluvoxamine maleate tablets is cont

India - English - Central Drugs Standard Control Organization

ranbaxy - ramelteon - tab - 8mg - 10

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

apotex corp - fluvoxamine maleate (unii: 5lgn83g74v) (fluvoxamine - unii:o4l1xpo44w) - fluvoxamine maleate 25 mg - fluvoxamine maleate tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (ocd), as defined in dsm-iii-r or dsm-iv. the obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. obsessive compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. the efficacy of fluvoxamine maleate tablets was established in four trials in outpatients with ocd: two 10-week trials in adults, one 10-week trial in pediatric patients (ages 8 to 17), and one maintenance trial in adults [see clinical studies (14)]. coadministration coadministration of tizanidine, thioridazine, alosetron, or pimozide with fluvoxamine maleate tablets is contraindicated [see warnings and precautions (5.4, 5.5, 5.6, 5.7)]. serotonin syndrome and monoamine oxidase inhibitors (maois)   the use of maois intended to treat psychiatric disorders with fluvoxamine maleate tablets or within 14 days of stopping treatment with fluvoxamine maleate tablets is contraindicated because of an increased risk of serotonin syndrome. the use of fluvoxamine maleate tablets within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [see dosage and administration (2.4), warnings and precautions (5.2)]. starting fluvoxamine maleate tablets 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 (2.5), warnings and precautions (5.2)]. 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 based on data from published observational studies, exposure to ssris, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see warnings and precautions (5.10) and clinical considerations]. prolonged experience with fluvoxamine in pregnant women over decades, based on published observational studies, have not identified a clear drug-associated risk of major birth defects or miscarriage (see data). there are risks associated with untreated depression in pregnancy and risks of persistent pulmonary hypertension of the newborn (pphn) and poor neonatal adaptation with exposure to selective serotonin reuptake inhibitors (ssris), including fluvoxamine, during pregnancy (see clinical considerations).   when pregnant rats were treated orally with fluvoxamine throughout the period of organogenesis, increased embryofetal death and increased incidences of fetal eye abnormalities (folded retinas) was observed at doses ≥3 times the maximum recommended human dose (mrhd) of 300 mg/day given to adolescents on a mg/m2 basis. in addition, decreased fetal body weight was seen at a dose 6 times the mrhd given to adolescents on a mg/m2 basis. there were no adverse developmental effects in rabbits treated with fluvoxamine during the period of organogenesis up to a dose 2 times the mrhd given to adolescents on a mg/m2 basis. when fluvoxamine was administered orally to rats during pregnancy and lactation, increased pup mortality at birth was seen at a dose 2 times the mrhd given to adolescents on a mg/m2 basis. in addition, decreases in pup body weight and survival were observed at doses that are ≥0.13 times the mrhd given to adolescents (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 u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.   clinical considerations disease-associated maternal and/or embryo/fetal risk women who discontinue antidepressants during pregnancy are more likely to experience a relapse of major depression than women who continue antidepressants. this finding is from a prospective, longitudinal study that followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum.   maternal adverse reactions use of fluvoxamine maleate tablets in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see warnings and precautions (5.10)] . fetal/neonatal adverse reactions neonates exposed to fluvoxamine maleate tablets and other ssris or snris late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. such complications can arise immediately upon delivery. reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. these features are consistent with either a direct toxic effect of ssris and snris or, possibly, a drug discontinuation syndrome. it should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome [see warnings and precautions (5.2)] .   data human data exposure during late pregnancy to ssris may have an increased risk for persistent pulmonary hypertension of the newborn (pphn). pphn occurs in 1 to 2 per 1,000 live births in the general population and is associated with substantial neonatal morbidity and mortality.   animal data when pregnant rats were given oral doses of fluvoxamine (60, 120, or 240 mg/kg) throughout the period of organogenesis, developmental toxicity in the form of increased embryofetal death and increased incidences of fetal eye abnormalities (folded retinas) was observed at doses of 120 mg/kg or greater (3 times the mrhd of 300 mg/day, given to adolescents on a mg/m2 basis). decreased fetal body weight was seen at the high dose of 240 mg/kg/day (6 times the mrhd given to adolescents on a mg/m2 basis). the no effect dose for developmental toxicity in this study was 60 mg/kg/day (1.6 times the mrhd given to adolescents on a mg/m2 basis).   in a study in which pregnant rabbits were administered doses of up to 40 mg/kg (approximately 2.1 times the mrhd given to adolescents on a mg/m2 basis) during the period of organogenesis, no adverse effects on embryofetal development were observed.   in other reproduction studies in which female rats were dosed orally during pregnancy and lactation (5, 20, 80, or 160 mg/kg), increased pup mortality at birth was seen at doses of 80 mg/kg/day (2 times the mrhd given to adolescents on a mg/m2 basis) or greater and decreases in pup body weight and survival were observed at all doses (low effect dose approximately 0.13 times the mrhd given to adolescents on a mg/m2 basis). data from published literature report the presence of fluvoxamine is in human milk (see data). no adverse effects on the breastfed infant have been reported in most cases of maternal use of fluvoxamine during breastfeeding. however, there are reports of diarrhea, vomiting, decreased sleep, and agitation (see clinical considerations). there are no data on the effect of fluvoxamine on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for fluvoxamine and any potential adverse effects on the breastfed child from fluvoxamine or from the underlying maternal condition.   clinical considerations monitor infants exposed to fluvoxamine through breast milk for diarrhea, vomiting, decreased sleep, and agitation.   data milk drug concentrations ≤ 425 ng/ml were observed following maternal dosing of fluvoxamine 25 mg/day to 300 mg/day in published case reports and case series. infertility animal findings suggest fertility may be impaired while taking fluvoxamine [see nonclinical toxicology (13.1)]. the efficacy of fluvoxamine maleate for the treatment of obsessive compulsive disorder was demonstrated in a 10-week multicenter placebo controlled study with 120 outpatients ages 8 to 17. in addition, 99 of these outpatients continued open-label fluvoxamine maleate treatment for up to another one to three years, equivalent to 94 patient years. the adverse event profile observed in that study was generally similar to that observed in adult studies with fluvoxamine [ see adverse reactions (6.3), dosage and administration (2.2)]. decreased appetite and weight loss have been observed in association with the use of fluvoxamine as well as other ssris. consequently, regular monitoring of weight and growth is recommended if treatment of a child with an ssri is to be continued long term.   the risks, if any, that may be associated with fluvoxamine’s extended use in children and adolescents with ocd have not been systematically assessed. the prescriber should be mindful that the evidence relied upon to conclude that fluvoxamine is safe for use in children and adolescents derives from relatively short term clinical studies and from extrapolation of experience gained with adult patients. in particular, there are no studies that directly evaluate the effects of long term fluvoxamine use on the growth, cognitive behavioral development, and maturation of children and adolescents. although there is no affirmative finding to suggest that fluvoxamine possesses a capacity to adversely affect growth, development or maturation, the absence of such findings is not compelling evidence of the absence of the potential of fluvoxamine to have adverse effects in chronic use [see warnings and precautions (5.1)].   safety and effectiveness in the pediatric population other than pediatric patients with ocd have not been established [see boxed warning; warnings and precautions (5.1)] . anyone considering the use of fluvoxamine maleate tablets in a child or adolescent must balance the potential risks with the clinical need. approximately 230 patients participating in controlled premarketing studies with fluvoxamine maleate tablets were 65 years of age or over. no overall differences in safety were observed between these patients and younger patients. other reported clinical experience has not identified differences in response between the elderly and younger patients. however, ssris and snris, including fluvoxamine maleate tablets, have been associated with several cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse event [see warnings and precautions (5.13)] . furthermore, the clearance of fluvoxamine is decreased by about 50% in elderly compared to younger patients [see clinical pharmacology (12.3)], and greater sensitivity of some older individuals also cannot be ruled out. consequently, a lower starting dose should be considered in elderly patients and fluvoxamine maleate tablets should be slowly titrated during initiation of therapy. fluvoxamine maleate tablets are not a controlled substance. the potential for abuse, tolerance and physical dependence with fluvoxamine maleate has been studied in a nonhuman primate model. no evidence of dependency phenomena was found. the discontinuation effects of fluvoxamine maleate tablets were not systematically evaluated in controlled clinical trials. fluvoxamine maleate tablets were not systematically studied in clinical trials for potential for abuse, but there was no indication of drug-seeking behavior in clinical trials. it should be noted, however, that patients at risk for drug dependency were systematically excluded from investigational studies of fluvoxamine maleate. generally, it is not possible to predict on the basis of preclinical or premarketing clinical experience the extent to which a cns active drug will be misused, diverted, and/or abused once marketed. consequently, physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely, observing them for signs of fluvoxamine maleate misuse or abuse (i.e., development of tolerance, incrementation of dose, drug-seeking behavior).

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

ani pharmaceuticals, inc. - fluvoxamine maleate (unii: 5lgn83g74v) (fluvoxamine - unii:o4l1xpo44w) - fluvoxamine maleate 25 mg - fluvoxamine maleate tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (ocd), as defined in dsm-iii-r or dsm-iv. the obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. obsessive compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. the efficacy of fluvoxamine maleate tablets was established in four trials in outpatients with ocd: two 10-week trials in adults, one 10-week trial in pediatric patients (ages 8-17), and one maintenance trial in adults [see clinical studies (14)] . coadministration coadministration of tizanidine, thioridazine, alosetron, or pimozide with fluvoxamine maleate tablets is contraindicated [see warnings and precautions (5.4,

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

aidarex pharmaceuticals llc - fluvoxamine maleate (unii: 5lgn83g74v) (fluvoxamine - unii:o4l1xpo44w) - fluvoxamine maleate 50 mg - fluvoxamine maleate tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive compulsive disorder (ocd), as defined in dsm-iii-r or dsm-iv. the obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. obsessive compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. the efficacy of fluvoxamine maleate tablets was established in four trials in outpatients with ocd: two 10-week trials in adults, one 10-week trial in pediatric patients (ages 8-17), and one maintenance trial in adults. [see clinical studies (14)]. the use of maois intended to treat psychiatric disorders with fluvoxamine maleate tablets or within 14 days of stopping treatment with fluvoxamine maleate tablets is contra

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

bryant ranch prepack - itraconazole (unii: 304nug5gf4) (itraconazole - unii:304nug5gf4) - itraconazole 100 mg

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

eon labs, inc. - itraconazole (unii: 304nug5gf4) (itraconazole - unii:304nug5gf4) - itraconazole 100 mg

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

accord healthcare inc. - itraconazole (unii: 304nug5gf4) (itraconazole - unii:304nug5gf4) - itraconazole 100 mg - itraconazole capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: - blastomycosis, pulmonary and extrapulmonary - histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and - aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin b therapy. specimens for fungal cultures and other relevant laboratory studies (wet mount, histopathology, serology) should be obtained before therapy to isolate and identify causative organisms. therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, antiinfective therapy should be adjusted accordingly. itraconazole capsules are also indicated for the treatment of the following fungal infections in non-immunocompromised patients: - onychomycosis of the toenail, with or without fingernail involvement, due to dermatophytes (tinea unguium), and - onychomycosis of the fingernail due to dermatophytes (tinea unguium). prior to initiating treatment, appropriate nail specimens for laboratory testing (koh preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis. (see clinical pharmacology: special populations, contraindications, warnings, and adverse reactions: post-marketing experience for more information.) analyses were conducted on data from two open-label, non-concurrently controlled studies (n=73 combined) in patients with normal or abnormal immune status. the median dose was 200 mg/day. a response for most signs and symptoms was observed within the first 2 weeks, and all signs and symptoms cleared between 3 and 6 months. results of these two studies demonstrated substantial evidence of the effectiveness of itraconazole for the treatment of blastomycosis compared with the natural history of untreated cases. analyses were conducted on data from two open-label, non-concurrently controlled studies (n=34 combined) in patients with normal or abnormal immune status (not including hiv-infected patients). the median dose was 200 mg/day. a response for most signs and symptoms was observed within the first 2 weeks, and all signs and symptoms cleared between 3 and 12 months. results of these two studies demonstrated substantial evidence of the effectiveness of itraconazole for the treatment of histoplasmosis, compared with the natural history of untreated cases. data from a small number of hiv-infected patients suggested that the response rate of histoplasmosis in hiv-infected patients is similar to that of non-hiv-infected patients. the clinical course of histoplasmosis in hiv-infected patients is more severe and usually requires maintenance therapy to prevent relapse. analyses were conducted on data from an open-label, "single-patient-use" protocol designed to make itraconazole available in the u.s. for patients who either failed or were intolerant of amphotericin b therapy (n=190). the findings were corroborated by two smaller open-label studies (n=31 combined) in the same patient population. most adult patients were treated with a daily dose of 200 to 400 mg, with a median duration of 3 months. results of these studies demonstrated substantial evidence of effectiveness of itraconazole as a second-line therapy for the treatment of aspergillosis compared with the natural history of the disease in patients who either failed or were intolerant of amphotericin b therapy. analyses were conducted on data from three double-blind, placebo-controlled studies (n=214 total; 110 given itraconazole capsules) in which patients with onychomycosis of the toenails received 200 mg of itraconazole capsules once daily for 12 consecutive weeks. results of these studies demonstrated mycologic cure, defined as simultaneous occurrence of negative koh plus negative culture, in 54% of patients. thirty-five percent (35%) of patients were considered an overall success (mycologic cure plus clear or minimal nail involvement with significantly decreased signs) and 14% of patients demonstrated mycologic cure plus clinical cure (clearance of all signs, with or without residual nail deformity). the mean time to overall success was approximately 10 months. twenty-one percent (21%) of the overall success group had a relapse (worsening of the global score or conversion of koh or culture from negative to positive). analyses were conducted on data from a double-blind, placebo-controlled study (n=73 total; 37 given itraconazole capsules) in which patients with onychomycosis of the fingernails received a 1-week course of 200 mg of itraconazole capsules b.i.d., followed by a 3-week period without itraconazole, which was followed by a second 1-week course of 200 mg of itraconazole capsules b.i.d. results demonstrated mycologic cure in 61% of patients. fifty-six percent (56%) of patients were considered an overall success and 47% of patients demonstrated mycologic cure plus clinical cure. the mean time to overall success was approximately 5 months. none of the patients who achieved overall success relapsed. itraconazole capsules should not be administered for the treatment of onychomycosis in patients with evidence of ventricular dysfunction such as congestive heart failure (chf) or a history of chf. (see boxed warning, warnings, precautions: drug interactions-calcium channel blockers, adverse reactions: post-marketing experience, and clinical pharmacology: special populations.) coadministration of a number of cyp3a4 substrates are contraindicated with itraconazole. plasma concentrations increase for the following drugs: levaceytlmethadol (levomethadyl), methadone, disopyramide, dofetilide, dronedarone, quinidine, isavuconazole, ergot alkaloids (such as dihydroergotamine, ergometrine (ergonovine), ergotamine, methylergometrine (methylergonovine)), irinotecan, lurasidone, oral midazolam, pimozide, triazolam, felodipine, nisoldipine, ivabradine, ranolazine, eplerenone, cisapride, naloxegol, lomitapide, lovastatin, simvastatin, avanafil, ticagrelor. in addition, coadministration with colchicine, fesoterodine and solifenacin is contraindicated in subjects with varying degrees of renal or hepatic impairment, and coadministration with eliglustat is contraindicated in subjects that are poor or intermediate metabolizers of cyp2d6 and in subjects taking strong or moderate cyp2d6 inhibitors. (see precautions: drug interactions section for specific examples.) this increase in drug concentrations caused by coadministration with itraconazole may increase or prolong both the pharmacologic effects and/or adverse reactions to these drugs. for example, increased plasma concentrations of some of these drugs can lead to qt prolongation and ventricular tachyarrhythmias including occurrences of torsade de pointes, a potentially fatal arrhythmia. specific examples are listed in precautions: drug interactions. itraconazole should not be administered for the treatment of onychomycosis to pregnant patients or to women contemplating pregnancy. itraconazole is contraindicated for patients who have shown hypersensitivity to itraconazole. there is limited information regarding cross-hypersensitivity between itraconazole and other azole antifungal agents. caution should be used when prescribing itraconazole to patients with hypersensitivity to other azoles.

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

preferred pharmaceuticals, inc. - ketoconazole (unii: r9400w927i) (ketoconazole - unii:r9400w927i) - ketoconazole 200 mg - ketoconazole tablets are not indicated for treatment of onychomycosis, cutaneous dermatophyte infections, or candida infections. ketoconazole tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks. ketoconazole tablets are indicated for the treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. ketoconazole tablets should not be used for fungal meningitis because it penetrates poorly into the cerebrospinal fluid. coadministration of a number of cyp3a4 substrates such as dofetilide, quinidine cisapride and pimozide is contraindicated with ketoconazole tablets. coadministration with ketoconazole can cause elevated plasma concentrations of these drugs and may increase or prolong both therapeutic and adverse effects to such an extent that

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

ascend laboratories, llc - itraconazole (unii: 304nug5gf4) (itraconazole - unii:304nug5gf4) - itraconazole 100 mg - itraconazole capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: 1. blastomycosis, pulmonary and extrapulmonary 2. histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and 3. aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin b therapy. specimens for fungal cultures and other relevant laboratory studies (wet mount, histopathology,serology) should be obtained before therapy to isolate and identify causative organisms. therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, antiinfective therapy should be adjusted accordingly. itraconazole capsules are also indicated for the treatment of the following fungal infections in non-immunocompromised patients: 1. onychomycosis of the toenail, with or without fingernail involveme