FLUOXETINE capsule Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

fluoxetine capsule

heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc. - fluoxetine hydrochloride (unii: i9w7n6b1kj) (fluoxetine - unii:01k63sup8d) - fluoxetine 10 mg - fluoxetine capsules 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 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 monotherapy is not indicated for the treatment of depressive episodes associated with bipolar i disorder or the treatment of treatment resistant depression. when using fluoxetine and olanzapine in combination, also refer to the clinical studies section of the package insert for symbyax® . when using fluoxetine and olanzapine in combination, also refer to the contraindications section of the package insert for symbyax. the use of maois intended to treat psychiatric disorders with fluoxetine or within 5 weeks of stopping treatment with fluoxetine is contraindicated because of an increased risk of serotonin syndrome. the use of fluoxetine within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [see dosage and administration (2.9) and warnings and precautions (5.2) ]. starting fluoxetine 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 (2.10) and warnings and precautions (5.2) ]. the use of fluoxetine is contraindicated with the following: - pimozide [seewarnings and precautions (5.11) and drug interactions (7.7, 7.8) ] - thioridazine [see warnings and precautions (5.11) and drug interactions (7.7, 7.8) ] pimozide and thioridazine prolong the qt interval. fluoxetine can increase the levels of pimozide and thioridazine through inhibition of cyp2d6. fluoxetine can also prolong the qt interval. when using fluoxetine and olanzapine in combination, also refer to the use in specific populations section of the package insert for symbyax. 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 (5.7) and clinical considerations ]. available data from published epidemiologic studies and postmarketing reports over several decades have not established an increased risk of major birth defects or miscarriage. some studies have reported an increased incidence of cardiovascular malformations; however, these studies results do not establish a causal relationship (see data ). there are risks associated with untreated depression in pregnancy and risks of persistent pulmonary hypertension of the newborn (pphn) (see data ) and poor neonatal adaptation with exposure to selective serotonin reuptake inhibitors (ssris), including fluoxetine, during pregnancy (see clinical considerations ). in rats and rabbits treated with fluoxetine during the period of organogenesis, there was no evidence of developmental effects at doses up to 1.6 and 3.9 times, respectively, the maximum recommended human dose (mrhd) of 60 mg/day given to adolescents on a mg/m2 basis. however, in other reproductive studies in rats, an increase in stillborn pups, a decrease in pup weight, and an increase in pup deaths early after birth occurred at doses that are 1.5 times (during gestation) and 0.97 time (during gestation and lactation) the mrhd given to adolescents on a mg/m2 basis. 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. 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 fluoxetine in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see warnings and precautions (5.7)]. fetal/neonatal adverse reactions neonates exposed to fluoxetine and other ssri 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, tremors, jitteriness, irritability, and constant crying. these findings 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 - it has been shown that ssris (including fluoxetine) can cross the placenta. published epidemiological studies of pregnant women exposed to fluoxetine have not established an increased risk of major birth defects, miscarriage, and other adverse developmental outcomes. several publications reported an increased incidence of cardiovascular malformations in children with in utero exposure to fluoxetine. however, these studies results do not establish a causal relationship. methodologic limitations of these observational studies include possible exposure and outcome misclassification, lack of adequate controls, adjustment for confounders and confirmatory studies. however, these studies cannot definitely establish or exclude any drug-associated risk during pregnancy. exposure to ssris, particularly later in pregnancy, may have an increased risk for 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 - in embryofetal development studies in rats and rabbits, there was no evidence of malformations or developmental variations following administration of fluoxetine at doses up to 12.5 and 15 mg/kg/day, respectively (1.6 and 3.9 times, respectively, the mrhd of 60 mg given to adolescents on a mg/m2 basis) throughout organogenesis. however, in rat reproduction studies, an increase in stillborn pups, a decrease in pup weight, and an increase in pup deaths during the first 7 days postpartum occurred following maternal exposure to 12 mg/kg/day (1.5 times the mrhd given to adolescents on a mg/m2 basis) during gestation or 7.5 mg/kg/day (0.97 time the mrhd given to adolescents on a mg/m2 basis) during gestation and lactation. there was no evidence of developmental neurotoxicity in the surviving offspring of rats treated with 12 mg/kg/day during gestation. the no-effect dose for rat pup mortality was 5 mg/kg/day (0.65 time the mrhd given to adolescents on a mg/m2 basis). risk summary data from published literature report the presence of fluoxetine and norfluoxetine in human milk (see data ). there are reports of agitation, irritability, poor feeding, and poor weight gain in infants exposed to fluoxetine through breast milk (see clinical considerations ). there are no data on the effect of fluoxetine or its metabolites on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for fluoxetine and any potential adverse effects on the breastfed child from fluoxetine or the underlying maternal condition. clinical considerations infants exposed to fluoxetine should be monitored for agitation, irritability, poor feeding, and poor weight gain. data a study of 19 nursing mothers on fluoxetine with daily doses of 10 to 60 mg showed that fluoxetine was detectable in 30% of nursing infant sera (range: 1 to 84 ng/ml) whereas norfluoxetine was found in 85% (range: <1 to 265 ng/ml). use of fluoxetine in children - the efficacy of fluoxetine for the treatment of major depressive disorder was demonstrated in two 8- to 9-week placebo-controlled clinical trials with 315 pediatric outpatients ages 8 to ≤18 [see clinical studies (14.1) ]. the efficacy of fluoxetine for the treatment of ocd was demonstrated in one 13-week placebo-controlled clinical trial with 103 pediatric outpatients ages 7 to <18 [see clinical studies (14.2) ]. the safety and effectiveness in pediatric patients <8 years of age in major depressive disorder and <7 years of age in ocd have not been established. fluoxetine pharmacokinetics were evaluated in 21 pediatric patients (ages 6 to ≤18) with major depressive disorder or ocd [see clinical pharmacology (12.3) ]. the acute adverse reaction profiles observed in the 3 studies (n=418 randomized; 228 fluoxetine-treated, 190 placebo-treated) were generally similar to that observed in adult studies with fluoxetine. the longer-term adverse reaction profile observed in the 19-week major depressive disorder study (n=219 randomized; 109 fluoxetine-treated, 110 placebo-treated) was also similar to that observed in adult trials with fluoxetine [see adverse reactions (6.1) ]. manic reaction, including mania and hypomania, was reported in 6 (1 mania, 5 hypomania) out of 228 (2.6%) fluoxetine-treated patients and in 0 out of 190 (0%) placebo-treated patients. mania/hypomania led to the discontinuation of 4 (1.8%) fluoxetine-treated patients from the acute phases of the 3 studies combined. consequently, regular monitoring for the occurrence of mania/hypomania is recommended. as with other ssris, decreased weight gain has been observed in association with the use of fluoxetine in children and adolescent patients. after 19 weeks of treatment in a clinical trial, pediatric subjects treated with fluoxetine gained an average of 1.1 cm less in height and 1.1 kg less in weight than subjects treated with placebo. in addition, fluoxetine treatment was associated with a decrease in alkaline phosphatase levels. the safety of fluoxetine treatment for pediatric patients has not been systematically assessed for chronic treatment longer than several months in duration. in particular, there are no studies that directly evaluate the longer-term effects of fluoxetine on the growth, development and maturation of children and adolescent patients. therefore, height and weight should be monitored periodically in pediatric patients receiving fluoxetine [see warnings and precautions (5.6) ]. fluoxetine is approved for use in pediatric patients with mdd and ocd [see box warning and warnings and precautions (5.1) ]. anyone considering the use of fluoxetine in a child or adolescent must balance the potential risks with the clinical need. animal data - significant toxicity on muscle tissue, neurobehavior, reproductive organs, and bone development has been observed following exposure of juvenile rats to fluoxetine from weaning through maturity. oral administration of fluoxetine to rats from weaning postnatal day 21 through adulthood day 90 at 3, 10, or 30 mg/kg/day was associated with testicular degeneration and necrosis, epididymal vacuolation and hypospermia (at 30 mg/kg/day corresponding to plasma exposures [auc] approximately 5 to 10 times the average auc in pediatric patients at the mrhd of 20 mg/day), increased serum levels of creatine kinase (at auc as low as 1 to 2 times the average auc in pediatric patients at the mrhd of 20 mg/day), skeletal muscle degeneration and necrosis, decreased femur length/growth and body weight gain (at auc 5 to 10 times the average auc in pediatric patients at the mrhd of 20 mg/day). the high dose of 30 mg/kg/day exceeded a maximum tolerated dose. when animals were evaluated after a drug-free period (up to 11 weeks after cessation of dosing), fluoxetine was associated with neurobehavioral abnormalities (decreased reactivity at auc as low as approximately 0.1 to 0.2 times the average auc in pediatric patients at the mrhd and learning deficit at the high dose), and reproductive functional impairment (decreased mating at all doses and impaired fertility at the high dose). in addition, the testicular and epididymal microscopic lesions and decreased sperm concentrations found in high dose group were also observed, indicating that the drug effects on reproductive organs are irreversible. the reversibility of fluoxetine-induced muscle damage was not assessed. these fluoxetine toxicities in juvenile rats have not been observed in adult animals. plasma exposures (auc) to fluoxetine in juvenile rats receiving 3, 10, or 30 mg/kg/day doses in this study are approximately 0.1 to 0.2, 1 to 2, and 5 to 10 times, respectively, the average exposure in pediatric patients receiving the mrhd of 20 mg/day. rat exposures to the major metabolite, norfluoxetine, are approximately 0.3 to 0.8, 1 to 8, and 3 to 20 times, respectively, the pediatric exposure at the mrhd. a specific effect on bone development was reported in juvenile mice administered fluoxetine by the intraperitoneal route to 4 week old mice for 4 weeks at doses 0.5 and 2 times the oral mrhd of 20 mg/day on mg/m2 basis. there was a decrease in bone mineralization and density at both doses, but the overall growth (body weight gain or femur length) was not affected. use of fluoxetine in combination with olanzapine in children and adolescents: safety and efficacy of fluoxetine and olanzapine in combination in patients 10 to 17 years of age have been established for the acute treatment of depressive episodes associated with bipolar i disorder. safety and effectiveness of fluoxetine and olanzapine in combination in patients less than 10 years of age have not been established. us fluoxetine clinical trials included 687 patients ≥65 years of age and 93 patients ≥75 years of age. the efficacy in geriatric patients has been established [see clinical studies (14.1) ]. for pharmacokinetic information in geriatric patients, [see clinical pharmacology (12.4) ]. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. snris and ssris, including fluoxetine, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction [see warnings and precautions (5.9) ]. clinical studies of olanzapine and fluoxetine in combination did not include sufficient numbers of patients ≥65 years of age to determine whether they respond differently from younger patients. in subjects with cirrhosis of the liver, the clearances of fluoxetine and its active metabolite, norfluoxetine, were decreased, thus increasing the elimination half-lives of these substances. a lower or less frequent dose of fluoxetine should be used in patients with cirrhosis. caution is advised when using fluoxetine in patients with diseases or conditions that could affect its metabolism [see dosage and administration (2.7) and clinical pharmacology (12.4) ]. fluoxetine has not been systematically studied, in animals or humans, for its potential for abuse, tolerance, or physical dependence. while the premarketing clinical experience with fluoxetine did not reveal any tendency for a withdrawal syndrome or any drug seeking behavior, these observations were not systematic and it is not possible to predict on the basis of this limited experience the extent to which a cns active drug will be misused, diverted, and/or abused once marketed. consequently, healthcare providers should carefully evaluate patients for history of drug abuse and follow such patients closely, observing them for signs of misuse or abuse of fluoxetine (e.g., development of tolerance, incrementation of dose, drug-seeking behavior).

METOCLOPRAMIDE- metoclopramide hydrochloride injection Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

metoclopramide- metoclopramide hydrochloride injection

heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc. - metoclopramide hydrochloride (unii: w1792a2rvd) (metoclopramide - unii:l4yeb44i46) - metoclopramide 5 mg in 1 ml - diabetic gastroparesis (diabetic gastric stasis) metoclopramide injection, usp (metoclopramide hydrochloride, usp) is indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis. the prevention of nausea and vomiting associated with emetogenic cancer chemotherapy metoclopramide injection, usp is indicated for the prophylaxis of vomiting associated with emetogenic cancer chemotherapy. the prevention of postoperative nausea and vomiting metoclopramide injection, usp is indicated for the prophylaxis of postoperative nausea and vomiting in those circumstances where nasogastric suction is undesirable. small bowel intubation metoclopramide injection, usp may be used to facilitate small bowel intubation in adults and pediatric patients in whom the tube does not pass the pylorus with conventional maneuvers. radiological examination metoclopramide injection, usp may be used to stimulate gastric emptying and intestinal transit of barium in cases where delayed emptying interferes with radiological examination of the stomach and/or small intestine. metoclopramide should not be used whenever stimulation of gastrointestinal motility might be dangerous, e.g., in the presence of gastrointestinal hemorrhage, mechanical obstruction, or perforation. metoclopramide is contraindicated in patients with pheochromocytoma because the drug may cause a hypertensive crisis, probably due to release of catecholamines from the tumor. such hypertensive crises may be controlled by phentolamine. metoclopramide is contraindicated in patients with known sensitivity or intolerance to the drug. metoclopramide should not be used in epileptics or patients receiving other drugs which are likely to cause extrapyramidal reactions, since the frequency and severity of seizures or extrapyramidal reactions may be increased.

MAYNE PHARMA DOXYCYCLINE doxycycline 100mg capsules Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

mayne pharma doxycycline doxycycline 100mg capsules

mayne pharma international pty ltd - doxycycline hyclate, quantity: 116.3 mg (equivalent: doxycycline, qty 100 mg) - capsule, modified release - excipient ingredients: microcrystalline cellulose; purified water; hypromellose phthalate; povidone; diethyl phthalate; magnesium stearate; wheat starch; hypromellose; lactose monohydrate; hyprolose; gelatin; ethanol; shellac; pharmaceutical glaze; carbon black - doxycycline is primarily bacteriostatic and is thought to exert its antimicrobial effect by the inhibition of protein synthesis. doxycycline is active against a wide range of gram-positive and gram-negative organisms. note: the 50 mg capsule is not a paediatric formulation. mayne pharma doxycycline capsules are indicated in the treatment of infections caused by the following micro-organisms: mycoplasma pneumoniae: primary atypical pneumonia. rickettsiae: queensland tick typhus, typhus fever and q fever. agents of psittacosis. calymmatobacterium (donovania) granulomitis: granuloma inguinale. agents of lymphogranuloma venereum. borreliae: relapsing fever. chlamydia trachomatis. mayne pharma doxycycline capsules are indicated in the treatment of trachoma, although the infectious agent is not always eliminated, as judged by immunofluorescence. inclusion conjunctivitis may be treated with oral doxycycline capsules alone, or in combination with topical agents. mayne pharma doxycycline is indicated in the treatment of infections caused by the following gram-negative micro-organisms: vibrio species: cholera. brucella species: brucellosis (in conjunction with streptomycin). yersinia pestis: plague. francisella tularensis: tularemia. bartonella bacilliformis: bartonellosis. bacteroides species. when penicillin is contraindicated, doxycycline is an alternative drug in the treatment of infections due to: treponema pallidum: syphilis. treponema pertenue: yaws. neisseria gonorrhoea: gonorrhoea (see dosage and administration). mayne pharma doxycycline capsules is not the drug of choice in the treatment of any type of staphylococcal infection or infections caused by streptococcus pneumoniae, haemophilus influenzae, streptococcus pyogenes, streptococcus faecalis, or any type of enteric bacteria because many strains of these organisms have been shown to be resistant to doxycycline. doxycycline should not be used in these infections unless the organism has been shown to be sensitive. for upper respiratory tract infections due to group a beta-haemolytic streptococci (including prophylaxis of rheumatic fever) penicillin is the usual drug of choice. doxycycline is active against both pre-erythroycitic and asexual bloodstages of plasmodium falciparum. the tetracyclines are only partially active against the pre-erythrocytic stages of plasmodium vivax and protection depends on drug suppression of the blood stages. doxycycline has no activity against the relapsing forms (hypnozoites) of plasmodium vivax. doxycycline is indicated, in adults and children older than 10 years, as chemoprophylaxis for malaria caused by plasmodium falciparum and, in combination with other antimalarial agents, against malaria caused by plasmodium vivax. doxycycline is only able to suppress malaria caused by p. vivax. as there are relatively few locations where p. vivax does not co-exist to some extent with p. falciparum, it is recommended that doxycycline should be used routinely with other agents, for example chloroquine. in acute intestinal amoebiasis mayne pharma doxycycline capsules may be a useful adjunct to amoebicides. in severe acne mayne pharma doxycycline capsules may be a useful adjunctive therapy.

MAYNE PHARMA DOXYCYCLINE doxycycline 50mg capsules Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

mayne pharma doxycycline doxycycline 50mg capsules

mayne pharma international pty ltd - doxycycline hyclate, quantity: 58.15 mg (equivalent: doxycycline, qty 50 mg) - capsule, modified release - excipient ingredients: lactose monohydrate; microcrystalline cellulose; magnesium stearate; hypromellose phthalate; hypromellose; hyprolose; povidone; wheat starch; diethyl phthalate; purified water; gelatin; ethanol; shellac; pharmaceutical glaze; carbon black - doxycycline is primarily bacteriostatic and is thought to exert its antimicrobial effect by the inhibition of protein synthesis. doxycycline is active against a wide range of gram-positive and gram-negative organisms. note: the 50 mg capsule is not a paediatric formulation. mayne pharma doxycycline capsules are indicated in the treatment of infections caused by the following micro-organisms: mycoplasma pneumoniae: primary atypical pneumonia. rickettsiae: queensland tick typhus, typhus fever and q fever. agents of psittacosis. calymmatobacterium (donovania) granulomitis: granuloma inguinale. agents of lymphogranuloma venereum. borreliae: relapsing fever. chlamydia trachomatis. mayne pharma doxycycline capsules are indicated in the treatment of trachoma, although the infectious agent is not always eliminated, as judged by immunofluorescence. inclusion conjunctivitis may be treated with oral doxycycline capsules alone, or in combination with topical agents. mayne pharma doxycycline is indicated in the treatment of infections caused by the following gram-negative micro-organisms: vibrio species: cholera. brucella species: brucellosis (in conjunction with streptomycin). yersinia pestis: plague. francisella tularensis: tularemia. bartonella bacilliformis: bartonellosis. bacteroides species. when penicillin is contraindicated, doxycycline is an alternative drug in the treatment of infections due to: treponema pallidum: syphilis. treponema pertenue: yaws. neisseria gonorrhoea: gonorrhoea (see dosage and administration). mayne pharma doxycycline capsules is not the drug of choice in the treatment of any type of staphylococcal infection or infections caused by streptococcus pneumoniae, haemophilus influenzae, streptococcus pyogenes, streptococcus faecalis, or any type of enteric bacteria because many strains of these organisms have been shown to be resistant to doxycycline. doxycycline should not be used in these infections unless the organism has been shown to be sensitive. for upper respiratory tract infections due to group a beta-haemolytic streptococci (including prophylaxis of rheumatic fever) penicillin is the usual drug of choice. doxycycline is active against both pre-erythroycitic and asexual bloodstages of plasmodium falciparum. the tetracyclines are only partially active against the pre-erythrocytic stages of plasmodium vivax and protection depends on drug suppression of the blood stages. doxycycline has no activity against the relapsing forms (hypnozoites) of plasmodium vivax. doxycycline is indicated, in adults and children older than 10 years, as chemoprophylaxis for malaria caused by plasmodium falciparum and, in combination with other antimalarial agents, against malaria caused by plasmodium vivax. doxycycline is only able to suppress malaria caused by p. vivax. as there are relatively few locations where p. vivax does not co-exist to some extent with p. falciparum, it is recommended that doxycycline should be used routinely with other agents, for example chloroquine. in acute intestinal amoebiasis manye pharma doxycycline capsules may be a useful adjunct to amoebicides. in severe acne mayne pharma doxycycline capsules may be a useful adjunctive therapy

Tadalafil Aristo Pharma 5mg film-coated tablets Մալթա - անգլերեն - Medicines Authority

tadalafil aristo pharma 5mg film-coated tablets

aristo pharma gmbh wallenroder straße 8–10, 13435, berlin, germany - tadalafil - film-coated tablet - tadalafil 5 mg - urologicals

Tadalafil Aristo Pharma 10mg film-coated tablets Մալթա - անգլերեն - Medicines Authority

tadalafil aristo pharma 10mg film-coated tablets

aristo pharma gmbh wallenroder straße 8–10, 13435, berlin, germany - tadalafil - film-coated tablet - tadalafil 10 mg - urologicals

Tadalafil Aristo Pharma 20mg film-coated tablets Մալթա - անգլերեն - Medicines Authority

tadalafil aristo pharma 20mg film-coated tablets

aristo pharma gmbh wallenroder straße 8–10, 13435, berlin, germany - tadalafil - film-coated tablet - tadalafil 20 mg - urologicals

KETOCONAZOLE tablet Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

ketoconazole tablet

strides pharma science limited - ketoconazole (unii: r9400w927i) (ketoconazole - unii:r9400w927i) - 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. drug interactions 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 s