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

zydus lifesciences limited - deferasirox (unii: v8g4mof2v9) (deferasirox - unii:v8g4mof2v9) - deferasirox tablets are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. deferasirox tablets are indicated for the treatment of chronic iron overload in patients 10 years of age and older with non-transfusion-dependent thalassemia (ntdt) syndromes and with a liver iron concentration (lic) of at least 5 milligrams of iron per gram of liver dry weight (mg fe/g dw) and a serum ferritin greater than 300 mcg/l. this indication is approved under accelerated approval based on a reduction of liver iron concentrations (to less than 5 mg fe/g dw) and serum ferritin levels [ see clinical studies (14)] . continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. the safety and efficacy of deferasirox tablets when administered with other iron chelation therapy have not been established. deferasirox tablets are contraindicated in patients with: -   est

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

zydus lifesciences limited - deferasirox (unii: v8g4mof2v9) (deferasirox - unii:v8g4mof2v9) -

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

zydus pharmaceuticals usa inc. - mesalamine (unii: 4q81i59gxc) (mesalamine - unii:4q81i59gxc) - mesalamine 1.2 g - mesalamine delayed-release tablets are indicated for the: - induction and maintenance of remission in adult patients with mildly to moderately active ulcerative colitis. - treatment of mildly to moderately active ulcerative colitis in pediatric patients weighing at least 24 kg. mesalamine delayed-release tablets are contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, or to any of the ingredients of mesalamine delayed-release tablets [see warnings and precautions (5.3), adverse reactions (6.2), description (11) ]. risk summary published data from meta-analyses, cohort studies, and case series on the use of mesalamine during pregnancy have not reliably informed an association with mesalamine and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data). there are adverse effects on maternal and fetal outcomes associated with ulcerative colitis in pregnancy (see clinical considerations). in animal reproduction studies, there were no adv

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

zydus lifesciences limited - pravastatin sodium (unii: 3m8608uq61) (pravastatin - unii:kxo2kt9n0g) - pravastatin sodium 10 mg - therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. in hypercholesterolemic patients without clinically evident coronary heart disease (chd), pravastatin sodium tablet, usp is indicated to: -   reduce the risk of myocardial infarction (mi). -   reduce the risk of undergoing myocardial revascularization procedures. -   reduce the risk of cardiovascular mortality with no increase in death from non-cardiovascular causes. in patients with clinically evident chd, pravastatin sodium tablet is indicated to: -   reduce the risk of total mortality by reducing coronary death. -   reduce the risk of mi. -   reduce the risk of undergoing myocardial revascularization procedures. -  

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

zydus lifesciences limited - ribavirin (unii: 49717awg6k) (ribavirin - unii:49717awg6k) - ribavirin 200 mg - ribavirin tablets in combination with peginterferon alfa-2a are indicated for the treatment of patients 5 years of age and older with chronic hepatitis c (chc) virus infection who have compensated liver disease and have not been previously treated with interferon alpha. the following points should be considered when initiating ribavirin tablets combination therapy with peginterferon alfa-2a: - this indication is based on clinical trials of combination therapy in patients with chc and compensated liver disease, some of whom had histological evidence of cirrhosis (child-pugh class a), and in adult patients with clinically stable hiv disease and cd4 count greater than 100 cells/mm3 . - this indication is based on achieving undetectable hcv rna after treatment for 24 or 48 weeks, based on hcv genotype, and maintaining a sustained virologic response (svr) 24 weeks after the last dose. - safety and efficacy data are not available for treatment longer than 48 weeks. - the safe

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

zydus lifesciences limited - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 25 mg - topiramate tablets and topiramate capsules are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years of age and older. topiramate tablets and topiramate capsules are indicated as adjunctive therapy for  for the treatment of partial-onset seizures,  primary generalized tonic-clonic seizures, and seizures associated with lennox-gastaut syndrome in patients 2 years of age and older. topiramate tablets and topiramate capsules are indicated for the preventive treatment of migraine in patients 12 years of age and older. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to topiramate during pregnancy. patients should be encouraged to enroll in the north american antiepileptic drug (naaed) pregnancy registry if they become pregnant. this registry is collecting information about the safety of antiepileptic drugs during pregnancy. to enroll, patients can call the toll-f

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

zydus pharmaceuticals usa inc. - tramadol hydrochloride (unii: 9n7r477wck) (tramadol - unii:39j1lgj30j) - tramadol hydrochloride 50 mg - tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. l imitations of use because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosages or duration [see warnings and precautions (5.1)] , reserve tramadol hydrochloride for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: - have not been tolerated or are not expected to be tolerated. - have not provided adequate analgesia or are not expected to provide adequate analgesia. tramadol hydrochloride should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate. tramadol hydrochloride tablets are contraindicated for: - all children younger than 12 years of age [see warnings and precautions (5.6)]. - post-operative ma

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

zydus lifesciences limited - ziprasidone hydrochloride (unii: 216x081oru) (ziprasidone - unii:6uka5vej6x) - ziprasidone 20 mg - ziprasidone hydrochloride capsules are indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. when deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone's greater capacity to prolong the qt/qtc interval compared to several other antipsychotic drugs [see warnings and precautions (5.3 )]. prolongation of the qtc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. in many cases this would lead to the conclusion that other drugs should be tried first. whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see warnings and precautions (5.3)] schizophrenia -   ziprasidone is indicated for the

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

zydus lifesciences limited - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 25 mg - topiramate extended-release capsules are indicated as initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 6 years of age and older [see clinical studies (14.2)] . topiramate extended-release capsules are indicated as adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with lennox-gastaut syndrome in patients 6 years of age and older [see clinical studies (14.3)] . topiramate extended-release capsules are indicated for the prophylaxis of migraine headache in patients 12 years of age and older [see clinical studies (14.4)].   topiramate extended-release capsules are contraindicated in patients: -   with recent alcohol use (i.e., within 6 hours prior to and 6 hours after topiramate extended-release capsules use) [see warnings and precautions (5.5)] pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepile

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

zydus lifesciences limited - trazodone hydrochloride (unii: 6e8zo8lrnm) (trazodone - unii:ybk48bxk30) - trazodone hydrochloride 50 mg - trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (mdd) in adults. trazodone hydrochloride tablets are contraindicated in: -   patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (maois), including maois such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see warnings and precautions (5.2), drug interactions (7.1)]. 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 hydrochloride tablets use in pregnant women have not identifi