Natco Pharma Limited - search results

natco pharma limited - ondansetron hydrochloride (unii: nmh84ozk2b) (ondansetron - unii:4af302esos) - ondansetron tablets are indicated for the prevention of nausea and vomiting associated with: - highly emetogenic cancer chemotherapy, including cisplatin greater than or equal to 50 mg/m2 . - initial and repeat courses of moderately emetogenic cancer chemotherapy. - radiotherapy in patients receiving either total body irradiation, single high-dose fraction to the abdomen, or daily fractions to the abdomen. ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting. ondansetron tablets are contraindicated in patients: - known to have hypersensitivity (e.g., anaphylaxis) to ondansetron or any of the components of the formulation [see adverse reactions (6.2)]. - receiving concomitant apomorphine due to the risk of profound hypotension and loss of consciousness. risk summary published epidemiological studies on the association between ondansetron use and major birth defects have reported inconsistent findings and have important methodological limitations that preclude

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

letrozole tablet

natco pharma limited - letrozole (unii: 7lkk855w8i) (letrozole - unii:7lkk855w8i) - letrozole tablets are indicated for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer. letrozole tablets are indicated for the extended adjuvant treatment of early breast cancer in postmenopausal women, who have received 5 years of adjuvant tamoxifen therapy. the effectiveness of letrozole tablets in extended adjuvant treatment of early breast cancer is based on an analysis of disease-free survival in patients treated with letrozole tablets for a median of 60 months [see clinical studies (14.2, 14.3)]. letrozole tablets are indicated for first-line treatment of postmenopausal women with hormone receptor positive or unknown, locally advanced or metastatic breast cancer. letrozole tablets are also indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy [see clinical studies (14.4, 14.5)]. - pregnancy: letrozole can cause fetal harm [see use in specific populations (8.1)]. - known hyperse

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

alprazolam tablet

natco pharma usa llc - alprazolam (unii: yu55mq3izy) (alprazolam - unii:yu55mq3izy) - alprazolam tablets are indicated for the: - acute treatment of generalized anxiety disorder (gad) in adults. - treatment of panic disorder (pd), with or without agoraphobia in adults. alprazolam tablets are contraindicated in patients: - with known hypersensitivity to alprazolam or other benzodiazepines. angioedema has been reported [see adverse reactions (6.2)]. - taking strong cytochrome p450 3a (cyp3a) inhibitors (e.g., ketoconazole, itraconazole), except ritonavir [see dosage and administration (2.6), warnings and precautions (5.5), drug interactions (7.1)] pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to psychiatric medications, including alprazolam tablets, during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for psychiatric medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/. risk summary