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

zydus lifesciences limited - piroxicam (unii: 13t4o6vmam) (piroxicam - unii:13t4o6vmam) - piroxicam capsules, usp are indicated: - for relief of the signs and symptoms of osteoarthritis. - for relief of the signs and symptoms of rheumatoid arthritis. piroxicam is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to piroxicam or any components of the drug product [see warnings and precautions (5.7, 5.9)] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [see warnings and precautions (5.7, 5.8)] - in the setting of coronary artery bypass graft (cabg) surgery [see warnings and precautions (5.1 )] pregnancy category c prior to 30 weeks gestation; category d starting at 30 weeks gestation. risk summary use of nsaids, including piroxicam, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. avoid use of nsaids, including

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

zydus lifesciences limited - mesalamine (unii: 4q81i59gxc) (mesalamine - unii:4q81i59gxc) - mesalamine 1.2 g - mesalamine delayed-release tablets are indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis. mesalamine delayed-release tablets are contraindicated in patients with known hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of mesalamine delayed-release tablets [see warnings and precautions (5.3), description (11), adverse reactions (6.2) ]. 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 adverse developmental outcomes with administration of oral mesalamine during organogenesis to

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

zydus lifesciences limited - clopidogrel bisulfate (unii: 08i79htp27) (clopidogrel - unii:a74586sno7) - clopidogrel 75 mg - - clopidogrel tablet is indicated to reduce the rate of myocardial infarction (mi) and stroke in patients with non-st-segment elevation acs (unstable angina [ua]/non-st-elevation myocardial infarction [nstemi]), including patients who are to be managed medically and those who are to be managed with coronary revascularization. clopidogrel tablets should be administered in conjunction with aspirin. - clopidogrel tablet is indicated to reduce the rate of myocardial infarction and stroke in patients with acute st-elevation myocardial infarction (stemi) who are to be managed medically. clopidogrel tablets should be administered in conjunction with aspirin.  in patients with established peripheral arterial disease or with a history of recent myocardial infarction (mi) or recent stroke clopidogrel tablet is indicated to reduce the rate of mi and stroke. clopidogrel bisulfate is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracran

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

zydus lifesciences limited - methotrexate (unii: yl5fz2y5u1) (methotrexate - unii:yl5fz2y5u1) - methotrexate 2.5 mg - methotrexate tablets, usp are indicated in the treatment of gestational choriocarcinoma, chorioadenoma destruens and hydatidiform mole.  methotrexate tablets, usp are used in maintenance therapy in combination with other chemotherapeutic agents. methotrexate  tablets, usp are used alone or in combination with other anticancer agents in the treatment of breast cancer, epidermoid cancers of the head and neck, advanced mycosis fungoides (cutaneous t cell lymphoma), and lung cancer, particularly squamous cell and small cell types. methotrexate  tablets, usp are also used in combination with other chemotherapeutic agents in the treatment of advanced stage non-hodgkin's lymphomas. methotrexate is indicated in the symptomatic control of severe, recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy, but only when the diagnosis has been established, as by biopsy and/or after dermatologic consultation . it is important to ensure that a psoriasis "flare" is not due to an undiagnos

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

unit dose services - methylprednisolone (unii: x4w7zr7023) (methylprednisolone - unii:x4w7zr7023) - methylprednisolone 4 mg - methylprednisolone tablets are indicated in the following conditions: 1.endocrine disorders primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). congenital adrenal hyperplasia nonsuppurative thyroiditis hypercalcemia associated with cancer 2.rheumatic disorders as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) ankylosing spondylitis acute and subacute bursitis synovitis of osteoarthritis acute nonspecific tenosynovitis post-traumatic osteoarthritis psoriatic arthritis epicondylitis acute gouty arthritis 3.collagen diseases during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus

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

unit dose services - atorvastatin calcium (unii: 48a5m73z4q) (atorvastatin - unii:a0jwa85v8f) - atorvastatin 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 recommended 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 patients with chd or multiple risk factors for chd, atorvastatin calcium tablets can be started simultaneously with diet. in adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low hdl-c, or a family history of early coronary heart disease, atorvastatin calcium tablets are indicated to: - reduce the risk of myocardial infarction - reduce the risk of stroke - reduce the risk for revascularization procedures and angina in patients with type 2 diabetes, and without clinically evident coronary heart disease, but

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

zydus lifesciences limited - doxazosin mesylate (unii: 86p6pqk0mu) (doxazosin - unii:nw1291f1w8) - doxazosin 1 mg -       doxazosin tablets are indicated for the treatment of the signs and symptoms of bph. doxazosin tablets are indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including this drug. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program's joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). n

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

zydus lifesciences limited - linezolid (unii: isq9i6j12j) (linezolid - unii:isq9i6j12j) - linezolid 600 mg - linezolid tablet is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. linezolid tablet is not indicated for the treatment of gram-negative infections. it is critical that specific gram-negative therapy be initiated immediately if a concomitant gram-negative pathogen is documented or suspected [see warnings and precautions (5.4) ]. nosocomial pneumonia caused by staphylococcus aureus (methicillin-susceptible and -resistant isolates) or streptococcus pneumoniae [see clinical studies (14) ]. community-acquired pneumonia caused by streptococcus pneumoniae , including cases with concurrent bacteremia, or staphylococcus aureus (methicillin-susceptible isolates only) [see clinical studies (14) ]. complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis , caused by staphylococcus aureus (methicillin-susceptible and -resistant isolates), streptococcus pyogen

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

zydus lifesciences limited - nateglinide (unii: 41x3pwk4o2) (nateglinide - unii:41x3pwk4o2) - nateglinide 60 mg - nateglinide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use: nateglinide tablets should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. nateglinide is contraindicated in patients with a history of hypersensitivity to nateglinide or its inactive ingredients. pregnancy category c there are no adequate and well-controlled studies of nateglinide in pregnant women. it is unknown whether nateglinide can cause fetal harm when administered to a pregnant woman. nateglinide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. in the rabbit, embryonic development was adversely affected and the incidence of gall bladder agenesis or small gallbladder was increased at a dose of 500 mg/kg (approximately 27 times the human therapeutic exposure of 120 mg three times daily, based on body surface area). nateglinide was not terato

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

zydus lifesciences limited - entecavir (unii: 5968y6h45m) (entecavir anhydrous - unii:nnu2o4609d) - entecavir 0.5 mg - entecavir tablets are indicated for the treatment of chronic hepatitis b virus infection in adults and pediatric patients 2 years of age and older with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (alt or ast) or histologically active disease. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to entecavir during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary prospective pregnancy data from the apr are not sufficient to adequately assess the risk of birth defects, miscarriage or adverse maternal or fetal outcomes. entecavir use during pregnancy has been evaluated in a limited number of individuals reported to the apr and the number of exposures to entecavir is insufficient to make a risk assessment compared to a reference population. the estimated background rate for ma