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

zydus lifesciences limited - finasteride (unii: 57gno57u7g) (finasteride - unii:57gno57u7g) - finasteride 5 mg - finasteride tablets are indicated for the treatment of symptomatic benign prostatic hyperplasia (bph) in men with an enlarged prostate to: -improve symptoms -reduce the risk of the need for surgery including transurethral resection of the prostate (turp) and prostatectomy. finasteride tablets  administered in combination with the alpha-blocker doxazosin are indicated to reduce the risk of symptomatic progression of bph (a confirmed ≥ 4 point increase in american urological association (aua) symptom score). finasteride tablets are not approved for the prevention of prostate cancer. finasteride tablets are contraindicated in the following: - hypersensitivity to any component of this medication. - pregnancy. finasteride use is contraindicated in women when they are or may potentially be pregnant. because of the ability of type ii 5α-reductase inhibitors to inhibit the conversion of testosterone to 5α-dihydrotestosterone (dht), finasteride may cause abnormalities of the external genitalia of a male fetus of a pre

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

zydus lifesciences limited - methylprednisolone (unii: x4w7zr7023) (methylprednisolone - unii:x4w7zr7023) - methylprednisolone 4 mg - methylprednisolone tablets are indicated in the following conditions: 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 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 during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus systemic dermatomyositis (polymyositis) acute rheumatic carditis

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

zydus lifesciences limited - bumetanide (unii: 0y2s3xuq5h) (bumetanide - unii:0y2s3xuq5h) - bumetanide 0.5 mg - bumetanide tablets usp are indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease, including the nephrotic syndrome. almost equal diuretic response occurs after oral and parenteral administration of bumetanide. therefore, if impaired gastrointestinal absorption is suspected or oral administration is not practical, bumetanide should be given by the intramuscular or intravenous route. successful treatment with bumetanide tablets usp following instances of allergic reactions to furosemide suggests a lack of cross-sensitivity. bumetanide is contraindicated in anuria. although bumetanide tablets can be used to induce diuresis in renal insufficiency, any marked increase in blood urea nitrogen or creatinine, or the development of oliguria during therapy of patients with progressive renal disease, is an indication for discontinuation of treatment with bumetanide tablets. bumetanide is also contraindicated in patients in hepatic coma or in states of severe electrolyte depletion until the condition is improved or corrected. bumetanide is contraindicated in patients hypersensitive to this drug.

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

zydus lifesciences limited - tamoxifen citrate (unii: 7frv7310n6) (tamoxifen - unii:094zi81y45) - tamoxifen 10 mg - metastatic breast cancer tamoxifen citrate tablets are effective in the treatment of metastatic breast cancer in women and men. in premenopausal women with metastatic breast cancer, tamoxifen is an alternative to oophorectomy or ovarian irradiation. available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from tamoxifen therapy. adjuvant treatment of breast cancer tamoxifen citrate tablets are indicated for the treatment of node-positive breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. in some tamoxifen adjuvant studies, most of the benefit to date has been in the subgroup with four or more positive axillary nodes. tamoxifen citrate tablets are indicated for the treatment of axillary node-negative breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. the estrogen and progesterone receptor values may help to predict whe

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

zydus lifesciences limited - pitavastatin (unii: m5681q5f9p) (pitavastatin - unii:m5681q5f9p) - pitavastatin 1 mg - drug therapy should be one component of multiple-risk-factor intervention in individuals who require modifications of their lipid profile. lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol only when the response to diet and other nonpharmacological measures has been inadequate. zypitamag™ is indicated as an adjunctive therapy to diet to reduce elevated total cholesterol (tc), low-density lipoprotein cholesterol (ldl-c), apolipoprotein b (apo b), triglycerides (tg), and to increase hdl-c in adult patients with primary hyperlipidemia or mixed dyslipidemia. doses of zypitamag greater than 4 mg once daily were associated with an increased risk for severe myopathy in premarketing clinical studies. do not exceed 4 mg once daily dosing of zypitamag. the effect of zypitamag on cardiovascular morbidity and mortality has not been determined. zypitamag has not been studied in fredrickson type i, iii, and v dyslipidemias. the use of zypitamag is contraindicated in the

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

zydus lifesciences limited - fesoterodine fumarate (unii: eos72165s7) (fesoterodine - unii:621g617227) - fesoterodine fumarate 4 mg - fesoterodine fumarate extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. fesoterodine fumarate extended-release tablets are contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. fesoterodine fumarate extended-release tablets are also contraindicated in patients with known hypersensitivity to the drug or its ingredients, or to tolterodine tartrate tablets or tolterodine tartrate extended-release capsules [see  clinical  pharmacology  (12.1) ]. risk summary there are no data with the use of fesoterodine fumarate in pregnant women to inform a drug associated risk for birth defects or miscarriage. in animal reproduction studies, oral administration of fesoterodine to pregnant mice and rabbits during organogenesis resulted in fetotoxicity at maternal exposures that were 6 and 3 times, respectively, the maximum recommended human dose (mrhd) o

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 - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288), olmesartan medoxomil (unii: 6m97xtv3hd) (olmesartan - unii:8w1iqp3u10) - amlodipine 5 mg - amlodipine and olmesartan medoxomil  tablets are indicated for the treatment of hypertension, alone or with other antihypertensive agents, 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 the class to which this drug principally belongs. there are no controlled trials demonstrating risk reduction with amlodipine and olmesartan medoxomil tablets. 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 pressur

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

zydus lifesciences limited - aspirin (unii: r16co5y76e) (aspirin - unii:r16co5y76e), dipyridamole (unii: 64alc7f90c) (dipyridamole - unii:64alc7f90c) - aspirin 25 mg - aspirin and extended-release dipyridamole capsules are indicated to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis. aspirin and extended-release dipyridamole capsules are contraindicated in patients with known hypersensitivity to any of the product components. aspirin is contraindicated in patients with known allergy to nonsteroidal anti-inflammatory drug (nsaid) products and in patients with the syndrome of asthma, rhinitis, and nasal polyps. aspirin may cause severe urticaria, angioedema or bronchospasm. do not use aspirin in children or teenagers with viral infections because of the risk of reye syndrome. risk summary available data from published studies and postmarketing experience with aspirin and extended-release dipyridamole capsule use during pregnancy have not identified a clear association between aspirin and extended-release dipyridamole capsule use and major birth defects, miscarriage, or adverse maternal or fetal

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

zydus lifesciences limited - doxycycline (unii: n12000u13o) (doxycycline anhydrous - unii:334895s862) - doxycycline anhydrous 50 mg - to reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline tablets and other antibacterial drugs, doxycycline tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy. doxycycline is indicated for the treatment of the following infections: rocky mountain spotted fever, typhus fever and the typhus group, q fever, rickettsialpox, and tick fevers caused by rickettsiae. respiratory tract infections caused by mycoplasma pneumoniae . lymphogranuloma venereum caused by chlamydia trachomatis. psittacosis (ornithosis) caused by chlamydophila psittaci. trachoma caused by chlamydia trachomatis , although the infectious agent is not always eliminated a