संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

wockhardt limited - levofloxacin (unii: 6gnt3y5lmf) (levofloxacin anhydrous - unii:rix4e89y14) - levofloxacin 250 mg - to reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets and other antibacterial drugs, levofloxacin 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 the empiric selection of therapy. levofloxacin tablets are indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. culture and susceptibility testing appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin [see mic

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

wockhardt limited - lamotrigine (unii: u3h27498ks) (lamotrigine - unii:u3h27498ks) - lamotrigine 25 mg - lamotrigine extended-release tablets are indicated as adjunctive therapy for partial onset seizures with or without secondary generalization in patients ≥13 years of age. safety and effectiveness of lamotrigine extended-release tablets for use in patients less than 13 years of age have not been established. lamotrigine extended-release tablet is contraindicated in patients who have demonstrated hypersensitivity (e.g., rash, angioedema, acute urticaria, extensive pruritus, mucosal ulceration) to the drug or its ingredients [see boxed warning, warnings and precautions (5.1, 5.2)]. as with other aeds, physiological changes during pregnancy may affect lamotrigine concentrations and/or therapeutic effect. there have been reports of decreased lamotrigine concentrations during pregnancy and restoration of pre-partum concentrations after delivery. dosage adjustments may be necessary to maintain clinical response. pregnancy category c. there are no adequate and well-controlled studies in pregnant women. in animal stud

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

wockhardt usa llc. - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride 100 mg - bupropion hydrochloride extended-release tablets (sr) are indicated for the treatment of major depressive disorder (mdd), as defined by the diagnostic and statistical manual (dsm) . the efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with mdd [see clinical studies (14)] . the efficacy of bupropion hydrochloride extended-release tablets (sr) in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial [see clinical studies (14)] . - bupropion hydrochloride extended-release tablets (sr) are contraindicated in patients with a seizure disorder. - bupropion hydrochloride extended-release tablets (sr) are contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was observed in such patients treated

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

wockhardt usa llc. - olopatadine hydrochloride (unii: 2xg66w44kf) (olopatadine - unii:d27v6190pm) - olopatadine 1 mg in 1 ml - olopatadine hydrochloride ophthalmic solution usp, 0.1 % is indicated for the treatment of the signs and symptoms of allergic conjunctivitis. olopatadine hydrochloride ophthalmic solution 0.1 % is contraindicated in persons with a known hypersensitivity to olopatadine hydrochloride or any components of olopatadine hydrochloride ophthalmic solution 0.1 %.

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

wockhardt usa llc. - oxacillin sodium (unii: g0v6c994q5) (oxacillin - unii:uh95vd7v76) - oxacillin is indicated in the treatment of infections caused by penicillinase producing staphylococci which have demonstrated susceptibility to the drug. cultures and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (see clinical pharmacology-susceptibility test methods ). oxacillin may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of susceptibility test results. oxacillin should not be used in infections caused by organisms susceptible to penicillin g. if the susceptibility tests indicate that the infection is due to an organism other than a resistant staphylococcus , therapy should not be continued with oxacillin. to reduce the development of drug-resistant bacteria and maintain the effectiveness of oxacillin for injection, usp and other antibacterial drugs, oxacillin for injection, usp should be used only to treat or prevent infections that are proven or strongl

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

wockhardt limited - zonisamide (unii: 459384h98v) (zonisamide - unii:459384h98v) - zonisamide 25 mg - zonisamide capsule is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. the active ingredient is zonisamide, 1,2-benzisoxazole-3-methanesulfonamide. the empirical formula is c8 h8 n2 o3 s with a molecular weight of 212.23. zonisamide is a white powder, pka = 10.2, and is moderately soluble in water (0.80 mg/ml) and 0.1 n hcl (0.50 mg/ml). the chemical structure is: zonisamide capsules are supplied for oral administration as capsules containing 25 mg, 50 mg and 100 mg zonisamide. each capsule contains the labeled amount of zonisamide plus the following inactive ingredients: microcrystalline cellulose, sodium lauryl sulfate, hydrogenated vegetable oil, colloidal silicon dioxide, sodium starch glycolate, talc, gelatin, titanium dioxide. for 100 mg d&c red # 28, d&c yellow # 10, and fd&c # yellow 6 and for 50 mg contains fd&c red # 40, fd&c yellow # 5, and fd&c blue # 1.

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

tya pharmaceuticals - phenytoin sodium (unii: 4182431bjh) (phenytoin - unii:6158tkw0c5) - phenytoin sodium 100 mg - extended phenytoin sodium capsules, usp are indicated for the control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. phenytoin serum level determinations may be necessary for optimal dosage adjustments (see and sections). dosage and administrationclinical pharmacology phenytoin is contraindicated in those patients who are hypersensitive to phenytoin or other hydantoins.

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

wockhardt limited - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride 100 mg - bupropion hydrochloride extended-release tablets (sr) are indicated for the treatment of major depressive disorder. the efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of depressed inpatients and in one 6-week controlled trial of depressed outpatients whose diagnoses corresponded most closely to the major depression category of the apa diagnostic and statistical manual (dsm) (see clinical pharmacology). a major depressive episode (dsm-iv) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a

ऑस्ट्रेलिया - अंग्रेज़ी - Department of Health (Therapeutic Goods Administration)

wockhardt bio pty ltd - daptomycin, quantity: 500 mg - injection, powder for - excipient ingredients: sodium hydroxide - daptomycin is active against gram positive bacteria only. in mixed infections where gram negative and/or certain types of anaerobic bacteria are suspected, daptomycin should be co-administered with appropriate antibacterial agent(s).,consideration should be given to official guidance on the appropriate use of antibacterial agents. daptomycin is not indicated for the treatment of pneumonia.,adult patients (?18 years of age),complicated skin and skin structure infections,daptomycin wkt is indicated for the treatment of adults (? 18 years of age) with complicated skin and skin structure infections (csssi) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,staphylococcus aureus bloodstream infections (bacteraemia),daptomycin wkt is indicated in adults (?18 years of age) for staphylococcus aureus bloodstream infections (bacteraemia), including right-sided native valve infective endocarditis (rie), caused by methicillin-susceptible and methicillin-resistant isolates.,the efficacy of daptomycin in patients with prosthetic heart valves or in left-sided endocarditis due to staphylococcus aureus has not been demonstrated. in the setting of staphylococcus aureus bacteraemia (sab), if a focus of infection is diagnosed as left-sided endocarditis after daptomycin therapy has been initiated, then consideration should be given to instituting alternative antibacterial therapy (see section 4.4 special warnings and precautions for use).,paediatric patients (1 to 17 years of age),daptomycin is not indicated for treatment of patients less than 1 year of age (see section 4.4 special warnings and precautions for use, paediatric use).,daptomycin has not been studied in treatment of infective endocarditis in children (see section 5.1 pharmacodynamic properties, clinical trials and section 4.4 special warnings and precautions for use).,complicated skin and skin structure infections,daptomycin wkt is indicated for the treatment of patients aged 1 to 17 years with complicated skin and skin structure infections (csssi) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,staphylococcus aureus bloodstream infections (bacteraemia),daptomycin wkt is indicated in paediatric patients (1 to 17 years of age) with staphylococcus aureus bacteraemia not due to pneumonia, caused by daptomycin-susceptible isolates. empiric treatment should be reviewed based on the results of susceptibility testing. prescribing should be in accordance with nationally or locally-endorsed guidelines for the treatment of staphylococcus aureus bacteraemia.

ऑस्ट्रेलिया - अंग्रेज़ी - Department of Health (Therapeutic Goods Administration)

wockhardt bio pty ltd - daptomycin, quantity: 350 mg - injection, powder for - excipient ingredients: sodium hydroxide - daptomycin is active against gram positive bacteria only. in mixed infections where gram negative and/or certain types of anaerobic bacteria are suspected, daptomycin should be co-administered with appropriate antibacterial agent(s).,consideration should be given to official guidance on the appropriate use of antibacterial agents. daptomycin is not indicated for the treatment of pneumonia.,adult patients (?18 years of age),complicated skin and skin structure infections,daptomycin wkt is indicated for the treatment of adults (? 18 years of age) with complicated skin and skin structure infections (csssi) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,staphylococcus aureus bloodstream infections (bacteraemia),daptomycin wkt is indicated in adults (?18 years of age) for staphylococcus aureus bloodstream infections (bacteraemia), including right-sided native valve infective endocarditis (rie), caused by methicillin-susceptible and methicillin-resistant isolates.,the efficacy of daptomycin in patients with prosthetic heart valves or in left-sided endocarditis due to staphylococcus aureus has not been demonstrated. in the setting of staphylococcus aureus bacteraemia (sab), if a focus of infection is diagnosed as left-sided endocarditis after daptomycin therapy has been initiated, then consideration should be given to instituting alternative antibacterial therapy (see section 4.4 special warnings and precautions for use).,paediatric patients (1 to 17 years of age),daptomycin is not indicated for treatment of patients less than 1 year of age (see section 4.4 special warnings and precautions for use, paediatric use).,daptomycin has not been studied in treatment of infective endocarditis in children (see section 5.1 pharmacodynamic properties, clinical trials and section 4.4 special warnings and precautions for use).,complicated skin and skin structure infections,daptomycin wkt is indicated for the treatment of patients aged 1 to 17 years with complicated skin and skin structure infections (csssi) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,staphylococcus aureus bloodstream infections (bacteraemia),daptomycin wkt is indicated in paediatric patients (1 to 17 years of age) with staphylococcus aureus bacteraemia not due to pneumonia, caused by daptomycin-susceptible isolates. empiric treatment should be reviewed based on the results of susceptibility testing. prescribing should be in accordance with nationally or locally-endorsed guidelines for the treatment of staphylococcus aureus bacteraemia.