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eugia us llc - piperacillin sodium (unii: m98t69q7hp) (piperacillin anhydrous - unii:9i628532gx), tazobactam sodium (unii: uxa545abtt) (tazobactam - unii:se10g96m8w) - piperacillin anhydrous 2 g - piperacillin and tazobactam for injection is indicated in adults and pediatric patients (2 months of age and older) for the treatment of appendicitis (complicated by rupture or abscess) and peritonitis caused by beta-lactamase producing isolates of escherichia coli or the following members of the bacteroides fragilis group: b. fragilis , b. ovatus , b. thetaiotaomicron , or b. vulgatus . piperacillin and tazobactam for injection is indicated in adults and pediatric patients (2 months of age and older) for the treatment of nosocomial pneumonia (moderate to severe) caused by beta-lactamase producing isolates of staphylococcus aureus and by piperacillin and tazobactam-susceptible acinetobacter baumannii , haemophilus influenzae , klebsiella pneumoniae , and pseudomonas aeruginosa (nosocomial pneumonia caused by p. aeruginosa should be treated in combination with an aminoglycoside) [see dosage and administration (2)] . piperacillin and tazobactam for injection is indicated in adults for the treatment of uncomplicated and complicated skin and skin structure infections, including cellulitis, cutaneous abscesses and ischemic/diabetic foot infections caused by beta-lactamase producing isolates of staphylococcus aureus . piperacillin and tazobactam for injection is indicated in adults for the treatment of postpartum endometritis or pelvic inflammatory disease caused by beta-lactamase producing isolates of escherichia coli . piperacillin and tazobactam for injection is indicated in adults for the treatment of community-acquired pneumonia (moderate severity only) caused by beta-lactamase producing isolates of haemophilus influenzae . to reduce the development of drug-resistant bacteria and maintain the effectiveness of piperacillin and tazobactam for injection and other antibacterial drugs, piperacillin and tazobactam for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by 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. piperacillin and tazobactam for injection is contraindicated in patients with a history of allergic reactions to any of the penicillins, cephalosporins, or beta-lactamase inhibitors. risk summary piperacillin and tazobactam cross the placenta in humans. however, there are insufficient data with piperacillin and/or tazobactam in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. no fetal structural abnormalities were observed in rats or mice when piperacillin and tazobactam was administered intravenously during organogenesis at doses 1 to 2 times and 2 to 3 times the human dose of piperacillin and tazobactam, respectively, based on body-surface area (mg/m2 ). however, fetotoxicity in the presence of maternal toxicity was observed in developmental toxicity and peri/postnatal studies conducted in rats (intraperitoneal administration prior to mating and throughout gestation or from gestation day 17 through lactation day 21) at doses less than the maximum recommended human daily dose based on body-surface area (mg/m2 ) (see data) . the background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data in embryo-fetal development studies in mice and rats, pregnant animals received intravenous doses of piperacillin and tazobactam up to 3,000/750 mg/kg/day during the period of organogenesis. there was no evidence of teratogenicity up to the highest dose evaluated, which is 1 to 2 times and 2 to 3 times the human dose of piperacillin and tazobactam, in mice and rats respectively, based on body-surface area (mg/m2 ). fetal body weights were reduced in rats at maternally toxic doses at or above 500/62.5 mg/kg/day, minimally representing 0.4 times the human dose of both piperacillin and tazobactam based on body-surface area (mg/m2 ). a fertility and general reproduction study in rats using intraperitoneal administration of tazobactam or the combination piperacillin and tazobactam prior to mating and through the end of gestation, reported a decrease in litter size in the presence of maternal toxicity at 640 mg/kg/day tazobactam (4 times the human dose of tazobactam based on body-surface area), and decreased litter size and an increase in fetuses with ossification delays and variations of ribs, concurrent with maternal toxicity at ≥640/160 mg/kg/day piperacillin and tazobactam (0.5 times and 1 times the human dose of piperacillin and tazobactam, respectively, based on body-surface area). peri/postnatal development in rats was impaired with reduced pup weights, increased stillbirths, and increased pup mortality concurrent with maternal toxicity after intraperitoneal administration of tazobactam alone at doses ≥320 mg/kg/day (2 times the human dose based on body surface area) or of the combination piperacillin and tazobactam at doses ≥640/160 mg/kg/day (0.5 times and 1 times the human dose of piperacillin and tazobactam, respectively, based on body-surface area) from gestation day 17 through lactation day 21. risk summary piperacillin is excreted in human milk; tazobactam concentrations in human milk have not been studied. no information is available on the effects of piperacillin and tazobactam on the breastfed child or on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for piperacillin and tazobactam and any potential adverse effects on the breastfed child from piperacillin and tazobactam or from the underlying maternal condition. the safety and effectiveness of piperacillin and tazobactam for intra-abdominal infections, and nosocomial pneumonia have been established in pediatric patients 2 months of age and older. use of piperacillin and tazobactam in pediatric patients 2 months of age and older with intra-abdominal infections including appendicitis and/or peritonitis is supported by evidence from well-controlled studies and pharmacokinetic studies in adults and in pediatric patients. this includes a prospective, randomized, comparative, open-label clinical trial with 542 pediatric patients 2 to 12 years of age with intra-abdominal infections (including appendicitis and/or peritonitis), in which 273 pediatric patients received piperacillin and tazobactam [see  adverse reactions (6.1) and clinical pharmacology (12.3) ] . use of piperacillin and tazobactam in pediatric patients 2 months of age and older with nosocomial pneumonia is supported by evidence from well-controlled studies in adults with nosocomial pneumonia, a simulation study performed with a population pharmacokinetic model, and a retrospective, cohort study of pediatric patients with nosocomial pneumonia in which 140 pediatric patients were treated with piperacillin and tazobactam and 267 patients treated with comparators (which included ticarcillin-clavulanate, carbapenems, ceftazidime, cefepime, or ciprofloxacin) [see adverse reactions (6.1) and clinical pharmacology (12.3)]. the safety and effectiveness of piperacillin and tazobactam have not been established in pediatric patients less than 2 months of age [see clinical pharmacology (12) and dosage and administration (2)] . dosage of piperacillin and tazobactam in pediatric patients with renal impairment has not been determined. patients over 65 years are not at an increased risk of developing adverse effects solely because of age. however, dosage should be adjusted in the presence of renal impairment [see dosage and administration (2) ] . in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. piperacillin and tazobactam for injection contains 54 mg (2.35 meq) of sodium per gram of piperacillin in the combination product. at the usual recommended doses, patients would receive between 648 and 864 mg/day (28.2 and 37.6 meq) of sodium. the geriatric population may respond with a blunted natriuresis to salt loading. this may be clinically important with regard to such diseases as congestive heart failure. this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. in patients with creatinine clearance ≤ 40 ml/min and dialysis patients (hemodialysis and capd), the intravenous dose of piperacillin and tazobactam for injection should be reduced to the degree of renal function impairment [see dosage and administration (2) ] . dosage adjustment of piperacillin and tazobactam for injection is not warranted in patients with hepatic cirrhosis [see clinical pharmacology (12.3) ] .  as with other semisynthetic penicillins, piperacillin therapy has been associated with an increased incidence of fever and rash in cystic fibrosis patients.

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eugia us llc - fluphenazine decanoate (unii: fmu62k1l3c) (fluphenazine - unii:s79426a41z) - fluphenazine decanoate 125 mg in 5 ml - fluphenazine decanoate injection is a long-acting parenteral antipsychotic drug intended for use in the management of patients requiring prolonged parenteral neuroleptic therapy (e.g., chronic schizophrenics). fluphenazine decanoate injection has not been shown effective in the management of behavioral complications in patients with mental retardation. phenothiazines are contraindicated in patients with suspected or established subcortical brain damage. phenothiazine compounds should not be used in patients receiving large doses of hypnotics. fluphenazine decanoate injection is contraindicated in comatose or severely depressed states. the presence of blood dyscrasia or liver damage precludes the use of fluphenazine decanoate. fluphenazine decanoate injection is not intended for use in children under 12 years of age. fluphenazine decanoate injection is contraindicated in patients who have shown hypersensitivity to fluphenazine; cross-sensitivity to phenothiazine derivatives may oc

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eugia us llc - zoledronic acid (unii: 6xc1pad3kf) (zoledronic acid anhydrous - unii:70hz18ph24) - zoledronic acid anhydrous 5 mg in 100 ml - zoledronic acid injection is indicated for treatment of paget’s disease of bone in men and women. treatment is indicated in patients with paget’s disease of bone with elevations in serum alkaline phosphatase of two times or higher than the upper limit of the age-specific normal reference range, or those who are symptomatic, or those at risk for complications from their disease [see clinical studies (14.5) ] . zoledronic acid is contraindicated in patients with the following conditions: - hypocalcemia [see warnings and precautions (5.2) ] - creatinine clearance less than 35 ml/min and in those with evidence of acute renal impairment due to an increased risk of renal failure [see warnings and precautions (5.3) ] . - known hypersensitivity to zoledronic acid or any components of zoledronic acid injection. hypersensitivity reactions including urticaria, angioedema, and anaphylactic reaction/shock have been reported [see adverse reactions (6.2) ] . risk summary available data on the use of zoledronic acid in p

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eugia us llc - ondansetron hydrochloride (unii: nmh84ozk2b) (ondansetron - unii:4af302esos) - ondansetron injection is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin. ondansetron injection is approved for patients aged 6 months and older. ondansetron injection is indicated for the prevention of postoperative nausea and/or vomiting. as with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/or vomiting will occur postoperatively. in patients in whom nausea and/or vomiting must be avoided postoperatively, ondansetron injection is recommended even when the incidence of postoperative nausea and/or vomiting is low. for patients who do not receive prophylactic ondansetron injection and experience nausea and/or vomiting postoperatively, ondansetron injection may be given to prevent further episodes. ondansetron injection is approved for patients aged 1 month and older. ondansetron injection is contraindicated for patients known to have hypersensitivity (e.g., anaphylaxis) to this product or any of its components. anaphylactic reactions have been reported in patients taking ondansetron [see adverse reactions (6.2)] . the concomitant use of apomorphine with ondansetron is contraindicated based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron. 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 conclusions about the safety of ondansetron use in pregnancy (see data) . available postmarketing data have not identified a drug-associated risk of miscarriage or adverse maternal outcomes. reproductive studies in rats and rabbits did not show evidence of harm to the fetus when ondansetron was administered intravenously during organogenesis at approximately 3.6 and 2.9 times the maximum recommended human intravenous dose of 0.15 mg/kg given three times a day, based on body surface area (bsa), respectively (see data). the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, miscarriages, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data human data available data on ondansetron use in pregnant women from several published epidemiological studies preclude an assessment of a drug-associated risk of adverse fetal outcomes due to important methodological limitations, including the uncertainty of whether women who filled a prescription actually took the medication, the concomitant use of other medications or treatments, recall bias, and other unadjusted confounders. ondansetron exposure in utero has not been associated with overall major congenital malformations in aggregate analyses. one large retrospective cohort study examined 1970 women who received a prescription for ondansetron during pregnancy and reported no association between ondansetron exposure and major congenital malformations, miscarriage, stillbirth, preterm delivery, infants of low birth weight, or infants small for gestational age.  two large retrospective cohort studies and one case-control study have assessed ondansetron exposure in the first trimester and risk of cardiovascular defects with inconsistent findings. relative risks (rr) ranged from 0.97 (95% ci 0.86 to 1.10) to 1.62 (95% ci 1.04, 2.54). a subset analysis in one of the cohort studies observed that ondansetron was specifically associated with cardiac septal defects (rr 2.05, 95% ci 1.19, 3.28); however this association was not confirmed in other studies. several studies have assessed ondansetron and the risk of oral clefts with inconsistent findings. a retrospective cohort study of 1.8 million pregnancies in the u.s. medicaid database showed an increased risk of oral clefts among 88,467 pregnancies in which oral ondansetron was prescribed in the first trimester (rr 1.24, 95% ci 1.03, 1.48), but no such association was reported with intravenous ondansetron in 23,866 pregnancies (rr 0.95, 95% ci 0.63, 1.43). in the subgroup of women who received both forms of administration, the rr was 1.07 (95% ci 0.59, 1.93). two case-control studies, using data from birth defects surveillance programs, reported conflicting associations between maternal use of ondansetron and isolated cleft palate (or 1.6 [95% ci 1.1, 2.3] and 0.5 [95% ci 0.3, 1.0]). it is unknown whether ondansetron exposure in utero in the cases of cleft palate occurred during the time of palate formation (the palate is formed between the 6th and 9th weeks of pregnancy). animal data  in embryo-fetal development studies in rats and rabbits, pregnant animals received intravenous doses of ondansetron up to 10 mg/kg/day and 4 mg/kg/day, respectively, during the period of organogenesis. with the exception of short periods of maternal weight loss and a slight increase in the incidence of early uterine deaths at the high dose level in rabbits, there were no significant effects of ondansetron on the maternal animals or the development of the offspring. at doses of 10 mg/kg/day in rats and 4 mg/kg/day in rabbits, the maternal exposure margin was approximately 3.6 and 2.9 times the maximum recommended human oral dose of 0.15 mg/kg given three times a day, respectively, based on bsa. no intravenous pre- and post-natal developmental toxicity study was performed with ondansetron. in an oral pre- and post-natal development study pregnant rats received oral doses of ondansetron up to 15 mg/kg/day from day 17 of pregnancy to litter day 21. with the exception of a slight reduction in maternal body weight gain, there were no effects upon the pregnant rats and the pre- and postnatal development of their offspring, including reproductive performance of the mated f1 generation. risk summary it is not known whether ondansetron is present in human milk. there are no data on the effects of ondansetron on the breastfed infant or the effects on milk production. however, it has been demonstrated that ondansetron is present in the milk of rats. when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ondansetron and any potential adverse effects on the breast-fed infant from ondansetron or from the underlying maternal condition. little information is available about the use of ondansetron in pediatric surgical patients younger than 1 month [see clinical studies (14.2)]. little information is available about the use of ondansetron in pediatric cancer patients younger than 6 months [see clinical studies (14.1), dosage and administration (2)]. the clearance of ondansetron in pediatric patients aged 1 month to 4 months is slower and the half-life is ~2.5-fold longer than patients who are aged > 4 to 24 months. as a precaution, it is recommended that patients younger than 4 months receiving this drug be closely monitored [see clinical pharmacology (12.3)]. of the total number of subjects enrolled in cancer chemotherapy-induced and postoperative nausea and vomiting u.s.- and foreign-controlled clinical trials, 862 were aged 65 years and older. no overall differences in safety or effectiveness were observed between subjects 65 years and older and younger subjects. a reduction in clearance and increase in elimination half-life were seen in patients older than 75 years compared with younger subjects [see clinical pharmacology (12.3)] . there were an insufficient number of patients older than 75 years of age and older in the clinical trials to permit safety or efficacy conclusions in this age-group. other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. dosage adjustment is not needed in patients over the age of 65. in patients with severe hepatic impairment (child-pugh score of 10 or greater), clearance is reduced and apparent volume of distribution is increased with a resultant increase in plasma half-life [see clinical pharmacology (12.3) ] . in such patients, a total daily dose of 8 mg should not be exceeded [see dosage and administration (2.3 )] . although plasma clearance is reduced in patients with severe renal impairment (creatinine clearance < 30 ml/min), no dosage adjustment is recommended [see clinical pharmacology (12.3) ] . animal studies have shown that ondansetron is not discriminated as a benzodiazepine nor does it substitute for benzodiazepines in direct addiction studies.

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eugia us llc - dexamethasone sodium phosphate (unii: ai9376y64p) (dexamethasone - unii:7s5i7g3jql) - a. intravenous or intramuscular administration . when oral therapy is not feasible and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, those products labeled for intravenous or intramuscular use are indicated as follows: 1. endocrine disorders . primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplementation may be necessary, particularly when synthetic analogs are used). preoperatively, and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful. shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected. 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: post-traumatic osteoarthritis. synovitis of osteoarthritis. rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). acute and subacute bursitis. epicondylitis. acute nonspecific tenosynovitis. acute gouty arthritis. psoriatic arthritis. ankylosing spondylitis. 3.     collagen diseases. during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus. acute rheumatic carditis. 4.    dermatologic diseases. pemphigus. severe erythema multiforme (stevens-johnson syndrome). exfoliative dermatitis. bullous dermatitis herpetiformis. severe seborrheic dermatitis. severe psoriasis. mycosis fungoides. 5.     allergic states. control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in: bronchial asthma. contact dermatitis. atopic dermatitis. serum sickness. seasonal or perennial allergic rhinitis. drug hypersensitivity reactions. urticarial transfusion reactions. acute noninfectious laryngeal edema (epinephrine is the drug of first choice). 6.    ophthalmic diseases. severe acute and chronic allergic and inflammatory processes involving the eye, such as: herpes zoster ophthalmicus. iritis, iridocyclitis. chorioretinitis. diffuse posterior uveitis and choroiditis. optic neuritis. sympathetic ophthalmia. anterior segment inflammation. allergic conjunctivitis. allergic corneal marginal ulcers. keratitis. 7.   gastrointestinal diseases . to tide the patient over a critical period of the disease in: ulcerative colitis (systemic therapy). regional enteritis (systemic therapy). 8.   respiratory diseases: symptomatic sarcoidosis. berylliosis. fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate anti-tuberculosis chemotherapy. loeffler's syndrome not manageable by other means. aspiration pneumonitis. 9.  hematologic disorders: acquired (autoimmune) hemolytic anemia. idiopathic thrombocytopenic purpura in adults (i.v. only; i.m. administration is contraindicated). secondary thrombocytopenia in adults. erythroblastopenia (rbc anemia). congenital (erythroid) hypoplastic anemia. 10. neoplastic diseases. for palliative management of: leukemias and lymphomas in adults. acute leukemia of childhood. 11. edematous states. to induce diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 12. nervous system. acute exacerbations of multiple sclerosis. 13. miscellaneous. tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate anti-tuberculosis chemotherapy. trichinosis with neurologic or myocardial involvement. diagnostic testing of adrenocortical hyperfunction. cerebral edema of diverse etiologies in conjunction with adequate neurological evaluation and management. b. intra-articular or soft tissue administration. when the strength and dosage form of the drug lend the preparation to the treatment of the condition, those products labeled for intra-articular or soft tissue administration are indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: synovitis of osteoarthritis. rheumatoid arthritis. acute and subacute bursitis. acute gouty arthritis. epicondylitis. acute nonspecific tenosynovitis. post-traumatic osteoarthritis. c. intralesional administration. when the strength and dosage form of the drug lend the preparation to the treatment of the condition, those products labeled for intralesional administration are indicated for: keloids. localized hypertrophic, infiltrated, inflammatory lesions of: lichen planus, psoriatic plaques, granuloma annulare, and lichen simplex chronicus (neurodermatitis). discoid lupus erythematosus. necrobiosis lipoidica diabeticorum. alopecia areata. they also may be useful in cystic tumors of an aponeurosis tendon (ganglia). systemic fungal infections.

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eugia us llc - progesterone (unii: 4g7ds2q64y) (progesterone - unii:4g7ds2q64y) - this drug is indicated in amenorrhea and abnormal uterine bleeding due to hormonal imbalance in the absence of organic pathology, such as submucous fibroids or uterine cancer. - current or past history of thrombophlebitis, thromboembolic disorders, or cerebral apoplexy. - liver dysfunction or disease. - known or suspected malignancy of breast or genital organs. - undiagnosed vaginal bleeding. - missed abortion. - known sensitivity to progesterone injection. - known sensitivity to sesame oil/seeds.

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eugia us llc - nafcillin sodium (unii: 49g3001bck) (nafcillin - unii:4cnz27m7rv) - nafcillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. culture and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (see clinical pharmacology- susceptibility test methods ). nafcillin should not be used in infections caused by organisms susceptible to penicillin g. if the susceptibility tests indicate that the infection is due to methicillin-resistant staphylococcus sp., therapy with nafcillin for injection, usp should be discontinued and alternative therapy provided. to reduce the development of drug-resistant bacteria and maintain the effectiveness of nafcillin for injection, usp and other antibacterial drugs, nafcillin for injection, usp 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

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auromedics pharma llc - furosemide (unii: 7lxu5n7zo5) (furosemide - unii:7lxu5n7zo5) - parenteral therapy should be reserved for patients unable to take oral medication or for patients in emergency clinical situations. edema: furosemide injection is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. furosemide injection is particularly useful when an agent with greater diuretic potential is desired. furosemide injection is indicated as adjunctive therapy in acute pulmonary edema. the intravenous administration of furosemide injection is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema. if gastrointestinal absorption is impaired or oral medication is not practical for any reason, furosemide injection is indicated by the intravenous or intramuscular route. parenteral use should be replaced with oral furosemide as soon as practical. furosemide is contraindicated in patients with anuria and in patients with a his

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eugia us llc - nafcillin sodium (unii: 49g3001bck) (nafcillin - unii:4cnz27m7rv) - nafcillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. culture and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (see clinical pharmacology - susceptibility test methods ) . nafcillin should not be used in infections caused by organisms susceptible to penicillin g. if the susceptibility tests indicate that the infection is due to a methicillin-resistant staphylococcus sp., therapy with nafcillin for injection, usp should be discontinued and alternative therapy provided. to reduce the development of drug-resistant bacteria and maintain the effectiveness of nafcillin for injection, usp and other antibacterial drugs, nafcillin for injection, usp 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. a history of a hypersensitivity (anaphylactic) reaction to any penicillin is a contraindication.

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eugia us llc - nafcillin sodium (unii: 49g3001bck) (nafcillin - unii:4cnz27m7rv) - nafcillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. culture and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (see clinical pharmacology - susceptibility test methods ) . nafcillin should not be used in infections caused by organisms susceptible to penicillin g. if the susceptibility tests indicate that the infection is due to methicillin-resistant staphylococcus sp., therapy with nafcillin for injection, usp should be discontinued and alternative therapy provided. to reduce the development of drug-resistant bacteria and maintain the effectiveness of nafcillin for injection, usp and other antibacterial drugs, nafcillin for injection, usp 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. a history of a hypersensitivity (anaphylactic) reaction to any penicillin is a contraindication.