США - англійська - NLM (National Library of Medicine)

xgen pharmaceuticals djb, inc. - neomycin sulfate (unii: 057y626693) (neomycin - unii:i16qd7x297) - neomycin sulfate 500 mg - to reduce the development of drug-resistant bacteria and maintain the effectiveness of neomycin sulfate tablets, usp and other antibacterial drugs, neomycin sulfate tablets, 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. neomycin sulfate tablets, usp are indicated as adjunctive therapy as part of a regimen for the suppression of the normal bacterial flora of the bowel, e.g. preoperative preparation of the bowel. it is given concomitantly with erythromycin enteric-coated base (see dosage and administration section) . neomycin sulfate has been shown to be effective adjunctive therapy in hepatic coma by reduction of the ammonia-forming bacteria in the intestinal

США - англійська - NLM (National Library of Medicine)

xgen pharmaceuticals djb, inc. - folic acid (unii: 935e97boy8) (folic acid - unii:935e97boy8) - folic acid injection, usp alone is effective in the treatment of megaloblastic anemias due to a deficiency of folic acid as may be seen in tropical or nontropical sprue, in anemias of nutritional origin, pregnancy, infancy or childhood.

США - англійська - NLM (National Library of Medicine)

xgen pharmaceuticals djb, inc. - polymyxin b sulfate (unii: 19371312d4) (polymyxin b - unii:j2vz07j96k) - acute infections caused by susceptible strains of pseudomonas aeruginosa. polymyxin b sulfate is a drug of choice in the treatment of infections of the urinary tract, meninges, and bloodstream caused by susceptible strains of ps . aeruginosa . it may also be used topically and subconjunctivally in the treatment of infections of the eye caused by susceptible strains of ps . aeruginosa . it may be indicated in serious infections caused by susceptible strains of the following organisms, when less potentially toxic drugs are ineffective or contraindicated: h influenzae , specifically meningeal infections. escherichia   coli , specifically urinary tract infections. aerobacter aerogenes , specifically bacteremia. klebsiella   pneumoniae , specifically bacteremia. note: in meningeal infections, polymyxin b sulfate should be administered only by the intrathecal route. to reduce the development of drug-resistant bac

США - англійська - NLM (National Library of Medicine)

xgen pharmaceuticals djb, inc. - hydralazine hydrochloride (unii: fd171b778y) (hydralazine - unii:26nak24ls8) - hydralazine hydrochloride 20 mg in 1 ml - severe essential hypertension when the drug cannot be given orally or when there is an urgent need to lower blood pressure. hypersensitivity to hydralazine; coronary artery disease; mitral valvular rheumatic heart disease.

США - англійська - NLM (National Library of Medicine)

xgen pharmaceuticals djb, inc. - voriconazole (unii: jfu09i87tr) (voriconazole - unii:jfu09i87tr) - voriconazole 10 mg in 1 ml - voriconazole for injection is indicated in adults and pediatric patients (aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight) for the treatment of invasive aspergillosis (ia). in clinical trials, the majority of isolates recovered were aspergillus fumigatus . there was a small number of cases of culture-proven disease due to species of aspergillus other than a. fumigatus [see clinical studies (14.1) and microbiology (12.4)] . voriconazole for injection is indicated in adult and pediatric patients (aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight) for the treatment of candidemia in non-neutropenic patients and the following candida infections: disseminated infections in skin and infections in abdomen, kidney, bladder wall, and wounds [see clinical studies (14.2) and microbiology (12.4) ]. voriconazole for injection is indicated for the treatment of serious fungal infections caused by scedosporium apiospermum (asexual form of pseudallescheria boydii ) and fusarium spp . including fusarium solani , in adult and pediatric patients (aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight) intolerant of, or refractory to, other therapy [see clinical studies (14.3) and microbiology (12.4) ]. specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative organism(s). therapy may be instituted before the results of the cultures and other laboratory studies are known. however, once these results become available, antifungal therapy should be adjusted accordingly. additional pediatric use information is approved for pf prism c.v.’s vfend (voriconazole) for injection. however, due to pf prism c.v.’s marketing exclusivity rights, this drug product is not labeled with that information. - voriconazole for injection is contraindicated in patients with known hypersensitivity to voriconazole or its excipients. there is no information regarding cross-sensitivity between voriconazole for injection (voriconazole) and other azole antifungal agents. caution should be used when prescribing voriconazole for injection to patients with hypersensitivity to other azoles. - coadministration of pimozide, quinidine or ivabradine with voriconazole for injection is contraindicated because increased plasma concentrations of these drugs can lead to qt prolongation and rare occurrences of torsade de pointes [see drug interactions (7) ]. - coadministration of voriconazole for injection with sirolimus is contraindicated because voriconazole for injection significantly increases sirolimus concentrations [ see drug interactions (7) and clinical pharmacology (12.3) ]. - coadministration of voriconazole for injection with rifampin, carbamazepine, long-acting barbiturates and st. john's wort is contraindicated because these drugs are likely to decrease plasma voriconazole concentrations significantly [see drug interactions (7) and clinical pharmacology (12.3) ]. - coadministration of standard doses of voriconazole with efavirenz doses of 400 mg every 24 hours or higher is contraindicated, because efavirenz significantly decreases plasma voriconazole concentrations in healthy subjects at these doses. voriconazole also significantly increases efavirenz plasma concentrations [ see drug interactions (7) and clinical pharmacology (12.3) ]. - coadministration of voriconazole for injection with high-dose ritonavir (400 mg every 12 hours) is contraindicated because ritonavir (400 mg every 12 hours) significantly decreases plasma voriconazole concentrations. coadministration of voriconazole and low-dose ritonavir (100 mg every 12 hours) should be avoided, unless an assessment of the benefit/risk to the patient justifies the use of voriconazole [ see drug interactions (7) and clinical pharmacology (12.3) ]. - coadministration of voriconazole for injection with rifabutin is contraindicated since voriconazole for injection significantly increases rifabutin plasma concentrations and rifabutin also significantly decreases voriconazole plasma concentrations [ see drug interactions (7) and clinical pharmacology (12.3) ]. - coadministration of voriconazole for injection with ergot alkaloids (ergotamine and dihydroergotamine) is contraindicated because voriconazole for injection may increase the plasma concentration of ergot alkaloids, which may lead to ergotism [ see drug interactions (7) ]. - coadministration of voriconazole for injection with naloxegol is contraindicated because voriconazole for injection may increase plasma concentrations of naloxegol which may precipitate opioid withdrawal symptoms [ see drug interactions (7) ]. - coadministration of voriconazole for injection with tolvaptan is contraindicated because voriconazole for injection may increase tolvaptan plasma concentrations and increase risk of adverse reactions [ see drug interactions (7) ]. - coadministration of voriconazole for injection with venetoclax at initiation and during the ramp-up phase is contraindicated in patients with chronic lymphocytic leukemia (cll) or small lymphocytic lymphoma (sll) due to the potential for increased risk of tumor lysis syndrome [ see drug interactions (7)]. - ​coadministration of voriconazole for injection with lurasidone is contraindicated since it may result in significant increases in lurasidone exposure and the potential for serious adverse reactions [see drug interactions (7) ]. risk summary voriconazole can cause fetal harm when administered to a pregnant woman. there are no available data on the use of voriconazole for injection in pregnant women. in animal reproduction studies, oral voriconazole was associated with fetal malformations in rats and fetal toxicity in rabbits. cleft palates and hydronephrosis/hydroureter were observed in rat pups exposed to voriconazole during organogenesis at and above 10 mg/kg (0.3 times the rmd of 200 mg every 12 hours based on body surface area comparisons). in rabbits, embryomortality, reduced fetal weight and increased incidence of skeletal variations, cervical ribs and extrasternal ossification sites were observed in pups when pregnant rabbits were orally dosed at 100 mg/kg (6 times the rmd based on body surface area comparisons) during organogenesis. rats exposed to voriconazole from implantation to weaning experienced increased gestational length and dystocia, which were associated with increased perinatal pup mortality at the 10 mg/kg dose [see data ]. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, inform the patient of the potential hazard to the fetus [see warnings and precautions (5.9)]. the background risk of major birth defects and miscarriage for the indicated populations is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20% respectively. data animal data voriconazole was administered orally to pregnant rats during organogenesis (gestation days 6-17) at 10, 30, and 60 mg/kg/day. voriconazole was associated with increased incidences of the malformations in hydroureter and hydronephrosis at 10 mg/kg/day or greater, approximately 0.3 times the recommended human dose (rmd) based on body surface area comparisons, and cleft palate at 60 mg/kg, approximately 2 times the rmd based on body surface area comparisons. reduced ossification of sacral and caudal vertebrae, skull, pubic, and hyoid bone, supernumerary ribs, anomalies of the sternebrae, and dilatation of the ureter/renal pelvis were also observed at doses of 10 mg/kg or greater. there was no evidence of maternal toxicity at any dose. voriconazole was administered orally to pregnant rabbits during the period of organogenesis (gestation days 7-19) at 10, 40, and 100 mg/kg/day. voriconazole was associated with increased post-implantation loss and decreased fetal body weight, in association with maternal toxicity (decreased body weight gain and food consumption) at 100 mg/kg/day (6 times the rmd based on body surface area comparisons). fetal skeletal variations (increases in the incidence of cervical rib and extra sternebral ossification sites) were observed at 100 mg/kg/day. in a peri- and postnatal toxicity study in rats, voriconazole was administered orally to female rats from implantation through the end of lactation at 1, 3, and 10 mg/kg/day. voriconazole prolonged the duration of gestation and labor and produced dystocia with related increases in maternal mortality and decreases in perinatal survival of f1 pups at 10 mg/kg/day, approximately 0.3 times the rmd. risk summary no data are available regarding the presence of voriconazole in human milk, the effects of voriconazole on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for voriconazole for injection and any potential adverse effects on the breastfed child from voriconazole for injection or from the underlying maternal condition. contraception advise females of reproductive potential to use effective contraception during treatment with voriconazole for injection. the coadministration of voriconazole with the oral contraceptive, ortho-novum ® (35 mcg ethinyl estradiol and 1 mg norethindrone), results in an interaction between these two drugs, but is unlikely to reduce the contraceptive effect. monitoring for adverse reactions associated with oral contraceptives and voriconazole is recommended [ see drug interactions (7) and clinical pharmacology (12.3) ]. the safety and effectiveness of voriconazole have been established in pediatric patients aged 12 to 14 years weighing greater than or equal to 50 kg and those aged 15 years and older regardless of body weight based on evidence from adequate and well-controlled studies in adult and pediatric patients and additional pediatric pharmacokinetic and safety data. a total of 51 pediatric patients aged 12 to less than 18 [n=51] from eight adult therapeutic trials provided safety information for voriconazole use in the pediatric population [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14)]. safety and effectiveness in pediatric patients below the age of 2 years has not been established. therefore, voriconazole for injection is not recommended for pediatric patients less than 2 years of age. a higher frequency of liver enzyme elevations was observed in the pediatric patients [ see dosage and administration (2.5), warnings and precautions (5.1), and adverse reactions (6.1)]. the frequency of phototoxicity reactions is higher in the pediatric population. squamous cell carcinoma has been reported in patients who experience photosensitivity reactions. stringent measures for photoprotection are warranted. sun avoidance and dermatologic follow-up are recommended in pediatric patients experiencing photoaging injuries, such as lentigines or ephelides, even after treatment discontinuation [ see warnings and precautions (5.6)] . voriconazole for injection has not been studied in pediatric patients with hepatic or renal impairment [ see dosage and administration ( 2.5, 2.6) ]. hepatic function and serum creatinine levels should be closely monitored in pediatric patients [see dosage and administration (2.6) and warnings and precautions ( 5.1, 5.10) ]. additional pediatric use information is approved for pf prism c.v.’s vfend (voriconazole) for injection. however, due to pf prism c.v.’s marketing exclusivity rights, this drug product is not labeled with that information. in multiple dose therapeutic trials of voriconazole, 9.2% of patients were ≥ 65 years of age and 1.8% of patients were ≥ 75 years of age. in a study in healthy subjects, the systemic exposure (auc) and peak plasma concentrations (c max ) were increased in elderly males compared to young males. pharmacokinetic data obtained from 552 patients from 10 voriconazole therapeutic trials showed that voriconazole plasma concentrations in the elderly patients were approximately 80% to 90% higher than those in younger patients after either iv or oral administration. however, the overall safety profile of the elderly patients was similar to that of the young so no dosage adjustment is recommended [see clinical pharmacology (12.3)].

США - англійська - NLM (National Library of Medicine)

xgen pharmaceuticals djb, inc. - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam 500 mg in 5 ml - levetiracetam is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. levetiracetam is indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy. levetirecetam is indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy. levetiracetam injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible. levetiracetam injection is contraindicted in patients with a hypersensitivity to levetiracetam.  reactions have included anaphylaxis and angioedema. [see warnings and precautions (5.3) ]. there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), including levetiracetam injection, during pregnancy. encourage women who are taking levetiraceta

США - англійська - NLM (National Library of Medicine)

xgen pharmaceuticals djb, inc. - colistimethate sodium (unii: xw0e5ys77g) (colistimethate - unii:dl2r53p963) - colistin 150 mg in 2 ml - colistimethate for injection is indicated for the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacilli. it is particularly indicated when the infection is caused by sensitive strains of pseudomonas aeruginosa . this antibiotic is not indicated for infections due to proteus or neisseria . colistimethate for injection has proven clinically effective in treatment of infections due to the following gram-negative organisms: enterobacter aerogenes, escherichia coli, klebsiella pneumoniae , and pseudomonas aeruginosa. colistimethate for injection may be used to initiate therapy in serious infections that are suspected to be due to gram-negative organisms and in the treatment of infections due to susceptible gram-negative pathogenic bacilli. to reduce the development of drug-resistant bacteria and maintain the effectiveness of colistimethate for injection and other antibacterial drugs, colistimethate for in

США - англійська - NLM (National Library of Medicine)

xgen pharmaceuticals djb, inc. - pentamidine isethionate (unii: v2p3k60da2) (pentamidine - unii:673lc5j4lq) - pentamidine isethionate for injection is indicated for the treatment of pneumonia due to pneumocystis carinii . contraindicated in patients with a history of hypersensitivity to pentamidine isethionate.

США - англійська - NLM (National Library of Medicine)

xgen pharmaceuticals djb, inc. - ibuprofen lysine (unii: n01orx9d6s) (ibuprofen - unii:wk2xyi10qm) - ibuprofen 10 mg in 1 ml - ibuprofen lysine injection is indicated to close a clinically significant patent ductus arteriosus (pda) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management (e.g., fluid restriction, diuretics, respiratory support, etc.) is ineffective. the clinical trial was conducted among infants with an asymptomatic pda. however, the consequences beyond 8 weeks after treatment have not been evaluated; therefore, treatment should be reserved for infants with clear evidence of a clinically significant pda. ibuprofen lysine injection is contraindicated in: - preterm infants with proven or suspected infection that is untreated; - preterm infants with congenital heart disease in whom patency of the pda is necessary for satisfactory pulmonary or systemic blood flow (e.g., pulmonary atresia, severe tetralogy of fallot, severe coarctation of the aorta); - preterm infants who are bleeding, especially those with active intracranial hemorrhage or gastrointestinal bleeding; - preterm infants with thrombocytopenia; - preterm infants with coagulation defects; - preterm infants with or who are suspected of having necrotizing enterocolitis; - preterm infants with significant impairment of renal function. safety and effectiveness have only been established in premature infants.

США - англійська - NLM (National Library of Medicine)

xgen pharmaceuticals djb, inc. - nystatin (unii: bdf1o1c72e) (nystatin - unii:bdf1o1c72e) - nystatin 100000 [usp'u] in 1 g - nystatin topical powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by candida albicans  and other susceptible candida species. nystatin topical powder is not indicated for systemic, oral, intravaginal or ophthalmic use.  nystatin topical powder is contraindicated in patients with a history of hypersensitivity to any of its components.