Združene države Amerike - angleščina - NLM (National Library of Medicine)

greenstone llc - azithromycin dihydrate (unii: 5fd1131i7s) (azithromycin anhydrous - unii:j2klz20u1m) - azithromycin anhydrous 600 mg - azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. non-gonococcal urethritis and cervicitis due to chlamydia trachomatis. prophylaxis of disseminated mycobacterium avium complex (mac) disease azithromycin, taken alone or in combination with rifabutin at its approved dose, is indicated for the prevention of disseminated mac disease in persons with advanced hiv infection [see dosage and administration (2)]. treatment of disseminated mac disease azithromycin, taken in combination with ethambutol, is indicated for the treatment of disseminated mac infections in persons with advanced hiv infection [see use in specific populations (8.4) and clinical studies (14.1)]. to reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat infection

Združene države Amerike - angleščina - NLM (National Library of Medicine)

amneal pharmaceuticals llc - atovaquone (unii: y883p1z2lt) (atovaquone - unii:y883p1z2lt) - atovaquone 750 mg in 5 ml - atovaquone oral suspension is indicated for the prevention of pneumocystis jirovecii pneumonia (pcp) in adults and adolescents (aged 13 years and older) who cannot tolerate trimethoprim-sulfamethoxazole (tmp-smx).  atovaquone oral suspension is indicated for the acute oral treatment of mild-to-moderate pcp in adults and adolescents (aged 13 years and older) who cannot tolerate tmp-smx.  clinical experience with atovaquone oral suspension for the treatment of pcp has been limited to subjects with mild-to-moderate pcp (alveolar-arterial oxygen diffusion gradient [(a-a)do2 ] ≤45 mm hg). treatment of more severe episodes of pcp with atovaquone oral suspension has not been studied. the efficacy of atovaquone in subjects who are failing therapy with tmp-smx has also not been studied.  atovaquone oral suspension is contraindicated in patients who develop or have a history of hypersensitivity reactions (e.g., angioedema, bronchospasm, throat tightness, urticaria) to atovaquone or any of the components of atovaquone oral suspension. risk summary available data from postmarketing experience with use of atovaquone in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. pregnant women with hiv who are infected with pcp are at increased risk of adverse pregnancy outcomes (see clinical considerations) . atovaquone given orally by gavage to pregnant rats and rabbits during organogenesis did not cause fetal malformations at plasma concentrations up to 3 times and 0.5 times, respectively, the estimated human exposure based on steady-state plasma concentrations (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk: pregnant women with hiv who are infected with pcp are at increased risk of severe illness and maternal death associated with pcp compared with non-pregnant women. data animal data: atovaquone administered in oral doses of 250 mg/kg/day, 500 mg/kg/day, and 1,000 mg/kg/day to pregnant rats during organogenesis (gestation day [gd] 6 to gd15) did not cause maternal or embryo-fetal toxicity at doses up to 1,000 mg/kg/day corresponding to maternal plasma concentrations approximately 3 times the estimated human exposure during the treatment of pcp based on steady-state plasma concentrations. in pregnant rabbits, atovaquone administered in oral doses of 300 mg/kg/day, 600 mg/kg/day, and 1,200 mg/kg/day during organogenesis (gd6 to gd18) caused decreased fetal body length at a maternally toxic dose of 1,200 mg/kg/day corresponding to a plasma concentration that is approximately 0.5 times the estimated human exposure based on steady-state plasma concentrations. in a pre- and post-natal study in rats, atovaquone administered in oral doses of 250, 500, and 1,000 mg/kg/day from gd15 until lactation day (ld) 20 did not impair the growth or developmental effects in first generation offspring at doses up to 1,000 mg/kg/day corresponding to approximately 3 times the estimated human exposure based on steady-state plasma concentrations during the treatment of pcp. atovaquone crossed the placenta and was present in fetal rat and rabbit tissue. risk summary the centers for disease control and prevention recommend that hiv-1-infected mothers not breastfeed their infants to avoid risking postnatal transmission of hiv-1. there are no data on the presence of atovaquone in human milk, the effects on the breastfed child, or the effects on milk production. atovaquone was detected in rat milk when lactating rats were administered oral atovaquone (see data) . when a drug is present in animal milk, it is likely the drug will be present in human milk. because of the potential for hiv-1 transmission to hiv-negative infants, instruct mothers with hiv-1 not to breastfeed if they are taking atovaquone for the prevention or treatment of pcp. data in a rat study with doses of 10 mg/kg and 250 mg/kg given orally by gavage on postpartum day 11, atovaquone concentrations in the milk were 30% of the concurrent atovaquone concentrations in the maternal plasma at both doses. the concentration of drug in animal milk does not necessarily predict the concentration of drug in human milk. evidence of safety and effectiveness in pediatric patients (aged 12 years and younger) has not been established. in a trial of atovaquone oral suspension administered once daily with food for 12 days to 27 hiv-1-infected, asymptomatic infants and children aged between 1 month and 13 years, the pharmacokinetics of atovaquone were age-dependent. the average steady-state plasma atovaquone concentrations in the 24 subjects with available concentration data are shown in table 5. table 5. average steady-state plasma atovaquone concentrations in pediatric subjects age dose of atovaquone oral suspension 10 mg/kg 30 mg/kg 45 mg/kg average css in mcg/ml (mean ± sd) 1 to 3 months 5.9 (n = 1) 27.8 ± 5.8 (n = 4) _ >3 to 24 months 5.7 ± 5.1 (n = 4) 9.8 ± 3.2 (n = 4) 15.4 ± 6.6 (n = 4) >2 to 13 years 16.8 ± 6.4 (n = 4) 37.1 ± 10.9 (n = 3) _ css = concentration at steady-state. clinical trials of atovaquone did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects.

Združene države Amerike - angleščina - NLM (National Library of Medicine)

prasco laboratories - atovaquone (unii: y883p1z2lt) (atovaquone - unii:y883p1z2lt) - atovaquone 750 mg in 5 ml - atovaquone oral suspension is indicated for the prevention of pneumocystis jirovecii pneumonia (pcp) in adults and adolescents (aged 13 years and older) who cannot tolerate trimethoprim-sulfamethoxazole (tmp-smx). atovaquone oral suspension is indicated for the acute oral treatment of mild-to-moderate pcp in adults and adolescents (aged 13 years and older) who cannot tolerate tmp-smx. clinical experience with atovaquone oral suspension for the treatment of pcp has been limited to subjects with mild-to-moderate pcp (alveolar-arterial oxygen diffusion gradient [(a-a)do2 ] ≤45 mm hg). treatment of more severe episodes of pcp with atovaquone oral suspension has not been studied. the efficacy of atovaquone oral suspension in subjects who are failing therapy with tmp-smx has also not been studied. atovaquone oral suspension is contraindicated in patients who develop or have a history of hypersensitivity reactions (e.g., angioedema, bronchospasm, throat tightness, urticaria) to atovaquone or to any component of the

Združene države Amerike - angleščina - NLM (National Library of Medicine)

glaxosmithkline llc - atovaquone (unii: y883p1z2lt) (atovaquone - unii:y883p1z2lt) - atovaquone 750 mg in 5 ml - mepron oral suspension is indicated for the prevention of pneumocystis jirovecii pneumonia (pcp) in adults and adolescents (aged 13 years and older) who cannot tolerate trimethoprim-sulfamethoxazole (tmp-smx). mepron oral suspension is indicated for the acute oral treatment of mild-to-moderate pcp in adults and adolescents (aged 13 years and older) who cannot tolerate tmp-smx. clinical experience with mepron for the treatment of pcp has been limited to subjects with mild-to-moderate pcp (alveolar-arterial oxygen diffusion gradient [(a-a)do2 ] ≤45 mm hg). treatment of more severe episodes of pcp with mepron has not been studied. the efficacy of mepron in subjects who are failing therapy with tmp-smx has also not been studied. mepron oral suspension is contraindicated in patients who develop or have a history of hypersensitivity reactions (e.g., angioedema, bronchospasm, throat tightness, urticaria) to atovaquone or any of the components of mepron. risk summary available data from postmarketing experience with

Združene države Amerike - angleščina - NLM (National Library of Medicine)

veloxis pharmaceuticals, inc - tacrolimus (unii: wm0haq4wnm) (tacrolimus anhydrous - unii:y5l2157c4j) - tacrolimus anhydrous 0.75 mg - envarsus xr is indicated for the prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants [see clinical studies (14.1)]. envarsus xr is indicated for the prophylaxis of organ rejection in kidney transplant patients converted from tacrolimus immediate-release formulations, in combination with other immunosuppressants [see clinical studies (14.2)]. envarsus xr is contraindicated in patients with known hypersensitivity to tacrolimus or to any of the ingredients in envarsus xr. pregnancy exposure registry there is a pregnancy registry that monitors pregnancy outcomes in women exposed to envarsus xr during pregnancy. the transplantation pregnancy registry international (tpri) is a voluntary pregnancy exposure registry that monitors outcomes of pregnancy in female transplant recipients and those fathered by male transplant recipients exposed to immunosuppressants including tacrolimus. healthcare providers are encouraged to advise their patients to register by contacting the transplantation pregnancy registry international at 1-877-955-6877 or https://www.transplantpregnancyregistry.org. risk summary tacrolimus can cause fetal harm when administered to a pregnant woman. data from postmarketing surveillance and tpri suggest that infants exposed to tacrolimus in utero are at a risk of prematurity, birth defects/congenital anomalies, low birth weight, and fetal distress [see human data]. advise pregnant women of the potential risk to the fetus. administration of oral tacrolimus to pregnant rabbits and rats throughout the period of organogenesis was associated with maternal toxicity/lethality, and an increased incidence of abortion, malformation and embryofetal death at clinically relevant doses (0.7 to 3.7 times the recommended clinical dose [0.14 mg/kg/day], on a mg/m² basis). administration of oral tacrolimus to pregnant rats after organogenesis and throughout lactation produced maternal toxicity, effects on parturition, reduced pup viability and reduced pup weight at clinically relevant doses (1.2 to 3.7 times the recommended clinical dose, on a mg/m² basis). administration of oral tacrolimus to rats prior to mating, and throughout gestation and lactation produced maternal toxicity/lethality, marked effects on parturition, embryofetal loss, malformations, and reduced pup viability at clinically relevant doses (1.2 to 3.7 times the recommended clinical dose, on a mg/m² basis). interventricular septal defects, hydronephrosis, craniofacial malformations and skeletal effects were observed in offspring that died [see animal data]. the background risk of major birth defects and miscarriage in 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. clinical considerations disease-associated maternal and/or embryo-fetal risk risks during pregnancy are increased in organ transplant recipients. the risk of premature delivery following transplantation is increased. pre-existing hypertension and diabetes confer additional risk to the pregnancy of an organ transplant recipient. pre-gestational and gestational diabetes are associated with birth defects/congenital anomalies, hypertension, low birth weight and fetal death. cholestasis of pregnancy (cop) was reported in 7% of liver or liver-kidney (lk) transplant recipients, compared with approximately 1% of pregnancies in the general population. however, cop symptoms resolved postpartum and no long-term effects on the offspring were reported. maternal adverse reactions envarsus xr may increase hyperglycemia in pregnant women with diabetes (including gestational diabetes). monitor maternal blood glucose levels regularly [see warnings and precautions (5.4)]. envarsus xr may exacerbate hypertension in pregnant women and increase pre-eclampsia. monitor and control blood pressure [see warnings and precautions (5.7, 5.8)]. fetal/neonatal adverse reactions renal dysfunction, transient neonatal hyperkalemia and low birth weight have been reported at the time of delivery in infants of mothers taking envarsus xr. labor or delivery there is an increased risk for premature delivery (<37 weeks) following transplantation and maternal exposure to envarsus xr. data human data there are no adequate and well controlled studies on the effects of tacrolimus in human pregnancy. safety data from the tpri and postmarketing surveillance suggest infants exposed to tacrolimus in utero have an increased risk for miscarriage, pre-term delivery (<37 weeks), low birth weight (<2500 g), birth defects/congenital anomalies and fetal distress. tpri reported 450 and 241 total pregnancies in kidney and liver transplant recipients exposed to tacrolimus, respectively. the tpri pregnancy outcomes are summarized in table 8. in the table below, the number of recipients exposed to tacrolimus concomitantly with mycophenolic acid (mpa) products during the preconception and first trimester periods is high (27% and 29% for renal and liver transplant recipients, respectively). because mpa products may also cause birth defects, the birth defect rate may be confounded and this should be taken into consideration when reviewing the data, particularly for birth defects. birth defects observed include cardiac malformations, craniofacial malformations, renal/urogenital disorders, skeletal abnormalities, neurological abnormalities and multiple malformations. * includes multiple births and terminations. † birth defect rate confounded by concomitant mpa products exposure in over half of offspring with birth defects. additional information reported by tpri in pregnant transplant patients receiving tacrolimus included diabetes during pregnancy in 9% of kidney recipients and 13% of liver recipients and hypertension during pregnancy in 53% of kidney recipients and 16.2% of liver recipients. animal data administration of oral tacrolimus to pregnant rabbits throughout organogenesis produced maternal toxicity and abortion at 0.32 mg/kg (0.7 times the recommended clinical dose based on body surface area). at 1 mg/kg (2.3 times the recommended clinical dose) embryofetal lethality and fetal malformations (ventricular hypoplasia, interventricular septal defect, bulbous aortic arch, stenosis of ductus arteriosus, omphalocele, gallbladder agenesis, skeletal anomalies) were observed. administration of 3.2 mg/kg oral tacrolimus (3.7 times the recommended clinical dose) to pregnant rats throughout organogenesis produced maternal toxicity/lethality, embryofetal lethality and decreased fetal body weight in the offspring of c-sectioned dams; and decreased pup viability and interventricular septal defect in offspring of dams that delivered. in a peri/postnatal development study, oral administration of tacrolimus to pregnant rats during late gestation (after organogenesis) and throughout lactation produced maternal toxicity, effects of parturition, and reduced pup viability at 3.2 mg/kg (3.7 times the recommended clinical dose); among these pups that died early, an increased incidence of kidney hydronephrosis was observed. reduced pup weight was observed at 1mg/kg (1.2 times the recommended clinical dose). administration of oral tacrolimus to rats prior to mating, and throughout gestation and lactation produced maternal toxicity/lethality, embryofetal loss and reduced pup viability at 3.2 mg/kg (3.7 times the recommended clinical dose). interventricular septal defects, hydronephrosis, craniofacial malformations and skeletal effects were observed in offspring that died. effects on parturition (incomplete delivery of nonviable pups) were observed at 1 mg/kg (1.2 times the recommended clinical dose) [see nonclinical toxicology (13.1)]. risk summary controlled lactation studies have not been conducted in humans; however tacrolimus has been reported to be present in human milk. the effects of tacrolimus on the breastfed infant, or on milk production have not been assessed. tacrolimus is excreted in rat milk and in peri-/postnatal rat studies, exposure to tacrolimus during the postnatal period was associated with developmental toxicity in the offspring at clinically relevant doses [see pregnancy (8.1), nonclinical toxicology (13.1)]. the development and health benefits of breastfeeding should be considered along with the mother’s clinical need for envarsus xr and any potential adverse effects on the breastfed child from envarsus xr or from the underlying maternal condition. contraception envarsus xr can cause fetal harm when administered to pregnant women. advise female and male patients of reproductive potential to speak with their healthcare provider on family planning options including appropriate contraception prior to starting treatment with envarsus xr [see use in specific populations (8.1), nonclinical toxicology (13.1)]. infertility based on findings in animals, male and female fertility may be compromised by treatment with envarsus xr [see nonclinical toxicology (13.1)]. the safety and effectiveness of envarsus xr in pediatric patients have not been established. clinical studies of envarsus xr did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. in studies 1, 2 and 3, there were 37 patients 65 years of age and older, and no patients were over 75 years [see clinical studies (14)] . other reported clinical experience has not identified differences in responses between the elderly and younger patients. 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. the pharmacokinetics of tacrolimus in patients with renal impairment was similar to that in healthy subjects with normal renal function. however, due to its potential for nephrotoxicity, monitoring of renal function in patients with renal impairment is recommended; tacrolimus dosage should be reduced if indicated [see warnings and precautions (5.5) and clinical pharmacology (12.3)] . the mean clearance of tacrolimus was substantially lower in patients with severe hepatic impairment (mean child-pugh score: >10) compared to healthy subjects with normal hepatic function [see clinical pharmacology (12.3)] . with greater tacrolimus whole blood trough concentrations in patients with severe hepatic impairment, there is a greater risk of adverse reactions and dosage reduction is recommended [see dosage and administration (2.4)] . for patients with moderate hepatic impairment, monitor tacrolimus whole blood trough concentrations. for patients with mild hepatic impairment, no dosage adjustments are needed. african-american patients may need to be titrated to higher envarsus xr dosages to attain comparable trough concentrations compared to caucasian patients. the pharmacokinetics of envarsus xr were evaluated in a study of 46 stable african-american kidney transplant recipients converted from tacrolimus immediate-release to envarsus xr and indicated that an 80% conversion factor is appropriate for african-american patients [see dosage and administration (2.4), clinical pharmacology (12.3)] . african-american and hispanic kidney transplant patients are at an increased risk for new onset diabetes after transplant. monitor blood glucose concentrations and treat appropriately [see warnings and precautions (5.4)].

Združene države Amerike - angleščina - NLM (National Library of Medicine)

preferred pharmaceuticals, inc. - azithromycin dihydrate (unii: 5fd1131i7s) (azithromycin anhydrous - unii:j2klz20u1m) - azithromycin anhydrous 1 g - azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. non-gonococcal urethritis and cervicitis due to chlamydia trachomatis. prophylaxis of disseminated mycobacterium avium complex (mac) disease azithromycin, taken alone or in combination with rifabutin at its approved dose, is indicated for the prevention of disseminated mac disease in persons with advanced hiv infection [see dosage and administration (2)]. treatment of disseminated mac disease azithromycin, taken in combination with ethambutol, is indicated for the treatment of disseminated mac infections in persons with advanced hiv infection [see use in specific populations (8.4) and clinical studies (14.1)]. to reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat infection

Združene države Amerike - angleščina - NLM (National Library of Medicine)

lupin limited - azithromycin monohydrate (unii: jte4mnn1md) (azithromycin anhydrous - unii:j2klz20u1m) - azithromycin anhydrous 600 mg - to reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin tablets usp and other antibacterial drugs, azithromycin tablets usp should be used only to treat 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. azithromycin tablets usp are a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. prophylaxis of disseminated mycobacterium avium complex (mac) disease azithromycin tablets usp, taken alone or in combination with rifabutin at its approved dose, is indicated for the prevention of disseminated mac disease in persons with ad

Združene države Amerike - angleščina - NLM (National Library of Medicine)

merck sharp & dohme corp. - boceprevir (unii: 89bt58kelh) (boceprevir - unii:89bt58kelh) - boceprevir 200 mg

Združene države Amerike - angleščina - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - atovaquone (unii: y883p1z2lt) (atovaquone - unii:y883p1z2lt), proguanil hydrochloride (unii: r71y86m0wt) (proguanil - unii:s61k3p7b2v) - atovaquone 250 mg - atovaquone and proguanil hydrochloride tablets are indicated for the prophylaxis of plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported. atovaquone and proguanil hydrochloride tablets are indicated for the treatment of acute, uncomplicated p. falciparum malaria. atovaquone and proguanil hydrochloride have been shown to be effective in regions where the drugs chloroquine, halofantrine, mefloquine, and amodiaquine may have unacceptable failure rates, presumably due to drug resistance. - atovaquone and proguanil hydrochloride tablets are contraindicated in individuals with known hypersensitivity reactions (e.g., anaphylaxis, erythema multiforme or stevens-johnson syndrome, angioedema, vasculitis) to atovaquone or proguanil hydrochloride or any component of the formulation. - atovaquone and proguanil hydrochloride tablets are contraindicated for prophylaxis of p.   falciparum malaria in patients with sever

Združene države Amerike - angleščina - NLM (National Library of Medicine)

prasco laboratories - atovaquone (unii: y883p1z2lt) (atovaquone - unii:y883p1z2lt), proguanil hydrochloride (unii: r71y86m0wt) (proguanil - unii:s61k3p7b2v) - atovaquone 250 mg - atovaquone and proguanil hydrochloride tablets are indicated for the prophylaxis of plasmodium falciparum malaria, including in areas where chloroquine resistance has been reported. atovaquone and proguanil hydrochloride tablets are indicated for the treatment of acute, uncomplicated p. falciparum malaria. atovaquone and proguanil hydrochloride have been shown to be effective in regions where the drugs chloroquine, halofantrine, mefloquine, and amodiaquine may have unacceptable failure rates, presumably due to drug resistance. risk summary available data from published literature and postmarketing experience with use of atovaquone and proguanil hydrochloride in pregnant women are insufficient to identify a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. the proguanil component of atovaquone and proguanil hydrochloride tablets acts to inhibit parasitic dihydrofolate reductase; however, pregnant women and females of reproductive potential should continue fola