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

tetraphase pharmaceuticals, inc. - eravacycline dihydrochloride (unii: wk1nmh89vj) (eravacycline - unii:07896928zc) - xerava is indicated for the treatment of complicated intra‑abdominal infections (ciai) caused by susceptible microorganisms: escherichia coli, klebsiella pneumoniae, citrobacter freundii, enterobacter cloacae, klebsiella oxytoca, enterococcus faecalis, enterococcus faecium, staphylococcus aureus, streptococcus anginosus group, clostridium perfringens, bacteroides species, and parabacteroides distasonis in patients 18 years or older [see microbiology (12.4) and clinical studies (14.1)] . limitations of use xerava is not indicated for the treatment of complicated urinary tract infections (cuti) [see clinical studies (14.2)] . to reduce the development of drug-resistant bacteria and maintain the effectiveness of xerava and other antibacterial drugs, xerava 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. xerava is contraindicated for use in patients with known hypersensitivity to eravacycline, tetracycline-class antibacterial drugs, or to any of the excipients [see warnings and precautions (5.1) and adverse reactions (6)] . xerava, like other tetracycline-class antibacterial drugs, may cause discoloration of deciduous teeth and reversible inhibition of bone growth when administered during the second and third trimester of pregnancy [see warnings and precautions (5.1, 5.2), data, use in specific populations (8.4)] . the limited available data with xerava use in pregnant women are insufficient to inform drug‑associated risk of major birth defects and miscarriages. animal studies indicate that eravacycline crosses the placenta and is found in fetal plasma; doses greater than approximately 3- and 2.8- times the clinical exposure, based on auc in rats and rabbits, respectively, administered during the period of organogenesis, were associated with decreased ossification, decreased fetal body weight, and/or increased post-implantation loss [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 estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. animal data embryo-fetal development studies in rats and rabbits reported no treatment-related effects at approximately 3 and 2.8 times the clinical exposure (based on auc). dosing was during the period of organogenesis, i.e., gestation days 7-17 in rats and gestation days 7-19 in rabbits. higher doses, approximately 8.6 and 6.3 times the clinical exposure (based on auc) in rats and rabbits, respectively, were associated with fetal effects including increased post-implantation loss, reduced fetal body weights, and delays in skeletal ossification in both species, and abortion in the rabbit. a peri-natal and post-natal rat toxicity study demonstrated that eravacycline crosses the placenta and is found in fetal plasma following intravenous administration to the dams. this study did not demonstrate anatomical malformations, but there were early decreases in pup weight that were later comparable to controls and a non-significant trend toward increased stillbirths or dead pups during lactation. f1 males from dams treated with 10 mg/kg/day eravacycline that continued to fertility testing had decreased testis and epididymis weights at approximately post-natal day 111 that may have been at least partially related to lower body weights in this group. tetracyclines cross the placenta, are found in fetal tissues, and can have toxic effects on the developing fetus (often related to retardation of skeletal development). evidence of embryotoxicity also has been noted in animals treated early in pregnancy. it is not known whether xerava is excreted in human breast milk. eravacycline (and its metabolites) is excreted in the milk of lactating rats (see data) . tetracyclines are excreted in human milk; however, the extent of absorption of tetracyclines, including eravacycline, by the breastfed infant is not known. there are no data on the effects of xerava on the breastfed infant, or the effects on milk production. because there are other antibacterial drug options available to treat ciai in lactating women and because of the potential for serious adverse reactions, including tooth discoloration and inhibition of bone growth, advise patients that breastfeeding is not recommended during treatment with xerava and for 4 days (based on half-life) after the last dose. animal data eravacycline (and its metabolites) was excreted in the milk of lactating rats on post-natal day 15 following intravenous administration of 3, 5, and 10 mg/kg/day eravacycline. based on animal studies, xerava can lead to impaired spermiation and sperm maturation, resulting in abnormal sperm morphology and poor motility. the effect is reversible in rats. the long-term effects of xerava on male fertility have not been studied [see nonclinical toxicology (13.1)] . the safety and effectiveness of xerava in pediatric patients have not been established. due to the adverse effects of the tetracycline-class of drugs, including xerava on tooth development and bone growth, use of xerava in pediatric patients less than 8 years of age is not recommended [see warnings and precautions (5.1, 5.2)] of the total number of patients with ciai who received xerava in phase 3 clinical trials (n = 520), 158 subjects were ≥ 65 years of age, while 59 subjects were ≥ 75 years of age. no overall differences in safety or efficacy were observed between these subjects and younger subjects. no clinically relevant differences in the pharmacokinetics of eravacycline were observed with respect to age in a population pharmacokinetic analysis of eravacycline [see clinical pharmacology (12.3)] . no dosage adjustment is warranted for xerava in patients with mild to moderate hepatic impairment (child pugh a and child pugh b). adjust xerava dosage in patients with severe hepatic impairment (child pugh c) [see dosage and administration (2.2) and clinical pharmacology (12.3)] . no dosage adjustment is necessary for xerava in patients with renal impairment [see clinical pharmacology (12.3)] .

European Union - English - EMA (European Medicines Agency)

paion deutschland gmbh - eravacycline - infection; bacterial infections - antibacterials for systemic use, - xerava is indicated for the treatment of complicated intra-abdominal infections (ciai) in adults.consideration should be given to official guidance on the appropriate use of antibacterial agents.

Singapore - English - HSA (Health Sciences Authority)

everest medicines (singapore) pte. ltd. - eravacycline dihydrochloride eqv eravacycline - injection, powder, lyophilized, for solution - eravacycline dihydrochloride eqv eravacycline 50mg/vial

Singapore - English - HSA (Health Sciences Authority)

premier diagnostics pte. ltd. - microbiology - mts™ is a quantitative assay for determining the minimum inhibitory concentration (mic) of antimicrobial agents against microorganisms and for detecting the resistance mechanisms

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

avkare - tetracycline hydrochloride (unii: p6r62377kv) (tetracycline - unii:f8vb5m810t) - tetracycline hydrochloride 250 mg - to reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride 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. tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: - upper respiratory tract infections caused by streptococcus pyogenes , streptococcus pneumoniae and hemophilus influenzae . note: tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible. - lower respiratory tract infections caused by streptococcus

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

norbrook laboratories limited - oxytetracycline (unii: x20i9en955) (oxytetracycline anhydrous - unii:slf0d9077s) - oxytetracycline 200 mg in 1 ml - oxytetracycline injection 200 is intended for use in the treatment of the following diseases in beef cattle; dairy cattle; calves, including preruminating (veal) calves; and swine when due to oxytetracycline-susceptible organisms: cattle: oxytetracycline injection 200 is indicated in the treatment of pneumonia and shipping fever complex associated with pasteurella spp. and haemophilus spp.; infectious bovine keratoconjunctivitis (pink eye) caused by moraxella bovis; foot rot and diphtheria caused by fusobacterium necrophorum; bacterial enteritis (scours) caused by escherichia coli; wooden tongue caused by actinobacillus lignieresii; leptospirosis caused by leptospira pomona; and wound infections and acute metritis caused by strains of staphylococci and streptococci organisms sensitive to oxytetracycline. swine: oxytetracycline injection 200 is indicated in the treatment of bacterial enteritis (scours, colibacillosis) caused by escherichia coli ; pneumonia caused by pasteurella multocida; and leptosp

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

state of florida doh central pharmacy - tetracycline hydrochloride (unii: p6r62377kv) (tetracycline - unii:f8vb5m810t) - tetracycline hydrochloride 500 mg - tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: - upper respiratory tract infections caused by streptococcus pyogenes , streptococcus pneumoniae and hemophilus influenzae . note: tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible. - lower respiratory tract infections caused by streptococcus pyogenes , streptococcus pneumoniae , mycoplasma pneumoniae (eaton agent, and klebsiellasp .) - skin and soft tissue infections caused by streptococcus pyogenes , staphylococcus aureaus . (tetracyclines are not the drugs of choice in the treatment of any type of staphylococcal infections.) - infections caused by rickettsia including rocky mountain spotted fever, typhus group infections, q fever, rickettsialpox. - psittacosis of ornithosis caused by chlamydia psittaci . - infections caused by chlamydia trachomatis such as uncomplicated urethral, endocer

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

aspen veterinary resources - tetracycline (unii: f8vb5m810t) (tetracycline - unii:f8vb5m810t) - tetracycline 324 g in 2.27 kg - indications : for use in the control and treatment of the following conditions in swine, calves, and poultry. for swine and calves indications: use for the control and treatment of bacterial enteritis (scours) caused by escherichia coli ; bacterial pneumonia associated with actinobacillus pleuropneumoniae, pasteurella spp. and klebsiella spp. sensitive to tetracycline hydrochloride.  for chickens indications: use for the control of chronic respiratory disease (crd) and air sac disease caused by mycoplasma gallisepticum and escherichia coli ; infectious synovitis caused by mycoplasma synoviae sensitive to tetracycline hydrochloride.  for turkeys indications : use for the control of infectious synovitis caused by mycoplasma synoviae ; bluecomb (transmissible enteritis, coronaviral enteritis) complicated by organisms sensitive to tetracycline hydrochloride.

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

heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc. - tetracycline hydrochloride (unii: p6r62377kv) (tetracycline - unii:f8vb5m810t) - tetracycline hydrochloride 250 mg - to reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride 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. tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: - upper respiratory tract infections caused by streptococcus pyogenes, streptococcus pneumoniae and hemophilus influenzae. note: tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible. - lower respiratory tract infections caused by strep

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

actavis pharma, inc. - tetracycline hydrochloride (unii: p6r62377kv) (tetracycline - unii:f8vb5m810t) - tetracycline hydrochloride 250 mg - to reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride capsules and other antibacterial drugs, tetracycline hydrochloride capsules 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. tetracycline is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: - upper respiratory tract infections caused by streptococcus pyogenes , streptococcus pneumoniae and haemophilus influenzae . note: tetracycline should not be used for streptococcal disease unless the organism has been demonstrated to be susceptible. - lower respiratory tract infections caused