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camber pharmaceuticals, inc. - levofloxacin (unii: 6gnt3y5lmf) (levofloxacin anhydrous - unii:rix4e89y14) - levofloxacin anhydrous 250 mg - levofloxacin tablets are indicated in adult patients for the treatment of nosocomial pneumonia due to methicillin-susceptible staphylococcus aureus, pseudomonas aeruginosa, serratia marcescens, escherichia coli,  klebsiella pneumoniae, haemophilus influenzae, or streptococcus pneumoniae. adjunctive therapy should be used as clinically indicated. where pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended [see clinical studies ( 14.1)]. levofloxacin tablets are indicated in adult patients for the treatment of community-acquired pneumonia due to methicillin-susceptible staphylococcus aureus, streptococcus pneumoniae (including  multi-drug-resistant streptococcus pneumoniae [mdrsp]), haemophilus influenzae, haemophilus parainfluenzae, klebsiella pneumoniae, moraxella catarrhalis, chlamydophila pneumoniae, legionella pneumophila, or mycoplasma pneumoniae [see dosage and administration ( 2.1) and clinical studies ( 14.2)]. mdrsp isolates are isolates resistant to two or more of the following antibacterials: penicillin (mic ≥2 mcg/ml), 2 nd generation cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole. levofloxacin tablets are indicated in adult patients for the treatment of community-acquired pneumonia due to streptococcus pneumoniae (excluding multi-drug-resistant isolates [mdrsp]),  haemophilus influenzae, haemophilus parainfluenzae, mycoplasma pneumoniae, or chlamydophila pneumoniae [see dosage and administration ( 2.1) and clinical studies ( 14.3)].  levofloxacin tablets are indicated in adult patients for the treatment of complicated skin and skin structure infections due to methicillin-susceptible staphylococcus aureus, enterococcus faecalis, streptococcus pyogenes, or proteus mirabilis [see clinical studies ( 14.5)]. levofloxacin tablets are indicated in adult patients for the treatment of uncomplicated skin and skin structure infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to methicillin-susceptible staphylococcus aureus, or streptococcus pyogenes. levofloxacin tablets are indicated in adult patients for the treatment of chronic bacterial prostatitis due to escherichia coli, enterococcus faecalis, or methicillin-susceptible staphylococcus epidermidis [see clinical studies ( 14.6)]. levofloxacin tablets are indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized bacillus anthracis in adults and pediatric patients, 6 months of age and older [see dosage and administration ( 2.2)].  the effectiveness of levofloxacin tablets is based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit. levofloxacin tablets have not been tested in humans for the post-exposure prevention of inhalation anthrax. the safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations of therapy beyond 14 days has not been studied. prolonged levofloxacin tablets therapy should only be used when the benefit outweighs the risk [see clinical studies ( 14.9 )]. levofloxacin tablets are indicated for treatment of plague, including pneumonic and septicemic plague, due to yersinia pestis ( y. pestis ) and prophylaxis for plague in adults and pediatric patients, 6 months of age and older [see dosage and administration ( 2.2)]. efficacy studies of levofloxacin tablets could not be conducted in humans with plague for ethical and feasibility reasons. therefore, approval of this indication was based on an efficacy study conducted in animals [see clinical studies ( 14.10)]. levofloxacin tablets are indicated in adult patients for the treatment of complicated urinary tract infections due to escherichia coli, klebsiella pneumoniae, or proteus mirabilis [see clinical studies ( 14.7)].  levofloxacin tablets are indicated in adult patients for the treatment of complicated urinary tract infections (mild to moderate) due to enterococcus faecalis, enterobacter cloacae, escherichia coli, klebsiella pneumoniae, proteus mirabilis, or pseudomonas aeruginosa [see clinical studies (14.8) ]. levofloxacin tablets are indicated in adult patients for the treatment of acute pyelonephritis caused by escherichia coli, including cases with concurrent bacteremia [see clinical studies (14.7, 14.8)]. levofloxacin tablets are indicated in adult patients  for the treatment of uncomplicated urinary tract infections (mild to moderate) due to escherichia coli, klebsiella pneumoniae, or staphylococcus saprophyticus. because fluoroquinolones, including levofloxacin tablets, have been associated with serious adverse reactions [see warnings and precautions ( 5.1 to  5.15 )] and for some patients uncomplicated urinary tract infection is self-limiting, reserve levofloxacin tablets for treatment of uncomplicated urinary tract infections in patients who have no alternative treatment options. levofloxacin tablets are indicated in adult patients for the treatment of acute bacterial exacerbation of chronic bronchitis (abecb) due to methicillin-susceptible staphylococcus aureus, streptococcus pneumoniae, haemophilus influenzae, haemophilus parainfluenzae, or moraxella catarrhalis. because fluoroquinolones, including levofloxacin tablets, have been associated with serious adverse reactions [see warnings and precautions ( 5.1to  5.15 )] and for some patients abecb is self-limiting, reserve levofloxacin tablets for treatment of abecb in patients who have no alternative treatment options. levofloxacin tablets are indicated in adult patients for the treatment of acute bacterial sinusitis (abs) due to streptococcus pneumoniae, haemophilus influenzae, or moraxella catarrhalis [see clinical studies ( 14.4)]. because fluoroquinolones, including levofloxacin tablets, have been associated with serious adverse reactions [see warnings and precautions ( 5.1to  5.15)] and for some patients abs is self-limiting, reserve levofloxacin tablets for treatment of abs in patients who have no alternative treatment options. to reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets and other antibacterial drugs, levofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. culture and susceptibility testing appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin [see microbiology ( 12.4)] . therapy with levofloxacin tablets may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected. as with other drugs in this class, some isolates of pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with levofloxacin tablets. culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance. levofloxacin tablets are contraindicated in persons with known hypersensitivity to levofloxacin, or other quinolone antibacterials [see warnings and precautions ( 5.3)]. risk summary published information from case reports, case control studies and observational studies on levofloxacin administered during pregnancy have not identified any drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, oral administration of levofloxacin to pregnant rats and rabbits during organogenesis at doses up to 9.4 times and 1.1 times the maximum recommended human dose (mrhd), respectively, did not result in teratogenicity. fetal toxicity was seen in the rat study, but was absent at doses up to 1.2 times the maximum recommended human dose (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 risks of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.  data animal data levofloxacin was not teratogenic in an embryofetal development study in rats treated during organogenesis with oral doses as high as 810 mg/kg/day which corresponds to 9.4 times the mrhd (based upon doses normalized for total body surface area). the oral dose of 810 mg/kg/day (high dose) to rats caused decreased fetal body weight and increased fetal mortality that was not seen at the next lower dose (mid-dose, 90 mg/kg/day, equivalent to 1.2 times the mrhd (based upon doses normalized for total body surface area). maternal toxicity was limited to lower weight gain in the mid and high dose groups. no teratogenicity was observed in an embryofetal development study in rabbits dosed orally during organogenesis with doses as high as 50 mg/kg/day, which corresponds to 1.1 times the mrhd (based upon doses normalized for total body surface area). maternal toxicity at that dose consisted of lower weight gain and decreased food consumption relative to controls and abortion in four of sixteen dams. risk summary published literature reports that levofloxacin is present in human milk following intravenous and oral administration ( see data ). there is no information regarding effects of levofloxacin on milk production or the breastfed infant. because of the potential risks of serious adverse reactions, in breastfed infants, for most indications, a lactating woman may consider pumping and discarding breast milk during treatment with levofloxacin and an additional two days (five half-lives) after the last dose. alternatively, advise a lactating woman that breastfeeding is not recommended during treatment with levofloxacin and for an additional two days (five half-lives) after the last dose [see use in specific populations (8.4) and clinical pharmacology (12.3)] . however, for inhalation anthrax (post exposure), during an incident resulting in exposure to anthrax, the risk-benefit assessment of continuing breastfeeding while the mother (and potentially the infant) is (are) on levofloxacin may be acceptable [see dosage and administration (2.2), pediatric use (8.4), and clinical studies (14.2)]. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for levofloxacin and any potential adverse effects on the breastfed child from levofloxacin or from the underlying maternal condition. data a published literature reports that peak levofloxacin human milk concentration was 8.2 mg/l at 5 hours after dosing in a woman who received 500 mg of intravenous, followed by oral, levofloxacin daily. for an infant fed exclusively with human milk (approximately 900 ml/day), an estimated maximum daily dose of levofloxacin through breastfeeding is 5 mg (i.e., approximately 1% of maternal daily dose). the above data come from a single case and may not be generalizable to the general population of lactating women. quinolones, including levofloxacin, cause arthropathy and osteochondrosis in juvenile animals of several species. [see warnings and precautions ( 5.12) and animal toxicology and/or pharmacology ( 13.2)]. inhalational anthrax (post-exposure) levofloxacin is indicated in pediatric patients 6 months of age and older, for inhalational anthrax (post-exposure). the risk-benefit assessment indicates that administration of levofloxacin to pediatric patients is appropriate. the safety of levofloxacin in pediatric patients treated for more than 14 days has not been studied [see indications and usage (1.7),   dosage and administration ( 2.2 ) and clinical studies ( 14.9)]. plague levofloxacin is indicated in pediatric patients, 6 months of age and older, for treatment of plague, including pneumonic and septicemic plague due to yersinia pestis (y. pestis) and prophylaxis for plague. efficacy studies of levofloxacin could not be conducted in humans with pneumonic plague for ethical and feasibility reasons. therefore, approval of this indication was based on an efficacy study conducted in animals. the risk-benefit assessment indicates that administration of levofloxacin to pediatric patients is appropriate [see indications and usage ( 1.8),  dosage and administration ( 2.2)  and clinical studies ( 14.10 )]. safety and effectiveness of levofloxacin in pediatric patients below the age of six months have not been established. pharmacokinetics following intravenous administration the pharmacokinetics of levofloxacin following a single intravenous dose were investigated in pediatric patients ranging in age from six months to 16 years. pediatric patients cleared levofloxacin faster than adult patients resulting in lower plasma exposures than adults for a given mg/kg dose [see clinical pharmacology ( 12.3) and clinical studies ( 14.9) ]. dosage in pediatric patients with inhalational anthrax or plague for the recommended levofloxacin tablet dosage in pediatric patients with inhalational anthrax or plague, see dosage and administration ( 2.2 ). levofloxacin tablets cannot be administered to pediatric patients who weigh less than 30 kg because of the limitations of the available strengths. alternative formulations of levofloxacin may be considered for pediatric patients who weigh less than 30 kg. adverse reactions in clinical trials, 1,534 pediatric patients (6 months to 16 years of age) were treated with oral and intravenous levofloxacin. pediatric patients 6 months to 5 years of age received levofloxacin 10 mg/kg twice a day and pediatric patients greater than 5 years of age received 10 mg/kg once a day (maximum 500 mg per day) for approximately 10 days. levofloxacin tablets can only be administered to pediatric patients with inhalational anthrax (post-exposure) or plague who are 30 kg or greater due to the limitations of the available strengths [see dosage and administration ( 2.2)]. a subset of pediatric patients in the clinical trials (1,340 levofloxacin-treated and 893 non-fluoroquinolone-treated) enrolled in a prospective, long-term surveillance study to assess the incidence of protocol-defined musculoskeletal disorders (arthralgia, arthritis, tendinopathy, gait abnormality) during 60 days and 1 year following the first dose of the study drug. pediatric patients treated with levofloxacin had a significantly higher incidence of musculoskeletal disorders when compared to the non-fluoroquinolone-treated children as illustrated in table 7. levofloxacin tablets can only be administered to pediatric patients with inhalational anthrax (post-exposure) or plague who are 30 kg or greater due to the limitations of the available strengths [see dosage and administration ( 2.2 )]. table 7:  incidence of musculoskeletal disorders in pediatric clinical trial * non-fluoroquinolone: ceftriaxone, amoxicillin/clavulanate, clarithromycin † 2-sided fisher's exact test  ‡  there were 1,199 levofloxacin-treated and 804 non-fluoroquinolone-treated pediatric patients who had a one-year evaluation visit. however, the incidence of musculoskeletal disorders was calculated using all reported events during the specified period for all pediatric patients enrolled regardless of whether they completed the 1-year evaluation visit. arthralgia was the most frequently occurring musculoskeletal disorder in both treatment groups. most of the musculoskeletal disorders in both groups involved multiple weight-bearing joints. disorders were moderate in 8/46 (17%) children and mild in 35/46 (76%) levofloxacin-treated pediatric patients and most were treated with analgesics. the median time to resolution was 7 days for levofloxacin-treated pediatric patients and 9 for non-fluoroquinolone-treated children (approximately 80% resolved within 2 months in both groups). no pediatric patient had a severe or serious disorder and all musculoskeletal disorders resolved without sequelae. vomiting and diarrhea were the most frequently reported adverse reactions, occurring in similar frequency in the levofloxacin-treated and non-fluoroquinolone-treated pediatric patients. in addition to the adverse reactions reported in pediatric patients in clinical trials, adverse reactions reported in adults during clinical trials or post-marketing experience [see adverse reactions ( 6)] may also be expected to occur in pediatric patients. geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as levofloxacin. this risk is further increased in patients receiving concomitant corticosteroid therapy. tendinitis or tendon rupture can involve the achilles, hand, shoulder, or other tendon sites and can occur during or after completion of therapy; cases occurring up to several months after fluoroquinolone treatment have been reported. caution should be used when prescribing levofloxacin to elderly patients especially those on corticosteroids. patients should be informed of this potential side effect and advised to discontinue  levofloxacin and contact their healthcare provider if any symptoms of tendinitis or tendon rupture occur [see boxed warning; warnings and precautions ( 5.2); and adverse reactions ( 6.3)]. in phase 3 clinical trials, 1,945 levofloxacin-treated patients (26%) were ≥ 65 years of age. of these, 1,081 patients (14%) were between the ages of 65 and 74 and 864 patients (12%) were 75 years or older. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out. severe, and sometimes fatal, cases of hepatotoxicity have been reported post-marketing in association with levofloxacin. the majority of fatal hepatotoxicity reports occurred in patients 65 years of age or older and most were not associated with hypersensitivity. levofloxacin should be discontinued immediately if the patient develops signs and symptoms of hepatitis [see warnings and precautions ( 5.8)]. epidemiologic studies report an increased rate of aortic aneurysm and dissection within two months following use of fluoroquinolones, particularly in elderly patients [see warnings and precautions ( 5.9)]. elderly patients may be more susceptible to drug-associated effects on the qt interval. therefore, precaution should be taken when using levofloxacin with concomitant drugs that can result in prolongation of the qt interval (e.g., class ia or class iii antiarrhythmics) or in patients with risk factors for torsade de pointes (e.g., known qt prolongation, uncorrected hypokalemia) [see warnings and precautions ( 5.11)]. the pharmacokinetic properties of levofloxacin in younger adults and elderly adults do not differ significantly when creatinine clearance is taken into consideration. however, since the drug is known to be substantially excreted by the kidney, 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 [ see clinical pharmacology ( 12.3)]. clearance of levofloxacin is substantially reduced and plasma elimination half-life is substantially prolonged in patients with renal impairment (creatinine clearance < 50 ml/min), requiring dosage adjustment in such patients to avoid accumulation. neither hemodialysis nor continuous ambulatory peritoneal dialysis (capd) is effective in removal of levofloxacin from the body, indicating that supplemental doses of levofloxacin are not required following hemodialysis or capd [see dosage and administration ( 2.3)]. pharmacokinetic studies in patients with hepatic impairment have not been conducted. due to the limited extent of levofloxacin metabolism, the pharmacokinetics of levofloxacin are not expected to be affected by hepatic impairment.

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sun pharmaceutical industries, inc. - doxycycline hyclate (unii: 19xts3t51u) (doxycycline anhydrous - unii:334895s862) - doxycycline anhydrous 50 mg - to reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate 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. treatment: doxycycline is indicated for the treatment of the following infections: - rocky mountain spotted fever, typhus fever and the typhus group, q fever, rickettsialpox, and tick fevers caused by rickettsiae. - respiratory tract infections caused by mycoplasma pneumoniae . - lymphogranuloma venereum caused by chlamydia trachomatis . - psittacosis (ornithosis) caused by chlamydophila psittaci . - trachoma caused by chlamydia trachomatis , although the infectious agent is not always eliminated, as judged by immunofluorescence. - inclusion conjunctivitis caused by chlamydia trachomatis . - uncomplicated urethral, endocervical, or rectal infections in adults caused by chlamydia trachomatis . - nongonococcal urethritis caused by ureaplasma urealyticum . - relapsing fever due to borrelia recurrentis . doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms: - chancroid caused by haemophilus ducreyi . - plague due to yersinia pestis . - tularemia due to francisella tularensis . - cholera caused by vibrio cholerae . - campylobacter fetus infections caused by campylobacter fetus . - brucellosis due to brucella species (in conjunction with streptomycin). - bartonellosis due to bartonella bacilliformis . - granuloma inguinale caused by klebsiella granulomatis . because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. doxycycline is indicated for treatment of infections caused by the following gram-negative bacteria, when bacteriologic testing indicates appropriate susceptibility to the drug: - escherichia coli. - enterobacter aerogenes . - shigella species. - acinetobacter species. - respiratory tract infections caused by haemophilus influenzae . - respiratory tract and urinary tract infections caused by klebsiella species. doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: - upper respiratory infections caused by streptococcus pneumoniae . - anthrax due to bacillus anthracis , including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized bacillus anthracis . when penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections: - uncomplicated gonorrhea caused by neisseria gonorrhoeae . - syphilis caused by treponema pallidum . - yaws caused by treponema pallidum subspecies pertenue . - listeriosis due to listeria monocytogenes . - vincent's infection caused by fusobacterium fusiforme . - actinomycosis caused by actinomyces israelii . - infections caused by clostridium species. in acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. in severe acne, doxycycline may be useful adjunctive therapy. prophylaxis: doxycycline is indicated for the prophylaxis of malaria due to plasmodium falciparum in short-term travelers (<4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains. (see dosage and administrationsection and information for patientssubsection of the precautionssection.) this drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

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remedyrepack inc. - doxycycline (unii: n12000u13o) (doxycycline anhydrous - unii:334895s862) - doxycycline anhydrous 100 mg - to reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline capsules usp and other antibacterial drugs, doxycycline capsules 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. doxycycline capsules usp is indicated for the treatment of the following infections: rocky mountain spotted fever, typhus fever and the typhus group, q fever, rickettsialpox, and tick fevers caused by rickettsiae. respiratory tract infections caused by mycoplasma pneumoniae . lymphogranuloma venereum caused by chlamydia trachomatis. psittacosis (ornithosis) caused by chlamydophila psittaci. trachoma caused by chlamydia trachomatis , although the infectious agent is not always eliminated as judged by immunofluorescence. inclusion conjunctivitis caused by chlamydia trachomatis . uncomplicated urethral, endocervical or rectal infections in adults caused by chlamydia trachomatis . nongonococcal urethritis caused by ureaplasma urealyticum . relapsing fever due to borrelia recurrentis . doxycycline capsules usp is also indicated for the treatment of infections caused by the following gram-negative microorganisms: chancroid caused by haemophilus ducreyi. plague due to yersinia pestis. tularemia due to francisella tularensis. cholera caused by vibrio cholerae. campylobacter fetus infections caused by campylobacter fetus. brucellosis due to brucella species (in conjunction with streptomycin). bartonellosis due to bartonella bacilliformis. granuloma inguinale caused by  klebsiella granulomatis. because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. doxycycline capsules usp is indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug: escherichia coli enterobacter aerogenes shigella species acinetobacter species respiratory tract infections caused by haemophilus influenzae. respiratory tract and urinary tract infections caused by klebsiella species. doxycycline capsules usp is indicated for treatment of infections caused by the following gram-positive microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug: upper respiratory infections caused by streptococcus pneumoniae anthrax due to bacillus anthracis, including inhalational anthrax (post-exposure); to reduce the incidence or progression of disease following exposure to aerosolized bacillus anthracis. when penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections: uncomplicated gonorrhea caused by neisseria gonorrhoeae . syphilis caused by treponema pallidum. yaws caused by treponema pallidum subspecies pertenue . listeriosis due to listeria monocytogenes. vincent’s infection caused by fusobacterium fusiforme. actinomycosis caused by actinomyces israelii . infections caused by clostridium species. in acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. in severe acne, doxycycline may be useful adjunctive therapy. this drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

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avpak - doxycycline hyclate (unii: 19xts3t51u) (doxycycline anhydrous - unii:334895s862) - doxycycline anhydrous 50 mg - to reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate and other antibacterial drugs, doxycycline hyclate 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. treatment: doxycycline is indicated for the treatment of the following infections: - rocky mountain spotted fever, typhus fever and the typhus group, q fever, rickettsialpox, and tick fevers caused by rickettsiae. - respiratory tract infections caused by mycoplasma pneumoniae . - lymphogranuloma venereum caused by chlamydia trachomatis . - psittacosis (ornithosis) caused by chlamydophila psittaci . - trachoma caused by chlamydia trachomatis , although the infectious agent is not always eliminated, as judged by immunofluorescence. - inclusion conjunctivitis caused by chlamydia trachomatis . - uncomplicated urethral, endocervical, or rectal infections in adults caused by chlamydia trachomatis . - nongonococcal urethritis caused by ureaplasma urealyticum . - relapsing fever due to borrelia recurrentis . doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms: - chancroid caused by haemophilus ducreyi . - plague due to yersinia pestis . - tularemia due to francisella tularensis . - cholera caused by vibrio cholerae . - campylobacter fetus infections caused by campylobacter fetus . - brucellosis due to brucella species (in conjunction with streptomycin). - bartonellosis due to bartonella bacilliformis . - granuloma inguinale caused by klebsiella granulomatis . because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. doxycycline is indicated for treatment of infections caused by the following gram-negative bacteria, when bacteriologic testing indicates appropriate susceptibility to the drug: - escherichia coli. - enterobacter aerogenes . - shigella species. - acinetobacter species. - respiratory tract infections caused by haemophilus influenzae . - respiratory tract and urinary tract infections caused by klebsiella species. doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: - upper respiratory infections caused by streptococcus pneumoniae . - anthrax due to bacillus anthracis , including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized bacillus anthracis . when penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections: - uncomplicated gonorrhea caused by neisseria gonorrhoeae . - syphilis caused by treponema pallidum . - yaws caused by treponema pallidum subspecies pertenue . - listeriosis due to listeria monocytogenes . - vincent's infection caused by fusobacterium fusiforme . - actinomycosis caused by actinomyces israelii . - infections caused by clostridium species. in acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. in severe acne, doxycycline may be useful adjunctive therapy. prophylaxis: doxycycline is indicated for the prophylaxis of malaria due to plasmodium falciparum in short-term travelers (<4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains. (see dosage and administration section and information for patients subsection of the precautions section.) this drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

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lupin pharmaceuticals, inc. - doxycycline hyclate (unii: 19xts3t51u) (doxycycline anhydrous - unii:334895s862) - doxycycline anhydrous 75 mg - doxycycline hyclate tablets are indicated for treatment of rocky mountain spotted fever, typhus fever and the typhus group, q fever, rickettsial pox, and tick fevers caused by rickettsiae . doxycycline hyclate tablets are indicated for treatment of the following sexually transmitted infections: - uncomplicated urethral, endocervical or rectal infections caused by chlamydia trachomatis . - nongonococcal urethritis caused by ureaplasma urealyticum . - lymphogranuloma venereum caused by chlamydia trachomatis . - granuloma inguinale caused by klebsiella granulomatis . - uncomplicated gonorrhea caused by neisseria gonorrhoeae . - chancroid caused by haemophilus ducreyi . doxycycline hyclate tablets are indicated for treatment of the following respiratory tract infections: - respiratory tract infections caused by mycoplasma pneumoniae . - psittacosis (ornithosis) caused by chlamydophila psittaci . - because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. - doxycycline is indicated for treatment of infections caused by the following microorganisms, when bacteriological testing indicates appropriate susceptibility to the drug: - respiratory tract infections caused by haemophilus influenzae . - respiratory tract infections caused by klebsiella species . - upper respiratory infections caused by streptococcus pneumoniae . doxycycline hyclate tablets are indicated for treatment of the following specific bacterial infections: - relapsing fever due to borrelia recurrentis . - plague due to yersinia pestis . - tularemia due to francisella tularensis . - cholera caused by vibrio cholerae . - campylobacter fetus infections caused by campylobacter fetus . - brucellosis due to brucella species (in conjunction with streptomycin). - bartonellosis due to bartonella bacilliformis. because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. doxycycline hyclate tablets are indicated for treatment of infections caused by the following gram-negative microorganisms, when bacteriological testing indicates appropriate susceptibility to the drug: - escherichia coli - enterobacter aerogenes - shigella species - acinetobacter species - urinary tract infections caused by klebsiella species. doxycycline hyclate tablets are indicated for treatment of the following ophthalmic infections: - trachoma caused by chlamydia trachomatis , although the infectious agent is not always eliminated as judged by immunofluorescence. - inclusion conjunctivitis caused by chlamydia trachomatis . doxycycline hyclate tablets are indicated for the treatment of anthrax due to bacillus anthracis , including inhalational anthrax (post-exposure); to reduce the incidence or progression of disease following exposure to aerosolized bacillus anthracis . doxycycline hyclate tablets are indicated as an alternative treatment for the following selected infections when penicillin is contraindicated: - syphilis caused by treponema pallidum . - yaws caused by treponema pallidum subspecies pertenue . - listeriosis due to listeria monocytogenes . - vincent's infection caused by fusobacterium fusiforme. - actinomycosis caused by actinomyces israelii . - infections caused by clostridium species. in acute intestinal amebiasis, doxycycline hyclate tablets may be a useful adjunct to amebicides. in severe acne, doxycycline hyclate tablets may be useful adjunctive therapy. doxycycline hyclate tablets are indicated for the prophylaxis of malaria due to plasmodium falciparum in short-term travelers (less than 4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains [see dosage and administration (2.4) and patient counseling information (17)]. to reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate tablets and other antibacterial drugs, doxycycline hyclate tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. doxycycline hyclate is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. risk summary doxycycline hyclate, like other tetracycline-class antibacterial drugs, may cause discoloration deciduous teeth, and reversible inhibition of bone growth when administered during the second and third trimester of pregnancy [see warnings and precautions (5.1) and (5.2)]. available data from published studies over decades have not shown a difference in major birth defect risk compared to unexposed pregnancies with doxycycline exposure in the first trimester of pregnancy (see data). there are no available data on the risk of miscarriage following exposure to doxycycline in pregnancy. advise the patient of the potential risk to the fetus if doxycycline hyclate is used during pregnancy. 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. data human data: a retrospective cohort study of 1,690 pregnant patients who received doxycycline prescriptions in the first trimester of pregnancy compared to an unexposed pregnant cohort showed no difference in the major malformation rate. there is no information on the dose or duration of treatment, or if the patients actually ingested the doxycycline that was prescribed. other published studies on exposure to doxycycline in the first trimester of pregnancy have small sample sizes; however, these studies have not shown an increased risk of major malformations. the use of tetracyclines during tooth development (second and third trimester of pregnancy) may cause permanent discoloration of the teeth (yellow-gray-brown). this adverse reaction is more common during long-term use of the drug but has been observed following repeated short-term courses. [see warnings and precautions (5.1,5.2)] . animal data: results of animal studies indicate that 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 risk summary based on available published data, doxycycline is present in human milk. there are no data that inform the levels of doxycycline in breastmilk, the effects on the breastfed infant, or the effects on milk production. 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 doxycycline hyclate and for 5 days after the last dose. infertility based on findings from a fertility study in animals, doxycycline may impair female and male fertility. the reversibility of this finding is unclear. [see nonclinical toxicology (13.1)]. because of the effects of drugs of the tetracycline-class on tooth development and growth, use doxycycline hyclate in pediatric patients 8 years of age or less only when the potential benefits are expected to outweigh the risks in severe or life-threatening conditions (e.g., anthrax, rocky mountain spotted fever), particularly when there are no alternative therapies [see warnings and precautions (5.1, 1.1) and dosage and administration (2.1, 2.5)] . clinical studies of doxycycline hyclate tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. doxycycline hyclate tablets each contains less than 1 mg of sodium.

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

pd-rx pharmaceuticals, inc. - doxycycline hyclate (unii: 19xts3t51u) (doxycycline anhydrous - unii:334895s862) - doxycycline anhydrous 50 mg - to reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate capsules and other antibacterial drugs, doxycycline hyclate 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. doxycycline is indicated for the treatment of the following infections: - rocky mountain spotted fever, typhus fever and the typhus group, q fever, rickettsialpox, and tick fevers caused by rickettsiae. - respiratory tract infections caused by mycoplasma pneumoniae . - lymphogranuloma venereum caused by chlamydia trachomatis . - psittacosis (ornithosis) caused by chlamydophila psittaci . - trachoma caused by chlamydia trachomatis , although the infectious agent is not always eliminated, as judged by immunofluorescence. - inclusion conjunctivitis caused by chlamydia trachomatis . - uncomplicated urethral, endocervical, or rectal infections in adults caused by chlamydia trachomatis. - nongonococcal urethritis caused by ureaplasma urealyticum . - relapsing fever due to borrelia recurrentis . doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms: - chancroid caused by haemophilus ducreyi . - plague due to yersinia pestis . - tularemia due to francisella tularensis . - cholera caused by vibrio cholerae. - campylobacter fetus infections caused by campylobacter fetus . - brucellosis due to brucella species (in conjunction with streptomycin). - bartonellosis due to bartonella bacilliformis . - granuloma inguinale caused by klebsiella granulomatis . because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. doxycycline is indicated for treatment of infections caused by the following gram-negative bacteria, when bacteriologic testing indicates appropriate susceptibility to the drug: - escherichia coli. - enterobacter aerogenes . - shigella species. - acinetobacter species. - respiratory tract infections caused by haemophilus influenzae . - respiratory tract and urinary tract infections caused by klebsiella species. doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: - upper respiratory infections caused by streptococcus pneumoniae . - anthrax due to bacillus anthracis , including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized bacillus anthracis . when penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections: - uncomplicated gonorrhea caused by neisseria gonorrhoeae . - syphilis caused by treponema pallidum . - yaws caused by treponema pallidum subspecies pertenue . - listeriosis due to listeria monocytogenes . - vincent’s infection caused by fusobacterium fusiforme . - actinomycosis caused by actinomyces israelii . - infections caused by clostridium species. in acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. in severe acne, doxycycline may be useful adjunctive therapy. doxycycline is indicated for the prophylaxis of malaria due to plasmodium falciparum in short-term travelers (<4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains (see dosage and administration section and information for patients subsection of the precautions section). this drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

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

major pharmaceuticals - demeclocycline hydrochloride (unii: 29o079ntyt) (demeclocycline - unii:5r5w9ici6o) - demeclocycline hydrochloride 150 mg - demeclocycline hcl tablets, usp are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions below: rocky mountain spotted fever, typhus fever and the typhus group, q fever, rickettsialpox and tick fevers caused by rickettsiae; respiratory tract infections caused by mycoplasma pneumoniae lymphogranuloma venereum due to chlamydia trachomatis psittacosis (ornithosis) due to chlamydia psittaci trachoma due to chlamydia trachomatis , although the infectious agent is not always eliminated as judged by immunofluorescence inclusion conjunctivitis caused by chlamydia trachomatis nongonococcal urethritis in adults caused by ureaplasma urealyticum or chlamydia trachomatis relapsing fever due to borrelia recurrentis chancroid caused by haemophilus ducreyi plague due to yersinia pestis tularemia due to francisella tularensis cholera caused by vibrio cholerae campylobacter fetus infections cause by campylobacter fetus brucellosis due to brucella species

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

avkare, inc. - demeclocycline hydrochloride (unii: 29o079ntyt) (demeclocycline - unii:5r5w9ici6o) - demeclocycline hydrochloride 150 mg - demeclocycline hcl tablets, usp are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions below: rocky mountain spotted fever, typhus fever and the typhus group, q fever, rickettsialpox and tick fevers caused by rickettsiae; respiratory tract infections caused by mycoplasma pneumoniae lymphogranuloma venereum due to chlamydia trachomatis psittacosis (ornithosis) due to chlamydia psittaci trachoma due to chlamydia trachomatis , although the infectious agent is not always eliminated as judged by immunofluorescence inclusion conjunctivitis caused by chlamydia trachomatis nongonococcal urethritis in adults caused by ureaplasma urealyticum or chlamydia trachomatis relapsing fever due to borrelia recurrentis chancroid caused by haemophilus ducreyi plague due to yersinia pestis tularemia due to francisella tularensis cholera caused by vibrio cholerae campylobacter fetus infections cause by campylobacter fetus brucellosis due to brucella species

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

amneal pharmaceuticals llc - demeclocycline hydrochloride (unii: 29o079ntyt) (demeclocycline - unii:5r5w9ici6o) - demeclocycline hydrochloride 150 mg - demeclocycline hcl tablets are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions below: rocky mountain spotted fever, typhus fever and the typhus group, q fever, rickettsialpox and tick fevers caused by rickettsiae; respiratory tract infections caused by mycoplasma pneumoniae lymphogranuloma venereum due to chlamydia trachomatis psittacosis (ornithosis) due to chlamydia psittaci trachoma due to chlamydia trachomatis , although the infectious agent is not always eliminated as judged by immunofluorescence inclusion conjunctivitis caused by chlamydia trachomatis nongonococcal urethritis in adults caused by ureaplasma urealyticum or chlamydia trachomatis relapsing fever due to borrelia recurrentis chancroid caused by haemophilus ducreyi plague due to yersinia pestis tularemia due to francisella tularensis cholera caused by vibrio cholerae campylobacter fetus infections cause by campylobacter fetus brucellosis due to brucella species (in conjunction with streptomycin); bartonellosis due to bartonella bacilliformis granuloma inguinale caused by calymmatobacterium granulomatis demeclocycline hcl tablets are indicated for treatment of infections by the following gram-negative microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug: escherichia coli enterobacter aerogenes shigella species acinetobacter species respiratory tract infections caused by haemophilus influenzae respiratory tract and urinary tract infections caused by klebsiella species demeclocycline hcl tablets are indicated for treatment of infections caused by the following gram-positive microorganisms, when bacteriologic testing indicates appropriate susceptibility to the drug: upper respiratory infections caused by streptococcus pneumoniae skin and skin structure infections caused by staphylococcus aureus . (note: tetracyclines, including demeclocycline, are not the drugs of choice in the treatment of any type of staphylococcal infection). when penicillin is contraindicated, tetracyclines, including demeclocycline hcl, are alternative drugs in the treatment of the following infections: uncomplicated urethritis in men due to neisseria gonorrhoeae , and for the treatment of other uncomplicated gonococcal infections infections in women caused by neisseria gonorrhoeae syphilis caused by treponema pallidum subspecies pallidum yaws caused by treponema pallidum subspecies pertenue listeriosis due to listeria monocytogenes anthrax due to bacillus anthracis vincent’s infection caused by fusobacterium fusiforme actinomycosis caused by actinomyces israelii clostridial diseases caused by clostridium species in acute intestinal amebiasis, demeclocycline hcl may be a useful adjunct to amebicides. in severe acne, demeclocycline hcl may be a useful adjunctive therapy. to reduce the development of drug-resistant bacteria and maintain the effectiveness of demeclocycline hcl tablets and other antibacterial drugs, demeclocycline hcl tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. this drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines or any of the components of the product formulation.

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

american health packaging - demeclocycline hydrochloride (unii: 29o079ntyt) (demeclocycline - unii:5r5w9ici6o) - demeclocycline hydrochloride 150 mg - demeclocycline hcl tablets are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions below: rocky mountain spotted fever, typhus fever and the typhus group, q fever, rickettsialpox and tick fevers caused by rickettsiae; respiratory tract infections caused by mycoplasma pneumoniae lymphogranuloma venereum due to chlamydia trachomatis psittacosis (ornithosis) due to chlamydia psittaci trachoma due to chlamydia trachomatis , although the infectious agent is not always eliminated as judged by immunofluorescence inclusion conjunctivitis caused by chlamydia trachomatis nongonococcal urethritis in adults caused by ureaplasma urealyticum or chlamydia trachomatis relapsing fever due to borrelia recurrentis chancroid caused by haemophilus ducreyi plague due to yersinia pestis tularemia due to francisella tula