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

prasco laboratories - lanthanum carbonate (unii: 490d9f069t) (lanthanum cation (3+) - unii:o7fu5x12w5) - lanthanum cation (3+) 500 mg - lanthanum carbonate is a phosphate binder indicated to reduce serum phosphate in patients with end-stage renal disease (esrd). management of elevated serum phosphorus levels in patients with esrd usually includes all of the following: reduction in dietary intake of phosphate, removal of phosphate by dialysis, and reduction of intestinal phosphate absorption with phosphate binders. contraindicated in bowel obstruction, including ileus and fecal impaction. risk summary available data from case reports with use of lanthanum carbonate in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies, oral administration of lanthanum carbonate to pregnant rats and rabbits during organogenesis at doses 3 and 2.5 times, respectively, the maximum recommended human dose (mrhd), resulted in no adverse developmental effects. in rabbits, lanthanum carbonate doses 5 times the mrhd was associated with maternal toxicity and resulted in increased post-implantation loss, reduced fetal weights, and delayed fetal ossification (see data ). deposition of lanthanum into developing bone, including growth plate, was observed in juvenile animals in long-term animal studies with lanthanum carbonate [see use in specific populations (8.4)] . use a non-lanthanum containing phosphate binder in a pregnant woman. 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 defect and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data animal data in pregnant rats, oral administration of lanthanum carbonate at doses as high as 2,000 mg/kg/day during organogenesis resulted in no evidence of harm to the fetus. the mrhd for lanthanum carbonate is 5,725 mg, representing a dose of 95.4 mg/kg, or 3,530 mg/m2 for a 60-kg patient. the 2,000-mg/kg/day dose in the rat is equivalent to 12,000 mg/m2 , 3 times the mrhd. in pregnant rabbits, oral administration of lanthanum carbonate at 1,500 mg/kg/day (18,000 mg/m2 ; 5 times the daily mrhd) during organogenesis was associated with increased postimplantation loss, reduced fetal weights, and delayed fetal ossification. no effects on the pregnant rabbits or fetuses were observed at 750 mg/kg/day (9,000 mg/m2 ; 2.5 times the mrhd). in a pre- and postnatal development study in the rat, pregnant rats were dosed at up to 2,000 mg/kg/day (12,000 mg/m2 /day; equivalent to 3 times the mrhd) from day 6 of pregnancy through 20 days postpartum (including lactation). at 2,000 mg/kg/day, no maternal toxicity was observed, nor were any changes seen with respect to gestational length or delivery; however, piloerection/pallor, delayed eye opening, decreased body weight, and delayed sexual development were observed in the offspring at 2,000 mg/kg/day. at 200 and 600 mg/kg/day (equivalent to 0.3 and 1 time the mrhd, respectively), slight delays in sexual development (delayed vaginal opening) were observed in the female offspring [see nonclinical toxicology (13.2)] . risk summary there are no data on the presence of lanthanum carbonate from lanthanum carbonate in human milk, the effects on the breastfed infant, or the effects on milk production. deposition of lanthanum into developing bone, including growth plate, was observed in juvenile animals in long-term animal studies with lanthanum carbonate [see use in specific populations (8.4)] . use a non-lanthanum containing phosphate binder in a lactating woman. the safety and efficacy of lanthanum carbonate in pediatric patients have not been established. while growth abnormalities were not identified in long-term animal studies, lanthanum was deposited into developing bone, including growth plate. the consequences of such deposition in developing bone in pediatric patients are unknown; therefore, the use of lanthanum carbonate in this population is not recommended. of the total number of patients in clinical studies of lanthanum carbonate, 32% (538) were ≥65 years of age, while 9.3% (159) were ≥75 years of age. no overall differences in safety or effectiveness were observed between patients ≥65 years of age and younger patients.

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novel laboratories, inc. - doxycycline hyclate (unii: 19xts3t51u) (doxycycline anhydrous - unii:334895s862) - to reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate tablets, usp and other antibacterial drugs, doxycycline hyclate tablets, usp should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. 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 t

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

lupin pharmaceuticals,inc. - doxycycline hyclate (unii: 19xts3t51u) (doxycycline anhydrous - unii:334895s862) - to reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate tablets, usp and other antibacterial drugs, doxycycline hyclate tablets, usp should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. 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.

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

heritage pharmaceuticals inc. - doxycycline hyclate (unii: 19xts3t51u) (doxycycline anhydrous - unii:334895s862) - to reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline hyclate tablets, usp and other antibacterial drugs, doxycycline hyclate tablets, usp should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. 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

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

viona pharmaceuticals inc - doxycycline hyclate (unii: 19xts3t51u) (doxycycline anhydrous - unii:334895s862) - to reduce the development of drug-resistant bacteria and maintain 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 tablets are indicated for  the treatment of 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 trachomati

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

apotex corp. - doxycycline hyclate (unii: 19xts3t51u) (doxycycline anhydrous - unii:334895s862) - 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 tablets are contraindicated in persons who have shown hypersensitivity to any of the tetracyclines. risk summary doxycycline hyclate tablets, 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 tablets 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 hylcate tablets 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 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.

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

actavis pharma, inc. - doxycycline hyclate (unii: 19xts3t51u) (doxycycline anhydrous - unii:334895s862) - doxycycline hyclate delayed-release tablets are indicated for treatment of rocky mountain spotted fever, typhus fever and the typhus group, q fever, rickettsialpox, and tick fevers caused by rickettsiae . doxycycline hyclate delayed-release 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 delayed-release tablets are indicated for treatment of the following respiratory 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 t

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

zydus pharmaceuticals usa inc. - doxycycline hyclate (unii: 19xts3t51u) (doxycycline anhydrous - unii:334895s862) - to reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate delayed-release tablets and other antibacterial drugs, doxycycline hyclate delayed-release 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 is a tetracycline-class antibacterial indicated in the following conditions or diseases: rocky mountain spotted fever, typhus fever and the typhus group, q fever, rickettsialpox, and tick fevers caused by rickettsiae . uncomplicated urethral, endocervical or rectal infections caused by chlamydia trachomatis. nongonococcal urethritis caused by ureaplasma urealyticum . lymphogranuloma venereum caused by chlamydia t

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

ajanta pharma usa inc. - doxycycline hyclate (unii: 19xts3t51u) (doxycycline anhydrous - unii:334895s862) - 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 o

Canada - English - Health Canada

natco pharma (canada) inc - lanthanum (lanthanum carbonate dihydrate) - tablet (chewable) - 250mg - lanthanum (lanthanum carbonate dihydrate) 250mg - phosphate-removing agents