Stany Zjednoczone - angielski - NLM (National Library of Medicine)

indicus pharma llc - minocycline hydrochloride (unii: 0020414e5u) (minocycline - unii:fyy3r43wgo) - tablet, film coated - 50 mg - minocycline hydrochloride tablets are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms: 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) due to chlamydia psittaci . trachoma caused by chlamydia trachomatis , although the infectious agent is not always eliminated, as judged by immunoflourescence. inclusion conjunctivitis caused by chlamydia trachomatis . nongonococcal urethritis, endocervical, or rectal infections 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 infect

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

torrent pharmaceuticals limited - minocycline hydrochloride (unii: 0020414e5u) (minocycline - unii:fyy3r43wgo) - minocycline 50 mg - minocycline hydrochloride capsules, usp are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms: 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) due to 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 . nongonococcal urethritis, endocervical, or rectal infections 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 caused by campylobacter fetus . brucellosis due to brucella species (in conjunction with streptomycin). bartonellosis due to bartonella bacilliformis. granuloma inguinale caused by klebsiella granulomatis . minocycline is indicated for the 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. minocycline hydrochloride capsules, usp are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: upper respiratory tract infections caused by streptococcus pneumoniae . skin and skin structure infections caused by staphylococcus aureus (note: minocycline is not the drug of choice in the treatment of any type of staphylococcal infection). when penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections: uncomplicated urethritis in men due to neisseria gonorrhoeae and for the treatment of other 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 .  infections caused by clostridium species. in acute intestinal amebiasis , minocycline may be a useful adjunct to amebicides. in severe acne , minocycline may be useful adjunctive therapy. oral minocycline is indicated in the treatment of asymptomatic carriers of neisseria meningitidis to eliminate meningococci from the nasopharynx. in order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. it is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high. oral minocycline is not indicated for the treatment of meningococcal infection . although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by mycobacterium marinum . to reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules, usp and other antibacterial drugs, minocycline hydrochloride 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. this drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines or to any of the components of the product formulation.

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc. - minocycline hydrochloride (unii: 0020414e5u) (minocycline - unii:fyy3r43wgo) - minocycline 50 mg - minocycline hydrochloride capsules usp are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms: 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) due to 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 . nongonococcal urethritis, endocervical, or rectal infections 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 caused

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

golden state medical supply, inc. - demeclocycline hydrochloride (unii: 29o079ntyt) (demeclocycline - unii:5r5w9ici6o) - demeclocycline hydrochloride 300 mg - demeclocycline hydrochloride tablets usp is 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 ; tu

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - demeclocycline hydrochloride (unii: 29o079ntyt) (demeclocycline - unii:5r5w9ici6o) - demeclocycline hydrochloride 150 mg - demeclocycline hydrochloride 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 caused by campylobacter fetus ; br

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - tamoxifen citrate (unii: 7frv7310n6) (tamoxifen - unii:094zi81y45) - tamoxifen 10 mg - tamoxifen citrate tablets are effective in the treatment of metastatic breast cancer in women and men. in premenopausal women with metastatic breast cancer, tamoxifen citrate tablets are an alternative to oophorectomy or ovarian irradiation. available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from tamoxifen citrate tablet therapy. tamoxifen citrate tablets are indicated for the treatment of node-positive breast cancer in postmenopausal women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. in some tamoxifen adjuvant studies, most of the benefit to date has been in the subgroup with four or more positive axillary nodes. tamoxifen citrate tablets are indicated for the treatment of axillary node-negative breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. the estrogen- and progesterone-receptor values may help to predict whether adjuvant

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

lupin pharmaceuticals, inc. - azithromycin monohydrate (unii: jte4mnn1md) (azithromycin anhydrous - unii:j2klz20u1m) - azithromycin anhydrous 250 mg - azithromycin tablets are a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. recommended dosages and durations of therapy in adult and pediatric patient populations vary in these indications. [see dosage and administration (2)] - acute bacterial exacerbations of chronic bronchitis due to haemophilus influenzae , moraxella catarrhalis, or streptococcus pneumoniae . - acute bacterial sinusitis due to haemophilus influenzae , moraxella catarrhalis or streptococcus pneumoniae . - community-acquired pneumonia due to chlamydophila pneumoniae , haemophilus influenzae , mycoplasma pneumoniae, or streptococcus pneumoniae in patients appropriate for oral therapy. - pharyngitis/tonsillitis caused by streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy. - uncomplicated skin and skin structure infections due to staphylococcus aureus , streptococcus pyogenes , or streptococcus agalactiae . - urethritis and cervicitis due to chlamydia trachomatis or neisseria gonorrhoeae . - genital ulcer disease in men due to haemophilus ducreyi (chancroid). due to the small number of women included in clinical trials, the efficacy of azithromycin in the treatment of chancroid in women has not been established. [see use in specific populations (8.4) and clinical studies (14.2)] -   acute otitis media (>6 months of age) caused by haemophilus influenzae , moraxella catarrhalis, or streptococcus pneumoniae. -   community-acquired pneumonia (>6 months of age) due to chlamydophila pneumoniae , haemophilus influenzae , mycoplasma pneumoniae , or streptococcus pneumoniae in patients appropriate for oral therapy. -   pharyngitis/tonsillitis (>2 years of age) caused by streptococcus pyogenes as an alternative to first-line therapy in individuals who cannot use first-line therapy. azithromycin should not be used in patients with pneumonia who are judged to be inappropriate for oral therapy because of moderate to severe illness or risk factors such as any of the following: - patients with cystic fibrosis, - patients with nosocomial infections, - patients with known or suspected bacteremia, - patients requiring hospitalization, - elderly or debilitated patients, or - patients with significant underlying health problems that may compromise their ability to respond to their illness (including immunodeficiency or functional asplenia). to reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. azithromycin is contraindicated in patients with known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide drug. azithromycin is contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of azithromycin. risk summary available data from published literature and postmarketing experience over several decades with azithromycin use in pregnant women have not identified any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data) . developmental toxicity studies with azithromycin in rats, mice, and rabbits showed no drug-induced fetal malformations at doses up to 4, 2, and 2 times, respectively, an adult human daily dose of 500 mg based on body surface area. decreased viability and delayed development were observed in the offspring of pregnant rats administered azithromycin from day 6 of pregnancy through weaning at a dose equivalent to 4 times an adult human daily dose of 500 mg based on body surface area (see data). the estimated background risk of major birth defects and miscarriage for the indicated populations 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: available data from published observational studies, case series, and case reports over several decades do not suggest an increased risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes with azithromycin use in pregnant women. limitations of these data include the lack of randomization and inability to control for confounders such as underlying maternal disease and maternal use of concomitant medications. animal data: azithromycin administered during the period of organogenesis did not cause fetal malformations in rats and mice at oral doses up to 200 mg/kg/day (moderately maternally toxic). based on body surface area, this dose is approximately 4 (rats) and 2 (mice) times an adult human daily dose of 500 mg. in rabbits administered azithromycin at oral doses of 10, 20, and 40 mg/kg/day during organogenesis, reduced maternal body weight and food consumption were observed in all groups; no evidence of fetotoxicity or teratogenicity was observed at these doses, the highest of which is estimated to be 2 times an adult human daily dose of 500 mg based on body surface area. in a pre-and postnatal development study, azithromycin was administered orally to pregnant rats from day 6 of pregnancy until weaning at doses of 50 or 200 mg/kg/day. maternal toxicity (reduced food consumption and body weight gain; increased stress at parturition) was observed at the higher dose. effects in the offspring were noted at 200 mg/kg/day during the postnatal development period (decreased viability, delayed developmental landmarks). these effects were not observed in a pre-and postnatal rat study when up to 200 mg/kg/day of azithromycin was given orally beginning on day 15 of pregnancy until weaning. risk summary azithromycin is present in human milk (see data) . non-serious adverse reactions have been reported in breastfed infants after maternal administration of azithromycin (see clinical considerations) . there are no available data on the effects of azithromycin on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for azithromycin and any potential adverse effects on the breastfed infant from azithromycin or from the underlying maternal condition. clinical considerations advise women to monitor the breastfed infant for diarrhea, vomiting, or rash. data azithromycin breastmilk concentrations were measured in 20 women after receiving a single 2 g oral dose of azithromycin during labor. breastmilk samples collected on days 3 and 6 postpartum as well as 2 and 4 weeks postpartum revealed the presence of azithromycin in breastmilk up to 4 weeks after dosing. in another study, a single dose of azithromycin 500 mg was administered intravenously to 8 women prior to incision for cesarean section. breastmilk (colostrum) samples obtained between 12 and 48 hours after dosing revealed that azithromycin persisted in breastmilk up to 48 hours. [see clinical pharmacology (12.3), indications and usage (1.2), and dosage and administration (2.2)] safety and effectiveness in the treatment of pediatric patients with acute otitis media, acute bacterial sinusitis and community-acquired pneumonia under 6 months of age have not been established. use of azithromycin for the treatment of acute bacterial sinusitis and community-acquired pneumonia in pediatric patients (6 months of age or greater) is supported by adequate and well-controlled trials in adults. pharyngitis/tonsillitis safety and effectiveness in the treatment of pediatric patients with pharyngitis/tonsillitis under 2 years of age have not been established. in multiple-dose clinical trials of oral azithromycin, 9% of patients were at least 65 years of age (458/4949) and 3% of patients (144/4949) were at least 75 years of age. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in response between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. elderly patients may be more susceptible to development of torsades de pointes arrhythmias than younger patients. [see warnings and precautions (5.4)]  

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

nucare pharmaceuticals, inc. - minocycline hydrochloride (unii: 0020414e5u) (minocycline - unii:fyy3r43wgo) - minocycline 100 mg - minocycline hydrochloride capsules, usp are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms: ·     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) due to chlamydia psittaci. ·   trachoma caused by chlamydia trachomatis , although the infectious agent is not always eliminated, as judged by immunofluorescence. ·     inclusion conjunctivitis caused by chlamydia trachomatis . ·     nongonococcal urethritis, endocervical, or rectal infections 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 cau

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

preferred pharmaceuticals inc. - minocycline hydrochloride (unii: 0020414e5u) (minocycline - unii:fyy3r43wgo) - minocycline 100 mg - minocycline hydrochloride capsules, usp are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms: ·     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) due to chlamydia psittaci. ·   trachoma caused by chlamydia trachomatis , although the infectious agent is not always eliminated, as judged by immunofluorescence. ·     inclusion conjunctivitis caused by chlamydia trachomatis . ·     nongonococcal urethritis, endocervical, or rectal infections 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 cau

Stany Zjednoczone - angielski - NLM (National Library of Medicine)

avkare - minocycline hydrochloride (unii: 0020414e5u) (minocycline - unii:fyy3r43wgo) - minocycline 50 mg - minocycline hydrochloride tablets are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms: - 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) due to chlamydia psittaci . - trachoma caused by chlamydia trachomatis , although the infectious agent is not always eliminated, as judged by immunofluorescence. - inclusion conjunctivitis caused by chlamydia trachomatis . - nongonococcal urethritis, endocervical, or rectal infections 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 caused by campylobacter fetus . - brucellosis due to brucella species (in conjunction with streptomycin). - bartonellosis due to bartonella bacilliformis . - granuloma inguinale caused by calymmatobacterium granulomatis . minocycline 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. minocycline hydrochloride tablets are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: - upper respiratory tract infections caused by streptococcus pneumoniae - skin and skin structure infections caused by staphylococcus aureus . (note: minocycline is not the drug of choice in the treatment of any type of staphylococcal infection.) when penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections: - uncomplicated urethritis in men due to neisseria gonorrhoeae and for the treatment of other 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. - infections caused by clostridium species. in acute intestinal amebiasis , minocycline may be a useful adjunct to amebicides. in severe acne , minocycline may be useful adjunctive therapy. oral minocycline is indicated in the treatment of asymptomatic carriers of neisseria meningitidis to eliminate the meningococci from the nasopharynx. in order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. it is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high. oral minocycline is not indicated for the treatment of meningococcal infection. although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by mycobacterium marinum . to reduce the development of drug-resistant bacteria and maintain the effectiveness of, minocycline hydrochloride tablets and other antibacterial drugs, minocycline hydrochloride 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 to any of the components of the product formulation.