Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - doxycycline hyclate, quantity: 115.4 mg (equivalent: doxycycline, qty 100 mg) - tablet, film coated - excipient ingredients: microcrystalline cellulose; maize starch; colloidal anhydrous silica; magnesium stearate; titanium dioxide; hypromellose; indigo carmine; macrogol 4000 - other conditions: protect from moisture. indications: infections caused by the following organisms; mycoplasma pneumoniae (primary atypical pneumonia); rickettsiae (queensland tick typhus, epidemic typhus fever, q fever, murine endemic typhus fever, australo-pacific endemic scrub typhus); chlamydia psittaci (psittacosis); chlamydia trachomatis (lymphogranuloma venereum, trachoma, inclusion conjunctivitis). (doxycycline is indicated in the treatment of trachoma, although the infectious agent is not always eliminated, as judged by immunofluorescence. inclusion conjunctivitis may be treated with oral doxycycline alone, or in combination with topical agents). borreliae (relapsing fever). calymmatobacterium (donovania) granulomatis (granuloma inguinale). infections caused by the following gram- negative microorganisms: vibrio species (chlorea), brucella sp. (brucellosis; in conjuction with streptomycin), haemophilus ducreyi (chancroid), yersinia pestis (plague), francisella turarenis (tularaemia), bartonella bacilliformis (bartonellosis), bacteroides sp. when penicillin is contraindicated, doxy-100 is an alternative drug in the treatment of infections due to: treponema pallidum (syphilis); treponema pertenue (yaws); neisseria gonorrhoea (see dosage and administration). doxy-100 is not the drug of choice in the treatment of any type of staphylococcal infection or infections due to streptococcus pneumoniae, haemophilus infuenzae, streptococcus pyogenes, streptococcus faecalis or any type of enteric bacteria because many strains of these organisms have been shown to be resistant to doxycycline. doxy-100 should not be used in these infections unless the organism has been shown to be sensitive. for upper respiratory infections due to group a beta-haemolytic streptococci (including prophylaxis of rheumatic fever), penicillin is the usual drug of choice. in acute intestinal amoebiasis, doxycycline may be a useful adjunct to amoebicides. in severe acne, doxycycline may be useful adjunctive therapy. doxycycline is indicated, in adults and children older than 10 years, as chemoprophylaxis for malaria caused by plasmodium falciparum and, in combination with other antimalarial agents, against malaria caused by plasmodium vivax. doxycycline is only able to suppress malaria caused by p. vivax. as there are relatively few locations where p. vivax does not co-exist to some extent with p. falciparum, it is recommended that doxycycline should be used routinely with other agents, for example, chloroquine.

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

heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc. - doxycycline hyclate (unii: 19xts3t51u) (doxycycline anhydrous - unii:334895s862) - doxycycline anhydrous 75 mg - 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 bee

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

mayne pharma commercial llc - doxycycline hyclate (unii: 19xts3t51u) (doxycycline anhydrous - unii:334895s862) - doxycycline anhydrous 75 mg - 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)

mayne pharma commercial llc - doxycycline hyclate (unii: 19xts3t51u) (doxycycline anhydrous - unii:334895s862) - doxycycline anhydrous 50 mg - 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)

physicians total care, inc. - doxycycline hyclate (unii: 19xts3t51u) (doxycycline anhydrous - unii:334895s862) - doxycycline anhydrous 20 mg - doxycycline hyclate is indicated for use as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis. this drug is contraindicated in persons who have shown hypersensitivity to doxycycline or any of the other tetracyclines.

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

prasco laboratories - doxycycline (unii: n12000u13o) (doxycycline anhydrous - unii:334895s862) - doxycycline anhydrous 40 mg - doxycycline 40 mg is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. no meaningful effect was demonstrated for generalized erythema (redness) of rosacea. this formulation of doxycycline has not been evaluated in the treatment or prevention of infections. do not use doxycycline 40 mg for treating bacterial infections, providing antibacterial prophylaxis, or reducing the numbers or eliminating microorganisms associated with any bacterial disease. to reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, doxycycline 40 mg should be used only as indicated. doxycycline 40 mg has not been evaluated for the treatment of the erythematous, telangiectatic, or ocular components of rosacea. this drug is contraindicated in persons who have shown hypersensitivity to doxycycline or any other tetracyclines. risk summary doxycycline may cause reversible inhibition of bone growth and permanent discoloration of deciduous teeth when administered during the second and third trimesters of pregnancy [see warnings and precautions (5.1 and 5.2) ]. available data from published studies have not shown a difference in major birth defect risk with doxycycline exposure in the first trimester of pregnancy compared to unexposed pregnancies. avoid use of doxycycline 40 mg during the second and third trimester of pregnancy. the 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 2–4% and 15–20%, respectively. data human data published studies, including epidemiological and observational studies, with use of doxycycline during the first trimester of pregnancy have not identified drug-related increases in major birth defects. the use of tetracycline during tooth development (second and third trimester of pregnancy) may cause permanent discoloration of deciduous 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. animal data results from animal studies indicate that doxycycline crosses the placenta and is found in fetal tissues. risk summary based on available published data, doxycycline is likely to be present in human breast milk but the specific concentration in breastmilk is not clear. there is no information on the effects of doxycycline on the breastfed infant or the effects on milk production. because there are other antibacterial drug options available to treat rosacea in lactating women and because of the potential for serious adverse reactions, including tooth discoloration and inhibition of bone growth, advise patients that breastfeeding is not recommended during treatment with doxycycline 40 mg and for 5 days after the last dose. doxycycline 40 mg should not be used in infants and children less than 8 years of age [see warnings and precautions (5.1) ]. doxycycline 40 mg has not been studied in children of any age with regard to safety or efficacy, therefore use in children is not recommended. clinical studies of doxycycline 40 mg 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 elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy.

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

owen laboratories, inc. - doxycycline (unii: n12000u13o) (doxycycline anhydrous - unii:334895s862) - doxycycline anhydrous 40 mg - doxycycline 40 mg is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. no meaningful effect was demonstrated for generalized erythema (redness) of rosacea. this formulation of doxycycline has not been evaluated in the treatment or prevention of infections. doxycycline 40 mg should not be used for treating bacterial infections, providing antibacterial prophylaxis, or reducing the numbers or eliminating microorganisms associated with any bacterial disease. to reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, doxycycline 40 mg should be used only as indicated. efficacy of doxycycline 40 mg beyond 16 weeks and safety beyond 9 months have not been established. doxycycline 40 mg has not been evaluated for the treatment of the erythematous, telangiectatic, or ocular components of rosacea. this drug is contraindicated in persons who have shown hypersensitivity to doxycycline or any of the

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

sun pharmaceutical industries, inc. - doxycycline hyclate (unii: 19xts3t51u) (doxycycline anhydrous - unii:334895s862) - doxycycline anhydrous 20 mg - doxycycline hyclate is indicated for use as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis. this drug is contraindicated in persons who have shown hypersensitivity to doxycycline or any of the other tetracyclines.

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

lannett company, inc. - doxycycline hyclate (unii: 19xts3t51u) (doxycycline anhydrous - unii:334895s862) - doxycycline anhydrous 20 mg - doxycycline hyclate tablets are indicated for use as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis. to reduce the development of drug-resistant bacteria and maintain the 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. this drug is contraindicated in persons who have shown hypersensitivity to doxycycline or any of the other tetracyclines.

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

aidarex pharmaceuticals llc - doxycycline hyclate (unii: 19xts3t51u) (doxycycline anhydrous - unii:334895s862) - doxycycline anhydrous 20 mg - doxycycline hyclate tablets are indicated for use as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis. to reduce the development of drug-resistant bacteria and maintain the 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. this drug is contraindicated in persons who have shown hypersensitivity to doxycycline or any of the other tetracyclines.