s, 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).

difficile produces toxins a and b which contribute to the development of cdad. hypertoxin producing strains of c. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. cdad must be considered in all patients who present with diarrhea following the use of antibacterial drugs. careful medical history is necessary since cdad has been reported to occur over two months after the administration of antibacterial agents. if cdad is suspected or confirmed, ongoing use of antibacterial drugs not directed against c. difficile may need to be discontinued. appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of c. difficile, and surgical evaluation should be instituted as clinically indicated. severe skin reactions, such as exfoliative dermatitis, erythema multiforme, stevens­johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (dress) have been reported in patients receiving doxycycline. (see adverse reactions.) if severe skin reactions occur, doxycycline should be discontinued immediately and appropriate therapy should be instituted. intracranial hypertension (ih, pseudotumor cerebri) has been associated with the use of tetracyclines including doxycycline hyclate capsules. clinical manifestations of ih include headache, blurred vision, diplopia, and vision loss; papilledema can be found on fundoscopy. women of childbearing age who are overweight or have a history of ih are at greater risk for developing tetracycline associated ih. concomitant use of isotretinoin and doxycycline hyclate capsules should be avoided because isotretinoin is also known to cause pseudotumor cerebri. although ih typically resolves after discontinuation of treatment, the possibility for permanent visual loss exists. if visual disturbance occurs during treatment, prompt ophthalmologic evaluation is warranted. since intracranial pressure can remain elevated for weeks after drug cessation patients should be monitored until they stabilize. all tetracyclines form a stable calcium complex in any bone-forming tissue. a decrease in fibula growth rate has been observed in prematures given oral tetracycline in doses of 25 mg/kg every 6 hours. this reaction was shown to be reversible when the drug was discontinued. 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 has also been noted in animals treated early in pregnancy. if any tetracycline is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. the antianabolic action of the tetracyclines may cause an increase in bun. studies to date indicate that this does not occur with the use of doxycycline in patients with impaired renal function. photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur with tetracycline drugs, and treatment should be discontinued at the first evidence of skin erythema.

weight divided into two doses on the first day of treatment, followed by a maintenance dose of 2.2 mg/kg of body weight (given as a single daily dose or divided into twice daily doses). for pediatric patients weighing over 45 kg, the usual adult dose should be used. the therapeutic antibacterial serum activity will usually persist for 24 hours following recommended dosage. when used in streptococcal infections, therapy should be continued for 10 days. administration of adequate amounts of fluid along with capsule and tablet forms of drugs in the tetracycline class is recommended to wash down the drugs and reduce the risk of esophageal irritation and ulceration (see adverse reactions). if gastric irritation occurs, it is recommended that doxycycline be given with food or milk. the absorption of doxycycline is not markedly influenced by simultaneous ingestion of food or milk. studies to date have indicated that administration of doxycycline at the usual recommended doses does not lead to excessive accumulation of doxycycline in patients with renal impairment. uncomplicated gonococcal infections in adults (except anorectal infections in men): 100 mg, by mouth, twice a day for 7 days. as an alternate single visit dose, administer 300 mg stat followed in one hour by a second 300 mg dose. the dose may be administered with food, including milk or carbonated beverage, as required. uncomplicated urethral, endocervical, or rectal infection in adults caused by chlamydia trachomatis: 100 mg, by mouth, twice a day for 7 days. nongonococcal urethritis (ngu) caused by c. trachomatis or u. urealyticum: 100 mg, by mouth, twice a day for 7 days. syphilis - early: patients who are allergic to penicillin should be treated with doxycycline 100 mg, by mouth, twice a day for 2 weeks. syphilis of more than one year’s duration: patients who are allergic to penicillin should be treated with doxycycline 100 mg, by mouth, twice a day for 4 weeks. acute epididymo-orchitis caused by n. gonorrhoeae: 100 mg, by mouth, twice a day for at least 10 days. acute epididymo-orchitis caused by c. trachomatis: 100 mg, by mouth, twice a day for at least 10 days. for prophylaxis of malaria: for adults, the recommended dose is 100 mg daily. for children over 8 years of age, the recommended dose is 2 mg/kg given once daily up to the adult dose. prophylaxis should begin 1 to 2 days before travel to the malarious area. prophylaxis should be continued daily during travel in the malarious area and for 4 weeks after the traveler leaves the malarious area. inhalational anthrax (post-exposure): adults: 100 mg of doxycycline, by mouth, twice a day for 60 days. children: weighing less than 45 kg; 2.2 mg/kg of body weight, by mouth, twice a day for 60 days. children weighing 45 kg or more should receive the adult dose.

ine class. most of these patients took medications immediately before going to bed. (see dosage and administration.) skin: toxic epidermal necrolysis, stevens-johnson syndrome, erythema multiforme, maculopapular and erythematous rashes. exfoliative dermatitis has been reported but is uncommon. photosensitivity is discussed above (see warnings.) renal toxicity: rise in bun has been reported and is apparently dose related (see warnings.) immune: hypersensitivity reactions including urticaria, angioneurotic edema, anaphylaxis, anaphylactoid purpura, serum sickness, pericarditis, exacerbation of systemic lupus erythematosus, and drug rash with eosinophilia and systemic symptoms (dress). blood: hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia have been reported. other: bulging fontanels in infants and intracranial hypertension in adults (see warnings.) when given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of the thyroid gland. no abnormalities of thyroid function studies are known to occur. to report suspected adverse reactions, contact west-ward pharmaceuticals corp. at 1-877-233-2001, or fda at 1-800-fda-1088 or www.fda.gov/medwatch.

ate that tetracyclines cross the placenta and are found in fetal tissues. microbiology mechanism of action doxycycline inhibits bacterial protein synthesis by binding to the 30s ribosomal subunit. doxycycline has bacteriostatic activity against a broad range of gram-positive and gram-negative bacteria. resistance cross resistance with other tetracyclines is common. antimicrobial activity doxycycline has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections as described in the indications and usage section of the package insert for doxycycline hyclate capsules. gram-negative bacteria acinetobacter species bartonella bacilliformis brucella species klebsiella species klebsiella granulomatis campylobacter fetus enterobacter aerogenes escherichia coli francisella tularensis haemophilus ducreyi haemophilus influenza neisseria gonorrhoeae shigella species vibrio cholerae yersinia pestis gram-positive bacteria bacillus anthracis listeria monocytogenes streptococcus pneumoniae anaerobic bacteria clostridium species fusobacterium fusiforme propionibacterium acnes other bacteria nocardiae and other aerobic actinomyces species borrelia recurrentis chlamydophila psittaci chlamydia trachomatis mycoplasma pneumoniae rickettsiae treponema pallidum treponema pallidum subspecies pertenue ureaplasma urealyticum parasites balantidium coli entamoeba species plasmodium falciparum* *doxycycline has been found to be active against the asexual erythrocytic forms of plasmodium falciparum, but not against the gametocytes of p. falciparum. the precise mechanism of action of the drug is not known. susceptibility testing for specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by fda for this drug, please see: https://www.fda.gov/stic.