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To reduce the development of drug-resistant bacteria and maintain the effectiveness of DORYX and other antibacterial drugs, DORYX should be used only to treat or prevent infections that are proven or strongly suspected to be caused by 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 empire 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 also is 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 microorganisms, when bacteriological testing indicates appropriate susceptibility to the drug:
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
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 PATIENT INFORMATION section).
DOSAGE AND ADMINISTRATION
The usual dosage and frequency of administration of doxycycline differs from that of the other tetracyclines. Exceeding the recommended dosage may result in an increased incidence of side effects.
Adults: The usual dose of oral doxycycline is 200 mg on the first day of treatment (administered 100 mg every 12 hours), followed by a maintenance dose of 100 mg daily. The maintenance dose may be administered as a single dose or as 50 mg every 12 hours. In the management of more severe infections (particularly chronic infections of the urinary tract), 100 mg every 12 hours is recommended.
For children above eight years of age: The recommended dosage schedule for children weighing 45 kg or less is 4.4 mg/kg of body weight divided into two doses on the first day of treatment, followed by 2.2 mg/kg of body weight given as a single daily dose or divided into two doses on subsequent days. For more severe infections up to 4.4 mg/kg of body weight may be used. For children 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, doxycycline may be given with food or milk.
Studies to date have indicated that administration of doxycycline at the usual recommended doses does not lead to excessive accumulation of the antibacterial 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 alternative single visit dose, administer 300 mg stat followed in an 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 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 or 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 traveller 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 100 lb (45 kg); 1 mg/lb (2.2 mg/kg) of body weight, by mouth, twice-a day for 60 days. Children weighing 100 lb or more should receive the adult dose.
Sprinkling the Capsule Contents on Applesauce
DORYX Capsules may also be administered by carefully opening the capsule and sprinkling the capsule contents on a spoonful of applesauce. However, any loss of pellets in the transfer would prevent using the dose. The applesauce should be swallowed immediately without chewing and followed with a cool 8-ounce glass of water to ensure complete swallowing of the capsule contents. The applesauce should not be hot, and it should be soft enough to be swallowed without chewing. In the event that a prepared dose of applesauce/DORYX pellets cannot be taken immediately, the mixture should be discarded and not stored for later use.
DORYX® (doxycycline hyclate) Delayed-Release Capsules, 100 mg have a dark yellow transparent body, with light blue opaque cap; the capsule bearing the inscription “DORYX” and “WC” in a circl e, printed in white. Pellets are colored yellow. Each capsule contains specially coated pellets of doxycycline hyclate equivalent to 100 mg of doxycycline supplied in:
Bottles of 50 capsules N 51862-XXX-XX
DORYX® (doxycycline hyclate) Delayed-Release Capsules, 75 mg have an orange transparent body, with green opaque cap: the capsule bearing the inscription “DORYX” and “75 mg” in black. Pellets are colored yellow. Each capsule contains specially coated pellets of doxycycline hyclate equivalent to 75 mg of doxycycline supplied in:
Bottles of 60 tablets N 51862-XXX-XX
Store at controlled room temperature below 25° C (77° F).
Manufactured by: Mayne Pharma International Pty Ltd, Salisbury South, SA 5106 Australia. Revised: Aug 2015
Last reviewed on RxList: 9/17/2015
This monograph has been modified to include the generic and brand name in many instances.
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