Doxycycline Monohydrate 100 MG Oral Capsule
INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline capsules, USP and other antibacterial drugs, doxycycline 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. Doxycycline capsules, USP are 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 capsules, USP are 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 capsules, USP are 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 . Doxycycline capsules, USP are 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 capsules, USP are 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 capsules, USP may be a useful adjunct to amebicides. In severe acne, doxycycline capsules, USP may be useful adjunctive therapy.
sun pharmaceutical industries, inc.
CAPSULE BLUE RX616
RX616 CAPSULE BLUE
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Doxycycline Monohydrate 100 MG Oral Capsule
sun pharmaceutical industries, inc.
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HOW SUPPLIED
DOXYCYCLINE capsules, USP 50 mg have light greenish yellow powder filled in size ‘4’ blue opaque cap/blue opaque body, hard gelatin capsules, imprinted with “RX614” on cap and body in black ink. Each capsule contains
DOXYCYCLINE monohydrate, USP equivalent to 50 mg of
DOXYCYCLINE.
DOXYCYCLINE capsules, USP 50 mg are available in: Bottles of 20 capsules NDC 63304-614-20 Bottles of 100 capsules NDC 63304-614-01 Bottles of 120 capsules NDC 63304-614-13 Bottles of 500 capsules NDC 63304-614-05
DOXYCYCLINE capsules, USP 75 mg have light greenish yellow powder filled in size ‘3’ reflex blue opaque cap/blue opaque body, hard gelatin capsules, imprinted with “RX615” on cap and body in black ink. Each capsule contains
DOXYCYCLINE monohydrate, USP equivalent to 75 mg of
DOXYCYCLINE.
DOXYCYCLINE capsules, USP 75 mg are available in: Bottles of 100 capsules NDC 63304-615-01 Bottles of 500 capsules NDC 63304-615-05 Unit-dose blister pack of 1 capsule NDC 63304-615-11
DOXYCYCLINE capsules, USP 100 mg have light greenish yellow powder filled in size ‘2’ reflex blue opaque cap/blue opaque body, hard gelatin capsules, imprinted with “RX616” on cap and body in black ink. Each capsule contains
DOXYCYCLINE monohydrate, USP equivalent to 100 mg of
DOXYCYCLINE.
DOXYCYCLINE capsules, USP 100 mg are available in: Bottles of 20 capsules NDC 63304-616-20 Bottles of 50 capsules NDC 63304-616-50 Bottles of 100 capsules NDC 63304-616-01 Bottles of 120 capsules NDC 63304-616-13 Bottles of 500 capsules NDC 63304-616-05 Dispense in a tight, light-resistant container as defined in the USP/NF. Store at 20° - 25° C (68° - 77° F) [See USP Controlled Room Temperature]. Protect from light. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
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