Demeclocycline Hydrochloride 150 MG Oral Tablet
INDICATIONS AND USAGE Demeclocycline HCl 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 cause by Campylobacter fetus Brucellosis due to Brucella species (in conjunction with streptomycin); Bartonellosis due to Bartonella bacilliformis Granuloma inguinale caused by Calymmatobacterium granulomatis Demeclocycline HCl tablets are indicated for treatment of infections 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 Demeclocycline HCl tablets 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 Skin and skin structure infections caused by Staphylococcus aureus . (Note: Tetracyclines, including demeclocycline, are not the drugs of choice in the treatment of any type of staphylococcal infection). When penicillin is contraindicated, tetracyclines, including demeclocycline HCl, are alternative drugs in the treatment of the following infections: Uncomplicated urethritis in men due to Neisseria gonorrhoeae , and for the treatment of other uncomplicated 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 Clostridial diseases caused by Clostridium species In acute intestinal amebiasis, demeclocycline HCl may be a useful adjunct to amebicides. In severe acne, demeclocycline HCl may be a useful adjunctive therapy. To reduce the development of drug-resistant bacteria and maintain the effectiveness of demeclocycline HCl tablets and other antibacterial drugs, demeclocycline HCl 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.
Amneal Pharmaceuticals LLC
ROUND RED AN 54
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HOW SUPPLIED
DEMECLOCYCLINE HCl tablets, USP, 150 mg, are supplied as round, convex, red, film-coated tablets, debossed with “AN” above “54” on one side and plain on the other side. They are available as follows: Bottles of 100: NDC 65162-554-10
DEMECLOCYCLINE HCl tablets, USP, 300 mg, are supplied as round, convex, red, film-coated tablets, debossed with “AN” above “55” on one side and plain on the other side. They are available as follows: Bottles of 48: NDC 65162-555-48 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP. Protect from light. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
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