INDICATIONS AND USAGE Minocycline hydrochloride capsules, USP are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms: 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) due to 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 . Nongonococcal urethritis, endocervical, or rectal infections 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 caused by Campylobacter fetus . Brucellosis due to Brucella species (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis . Granuloma inguinale caused by Klebsiella granulomatis . Minocycline is indicated for the 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. Minocycline hydrochloride capsules, USP are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: Upper respiratory tract infections caused by Streptococcus pneumoniae . Skin and skin structure infections caused by Staphylococcus aureus . (Note: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection.) When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections: Uncomplicated urethritis in men due to Neisseria gonorrhoeae and for the treatment of other 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 . Infections caused by Clostridium species. In acute intestinal amebiasis , minocycline may be a useful adjunct to amebicides. In severe acne , minocycline may be useful adjunctive therapy. Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high. Oral minocycline is not indicated for the treatment of meningococcal infection . Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum . To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules, USP and other antibacterial drugs, minocycline hydrochloride 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.
Aurobindo Pharma Limited
MINOCYCLINE HYDROCHLORIDE capsules USP contains
MINOCYCLINE HYDROCHLORIDE USP equivalent to minocycline 50 mg, 75 mg and 100 mg.
MINOCYCLINE HYDROCHLORIDE capsules USP, 50 mg are pink/pink size ā3ā hard gelatin capsule filled with yellow granular powder and imprinted with āCā on pink cap and ā76ā on pink body with black ink. Bottles of 100 NDC 65862-209-01 Bottles of 500 NDC 65862-209-05 Bottles of 1,000 NDC 65862-209-99
MINOCYCLINE HYDROCHLORIDE capsules USP, 75 mg are white/grey size ā3ā hard gelatin capsule filled with yellow granular powder and imprinted with āCā on white cap and ā77ā on grey body with black ink. Bottles of 100 NDC 65862-210-01 Bottles of 500 NDC 65862-210-05 Bottles of 1,000 NDC 65862-210-99
MINOCYCLINE HYDROCHLORIDE capsules USP, 100 mg are maroon/pink size ā2ā hard gelatin capsule filled with yellow granular powder and imprinted with āCā on maroon cap and ā78ā on pink body with black ink. Bottles of 50 NDC 65862-211-50 Bottles of 500 NDC 65862-211-05 Bottles of 1,000 NDC 65862-211-99 Store at 20Ā° to 25Ā°C (68Ā° to 77Ā°F); excursions permitted to 15Ā° to 30Ā°C (59Ā° to 86Ā°F) [see USP Controlled Room Temperature]. Protect from light, moisture, and excessive heat. Dispense in a tight, light-resistant container as defined in the USP.
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