"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
MINOCIN® (minocycline) Pellet-Filled Capsules 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 Chlamydia 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 Calymmatobacterium granulomatis.
- 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.
MINOCIN® (minocycline) Pellet-Filled Capsules 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.
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 MINOCIN® (minocycline hydrochloride) Pellet-Filled Capsules and other antibacterial drugs, MINOCIN ® (minocycline hydrochloride) Pellet-Filled Capsules 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.
DOSAGE AND ADMINISTRATION
THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF MINOCYCLINE DIFFERS FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS.
MINOCIN® (minocycline) Pellet-Filled Capsules Capsules may be taken with or without food (See CLINICAL PHARMACOLOGY.)
Ingestion of adequate amounts of fluids along with capsule and tablet forms of drugs in the tetracycline-class is recommended to reduce the risk of esophageal irritation and ulceration. The pellet-filled capsules should be swallowed whole.
For Pediatric Patients Above 8 Years Of Age
Usual pediatric dose: 4 mg/kg initially followed by 2 mg/kg every 12 hours, not to exceed the usual adult dose.
The usual dosage of MINOCIN® (minocycline) Pellet-Filled Capsules is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg pellet-filled capsules may be given initially followed by one 50 mg capsule 4 times daily.
Uncomplicated gonococcal infections other than urethritis and anorectal infections in men: 200 mg initially, followed by 100 mg every 12 hours for a minimum of 4 days, with post-therapy cultures within 2 to 3 days.
In the treatment of uncomplicated gonococcal urethritis in men, 100 mg every 12 hours for 5 days is recommended.
For the treatment of syphilis, the usual dosage of minocycline hydrochloride should be administered over a period of 10 to 15 days. Close follow-up, including laboratory tests, is recommended.
In the treatment of meningococcal carrier state, the recommended dosage is 100 mg every 12 hours for 5 days.
Mycobacterium marinum infections: Although optimal doses have not been established, 100 mg every 12 hours for 6 to 8 weeks have been used successfully in a limited number of cases.
Uncomplicated urethral, endocervical, or rectal infection in adults caused by Chlamydia trachomatis or Ureaplasma urealyticum: 100 mg orally, every 12 hours for at least 7 days.
Ingestion of adequate amounts of fluids along with capsule and tablet forms of drugs in the tetracycline-class is recommended to reduce the risk of esophageal irritation and ulceration.
The pharmacokinetics of minocycline in patients with renal impairment (CLCR (80 mL/min) have not been fully characterized. Current data are insufficient to determine if a dosage adjustment is warranted. The total daily dosage should not exceed 200 mg in 24 hours. However, due to the anti-anabolic effect of tetracyclines, BUN and creatinine should be monitored. (See WARNINGS.)
MINOCIN® (minocycline) Pellet-Filled Capsules are supplied as capsules containing minocycline hydrochloride equivalent to 100 mg and 50 mg minocycline.
100 mg, two-piece, hard-shell capsule with an opaque light green cap and a transparent green body, printed in white ink with "Triax"over "M0100" on one half and "Triax" over "100 mg" on the other half. Each capsule contains pellets of minocycline HCl equivalent to 100 mg of minocycline, supplied as follows:
NDC 14290-500-87............Bottle of 60
50 mg, two-piece, hard-shell capsule with an opaque yellow cap and a transparent green body, printed in black ink with "Triax" over "M050" on one half and "Triax" over "50 mg" on the other half. Each capsule contains pellets of minocycline HCl equivalent to 50 mg of minocycline, supplied as follows:
NDC 14290-501-87.............Bottle of 60
Store at controlled room temperature 20° to 25°C (68° to 77°F).
Protect from light, moisture, and excessive heat.
Dispense in a tight, light-resistant container as defined in the USP.
Manufactured for: Triax Pharmaceuticals, LLC Cranford, NJ 07016. By: Patheon Pharmaceuticals Inc., Cincinnati, OH 45237. Marketed and Distributed by: Triax Pharmaceuticals, LLC, Cranford, NJ 07016. 05/08. FDA rev date: 06/30/08
Last reviewed on RxList: 8/1/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Minocin Capsules Information
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