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Minocycline (Minocycline Hydrochloride) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Minocycline hydrochloride tablets 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 immunoflourescence.
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.

Minocycline is 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.

Minocycline hydrochloride tablets 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 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 meningitides to eliminate the meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carrier, 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 tablets and other antibacterial drugs, minocycline hydrochloride 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 antimicrobial 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.

Minocycline hydrochloride tablets should be taken at least one hour before meals or 2 hours after meals (see CLINICAL PHARMACOLOGY).

For Pediatric Patients Above 8 Years of Age

Usual pediatric dose: 4 mg/kg initially followed by 2 mg/kg every 12 hours.

Adults

The usual dosage of minocycline hydrochloride tablets is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg tablets may be given initially followed by one 50 mg tablet four 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 four 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 five 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 urethra, endocervical, or rectal infection in adults caused by Chlamydia trachomatis or Ureaplasma urealyticum: 100 mg orally, every 12 hours for at least seven days.

Ingestion of adequate amounts of fluids along with tablet form of drugs in the tetracycline-class is recommended to reduce the risk of esophageal irritation and ulceration.

In patients with renal impairment (see WARNINGS), the total dosage should be decreased by either reducing the recommended individual doses and/or by extending the time interval between doses.

HOW SUPPLIED

Minocycline hydrochloride tablets are supplied as aqueous film coated tablets containing minocycline hydrochloride equivalent to 100 mg, 75 mg and 50 mg minocycline.
The 100 mg tablets are dark grey, round, biconvex, film coated tablets debossed “I-73” on one side and plain on the other. Each tablet contains minocycline hydrochloride equivalent to 100 mg minocycline, supplied as follows:
(NDC 24724-003-05) Bottle of 50
(NDC 24724-003-10) Bottle of 1000

The 75 mg tablets are grey, round, biconvex, film coated tablets debossed “I-72” on one side and plain on the other. Each tablet contains minocycline hydrochloride equivalent to 75 mg minocycline, supplied as follows:
(NDC 24724-002-01) Bottle of 100
(NDC 24724-002-10) Bottle of 1000

The 50 mg tablets are yellow, round, biconvex, film coated tablets debossed “I-71” on one side and plain on the other. Each tablet contains minocycline hydrochloride equivalent to 50 mg minocycline, supplied as follows:
(NDC 24724-001-01) Bottle of 100
(NDC 24724-001-10) Bottle of 1000

Store between 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

Protect from light, moisture and excessive heat.

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