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Minocin

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Minocin

Indications
Dosage
How Supplied

INDICATIONS

MINOCIN® (minocycline hydrochloride oral suspension) Oral Suspension is 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, rickettsial pox 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.

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.

MINOCIN® (minocycline hydrochloride oral suspension) Oral Suspension is 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 MINOCIN® (minocycline hydrochloride oral suspension) Oral Suspension and other antibacterial drugs, MINOCIN® (minocycline hydrochloride oral suspension) Oral Suspension 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.

Therapy should be continued for at least 24 to 48 hours after symptoms and fever have subsided.

Studies to date have indicated that the absorption of MINOCIN® (minocycline hydrochloride oral suspension) Oral Suspension is not notably influenced by foods and dairy products.

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.)

In the treatment of streptococcal infections, a therapeutic dose of tetracycline should be administered for at least ten days.

For Pediatric Patients Above 8 Years Of Age

The usual dosage of MINOCIN® (minocycline hydrochloride oral suspension) is 4 mg/kg initially followed by 2 mg/kg every 12 hours, not to exceed the usual adult dose.

Adults

The usual dosage of MINOCIN® (minocycline hydrochloride oral suspension) is 200 mg initially followed by 100 mg every 12 hours.

For treatment of syphilis, the usual dosage of MINOCIN® (minocycline hydrochloride oral suspension) should be administered over a period of 10 to 15 days. Close follow up, including laboratory tests, is recommended.

Gonorrhea patients sensitive to penicillin may be treated with MINOCIN® (minocycline hydrochloride oral suspension) , administered as 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 meningococcal carrier state, 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.1

In the treatment of uncomplicated gonococcal urethritis in men, 100 mg twice a day orally for 5 days is recommended.

HOW SUPPLIED

MINOCIN® (minocycline hydrochloride) Oral Suspension contains minocycline hydrochloride equivalent to 50 mg minocycline per teaspoonful (5 mL). Preserved with propylparaben 0.10% and butylparaben 0.06% with Alcohol USP 5% v/v. Custard-flavored.

NDC 14290-545-61 Bottle 2 fl.oz. (60 mL)

Store at controlled room temperature 20° to 25°C (68° to 77°F). DO NOT FREEZE.

This product's label may have been updated. For current package insert and further product information, please visit www.triaxpharma.com or call our toll-free number: 866-48- TRIAX (87429). Call between 9:00 a.m. and 3:00 p.m. Eastern Time, Monday through Friday.

Manufactured for Triax Pharmaceuticals, LLC 20 Commerce Drive, Cranford, NJ 07016. By Wyeth Pharmaceuticals Inc., Philadelphia, PA 19101. Rev 10/06. FDA Rev date: 1/16/2007

Last reviewed on RxList: 2/20/2008
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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