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Minocin Capsules

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Minocin Capsules

Minocin Capsules

INDICATIONS

MINOCIN® (minocycline) Pellet-Filled Capsules are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms:

Minocycline is indicated for the treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:

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:

When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections:

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) 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.

Adults

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.)

HOW SUPPLIED

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.

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