Symptomatic Trichomoniasis

Flagyl is indicated for the treatment of symptomatic trichomoniasis in females and males when the presence of thetrichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures).

Asymptomatic Trichomoniasis

Flagyl is indicated in the treatment of asymptomatic females when the organism is associated with endocervi-citis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite.

Treatment of Asymptomatic Consorts.

T. vagi-nalis infection is a venereal disease. Therefore, asymptomatic sexual partners of treated patients should be treated simultaneously if the organism has been found to be present, in order to prevent reinfection of the partner. The decision as to whether to treat an asymptomatic male partner who has a negative culture or one for whom no culture has been attempted is an individual one. In making this decision, it should be noted that there is evidence that a woman may become reinfected if her consort is not treated. Also, since there can be considerable difficulty in isolating the organism from the asymptomatic male carrier, negative smears and cultures cannot be relied upon in this regard. In any event, the consort should be treated with Flagyl in cases of reinfection.

Amebiasis

Flagyl is indicated in the treatment of acute intestinal amebiasis (amebic dysen-tery)and amebic liver abscess.

In amebic liver abscess, Flagyl therapy does not obviate the need for aspiration or drainage of pus.

Anaerobic Bacterial Infections

Flagyl is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Indicated surgical procedures should be performed in conjunction with Flagyl therapy. In a mixed aerobic and anaerobic infection, antimicrobials appropriate for the treatment of the aerobic infection should be used in addition to Flagyl.

In the treatment of most serious anaerobic infections, Flagyl I.V. (metronidazole hydrochloride) or Flagyl I.V. RTU® (metronidazole) is usually administered initially. This may be followed by oral ther-apy with Flagyl (metronidazole) at the discretion of the physician.

INTRA-ABDOMINAL INFECTIONS, including peritonitis, intra-abdominal abscess, and liver abscess, caused by Bacteroides species including the B. fragilis group (B. fragilis, B. distasonis,B. ovatus, B. thetaiotaomicron, B. vulgatus), Clostrid-ium species, Eubacterium species, Peptococcus niger, and Peptostreptococcus species.

SKIN AND SKIN STRUCTURE INFECTIONS caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcus niger,Peptostreptococcus species, and Fusobacte-rium species.

GYNECOLOGIC INFECTIONS, including endo-metritis, endomyometritis, tubo-ovarian abscess, and postsurgical vaginal cuff infection, caused by Bacteroides species including the B. fragilis group, Clostridium species, Peptococcusniger, and Pepto-streptococcus species.

BACTERIAL SEPTICEMIA caused by Bacteroides species including the B. fragilis group, and Clos-tridium species.

BONE AND JOINT INFECTIONS, as adjunctive therapy, caused by Bacteroides species including the B. fragilis group.

CENTRAL NERVOUS SYSTEM (CNS) INFECTIONS, including meningitis and brain abscess, caused by Bacteroides species including the B.fragilis group.

LOWER RESPIRATORY TRACT INFECTIONS, including pneumonia, empyema, and lung abscess, caused by Bacteroides species including the B. fragilis group.

ENDOCARDITIS caused by Bacteroides species including the B.fragilis group.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Flagyl and other antibacterial drugs, Flagyl 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.

In elderly patients, the pharmacokinetics of metro-nidazole may be altered, and, therefore, monitoring of serum levels may be necessary to adjust the metronidazole dosage accordingly.

Trichomoniasis

In the Female

One-day treatment—two grams of Flagyl, given either as a single dose or in two divided doses of one gram each given in the same day.

Seven-day course of treatment—250 mg three times daily for seven consecutive days. There is some indication from controlled comparative studies that cure rates as determined by vaginal smears, signs and symptoms, may be higher after a seven-day course of treatment than after a one-day treatment regimen.

The dosage regimen should be individualized. Single-dose treatment can assure compliance, especially if administered under supervision, in those patients who cannot be relied on to continue the seven-day regimen. A seven-day course of treatment may minimize reinfection by protecting the patient long enough for the sexual contacts to obtain appropriate treatment. Further, some patients may tolerate one treatment regimen better than the other.

Pregnant patients should not be treated during the first trimester. (See CONTRAINDICATIONS.) In pregnant patients in whom alternative treatment has been inadequate, the one-day course of therapy should not be used, as it results in higher serum levels which can reach the fetal circulation (see PRECAUTIONS, Pregnancy).

When repeat courses of the drug are required, it is recommended that an interval of four to six weeks elapse between courses and that the presence of the trichomonad be reconfirmed by appropriate laboratory measures. Total and differential leukocyte counts should be made before and after re-treatment.

In the Male

Treatment should be individualized as for the female.

Amebiasis

Adults

For acute intestinal amebiasis (acute amebic dysentery): 750 mg orally three times daily for 5 to 10 days.

For amebic liver abscess: 500 mg or 750 mg orally three times daily for 5 to 10 days.

Pediatric patients: 35 to 50 mg/kg/24 hours, divided into three doses, orally for 10 days.

Anaerobic Bacterial Infections

In the treatment of most serious anaerobic infections, Flagyl I.V. (met-ronidazole hydrochloride) or Flagyl I.V. RTU® (met-ronidazole) is usually administered initially.

The usual adult oral dosage is 7.5 mg/kg every six hours (approx. 500 mg for a 70-kg adult). A maximum of 4 g should not be exceeded during a 24-hour period.

The usual duration of therapy is 7 to 10 days; however, infections of the bone and joint, lower respiratory tract, and endocardium may require longer treatment.

Patients with severe hepatic disease metabolize metronidazole slowly, with resultant accumulation of metronidazole and its metabolites in the plasma. Accordingly, for such patients, doses below those usually recommended should be administered cautiously. Close monitoring of plasma metronidazole levels²and toxicity is recommended.

The dose of Flagyl should not be specifically reduced in anuric patients since accumulated metabolites may be rapidly removed by dialysis.

Flagyl 250-mg tablets are round, blue, film coated, with SEARLE and 1831 debossed on one side and FLAGYL and 250 on the other side; bottles of 50, 100, and 2,500.

Flagyl 500-mg tablets are oblong, blue, film coated, with FLAGYL debossed on one side and 500 on the other side; bottles of 50, 100, and 500.

Storage and Stability: Store below 77°F (25°C) and protect from light.

REFERENCES

2. Ralph, E.D., and Kirby, W.M.M.: Bioassay of Met-ronidazole With Either Anaerobic or Aerobic Incubation, J. Infect. Dis. 132:587–591 (Nov.) 1975; or Gulaid, et al.: Determination of Metronidazole and Its Major Metabolites in Biological Fluids by High Pressure Liquid Chromatography, Br. J. Clin. Phar-macol. 6:430–432, 1978.

Revised: August 2003
G.D. Searle LLC
A subsidiary of Pharmacia Corporation Chicago, IL 60680, USA
Flagyl®
metronidazole tablets
FDA rev date: 3/17/2004

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