Metronidazole

For the topical treatment of Rosacea (inflammatory papulopustules rosacea related).

NIDAGEL is indicated for the treatment of bacterial vaginosis (formerly called nonspecific vaginitis, Gardnerella vaginalis or Haemophilus vaginitis) in adult women. A clinical diagnosis of bacterial vaginosis is usually defined by the presence of a homogenous vaginal discharge that: a.

5; b. emits a fishy amine odour when mixed with a 10% KOH solution; c. contains clue cells on microscopic examination. , Trichomonas vaginalis, Chlamydia trachomatis, Neisseria gonorrhoeae, Candida albicans and herpes simplex virus should be ruled out.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of NIDAGEL and other antibacterial drugs, NIDAGEL should be used only to treat 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.

INDICATIONS AND USAGE

Symptomatic Trichomoniasis. Metronidazole tablets are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures).

Asymptomatic Trichomoniasis. Metronidazole tablets are indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, 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 Sexual Partners. T. vaginalis 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.