Metronidazol

Metronidazole

Usos autorizados

• 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.

Formas y dosis

• Metronidazole tablets, USP are available as follows: 250 mg - White, round, convex tablets debossed " PLIVA 333 " on one side and unscored on the other side.

No debe usarse en caso de

• Hypersensitivity Metronidazole tablets are contraindicated in patients with a prior history of hypersensitivity to metronidazole or other nitroimidazole derivatives.
• In patients with trichomoniasis, metronidazole tablets are contraindicated during the first trimester of pregnancy (see PRECAUTIONS).
• Psychotic Reaction with Disulfiram Use of oral metronidazole is associated with psychotic reactions in alcoholic patients who were using disulfiram concurrently.
• Do not administer metronidazole to patients who have taken disulfiram within the last two weeks (see PRECAUTIONS, Drug Interactions).

Advertencias y precauciones

• Hypersensitivity Reactions Hypersensitivity reactions including severe cutaneous adverse reactions (SCARs) can be serious and potentially life threatening (see ADVERSE REACTIONS).
• Severe Cutaneous Adverse Reactions Severe cutaneous adverse reactions (SCARs) including toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported with the use of metronidazole.
• Symptoms can be serious and potentially life threatening.
• If symptoms or signs of SCARs develop, discontinue metronidazole immediately and institute appropriate therapy.

Efectos adversos frecuentes

• most common adverse reactions reported have been referable to the gastrointestinal tract, particularly nausea, sometimes accompanied by headache, anorexia, and occasionally vomiting; diarrhea; epigastric distress; and abdominal cramping and constipation.

Mecanismo de acción

Microbiology Mechanism of Action Metronidazole, a nitroimidazole, exerts antibacterial effects in an anaerobic environment against most obligate anaerobes. Once metronidazole enters the organism by passive diffusion and activated in the cytoplasm of susceptible anaerobic bacteria, it is reduced; this process includes intracellular electron transport proteins such as ferredoxin, transfer of an electron to the nitro group of the metronidazole, and formation of a short-lived nitroso free radical.

Titular de la autorización:

Teva Pharmaceuticals USA, Inc.

Versión de la ficha:

16 de julio de 2024

Las secciones anteriores están citadas de la ficha en inglés, porque es ese documento el que porta la autorización. Cuando una autoridad europea publica la misma información en español, el enlace figura en las fuentes. No traducimos por nuestra cuenta los textos reguladores: un error de traducción en una contraindicación sería más peligroso que una línea en otro idioma.

Esta sección recoge la ficha técnica autorizada. El texto está condensado a partir del resumen de la propia autoridad, y el documento completo figura en las fuentes.