Flagyl Tablets 500 mg
Composition:

Active ingredient: Each tablet contains 500 mg metronidazole.
Excipients: Sorbitol 37.50 mg

Therapeutic indications:

Indicated for the treatment of infections caused by confirmed sensitive microorganisms, including:

• Amoebiasis

• Trichomoniasis of the urogenital system

• Nonspecific vaginitis

• Giardiasis

• Treatment of medical-surgical infections caused by sensitive anaerobic organisms

• Prevention of infections that may develop during surgery due to high risk of contact with sensitive anaerobic microorganisms

Dosage, frequency, and duration of use:

Amoebiasis:

• Adults: 1.5 g daily, divided into 3 doses.

• Children: 30-40 mg/kg/day, divided into three doses. Total daily dose should not exceed 2400 mg. In hepatic amoebiasis with abscess, metronidazole treatment should be combined with abscess drainage. Treatment duration is 7 consecutive days.

Trichomoniasis:

• Women (trichomonal urethritis and vaginitis): single dose of 2 grams (4 tablets).

• Even if the partner shows no symptoms or positive lab tests for Trichomonas vaginalis infection, simultaneous treatment of both partners is necessary.

Giardiasis:

• Adults: 750 mg to 1 g daily for 5 consecutive days.

• Children aged 10 to 15 years: 500 mg daily.

Nonspecific vaginitis:

• 500 mg twice daily for 7 days.

Treatment of infections caused by anaerobic organisms (first-line or subsequent treatment):

• Adults: 1-1.5 g daily.

• Children: 20-30 mg/kg/day.

Surgical chemoprophylaxis:
Published studies do not provide an ideal protocol for surgical prophylaxis. Metronidazole should be used in combination with an effective agent against Enterobacteriaceae. A dose of 500 mg every 8 hours provides adequate effect when administered approximately 48 hours before surgery. The last dose should be given at least 12 hours before surgery. Since the aim of chemoprophylaxis is to prevent bacterial inoculation in the gastrointestinal tract during surgery, continuation of the drug postoperatively (at least orally) is not beneficial. Children should be dosed 20-30 mg/kg/day following the same protocol.

Method of administration:
Administered orally. Can be taken with or without food.

Additional information for special populations:

Renal/hepatic impairment:
In severe hepatic impairment, dose and frequency should be adjusted based on the degree of metronidazole deficiency and serum levels. For renal impairment, see section 4.4.

Pediatric population:
Suspension form of FLAGYL is preferred for children.

Geriatric population:
Use with caution in elderly patients, especially at high doses.

Contraindications:

• Hypersensitivity to imidazole derivatives or any of the excipients.

• First trimester of pregnancy.

Storage:

Store below 25°C.