Section :
Flazol
📌 COMPOSITION
- Each 5 ml contains: Metronidazole Benzoate B.P. equivalent to Metronidazole 125 mg.
- Each tablet contains: Metronidazole B.P. 250 mg, 500 mg.
📌 DESCRIPTION
Flazol is an antiprotozoal and anaerobic antibacterial agent. It is well absorbed from the GIT after oral administration and peak concentrations are reached within 2-3 hours. It is distributed in all body tissues and fluids. It appears in breast milk, CSF and crosses the placenta. Metronidazole is metabolised in the liver and both the drug and its metabolite possess in vivo bactericidal activity. Metronidazole has an average elimination half‑life in healthy subjects of about 8 hours. The major route of excretion of Metronidazole and its metabolites is via the kidneys in urine (60% to 80% of the dose). Faecal excretion accounts for 6 to 15% of the dose.
📌 INDICATIONS
Flazol is indicated for the prevention and treatment of infections caused by susceptible micro‑organisms, e.g. amoebiasis, giardiasis, anaerobic infections and Crohn's disease.
📌 DOSAGE & ADMINISTRATION
Adults:
- Trichomoniasis: 2 g single dose or 500 mg/day in two divided doses for 10 days.
- Amoebiasis: 1.5 g daily in 3 divided doses for 5-10 days.
- Giardiasis: 750 mg to 1 g daily for 5 consecutive days.
- Crohn's disease: 500 mg twice daily.
Children:
| Indication | Age | Dose | Frequency |
|---|---|---|---|
| Giardiasis | 2-5 years | 5 ml | 3 times daily for 5-10 days |
| 6-10 years | 5-10 ml | ||
| over 10 years | 10 ml | ||
| Amoebiasis | - | 35-50 mg/kg/day | In 3 divided doses for 10 days |
| Anaerobic infections | - | 7 mg/kg body weight | 4 times daily (every 6 hours) |
| Crohn's disease | - | 7 mg/kg body weight | Twice daily |
📌 RESTRICTIONS ON USE
Contraindications
- Hypersensitivity to imidazole derivatives.
- First trimester of pregnancy.
Precautions
- Administer Metronidazole with caution to patients with CNS disease.
- Administer with caution and reduce the dose in patients with severe liver function impairment.
- In severe kidney impairment, 50% of the dose can be given at the usual dosing interval.
Use in pregnancy and lactation
- Metronidazole is contra‑indicated in the first trimester of pregnancy. In the second trimester and thereafter, its usage is restricted to patients in whom other alternative treatment has been inadequate.
- Metronidazole appears in breast milk and unnecessary exposure of the neonate to the drug should be avoided. A single dose of 2 grams is advised for the treatment of trichomoniasis in lactating mothers.
📌 ADVERSE EFFECTS
Nausea, headache, vomiting, constipation, metallic taste, reversible neutropenia, hypersensitivity reactions in the form of urticaria, erythematous rashes and fever.
📌 STORAGE INSTRUCTIONS
- Suspension: Store below 25°C. Protect from light.
- Tablets: Store below 25°C in a dry place. Protect from light.
📌 PHARMACEUTICAL FORMS
- Flazol Tablets: Pack of 20 tablets and hospital packs of different sizes.
- Flazol Suspension: Bottle of 100 ml.