Filmet 400

Indications

Filmet is prescribed for the treatment of various conditions, including:

• Preventing Post-Operative Infections: Effective against anaerobic bacteria such as Bacteroides and anaerobic streptococci.
• Treating Anaerobic Infections: Used for septicaemia, bacteraemia, peritonitis, brain abscesses, pelvic abscesses, pelvic cellulitis, and post-surgical wound infections caused by anaerobes.
• Managing Urogenital Trichomoniasis: Effective for trichomoniasis infections.
• Addressing Bacterial Vaginosis: Also known as non-specific vaginitis.
• Combating Amoebiasis: Treats all forms, including intestinal amoebiasis, extra-intestinal amoebiasis, and asymptomatic cyst passers.
• Treating Giardiasis: Effective for giardiasis infections.
• Acute Ulcerative Gingivitis: For the treatment of acute ulcerative gingivitis.
• Managing Infected Leg Ulcers and Pressure Sores: Treats leg ulcers and pressure sores with anaerobic infections.
• Addressing Acute Dental Infections: Effective for dental infections caused by anaerobic organisms.
• Managing Antibiotic-Associated Pseudomembranous Colitis: Useful in treating colitis associated with antibiotic use.

Pharmacology

Metronidazole, an imidazole-class antibacterial drug, functions as an antiprotozoal agent. The 5-nitro group of Metronidazole is metabolized by anaerobes, leading to a reduction that interacts with DNA, providing its bactericidal effects.

Dosage & Administration

Tablet and Suspension:

• Trichomoniasis:
  • Adults & Children over 10: 200 mg three times daily, or 400 mg twice daily for 7 days; alternatively, 800 mg in the morning and 1-2 gm at night for 2 days, or a single dose of 2 gm for 1 day.
  • Children: 7-10 years: 100 mg three times daily; 3-7 years: 100 mg twice daily; 1-3 years: 50 mg three times daily.
• Intestinal Amoebiasis:
  • Adults & Children over 10: 800 mg three times daily for 5 days.
  • Children: 7-10 years: 400 mg three times daily; 3-7 years: 200 mg four times daily; 1-3 years: 200 mg three times daily.
• Extra-intestinal & Asymptomatic Amoebiasis:
  • Adults & Children over 10: 400-800 mg three times daily for 5-10 days.
  • Children: 7-10 years: 200-400 mg three times daily; 3-7 years: 100-200 mg four times daily; 1-3 years: 100-200 mg three times daily.
• Giardiasis:
  • Adults & Children over 10: 2 gm once daily for 3 days.
  • Children: 7-10 years: 1 gm once daily; 3-7 years: 600-800 mg once daily; 1-3 years: 500 mg once daily.
• Acute Ulcerative Gingivitis:
  • Adults & Children over 10: 200 mg three times daily for 3 days.
  • Children: 7-10 years: 100 mg three times daily; 3-7 years: 100 mg twice daily; 1-3 years: 50 mg three times daily.
• Acute Dental Infections:
  • Adults & Children over 10: 200 mg three times daily for 3-7 days.
• Bacterial Vaginosis:
  • Adults & Children over 10: 400 mg twice daily for 7 days or a single dose of 2 gm.
• Leg Ulcers and Pressure Sores:
  • Adults & Children over 10: 400 mg three times daily for 7 days.
• Anaerobic Infections:
  • Adults & Children over 10: 800 mg initially, followed by 400 mg three times daily for 7 days.
  • Children: 1-10 years: 7.5 mg/kg three times daily.
• Surgical Prophylaxis:
  • Adults & Children over 10: 400 mg three times daily starting 24 hours before surgery for 1 day.
  • Children: 1-10 years: 7.5 mg/kg three times daily.

Vaginal Gel:

• Administer one applicator full (about 5 grams containing 37.5 mg of Metronidazole) intravaginally once or twice daily for 5 days. For once-daily dosing, use at bedtime.

Suppository:

• Anaerobic Infections:
  • Adults: 1 g every 8 hours for 3 days, then every 12 hours.
  • Children 5-10 years: 500 mg every 8 hours for 3 days, then every 12 hours; Over 10 years: Adult dose.
• Surgical Prophylaxis:
  • Adults: 1 g 2 hours before surgery; up to 3 additional doses of 1 g every 8 hours for high-risk procedures.
  • Children 5-10 years: 500 mg 2 hours before surgery; up to 3 additional doses of 500 mg every 8 hours for high-risk procedures.

IV Infusion:

• Metronidazole IV infusion should not be diluted or mixed with other drugs.
  • Adults and Children over 12 years: Infuse 500 mg every 8 hours at 5 ml/minute, with a maximum of 4 g per 24 hours. Generally, a 7-day treatment is adequate, but can be extended if needed. For surgical prophylaxis, administer shortly before surgery, followed by 8-hourly doses for the next 24 hours.
  • Children under 12 years: 7.5 mg/kg body weight every 8 hours at 5 ml/minute.

Interactions:

• Disulfiram: May cause psychotic reactions when used concurrently.
• Alcohol: Avoid alcoholic beverages and products containing alcohol during and at least one day after therapy to prevent disulfiram-like reactions.
• Oral Anticoagulants (Warfarin): May increase bleeding risk; monitor prothrombin time and adjust dosage accordingly.
• Lithium: May increase lithium levels.
• Cyclosporin: Monitor serum cyclosporin and creatinine levels.
• Phenytoin/Phenobarbital: May reduce Metronidazole levels.
• 5-Fluorouracil: Can increase toxicity of 5-fluorouracil.
• Busulfan: May increase busulfan toxicity.

Contraindications:

Metronidazole is contraindicated in individuals with a known hypersensitivity to Metronidazole or other Nitroimidazole derivatives.

Side Effects:

Possible side effects include metallic taste, nausea, vomiting, diarrhea, drowsiness, and rashes.

Pregnancy & Lactation:

Metronidazole is classified as US FDA Pregnancy Category B. Use during pregnancy only if necessary. It is excreted in breast milk; exercise caution when administering to nursing mothers.

Precautions & Warnings:

• If extended use is necessary, monitor hematological parameters and watch for adverse reactions like neuropathy.
• Use with caution in patients with hepatic encephalopathy.
• Warn patients that urine may darken during treatment.

Use in Special Populations:

• Hepatic Impairment: Dose reduction may be necessary for patients with severe hepatic impairment. Monitor for symptoms of encephalopathy.
• Renal Impairment: No dose adjustment is needed for renal failure, but re-administer after hemodialysis. No routine adjustments are needed for peritoneal dialysis.

Overdose Effects:

Overdoses up to 12 g have been reported with symptoms of vomiting, ataxia, and disorientation. There is no specific antidote; symptomatic and supportive treatment is recommended.

Therapeutic Class:

Amoebicides, Anti-diarrhoeal, Antiprotozoal

Storage Conditions:

Store below 30°C, protected from light, and out of reach of children. Do not use past the expiration date.