Filmet IV

Indications

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

• Prevention of Post-Operative Infections: Effective against anaerobic bacteria, including species of Bacteroides and anaerobic streptococci.
• Treatment of Severe Infections: Suitable for septicaemia, bacteraemia, peritonitis, brain abscesses, pelvic abscesses, pelvic cellulitis, and post-operative wound infections caused by anaerobes.
• Urogenital Trichomoniasis: Effective for treating trichomoniasis in both adults and children over 10 years.
• Bacterial Vaginosis: Also known as non-specific vaginitis.
• Amoebiasis: Treats all forms of amoebiasis, including intestinal, extra-intestinal, and asymptomatic cyst passers.
• Giardiasis: Effective for treating giardiasis.
• Acute Ulcerative Gingivitis: Provides relief from acute ulcerative gingivitis.
• Anaerobic Infections: Treats infected leg ulcers, pressure sores, and acute dental infections caused by anaerobic organisms.
• Antibiotic-Associated Colitis: Addresses pseudomembranous colitis associated with antibiotic use.

Pharmacology

Metronidazole, a member of the imidazole class, functions as an antiprotozoal agent. The drug’s 5-nitro group is metabolically reduced by anaerobes, with the reduced form interacting with DNA to exert bactericidal effects.

Dosage & Administration

• Tablets and Suspension:
  • Trichomoniasis:
    • Adults & Children over 10: 200 mg three times daily or 400 mg twice daily for 7 days; alternative regimens include 800 mg in the morning and 1-2 g at night for 2 days, or 2 g as a single dose for 1 day.
    • Children 7-10 years: 100 mg three times daily.
    • Children 3-7 years: 100 mg twice daily.
    • Children 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.
    • Children 3-7 years: 200 mg four times daily.
    • Children 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.
    • Children 3-7 years: 100-200 mg four times daily.
    • Children 1-3 years: 100-200 mg three times daily.
  • Giardiasis:
    • Adults & Children over 10: 2 g once daily for 3 days.
    • Children 7-10 years: 1 g once daily.
    • Children 3-7 years: 600-800 mg once daily.
    • Children 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.
    • Children 3-7 years: 100 mg twice daily.
    • Children 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 2 g as a single dose for 1 day.
  • 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 (approximately 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 1 g 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 may be given 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:
  • Adults and Children over 12 years: Infuse 500 mg every 8 hours at a rate of 5 ml/minute, not exceeding 4 g per 24 hours. Treatment duration is typically 7 days but may be extended if reinfection is likely. 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 per day every 8 hours at a rate of 5 ml/minute.

Always follow your physician’s instructions regarding medication use.

Interactions

• Disulfiram: Concurrent use may cause psychotic reactions.
• Alcohol: Avoid alcoholic beverages and alcohol-containing drugs during and at least one day after treatment to prevent disulfiram-like reactions.
• Oral Anticoagulants: May enhance anticoagulant effects; monitor prothrombin time and adjust therapy as needed.
• Lithium: May increase plasma levels of lithium.
• Cyclosporin: Monitor serum cyclosporin and serum creatinine closely.
• Phenytoin or Phenobarbital: May reduce Metronidazole levels.
• 5-Fluorouracil: May increase toxicity due to reduced clearance.
• Busulfan: May increase busulfan levels, leading to potential toxicity.

Contraindications

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

Side Effects

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

Pregnancy & Lactation

Metronidazole is classified as Pregnancy Category B by the US FDA. Use during pregnancy should be limited to cases where it is clearly needed. Metronidazole is excreted in human milk, so caution is advised when administering to nursing mothers.

Precautions & Warnings

• Long-term use may necessitate regular hematological testing to monitor for adverse effects such as neuropathy.
• Use with caution in patients with hepatic encephalopathy.
• Metronidazole may cause urine discoloration.

Use in Special Populations

• Hepatic Impairment: Reduced dosage may be required in cases of advanced hepatic insufficiency.
• Renal Impairment: Dosage adjustments are generally not needed for renal failure, but patients undergoing haemodialysis should receive Metronidazole immediately after dialysis.

Overdose Effects

High doses up to 12 g may result in vomiting, ataxia, and disorientation. Symptomatic and supportive treatment is recommended, as there is no specific antidote.

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 expiry date.