Amodis Suspension

Indications

Amodis serves as a treatment for various conditions, including:

• Preventing post-operative infections caused by anaerobic bacteria, particularly species like bacteroides and anaerobic streptococci.
• Managing septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis, and post-operative wound infections due to anaerobes.
• Treating urogenital trichomoniasis.
• Addressing bacterial vaginosis, also known as non-specific vaginitis.
• Combatting all forms of amoebiasis (intestinal, extra-intestinal disease, and asymptomatic cyst passers).
• Managing giardiasis.
• Addressing acute ulcerative gingivitis.
• Treating anaerobically infected leg ulcers and pressure sores.
• Managing acute dental infections due to anaerobic organisms.
• Addressing antibiotic-associated pseudomembranous colitis.

Pharmacology

Metronidazole, belonging to the imidazole class of antibacterial drugs, acts as an antiprotozoal agent. Anaerobic metabolism reduces the 5-nitro group of Metronidazole. Research indicates that the reduced form interacts with DNA, resulting in Metronidazole’s bactericidal action.

Dosage & Administration

For tablets and suspension:

• Trichomoniasis: Adults & Children over 10 yrs: 200 mg tid or 400 mg bid for 7 days; or 800 mg in the morning and 1-2 gm at night for 2 days; or 2 gm as a single dose for 1 day.
• Intestinal amoebiasis: Adults & Children over 10 yrs: 800 mg tid for 5 days; Children 7-10 yrs: 400 mg tid; Children 3-7 yrs: 200 mg qid; Children 1-3 yrs: 200 mg tid.
• Extra-intestinal & Asymptomatic amoebiasis: Adults & Children over 10 yrs: 400-800 mg tid for 5-10 days; Children 7-10 yrs: 200-400 mg tid; Children 3-7 yrs: 100-200 mg qid; Children 1-3 yrs: 100-200 mg tid.
• Giardiasis: Adults & Children over 10 yrs: 2 gm once daily for 3 days; Children 7-10 yrs: 1 gm once daily; Children 3-7 yrs: 600-800 mg once daily; Children 1-3 yrs: 500 mg once daily.
• Adults & Children over 10 yrs: 200 mg tid for 3 days; Children 7-10 yrs: 100 mg tid; Children 3-7 yrs: 100 mg bid; Children 1-3 yrs: 50 mg tid.
• For bacterial vaginosis:
  • Adults & Children over 10 yrs: 400 mg bid for 7 days; or 2 gm as a single dose for 1 day.

  For leg ulcers and pressure sores:

  • Adults & Children over 10 yrs: 400 mg tid for 7 days.

  For anaerobic infections:

  • Adults & Children over 10 yrs: 800 mg initially and then 400 mg tid for 7 days; Children 1-10 yrs: 7.5 mg/kg tid.

  For surgical prophylaxis:

  • Adults & Children over 10 yrs: 400 mg tid starting 24 hours before surgery for 1 day; Children 1-10 yrs: 7.5 mg/kg tid.

  For vaginal gel:

  • Administer one applicator full of Metronidazole gel intravaginally once or twice a day for 5 days.

  For suppository:

  • For 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.
  • For surgical prophylaxis: Adults: 1 g 2 hours before surgery; up to 3 further 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 further doses of 500 mg may be given every 8 hours for high-risk procedures.

  For IV infusion:

  • Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5 ml/minute, not exceeding 4 g in a 24-hour period. Treatment for 7 days is usually sufficient.
  • Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/minute.

  Interactions

  Amodis may interact with disulfiram, alcohol, oral anticoagulant therapy, lithium, cyclosporin, phenytoin or phenobarbital, 5-fluorouracil, and busulfan, necessitating careful monitoring and potential dosage adjustments.

  Contraindications

  Amodis is contraindicated in patients with a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.

  Side Effects

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

  Pregnancy & Lactation

  Amodis should be used during pregnancy only if clearly needed, as per FDA Pregnancy Category B. Caution should be exercised when administering to nursing women.

  Precautions & Warnings

  Regular hematological tests, especially leucocyte count, are recommended for prolonged administration. Caution is advised in patients with hepatic encephalopathy. Darkening of urine may occur.

  Use in Special Populations

  Hepatic impairment: Amodis clearance may be substantially impaired in advanced hepatic insufficiency. Dosage adjustment is necessary in such cases, with caution exercised in hepatic encephalopathy patients.

  Renal impairment: No dosage adjustment is required in renal failure, although metabolites may accumulate. In patients undergoing haemodialysis, Amodis and metabolites are efficiently removed. Immediate re-administration after haemodialysis is recommended.

  Overdose Effects

  Symptoms of overdose may include vomiting, ataxia, and slight disorientation. No specific antidote exists; symptomatic and supportive treatment should be initiated.

  Therapeutic Class

  Amodis falls under the category of amoebicides, anti-diarrheal, and antiprotozoal drugs.

  Storage Conditions

  Store Amodis below 30°C, protected from light, and out of children’s reach. Do not use beyond the expiry date.

  Common Questions about Amodis 400 mg Tablet

  • Amodis 400 mg Tablet is an antibiotic medication that inhibits the growth of bacteria and parasites.
  • It is used to treat and prevent various infections, including bacterial, viral, and parasitic.
  • Side effects may include diarrhoea, headache, weakness, painful urination, trouble sleeping, numbness, muscle weakness, and mouth ulcers.
  • Improvement in health conditions is typically observed within 1 or 2 days.
  • Contraindications include conditions such as hives, flushing, nasal congestion, dryness of the mouth, and fever.
  • It is not recommended for pregnant women unless absolutely necessary.
  • Taking more than the recommended dose can increase the risk of side effects.

  Quick Tips

  • Amodis treats infections caused by bacteria and parasites.
  • Side effects like nausea, stomach upset, and metallic taste may occur.
  • High doses or prolonged use may increase the risk of nerve damage.
  • Avoid alcohol consumption during and after treatment.
  • Inform your doctor if you have liver disease, as dosage adjustments may be needed.