Amodis 200 mg/5 ml

Description

Indications

Amodis is prescribed for the treatment and prevention of infections caused by anaerobic bacteria. It is particularly effective for:

• Preventing post-operative infections, especially those caused by Bacteroides species and anaerobic streptococci.
• Treating severe infections such as septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis, and post-operative wound infections.

Use this medication only as directed by a registered physician.

Pharmacology

Metronidazole, the active ingredient in Amodis, belongs to the imidazole class of antibacterial agents and functions as an antiprotozoal drug. Its bactericidal action occurs when anaerobic bacteria reduce its 5-nitro group metabolically, leading to interactions with DNA that result in bacterial death.

Dosage & Administration

Tablet and Suspension

Trichomoniasis

• Adults & Children over 10 years:
  • 200 mg three times daily or 400 mg twice daily for 7 days.
  • 800 mg in the morning and 1-2 g at night for 2 days.
  • A single 2 g dose 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 years: 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 years: 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 years: 2 g once daily for 3 days.
• Children:
  • 7-10 years: 1 g once daily.
  • 3-7 years: 600-800 mg once daily.
  • 1-3 years: 500 mg once daily.

Other Infections Amodis is also used for bacterial vaginosis, dental infections, ulcerative gingivitis, surgical prophylaxis, leg ulcers, pressure sores, and anaerobic infections. Dosage varies based on severity and age group.

Vaginal Gel

One applicator (5 g gel containing 37.5 mg Metronidazole) should be applied intravaginally once or twice daily for 5 days. For once-daily use, administer 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.
• Surgical Prophylaxis:
  • Adults: 1 g 2 hours before surgery, with 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, followed by up to 3 doses every 8 hours.

IV Infusion

Metronidazole IV infusion should not be diluted or mixed with other drugs.

• Adults & Children over 12 years: 500 mg every 8 hours via infusion at a rate of 5 ml/min. Do not exceed 4 g in 24 hours.
• Children under 12 years: 7.5 mg/kg body weight every 8 hours.

Drug Interactions

• Disulfiram: Concurrent use may lead to psychotic reactions.
• Alcohol: Avoid consumption during treatment and for at least one day afterward to prevent a disulfiram-like reaction.
• Warfarin & Anticoagulants: Increased risk of bleeding; frequent monitoring is required.
• Lithium & Cyclosporin: May increase plasma levels; regular monitoring is advised.
• Phenytoin, Phenobarbital, 5-Fluorouracil, and Busulfan: Drug interactions may alter plasma levels and toxicity.

Contraindications

Do not use Amodis if you have hypersensitivity to Metronidazole or other Nitroimidazole derivatives.

Side Effects

Common side effects include:

• Metallic taste
• Nausea, vomiting, diarrhea
• Drowsiness
• Skin rashes

Pregnancy & Lactation

• Pregnancy: Classified as FDA Category B. Should only be used if clearly necessary.
• Lactation: Metronidazole is excreted in breast milk; caution is advised when administering to nursing mothers.

Precautions & Warnings

• Long-term use requires monitoring for neurological side effects such as paresthesia, ataxia, dizziness, and seizures.
• Use cautiously in patients with hepatic encephalopathy.
• May cause urine to darken.

Special Populations

• Hepatic Impairment: Reduced dosage is recommended.
• Renal Impairment: No dose adjustment required, but re-administration is needed after dialysis.

Overdose Effects

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

Therapeutic Class

Amoebicides, Anti-diarrheal, Antiprotozoal.

Storage Conditions

• Store below 30°C.
• Protect from light.
• Keep out of reach of children.
• Do not use after the expiry date.