Amodis 400

Generic

Metronidazole

Indications

Metronidazole is indicated in the treatment of following diseases:

• The prevention of post-operative infections due to anaerobic bacteria (particularly species of bacteroides and anaerobic streptococci).
• The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis and post-operative wound infections caused by anaerobes.
• In the treatment of urogenital trichomoniasis.
• Bacterial vaginosis (also known as non-specific vaginitis).
• All forms of amoebiasis (intestinal, extra-intestinal disease and that of symptomless cyst passers).
• Giardiasis.
• Acute ulcerative gingivitis.
• Anaerobically infected leg ulcers and pressure sores.
• Acute dental infections due to anaerobic organisms.
• Antibiotic associated pseudomembranus colitis.

Pharmacology

Metronidazole is a member of the imidazole class of antibacterial drugs and is classified as an antiprotozoal drug in treatment. The 5 nitro group of metronidazole is reduced by the metabolism of anaerobic bacteria. Studies have shown that the reduced form of this drug interacts with DNA and produces the bactericidal effect of metronidazole.

Dosage & Administration

Tablet and Suspension:

Trichomoniasis (Adults & Children over 10 yrs)-

• 200 mg tid or 400 mg bid for 7 days
• 800 mg in the morning and 1-2 gm at night for 2 days
• 2 gm as a single dose for 1 days

Trichomoniasis (Children)-

• Children 7-10 yrs: 100 mg tid
• Children 3-7 yrs: 100 mg bid
• Children 1-3 yrs: 50 mg tid

Intestinal amoebiasis (Adults & Children over 10 yrs)- 

• 800 mg tid for 5 days

Intestinal amoebiasis (Children)-

• 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

Extra-intestinal & Asymptomatic amoebiasis (Children)-

• 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

Giardiasis (Children)-

• 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

Acute ulcerative  gingivitis (Adults & Children over 10 yrs)-

• 200 mg tid for 3 days

Acute ulcerative  gingivitis (Children)-

• Children 7-10 yrs: 100 mg tid
• Children 3-7 yrs: 100 mg bid
• Children 1-3 yrs: 50 mg tid

Acute dental infections (Adults & Children over 10 yrs)-

• 200 mg tid for 3-7 days

Bacterial Vaginosis (Adults & Children over 10 yrs)-

• 400 mg bid for 7 days
• 2 gm as a single dose for 1 days

Leg ulcers and pressure sores (Adults & Children over 10 yrs)-

• 400 mg tid for 7 days

Anaerobic infections (Adults & Children over 10 yrs)-

• 800 mg initially and then 400 mg tid for 7 days

Anaerobic infections (Children)-

• Children 1-10 yrs: 7.5 mg/kg tid

Surgical prophylaxis (Adults & Children over 10 yrs)-

• 400 mg tid started 24  hours before  surgery for 1 days

Surgical prophylaxis (Children)-

• Children 1-10 yrs: 7.5 mg/kg tid

Interaction

Disulfiram: Patients who use metronidazole and disulfiram at the same time have reported psychotic reactions. 
 

Alcohol: alcoholic beverages and alcohol-containing drugs should not be consumed during treatment and for at least one day after treatment, because disulfiram-like reactions (anti-abuse effects) (flushing, vomiting, tachycardia) may occur.

Oral anticoagulant therapy (warfarin type): The anticoagulant effect is enhanced, and the liver catabolism is reduced, leading to an increased risk of bleeding. In the case of co-administration, prothrombin time should be monitored more frequently and anticoagulant therapy should be adjusted during metronidazole treatment. 
 

Lithium: Metronidazole can increase the content of lithium in the plasma. 
 

Cyclosporine: When co-administration is required, serum cyclosporine and serum creatinine should be closely monitored. 
 

Phenytoin or phenobarbital: increased elimination of metronidazole leads to decreased plasma levels. 
 

5 Fluorouracil: The clearance rate of 5 Fluorouracil is reduced, which increases the toxicity of 5 Fluorouracil. 
 

Busulfan: Metronidazole may increase the plasma concentration of busulfan, which can cause severe busulfan toxicity.

Contraindications

Patients who have a history of allergy to metronidazole or other nitroimidazole derivatives should not use metronidazole.

Side Effects

Metallic smell, nausea, vomiting, diarrhea, drowsiness, and rash may occur during treatment.

Pregnancy & Lactation

The US FDA classifies pregnancy with metronidazole as B. However, there are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies do not always predict human response, the drug should be used during pregnancy only when clearly necessary. Metronidazole has been shown to be excreted in human milk. Therefore, caution should be exercised when administering metronidazole to lactating women.

Precautions & Warnings

If for convincing reasons, metronidazole must be administered for longer than the usual recommended duration, it is recommended to perform hematological tests, especially white blood cell counts, and monitor the patient for adverse reactions such as peripheral or central neuropathy (such as Such as feeling abnormal). , Ataxia, dizziness, seizures). 
 Metronidazole should be used with caution in patients with hepatic encephalopathy. 
 Patients should be informed that metronidazole may darken the urine.

Therapeutic Class

Amoebicides, Anti-diarrhoeal Antiprotozoal

Storage Conditions