Metro-IV 100 ml Infusion

Indications

Metronidazole is used to treat the following conditions:

• The prevention of anaerobic bacteria-related post-operative infections (particularly species of bacteroides and anaerobic streptococci).
• Anaerobe-caused septicaemia, bacteraemia, peritonitis, brain abscess, pelvic abscess, pelvic cellulitis, and post-operative wound infections.
• In the treatment of trichomoniasis of the urogenital tract.
• Bacterial vaginosis is a kind of bacterial vaginosis (also known as non-specific vaginitis).
• Amoebiasis in all its manifestations (intestinal, extra-intestinal disease and that of symptomless cyst passers).
• Giardiasis.
• Gingivitis with ulcers that is acute.
• Leg ulcers and pressure sores caused by anaerobic bacteria.
• Anaerobic microbes cause acute dental infections.
• Pseudomembranus colitis caused by antibiotics.

Pharmacology

Metronidazole belongs to the imidazole family of antibacterial drugs and is used as an antiprotozoal agent. Anaerobes decrease the 5-nitro group of Metronidazole metabolically. Metronidazole's bactericidal effect has been established in studies where the reduced form of the antibiotic interacts with DNA.

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

Vaginal Gel:

The recommended dose is one applicator full of Metronidazole gel (approximately 5 grams containing approximately 37.5 mg of Metronidazole) intravaginally once or twice a day for 5 days. For once a day dosing, Metronidazole gel should be administered 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 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.

IV Infusion:

Metronidazole intravenous infusion requires no dilution and should not be mixed with any other drugs prior to administration.

• Adults and children over 12 years: Infuse 500 mg 8 hourly at a rate of 5 ml/minute and a maximum of 4 g should not be exceeded during a 24-hour period. Treatment for 7 days is sufficient for most patients, but treatment can be extended, especially for cases where reinfection is likely. For surgical prophylaxis, administration shortly before surgery should be followed by 8-hourly doses for the next 24 hours.
• Children under 12 years: 7.5 mg/kg body weight/day every 8 hours at a rate of 5 ml/minute.

Interaction

• Disulfiram: Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
• Alcohol: Alcoholic beverages and drugs containing alcohol should not be consumed during therapy and for at least one day afterwards because of the possibility of a disulfiram-like (antabuse effect) reaction (flushing, vomiting, tachycardia). Oral anticoagulant therapy (warfarin type): Potentiation of the anticoagulant effect and increased hemorrhagic risk caused by decreased hepatic catabolism. In case of co-administration, prothrombin time should be more frequently monitored and anticoagulant therapy adjusted during treatment with metronidazole.
• Lithium: Plasma levels of lithium may be increased by metronidazole.
• Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.
• Phenytoin or phenobarbital: increased elimination of metronidazole resulting in reduced plasma levels.
• 5-Fluorouracil: Reduced clearance of 5-fluorouracil resulting in increased toxicity of 5-fluorouracil.
• Busulfan: Plasma levels of busulfan may be increased by metronidazole, which may lead to severe busulfan toxicity.

Contraindications

Metronidazole is not recommended for people who have previously had hypersensitivity to Metronidazole or other Nitroimidazole derivatives.

Side Effects

During therapy, metallic taste, nausea, vomiting, diarrhoea, sleepiness, and rashes may occur.

Pregnancy & Lactation

Metronidazole's Pregnancy Category in the United States is B. However, no appropriate and well-controlled trials in pregnant women exist. Because animal reproduction studies aren't usually predictive of human response, this medication should only be taken during pregnancy if absolutely necessary. Metronidazole has been proven to pass through human milk. As a result, while administering Metronidazole to a nursing mother, extreme caution should be taken.

Precautions & Warnings

• If for compelling reasons, metronidazole must be administered longer than the usually recommended duration, it is recommended that hematological tests, especially leucocyte count should be carried out regularly and that patients should be monitored for adverse reactions such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures).
• Metronidazole should be administered with caution to patients with hepatic encephalopathy.
• Patients should be warned that metronidazole may darken urine.

Therapeutic Class

Storage Conditions

Store at temperatures below 30°C. Keep away from direct sunlight. Keep medications out of children's reach. Do not use after the expiry date.

Pharmaceutical Name