Dirozyl 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 may be a part of the imidazole course of antibacterial medicate and is classified restoratively as an antiprotozoal operator. The 5-nitro gather of Metronidazole is decreased by anaerobes metabolically. Considers have illustrated that the decreased shape of this medicate interatomic with DNA and gives bactericidal activity of Metronidazole.

 

Administration & Dosage

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 daysIntestinal 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 daysGiardiasis (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 daysBacterial 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: Insane responses have been detailed in patients who were utilizing metronidazole and disulfiram concurrently. Alcohol: Alcoholic refreshments and drugs containing liquor ought to not be devoured amid treatment and for at slightest one day a while later since of the plausibility of a disulfiram-like (antabuse impact) response (flushing, heaving, tachycardia). Verbal anticoagulant treatment (warfarin sort): Potentiation of the anticoagulant impact and expanded hemorrhagic hazard caused by diminished hepatic catabolism. In case of co-administration, prothrombin time ought to be more habitually checked and anticoagulant treatment balanced amid treatment with metronidazole. Lithium: Plasma levels of lithium may be expanded by metronidazole.

 

Contraindications

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

 

Side Effects

Metallic taste, nausea, vomiting, diarrhoea, drowsiness, rashes may be observed during treatment.

 

Pregnancy & Lactation

US FDA Pregnancy Category of Metronidazole is B. There are, in any case, no satisfactory and well-controlled ponders in pregnant ladies. Since creature propagation ponders are not continuously prescient of human reaction, this medicate ought to be utilized amid pregnancy as it were in case clearly required. Metronidazole have been appeared to be excreted in human drain. So, caution ought to be worked out when Metronidazole is managed to a nursing lady.

 

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

Amoebicides, Anti-diarrhoeal Antiprotozoal

 

Storage Conditions

Protect from light and moisture by storing below 30°C. Keep the medicine out of children's reach.

 

Pharmaceutical Name

ACME Laboratories Ltd.