Indications

Dirozyl 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.

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Pharmacology

Metronidazole is a member of the imidazole class of antibacterial drug and is classified therapeutically as an antiprotozoal agent. The 5-nitro group of Metronidazole is reduced by anaerobes metabolically. Studies have demonstrated that the reduced form of this drug interacts with DNA and gives bactericidal action 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

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.

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Interaction

• Disulfiram: Psychotic reactions have been reported in patients who were using Dirozyl 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 Dirozyl.
• Lithium: Plasma levels of lithium may be increased by Dirozyl.
• Cyclosporin: Serum cyclosporin and serum creatinine should be closely monitored when co-administration is necessary.
• Phenytoin or phenobarbital: increased elimination of Dirozyl 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 Dirozyl, which may lead to severe busulfan toxicity.

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, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Metronidazole have been shown to be excreted in human milk. So, caution should be exercised when Metronidazole is administered to a nursing woman.

Precautions & Warnings

• If for compelling reasons, Dirozyl 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).
• Dirozyl should be administered with caution to patients with hepatic encephalopathy.
• Patients should be warned that Dirozyl may darken urine.

Use in Special Populations

Hepatic impairment: Dirozyl is mainly metabolised by hepatic oxidation. Substantial impairment of Dirozyl clearance may occur in the presence of advanced hepatic insufficiency. Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of Dirozyl may contribute to the symptoms of the encephalopathy. Dirozyl should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily. Patients should be warned that Dirozyl may darken urine.

Renal impairment: The elimination half-life of Dirozyl remains unchanged in the presence of renal failure. The dosage of Dirozyl therefore needs no reduction. Such patients however retain the metabolites of Dirozyl. The clinical significance of this is not known at present. In patients undergoing haemodialysis Dirozyl and metabolites are efficiently removed during an eight hour period of dialysis. Dirozyl should therefore be re-administered immediately after haemodialysis. No routine adjustment in the dosage of Dirozyl need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).

Overdose Effects

Single oral doses of Dirozyl, up to 12 g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation. There is no specific antidote for Dirozyl overdosages. In case of suspected massive overdosages, a symptomatic and supportive treatment should be instituted.

Therapeutic Class

Amoebicides, Anti-diarrhoeal Antiprotozoal

Storage Conditions

Store below 30°C. Keep protected from light. Keep medicines out of the reach of children. Do not use later than the date of expiry.

Common Questions about Dirozyl 500 mg/100 ml Injection

What is Dirozyl 500 mg/100 ml IV Infusion?

Dirozyl 500 mg/100 ml IV Infusion is an antibiotic medication that performs its action by preventing the growth of bacterias and parasites.

What are the uses of Dirozyl 500 mg/100 ml IV Infusion?

Dirozyl 500 mg/100 ml IV Infusion is used for the treatment and prevention from viral and parasitic infections. It also prevents bacterial infections such as cold, cough, flu and vaginal infections. It also controls liver, skin, joints, brain and respiratory tract infections.

What are the side effects of Dirozyl 500 mg/100 ml IV Infusion?

Some side effects of Dirozyl 500 mg/100 ml IV Infusion which are diarrhoea, headache, weakness, painful urination, trouble sleeping, numbness, muscle weakness and mouth ulcer.

How long do I need to use Dirozyl 500 mg/100 ml IV Infusion before I see improvement of my conditions?

Dirozyl 500 mg/100 ml IV Infusion takes 1 or 2 days before you see an improvement in your health conditions.

What are the contraindications to Dirozyl 500 mg/100 ml IV Infusion?

Dirozyl 500 mg/100 ml IV Infusion should not be used if you have the following conditions such as hives, flushing, nasal congestion, dryness of the mouth, fever, etc.

Is Dirozyl 500 mg/100 ml IV Infusion safe to use when pregnant?

Dirozyl 500 mg/100 ml IV Infusion is not recommended for use in pregnant women unless absolutely necessary.

Will Dirozyl 500 mg/100 ml IV Infusion be more effective if taken in more than the recommended dose?

No, taking higher than the recommended dose of Dirozyl 500 mg/100 ml IV Infusion lead to increased chances of side effects such as diarrhoea, excessive production of urine, headache, nausea, pain in the upper part of the stomach, painful and difficult urination, serious eating disorder (anorexia), etc.

Quick Tips

• Dirozyl 500 mg/100 ml IV Infusion treats infections caused by bacteria and parasites.
• Dirozyl 500 mg/100 ml IV Infusion may cause side effects like nausea, stomach upset, and a metallic taste in the mouth.
• Dirozyl 500 mg/100 ml IV Infusion used in a high dose or for a prolonged time increases the risk of side effects such as nerve damage. Take it only as prescribed by your doctor.
• Do not drink alcohol during or for 2-3 days after treatment with this medicine. You may develop nausea, vomiting, flushing and headache.
• Inform your doctor if you have liver disease. Your dose may need to be adjusted in severe liver disease.

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