Amotrex 400

Generic

Metronidazole

 

Indications

Metronidazole is prescribed to treat the following conditions:

• The prevention of anaerobic bacteria-related post-operative infections (particularly species of bacteroides and anaerobic streptococci).
• Treatment of anaerobe-caused septicaemia, bacteremia, 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 any kind (intestinal, extra-intestinal disease and that of symptomless cyst passers).
• Giardiasis.
• Acute gingivitis with ulcers.
• Leg ulcers and pressure sores that are anaerobically infected.
• Anaerobic microbes cause acute dental infections.
• Pseudomembranus colitis caused by antibiotics.

 

Pharmacology

Metronidazole is an antibacterial medication that belongs to the imidazole class and is used as an antiprotozoal agent. Anaerobes decrease the 5-nitro group of Metronidazole metabolically. Metronidazole's bactericidal action is due to the reduced form of the drug interacting with DNA, according to studies.

 

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.

 

Interactions

Disulfiram: Patients using metronidazole and disulfiram at the same time have experienced psychotic responses.

Because of the risk of a disulfiram-like (antabuse effect) reaction, alcoholic beverages and medications containing alcohol should be avoided during therapy and for at least one day following (flushing, vomiting, tachycardia). Warfarin-type oral anticoagulant therapy: Reduced hepatic catabolism causes potentiation of the anticoagulant action and increased hemorrhagic risk. During metronidazole medication, prothrombin time should be evaluated more regularly and anticoagulant therapy altered if co-administration is used. Metronidazole can raise lithium levels in the bloodstream.

When co-administration of cyclosporin and creatinine is required, serum cyclosporin and serum creatinine should be regularly monitored.

Metronidazole elimination is accelerated with phenytoin or phenobarbital, resulting in lower plasma levels.

5-Fluorouracil: A decrease in 5-fluorouracil clearance leads to an increase in 5-fluorouracil toxicity.

Busulfan: Metronidazole can raise busulfan levels in the blood, resulting in severe busulfan toxicity.

 

Contraindications

Patients having a history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives should avoid taking it.

 

Side Effects

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

 

Pregnancy & Lactation

Metronidazole is classified as a pregnancy category B by the US Food and Drug Administration. However, no suitable and well-controlled studies in pregnant women have been conducted. Because animal reproduction studies do not always predict human response, this medication should only be used during pregnancy if absolutely necessary. Human milk has been found to contain metronidazole. When Metronidazole is given to a breastfeeding mother, caution should be observed.

 

Precautions & Warnings

If metronidazole must be given for a longer period of time than is generally indicated, it is recommended that hematological tests, particularly leucocyte counts, be performed on a regular basis and that patients be watched for adverse responses such as peripheral or central neuropathy (such as paresthesia, ataxia, dizziness, convulsive seizures). Patients with hepatic encephalopathy should be given metronidazole with caution. Metronidazole might cause urine to discolor, thus patients should be cautioned.

 

Therapeutic Class

Anti-diarrhoeal Antiprotozoal Amoebicides

 

Storage Conditions

Keep it below 30°C. Protect yourself from the sun. Medicines should be kept out of the reach of youngsters. Do not use after the expiration date.

 

Pharmaceutical Name

ACI Limited