METROLYL (METRONIDAZOLE)

Route of administration:

Rectal Treatment of Anaerobic Infections: Adults and children over 10 years of age: 1 g suppository inserted into the rectum 8 hourly for 3 days. Oral medication with 400 mg 3 times a day should be substituted as soon as feasible. If rectal medication has to be continued for more than 3days then the suppositories should be inserted at 12 hourly intervals.

5 mg/kg bodyweight 3 times a day.

Infants and children under 5 years:

As for children of 5-10 years but with a reducted dose of suppositories (1½ of a 500 mg suppository for 1-5 years and ¼ of a 500 mg suppository for under 1 year).

Prevention of Anaerobic Infections:

Used in appendectomy and post-operative medication for elective colonic surgery. Adults and children over 10 years of age: 1 g suppository inserted into the rectum 2 hours before surgery and repeat at 8 hourly intervals until oral medication (200-400 mg 3 times a day) can be given to complete a 7day course.

If rectal medication is necessary after the third post-operative day, the frequency of administration should be reduced to 12 hourly. 5 mg/kg bodyweight three times daily becomes a possibility.

The frequency of adverse events listed below is defined using the following convention: very common ( 1/10); common ( 1/100 to < 1/10); uncommon ( 1/1,000 to < 1/100); rare ( 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).

Serious adverse reactions occur rarely with standard recommended regimens. Clinicians who contemplate continuous therapy for the relief of chronic conditions, for periods longer than those recommended, are advised to consider the possible therapeutic benefit against the risk of peripheral neuropathy.

Blood and lymphatic system disorders:

Very rare: agranulocytosis, neutropenia, thrombocytopenia, pancytopenia, Not known: leucopenia.

Immune system disorders:

Rare: anaphylaxis Not known: angiodema, urticaria, fever.

Metabolism and nutrition disorders:

Not known: anorexia.

Psychiatric disorders:

Very rare: psychotic disorders, including confusion and hallucinations. Not known: depressed mood. g. g. ataxia, dysathria, gait impairment, nystagmus and tremor) which may resolve on discontinuation of the drug. Not known: during intensive and/or prolonged metronidazole therapy, peripheral sensory neuropathy or transient epileptiform seizures have been reported.

In most cases neuropathy disappeared after treatment was stopped or when dosage was reduced.

Eye disorders:

Very rare: vision disorders such as diplopia and myopia, which in most cases, is transient.

Hepatotoxicity in patients with Cockayne Syndrome:

Cases of severe hepatotoxicity/acute hepatic failure, including cases with a fatal outcome with very rapid onset after treatment initiation in patients with Cockayne syndrome have been reported with products containing metronidazole for systemic use.

In this population, metronidazole should not be used unless the benefit is considered to outweigh the risk and if no alternative treatment is available. Liver function tests must be performed just prior to the start of therapy, throughout and after end of treatment until liver function is within normal ranges, or until the baseline values are reached.

If the liver function tests become markedly elevated during treatment, the drug should be discontinued. 8). Metronidazole has no direct activity against aerobic or facultative anaerobic bacterium. g. leucocyte count, are advised if administration with Metrolyl for more than 10 days is considered to be necessary.

g. paraesthesia, ataxia, dizziness, convulsive seizures. Metronidazole should be used with caution in patients with active or chronic severe peripheral and central nervous system disease due to the risk of neurological aggravation. There is a possibility that after Trichomonas vaginalis has been eliminated a gonococcal infection might be persistant.

The half-life elimination of metronidazole remains the same in patients with renal failure, therefore there is no needs for dose reduction. However, such patients retain the metabolites of metronidazole, the clinical significance of this is not known.

In patients undergoing haemodialysis metronidazole and its metabolites are efficiently removed during an eight hour dialysis period. Therefore, Metronidazole should be re-administered immediately after haemodialysis. No adjustment in the dosage of Metrolyl is required in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).

Known sensitivity to metronidazole or any of the excipients.