METRONIDAZOLE TABLETS 500MG

Indications:

Metronidazole is indicated in adults and children for the following indications:

1) Prevention of post-operative infections due to anaerobic bacteria, particularly species of bacteroids and anaerobic streptococci.

2) The treatment of septicaemia, bacteraemia, peritonitis, brain abscess, necrotising pneumonia, osteomyelitis, puerperal sepsis, pelvic abscess, pelvic cellulitis and post-operative wound infections from which pathogenic anaerobes have been isolated.

3) Urogenital trichomoniasis in the female (Trichomonas vaginalis), and in man.

4) Bacterial vaginosis (also known as non-specific vaginitis, anaerobic vaginosis or Gardnerella vaginalis).

5) All forms of amoebiasis (intestinal and extra-intestinal disease and asymptomatic cyst passers).

6) Giardiasis.

7) Acute ulcerative gingivitis.

8) Acute dental infections (eg acute pericoronitis and acute apical infections)

9) Anaerobically-infected leg ulcers and pressure sores.

10) Treatment of Helicobacter pylori infection associated with peptic ulcer as part of triple therapy.

Dosage and Administration:

Metronidazole Tablets should be taken during or after meals, swallowed with water and not chewed.

Elderly: Caution is advised in the elderly, particularly at high doses, although there is limited information available on modification of dosage.

Precautions & Warning:

• There is a possibility that after Trichomonas vaginalis has been eliminated a gonococcal infection might persist.

• Due to inadequate evidence on the mutagenicity risk in humans (see section 5.3), the use of metronidazole for longer treatment than usually required should be carefully considered.

• Neuropathy (central and peripheral): Regular clinical and laboratory monitoring (especially leukocyte count) are advised if administration of metronidazole for more than 10 days is considered to be necessary and patients should be monitored for adverse reactions, such as peripheral or central neuropathy (such as paraesthesia, ataxia, dizziness, vertigo, 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.

• Patients should abstain from alcohol for at least 48 hours following discontinuation of therapy with metronidazole. A disulfiram-like reaction with hypotension and flushing has occurred.

• Caution in patients with epilepsy or those who have had seizures as high doses of Metronidazole can induce seizures.

• Consideration of the therapeutic benefit against the risk of peripheral neuropathy is advised with continuous therapy for chronic conditions.

Contra-indications:

• Known hypersensitivity to nitroimidazoles, metronidazole or to any of the excipients.

• Pregnancy

• Breast feeding should be discontinued for 12-24 hours when single high dose (e.g. 2g) therapy is used.

Drug interactions:

Patients should be advised not to take alcohol during metronidazole therapy and for at least 48 hours afterwards because of the possibility of a disulfiram-like (antabuse effects) reaction. Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.

Storage instructions:

Store below 25°C. Protect from light.