Read this leaflet carefully before you start taking this medicine. (DOWNLOAD)
COMPOSITION: Each teaspoonful (5ml) of the suspension contains 200mg of metronidazole in the form of Metronidazole Benzoate.
PHARMACOLOGY: Metronidazole, a synthetic 5–nitroimidazole, has an antibiotic action that is based on the modification of the genetic substance of microorganisms. Its spectrum contains anaerobic bacteria (bacteroides fragilis, clostridia, fusobacteria, peptococci, peptostreptococci), certain other bacteria (e.g gardnerella vaginalis) and protozoa (giardia lamblia, entamoeba histolytica, trichomonas vaginalis). Bacterial tissue concentrations are achieved in the central nervous system, in the liver and the bile ducts, in the bones, in vaginal secretions and in the pelvic organs.
PHARMACOKINETICS: Metronidazole benzoate given orally is hydrolysed in the gastro intestinal tract to release metronidazole, which is then absorbed. Following administration, metronidazole is readily absorbed and bioavailability approaches 100%. Absorption may be delayed, but not reduced overall by administration with food. Metronidazole is widely distributed. It appears in most body tissues and fluids including bile, bone, liver, cerebral abscesses and achieves concentrations similar to that in plasma. Metronidazole is metabolized in the liver by side–chain oxidation andglucuronide formation. Metabolites are excreted in the urine. A small amount appears in the faeces. Elimination half–life is about 8 hours. Half–life is longer in neonates and patients with severe liver diseases and renal failure.
INDICATIONS: Used in the treatment and prophylaxis of susceptible bacterial and protozoan * infections such as amoebiasis, giardiasis, trichomoniasis, gingivitis, antibiotic–associated colitis. It
is used in conjuction with other drugs to eliminate H.pylori in peptic ulcer disease.
CONTRAINDICATIONS: Metronidazole is contraindicated in patients with a prior history of hypersensitivity to metronidazole, or other Nitroimidazole derivatives.
PRECAUTIONS: Metronidazole should be used with caution in patients with active disease of the central nervous system or blood. Doses should be reduced in patients with severe liver disease. ADVERSE REACTIONS: These are usually dose related. Most common are nausea, metallic taste, headache, anorexia and vomiting. Diarrhoea, furred tongue, glossitis and stomatitis may also occur. With high doses or prolonged usage, peripheral neuropathy and change in mood or mental state may occur.
OVERDOSAGE: This is no specific antidote for overdose. Management should consist of supportive and symptomatic therapy.
DOSAGE AND ADMINISTRATION:
Children 1-6 years: 2.5 5ml (1/2-1 teaspoonful) three times daily
Children 7 – 12 years: 5 10ml (1-2 teaspoonfuls) three times daily
PRESENTATION: Pack of 60ml
STORAGE: Store below 30°C dry place, protect from direct sunlight.
Keep all medicines out of reach of children.
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