Anzole®400
Metronidazole

COMPOSITION:
Anzole®400 tablet: Each film coated tablet contains Metronidazole BP 400mg.

PHARMACOLOGICAL INFORMATION:
Pharmacological Action
Metronidazole is an antimicrobial drug that is primarily active against obligate anaerobic microorganisms, both bacteria and protozoa.

Mechanism of Action
The 5-nitro group of metronidazole undergoes reductive transformation to an active metabolite that exerts a lethal effect on DNA of bacteria and ultimately contributes to cell death.

CLINICAL INFORMATION:
Therapeutic Indications:
Anzole®400 (Metronidazole) is indicated in the prophylaxis and treatment of infections in which anaerobic bacteria have been identified or are suspected to be the cause. It is indicated in -

• Urogenital trichomoniasis in the female and male
• Intestinal and extra-intestinal amoebiasis
• Giardiasis
• Anaerobic bacterial infections
• Non-specific vaginitis
• Anaerobically-infected ulcers and pressure sores

Dosage and Administration :
Adults

Indications	Duration in days	Adults & children over 10 years
Amoebic dysentery	5-10 or 2	800mg t.i.d.
Asymptomatic amoebiasis	5-10	400-800mg t.i.d.
Hepatic and extra-intestinal amoebiasis	5-10 or 2	400-800mg t.i.d.
Trichomoniasis consort treatment is recommended	7 or 2 or 1	200mg t.i.d. 800mg morning
Vincent's infection /Acute ulcerative gingivitis	3	200mg t.i.d. or 400mg b.i.d.
Anaerobic infection	7	400mg t.i.d.
Non specific vaginitis	7	400mg t.i.d.
Leg ulcer and pressure sores	7	400mg t.i.d.

Indications	Duration in days	Children
		7-10 years	3-7 years	1-3 years
Amoebic dysentery	5-10 or 2	400mg t.i.d.	200mg q.i.d.	200mg t.i.d.
Asymptomatic amoebiasis	5-10	200-400mg t.i.d	100-200mg q.i.d	100-200mg t.i.d
Hepatic and extra-intestinal amoebiasis	5-10 or 2	200-400mg t.i.d	100-200mg q.i.d.	100-200mg t.i.d.
Giardiasis	3	1g once daily	600mg once daily	400mg once daily
Trichomoniasis consort treatment is recommended	7 or 2 or 1	100mg t.i.d.	100mg b.i.d	50mg t.i.d.
Vincent's infection / Acute ulcerative gingivitis	3	100mg t.i.d.	100mg t.i.d.	50mg t.i.d.
Anaerobic infection	7	7.5mg/kg body weight t.i.d.
Non specific vaginitis	7
Leg ulcer and pressure sores	7

Contraindications
Anzole®400 is contraindicated in patients with prior history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.

Use in patient with Impaired Hepatic Function
Reduction in the dosage of Anzole®400 is required only when liver function is very poor.

Use in patient with Impaired Renal Function
Pharmacokinetic studies have indicated that doses of Anzole®400 need not be altered in patients with renal impairment although an additional dose after haemodialysis is recommended to replace that lost during haemodialysis.

Drug Interactions
Metronidazole has been found to interact with alcohol and warfarin, phenytonin, phenobarbitone, fluorouracil, disulfiram, lithium, and cimetidine.

Use in Pregnancy & Lactation
When metronidazole has been administered during pregnancy, no adverse effects have been noted in the mother or fetus. However, it is recommended that metronidazole not be given during the first trimester of pregnancy and avoided during the later trimesters if possible. If use is deemed necessary, short high-dose regimen is recommended. The efficacy of metronidazole in serious anaerobic infections has to be weighed against potential, but unproved, mutagenic and teratogenic effects. From limited data, metronidazole appears to cross the placenta, as would be expected from its lipid solubility. Metronidazole penetrates well into breast milk. If exposure of the neonates to metronidazole is to be avoided, breast-feeding should be delayed until 48 hours after discontinuing metronidazole in the mother.

Undesirable Effects
Undesirable effects of Metronidazole include gastrointestinal discomfort, nausea, coated tongue, dryness of mouth and unpleasant metallic or bitter taste, headache, pruritus and skin rashes and less frequently, vertigo, depression, insomnia, drowsiness, urethral discomfort, and darkening of the urine. Occasionally there may be temporary moderate leucopenia. Peripheral neuropathy has been reported in patients on prolonged therapy.

PHARMACEUTICAL INFORMATION
Storage & Conditions
Store in cool (below 30ºC) and dry place, away from light. Keep out of reach of children.
Presentation & Packaging
Anzole®400 tablet: Each box Containing 10x10 tablets in Alu-PVC blister pack.