Furazol is indicated in the prophylaxis and treatment of infections in which anaerobic bacteria have been identified or are suspected to be the cause.
Furazol is active against a wide range of pathogenic micro-organisms notably species of Bacteroides, Fusobacteria, Clostridia, Eubacteria, anaerobic cocci and Gardnerella vaginalis.
It is also active against Trichomonas, Entamoeba histolytica, Giardia lamblia and Balantidium coli.
Furazol is indicated in adults and children for the following indications:
- Treat infections of the blood, brain, lung, bones, genital tract, pelvic area, stomach and intestines.
- Treat gum ulcers and other dental infections.
- Treat infected leg ulcers and pressure sores.
- Prevent infections after surgery.

Oral route of administration.
Furazol tablets should be swallowed with water (not chewed). It is recommended that the tablets be taken during or after a meal.
To treat bacterial infection:
Adults: 2 tablets 3 times daily for 5 - 10 days.
To prevent infections from happening after surgery:
Adults:
- Start Taking Furazol Tablets 24 hours before your operation
- Take 400 mg of Furazol every 8 hours.
Children:
- Give your child Furazol Tablets 1-2 hours before their operation

Regular clinical and laboratory monitoring (especially leucocyte count) are advised if administration of Furazol 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, 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 persist.
The elimination half-life of metronidazole remains unchanged in the presence of renal failure.
The dosage of metronidazole therefore needs no reduction. Such patients however retain the metabolites of metronidazole. The clinical significance of this is not known at present.
In patients undergoing haemodialysis metronidazole and metabolites are efficiently removed during an eight hour period of dialysis. Metronidazole should therefore be re-administered immediately after haemodialysis.
No routine adjustment in the dosage of Furazol need be made in patients with renal failure undergoing intermittent peritoneal dialysis (IDP) or continuous ambulatory peritoneal dialysis (CAPD).
Metronidazole is mainly metabolised by hepatic oxidation. Substantial impairment of metronidazole clearance may occur in the presence of advanced hepatic insufficiency.
Significant cumulation may occur in patients with hepatic encephalopathy and the resulting high plasma concentrations of metronidazole may contribute to the symptoms of the encephalopathy. Furazol should therefore, be administered with caution to patients with hepatic encephalopathy. The daily dosage should be reduced to one third and may be administered once daily.
Patients should be warned that metronidazole may darken urine.
Due to inadequate evidence on the mutagenicity risk in humans, the use of Furazol for longer treatment than usually required should be carefully considered.

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 effect) reaction.
Psychotic reactions have been reported in patients who were using metronidazole and disulfiram concurrently.
Some potentiation of anticoagulant therapy has been reported when metronidazole has been used with the warfarin type oral anticoagulants. Dosage of the latter may require reducing.
Prothrombin times should be monitored. There is no interaction with heparin.
Lithium retention accompanied by evidence of possible renal damage has been reported in patients treated simultaneously with lithium and metronidazole. Lithium treatment should be tapered or withdrawn before administering metronidazole. Plasma concentrations of lithium, creatinine and electrolytes should be monitored in patients under treatment with lithium while they receive metronidazole.

Patients receiving phenobarbital or phenytoin metabolise metronidazole at a much greater rate than normally, reducing the half-life to approximately 3 hours.
Metronidazole reduces the clearance of 5 fluorouracil and can therefore result in increased toxicity of 5 fluorouracil.
Patients receiving ciclosporin are at risk of elevated ciclosporin serum levels. Serum ciclosporin and serum creatinine should be closely monitored when coadministration is necessary.
Plasma levels of busulfan may be increased by metronidazole which may lead to severe busulfan toxicity.

There is inadequate evidence of the safety of metronidazole in pregnancy but it has been in wide use for many years without apparent ill consequence. Nevertheless Furazol, like other medicines, should not be given during pregnancy or during lactation unless the physician considers it essential; in these circumstances the short, high-dosage regimens are not recommended.

Patients should be warned about the potential for drowsiness, dizziness, confusion, hallucinations, convulsions or transient visual disorders, and advised not to drive or operate machinery if these symptoms occur.

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
Nervous system disorders:
Very rare:
- encephalopathy (eg. confusion, fever, headache, hallucinations, paralysis, light sensitivity, disturbances in sight and movement, stiff neck) and subacute cerebellar syndrome (eg. ataxia, dysathria, gait impairment, nystagmus and tremor) which may resolve on discontinuation of
the drug.
- drowsiness, dizziness, convulsions, headaches

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.
- Aseptic meningitis
Eye disorders:
Very rare: vision disorders such as diplopia and myopia, which, in most cases, is transient.
Not Known: optic neuropathy/neuritis
Gastrointestinal disorders:
Not known: taste disorders, oral mucositis, furred tongue, nausea, vomiting, gastro-intestinal disturbances such as epigastric pain and diarrhoea.
Hepatobiliary disorders:
Very rare: abnormal liver function tests, cholestatic hepatitis, jaundice and pancreatitis which is reversible on drug withdrawal.
Skin and subcutaneous tissue disorders:
Very rare: skin rashes, pustular eruptions, pruritis, flushing
Not known: erythema multiforme.
Musculoskeletal, connective tissue and bone disorders:
Very rare: myalgia, arthralgia.
Renal and urinary disorders:
Very rare: darkening of urine (due to metronidazole metabolite).

Single oral doses of metronidazole, up to 12g have been reported in suicide attempts and accidental overdoses. Symptoms were limited to vomiting, ataxia and slight disorientation.
There is no specific antidote for metronidazole overdosage. In cases of suspected massive overdose, symptomatic and supportive treatment should be instituted.

Pharmacotherapeutic group: Antibacterials for systemic use.
Furazol is a well-tolerated formulation of diloxanide furoate and metronidazole, highly effective in the treatment of intestinal and extraintestinal amoebic infections.Diloxanide furoate is a luminal amoebicide acting on the amoebae in the lumen of the bowel.
Metronidazole has well- established bactericidal activity and is highly effective against anaerobic bacteria and protozoa; it is a tissue amoebicide, affecting the parasite in the intestinal wall or other organs. In amoebiasis, metronidazole acts as an amoebicide at all sites of infection with Entamoeba histolytica.Because of its rapid absorption, it is probably less effective against parasites in the bowel lumen and is therefore used in combination with a luminal amoebicide, such as diloxaide furoate, in the treatment of invasive amoebiasis.

Both diloxanide furoate and metronidazole benzoate after oral intake, are hydrolysed in the gastrointestinal tract to release diloxanide and metronidazole, respectively. The free diloxanide acts directly as an amoebicide. The resulting compounds are then absorbed.
Metronidazole is widely distributed in most body tissues and fluids and is metabolized in the liver by side chain oxidation and glucuronide formation. The majority of a dose is excreted in the urine, mainly as metabolites; a small amount appears in the faeces.

None Known.

Lactose, maize starch, sodium benzoate, magnesium stearate, quinoline yellow E104, microcrystalline cellulose, sodium starch glycolate, povidone K 30.

Not applicable

Store in the original package.
Store at a temperature not exceeding 30° C.

Furazol Tablets: Blisters of 10 tablets each. Boxes of 20, 30 or 1000 tablets each.

No special requirements