URANTOIN/NITROFURANTOIN

Poso logy Adu lts Acute uncomplicated urinary tract infections: 50 mg four times daily for 7 days Severe chronic recurrence: 100 mg four times day for 7 days Long term suppression: 50mg-100 mg once a day Prophylaxis: 50 mg four times daily for the duration of procedure and 3 days thereafter.

Paediatric Population Children and Infants over three months of age Acute Urinary Tract Infections: 3mg/kg/day in four divided doses for seven days. Suppressive: 1mg/kg, once a day. For children under 25kg body weight consideration should be given to the use of Nitrofurantoin Suspension.

Elderly Provided there is no significant renal impairment, in which Nitrofurantoin is contraindicated, the dosage should be that for any normal adult. 8). 4). Method of administration For oral use. This medicine should always be taken with food or milk.

Taking Urantoin Tablets / Nitrofurantoin Tablets with a meal improves absorption and is important for optimal efficacy.

A tabulated list of undesirable effects is outlined below:

The undesirable effects are listed according to organ systems and following frequencies: Rare (≥1/10,000 to <1/1,000) Not known (cannot be estimated from the available data) System organ class Frequency Adverse reaction Infections and infestations Not known Superinfections by fungi or resistant organisms such as Pseudomonas.

However, these are limited to the genitourinary tract Blood and lymphatic system disorders Rare Not known Aplastic anaemia Agranulocytosis, leucopenia, granulocytopenia, haemolytic anaemia, thrombocytopenia, glucose¬6- phosphate dehydrogenase deficiency anaemia, megaloblastic anaemia and eosinophilia Immune system disorders Not known Allergic skin reactions, angioneurotic oedema and anaphylaxis, cutaneous vasculitis Psychiatric disorders Not known Depression, euphoria, confusion, psychotic reactions Nervous system disorders Not known Peripheral neuropathy including optic neuritis (sensory as well as motor involvement), nystagmus, vertigo, dizziness, headache and drowsiness.

Benign intracranial hypertension Cardiac disorders Rare Collapse and cyanosis Respiratory, thoracic and mediastinal disorders Not known Acute pulmonary reactions, subacute pulmonary reactions*, chronic pulmonary reactions, cough, dyspnoea, pulmonary fibrosis; possible association with lupus- erythematous-like syndrome.

Gastrointestinal disorders Not known Sialadenitis, pancreatitis, nausea, anorexia, emesis, abdominal pain and diarrhoea. Hepatobiliary disorders Not known Cholestatic jaundice, chronic active hepatitis (fatalities have been reported), hepatic necrosis, autoimmune hepatitis Skin and subcutaneous tissue disorders Not known Transient alopecia Exfoliative dermatitis and erythema multiforme (including Stevens-Johnson Syndrome), maculopapular, erythematous or eczematous eruptions, urticaria, rash and pruritus.

Hepatotoxicity Hepatic reactions, including hepatitis, autoimmune hepatitis, cholestatic jaundice, chronic active hepatitis, and hepatic necrosis, occur rarely. Fatalities have been reported. The onset of chronic active hepatitis may be insidious, and patients should be monitored periodically for changes in biochemical tests that would indicate liver injury.

If hepatitis occurs, the drug should be withdrawn immediately and appropriate measures should be taken. Patients should be monitored closely for signs of hepatitis (particularly in long-term use). Urine may be coloured yellow or brown after taking Nitrofurantoin.

Patients on Nitrofurantoin are susceptible to false positive urinary glucose (if tested for reducing substances). Pulmonary adverse reactions Acute, subacute and chronic pulmonary reactions have been observed in patients treated with nitrofurantoin.

If these reactions occur, nitrofurantoin should be discontinued immediately. Signs of pulmonary damage include difficulty and or pain when breathing, shortness of breath and coughing up blood or mucus. Chronic pulmonary reactions Chronic pulmonary reactions (including pulmonary fibrosis and diffuse interstitial pneumonitis) can develop insidiously and can often occur in elderly patients.

Close monitoring of the lung disease of patients receiving long-term therapy is indicated (especially in the elderly). Acute pulmonary reactions Pulmonary reactions may be acute and usually occur within the first week of treatment. Increased vigilance for respiratory symptoms in patients who have just started therapy is warranted (especially in the elderly).

Nitrofurantoin should be discontinued at any sign of haemolysis in those with suspected glucose-6-phosphate dehydrogenase deficiency. Discontinue treatment with nitrofurantoin if otherwise unexplained pulmonary, hepatic, haematological or neurological syndromes occur.

1. o Patients suffering from renal dysfunction with a an eGFR of below 45 ml/minute. 6) o Acute porphyria o In infants under three months of age as well as pregnant patients at term (during labour and delivery) because of the theoretical possibility of haemolytic anaemia in the foetus or in the newborn infant due to immature erythrocyte enzyme systems.