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GENFURA is a brand name for Nitrofurantoin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: For the treatment of and prophylaxis against acute or recurrent uncomplicated pyelitis or lower urinary tract infection - either spontaneous or following surgical procedures. Nitrofurantoin is specifically indicated for the treatment of infections due to susceptible strains of Escherichia coli, Enterococci,…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Adults: • Acute uncomplicated urinary tract infections: 50 mg four times daily, for 7 days. • Severe chronic recurrence: 100 mg four times a day, for 7 days. • Long term suppression: 50 mg – 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; 3 mg/kg/day in four divided doses for 7 days. • Suppressive: 1 mg/kg, once a day. For children under 25kg body weight, consideration should be given to the use of nitrofurantoin oral suspension.
Elderly:
Provided there is no significant renal impairment, in which Nitrofurantoin is contraindicated; the dosage should be that for any normal adult. 4).
Method of administration:
For oral use. This medicine should always be taken with food or milk. Taking Genfura/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 form 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, 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-John 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 maybe 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. 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).
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).
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 neurologic symptoms occur.
1. • Patients suffering from renal dysfunction with an eGFR of less than 45 ml/min. 6). • Acute porphyria. • In infants under 3 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
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Lupus-like syndrome associated with pulmonary reaction. Drug Rash With Eosinophilia And Systemic Symptoms (DRESS syndrome), cutaneous vasculitis Renal and urinary disorders Not known Yellow or brown discolouration of urine, interstitial nephritis General disorders and administration site conditions Not known Asthenia, fever, chills, drug fever and arthralgia Investigations Not known False positive urinary glucose * Acute pulmonary reactions are commonly manifested by fever, chills, cough, chest pain, dyspnoea, pulmonary infiltration with consolidation or pleural effusion on chest x-ray and eosinophilia.
In subacute pulmonary reactions, fever and eosinophilia occur less often than in the acute form. Chronic pulmonary reactions occur rarely in patients who have received continuous therapy for six months or longer and are more common in elderly patients.
Changes in ECG have occurred, associated with pulmonary reactions. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
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Nitrofurantoin is not effective for the treatment of parenchymal infections of unilaterally non-functioning kidney. A surgical cause for infections should be excluded in recurrent or severe cases. Nitrofurantoin may be used with caution as short-course therapy only for the treatment of uncomplicated lower urinary tract infection in individual cases with an eGFR between 30-44 ml/min to treat resistant pathogens, when the benefits are expected to outweigh the risks.
Since pre-existing conditions may mask adverse reactions, Nitrofurantoin should be used with caution in patients with pulmonary disease, hepatic dysfunctions, neurological disorders and allergic diathesis. Peripheral neuropathy and susceptibility to peripheral neuropathy, which may become severe or irreversible, has occurred and may be life threatening.
Therefore, treatment should be stopped at the first signs of neural involvement (paraesthesia). Tablets contain lactose and sodium Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per 100 mg tablet, that is to say essentially ‘sodium-free’.