NITROFURANTOIN GLENMARK

Posology Adults and children over 12 years of age. g. at meal times). Acute or recurrent uncomplicated UTI and pyelitis -100mg twice daily for seven days. Surgical Prophylaxis - 100 mg twice daily on the day of the procedure and 3 days thereafter.

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

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 Aplastic anaemia Not known Agranulocytosis, leucopenia, granulocytopenia, haemolytic anaemia, thrombocytopenia,glucose¬6- phosphatedehydrogenase deficiency anaemia, megaloblasticanaemia and eosinophilia Immune system disorders Not known Anaphylaxis, , angioneuroticoedema , cutaneous vasculitis and allergic skin reactions Psychiatric disorders Not known psychotic reactions, depression, euphoria, confusion Nervous system disorders Not known Benign intracranial hypertension, peripheral neuropathy including optic neuritis (sensory as well as motor involvement), nystagmus, vertigo, dizziness, headache and drowsiness.

Cardiac disorders Rare Collapse and cyanosis Respiratory, thoracic and mediastinal disorders Not known Pulmonary fibrosis; possible association with lupus- erythematous-like syndrome. acute pulmonary reactions * subacute pulmonary reactions, * chronic pulmonary reactions, * cough, dyspnoea, Gastrointestinal disorders Not known Sialaodenitis, pancreatitis, , anorexia, emesis, abdominal pain, diarrhea and nausea Hepatobiliary disorders Not known Chronic active hepatitis**, hepatic necrosis, autoimmune hepatitis, cholestatic jaundice Skin and subcutaneous tissue disorders Not known Lupus-like syndrome associated with pulmonary reaction.

Drug Rash With Eosinophilia And Systemic Symptoms (DRESS syndrome), exfoliative dermatitis and erythema multiforme (including Stevens- Johnson Syndrome), maculopapular, erythematous or eczematous eruptions,urticaria, rash, and pruritis, Transient alopecia Renal and urinary disorders Not known Interstitial nephritis, yellow or brown discolouration of urine, 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 **Can be fatal 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 a unilaterally functioning kidney. A surgical cause for infection 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 hepatic or pulmonary adverse reactions, nitrofurantoin should be used with caution in patients with pulmonary disease, hepatic dysfunction, 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 (paraesthesiae). Nitrofurantoin should be used with caution in patients with anaemia, diabetes mellitus, electrolyte imbalance, debilitating conditions, and vitamin B (particularly folate) deficiency.

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 diseaseof 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).

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 signs of haemolysis in those with suspected glucose-6-phosphate dehydrogenase deficiency.

Gastrointestinal reactions may be minimised by taking the drug with food or milk, or by adjustment of dosage. 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.

For long term treatment monitor the patient closely for appearance of hepatic or pulmonary symptoms and other evidence of toxicity. Discontinue treatment with nitrofurantoin if otherwise unexplained pulmonary, hepatotoxic, haematological or neurological syndromes occur.

Excipients Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

1. • Patients suffering from renal dysfunction with an eGFR below 45 ml/minute. 6) • Acute porphyria. • 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.