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Drug Details

Macrodantin Capsules 100mg B.P.

• Drug Class Description
  Nitrofurans.
• Generic Name
  Macrocrystalline nitrofurantoin
• Presentation
  The 100 mg hard gelatin capsule has an opaque yellow cap and opaque white body with the Logo 'Eaton 009' divided between the body and the cap. .
• Description
  Macrodantin capsules containing 100 mg Nitrofurantoin Ph Eur in macrocrystalline form.
• Indications
  

  For the treatment of and prophylaxis against acute or recurrent, uncomplicated lower urinary tract infections or pyelitis either spontaneous or following surgical procedures.

  Nitrofurantoin is specifically indicated for the treatment of infections when due to susceptible strains of Escherichia coli,enterococci, staphylococci, Citrobacter, Klebsiella and Enterobacter.

• Adult Dosage
  

  Dosage:

  Adults

  Acute Uncomplicated Urinary Tract Infections (UTIs): 50 mg four times daily for seven days.

  Severe chronic recurrence (UTIs): 100 mg four times daily for seven days.

  Long term suppression: 50-100 mg once a day.

  Prophylaxis: 50 mg four times daily for the duration of procedure and for three days thereafter.

   

  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 25 kg body weight consideration should be given to the use of Furadantin® Suspension.

   

  Elderly

  Provided there is no significant renal impairment, in which Nitrofurantoin is contraindicated, the dosage should be that for any normal adult. See precaution and risks to elderly patients associated with long-term therapy

• Child Dosage
  

  Dosage:

  Adults

  Acute Uncomplicated Urinary Tract Infections (UTIs): 50 mg four times daily for seven days.

  Severe chronic recurrence (UTIs): 100 mg four times daily for seven days.

  Long term suppression: 50-100 mg once a day.

  Prophylaxis: 50 mg four times daily for the duration of procedure and for three days thereafter.

   

  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 25 kg body weight consideration should be given to the use of Furadantin® Suspension.

   

  Elderly

  Provided there is no significant renal impairment, in which Nitrofurantoin is contraindicated, the dosage should be that for any normal adult. See precaution and risks to elderly patients associated with long-term therapy

• Elderly Dosage
  

  Dosage:

  Adults

  Acute Uncomplicated Urinary Tract Infections (UTIs): 50 mg four times daily for seven days.

  Severe chronic recurrence (UTIs): 100 mg four times daily for seven days.

  Long term suppression: 50-100 mg once a day.

  Prophylaxis: 50 mg four times daily for the duration of procedure and for three days thereafter.

   

  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 25 kg body weight consideration should be given to the use of Furadantin® Suspension.

   

  Elderly

  Provided there is no significant renal impairment, in which Nitrofurantoin is contraindicated, the dosage should be that for any normal adult. See precaution and risks to elderly patients associated with long-term therapy

• Contra Indications
  

  Patients with known hypersensitivity to nitrofurantoin or other nitrofurans.

  Patients suffering from renal dysfunction with a creatinine clearance of less than 60 ml/minute or elevated serum creatinine.

  G6PD deficiency 

  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.

• Special Precautions
  

  Nitrofurantoin is not effective for the treatment of parenchymal infections of unilaterally nonfunctioning kidney. A surgical cause for infection should be excluded in recurrent or severe cases.

  Since pre-existing conditions may mask 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 in caution with patients with anaemia, diabetes mellitus, electrolyte imbalance, debilitating conditions and vitamin B (particularly folate) deficiency.

  Acute, subacute and chronic pulmonary reactions have been observed in patients treated with nitrofurantoin. If these reactions occur, nitrofurantoin should be discontinued immediately.

  Chronic pulmonary reactions (including pulmonary fibrosis and diffuse interstitial pneumonitis ) can develop insidiously, and may occur commonly in elderly patients. Close monitoring of the pulmonary conditions of patients receiving long-term therapy is warranted (especially in the elderly).

  Patient 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.

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

  For long-term treatment, monitor patients closely for evidence of hepatitis or pulmonary symptoms or other evidence of toxicity.

  Discontinue treatment with Nitrofurantoin if otherwise unexplained pulmonary, hepatic, haematological or neurological syndromes occur.

• Interactions
  

  1. Increased absorption with food or agents delaying gastric emptying.

  2. Decreased absorption with magnesium trisilicate.

  3. Decreased renal excretion of Nitrofurantoin by probenecid and sulphinpyrazone.

  4. Decreased anti-bacterial activity by carbonic anhydrase inhibitors and urine alkalisation.

  5. Anti-bacterial antagonism by quinolone anti-infectives.

  6. Interference with some tests for glucose in urine.

  7. As Nitrofurantoin belongs to the group of Antibacterials, it will have the following interactions:

  • Oestrogens: In common with other antibiotics, nitrofurantoin may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of oestrogen-containing contraceptive products. Therefore, patients should be warned appropriately and extra contraceptive precautions taken.

  • Typhoid Vaccine (oral): Antibacterials inactivate oral typhoid vaccine.

• Adverse Drug Reactions
  

  Respiratory

  If any of the following reactions occur the drug should be discontinued.

  Acute pulmonary reactions usually occur within the first week of treatment and are reversible with cessation of therapy. 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.

  Minor symptoms such as fever, chills, cough and dyspnoea may be significant. Collapse and cyanosis have been reported rarely. The severity of chronic pulmonary reactions and their degree of resolution appear to be related to the duration of therapy after the first clinical signs appear. It is important to recognise symptoms as early as possible. Pulmonary function may be impaired permanently, even after cessation of therapy.

   

  Hepatic

  Hepatic reactions including cholestatic jaundice and chronic active hepatitis occur rarely.

  Fatalities have been reported. Cholestatic jaundice is generally associated with short-term therapy (usually up to two weeks). Chronic active hepatitis, occasionally leading to hepatic necrosis is generally associated with long-term therapy (usually after six months). The onset may be insidious. Treatment should be stopped at the first sign of hepatotoxicity.

   

  Neurological

  Peripheral neuropathy (including optical neuritis) with symptoms of sensory as well as motor involvement, which may become severe or irreversible, has been reported infrequently. Less frequent reactions of unknown causal relationship are depression, euphoria, confusion, psychotic reactions, nystagmus, vertigo, dizziness, asthenia, headache and drowsiness. Treatment should be stopped at the first sign of neurological involvement.

   

  Gastrointestinal

  Nausea and anorexia have been reported. Emesis, abdominal pain and diarrhoea are less common gastrointestinal reactions.

   

  Haematological

  Agranulocytosis, leucopenia, granulocytopenia, haemolytic anaemia, thrombocytopenia and megaloblastic anaemia, glucose-6-phosphate dehydrogenase deficiency anaemia, and eosinophilia have been reported. Aplastic anaemia has been reported rarely. Cessation of therapy has generally returned the blood picture to normal.

   

  Hypersensitivity

  Allergic skin reactions manifesting as angioneurotic oedema, maculopapular, erythematous or eczematous eruptions, urticaria, and pruritus have occurred.

  Lupus-like syndrome associated with pulmonary reaction to Nitrofurantoin has been reported.

  Exfoliative dermatitis and erythema multiforme (including Stevens-Johnson Syndrome) have been reported rarely.

  Other hypersensitivity reactions include anaphylaxis, sialadenitis, pancreatitis, drug fever, and arthralgia.

   

  Miscellaneous

  Transient alopecia and benign intracranial hypertension. As with other antimicrobial agents, superinfections by fungi or resistant organisms such as Pseudomonas may occur. However, these are limited to the genito-urinary tract because suppression of normal bacterial flora does not occur elsewhere in the body