Macrodantin 50mg. 100mg Capsule

MACRODANTIN is indicated for the treatment and prevention of recurrence of uncomplicated lower urinary tract infections, e.g. pyelonephritis, pyelitis and cystitis. It is not indicated for the treatment of associated renal, cortical or perinephric abscesses.

Adults
Acute urinary tract infections: 50 mg to 100 mg four times a day, with meals and at bedtime.
To prevent recurrences: 50 mg to 100 mg per day.
Children
Acute urinary tract infections: Should be calculated on the basis of 5 mg/kg to 7 mg/kg of body mass per 24 hours to be given in divided doses four times a day (contraindicated for children under one month).
To prevent recurrences: 1 mg/kg/day for long-term therapy.
MACRODANTIN may be given with food or milk to further minimise gastric upset. Therapy should be continued for at least one week and for at least 3 days after sterility of the urine is obtained. Continued infection indicates need for re-evaluation.

Anuria, oliguria and renal impairment are contraindications to therapy with this medicine. Treatment of this type of patient carries an increased risk of toxicity because of impaired excretion of the medicine. Pregnant women at term, as well as infants under one month of age, because of the possibility of haemolytic anaemia due to immature enzyme systems (glutathione instability). Safe use in earlier pregnancy has not been established. Contraindicated in those patients with known sensitivity to MACRODANTIN (nitrofurantoin macrocrystals) and in those patients with a deficiency of glucose-6-phosphate dehydrogenase or nursing mothers of infants with this deficiency.

A course of therapy should not exceed 14 days and repeated courses should be separated by rest periods. Patients with a history of asthma may experience acute asthmatic attacks. Elderly patients and patients undergoing prolonged therapy should be monitored for changes in pulmonary function. Cases of haemolytic anaemia of the primaquine sensitivity type have been induced by MACRODANTIN. The haemolysis appears to be linked to a glucose-6-phosphate dehydrogenase deficiency in the red blood cells of the affected patients. Any sign of haemolysis is an indication to discontinue the medicine. Pseudomonas is the organism most commonly implicated in superinfections in patients treated with MACRODANTIN.

Precautions
Patients should be warned to report early signs of peripheral neuropathy. If peripheral neuropathy occurs the treatment should be discontinued. Care is required in patients with predisposing pulmonary, hepatic, neurological or allergic disorders and in those with conditions such as anaemia, diabetes mellitus, electrolyte imbalance, debility or vitamin B deficiency, which may predispose to peripheral neuropathy. Elderly patients are especially susceptible to the pulmonary intoxication of MACRODANTIN. Acute, subacute or chronic pulmonary reaction has been observed in patients treated with MACRODANTIN. If these reactions occur, the medicine should be withdrawn and appropriate measures should be taken. Excipients contains lactose which may have an effect on the glycaemic control of patients with diabetes mellitus. Patients with the rare hereditary conditions of galactose intolerance e.g. galactosaemia, Lapp lactase deficiency, glucose-galactose malabsorption or fructose intolerance should not take MACRODANTIN.

Probenecid or sulphinpyrazone may reduce the excretion of MACRODANTIN and should not be given concomitantly. Magnesium trisilicate may reduce the absorption of MACRODANTIN. MACRODANTIN may cause false positive reactions in urine tests for glucose using copper reduction methods. Antagonism between MACRODANTIN and nalidixic acid, and MACRODANTIN and oxolinic acid has been demonstrated in-vitro and MACRODANTIN should not be given concomitantly with quinolones.

Safe use in earlier pregnancy has not been established (see CONTRAINDICATIONS).

Not specified in the provided text.

Gastrointestinal reactions
Anorexia, nausea, and vomiting are the most frequent reactions; less frequently abdominal pain and diarrhoea.
Hypersensitivity reactions
Skin rashes and fever may occur. Anaphylaxis, erythema multiforme, exfoliative dermatitis, pancreatitis, a lupus-like syndrome, myalgia and arthralgia have been reported. Pulmonary sensitivity reactions may occur, which can be acute, subacute or chronic. Acute pulmonary sensitivity reaction is commonly manifested by sudden onset of fever, chills, eosinophilia, cough, chest pain, dyspnoea, pulmonary infiltration or consolidation and pleural effusion. The acute reactions usually occur within the first week of treatment and resolve with discontinuation of the medicine. More insidious subacute reactions have also been reported. Interstitial pulmonary fibrosis can occur in patients on chronic medication. Subacute or chronic pulmonary reaction is associated with prolonged therapy. Insidious onset of malaise, dyspnoea on exertion, cough, altered pulmonary function, and roentgenographic and histologic findings of diffuse interstitial pneumonitis or fibrosis or both are common manifestations. Impaired pulmonary function may result even after cessation of the medicine therapy.
Dermatological reactions
Maculopapular, erythematous, or eczematous eruption, pruritus, urticaria and angioedema.
Other sensitivity reactions
Hepatotoxicity including cholestatic jaundice and hepatitis may develop. Chronic active hepatitis and hepatocellular damage have been reported.
Haematological reactions
Haemolytic anaemia, granulocytopenia or agranulocytosis, eosinophilia and megaloblastic anaemia, leucopenia, thrombocytopenia in persons with a genetic deficiency of glucose-6-phosphate dehydrogenase.
Neurological reactions
Peripheral neuropathy, reversible headache, dizziness, nystagmus and drowsiness. Severe polyneuropathies with demyelination and degeneration of both sensory and motor nerves have been reported. Patients should be warned to report early signs or peripheral neuropathy such as paraesthesia.
Miscellaneous reactions
Transient alopecia. As with other antimicrobial medicines, superinfection by resistant organisms may occur. With MACRODANTIN, however, these are limited to the genito- urinary tract because suppression of normal bacterial flora elsewhere in the body does not occur.

See SIDE EFFECTS. Treatment is symptomatic and supportive.