Each tablet contains 50mg or 100mg Nitrofurantoin.
MECHANISM OF ACTION:
Nitrofurantoin is a broad-spectrum antibacterial agent, active against the majority of urinary tract pathogens. The mechanism of action of Nitrofurantoin is the interfering with the energy supply for normal growth and maintenance of bacteria. They also bind to bacterial ribosomal proteins at different sites, resulting in disruption of bacterial protein synthesis. Transferable resistance to Nitrofurantoin is a rare phenomenon. There is no cross resistance to antibiotics and sulphonamides.
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 due to susceptible strains of Escherichia Coli, Enterococci, Staphylococci, Citrobacter, Klebsiella and Enterobacter. Most strains of Proteus and Serratia are resistant. All pseudomonas strains are resistant.
Adults and children over ten years of age: The dose should be taken with food or milk (e.g. at meat times).
Acute uncomplicated urinary tract infections: 50mg four times daily for seven days.
Severe chronic recurrent infection: 100mg four times daily for seven days.
In the event of severe nausea the dose may be reduced, but not below 200mg/day. Should nausea persist the drug should be withdrawn.
Long term suppressive therapy: 50-100mg once a day at bedtime is suggested.
Surgical prophylaxis: 50mg four times daily on the day of the procedure and for the three days after.
Elderly: As for normal adult.
Anorexia, nausea, vomiting, and diarrhea, acute and chronic pulmonary reactions (pulmonary fibrosis reported, possible association with lupus erythematosus - like syndrome), peripheral neuropathy also reported, hypersensitivity reactions (including angioedema, anaphylaxis, urticaria, rash and pruritus).
Rarely: Dermatitis, hepatitis, blood disorders and transient alopecia.
Super-infections by fungi or resistant organism such as pseudomonas may occur. However, these are limited to genitourinary tract.
Patients with known hypersensitivity to Nitrofurantoin or other nitrofurans.
Patients suffering from renal dysfunction with a creatinine clearance of less than 60ml/minute or elevated serum creatinine.
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 infants due to immature erythrocyte enzyme systems.
Concomitant administration of magnesium trisilicate with nitrofurantoin reduces absorption.
Uricosuric such as probencid and sulphinpyrazone may inhibit renal tubular secretion of nitrofurantoin. The resulting increase in serum levels may increase toxicity. Decreased urinary levels could reduce its efficacy as a urinary tract antibacterial.
Concurrent use with quinolones is not recommended.
There may be decreased antibacterial activity for nitrofurantoin in the presence of carbonic anhydrase inhibitors and urine alkalizing agent.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:
Septi Fura does not interfere with the ability to drive or use machines.
USE IN PREGNANCY OR LACTATION:
Nitrofurantoin suitability in human pregnancy has been well documented. Pregnancy category B, to be used only if clearly indicated in pregnancy.
Nitrofurantoin is however contraindicated in pregnant women during labour and delivery, because of the possible risk of haemolysis of the infants immature red cells.
Nitrofurantoin is readily absorbed in the upper gastrointestinal tract. Intake with food or with milk increases absorption. Nitrofurantoin is loosely bound to plasma albumin (60-70)%.