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.
- The wide range of organisms sensitive to bactericidal activity include: Escherichia Coli, Enterococcus faecalis, Klebsiella species, Enterobacter species and Staphylococcus species.
- Most strains of Proteus and Serratia are resistant. All pseudomonas strains are resistant.
- For the treatment of and prophylaxis against acute or recurrent, uncomplicated lower urinary tract infections or pyelitis either spontaneous or following surgical procedures.
- strains of Escherichia Coli, Enterococci, Staphylococci and Klebsiella.
Nitrofurantoin is specifically indicated for the treatment of infections when due to susceptible
- Adults: 1- Acute Uncomplicated Urinary Tract Infections →50mg four times
daily for seven days
2- Severe Chronic Recurrence → 100mg four times a day for seven days
3- Long Term Suppression → 50mg - 100mg once a day.
4- Prophylaxis →50mg four times daily for the duration of procedure and
3 days thereafter.
- Paediatric: Children over three months of age
1- Acute Urinary Tract Infections → 3mg/kg/day in four divided doses
for seven days.
2- Suppressive →1mg/kg, once a day.
- 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.
- Hypersensitivity to nitrofurantoin or to any of the excipients.
- Patients suffering from renal dysfunction with a creatinine clearance of less than 60ml/minute or elevated serum creatinine.
- G6PD (Glucose-6-Phosphate dehydrogenase) deficiency.
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:
1- Absorption: Orally administered Nitrofurantoin is readily absorbed in the upper gastrointestinal tract and is rapidly excreted in the urine. Nitrofurantoin is loosely bound to plasma albumin (60-70)% and the blood concentrations at therapeutic dosages are usually low
2- Elimination: Maximum urinary excretion usually occurs 2-4 hours after administration of Nitrofurantoin. It has an elimination half-life of about 30 minutes