Septi Fura (Tablets)

Composition:
Each tablet contains 50mg or 100 mg Nitrofurantion.

Mechanism of Action:
Nitrofurantion is a broad-spectrum antibacterial agent, active against the majority of urinary tract pathogens. The mechanism of action of Nitrofurantion 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 Nitrofurantion is a rare phenomenon. There is no cross resistance to antibiotics and sulphonamides.

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

Dosage:
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: 100 mg four times daily for seven days.
In the event of severe nausea the dose may be reduced, but not below 200mg /days. Should nausea persist the drug should be withdrawn.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.

Side effects:
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 agioedema, 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.

Contraindications:
Patients with known hypersensitivity to Nitrofurantion 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.

Drug interactions:
Concomitant administration of magnesium trisilicate with nitrofurantion reduces absorption.
Uricosuric such as probencid and sulphinpyrazone may inhibit renal tubular secretion of nitrofurantion. 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 nitrofurantion in the presence of carbonic anhydrase inhibitors and urine alkalizing agent.

Precautions:

  • Gastrointestinal reactions may be minimized by taking the drug with food or milk or by adjustment of dosage.
  • Nitrofurantion is not effective for the treatment of non-functioning kidney.
  • Nitrofurantion should be used with caution in patients with pulmonary disease, hepatic dysfunction, neurological disorders, allergic diathesis, anemia, diabetes mellitus, electrolyte imbalance, and vitamin B (particularly folate) deficiency.
  • Nitrofurantion may cause haemolysis in patients with glucose -6 phosphate dehydrogenase deficiency. Haemolysis ceases when the drug is discontinued.
  • Discontinue treatment with Nitrofurantion, if unexplained pulmonary, hepatotoxic, hematological or neurological syndromes occur.
  • For long-term treatment, monitor patient closely for appearance of hepatic, pulmonary or neurological symptoms and other evidence of toxicity.

Effects on ability to drive and use machines:
Septi Fura does not interfere with the ability to drive or use machines.
 
Use in pregnancy and lactation:
Nitrofurantion suitability in human pregnancy has been well documented.
Nitrofurantion is however contraindicated in pregnant women during labour and delivery, because of the possible risk of haemolysis of the infant's immature red cells.

Pharmacokinetic properties:
Nitrofurantion is readily absorbed in the upper gastrointestinal tract. Intake with food or with milk increases absorption. Nitrofurantion is loosely bound to plasma albumin (60-70%).

Presentation:
Carton pack containing 3 blisters of 28 tablets, with leaflet.

 
 
 

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