Source: European Medicines Agency (EU)
Norfloxacina Sandoz 400 mg film-coated tablets is a broad-spectrum bactericidal/chemotherapeutic agent, indicated for the treatment of the following infections caused by norfloxacin-susceptible grampositive and gram-negative aerobic bacteria:
Consideration should be given to an official local guidance, e.g. national recommendations regarding the appropriate use and prescription of antibacterial agents.
The dosage depends on the susceptibility of the pathogens and severity of the disease; see recommended dosage in the table below. Oral norfloxacin containing products are not recommended for the treatment of acute or chronic complicated pyelonephritis. Susceptibility of the causative organism to the treatment should be tested (if possible), although therapy may be initiated before the results are available. In case of suspected failure of therapy, microbiological investigation for possible bacterial resistance should be undertaken.
| Diagnosis | Dosage | Therapy duration2 |
|---|---|---|
| Usual dosage for uncomplicated acute cystitis3 | 400 mg twice daily | 3 days |
| Usual dosage for urinary tract infections | 400 mg twice daily | 7-10 days1 |
| Complicated urinary tract infections | 400 mg twice daily | 2-3 weeks1 |
| Urinary infections associated with urological surgery or nephrolithiasis | The dosage lies between 400 mg BID and 400 mg TID. The daily dose and duration of therapy depends on the severity and relapse rate of the infection. |
1 Symptoms accompanying urinary tract infections such as burning on passing water or fever and pain subside after only one to two days. Nevertheless, the recommended length of treatment should be fully adhered to
2 Prolonged therapy should be guided by evaluation of response of the patient taking into account official therapeutic guidelines and assessment of the risk of development of resistance.
3 This condition is considered to be met in women.
Norfloxacina Sandoz is suitable for treatment of patients with renal insufficiency. In patients with severe impaired renal function, the advantages and disadvantages of the use of Norfloxacina Sandoz should be carefully weighed up in each individual case. For patients with a creatinine clearance ≤ 30 ml/min x 1.73 m² the recommended dosage is one Norfloxacina Sandoz 400 mg film-coated tablet daily.
At this dosage, fluid and tissue concentrations exceed the MlCs of most norfloxacin-susceptible pathogens responsible for urinary tract infections.
Pharmacokinetic studies have shown no evidence of differences in norfloxacin pharmacokinetics in elderly patients, apart from a slight prolongation of half-life. In the absence of renal impairment no adjustment of dosage is necessary for elderly patients.
Norfloxacina Sandoz is not recommended for use in children or growing adolescents (see section 4.3).
The film-coated tablets should be swallowed with sufficient fluid (e.g. a glass of water) at least one hour before or two hours after a meal or ingestion of milk (see also section 4.5 under the heading miscellaneous preparations).
The film-coated tablets should preferably be taken in the morning and evening. If only one dose is to be administered daily, this should always be taken at the same time of the day.
At present no experience is available with norfloxacin overdosing.
In the event of recent acute overdosage, the stomach should be emptied by inducing vomiting or by gastric lavage, and the patient carefully observed and given symptomatic and supportive treatment.
In recent acute overdosage patients should be advised to drink calcium-containing fluids so that norfloxacin forms a complex with calcium which undergoes only minimal absorption from the gastrointestinal tract.
Adequate hydration must be maintained.
Crystalluria was observed in few patients who had been treated with high doses of norfloxacin. These patients should drink enough liquid to ensure a proper state of hydration.
ECG monitoring should be undertaken, because of the possibility of QT interval prolongation.
Shelf-life: 3 years.
This medicinal product does not require any special storage conditions.
Al/PVC/PVDC-blister: 6, 10, 14, 20 and 50 film-coated tablets.
Not all pack sizes may be marketed.
None.
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