Sparfloxacin (DCI) 200 mg
Due to the risk of severe side effects, the use of sparfloxacin is indicated in case of failure of conventional treatment of acute lung Community radiologically documented:
- Either due to a strain of pneumococcus high level of resistance to penicillin (MIC> 1 mg / l) and resistant to other common antibiotics,
- Either occurring in an epidemiological environment such as the risk of observing such a multiresistant strain of pneumococcus is high.
- It is essential to avoid exposure to the sun, bright natural light and UV radiation for the duration of treatment and during the 5 days of arrest.
- Hypersensitivity to sparfloxacin or product of quinolone.
- Amidarone, sotalol and bepridil.
- Pregnancy and lactation.
- Children up to the end of growth
- History of tendon with fluoroquinolone
- Deficit in glucose-6-phosphate dehydrogenase.
- Césapride, giving medications torsades de pointes (amiodarone, diphemanil).
- Drugs giving torsades points (astemizole, bepridil, disopyramide, erythromycin, halofantrine, pentamidine, quinidine, satalol, sultopride, vincamine).
- Association against-indicated:
Amiodarone, diphemanil, cisapride
- Association advised against:
Astemizole, bepridil, disopyramide, erythromycin IV, halofantrine, pentamidine, quinidine, sotalol, sultopride, vincamine.
- Association requiring precautions for use:
Sucralfate, didanosine, iron salts (oral), topical gastrointestinal (salts, oxides and hydroxides of magnesium, aluminum and calcium, zinc salts (oral).
WARNINGS AND PRECAUTIONS
Phototoxicity may occur under overcast, or even in the absence of direct sunlight;
Consequently, patients should be advised to avoid sun exposure to bright light and UV radiation for the duration of treatment and during the 5 days of arrest.
Recovery may be slow and recurrence can occur even weeks after stopping sparfloxacin (prolonged QT interval)
- Conditions that predispose to the occurrence of torsades de pointes:
- Bradycardia from all sources
- Disorders of atrioventricular conduction.
- Cardiac Arrhythmia, especially bradyarrhythmias.
- Tendinitis: tendonitis and / or tendon rupture occur during treatment with quinolones.
In a subject suspected of tuberculosis, the potential activity of sparfloxacin mycobacteria must be taken into account. Sparfloxacin could negate the results of mycobacterial culture.
- Other skin reactions: rash, itching, swelling, blistering and rarely bullous reaction.
- Muscles and joints: muscle or joint pain, tendonitis, tendon rupture.
- Cardiovascular: rare disorders arrhythmia, bradycardia, tachycardia, and ventricular tachycardia.
- Gastrointestinal disorders: nausea, vomiting, diarrhea, abdominal pain, stomach ache, rarely pseudomembranous colitis.
- Reactions liver transaminase elevation rarely hepatitis.
- Nervous System: tremors, feeling drunk paraesthesia, sensory disturbances, headache and dizziness.
- Psychological disorders: hallucinations, sleep disorders in early treatment.
- General disorders: Hypersensitivity, including urticaria, angioedema, anaphylactic shock and angioedema.
- Hematology: Isolated cases of thrombocytopenia and rare cases of thrombocytopenic purpura.
- Ophthalmological disorders: conjunctivitis and uveitis.
DOSAGE AND DIRECTIONS FOR USE:
Subject with normal renal function: 400mg on the first day in a single dose, then 200 mg / day once daily.
The duration of maintenance therapy was 10 days on average, up to 14 days.
No benefit can be expected from the increase in the daily dose.
Subject renal insufficient:
- No studies have been conducted in subjects with moderate renal impairment (creatinine clearance ≥ 30 ml / min). Due to the low urinary excretion (about 10%), no dosage adjustment is necessary. Nevertheless, caution should be exercised in these patients.
- In severe renal impairment (creatinine clearance <30 ml / min), the following dosage schedule should be followed: 400mg loading dose on day 1 and 200 mg on day 3, and then every 48 hours for a maximum of 14 days.
- The data are insufficient for administration in hemodialysis or peritoneal dialysis in the event. Accordingly, the requirement for these patients is not recommended.
Patients with hepatic impairment:
- Hepatic impairment without cholestasis: no dosage adjustment is necessary.
- No data are available in patients with severe hepatic impairment.
Method of administration:
- This medicine may be taken with or without food, preferably in the evening.
Store at a temperature below 30.degree.
Registration no.: 09L-723