Source: Υπουργείο Υγείας (CY) Revision Year: 2022 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Ofloxacin is a synthetic 4-fluoroquinolone antibacterial agent with bactericidal activity against a wide range of Gram-negative and Gram-positive organisms. It is indicated for the treatment of the following infections when caused by sensitive organisms:
In the above-mentioned infections Medofloxine should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
The dose of ofloxacin is determined by the type and severity of the infection. The dosage range for adults is 200mg to 800mg daily. Up to 400mg may be given as a single dose, preferably in the morning; larger doses should be given as two divided doses. Generally, individual doses are to be given at approximately equal intervals.
Following a normal initial dose, dosage should be reduced in patients with impairment of renal function. When creatinine clearance is 20-50 ml/minute (serum creatinine 1.5-5.0 mg/dl) the dosage should be reduced by half (100-200 mg daily). If creatinine clearance is less than 20 ml/minute (serum creatinine greater than 5 mg/dl) 100 mg should be given every 24 hours. In patients undergoing haemodialysis or peritoneal dialysis, 100 mg should be given every 24 hours.
The excretion of ofloxacin may be reduced in patients with severe hepatic dysfunction.
No adjustment of dosage is required in the elderly, other than that imposed by consideration of renal or hepatic function (see section 4.4 QT interval prolongation).
Ofloxacin is not indicated for use in children or growing adolescents.
Medofloxine tablets should be swallowed whole with liquid; they should not be taken within two hours of magnesium/aluminium containing antacids, sucralfate, zinc or iron preparations since reduction of absorption of ofloxacin can occur.
Duration of treatment is dependent on the severity of the infection and the response to treatment. The usual treatment period is 5-10 days except in uncomplicated gonorrhoea, where a single dose is recommended.
Treatment should not exceed 2 months duration.
The most important signs to be expected following acute overdosage are CNS symptoms such as confusion, dizziness, impairment of consciousness and convulsive seizures as well as gastrointestinal reactions such as nausea and mucosal erosions.
In the case of overdose steps to remove any unabsorbed ofloxacin eg gastric lavage, administration of adsorbants and sodium sulphate, if possible during the first 30 minutes, are recommended; antacids are recommended for protection of the gastric mucosa.
Elimination of ofloxacin may be increased by forced diuresis.
In the event of overdose, symptomatic treatment should be implemented. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation.
3 years.
Store below 25°C in the original package, in order to protect from light.
Blisters of polyvinylchloride film and aluminium foil. Blister, with patient information leaflet, in a cardboard carton.
Packs of ten (10) and twenty (20) film-coated tablets are available.
Not all pack sizes may be marketed.
No special requirements for disposal.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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