OFLOXIN Film-coated tablet Ref.[50389] Active ingredients: Ofloxacin

Source: Υπουργείο Υγείας (CY)  Revision Year: 2022  Publisher: Codal-Synto Ltd, 21 Constantinoupoleos Street, 3011 Limassol, Cyprus

4.1. Therapeutic indications

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:

  • Uncomplicated acute cystitis
  • Urethritis
  • Complicated skin and soft-tissue infections
  • Acute exacerbation of chronic obstructive pulmonary disease including chronic bronchitis
  • Community acquired pneumonia

In the above-mentioned infections Ofloxin should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections.

  • Acute pyelonephritis
  • Complicated urinary tract infections
  • Non-gonococcal urethritis and cervicitis
  • Gonococcal urethritis and cervicitis due to susceptible Neisseria gonorrhoeae

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

4.2. Posology and method of administration

Posology

General dosage considerations

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.

Adults

  • Lower urinary tract infection: 200-400 mg daily.
  • Upper urinary tract infection: 200-400 mg daily increasing, if necessary, to 400 mg twice a day.
  • Lower respiratory tract infection: 400 mg daily increasing, if necessary, to 400 mg twice daily.
  • Gonococcal urethritis and cervicitis due to susceptible Neisseria gonorrhoea: A single dose of 400 mg.
  • Non-gonococcal urethritis and cervicitis: 400 mg daily in single or divided doses.
  • Complicated skin and soft tissue infections: 400 mg twice daily.

Impaired renal function

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.

Impaired liver function

The excretion of ofloxacin may be reduced in patients with severe hepatic dysfunction.

Elderly

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).

Paediatric population

Ofloxacin is not indicated for use in children or growing adolescents.

Method of administration

Ofloxin 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

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.

4.9. Overdose

Symptoms

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.

Management

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.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

Store below 25°C, in the original package in a dry place protected from light.

6.5. Nature and contents of container

Blisters of polyvinylchloride film and aluminium foil. Blister, with patient information leaflet, in a cardboard carton.

Packs of ten (10) film-coated tablets are available.

6.6. Special precautions for disposal and other handling

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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