COMPOSITION :

Each film coated tablet contains : Ofloxacin 200 mg , 400 mg.

DESCRIPTION :

Oflox (Ofloxacin) is a Fluoroquinolones with a wide range of antibacterial activity against both gram negative and gram

positive organisms. It acts as a specific inhibitor of bacterial DNA gyrase which is required for reproduction of bacteria that

leads to cell death. Ofloxacin is almost completely absorbed after oral administration. Maximal blood levels occur 1-3 hours

after dosing and the elimination half-life is 4-6 hours. Ofloxacin is primarily excreted unchanged in the urine.

INDICATIONS & Dosage:

- Upper and lower urinary tract infections: 200 - 400 mg daily ( increasing, if necessary, to 400 mg twice a day in case of

upper urinary tract infections) .

- Uncomplicated urethral and cervical gonorrhea : 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.

- Acute exacerbation of chronic bronchitis and community acquired pneumonia : 400 mg daily increasing, if necessary, to

400 mg twice daily.

- Severe traveler’s diarrhea : 400 mg as a single dose or once daily for three days if necessary.

- Typhoid fever : 15 mg / kg / day in 2 divided doses for 5 - 7 days.

Dose in patients with impaired renal function:

Creatinine clearance 50 – 20 ml/min. : 100 - 200 mg per 24 hours.

Creatinine clearance < 20 ml/min. or hemodialysis : 100mg per 24 hours or 200mg per 48 hours.

Dose in patients with impaired liver function: The maximum daily dose of 400 mg should not be exceeded.

RESTRICTIONS ON USE :

Contraindication

- Hypersensitivity to Ofloxacin or to other quinolones.

- Ofloxacin should not be used in patients with a history of tendinitis related to fluoroquinolone administration or a history of

epilepsy or convulsive seizure.

- Ofloxacin is contra-indicated in children or growing adolescents.

- Patients with glucose-6-phosphate dehydrogenase deficiency .

Precautions :

- Caution should be taken in patients with known risk factors for prolongation of the QT interval such as congenital long QT

syndrome ,concomitant use of drugs that are known to prolong the QT interval , electrolyte imbalance (e.g. hypokalaemia,

hypomagnesaemia), cardiac disease (e.g. heart failure, myocardial infarction, bradycardia) or elderly patients and women.

- Ofloxacin may cause muscle weakness , so it is not recommended in patients with a history of myasthenia gravis .

- Caution should be taken in patients with mental health problems, because Ofloxacin may affect on the mental case.

- Ofloxacin is not recommended for the treatment of known or suspected Methicillin-resistant S. aureus infections.

Pregnancy and Lactation

Oflox is contraindicated in pregnant and lactating women .

Effects on ability to drive and use machines

Patients may feel sleepy or dizzy while taking this medicine. If this happens, do not drive or use any machines.

DRUGS INTERACTIONS :

- Co-administration of Ofloxacin with drugs known to prolong the QT interval ( Class IA and III anti-arrhythmics, tricyclic

antidepressants, macrolides antibiotics , antipsychotics) may increase the risk of prolongation the QT interval.

- Co-administered of antacids containing magnesium or aluminium, sucralfate, zinc or iron medications can reduce

absorption of Ofloxacin. Therefore, ofloxacin should be taken 2 hours before taking these medications .

- Concomitant administration of Ofloxacin with anticoagulants may lead to prolong the bleeding time .

- Concomitant administration of Ofloxacin with theophylline or NSAIDs may lead to convulsive seizure.

- Concomitant administration of Ofloxacin with glibenclamide may cause a slight increase in serum concentrations; so

diabetes patients should be closely monitored.

- Concomitant administration of Ofloxacin with probenecid, cimetidine, furosemide and methotrexate may affect the tubular

renal secretion .

SIDE EFFECTS :

Uncommon effects : dizziness, headache, rash, diarrhea, abdominal pain. Rare effects: anaphylactic reaction, anorexia,

visual disturbance, tachycardia, hypotension, increase hepatic enzymes. Very rarely tinnitus, jaundice, muscle pain.

OVERDOSAGE :

Symptoms include confusion ,dizziness, impairment of consciousness, seizures, increase QT interval. It is recommended

that the treatment is by doing gastric lavage and taking active charcoal. ECG monitoring should be undertaken.

STORAGE INSTRUCTIONS :

Store below 30ºC, in a dry place.

PRESENTATIONS :

Oflox 200 mg, 400mg film coated tablets : pack of 10 tablets and hospital packs of different sizes.