OFLOXACIN 400

OFLOXACIN 400
Packing10 blister packs of 6 tablets
Shelf life36 months
CompositionOfloxacin 400 mg
Posology and pharmaceutical formFilm-coated tablet

Summary of product characteristic

Indications, posology and method of administration

THERAPEUTIC INDICATIONS
Ofloxacin is indicated in adults for the treatment of the following infections:

Nephritis and complicated urinary tract infections.
Prostatitis, epididymitis, and orchitis.
Pelvic inflammatory disease, as part of combination therapy.

In the following indications, ofloxacin should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections.

Complicated skin and subcutaneous tissue infection.
Community-acquired pneumonia.
Urethritis.
Uncomplicated cystitis.
Acute exacerbations of chronic obstructive pulmonary disease, including bronchitis.

Due to the association of fluoroquinolone antibiotics, including ofloxacin, with serious adverse reactions, and considering that acute exacerbations of chronic bronchitis and uncomplicated urinary tract infections (such as cystitis) may resolve spontaneously in some patients, ofloxacin should only be used in patients who have no alternative treatment options.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
POSOLOGY AND METHOD OF ADMINISTRATION
The usual recommended dose:
The dose of ofloxacin is determined by the type and severity of the infection. The dosage range for adults is 200 mg to 800 mg daily. Up to 400 mg may be given as a single dose, preferably in the morning. Larger doses should be divided into two doses. Generally, individual doses should be given at approximately equal intervals. Ofloxacin tablets should be swallowed whole with sufficient liquid before or during meal times. Avoid combining with antacids.
Community-acquired pneumonia: 400 mg daily, increasing if necessary, to 400 mg twice a day.
Complicated skin and subcutaneous tissue infection: 400 mg twice a day.

*Indications*	*Daily dosing regimen* *(according to the severity)*	*Duration of treatment* *(according to the severity)*
Complicated urinary tract infections	200 mg twice a day (can be increased to 400 mg twice a day)	7 – 21 days
Nephritis	200 mg twice a day (can be increased to 400 mg twice a day)	7 – 10 days (can be extended up to 14 days).
Acute prostatitis Chronic prostatitis	200 mg twice a day (can be increased to 400 mg twice a day)	2 – 4 weeks* 4 – 8 weeks*
Epididymitis and orchitis	200 mg twice a day (can be increased to 400 mg twice a day)	14 days
Pelvic inflammatory disease	400 mg twice a day	14 days
Complicated cystitis	200 mg twice a day	7 – 14 days
Non-gonococcal urethritis	300 mg twice a day	7 days
Gonococcal urethritis (due to Neisseria gonorrhoeae)	400 mg as a single dose	1 days
Uncomplicated cystitis	200 mg twice a day or 400 mg	3 days 1 days

* For long-term treatment of prostatitis, consideration may be given after carefully re-evaluating the patient.
Acute exacerbations of chronic obstructive pulmonary disease: 400 mg daily, increasing, if necessary, to 400 mg twice a day.
The medication can also be used to complete the treatment course in patients who have shown improvement after initial treatment with intravenous ofloxacin.
Impaired renal function:
In patients with impaired renal function, the recommended dosages for oral and intravenous administration are as follows:

*Creatinine Clearance*	**Dose (mg)***	*Doses/24 hours*	*Dosing interval*
50 – 20 ml/min	100 – 200	1 dose	Every 24 hours
< 20 ml/min** or dialysis or peritoneal dialysis	100 or 200	1 dose 1 dose	Every 24 hours Every 48 hours

* According to the prescription or dosing interval.
** The serum concentration of ofloxacin should be monitored in patients with severe renal impairment and those undergoing dialysis.
When creatinine clearance cannot be measured, it can be estimated with reference to the serum creatinine level using the following Cockcroft's formula for adults:
Men:

or

Women:

Impaired liver function (e.g., cirrhosis with ascites):
It is recommended that the dose should not exceed 400 mg ofloxacin daily, because of possible reduction of excretion.
Elderly:
The ofloxacin dose should not be adjusted based on age. However, particular attention should be given to impaired renal function in the elderly, and the dosage should be adjusted accordingly.
Paediatric population:
Ofloxacin is contraindicated for use in children or growing adolescents.
Duration:
The duration of treatment depends on the severity of the infection and the treatment response. Typically, the treatment duration is 5 – 10 days, except in the case of uncomplicated gonococcal infections, which are treated with a single dose.
Treatment should not exceed 2 months duration.
CONTRAINDICATIONS
The use of ofloxacin is contraindicated as follows::

Hypersensitivity to the active substance, to any other fluoroquinolone antibacterials, or to any of the excipients.
In patients with a history of tendon disorders related to fluoroquinolone administration.
In patients with a history of epilepsy or an existing central nervous system disorder with a lowered seizure threshold.
In children or growing adolescents, and in pregnant or breastfeeding women, since animal experiments do not entirely exclude the risk of damage to the growth‑plate cartilage in the growing organism cannot be entirely excluded.
In patients with latent or actual defects in glucose-6-phosphate dehydrogenase activity because they may be prone to haemolytic reactions when treated with quinolone antibacterial agents.

This information is for reference only. Please read the leaflet inside.

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