OFLOXACIN

Posology The dose of ofloxacin is determined by the location and type of infection. The recommended dose is 400 mg/day, preferably taken in the morning. In individual cases it may be necessary to increase the dose to a maximum total dose of 800 mg daily, which should be given as 400 mg twice daily, at approximately equal intervals.

g. of the respiratory or urinary tracts) or if the patient does not respond adequately. 4 400 mg single dose 1 day Gastroenteritis 200 mg twice daily Abdominal infections 200 mg twice daily ENT infections and chronic respiratory tract infections 200 mg twice daily Acute exacerbations of chronic obstructive pulmonary disease, including bronchitis 500 mg once daily 7–10 days Cystic fibrosis 400 mg once daily (can be increased up to 400 mg twice daily) *For prostatitis, extension of treatment can be considered after careful re-examination of the patient.

A single dose of 400 mg of ofloxacin is sufficient for the treatment of gonococcal urethritis and cervicitis due to susceptible Neisseria gonorrhoeae. 5 to 5 mg/dL 100 mg - 200 mg/24 hr <20mL/min** >5 mg/dL 100 mg every 24 hr Haemodialysis and peritoneal dialysis 100 mg every 24 hr Patients undergoing haemodialysis or peritoneal dialysis should be given 100 mg ofloxacin per day.

85 x (above value) Impaired liver function In patients with serious liver function impairment, such as cases of hepatic cirrhosis with ascites, ofloxacin excretion may be reduced. In this case, the maximum daily dose must not exceed 400 mg.

Elderly Age in itself does not necessitate dosage adjustment. However, special attention to renal function should be paid in elderly patients, and the dosage should be adapted accordingly (see section

The information given below is based on data from clinical studies and on extensive post marketing experience. System organ class Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (< 1/10,000) Not known (cannot be estimated from available data)* Infections and infestations Overgrowth of non-susceptible microorganism s incl.

g. 4). System organ class Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1,000) Very rare (< 1/10,000) Not known (cannot be estimated from available data)* Skin and subcutaneous tissue disorders Pruritus, Rash Urticaria, Hot flushes, Hyperhidrosis, Pustular rash Erythema multiforme, Toxic epidermal necrolysis, Photo- sensitivity reaction*, Drug eruption, Vascular purpura, Vasculitis, which can lead in exceptional cases to skin necrosis (vasculitis presents generally with petechiae, bleeding vesicles and small pimples with scabs and may even affect internal organs).

g. 4). A range of psychiatric symptoms may occur as part of these side effects, which may include, but are not necessarily limited to, sleep disorders, anxiety, panic attacks, confusion, or depression. There are no pharmacological treatments established to be effective treatments of the symptoms of long lasting or disabling side effects associated with fluoroquinolones.

The frequency of these prolonged, disabling and potentially irreversible serious drug reactions cannot be estimated with precision using available data, but the reporting incidence from adverse drug reaction reports indicates the frequency is at minimum between 1/1,000 and 1/10,000 (corresponding to the Rare frequency category).

**Post-marketing experience ***Cases of aortic aneurysm and dissection, sometimes complicated by rupture (including fatal ones), and of regurgitation/incompetence of any of the heart valves have been reported in patients receiving fluoroquinolones (see section […]

4. QT interval prolongation). 3). Duration The duration of treatment with Ofloxacin varies between 7 and 10 days depending on the susceptibility of the organism, severity of infection and clinical course. As with other antibiotics, it is recommended to continue treatment for an additional 3 days after the symptoms have disappeared.

The maximum daily dose is 800 mg. Method of administration For oral use. Ofloxacin tablets can also be used to complete a course of therapy in patients who have shown improvement during initial treatment with intravenous ofloxacin. Ofloxacin tablets should be swallowed whole with sufficient liquid before or during meal times.

5). 1. • In patients with a history of epilepsy or in patients predisposed to seizures due to pre- existing central nervous system disorders, such as craniocerebral trauma, central nervous system inflammation or cerebral infarction. • In patients with a history of tendon disorders related to fluoroquinolone administration • 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.

4 Special warnings and precautions for use Prolonged, disabling and potentially irreversible serious adverse drug reactions Cases of prolonged (continuing for months or years), disabling and potentially irreversible serious adverse drug reactions affecting different, sometimes multiple, body systems (including musculoskeletal, nervous, psychiatric and senses) have been reported in patients receiving quinolones and fluoroquinolones irrespective of their age and pre-existing risk factors.

There are no pharmacological treatments established to be effective treatments of the symptoms of long lasting or disabling side effects associated with fluoroquinolones. Ofloxacin should be discontinued immediately at the first signs or symptoms of any serious adverse reaction and patients should be advised to contact their prescriber for advice, so that symptoms can be appropriately investigated and to avoid further exposure which could potentially worsen adverse reactions.

1. • In patients with a history of epilepsy or in patients predisposed to seizures due to pre- existing central nervous system disorders, such as craniocerebral trauma, central nervous system inflammation or cerebral infarction. • In patients with a history of tendon disorders related to fluoroquinolone administration • 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.