OFLOXACIN

Posology General dosage recommendations:

The dose of ofloxacin should be 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. Generally, individual doses should be given at approximately equal intervals.

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. g. of the respiratory or urinary tracts) or if the patient does not respond adequately.

g. cirrhosis with ascites) It is recommended that a maximum daily dose of 400 mg of ofloxacin be not exceeded, because of possible reduction of excretion.

Elderly:

Age in itself does not impose to adapt the dosage of ofloxacin. 4).

Paediatric population:

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

Type and duration of treatment:

A daily dose of up to 400mg ofloxacin may be given as a single dose. In this case, it is preferable to administer ofloxacin in the morning. Daily doses of more than 400mg must be divided into two separate doses and be given at approximately equal intervals.

Duration of treatment is dependent on the severity of the infection and the response to treatment. The usual durations of treatment are stated in the table. In some instances, a minimum of 5 days treatment may be sufficient. Treatment should not exceed 2 months duration.

Method of administration Ofloxacin Tablets should be swallowed with sufficent amount of liquids They may be taken on an empty stomach or with meals. 5).

The overall frequency of adverse reactions from the clinical trial data base is about 7%. 0%). The frequencies of adverse events are ranked according to the following: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10 000 to < 1/1000), very rare (< 1/10, 000), not known (cannot be estimated from the available data) including isolated reports.

The information given below is based on data from clinical studies and on extensive post marketing experience. g. 4) Nervousness Nervous system disorders* headache, dizziness somnolence, paraesthesia, dysgeusia, parosmia peripheral sensory neuropathya, peripheral sensory motor neuropathya, convulsiona, extra- Tremor, Dyskinesia, Ageusia, Syncope pyramidal symptoms or other disorders of muscular coordination.

g. 4). 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).

4). g. isolated cases of smell, taste and hearing disorders) the adverse effects observed subsided after discontinuation of ofloxacin. Reporting of suspected adverse reactions […]

• 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.

8). 3). • Methicillin-resistant S. aureus are very likely to possess co-resistance to fluoroquinolones, including ofloxacin. Therefore ofloxacin is not recommended for the treatment of known or suspected MRSA infections unless laboratory results have confirmed susceptibility of the organism to ofloxacin (and commonly recommended antibacterial agents for the treatment of MRSA-infections are considered inappropriate).

• Resistance to fluoroquinolones of E. coli – the most common pathogen involved in urinary tract infections – varies across the European Union. Prescribers are advised to take into account the local prevalence of resistance in E. coli to fluoroquinolones.

8). Patients should be advised to contact their doctor immediately prior to continuing treatment if skin and/or mucosal reactions occur. • Hypersensitivity and allergic reactions have been reported for fluoroquinolones after first administration.

Anaphylactic and anaphylactoid reactions can progress to life-threatening shock, even after the first administration. g treatment for shock) should be initiated. The physician should inform the patient of this risk. • Ofloxacin is not the drug of first choice for pneumonia caused by Pneumococci or Mycoplama, or angina tonsillaris caused by β-haemolytic Streptococci.

Ofloxacin must not be used • in patients hypersensitive to ofloxacin, other quinolones, or any of the excipients • in patients with history of epilepsy or with any existing central nervous system disorder that is associated with a lower seizure threshold • in patients with history of tendon disorders related to fluoroquinolone administration • in children or adolescents in the growth phase* • during pregnancy* • in breast-feeding women* *because, judging from animal experiments, a risk of damage to the growth- plate cartilage in the growing organism cannot be entirely excluded.

Ofloxacin should not be given to patients with latent or actual defects in glucose-6-phosphate dehydrogenase activity because they are prone to haemolytic reactions when treated with quinolone antibacterial agents.