KLOF-200 Tablet

For the treatment of the following bacterial infections if these are due to ofloxacin-sensitive pathogens:

1) Lower respiratory tract infection caused by Haemophilus influenzae, Haemophilus parainfluenzae, Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis and Pseudomonas aeruginosa.

2) Infections of the urinary tract.

3) Sexually transmitted diseases: Acute uncomplicated urethral and cervical gonorrhoea, urethritis and cervicitis due to Chlamydia trachomatis. Mixed infections of the urethra and cervix due to Chlamydia trachomatis and Neisseria gonorrhoea.

Dosage

KLOF tablets should be swallowed with a little liquid. They may be taken on an empty stomach or with meals.

The dosage should be determined according to the sensitivity of the causative organism and the severity of the infection.

Uncomplicated Cystitis: 100mg twice daily for 3-7 days.

Pyelonephritis: 200mg twice daily for 5-7 days.

Infections of the lower respiratory tract: 400mg twice daily for 7-10 days. The daily dose may be altered depending on the severity of the infection.

Uncomplicated urethral and cervical gonorrhoea: A single dose of 400mg.

Urethritis and cervicitis due to Chlamydia trachomatis: 600mg daily in in divided doses for up to 7 days.

For patients with impaired renal function and elderly patients, the dosage should be adjusted according to the degree of impairment. With a creatinine clearance of less than 50mL to 20mL/min, a normal single dose should be administered every 24 hours, e.g. 200mg once daily.

With a creatinine clearance of less than 20mL/min, the normal single dose should be given initially. This dose should then be reduced to half and administered every 24 hours, e.g. 200mg initially, thereafter 100mg once daily.

Hypersensitivity to ofloxacin or related chemotherapeutic agents of the quinolone derivative group.

KLOF tablets should not be administered to pregnant or lactating women.

KLOF tablets should not be administered to patients with cerebral convulsive disorders.

KLOF tablets are contra-indicated in epileptics.

KLOF must not be used in patients with pre existing central nervous system lesions involving a lowered convulsant threshold e.g. after cerebrocranial injuries, inflammations in the region of the central nervous system, or stroke.

In children or adolescents in the growth phase.

In patients with a history of tendon disorders related to fluoroquinolone administration.

There have been symptoms such as facial oedema, swollen tongue, glottal oedema, tachycardia, dyspnoea and signs of imminent shock and acute anaphylaxis. In the event of such reactions, KLOF tablets should be discontinued immediately. Medical treatment (therapy for shock) is imperative.

Disturbances of the nervous system, headache, dizziness and restlessness are the most common. Others include drowsiness, insomnia, weakness, sleep disturbances, nightmare, unsteady gait and tremor (disturbance of muscular co-ordination), numbness and tingling in the limbs (paraesthesia), peripheral neuropathy, visual disturbances such as double vision and abnormal colour vision, disturbances of the senses of taste and smell, hallucinations, convulsions, psychotic reactions, agitation, anxiety, depression and confusion. These reactions have occurred mainly in elderly patients and patients with impaired renal function, but not exclusively. In some cases these reactions have occurred already after the first dose. In the event of such adverse reactions, KLOF tablets should be discontinued immediately and the doctor informed.

There have been reports of pain in joints and muscles.

Other side-effects: There have been cases of changes in the blood picture (leucopenia, eosinophilia, agranulocytosis, thrombocytopenia, anaemia), transient increases in liver enzymes and/or bilirubin and in serum creatinine. Crystalluria as well as interstitial nephritis and hepatitis may also occur.

Myalgia: gynaecomastia; and cardiovascular effects including tachycardia have been reported.

Gastro-intestinal symptoms may occur (gastric or abdominal symptoms, abdominal pain, loss of appetite, nausea, vomiting, diarrhoea). If severe and persistent diarrhoea occurs during or after therapy, the physician should be informed because in few cases this may point to serious intestinal disorder (pseudomembranous colitis) which requires immediate treatment. In such cases, KLOF tablets must be discontinued immediately and suitable therapy initiated.

In addition to rash and pruritus, hypersensitivity-type reactions affecting the skin have included, less frequently, vasculitis, erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis.

See the package insert about the details below:

Theophyllin

Products inhibiting peristalsis

Antacids containing aluminium, including sucralfate, and magnesium Hydroxide, aluminium phosphate or calcium, zinc, iron

Coumarin derivatives

Glibenclamide

Medicines that also undergo renal tubular secretion (such as probenecid, cimetidine, furosemide or methotrexate).

Contraindicated.

Even when used as instructed, KLOF tablets may alter reactivity to such an extent that the ability to drive vehicles or operate machinery may be impaired.

Clostridium difficile-associated disease.

Diarrhoea, particularly if severe and/or persistent, occurring during treatment or in the initial weeks following treatment with ofloxacin or with various other antibiotics, but especially broad spectrum antibiotics, may be symptomatic of Clostridium difficile-associated disease, the most severe form of which as pseudo-membranous colitis.

If a diagnosis of pseudomembranous colitis is suspected, ofloxacin should be stopped immediately and appropriate specified antibiotic therapy should be started without delay (e.g. vancomycin or metronidazole).

Tendinitis, less frequently observed, may occasionally lead to rupture, involving more particularly Achilles tendon, and occurring especially in elderly patients. Rupture seems to be favored by treatment with corticosteroids. The onset of signs of tendinitis requires to stop the treatment, to rest both Achilles tendons by appropriate immobilisation or special heel pieces, and to take orthopaedic advice.

Ofloxacin may aggravate myasthenia gravis.

Ofloxacin may negative the isolation of Mycobacterium tuberculosis, giving false negative results, in the bacteriological diagnosis of tuberculosis.

The serum concentration of ofloxacin should be monitored in patients with severe renal impairment and haemodialysis patients.

Although this has not been reported, the possibility cannot be ruled out that fluoroquinolones may trigger an attack of porphyria in predisposed patients.

Ofloxacin is a quinolone carboxylic acid derivative, which has a broad spectrum of antibacterial activity against both Gram-positive and Gram-negative bacteria. Ofloxacin exerts its effect by inhibiting the bacterial DNA gyrase, which is responsible for coiling the genetic material as a prerequisite for bacterial multiplication. The mode of action, range of activities, duration of action and MIC levels have been established mainly by means of in vitro studies using bacterial isolates.