INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION
TAFLOC 200 mg Tablets
TAFLOC 400 mg Tablets

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

TAFLOC 200 mg Tablets
TAFLOC 400 mg Tablets

COMPOSITION:
Each Tafloc 200 mg Tablet contains: 200 mg of ofloxacin.
Each Tafloc 400 mg Tablet contains: 400 mg of ofloxacin.

PHARMACOLOGICAL CLASSIFICATION:
A 20.1.1 : Broad and medium spectrum antibiotics

PHARMACOLOGICAL ACTION:
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.
Ofloxacin is readily absorbed and excreted mainly unchanged in the urine. The serum elimination half-life is approximately 6 to 8 hours.
Following oral administration, ofloxacin peak serum concentrations are reached within one to two hours. The plasma level usually achieved by the recommended dosage regimens (3 to 4 micrograms/mL) is in excess of the average MIC which is 1 to 2 micrograms/mL, for susceptible organisms.
Ofloxacin has a low (9,4%) plasma protein binding.
Ofloxacin has a bactericidal effect.
In vitro tests show that strains in which the sensitivity varies include pneumococci and ureaplasma urealyticum.
Strains that are normally resistant are:
Peptococcus, Peptostreptococcus, Eubacterium spp., Fusobacterium spp. and Treponema pallidum.

INDICATIONS:
Tafloc Tablets are indicated for the treatment of the following bacterial infections if these are due to ofloxacin-sensitive pathogens:

(i)	Lower respiratory tract infections caused by Haemophilus influenzae, Haemophilus parainfluenzae, Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis and Pseudomonas aeruginosa.
(ii)	Infections of the urinary tract.
(iii)	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.

CONTRA-INDICATIONS:
Hypersensitivity to ofloxacin or related chemotherapeutic agents of the quinolonederivative group.
Tafloc Tablets should not be administered to pregnant or lactating women.
Tafloc Tablets should not be administered to patients with cerebral convulsive disorders.
Tafloc is contra-indicated in epileptics. Tafloc 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 (see WARNINGS ).
In patients with a history of tendon disorders related to floroquinolone adminstration.

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

Animal studies have shown that ofloxacin may affect joint development in immature animals. Tafloc should therefore not be given to patients under 18 years of age.

Clostridium difficile - associated disease :
Diarhoea, particularly if severe and/or persistent, occuring during treatment or in the initial weeks following treatment with ofloxacin or with various other antibiotics, but especially broad spectrum antibiotics, may be sympomatic of Clostridium difficile-associated disease, the most severe form of which is 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 favoured 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 negativate the isolation of Mycobacterium tuberculosis, giving falsenegative 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.

DOSAGE AND DIRECTIONS FOR USE:
Tafloc 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.
The following dosages are recommended:
Uncomplicated Cystitis:
100 mg twice daily for 3 - 7 days.
Pyelonephritis:
200 mg twice daily for 5 - 7 days.
Infections of the lower respiratory tract:
400 mg 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 400 mg.
Urethritis and cervicitis due to Chlamydia trachomatis:
600 mg daily in divided doses for up to 7 days.
For patients with impaired renal function and elderly patients, the dosage of Tafloc Tablets should be adjusted according to the degree of impairment. With a creatinine clearance of less than 50 mL to 20 mL/minute, a normal single dose should be administered every 24 hours, e.g. 200 mg once daily.
With a creatinine clearance of less than 20 mL/minute, the normal single dose should be given initially. This dose should then be reduced to half and administered every 24 hours, e.g. 200 mg initially, thereafter 100 mg once daily.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
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, Tafloc 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, nightmares, 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, Tafloc Tablets should be discontinued immediately and the doctor informed.
There have been reports of pain in joints and muscles.
Other side-efects: 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 a serious intestinal disorder (pseudomembranous colitis) which requires immediate treatment. In such cases, Tafloc Tablets must be discontinued immediately and suitable therapy initiated.
In addition to rash and pruritis, hypersensitivity-type reactions affecting the skin have included, less frequently, vasculitis, erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis.
Photosensitivity has occurred
INTERACTIONS:
Steady state theophylline levels may increase when ofloxacin and theophylline are given concurrently. Concomitant administration of ofloxacin with theophylline may prolong the half-life of theophylline, elevate serum theophylline levels and may increase the risk of theophylline-related adverse reactions.
Products inhibiting peristalsis are contra-indicated.
If antacids containing aluminium, including sucralfate, and magnesium hydroxide, aluminium phosphate or calcium, zinc, iron, are taken at the same time, absorption of ofloxacin may be reduced,
Patients undergoing concomitant treatment with coumarin derivatives should be monitored carefully.
Excessive rises or falls in bloodsugar levels may occur less frequently especially in patients with diabetes mellitus. Ofloxacin may cause a slight increase in serum concentrations of glibenclamide if administered concomitantly.
Particularly in case of high dose therapy, mutual impairment of excretion and an increase in serum levels must be considered when quinolones are administered together with other medicines that also undergo renal tubular secretion (such as probenecid, cimetidine, furosemide or methotrexate).

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side-effects and Special Precautions". Treatment is symptomatic and supportive.

IDENTIFICATION:
Tafloc 200 mg Tablet: A round, white, biconvex, film-coated tablet.
Tafloc 400 mg Tablet: An oblong, pale yellow, biconvex, film-coated tablet, bisected on one side.

PRESENTATION:

Tafloc 200 mg Tablet:	Cardboard containers with a blister pack containing 6 or 10 tablets each.
Tafloc 400 mg Tablet:	Cardboard containers with a blister pack containing 10 or 100 tablets each.

STORAGE INSTRUCTIONS:
Store below 25°C in a dry place.
Protect from light.
Keep in the pack until required.
Do not use later than the date of expiry.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
Tafloc 200 mg Tablet: 35/20.1.1 /0174
Tafloc 400 mg Tablet: 35/20.1.1 /0175

NAME AND BUSINESS ADDRESS OF APPLICANT:
PHARMACARE LIMITED
7 Fairclough Road
Korsten
Port Elizabeth
6020
South Africa

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
10/10/2000

        D731
        A&S PRINTERS

New addition to this site: February 2004
Source: Community Pharmacy
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