INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo TAVALOXX (Tablets)

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

TAVALOXX (Tablets)

TAVALOXX 250 (Tablets)
TAVALOXX 500 (Tablets)
TAVALOXX 750 (Tablets)

COMPOSITION:
TAVALOXX 250: Each tablet contains levofloxacin hemihydrate equivalent to
levofloxacin 250 mg.
TAVALOXX 500: Each tablet contains levofloxacin hemihydrate equivalent to levofloxacin 500 mg.
TAVALOXX 750: Each tablet contains levofloxacin hemihydrate equivalent to levofloxacin 750 mg.

PHARMACOLOGICAL CLASSIFICATION:
A 20.1.1 Broad and medium spectrum antibiotics.

PHARMACOLOGICAL ACTION:
Levofloxacin is a broad spectrum bactericidal agent from the fluoroquinolone chemical group. Levofloxacin is the pure (-) –(S) –enantiomer of ofloxacin.
Mechanism of action:
Levofloxacin’s bactericidal action results from interference with the enzymes topoisomerase IV and DNA gyrase, which are needed for DNA replication, transcription, repair and recombination.
Levofloxacin is bactericidal in vitro. Cross-resistance exists between levofloxacin and other fluoroquinolones in vitro.
Generally there is no cross-resistance between levofloxacin and other classes of antibacterial agents, due to the mechanism of action of levofloxacin.
The antibacterial spectrum of levofloxacin covers many Gram-positive and Gram-negative bacteria. Levofloxacin can be used successfully against the following organisms:
Gram-negative organisms: Acinetobacter calcoaceticus, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Proteus mirabilis and Pseudomonas aeruginosa.
Gram-positive organisms: Staphylococcus aureus, Streptococcus faecalis, Streptococcus pneumoniae and Streptococcus pyogenes.
Other organisms: Chlamydia pneumoniae, Legionella pneumophila and Mycoplasma pneumoniae.

Pharmacokinetics:
Absorption:
After oral administration levofloxacin is rapidly and almost completely absorbed with peak plasma concentrations being reached within 1 hour. Food has minimal effect on the absorption of levofloxacin and the tablets may therefore be taken with or without food. The absolute bioavailability is about 100%.
Distribution, Metabolism and Excretion:
Levofloxacin is approximately 30 –40% bound to serum proteins. Steady-state is reached within three days.
Levofloxacin is metabolised to a small degree to inactive metabolites desmethyllevofloxacin and levofloxacin-N-oxide.
The elimination half-life of levofloxacin is six to eight hours after oral and intravenous administration. Levofloxacin is excreted largely unchanged, primarily via the kidneys.
Distribution in tissues and fluids:
Levofloxacin penetrates well into lung tissue, bone tissue, bronchial mucosa, epithelial lining fluid and blister fluid.

INDICATIONS:
TAVALOXX
can be used in adults, in the treatment of the following bacterial infections:
Acute exacerbations of chronic bronchitis: caused by E. coli, H. influenzae, H. parainfluenzae, K. pneumoniae, M. catarrhalis, S. aureus orS. pneumoniae.
Pneumonia (community-acquired): caused by E. coli, H. influenzae, H. parainfluenzae, K. pneumoniae, M. catarrhalis, S. aureus, S. pneumoniae, Chlamydia pneumoniae, Legionella pneumophila or Mycoplasma pneumoniae.
Sinusitis: caused by H. influenzae, H. parainfluenzae, M. catarrhalis, S. aureus or S. pneumoniae.
Urinary tract infections (complicated) and acute pyelonephritis: caused by Enterobacter cloacae, E. coli, K. pneumoniae, P. mirabilis, P. aeruginosa and S. faecalis.
Uncomplicated urinary tract infections in women: caused by E. coli. and K. pneumoniae.
Skin and soft tissue infections (uncomplicated): caused by S. aureus, S. faecalis, S. pyogenes, Acinetobacter calcoaceticus, E. cloacae, E. coli, K. pneumoniae, P. mirabilis or P. aeruginosa.
Skin and soft tissue infections (complicated): caused byS. aureus, S. faecalis, S. pyogenes, E. cloacae, E. coli, K. oxytoca, K. pneumoniae, P. mirabilis.
Intra-abdominal infections: caused byE. coli and anaerobic micro-organisms.

CONTRA-INDICATIONS:
The use of TAVALOXX is contra-indicated in:
Previous hypersensitivity reaction to levofloxacin, other quinolones, or any other ingredient.
Epilepsy.
Patients with history of tendon disorders associated with fluoroquinolone administration.
Children or adolescents (under 18 years of age).
Pregnancy and lactation.

WARNINGS:
TAVALOXX SHOULD NOT BE ADMINISTERED TO PATIENTS UNDER 18 YEARS OF AGE.
Caution should be exercised when using TAVALOXX in patients:
prone to seizures, such as patients with pre-existing central nervous system lesions,
being treated with fenbufen or non-steroidal anti-inflammatory medicines,
using medicines which lower the cerebral seizure threshold, such as theophylline,
driving or operating machinery, as the use of TAVALOXX may alter the ability to drive or to operate machinery,
being tested for tuberculosis as TAVALOXX inhibit the growth of Mycobacterium tuberculosis and therefore may give false-negative results in the bacteriological diagnosis of tuberculosis,
exposed to ultraviolet light such as sunlight through window glass or longer wavelength ultraviolet (UVA) from sunbeds, in order to prevent photosensitisation.

INTERACTIONS:
The absorption of TAVALOXX is significantly reduced when administered with iron salts, antacids and sucralfate. It is therefore recommended that preparations containing iron salts, sucralfate, magnesium- or aluminium-containing antacids should not be taken 2 hours before or after TAVALOXX administration.
TAVALOXX is known to inhibit hepatic drug metabolism and may interfere with the clearance of medicines, such as theophylline, fenbufen or similar non-steroidal anti-inflammatory medicines that lower the seizure threshold.

PREGNANCY AND LACTATION:
The use of TAVALOXX during pregnancy and lactation is contra-indicated.

DOSAGE AND DIRECTIONS FOR USE:
TAVALOXX
tablets should be swallowed whole, and should not be crushed.
TAVALOXX tablets may be taken with or without food.
TAVALOXX is to be taken once or twice daily in a usual dose of 250 or 500 mg. The dosage will depend on the type of pathogen and the severity of the infection.
The use of TAVALOXX should be continued for a minimum of 48 to 72 hours after it has become evident that the bacterial infection has been eradicated. The duration of therapy varies according to the type of infection and the course it takes.
The following daily doses are recommended for TAVALOXX:
Daily dosage recommended in patients with normal renal function:
Bronchitis, bacterial exacerbations: 500 mg once daily for 5 –10 days.
Pneumonia, community-acquired: 500 mg once or twice daily for 10 –14 days (the higher dosage is indicated in the presence of complicating factors e.g. advanced age, comorbidity).
Sinusitis: 500 mg once daily for 10 to 14 days.
Urinary tract infections (complicated) and acute pyelonephritis: 250 mg once daily for 10 days.
Urinary tract infections (uncomplicated) in women: 250 mg once daily for 3 days.
Uncomplicated skin and soft tissue infections: 250 - 500 mg once daily for 7 - 10 days.
Complicated skin and soft tissue infections: 500 mg once daily for 10 -14 days.
Intra-abdominal infections: 500 mg once daily for 10 - 14 days in combination with an appropriate antibiotic with anaerobic coverage.

Above infections when bacteraemia or septicaemia is present: 500 mg twice daily for 10 - 14 days.

Daily dosage recommended in patients with impaired renal function:
Dosage must be adjusted in these patients according to the degree of renal impairment (creatinine clearance <50 mL/min):
Patients with a creatinine clearance between 20 and 50 mL/min:
Patients who normally require 250 or 500 mg once daily: A normal dose should be given initially and then reduced to half the required dose once daily.
Patients who normally require 500 mg twice daily: The initial dose should be 500 mg followed by 250 mg twelve hourly.

Patients with a creatinine clearance between 10 and 19 mL/min:
Patients who normally require 250 mg once daily: A normal 250 mg dose should be given initially followed by 125 mg every 48 hours.
Patients who normally require 500 mg once daily: A normal 500 mg dose initially followed by 125 mg every 24 hours.
Patients who normally require 500 mg twice daily: 500 mg initially followed by 125 mg every 12 hours.

Patients with a creatinine clearance of less than 10 mL/min or in patients on haemodialysis or CAPD (Continuous Ambulatory Peritoneal Dialysis):
In patients who normally require 250 mg once daily: A normal 250 mg dose should be given initially followed by 125 mg every 48 hours.
Patients who normally require 500 mg once daily: A normal 500 mg dose initially followed by 125 mg every 24 hours.
Patients who normally require 500 mg twice daily: 500 mg initially followed by 125 mg every 24 hours.

No dosage adjustment is required in the elderly or in patients with hepatic impairment.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
The following side-effects have been reported:
Immune system disorders:
The following side-effects have been reported and frequencies are unknown: Allergic manifestations may occur, particularly hypersensitivity reactions of the skin such as pruritus, rash, urticaria and vasculitis. Isolated cases of severe bullous eruptions, including Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome) and erythema multiforme exudativum, have been reported.
Blood and lymphatic system disorders:
The following side-effects have been reported and frequencies are unknown: Haemolytic anaemia, eosinophilia, leucopenia, neutropenia, thrombocytopenia, pancytopenia and agranulocytosis have been reported.
Endocrine disorders:
The following side-effects have been reported and frequencies are unknown: Hypoglycaemia may occur, especially in diabetics.
Nervous system disorders:
Less frequent: Headaches, dizziness, sleep disturbances, unsteady gait and numbness and tingling in the limbs (paraesthesiae), visual and auditory disturbances, disturbances of taste and smell.
The following side-effects have been reported and frequencies are unknown: Tremor (disturbances of muscular co-ordination), hallucinations, convulsions and psychotic reactions such as agitation, anxiety, confusion, depression and restlessness.
In the event of such side-effects, TAVALOXX must be discontinued immediately and the medical practitioner informed.
Gastrointestinal disorders:
Less Frequent: Gastrointestinal symptoms may occur (loss of appetite, nausea, vomiting, gastric or abdominal symptoms, diarrhoea). The onset of diarrhoea, particularly if severe, persistent and/or bloody, during or after treatment with TAVALOXX, may be an indication of pseudomembranous colitis. Should pseudomembranous colitis be suspected, treatment must be stopped immediately and appropriate specific antibiotic therapy instituted.
Hepatobiliary disorders:
The following side-effects have been reported and frequencies are unknown: Hepatitis and transient increases in liver enzymes and/or bilirubin and serum creatinine have been observed.
Renal and urinary disorders:
The following side-effects have been reported and frequencies are unknown: Interstitial nephritis and acute renal failure may also occur.
Skin and subcutaneous tissue disorders:
The following side-effects have been reported and frequencies are unknown: Photosensitivity reactions (skin reactions after exposure to strong sunlight or artificial UV rays) have been reported.
Musculoskeletal disorders:
The following side-effects have been reported and frequencies are unknown: Tendinitis (e.g. Achilles tendon) is observed with quinolones. If suspected, treatment with TAVALOXX must be stopped immediately and appropriate treatment (e.g. immobilisation) must be initiated for the affected tendon. Other musculoskeletal side-effects, including arthralgia, myalgia, tendon rupture (Achilles tendon) and muscular weakness (of special importance in patients with myasthenia gravis) have been observed. Isolated cases of rhabdomyolysis have been reported.
General disorders:
The following side-effects have been reported and frequencies are unknown: There have been adverse reactions such as fever, allergic pneumonitis, angioedema, hypotension and anaphylactic-like shock. In the event of such reactions, TAVALOXX should be discontinued immediately. Medical treatment (therapy for shock) is imperative.
Fungal overgrowth, proliferation of other resistant micro-organisms and asthenia may occur. TAVALOXX are known to possibly trigger attacks of porphyria in patients with porphyria.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Based on animal studies, the most important adverse reactions to expect following acute overdosage of TAVALOXX are central nervous system symptoms such as confusion, dizziness, impairment of consciousness and convulsive seizures.
The treatment of an overdosage is symptomatic and supportive.
TAVALOXX is not effectively removed by hemodialysis or peritoneal dialysis.

IDENTIFICATION:
TAVALOXX 250
: Brownish pink, film-coated oval, biconvex tablets, debossed ‘250’ on one side and plain on the other side.
TAVALOXX 500: Bright yellow, film-coated oval, biconvex tablets, debossed ‘500’on one side and plain on the other side.
TAVALOXX 750: White, film-coated oval, biconvex tablets, debossed ‘750’ on one side and plain on the other side.

PRESENTATION:
TAVALOXX 250
: A carton containing blister strips of 3, 5 or 10 tablets.
TAVALOXX 500: A carton containing blister strips of 5 or 10 tablets.
TAVALOXX 750: A carton containing blister strips of 5 or 10 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C. Protect from light.
Keep the blisters in the outer carton until required for use.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBERS:
TAVALOXX 250
: 41/20.1.1/0007
TAVALOXX 500: 41/20.1.1/0008
TAVALOXX 750: 41/20.1.1/0009

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATES OF REGISTRATION:
CIPLA MEDPRO (PTY) LTD
Rosen Heights Pasita Street,
Rosen Park,
Bellville 7530, RSA.

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
October 2007

© CIPLA MEDPRO (PTY) LTD
AL21 D

New addition to this site: November 2016
Source: Company website
http://www.cipla.co.za/wp-content/uploads/2013/10/sep_tavaloxx.pdf

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2016