TAVANIC 750 TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Ranbaxy (SA) (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS LEVOFLOXACIN 750,0 mg

Authorization status:

Registered

Authorization date:

2013-10-10

Patient Information leaflet

_ _
Page 1 of 6
APPROVED PATIENT INFORMATION LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING TAVANIC 750.

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor or your
pharmacist.

TAVANIC 750 has been prescribed for you personally and you should not
share your
medicine with other people. It may harm them, even if their symptoms
are the same as yours.
SCHEDULING STATUS: S4
NAME OF THE MEDICINAL PRODUCT:
TAVANIC 750 (Tablet)
WHAT TAVANIC 750 CONTAINS:
Each tablet contains the active substance, levofloxacin hemihydrate
equivalent to 750 mg
levofloxacin. Each tablet also contains crospovidone, hypromellose,
macrogol 8 000,
microcrystalline cellulose, red ferric oxide, sodium stearyl fumarate,
talc, titanium dioxide and
yellow ferric oxide.
WHAT TAVANIC 750 IS USED FOR:
TAVANIC 750 belongs to the class of antibiotics known
as fluoroquinolone. It is used to treat bacterial infections. It works
by killing bacteria or
preventing their growth. Some infections for which TAVANIC 750 can be
used to treat are: mild
infections of the sinuses, mild chest infections in patients with
chronic bronchitis and mild
pneumonia.
BEFORE YOU USE TAVANIC 750:
_ _
Page 2 of 6
DO NOT TAKE TAVANIC 750:

If you are allergic to TAVANIC 750 or any other quinolone antibiotic
or any excipient
listed under ‘WHAT TAVANIC 750 CONTAINS’.

If you suffer from epilepsy (fits or convulsions).

If you have ever had tendon problems such as pain, inflammation or
rupture of a tendon
with treatment with an antibiotic of the fluoroquinolone class.

If you are pregnant or breastfeeding.

If you are under 18 years of age.
TAKE SPECIAL CARE WITH TAVANIC 750:

The risk of getting convulsions or fits may be increased if in the
past you have
experienced brain damage (such as stroke or severe brain injury) and
are now treated with
TAVANIC 750.

TAVANIC 750 must be stopped immediately, if you experience severe,
persistent, bloody
diarrhoea and your healthcare profes

Summary of Product characteristics

Page 1 of 14
APPROVED PACKAGE INSERT
PROPRIETARY NAME AND DOSAGE FORM
TAVANIC 750 (Tablets)
SCHEDULING STATUS: S4
COMPOSITION:
Each tablet contains levofloxacin hemihydrate equivalent to 750 mg
levofloxacin.
Each tablet also contains crospovidone, hypromellose, macrogol 8 000,
microcrystalline
cellulose, red ferric oxide, sodium stearyl fumarate, talc, titanium
dioxide and yellow ferric
oxide.
PHARMACOLOGICAL CLASSIFICATION:
A 20.1.1 Broad and Medium Spectrum Antibiotics
PHARMACOLOGICAL ACTION:
PHARMACODYNAMIC PROPERTIES
Levofloxacin is a synthetic broad spectrum antibacterial
fluoroquinolone, which is the S (-)
enantiomer
(levorotatory
form)
of
the
racemic
ofloxacin
for
oral
and
intravenous
administration. Levofloxacin acts on the DNA-DNA-gyrase complex by
inhibiting DNA-gyrase
(bacterial topoisomerase II), an enzyme required for DNA replication,
transcription, repair
and
recombination,
and
topoisomerase
IV.
Levofloxacin
is
bactericidal
_in _
_vitro_.
Its
antibacterial spectrum covers many Gram-positive and Gram-negative
bacteria.
Infections
caused
by
the
following
organisms
have
been
successfully
treated
with
levofloxacin 750 mg in clinical trials:
Gram-positive organisms:
Methicillin-sensitive _Staphylococcus aureus, Streptococcus
pneumoniae._
Page 2 of 14
Gram-negative organisms:
_Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella
catarrhalis. _
Other organisms:
_Chlamydia pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae.
_
_In vitro_ there is cross-resistance between levofloxacin and other
fluoroquinolones.
Due to the mechanism of action, there is generally no cross-resistance
between levofloxacin
and other classes of antibacterial agents.
PHARMACOKINETIC PROPERTIES
Food has little effect on the absorption of levofloxacin and the
tablets may be taken during or
between meals. The absorption of levofloxacin is significantly reduced
when administered
with iron salts, antacids and sucralfate.
ABSORPTION:
The absolute bioavailability is approximately 99 %.
Orally administered levofloxacin is r