Xorimax 250mg coated tablets

Χώρα: Σιγκαπούρη

Γλώσσα: Αγγλικά

Πηγή: HSA (Health Sciences Authority)

Δραστική ουσία:

CEFUROXIME AXETIL 300.72 mg EQV CEFUROXIME

Διαθέσιμο από:

SANDOZ SINGAPORE PTE. LTD.

Φαρμακολογική κατηγορία (ATC):

J01DC02

Δοσολογία:

250 mg

Φαρμακοτεχνική μορφή:

TABLET, COATED

Σύνθεση:

CEFUROXIME AXETIL 300.72 mg EQV CEFUROXIME 250 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

Prescription Only

Κατασκευάζεται από:

Sandoz Private Limited (Intermediate)

Καθεστώς αδειοδότησης:

ACTIVE

Ημερομηνία της άδειας:

2007-06-01

Αρχείο Π.Χ.Π.

Page 1 of 8
XORIMAX
® 250MG coated tablets
1
NAME OF THE MEDICINAL PRODUCT
Xorimax 250mg coated tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains cefuroxime axetil equivalent to 250 mg
cefuroxime.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Coated tablet.
White to slightly yellowish oblong, biconvex film coated tablet. Score
on both sides.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Xorimax is an oral prodrug of the bactericidal cephalosporin
antibiotic cefuroxime, which
is resistant to most β (beta)-lactamases and is active against a wide
range of Gram-
positive and Gram-negative organisms.
It is indicated for the treatment of infections caused by susceptible
bacteria.
Susceptibility to Xorimax will vary with geography and time, and it
should be used in
accordance with local official antibiotic prescribing guidelines and
local susceptibility
data (see section 5.1).
INDICATIONS INCLUDE:
- Upper respiratory tract infections for example, ear, nose, and
throat infections, such as
otitis media, sinusitis, tonsillitis, and pharyngitis
- Lower respiratory tract infections for example, pneumonia and acute
exacerbations of
chronic bronchitis
- Skin and soft tissue infections for example, furunculosis, pyoderma
and impetigo
- Genito-urinary tract infections for example, pyelonephritis,
cystitis, and urethritis
- Gonorrhoea, acute uncomplicated gonococcal urethritis, and
cervicitis
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The usual course of therapy is seven days (range 5 - 10 days). The
dosage and route of
administration are suited to the severity of the infection, the
sensitivity of the pathogen,
and the condition of the patient.
DOSAGE IN ADULTS:
INDICATION
DOSAGE
Most infections
250 mg twice daily
Urinary tract infections
250 mg twice daily
Page 2 of 8
Mild to moderate lower respiratory tract infections
250 mg twice daily
More severe lower respiratory tract infections, or if pneumonia
is suspected
500 mg twice daily
Pyelonephritis
250 mg twice daily
Unc