Auroxetil 125 (Cefuroxime Axetil Tablets 125 mg)

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

CEFUROXIME AXETIL

Boleh didapati daripada:

HEALOL PHARMACEUTICALS SDN. BHD.

INN (Nama Antarabangsa):

CEFUROXIME AXETIL

Unit dalam pakej:

50tablet Tablets

Dikeluarkan oleh:

Aurobindo Pharma Limited (Unit VI)

Risalah maklumat

AUROXETIL
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
Cefuroxime axetil (125mg, 250mg, 500mg)
1
WHAT IS IN THIS LEAFLET
1.
What Auroxetil is used for
2.
How Auroxetil works
3.
Before you use Auroxetil
4.
How to use Auroxetil
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Auroxetil
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT IS AUROXETIL USED FOR
Your doctor may have prescribed
Auroxetil tablets to treat one of the
following infections:
•
Upper respiratory tract
infections (including
infections occurring in the
ears, sinuses, tonsils and
throat)
•
Lower respiratory tract
infections, inflammation to
the lungs (pneumonia),
inflammation of the lung air
passages (acute bronchitis)
and acute exacerbations of
chronic bronchitis
•
Bladder infections
•
Skin infections recurring
boils, ulcers, contagious
infection of the skin
(impetigo)
•
Sexually transmitted
infections such as
Gonorrhoea, Gonococcal
urethritis and inflammation
of the cervix (cervicitis)
HOW AUROXETIL WORKS
Auroxetil is an antibiotic and belongs
to a class of medicines called
‘cephalosporins’. It is active against
a wide range of bacteria. It is used to
treat certain types of infections and
works by killing certain types of
bacteria.
BEFORE YOU USE AUROXETIL
_-When you must not use it _
If you are hypersensitive (allergic) to
cephalosporin class of antibiotics or
any of the other ingredients of
Auroxetil.
Tell your doctor if you are not sure
about any of the above: your doctor
will be able to advise you.
_-Before you start to use it _
Tell your doctor before you start to
take this medicine if:
•
You have previously
suffered from an allergic
reaction to penicillins or
other beta-lactam antibiotics
•
You suffer from any other
condition which causes
vomiting, diarrhoea as this
could stop your medicine
from being absorbed
properly. In this case your
doctor may recommend an
injection of cefuroxime
If after starting treatment, you begin
to experience symptoms of an

Ciri produk

URINARY TRACT INFECTIONS: 125 mg twice daily.
ACUTE EXACERBATIONS OF CHRONIC BRONCHITIS: Cefuroxime Sodium 750 mg
2-3 times a
day (IV or IM) for 48-72 hrs, followed by Cefuroxime Axetil 500 mg
twice a day oral therapy
for 5-10 days.
Sequential Therapy: PNEUMONIA: Cefuroxime Sodium 1.5 g 2-3 times a day
(IV or IM) for
48-72 hrs followed by Cefuroxime Axetil (Cefuroxime axetil) 500 mg
twice a day oral
therapy for 7-10 days.
PYELONEPHRITIS: 250 mg twice daily.
UNCOMPLICATED GONORRHOEA: Single dose of 1 g.
_ADULTS: _MOST INFECTIONS: 250 mg twice daily.
MILD TO MODERATE LOWER TRACT INFECTIONS EG, BRONCHITIS: 250 mg twice
daily.
MORE SEVERE LOWER TRACT INFECTIONS (OR IF PNEUMONIA IS SUSPECTED): 500
mg twice
daily.
WARNING AND PRECAUTIONS
Hypersensitivity to cephalosporins.
CONTRAINDICATIONS
Should be taken with food (Take immediately after food).
Serious and occasionally fatal hypersensitivity reactions (including
anaphylactoid and
severe cutaneous adverse reactions) have been reported in patients
receiving therapy
with β
–
lactams. Before initiating therapy with cefuroxime axetil, careful
inquiry should be
Special care is indicated in patients who have experienced an allergic
reaction to
penicillins or other β-lactams.
Peak serum levels (2-3 mg/L for a 125-mg dose, 4-6 mg/L for a 250-mg
dose, 5-8 mg/L for
a 500-mg dose and 9-14 mg/L for a 1-g dose) occur approximately 2-3
hrs after dosing
when taken after food, unlike IV dosing which peaks immediately.
Optimum absorption occurs when it is administered after a meal.
TOXICOLOGY: Preclinical Safety Data: Animal toxicity studies indicated
that Cefuroxime
axetil is of low toxicity with no significant findings.
Following administration of Cefuroxime axetil tablets, peak serum
levels (2.9 mg/L for a
125-mg dose, 4.4 mg/L for a 250-mg dose, 7.7 mg/L for a 500-mg dose
and 13.6 mg/L for a
1-g dose) occur approximately 2.4 hrs after dosing when taken with
food.
Serum levels of Cefuroxime are reduced by dialysis.
tract and rapidly hydrolysed in the intestinal mucosa and blood