AL-Cefuroxime cefuroxime 250mg film coated tablet blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cefuroxime axetil, Quantity: 300.715 mg

Available from:

Pharmacor Pty Ltd

INN (International Name):

Cefuroxime axetil

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: crospovidone; croscarmellose sodium; calcium carbonate; calcium stearate; purified water; colloidal anhydrous silica; microcrystalline cellulose; sodium lauryl sulfate; titanium dioxide; hypromellose; propylene glycol; brilliant blue FCF aluminium lake

Administration route:

Oral

Units in package:

2, 10, 14, 20, 50, 6

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Cefuroxime is indicated for the treatment of the following mild to moderately severe infections in adults caused by sensitive bacteria: Acute upper respiratory infections: otitis media, sinusitis, tonsillitis and pharyngitis. Acute exacerbations of chronic bronchitis, or acute bronchitis. Skin and skin structure infections for example, furunculosis, pyoderma and impetigo. Acute uncomplicated gonococcal urethritis, and cervicitis due to non-penicillinase producing gonococci.

Product summary:

Visual Identification: Blue color capsule shaped biconvex film coated tablets with '204' debossed on one side and plain on the other side.; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2017-03-27

Patient Information leaflet

AL-Cefuroxime
1
Ver 03
AL-CEFUROXIME
_cefuroxime (as axetil) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you take AL-Cefuroxime
tablets.
This leaflet answers some
common
questions
about AL-
Cefuroxime
.
It
does
not contain
all of the available
information.
It does not take the place of
talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has
weighed the expected benefits of
you taking AL-Cefuroxime
against the risks this medicine
could have for you
.
IF YOU HAVE ANY CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT AL-CEFUROXIME
IS USED FOR
AL-Cefuroxime works by killing
bacteria (germs) that cause
infections such as infections of
the:
•
EAR, NOSE AND THROAT
•
LUNGS OR CHEST
•
URINARY TRACT
•
SKIN AND SOFT TISSUES
AL-Cefuroxime is also used to treat
sexually transmitted infections
(urethritis and cervictis)
AL-Cefuroxime
belongs
to
a
group
of
medicines
called
cephalosporin antibiotics.
AL-Cefuroxime is not addictive.
BEFORE YOU TAKE
AL-
CEFUROXIME TABLETS
_DO NOT TAKE IF_
You must not take AL-
Cefuroxime tablets if:
•
YOU HAVE EVER HAD AN
ALLERGIC REACTION TO
CEFUROXIME, PENICILLIN OR ANY
OF THE INGREDIENTS LISTED
TOWARD THE END OF THIS
LEAFLET. (SEE INGREDIENTS)
•
THE EXPIRY DATE (EXP)
PRINTED ON THE PACK HAS
PASSED.
•
THE PACKAGING IS TORN OR
SHOWS SIGNS OF TAMPERING.
_TELL YOUR DOCTOR IF: _
_ _
YOU MUST TELL YOUR DOCTOR IF:
•
YOU ARE ALLERGIC TO FOODS,
DYES, PRESERVATIVES OR ANY
OTHER MEDICINES.
•
YOU HAVE HAD TO STOP
TAKING ANOTHER MEDICINE
FOR YOUR INFECTION.
•
YOU TEST YOUR URINE FOR
SUGAR. AL-CEFUROXIME
TABLETS MAY INTERFERE WITH
SOME URINE TESTS.
•
YOU HAVE KIDNEY PROBLEMS.
•
YOU ARE PREGNANT, THINK
YOU MAY BE PREGNANT OR
ARE BREASTFEEDING.
•
YOU ARE TAKING ANY OTHER
MEDICINES, INCLUDING
MEDICINES YOU BUY WITHOUT A
PRESCRIPTION.
•
YOU NEED A BLOOD TEST. AL-
CEFUROXIME CAN AFFECT THE
RESULTS OF A TES

Summary of Product characteristics

AL-CEFUROXIME
Ver 03
1
AUSTRALIAN PRODUCT INFORMATION -
AL-CEFUROXIME (CEFUROXIME (AS AXETIL))
1.
NAME OF THE MEDICINE
Cefuroxime Axetil
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
AL-CEFUROXIME is available in 2 strengths for oral administration
containing 250 mg and
500 mg cefuroxime axetil.
AL-CEFUROXIME 250 mg: Each film coated tablet contains 250 mg
cefuroxime (as
cefuroxime axetil)
AL-CEFUROXIME 500 mg: Each film coated tablet contains 500 mg
cefuroxime (as
cefuroxime axetil)
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Film coated tablets
AL-CEFUROXIME 250 mg:
Blue color capsule shaped biconvex film coated tablets with '204'
debossed on one side and
plain on the other side.
AL-CEFUROXIME 500 mg:
Blue color capsule shaped biconvex film coated tablets with '203'
debossed on one side and
plain on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Cefuroxime is indicated for the treatment of the following mild to
moderately severe
infections in adults caused by sensitive bacteria:
Acute upper respiratory infections: otitis media, sinusitis,
tonsillitis and pharyngitis.
Acute exacerbations of chronic bronchitis, or acute bronchitis.
Skin and skin structure infections for example, furunculosis, pyoderma
and impetigo.
Acute
uncomplicated
gonococcal
urethritis,
and
cervicitis
due
to
non-penicillinase
producing gonococci.
AL-CEFUROXIME
Ver 03
2
4.2. DOSE AND METHOD OF ADMINISTRATION
DOSAGE
The usual course of therapy with AL-CEFUROXIME tablets is 5 to 7 days
for treatment of
bronchitis, and 7 to 10 days for other infections.
_Adults _
Acute exacerbations of
Chronic bronchitis - 250 mg to 500 mg twice daily
Acute bronchitis - 250 mg to 500 mg twice daily
Uncomplicated gonococcal
urethritis or cervicitis - single dose of 1 g
Other infections - 250 mg twice daily
METHOD OF ADMINISTRATION
Tablets for oral administration.
Cefuroxime axetil should be taken after a light meal for optimum
absorption.
DOSAGE ADJUSTMENT
_Renal Impairment _
Cefuroxime is primaril