ZINNAT Cefuroxime 250mg tablet

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cefuroxime axetil, Quantity: 300.72 mg (Equivalent: cefuroxime, Qty 250 mg)

Available from:

Aspen Pharmacare Australia Pty Ltd

Pharmaceutical form:

Tablet, film coated

Composition:

Excipient Ingredients: propylene glycol; microcrystalline cellulose; croscarmellose sodium; hydrogenated vegetable oil; hypromellose; methyl hydroxybenzoate; colloidal anhydrous silica; propyl hydroxybenzoate; sodium lauryl sulfate; titanium dioxide; purified water; sodium benzoate; industrial methylated spirit

Administration route:

Oral

Units in package:

2,10,14, 20, 50 tablets

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: White to off-white, film coated, capsule shaped, biconvex tablets engraved 'GXES7' on one side and blank on the other.; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Registered

Authorization date:

1994-02-24

Patient Information leaflet

ZINNAT® TABLETS-11nov19
1
ZINNAT TABLETS
_cefuroxime axetil _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you take ZINNAT tablets.
This leaflet answers some common
questions about ZINNAT. 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
ZINNAT 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 ZINNAT IS USED
FOR
ZINNAT 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
ZINNAT is also used to treat
sexually transmitted infections
(urethritis and cervictis)
ZINNAT belongs to a group of
medicines called cephalosporin
antibiotics.
ZINNAT is not addictive.
BEFORE YOU TAKE
ZINNAT TABLETS
_DO NOT TAKE IF _
You must not take ZINNAT 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.
ZINNAT 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. ZINNAT
CAN AFFECT THE RESULTS OF A TEST
FOR BLOOD SUGAR LEVELS, OR A
BLOOD SCREEN CALLED THE COOMBS
TEST.
•
YOU ARE TAKING THE
CO

Summary of Product characteristics

zinnat-tabs-pi-11nov19
AUSTRALIAN PRODUCT INFORMATION
ZINNAT (CEFUROXIME AXETIL) TABLETS
1
NAME OF THE MEDICINE
Cefuroxime axetil
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zinnat Tablets 125 mg: Each tablet contains cefuroxime (as axetil) 125
mg
Zinnat Tablets 250 mg: Each tablet contains cefuroxime (as axetil) 250
mg
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Zinnat 125 mg and 250 mg tablets are present in blister and strip
packs.
Zinnat Tablets 125 mg: White, film coated, capsule shaped, biconvex
tablets engraved "GXES5"
on one face and blank on the other.
Zinnat Tablets 250 mg: White, film coated, capsule shaped, biconvex
tablets engraved "GXES7"
on one face and blank on the other.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC 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.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The usual course of therapy with Zinnat tablets is 5 to 7 days for
treatment of bronchitis, and 7 to
10 days for other infections.
Cefuroxime axetil should be taken after a light meal for optimum
absorption.
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
zinnat-tabs-pi-11nov19
RENAL IMPAIRMENT
Cefuroxime is primarily excreted by the kidneys. In patients with
markedly impaired renal
function it is recommended that the dosage of cefuroxime be reduced to
compensate for its slower
excretion.
4.3
C
ONTRAINDICATIONS
Patients with known hypersen