CEFACLOR SUN cefaclor 125mg/5mL (as monohydrate) powder for oral liquid bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

cefaclor monohydrate, Quantity: 26.23 mg/mL (Equivalent: cefaclor, Qty 25 mg/mL)

Available from:

Sun Pharma ANZ Pty Ltd

INN (International Name):

cefaclor monohydrate

Pharmaceutical form:

Oral Liquid, powder for

Composition:

Excipient Ingredients: citric acid; xanthan gum; sucrose; sodium citrate dihydrate; colloidal anhydrous silica; sodium benzoate; allura red AC; Flavour; potable water; simethicone; cetostearyl alcohol

Administration route:

Oral

Units in package:

100mL (Reconstituted)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Infections due to susceptible microorganisms. Lower respiratory infections, including pneumonia, bronchitis and exacerbations of chronic bronchitis. Upper respiratory tract infections, including pharyngitis and tonsillitis and otitis media. Skin and skin structure infections. Urinary tract infections, including pyelonephritis and cystitis. Note: Penicillin is the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefaclor appears to be as effective as phenoxymethylpenicillin in the eradication of Streptococci from the nasopharynx; however, substantial data establishing the efficacy of cefaclor in the subsequent prevention of rheumatic fever are not available at present. Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefaclor.

Product summary:

Visual Identification: White to off-white granular powder forming a red suspension on reconstitution with water.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 21 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2014-09-02

Patient Information leaflet

CEFACLOR SUN
1
CEFACLOR SUN
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING CEFACLOR SUN?
CEFACLOR SUN contains the active ingredient cefaclor monohydrate.
CEFACLOR SUN is used to treat infections caused by
bacteria in different parts of the body. For more information, see
Section 1. Why am I using CEFACLOR SUN? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE CEFACLOR SUN?
Do not use if you have ever had an allergic reaction to CEFACLOR SUN
or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
CEFACLOR SUN? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with CEFACLOR SUN and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE CEFACLOR SUN?
•
Your doctor will tell you how much CEFACLOR SUN you need to take.
•
This will depend on the type of infection you have.
More instructions can be found in Section 4. How do I use CEFACLOR
SUN? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING CEFACLOR SUN?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
CEFACLOR SUN.
•
Tell your doctor if the symptoms of your infection do not improve
within a few days, or if they become
worse.
•
If you become pregnant while you are taking CEFACLOR SUN, tell your
doctor immediately.
THINGS YOU
SHOULD NOT DO
•
Do not give CEFACLOR SUN to anyone else, even if they have the same
condition as you.
•
Do not use CEFACLOR SUN to treat any other complaints unless your
doctor tells you to.
•
Do not stop taking your medicine or change the dosage without checking
with your doctor.
DRIVING OR USING
MACHINES
•

Summary of Product characteristics

Product Information – Australia
Cefaclor SUN Suspension V1
Page 1
CEFACLOR SUN SUSPENSION
NAME OF THE MEDICINE
Cefaclor monohydrate
Chemical name:
3-chloro-7-D-(2-phenylglycinamido)-3-cephem-4-carboxylic acid
monohydrate.
Structural formula:
Molecular formula:
C
15
H
14
CIN
3
O
4
S.H
2
O.
Molecular Weight:
385.8
CAS Registry number:
70356-03-5.
DESCRIPTION
Cefaclor monohydrate is a white to off-white crystalline powder,
slightly soluble in water, but is insoluble in
alcohol and chloroform.
Each bottle contains cefaclor monohydrate as the active ingredient. In
addition, each bottle contains
the following inactive ingredients: xanthan gum, sodium benzoate,
sucrose, colloidal anhydrous silica,
allura red AC, strawberry flavouring (PI), sodium citrate, anhydrous
citric acid and simethicone
emulsion (PI).
PHARMACOLOGY
Cefaclor is a semisynthetic, broad spectrum cephalosporin antibiotic
for oral administration.
PHARMACOKINETICS
Cefaclor is well absorbed after oral administration, whether taken
with food or while fasting. However,
when it is taken with food, the peak concentration achieved is 50 to
75% of that observed when the drug
is administered to fasting subjects and generally appears from 45 to
60 minutes later. The presence of
food in the gastrointestinal tract does not alter the total amount of
cefaclor absorbed. Following
administration of 250 mg, 500 mg and 1 g doses to fasting subjects,
average peak plasma levels of
antibacterial activity (expressed as µg/mL of cefaclor) of 7, 13 and
23 µg/mL, respectively, were obtained
at 30 to 60 minutes. The reduced peak serum levels resulting from the
administration of cefaclor with food
should be considered with reference to the sensitivity of the
infecting organism, severity of illness, the
dose being administered and the variability in the peak plasma levels
which occur with cefaclor.
The plasma half-life in healthy subjects is independent of dosage form
and averages 40 to 60 minutes. In
elderly subjects (>65 years) with normal serum creatinine values, a
higher pe