CURAM DUO 400/57 amoxicillin 400 mg/5mL (as trihydrate) / clavulanic acid 57 mg/5mL (as potassium clavulanate) powder for suspension bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

potassium clavulanate, Quantity: 13.58 mg/mL (Equivalent: clavulanic acid, Qty 11.4 mg/mL); amoxicillin trihydrate, Quantity: 91.84 mg/mL (Equivalent: amoxicillin, Qty 80 mg/mL)

Available from:

Sandoz Pty Ltd

INN (International Name):

amoxicillin trihydrate,potassium clavulanate

Pharmaceutical form:

Suspension, powder for

Composition:

Excipient Ingredients: citric acid; Guar Gum; sodium citrate; purified talc; aspartame; silicon dioxide; Flavour

Administration route:

Oral

Units in package:

120 mL bottles, 150 mL bottles, 60 mL bottles

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Short-term treatment of the following bacterial infections when caused by sensitive organisms: skin and skin structure infections; urinary tract infections (complicated and uncomplicated); upper respiratory tract infections including sinusitis and otitis media; lower respiratory tract infections including acute exacerbations of chronic bronchitis and community acquired pneumonia. Appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to CURAM DUO 400/57. However, when there is reason to believe an infection may involve any of the beta-lactamase producing organisms listed in Microbiology, therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies. Once these results are known, therapy should be adjusted if appropriate. The treatment of mixed infections caused by amoxycillin susceptible organisms and beta-lactamase producing organisms susceptible to CURAM DUO 400/57 should not require the addition of another antibiotic due to the amoxycillin content of CURAM DUO 400/57.

Product summary:

Visual Identification: Off-white powder; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2009-03-06

Patient Information leaflet

CURAM
®
DUO 400/57
1
CURAM
® DUO 400/57
_amoxicillin (as trihydrate) and clavulanic acid (as potassium
clavulanate) 400 mg+57 mg/5 mL powder _
_for oral suspension _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Curam Duo 400/57.
It does not contain all 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 risks of your child taking this
medicine against the benefits they
expect it will have.
IF YOU HAVE ANY CONCERNS ABOUT
YOUR CHILD TAKING THIS MEDICINE,
ASK YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT CURAM DUO
400/57 IS USED FOR
This medicine is used to treat a wide
range of infections caused by
bacteria. These infections may affect:
•
the chest (bronchitis or
pneumonia)
•
the bladder (cystitis)
•
the sinuses (sinusitis)
•
the ears (otitis media)
•
or the skin.
It works by killing the bacteria that
cause these infections.
This medicine contains the active
ingredients amoxicillin (as
trihydrate) and clavulanic acid (as
potassium clavulanate). Amoxicillin
belongs to the penicillin group of
antibiotics. Clavulanic acid is used to
increase the effectiveness of
amoxicillin against certain types of
bacteria.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOUR CHILD.
Your doctor may have prescribed it
for another reason.
There is no evidence that this
medicine is addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU GIVE
CURAM DUO 400/57
_WHEN YOU MUST NOT GIVE IT _
DO NOT GIVE THIS MEDICINE IF YOUR
CHILD HAS AN ALLERGY TO:
•
amoxicillin trihydrate or
potassium clavulanate, the active
ingredients, or to any of the other
ingredients listed at the end of
this leaflet under Product
description
•
any other similar medicines (such
as penicillins, cephalosporins,
carbapenems, monobactams or
any other types of anti

Summary of Product characteristics

220930-Curam Duo-pi
Page 1 of 17
AUSTRALIAN PRODUCT INFORMATION
CURAM DUO 400/57 (AMOXICILLIN TRIHYDRATE/ POTASSIUM
CLAVULANATE) POWDER FOR SUSPENSION
1.
NAME OF THE MEDICINE
Amoxicillin Trihydrate and Potassium Clavulanate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Curam Duo 400/57 contains amoxicillin 400 mg/5 mL (as trihydrate) and
clavulanic acid
57 mg/5 mL (as potassium clavulanate).
_Excipients with known effect: _
When reconstituted as directed, Curam Duo 400/57 contains aspartame
8.5 mg/5 mL.
Each 5 mL of suspension contains 0.29 mmol of potassium. Also contains
sulfites.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Powder for Suspension: off-white powder and off-white suspension.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Curam Duo 400/57 (amoxicillin and clavulanic acid) is indicated for
the short-term treatment
of the following bacterial infections when caused by sensitive
organisms (see Section 5.1
Pharmacodynamic properties – Microbiology):

skin and skin structure infections;

urinary tract infections (complicated and uncomplicated);

upper respiratory tract infections including sinusitis and otitis
media;

lower respiratory tract infections including acute exacerbations of
chronic bronchitis
and community acquired pneumonia.
Appropriate culture and susceptibility studies should be performed to
identify the causative
organism(s) and determine its (their) susceptibility to Curam Duo
400/57
_ _
(amoxicillin and
clavulanic acid). However, when there is reason to believe an
infection may involve any of the
beta-lactamase producing organisms listed in Microbiology, therapy may
be instituted prior to
obtaining the results from bacteriological and susceptibility studies.
Once these results are
known, therapy should be adjusted if appropriate.
The treatment of mixed infections caused by amoxicillin susceptible
organisms and beta-
lactamase producing organisms susceptible to Curam Duo 400/57
_ _
(amoxicillin and clavulanic
acid) should