DISTAPH 250 dicloxacillin 250mg (as sodium) capsule bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

dicloxacillin sodium, Quantity: 271.2 mg (Equivalent: dicloxacillin, Qty 250 mg)

Available from:

Alphapharm Pty Ltd

INN (International Name):

Dicloxacillin sodium

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: Gelatin; purified water; titanium dioxide; colloidal anhydrous silica; magnesium stearate; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide

Administration route:

Oral

Units in package:

24 capsules, 30 capsule

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of confirmed or suspected staphylococcal and other Gram positive coccal infections, including skin and skin structure and wound infections, infected burns, cellulitis, osteomyelitis and pneumonia (note: benzylpenicillin is the drug of choice for the treatment of streptococcal pneumonia).,Bacteriological studies should be performed to determine the causative organisms and their susceptibility to dicloxacillin. Dicloxacillin has less intrinsic antibacterial activity and a narrower spectrum than benzylpenicillin. Dicloxacillin should therefore not be used in infections due to organisms susceptible to benzylpenicillin.,Important Note: When it is judged necessary that treatment is initiated before definitive culture and sensitivity results are known, if the microbiology report later indicates that the infection is due to an organism other than a benzylpenicillin resistant staphylococcus sensitive to dicloxacillin, the physician is advised to continue therapy with a drug other than dicloxacillin or any other penicillinase-resistant penicillin

Product summary:

Visual Identification: size 2 capsule with white opaque body and cap, printed "DX" on the cap and "250" on the body in black.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2014-10-28

Patient Information leaflet

DISTAPH
_dicloxacillin sodium_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Distaph.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Distaph against
the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT DISTAPH IS USED
FOR
Distaph is used to treat infections in
different parts of the body caused by
bacteria.
Distaph is an antibiotic that belongs
to a group of medicines called
penicillins. These medicines work by
killing the bacteria that are causing
your infection.
Distaph will not work against
infections caused by viruses, such as
colds or flu.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY DISTAPH HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
Distaph for another purpose.
Distaph is not recommended for use
in newborn infants as its safety and
effectiveness have not been
established in this age group.
Distaph is available only with a
doctor's prescription.
There is no evidence that Distaph is
addictive.
BEFORE YOU TAKE
DISTAPH
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE DISTAPH IF YOU HAVE
HAD AN ALLERGIC REACTION TO:
•
medicines containing
dicloxacillin or any other
penicillin e.g. amoxicillin
•
cephalosporin antibiotics
•
any of the ingredients listed at the
end of this leaflet
Some of the symptoms of an allergic
reaction may include skin rash,
itching or hives, swelling of the face,
lips, mouth, throat or other parts of
the body, shortness of breath,
wheezing or troubled breathing.
CHECK WITH YOUR DOCTOR OR
PHARMACIST IF YOU ARE NOT SURE
ABOUT ANY OF THE ABOVE.
DO NOT TAKE DISTAPH IF THE EXPIRY
DATE (EXP.) PRINTED ON THE BOTTLE
HAS PASSED
If you take this medicine after the
expiry date, it may not work as well.
DO NOT TAKE DISTAPH IF THE
PA

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
DISTAPH
_Dicloxacillin sodium capsules _
1
NAME OF THE MEDICINE
Dicloxacillin (as dicloxacillin sodium)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains dicloxacillin sodium equivalent to 250 mg or 500
mg dicloxacillin as the active
ingredient.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
DISTAPH 250
:
Dicloxacillin 250 mg capsule: Size 2 capsule with white opaque body
and cap,
marked ‘DX’ on the cap and ‘250’ on the body in black
DISTAPH 500
:
Dicloxacillin 500 mg capsule: Size 0 capsule with white opaque body
and cap,
marked ‘DX’ on the cap and ‘500’ on the body in black
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of confirmed or suspected staphylococcal and other Gram
positive coccal infections, including skin
and skin structure and wound infections, infected burns, cellulitis,
osteomyelitis and pneumonia (note:
benzylpenicillin is the drug of choice for the treatment of
streptococcal pneumonia).
Bacteriological studies should be performed to determine the causative
organisms and their susceptibility to
dicloxacillin.
Dicloxacillin
has
less
intrinsic
antibacterial
activity
and
a
narrower
spectrum
than
benzylpenicillin.
Dicloxacillin should therefore not be used in infections due to
organisms susceptible to benzylpenicillin.
_Important Note: _
When it is judged necessary that treatment is initiated before
definitive culture and sensitivity
results are known, if the microbiology report later indicates that the
infection is due to an organism other than
a benzylpenicillin resistant staphylococcus sensitive to
dicloxacillin, the physician is advised to continue
therapy with a drug other than dicloxacillin or any other
penicillinase-resistant penicillin.
4.2
DOSE AND METHOD OF ADMINISTRATION
Microbiological studies to determine the causative organism and their
susceptibility to the penicillinase
resistant penicillins should be performed. The duration of treatment
varies with the type and se