DICLOXACILLIN VIATRIS 250 dicloxacillin (as sodium) 250 mg 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 capsules

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:

2017-07-20

Patient Information leaflet

DICLOXACILLIN MYLAN
_dicloxacillin sodium_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Dicloxacillin Mylan.
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 Dicloxacillin
Mylan 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 DICLOXACILLIN
MYLAN IS USED FOR
Dicloxacillin Mylan is used to treat
infections in different parts of the
body caused by bacteria.
Dicloxacillin Mylan is an antibiotic
that belongs to a group of medicines
called penicillins. These medicines
work by killing the bacteria that are
causing your infection.
Dicloxacillin Mylan will not work
against infections caused by viruses,
such as colds or flu.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY DICLOXACILLIN
MYLAN HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
Dicloxacillin Mylan for another
purpose.
Dicloxacillin Mylan is not
recommended for use in newborn
infants as its safety and effectiveness
have not been established in this age
group.
Dicloxacillin Mylan is available only
with a doctor's prescription.
There is no evidence that
Dicloxacillin Mylan is addictive.
BEFORE YOU TAKE
DICLOXACILLIN MYLAN
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE DICLOXACILLIN MYLAN 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 DI

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
DICLOXACILLIN MYLAN
_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
DICLOXACILLIN
MYLAN 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
DICLOXACILLIN
MYLAN 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