DICLOXSIG dicloxacillin (as sodium) 250mg capsule bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

dicloxacillin sodium, Quantity: 271.26 mg (Equivalent: dicloxacillin, Qty 250 mg)

Available from:

Aspen Pharmacare Australia Pty Ltd

INN (International Name):

Dicloxacillin sodium

Pharmaceutical form:

Capsule

Composition:

Excipient Ingredients: silicon dioxide; magnesium stearate; Gelatin; titanium dioxide

Administration route:

Oral

Units in package:

24 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Dicloxsig is indicated in the 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. Dicloxsig should not be used in infections due to organisms susceptible to benzylpenicillin. Important Note: When it is judged necessary that the treatment be initiated before definitive culture and sensitivity results are known, if the microbiology report later indicates 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 1 hard gelatin capsule with white body and cap.; Container Type: Bottle; Container Material: Glass Type I Coloured; Container Life Time: 1 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2009-09-07

Patient Information leaflet

DICLOXSIG- Consumer Medicine Information
Page 1 of 4
DICLOXSIG
_ _
_dicloxacillin sodium _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about DICLOXSIG. It
does not contain all the available
information. It does not take place
of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of using DICLOXSIG
against the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read it again.
WHAT DICLOXSIG IS USED
FOR
The name of your medicine is
DICLOXSIG. It contains the active
ingredient dicloxacillin sodium._. _
DICLOXSIG is a type of antibiotic
that belongs to the group of
medicines called penicillins.
DICLOXSIG Dicloxacillin sodium
is a type of penicillin._ _
It is used to treat infections in
different parts of the body caused by
bacteria.
It works by killing the bacteria that
are causing the infection.
These infections may affect the skin
and skin structure, bones
(osteomyelitis), the joints, or the
chest (pneumonia). DICLOXSIG is
also used to treat surgical infections
and infected burns.
DICLOXSIG will not work against
infections caused by viruses such as
colds or the flu.
Your doctor may have prescribed
this medicine for another purpose.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT
WHY DICLOXSIG HAS BEEN
PRESCRIBED FOR YOU.
A doctor's prescription is required
for DICLOXSIG.
BEFORE YOU TAKE IT
_ _
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE DICLOXSIG IF YOU
HAVE EVER HAD AN ALLERGIC REACTION
TO:

DICLOXSIG OR ANY OTHER
PENICILLIN.

ANY OF THE OTHER INGREDIENTS
LISTED AT THE END OF THIS LEAFLET.

CEPHALOSPORINS
There is an increased chance of
being allergic to DICLOXSIG if
you are or have been allergic to
cephalosporins.
Some symptoms of an allergic
reaction may include urticaria, skin
rash and itching.
TELL YOUR DOCTOR IF YOU HAVE
SUFFERED FROM ANY OF TH

Summary of Product characteristics

DICLOXSIG- Product Information
Page 1 of 8
PRODUCT INFORMATION
DICLOXSIG
NAME OF MEDICINE
DICLOXSIG 250 MG CAPSULES: each capsule contains dicloxacillin sodium
equivalent
to 250 mg of dicloxacillin.
DICLOXSIG 500 MG CAPSULES: each capsule contains dicloxacillin sodium
equivalent
to 500 mg of dicloxacillin.
The structural formula of dicloxacillin sodium_ (CAS - 13412-64-1)
_is:
Molecular formula C
19
H
16
Cl
2
N
3
NaO
5
S.H
2
O and molecular weight = 510.3
SOLUBILITY: Freely soluble in water, soluble in alcohol and in
methanol. Slightly soluble in
acetone and the usual organic solvents.
DESCRIPTION
DICLOXSIG 250 mg and DICLOXSIG 500 mg capsules are hard gelatin
capsules containing
the
penicillinase-resistant,
acid-resistant,
semisynthetic
antibiotic
dicloxacillin
sodium
equivalent to 250 mg and 500 mg of dicloxacillin respectively.
DICLOXSIG 250 mg capsules are opaque white capsule (top and body) with
no printed
inscription.
DICLOXSIG 500 mg capsules are an opaque white body with light green
top, with no printed
inscription.
Dicloxacillin sodium is a white or almost white, crystalline powder;
it is hygroscopic.
Chemically
dicloxacillin
sodium
is
sodium
(2_S_,5_R_,6_R_)-6-[[[3-(2,6-dichlorophenyl)-5-
methylisoxazol-4-yl]carbonyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-
2-carboxylate monohydrate.
Cl
Cl
O
N
O
H
N
CH
3
S
N
H
H
O
CH
3
CH
3
COONa
H
DICLOXSIG- Product Information
Page 2 of 8
THE INACTIVE INGREDIENTS IN DICLOXSIG 250 MG CAPSULES are silicon
dioxide, magnesium
stearate, gelatin, titanium dioxide.
THE INACTIVE INGREDIENTS IN DICLOXSIG 500 MG CAPSULES are silicon
dioxide, magnesium
stearate, gelatin, titanium dioxide, Patent blue V and Quinoline
yellow.
PHARMACOLOGY
PHARMACOKINETICS
Dicloxacillin is resistant to destruction by acid. Absorption from the
gastrointestinal tract is
rapid, in fasting adults, 50% to 94% of an oral dose was absorbed with
peak serum levels
reached within 1 to 2 hours. Food in the gastrointestinal tract
decreases the absorption of
dicloxacillin. Serum levels after