Distaph

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Dicloxacillin sodium; dicloxacillin

Available from:

Alphapharm Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

DISTAPH

_contains the active ingredient 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 amoxycillin
•
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

Summary of Product characteristics

DISTAPH 
_Dicloxacillin (sodium) _

PRODUCT INFORMATION 

NAME OF THE MEDICINE 

The active ingredient of Distaph capsules is dicloxacillin (as
dicloxacillin sodium). 

Dicloxacillin sodium is the monohydrate sodium salt of dicloxacillin.
The chemical name for dicloxacillin sodium is 
(6R)-6-[3-(2,
6-dichlorophenyl)-5-methylisoxazole-4-carboxamido]-penicillanate. The
structural formula for 
dicloxacillin sodium is: 

Molecular Formula: 
C
19
H
16
Cl
2
N
3
NaO
5
S,H
2
O Molecular 
Weight: 
510.3 

CAS Registry No: 
13412-64-1 

DESCRIPTION

Dicloxacillin sodium is an antibiotic and a member of the
isoxazolyl penicillins. Dicloxacillin sodium is a white or 
almost white, crystalline powder. It is hygroscopic, freely soluble in
water, soluble in alcohol and in methanol. 

Each capsule contains dicloxacillin sodium equivalent to 250 mg or
500 mg dicloxacillin.  The inactive ingredients 
present are silica – colloidal anhydrous, magnesium
stearate, gelatin, titanium dioxide, sodium lauryl sulfate, 
water – potable, TekPrint SW-9008 (ARTG No: 2328) and TekPrint
SW-9009 (ARTG No: 2343). 

PHARMACOLOGY 

Dicloxacillin sodium is a semisynthetic penicillin that resists
inactivation by staphylococcal 
β-lactamase 
(penicillinase). Penicillinase resistant penicillins exert a
bactericidal action against penicillin-susceptible 
microorganisms during active multiplication. All penicillins inhibit
the biosynthesis of the bacterial cell wall. 

PHARMACOKINETICS 

_Absorption_.  Dicloxacillin is resistant to inactivation by gastric
acid and is rapidly absorbed from the 
gastrointestinal tract. Bioavailability after oral dosing to fasting
adults has been reported to range from 50 to 94% 
with peak levels occurring 1 to 2 hours post administration. The
bioavailability of dicloxacillin is decreased in the 
presence of food. 

Serum levels after oral administration are directly proportional
to dosage at