VANCOCIN vancomycin 125mg (125,000IU as hydrochloride) capsule blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

vancomycin hydrochloride, Quantity: 128 mg (Equivalent: vancomycin, Qty 125 mg)

Available from:

Aspen Pharmacare Australia Pty Ltd

Pharmaceutical form:

Capsule

Composition:

Excipient Ingredients: iron oxide red; Gelatin; indigo carmine; titanium dioxide; macrogol 6000; iron oxide yellow

Administration route:

Oral

Units in package:

20

Class:

Medicine Registered

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

This product accepted for registration as 'currently supplied' at the time of commencement of the Act. Revisions of Product Information was approved as specified in the letter of 13 August 1992 from Dr Alex Proudfoot advising of approval for registration of the goods. Indicated for the treatment of Staphylococcal enterocolitis and antibiotic - associated pseudomembranous colitis produced by C. difficile.

Product summary:

Visual Identification: 125mg (125,000 I.U.): hard gelatin capsules, size 2, with opaque blue cap and an opaque peach body.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-09-05

Patient Information leaflet

VANCOCIN Capsules CMI
Page 1 of 3
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions about Vancocin capsules. It
does
not
contain
all
the
available
information
that
is
known
about
Vancocin capsules.
It does not take the place of talking to
your doctor.
All medicines have risks and benefits.
Your doctor has weighed the risks of
you taking Vancocin capsules against
the benefits they expect it will have for
you.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT
TAKING
THIS
MEDICINE,
TALK
TO
YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THIS MEDICINE.
You may need to read it again.
WHAT VANCOCIN CAPSULES
ARE USED FOR
Vancocin capsules contains the active
vancomycin
(as
vancomycin
hydrochloride).
Vancocin
capsules
are
an
antibiotic
used
to
treat
serious
infections
involving the bowel. It works by killing
or stopping the growth of the bacteria
causing your infection.
ASK
YOUR
DOCTOR
IF
YOU
HAVE
ANY
QUESTIONS
ABOUT
WHY
VANCOCIN
CAPSULES
HAVE
BEEN
PRESCRIBED
FOR
YOU.
Your doctor may have prescribed it for
another purpose.
This medicine is only available with a
doctor’s prescription.
There is no evidence that it is addictive.
BEFORE YOU TAKE IT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE VANCOCIN CAPSULES IF YOU
HAVE EVER HAD AN ALLERGIC REACTION TO:
•
any
medicines
containing
vancomycin and similar antibiotics
e.g. teicoplanin.
•
any of the ingredients listed at the
end of this leaflet.
Signs
of
an
allergic
reaction
may
include shortness of breath, wheezing
or difficulty in breathing; swelling of
the face, lips, tongue or any other parts
of the body; rash, itching or hives on
the skin.
DO NOT TAKE VANCOCIN CAPSULES IF THE
EXPIRY DATE ON THE PACK HAS PASSED.
DO NOT TAKE VANCOCIN CAPSULES IF THE
PACKAGING IS TORN OR SHOWS SIGNS OF
TAMPERING.
_BEFORE YOU START TO TAKE IT _
TELL YOUR DOCTOR IF YOU ARE ALLERGIC TO
ANY
OTHER
MEDICINES
OR
ANY
FOODS,
DYES OR PRESERVATIVES.
TELL YOUR DOCTOR IF YOU HAVE OR HAVE
HAD
ANY
OF
THE
FOLLOWING
MEDICAL
CONDITIONS:
•
kidney or liver disease
•
a special sensory impairment (e.g.
blind

Summary of Product characteristics

Vancocin-PI
1
AUSTRALIAN PRODUCT INFORMATION
VANCOCIN (VANCOMYCIN HYDROCHLORIDE) CAPSULES
This preparation for the treatment of colitis is for oral use only.
VANCOCIN must be given orally
for
treatment
of
staphylococcal
enterocolitis
and
antibiotic-associated
pseudomembranous
colitis
produced
by
_Clostridium _
_difficile_.
If
parenteral
vancomycin
therapy
is
desired,
use
VANCOCIN CP (sterile vancomycin hydrochloride) intravenous, and
consult package insert
accompanying that preparation. Parenteral administration of VANCOCIN
CP is not effective for
treatment of staphylococcal enterocolitis and antibiotic-associated
pseudomembranous colitis
produced by _Clostridium difficile_; therefore, vancomycin
hydrochloride must be given orally for
these indications. Orally administered VANCOCIN is not effective for
other types of infections.
1
NAME OF THE MEDICINE
Vancomycin hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
VANCOCIN capsules contain the active ingredient vancomycin
hydrochloride equivalent to 125
mg or 250 mg of vancomycin.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
VANCOCIN 125 mg capsules are size 2, hard gelatin capsules, with
opaque blue cap and an opaque
peach body.
VANCOCIN 250 mg capsules are size 0, hard gelatin capsules, with
opaque blue cap and opaque
mushroom grey body.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
VANCOCIN capsules may be administered orally for the treatment of
staphylococcal enterocolitis
and
antibiotic-associated
pseudomembranous
colitis
produced
by_ _
_C. _
_difficile_.
Parenteral
administration of VANCOCIN is not effective for the above indications;
therefore VANCOCIN must
be given orally. VANCOCIN is not effective by the oral route for other
types of infection.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Adults
The
usual
daily
dosage
for
staphylococcal
enterocolitis
and
for
antibiotic
induced
pseudomembranous colitis produced by _C. difficile_ is 250 mg 6 hourly
for 5-10 days. However
doses of 500 mg to 2 g orally admin