VANCOCIN CP 1g powder for injection

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

vancomycin, Quantity: 1 g (Equivalent: vancomycin, Qty 1 million IU)

Available from:

Aspen Pharmacare Australia Pty Ltd

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: disodium edetate; sodium hydroxide; hydrochloric acid

Administration route:

Oral, Intravenous

Units in package:

1 x 1g, 10 x 1g

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Indicated for potentially life-threatening infections which cannot be treated with another effective, less toxic antimicrobial drug, including the penicillins and cephalosporins. Severe staphylococcal (including methicillin-resistant staphylococcal) infections in patients who cannot receive or who failed to respond to the penicillins and cephalosporins or who have infections with staphylococci that are resistant to other antibiotics. Once sensitivity data are available, therapy should be adjusted accordingly. Alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (eg E faecalis), only in combination with an aminoglycoside. For the treatment of diphtheroid endocarditis. In combination with rifampin, an aminoglycoside or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids. In other infections due to staphylococci including osteomyelitis, pneumonia, septicaemia, and soft tissue infections. Wh

Product summary:

Visual Identification: WHITE TO OFF-WHITE POWDER.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1992-11-18

Patient Information leaflet

VANCOCIN CP CMI - 230310
Page 1 of 3
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Vancocin CP powder
for injection. It does not contain all the
available information and 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 this medicine against the
benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT BEING
GIVEN THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THIS MEDICINE.
You may need to read it again.
WHAT VANCOCIN CP IS USED
FOR
Vancocin CP contains the active
vancomycin (as vancomycin
hydrochloride).
Vancocin CP is an antibiotic used to
treat serious infections caused by
bacteria (germs). These infections may
occur in different parts of the body.
Vancocin CP can also be used orally to
treat serious infections involving the
bowel.
Vancocin CP works by killing the
bacteria causing the infection.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY VANCOCIN CP
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed
Vancocin CP for another reason.
This medicine is only available with a
doctor’s prescription.
There is no evidence that it is addictive.
BEFORE YOU ARE GIVEN IT
_WHEN YOU MUST NOT BE GIVEN IT _
YOU SHOULD NOT BE GIVEN VANCOCIN
CP IF YOU HAVE EVER HAD AN ALLERGIC
REACTION TO:

any medicines containing
vancomycin hydrochloride

the inactive ingredient, disodium
edetate.
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.
YOU SHOULD NOT BE GIVEN VANCOCIN
CP IF THE PACKAGING IS TORN OR SHOWS
SIGNS OF TAMPERING.
YOU SHOULD NOT BE GIVEN VANCOCIN
CP IF THE EXPIRY DATE ON THE PACK HAS
PASSED.
If you are given this medicine after the
expiry date has passed it may not work
as well.
_BEFORE YOU ARE GIVEN IT _
TELL YOUR DOCTOR IF YOU ARE ALLERGIC TO
ANY OTHER MEDICINES (SUCH AS
TEICOPLANIN, A DRU

Summary of Product characteristics

VANCOCIN CP powder for injection vial - Product Information
Page 1 of 14
PRODUCT INFORMATION
VIALS
VANCOCIN CP
(Sterile Vancomycin Hydrochloride)
Intravenous
NAME OF THE MEDICINE
VANCOCIN CP (vancomycin hydrochloride) has the chemical formula
C
66
H
75
Cl
2
N
9
O
24
.HCl.
The formula weight is 1449; 500 mg of the base is equivalent to 0.35
mmol. The
CAS number is 1404-93-9.
The following structure of vancomycin hydrochloride has been confirmed
by X-ray
diffraction:
DESCRIPTION
Vancocin CP (Sterile Vancomycin Hydrochloride), Intravenous, is a
chromatographically purified tricyclic glycopeptide antibiotic derived
from
_Amycolatopsis orientalis _(formerly _Nocardia orientalis_) which is
bactericidal against
many gram-positive bacteria. It should be administered intravenously
in dilute
solution (_see_ DOSAGE AND ADMINISTRATION).
VANCOCIN CP powder for injection vial - Product Information
Page 2 of 14
Vancocin CP is available as sterile vials containing vancomycin
equivalent to either
500 mg (500,000 IU) or 1 g (1,000,000 IU) of vancomycin activity. It
is an off-white
lyophilised plug. When reconstituted in water, it is a clear solution
with a pH range
of 2.8 to 4.5. Disodium edetate has been added during processing.
Sodium
hydroxide and/or hydrochloric acid may be used during manufacture for
pH
adjustment.
CLINICAL PHARMACOLOGY
Vancocin CP is poorly absorbed after oral administration; it is given
intravenously for
therapy of systemic infections. Intramuscular injection is painful.
In subjects with normal kidney function, multiple intravenous dosing
of
1 g of vancomycin (15 mg/kg) infused over 60 minutes produces mean
plasma
concentrations of approximately 63 mg/L immediately at the completion
of infusion,
mean plasma concentrations of approximately 23 mg/L 2 hours after
infusion, and
mean plasma concentrations of approximately 8 mg/L 11 hours after the
end of the
infusion. Multiple dosing of 500 mg infused over 30 minutes produces
mean plasma
concentrations of about 49 mg/L at the completion of infusion, and
mean pla