AMIKACIN SXP amikacin (as sulfate) 500 mg/2mL solution for injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

amikacin, Quantity: 500 mg (Equivalent: amikacin sulfate, Qty 667.5 mg)

Available from:

Southern XP IP Pty Ltd

INN (International Name):

Amikacin

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sulfuric acid; sodium metabisulfite; sodium citrate dihydrate; water for injections

Administration route:

Intramuscular, Intravenous

Units in package:

10 ampoules, 5 ampoules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Amikacin SXP Injection is indicated in the short-term treatment of serious infections caused by susceptible strains of Gram negative bacteria (see Microbiology).,Staphylococcus aureus, including methicillin resistant strains, is the principal Gram positive organism sensitive to amikacin.,The use of amikacin in the treatment of staphylococcal infections should be restricted to second line therapy, and should be confined to patients suffering from severe infections caused by susceptible strains of staphylococcus who have failed to respond or are allergic to other available antibiotics.,Amikacin SXP Injection is indicated in the treatment of neonatal sepsis when sensitivity testing indicates that other aminoglycosides cannot be used.,In certain severe infections such as neonatal sepsis, concomitant therapy with a penicillin type drug maybe indicated because of the possibility of infections due to Gram positive organisms such as streptococci or pneumococci. If concomitant treatment with a penicillin type drug is indicated, then the drugs should be administered separately because in vitro mixing of the two drugs causes inactivation of amikacin.,Clinical studies have shown amikacin to be effective in treating bacteraemia, septicaemia including neonatal sepsis and serious infections of the respiratory tract, bones and joints, central nervous system, skin and skin structures (including those resulting from burns), intra-abdominal organs, postoperative infections and complicated and recurrent urinary tract infections, when caused by susceptible organisms.

Product summary:

Visual Identification: sterile, clear, colorless to slightly yellow solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2017-02-07

Patient Information leaflet

Amikacin SXP
1
AMIKACIN SXP
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I BEING GIVEN AMIKACIN SXP?
AMIKACIN SXP contains the active ingredient amikacin sulfate. AMIKACIN
SXP is an antibiotic used to kill bacteria or prevent
their growth.
For more information, see Section 1. Why am I being given AMIKACIN
SXP?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN AMIKACIN SXP?
Do not use if you have ever had an allergic reaction to amikacin
sulfate or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I am
given AMIKACIN SXP?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with AMIKACIN SXP and affect how it
works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW AM I GIVEN AMIKACIN SXP?
•
Your doctor will decide what dose you will receive and how long you
will receive it, depending on your condition and
other factors, such as your weight and kidney function.
•
For most infections, AMIKACIN SXP is usually given in divided doses
throughout the day.
•
AMIKACIN SXP is usually given as an injection into a muscle. It can
also be given as a slow injection into a vein
(intravenously). AMIKACIN SXP must only be given by a doctor or a
nurse.
More instructions can be found in Section 4. How am I given AMIKACIN
SXP? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE BEING GIVEN AMIKACIN SXP?
THINGS YOU
SHOULD DO
•
Tell any doctor, dentist or and pharmacist who is treating you that
you are taking AMIKACIN SXP.
•
Before starting any new medicine, tell your doctor, dentist or
pharmacist that you are taking AMIKACIN SXP.
•
If you plan to have surgery that needs a general anaest

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
AMIKACIN SXP (AMIKACIN SULFATE) SOLUTION FOR INJECTION
_ _
1. NAME OF THE MEDICINE
Amikacin sulfate.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Amikacin SXP injection contains the active ingredient amikacin
sulfate. Each mL of amikacin SXP injection
contains amikacin sulfate equivalent to amikacin activity 250 mg
(250,000 IU).
Excipients with known effect: sodium metabisulfite.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
Amikacin SXP solution for injection is a sterile, clear, colourless to
slightly yellow solution.
Amikacin SXP Injection is available in 500 mg/2 mL strength.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Amikacin SXP Injection is indicated in the short-term treatment of
serious infections caused by susceptible
strains of Gram negative bacteria (see Section 5.1 PHARMACODYNAMIC
PROPERTIES, Microbiology).
_Staphylococcus _
_aureus_,
including
methicillin
resistant
strains,
is
the
principal
Gram
positive
organism
sensitive to amikacin.
The use of amikacin in the treatment of staphylococcal infections
should be restricted to second line therapy,
and should be confined to patients suffering from severe infections
caused by susceptible strains of
staphylococcus who have failed to respond or are allergic to other
available antibiotics.
Amikacin SXP Injection is indicated in the treatment of neonatal
sepsis when sensitivity testing indicates that
other aminoglycosides cannot be used.
In certain severe infections such as neonatal sepsis, concomitant
therapy with a penicillin type drug may be
indicated because of the possibility of infections due to Gram
positive organisms such as streptococci or
pneumococci. If concomitant treatment with a penicillin type drug is
indicated, then the drugs should be
administered separately because _in vitro_ mixing of the two drugs
causes inactivation of amikacin.
Clinical studies have shown amikacin to be effective in treating
bacteraemia, septicaemia including neonatal
sepsis and seriou