DAPTOMYCIN DR.REDDY'S daptomycin 350 mg powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

daptomycin, Quantity: 350 mg

Available from:

Dr Reddys Laboratories Australia Pty Ltd

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: sodium hydroxide

Administration route:

Intravenous

Units in package:

1

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Daptomycin is active against Gram positive bacteria only. In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, Daptomycin should be co-administered with appropriate antibacterial agent(s).,Consideration should be given to official guidance on the appropriate use of antibacterial agents.,Daptomycin is not indicated for the treatment of pneumonia.,Adult patients (?18 years of age) Complicated Skin and Skin Structure Infections,Daptomycin is indicated for the treatment of adults (? 18 years of age) with complicated skin and skin structure infections (cSSSI) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,Staphylococcus aureus Bloodstream Infections (Bacteraemia),Daptomycin is indicated in adults (?18 years of age) for Staphylococcus aureus bloodstream infections (bacteraemia), including right-sided native valve infective endocarditis (RIE), caused by methicillin-susceptible and methicillin-resistant isolates.,The efficacy of daptomycin in patients with prosthetic heart valves or in left-sided endocarditis due to Staphylococcus aureus has not been demonstrated. In the setting of Staphylococcus aureus bacteraemia (SAB), if a focus of infection is diagnosed as left-sided endocarditis after Daptomycin therapy has been initiated, then consideration should be given to instituting alternative antibacterial therapy (see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).,Paediatric patients (1 to 17 years of age),Daptomycin is not indicated for treatment of patients less than 1 year of age (see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE, Paediatric use).,Daptomycin has not been studied in treatment of infective endocarditis in children (see Section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials and Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).,Complicated Skin and Skin Structure Infections,Daptomycin is indicated for the treatment of patients aged 1 to 17 years with complicated skin and skin structure infections (cSSSI) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.,Staphylococcus aureus Bloodstream Infections (Bacteraemia),Daptomycin is indicated in paediatric patients (1 to 17 years of age) with Staphylococcus aureus bacteraemia not due to pneumonia, caused by daptomycin-susceptible isolates. Empiric treatment should be reviewed based on the results of susceptibility testing. Prescribing should be in accordance with nationally or locally-endorsed guidelines for the treatment of Staphylococcus aureus bacteraemia.

Product summary:

Visual Identification: A pale yellow to light brown lyophilized cake or powder.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2021-04-15

Patient Information leaflet

DAPTOMYCIN DR.REDDY'S
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
DAPTOMYCIN DR.REDDY'S
?
Daptomycin Dr.Reddy's
contains the active ingredient daptomycin.
It
is used in adults and children (1 to 17 years of age) to treat
complicated
infections of the skin and the tissues under the skin.
For more information, see Section 1. Why am I being given
Daptomycin Dr.Reddy's
? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN
DAPTOMYCIN DR.REDDY'S
?
Do not use if you have ever had an allergic reaction to
Daptomycin Dr.Reddy's
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
Daptomycin Dr.Reddy's
? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with
Daptomycin Dr.Reddy's
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 IS
DAPTOMYCIN DR.REDDY'S GIVEN?
Daptomycin Dr.Reddy's
will be given to you by a doctor or a nurse as it needs to be given as
an injection or infusion into a vein.
•
For adults, the dose will depend on how much you weigh and the type of
infection being treated.
•
For children (1 to 17 years of age), the dose will depend on the age
of the patient, how much the child weighs, and the type of
infection being treated.
More instructions can be found in Section 4. How is
Daptomycin Dr.Reddy's
given? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE BEING GIVEN
DAPTOMYCIN DR.REDDY'S
?
THINGS YOU
SHOULD DO
•
If the symptoms of your infection do not improve, or if they become
worse, tell your doctor.
•
If you develop itching with swelling or skin rash or difficulty
breathing while you are being given
Daptomycin D

Summary of Product characteristics

1
AUSTRALIAN
PRODUCT
INFORMATION
–
DAPTOMYCIN
DR.REDDY’S
(DAPTOMYCIN)
1
NAME OF THE MEDICINE
daptomycin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
DAPTOMYCIN DR.REDDY’S 350 mg powder for injection
DAPTOMYCIN DR.REDDY’S 500 mg powder for injection
Daptomycin is the active ingredient in DAPTOMYCIN DR.REDDY’S. It is
a cyclic
lipopeptide antibacterial agent
derived from the fermentation of _Streptomyces roseosporus_.
Active ingredient:
daptomycin
Chemical names:
N-decanoly-L- tryptophyl-D-asparaginyl-L-aspartyl-L-
threonylglycyl- L-ornithyl-L-aspartyl-D-alanyl-L-
aspartylglycyl-D-seryl-_threo_-3- methyl-L-glutamyl-3-
anthraniloyl-L-alanine

1
-lactone
Molecular weight:
1620.67
Molecular formula
C
72
H
101
N
17
O
26
DAPTOMYCIN DR.REDDY’S
is
supplied
in
a
single-dose
15
mL
vial,
as
a
sterile,
preservative-free, pale yellow to light brown, lyophilised cake or
powder containing 350 mg
or 500 mg of daptomycin for intravenous (IV) use following
reconstitution with 0.9 % sodium
chloride solution for injection.
Daptomycin has a high aqueous solubility (

1 g/mL).
The only inactive ingredient is sodium hydroxide, which is used in
minimal quantities for pH
adjustment.
3
PHARMACEUTICAL FORM
Powder for injection.
Sterile, preservative-free, pale yellow to light brown, lyophilised
cake or powder.
4
CLINICAL PARTICULARS
4.1 T
HERAPEUTIC INDICATIONS
Daptomycin is active against Gram positive bacteria only. In mixed
infections where Gram
negative and/or certain types of anaerobic bacteria are suspected,
Daptomycin should be co-
administered with appropriate antibacterial agent(s).
Consideration should be given to official guidance on the appropriate
use of antibacterial
agents.
2
Daptomycin is not indicated for the treatment of pneumonia.
Adult patients (≥18 years of age)
_Complicated Skin and Skin Structure Infections_
_ _
DAPTOMYCIN DR.REDDY’S is indicated for the treatment of adults (≥
18 years of age) with
complicated skin and skin structure infections (cSSSI) who require
parenteral therapy and who
hav