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DAPTOMYCIN DR. REDDYS 350 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION

Active substance(s): DAPTOMYCIN

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125 mm

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Package leaflet: Information for the patient

Daptomycin 350 mg Powder for Solution for Injection/Infusion
Daptomycin 500 mg Powder for Solution for Injection/Infusion
daptomycin

What is in this leaflet

1. What Daptomycin is and what it is used for
2. What you need to know before you are given
Daptomycin
3. How Daptomycin is given
4. Possible side effects
5. How to store Daptomycin
6. Contents of the pack and other information

The active substance in Daptomycin powder for solution
for injection/infusion is daptomycin. Daptomycin is an
antibacterial that can stop the growth of certain bacteria.
Daptomycin is used in adults and in children and
adolescents (age from 2 to 17 years) to treat infections of
the skin and the tissues below the skin. It is also used in
adults to treat infections in the tissues that line the inside
of the heart (including heart valves) which are caused by a
bacterium called Staphyloccocus aureus and to treat
infections in the blood caused by the same bacterium
when associated with skin or heart infection.
Depending on the type of infection(s) that you have, your
doctor may also prescribe other antibacterials while you
are receiving treatment with Daptomycin.

You should not be given Daptomycin

• if you are allergic to daptomycin or to sodium hydroxide
or to any of the other ingredients of this medicine (listed
in section 6).
If this applies to you, tell your doctor or nurse. If you think
you may be allergic, ask your doctor or nurse for advice.

Warnings and precautions

Daptomycin may interfere with laboratory tests that
measure how well your blood is clotting. The results can
suggest poor blood clotting when, in fact, there is no
problem. Therefore it is important that your doctor takes into
account that you are receiving Daptomycin. Please inform
your doctor that you are on treatment with Daptomycin.

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Use in elderly

People over the age of 65 can be given the same dose as
other adults, provided their kidneys are working well.

Other medicines and Daptomycin

Tell your doctor or nurse if you are taking, have recently
taken or might take any other medicines. It is particularly
important that you mention the following:
• medicines called statins or fibrates (to lower
cholesterol) or ciclosporin (a medicinal product used in
transplantation to prevent organ rejection or for other
conditions, e.g. rheumatoid arthritis or atopic
dermatitis). It is possible that the risk of side effects
affecting the muscles may be higher when any of these
medicines (and some others that can affect muscles) is
taken during treatment with Daptomycin. Your doctor
may decide not to give you Daptomycin or to stop the
other medicine for a while
• pain killing medicines called non-steroidal
anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors
(e.g. celecoxib). These could interfere with the effects
of Daptomycin in the kidney
• oral anti-coagulants (e.g. warfarin), which are medicines
that prevent blood from clotting. It may be necessary for
your doctor to monitor your blood clotting times.

Pregnancy and breast-feeding

Daptomycin is not usually given to pregnant women. If you
are pregnant or breast-feeding, think you may be pregnant
or are planning to have a baby, ask your doctor or
pharmacist for advice before you are given this medicine.
Do not breast-feed if you are receiving Daptomycin,
because it may pass into your breast milk and could affect
the baby.

Driving and using machines

Daptomycin has no known effects on the ability to drive or
use machines.

3. How Daptomycin is given
Daptomycin will usually be given to you by a doctor or a
nurse.
The dose will depend on how much you weigh and the type
of infection being treated. The usual dose for adults is 4 mg
for every kilogram (kg) of body weight once daily for skin
infections or 6 mg for every kg of body weight once daily for
a heart infection or a blood infection associated with skin or
heart infection. In adult patients, this dose is given directly
into your blood stream (into a vein), either as an infusion
lasting about 30 minutes or as an injection lasting about
2 minutes. The same dose is recommended in people aged
over 65 years provided their kidneys are working well.

Children and adolescents (2 to 17 years of age)

The dose for children and adolescents (2 to 17 years of age)
being treated for skin infection will depend on the age of
patient. The recommended doses based on age are shown
in the table below:
Duration of
Age group
Dosage
treatment
5 mg/kg once every 24 hours
12 to 17 years
infused over 30 minutes
7 mg/kg once every 24 hours Up to 14 days
7 to 11 years
infused over 30 minutes
9
mg/kg
once every 24 hours
2 to 6 years
infused over 60 minutes
If your kidneys do not work well, you may receive
Daptomycin less often, e.g. once every other day. If you
are receiving dialysis, and your next dose of Daptomycin
is due on a dialysis day, you will be usually given
Daptomycin after the dialysis session.

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Tell your doctor straight away if you develop any of
the following symptoms:
• serious, acute allergic reactions have been observed in
patients treated with nearly all antibacterial agents,
including Daptomycin. Tell a doctor or a nurse straight
away if you experience symptoms suggestive of allergic
reaction, such as wheezing, difficulty breathing,
swelling of the face, neck and throat, rashes and hives,
fever (see section 4 of this leaflet for more information)
• any unusual tingling or numbness of the hands or feet,
loss of feeling or difficulties with movements. If this
happens, tell your doctor who will decide whether you
should continue the treatment
• diarrhoea, especially if you notice blood or mucus, or if
diarrhoea becomes severe or persistent
• new or worsening fever, cough or difficulty breathing.
These may be signs of a rare but serious lung disorder
called eosinophilic pneumonia. Your doctor will check
the condition of your lungs and decide whether or not
you should continue Daptomycin treatment.

Daptomycin should not be administered to children below
one year of age as studies in animals have indicated that
this age group may experience severe side effects.

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Talk to your doctor or nurse before you are given
Daptomycin:
• if you have, or have previously had kidney problems.
Your doctor may need to change the dose of
Daptomycin (see section 3 of this leaflet)
• occasionally, patients receiving Daptomycin may
develop tender or aching muscles or muscle weakness
(see section 4 of this leaflet for more information). If this
happens tell your doctor. Your doctor will make sure
you have a blood test and will advise whether or not to
continue with Daptomycin. The symptoms generally go
away within a few days of stopping Daptomycin
• if you are very overweight. There is a possibility that
your blood levels of Daptomycin could be higher than
those found in persons of average weight and you may
need careful monitoring in case of side effects.
If any of these applies to you, tell your doctor or nurse
before you are given Daptomycin.

Children and adolescents

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2. What you need to know before you are given
Daptomycin

Your doctor will perform blood tests to monitor the health
of your muscles both before you start treatment and
frequently during treatment with Daptomycin.

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1. What Daptomycin is and what it is used for

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Read all of this leaflet carefully before you start using this medicine because it contains important information
for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of
illness are the same as yours.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet.
See section 4.

Artwork
Important:
Please refer to the Summary of Product Characteristics before prescribing.

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The following information is intended for healthcare professionals only

Dr Reddy’s

Brand:

Product Name: Daptomycin
Strength

350 mg, 500 mg

Daptomycin may be administered intravenously as an infusion over 30 or 60 minutes or as an injection over 2 minutes.
Preparation of the solution for infusion requires an additional dilution step as detailed below.

Form:

Powder for Solution for
Injection/Infusion

Daptomycin given as an intravenous infusion over 30 or 60 minutes

Component:

Leaflet

Pack Size:

Various

Country:

UK

Date Created:

28/04/2017

Instructions for use and handling

A 50 mg/ml concentration of Daptomycin for infusion can be achieved by reconstituting the lyophilised product with 7 ml
(for Daptomycin 350 mg powder) or 10 ml (for Daptomycin 500 mg powder) of sodium chloride 9 mg/ml (0.9%) solution for
injection.
The lyophilised product takes approximately 15 minutes to dissolve. The fully reconstituted product will appear clear and
may have a few small bubbles or foam around the edge of the vial.

Stability of the diluted solution in infusion bags is established as 12 hours at 25°C or 24 hours if stored under refrigeration
at 2°C-8°C.

Version:

1.4

Technical Information
Die Cut

Dimensions:

Colours
Process Black

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The combined storage time (reconstituted solution in vial and diluted solution in infusion bag) at 25°C must not exceed
12 hours (24 hours if refrigerated).

Date Modified: 11/08/2017
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To prepare Daptomycin for intravenous infusion, please adhere to the following instructions: Aseptic technique should be
used throughout to reconstitute lyophilised Daptomycin.
1. The polypropylene flip off cap should be removed to expose the central portions of the rubber stopper. Wipe the top of
the rubber stopper with an alcohol swab or other antiseptic solution and allow to dry. After cleaning, do not touch the
rubber stopper or allow it to touch any other surface. Draw 7 ml (for Daptomycin 350 mg powder) or 10 ml (for
Daptomycin 500 mg powder) of sodium chloride 9 mg/ml (0.9%) solution for injection into a syringe, using a sterile
transfer needle that is 21 gauge or smaller in diameter, or a needleless device, then slowly inject through the centre of
the rubber stopper into the vial pointing the needle towards the wall of the vial.
2. The vial should be gently rotated to ensure complete wetting of the product and then allowed to stand for 10 minutes.
3. Finally the vial should be gently rotated/swirled for a few minutes as needed to obtain a clear reconstituted solution.
Vigorous shaking/agitation should be avoided to prevent foaming of the product.
4. The reconstituted solution should be checked carefully to ensure that the product is in solution and visually inspected
for the absence of particulates prior to use. Reconstituted solutions of Daptomycin range in colour from pale yellow to
light brown.
5. Slowly remove the reconstituted liquid (50 mg daptomycin/ml) from the vial using a sterile needle that is 21 gauge or
smaller in diameter and a new syringe; as described in step 6.
6. Invert the vial in order to allow the solution to drain towards the stopper. Using the new syringe, insert the needle into
the inverted vial. Keeping the vial inverted, position the needle tip at the very bottom of the solution in the vial when
drawing the solution into the syringe. Before removing the needle from the vial, pull the plunger all the way back to the
end of the syringe barrel in order to remove all of the solution from the inverted vial.
7. The reconstituted solution should then be diluted with sodium chloride 9 mg/ml (0.9%) (typical volume 50 ml).
8. If to be administrated from the syringe, replace needle with a new needle for the intravenous infusion.
9. Expel air, large bubbles, and any excess solution in order to obtain the required dose.
10. The reconstituted and diluted solution should then be infused intravenously over 30 or 60 minutes.

Guides

150 x 450 mm

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125 mm

A course of treatment usually lasts for 1 to 2 weeks for
skin infections. For blood or heart infections and skin
infections your doctor will decide how long you should be
treated.

4. Possible side effects
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
The most serious side effects are described below:

Tell your doctor straight away if you experience
unexplained muscle pain, tenderness, or weakness.
In very rare cases (reported in less than 1 in every
10,000 patients), muscle problems can be serious,
including muscle breakdown (rhabdomyolysis), which can
result in kidney damage.

The most frequently reported side effects are described
below:
Common side effects (may affect up to 1 in 10 people)
• fungal infections such as thrush
• urinary tract infection
• decreased number of red blood cells (anaemia)
• dizziness, anxiety, difficulty in sleeping
• headache
• fever, weakness (asthenia)
• high or low blood pressure
• constipation, abdominal pain
• diarrhoea, feeling sick (nausea) or being sick (vomiting)
• flatulence
• abdominal swelling or bloating
• skin rash or itching
• pain, itchiness or redness at the site of infusion
• pain in arms or legs
• blood testing showing higher levels of liver enzymes or
creatine phosphokinase (CPK)

5. How to store Daptomycin
Keep this medicine out of the sight and reach of children.
Store in a refrigerator (2°C-8°C).
After reconstitution: Chemical and physical in-use stability
of the reconstituted solution in the vial has been
demonstrated for 12 hours at 25°C and up to 48 hours at
2°C-8°C. Chemical and physical stability of the diluted
solution in infusion bags is established as 12 hours at
25°C or 24 hours at 2°C-8°C.
For the 30-minute intravenous infusion, the combined
storage time (reconstituted solution in vial and diluted
solution in infusion bag; see section 6.6) at 25°C must not
exceed 12 hours (or 24 at 2°C-8°C).
For the 2-minute intravenous injection, the storage time of
the reconstituted solution in the vial (see section 6.6) at
25°C must not exceed 12 hours (or 48 at 2°C-8°C).
However, from a microbiological point of view the product
should be used immediately. No preservative or
bacteriostatic agent is present in this product. If not used
immediately, in-use storage times are the responsibility of
the user and would not normally be longer than 24 hours
at 2°C-8°C, unless reconstitution/dilution has taken place
in controlled and validated aseptic conditions.
Do not use this medicine after the expiry date which is
stated on the carton and label after EXP. The expiry date
refers to the last day of that month.
Do not use this medicine if you notice visible signs of
deterioration.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw away
medicines you no longer use. These measures will help
protect the environment.

6. Contents of the pack and other information
What Daptomycin contains

The active substance is daptomycin.
Daptomycin 350 mg: One vial of powder contains 350 mg
daptomycin. One ml provides 50 mg of daptomycin after
reconstitution with 7 ml of sodium chloride 9 mg/ml (0.9%)
solution.
Daptomycin 500 mg: One vial of powder contains 500 mg
daptomycin. One ml provides 50 mg of daptomycin after
reconstitution with 10 ml of sodium chloride 9 mg/ml
(0.9%) solution.
The other ingredient is sodium hydroxide.

What Daptomycin looks like and contents of the
pack
Daptomycin powder for solution for injection/infusion is
supplied as a pale yellow to light brown cake or powder in
a glass vial. It is mixed with a solvent to form a liquid
before it is administered.
Daptomycin is available in packs containing 1 vial.

Marketing Authorisation Holder and
Manufacturer

Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road,
Beverley, East Yorkshire, HU17 0LD, United Kingdom
This leaflet was last revised in 08/2017

Daptomycin given as 2-minute intravenous injection (adult patients only)

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The following information is intended for healthcare professionals only

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Other side effects which may occur following Daptomycin
treatment are described below:
Uncommon side effects (may affect up to 1 in 100 people)
• blood disorders (e.g increased number of small blood
particles called platelets, which may increase the
tendency for blood clotting, or higher levels of certain
types of white blood cells)
• decreased appetite
• tingling or numbness of the hands or feet,
taste disturbance
• trembling
• changes in heart rhythm, flushes
• indigestion (dyspepsia), inflammation of the tongue
• itchy rash of skin
• muscle pain or weakness, inflammation of the muscles
(myositis), joint pain
• kidney problems
• inflammation and irritation of the vagina
• general pain or weakness, tiredness (fatigue)
• blood test showing increased levels of blood sugar,
serum creatinine, myoglobin, or lactate dehydrogenase
(LDH), prolonged blood clotting time or imbalance of salts

If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow
Card Scheme, website www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more
information on the safety of this medicine.

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450 mm

If you experience raised or fluid-filled skin spots over a large
area of your body, tell your doctor or nurse straight away.

Reporting of side effects

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Serious side effects with frequency not known
(frequency cannot be estimated from the available data)
A rare but potentially serious lung disorder called
eosinophilic pneumonia has been reported in patients
given Daptomycin, mostly after more than 2 weeks of
treatment. The symptoms can include difficulty breathing,
new or worsening cough, or new or worsening fever. If you
experience these symptoms, tell your doctor or nurse
straight away.

Frequency not known (frequency cannot be estimated
from the available data)
Antibacterial-associated colitis, including
pseudomembranous colitis (severe or persistent diarrhoea
containing blood and/or mucus, associated with abdominal
pain or fever).

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Very rare serious side effects (may affect up to
1 in 10,000 people)
A hypersensitivity reaction (serious allergic reaction
including anaphylaxis, angioedema, drug rash with
eosinophilia and systemic symptoms (DRESS)) has been
reported in some cases during administration of
Daptomycin. This serious allergic reaction needs
immediate medical attention. Tell your doctor or nurse
straight away if you experience any of the following
symptoms:
• chest pain or tightness
• rash with blistering, sometimes affecting the mouth and
genitals
• swelling around throat
• rapid or weak pulse
• wheezing
• fever
• shivering or trembling
• hot flushes
• dizziness
• fainting
• metallic taste

Rare side effects (may affect up to 1 in 1,000 people)
• yellowing of the skin and eyes
• prothrombin time prolonged

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Detailed instructions for use and handling are given at the
end of the leaflet.

20 mm

Water should not be used for reconstitution of Daptomycin for intravenous injection. Daptomycin should only be
reconstituted with sodium chloride 9 mg/ml (0.9%).
A 50 mg/ml concentration of Daptomycin for injection is obtained by reconstituting the lyophilised product with 7 ml
(for Daptomycin 350 mg powder) or 10 ml (for Daptomycin 500 mg powder) of sodium chloride 9 mg/ml (0.9%) solution
for injection.
The lyophilised product takes approximately 15 minutes to dissolve. The fully reconstituted product will appear clear and
may have a few small bubbles or foam around the edge of the vial.

However, from a microbiological point of view the product should be used immediately. If not used immediately, in-use
storage times are the responsibility of the user and would normally not be longer than 24 hours at 2°C-8°C unless
reconstitution /dilution has taken place in controlled and validated aseptic conditions.
This medicinal product must not be mixed with other medicinal products except those mentioned above.
Daptomycin vials are for single-use only. Any unused portion remaining in the vial should be discarded.

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Chemical and physical in-use stability on the reconstituted solution in the vial has been demonstrated for 12 hours at
25°C and up to 48 hours if stored under refrigeration (2°C-8°C).

56 mm

To prepare Daptomycin for intravenous injection, please adhere to the following instructions: Aseptic technique should be
used throughout to reconstitute lyophilised Daptomycin.
1. The polypropylene flip off cap should be removed to expose the central portions of the rubber stopper. Wipe the top of
the rubber stopper with an alcohol swab or other antiseptic solution and allow to dry. After cleaning, do not touch the
rubber stopper or allow it to touch any other surface. Draw 7 ml (for Daptomycin 350 mg powder) or 10 ml (for
Daptomycin 500 mg powder) of sodium chloride 9 mg/ml (0.9%) solution for injection into a syringe using a sterile
transfer needle that is 21 gauge or smaller diameter, or a needleless device, then slowly inject through the centre of
the rubber stopper into the vial pointing the needle towards the wall of the vial.
2. The vial should be gently rotated to ensure complete wetting of the product and then allowed to stand for 10 minutes.
3. Finally the vial should be gently rotated/swirled for a few minutes as needed to obtain a clear reconstituted solution.
Vigorous shaking/agitation should be avoided to prevent foaming of the product.
4. The reconstituted solution should be checked carefully to ensure that the product is in solution and visually inspected
for the absence of particulates prior to use. Reconstituted solutions of Daptomycin range in colour from pale yellow to
light brown.
5. Slowly remove the reconstituted liquid (50 mg daptomycin/ml) from the vial using a sterile needle that is 21 gauge or
smaller in diameter and a new syringe; as described in step 6.
6. Invert the vial in order to allow the solution to drain towards the stopper. Using a new syringe, insert the needle into
the inverted vial. Keeping the vial inverted, position the needle tip at the very bottom of the solution in the vial when
drawing the solution into the syringe. Before removing the needle from the vial, pull the plunger all the way back to the
end of the syringe barrel in order to remove all of the solution from the inverted vial.
7. Replace needle with a new needle for the intravenous injection.
8. Expel air, large bubbles, and any excess solution in order to obtain the required dose.
9. The reconstituted solution should then be injected intravenously slowly over 2 minutes.

+ Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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