The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 08553/0581.
Daptomycin Dr. Reddy's 350 mg & 500 mg Powder for Solution for Injection/Infusion
Daptomycin 350 mg Powder for Solution for Injection/Infusion
Daptomycin 500 mg Powder for Solution for Injection/Infusion
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 1 to 17 years) to treat infections of the skin and the tissues below the skin. It is also used to treat infections in the blood when associated with skin infection. Daptomycin 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 type of bacteria called Staphyloccocus aureus. It is also used to treat infections in the blood caused by the same type of bacteria when associated with 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.
If this applies to you, tell your doctor or nurse. If you think you may be allergic, ask your doctor or nurse for advice.
Talk to your doctor or nurse before you are given Daptomycin:
If any of these applies to you, tell your doctor or nurse before you are given Daptomycin.
Tell your doctor or nurse straight away if you develop any of the following symptoms:
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.
Your doctor will perform blood tests to monitor the health of your muscles both before you start treatment and frequently during treatment with Daptomycin.
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.
People over the age of 65 can be given the same dose as other adults, provided their kidneys are working well.
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:
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.
Daptomycin has no known effects on the ability to drive or use machines.
This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free’.
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.
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.
The dose for children and adolescents (1 to 17 years of age) will depend on the age of patient and the type of infection being treated.This dose is given directly into the blood stream (into a vein), as an infusion lasting about 30-60 minutes.
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.
Detailed instructions for use and handling are given at the end of the leaflet.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most serious side effects are described below:
Serious side effects with frequency not known
(frequency cannot be estimated from the available data)
A hypersensitivity reaction (serious allergic reaction including anaphylaxis and angioedema) 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:
Tell your doctor straight away if you experience unexplained muscle pain, tenderness, or weakness. Muscle problems can be serious, including muscle breakdown (rhabdomyolysis), which can result in kidney damage.
If you experience these symptoms, tell your doctor or nurse straight away. Your doctor will perform additional test to make a diagnosis.
If you experience raised or fluid-filled skin spots over a large area of your body, tell your doctor or nurse straight away.
The most frequently reported side effects are described below:
Common side effects (may affect up to 1 in 10 people)
Other side effects which may occur following daptomycin treatment are described below:
Uncommon side effects (may affect up to 1 in 100 people)
Rare side effects (may affect up to 1 in 1,000 people)
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), easy bruising, bleeding gums, or nosebleeds.
If you get any side effects, talk to your doctor, pharmacist 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
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.
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.
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.
This leaflet was last revised in 05/2022