daptomycin
Cubicin · ATC code J01XX09
Brand names: Cubicin, Daptomycin Accord Healthcare, Daptomycin Accordpharma, Daptomycin Betapharm, Daptomycin Hikma, Daptomycin Mip, Daptomycin Norameda, Daptomycin Noridem, Daptomycin Panpharma, Daptomycin Rokitan, Daptomycin Accord, Daptomycin Amarox, Daptomycin Beta, Daptomycin Cipla, Daptomycin Eberth …
- Key facts
- Active substance
- daptomycin
- ATC code
- J01XX09
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Cubicin 350 mg powder for solution for injection or infusion / Cubicin 500 mg powder for solution for injection or infusion
- Marketing authorisation holder
- 9583
- Information as of
- 2026-10-27
Key facts
Daptomycin is a cyclic lipopeptide antibiotic (Cubicin) active against Gram-positive bacteria only. It is used for complicated skin and soft-tissue infections, right-sided endocarditis and S. aureus bacteraemia.
What it is used for
- Complicated skin and soft-tissue infections (cSSTI) in adults and children (1 to 17 years)
- Right-sided infective endocarditis (RIE) due to Staphylococcus aureus in adults
- Staphylococcus aureus bacteraemia (SAB) in adults (with RIE or cSSTI) and children (with cSSTI)
- In mixed infections with Gram-negative organisms, co-administered with appropriate antibacterials
Dosing
- Adults, cSSTI without SAB: 4 mg/kg once every 24 hours for 7-14 days
- Adults, cSSTI with SAB or RIE: 6 mg/kg once every 24 hours
- Intravenous infusion over 30 minutes or injection over 2 minutes; not more often than once a day
- Renal impairment with CrCl < 30 ml/min: same dose every 48 hours
- Paediatric doses by age are in the full text
- CPK measured at baseline and at least weekly
Contraindications
- Hypersensitivity to the active substance or any of the excipients
Important warnings
- Anaphylaxis/hypersensitivity reactions: discontinue if they occur
- Not effective and not indicated for pneumonia
- Limited data in RIE; efficacy in prosthetic valve infection or left-sided endocarditis not demonstrated
- In renal impairment (CrCl < 80 ml/min) use only if benefit outweighs risk, with close monitoring
- Deep-seated infections may need prompt surgical intervention
Side effects
- Common: fungal and urinary tract infections, anaemia, anxiety, insomnia, dizziness, headache
- Common: nausea, vomiting, constipation, diarrhoea, abdominal pain
- Common: abnormal liver function tests, increased CPK, rash, pruritus, limb pain, pyrexia
- Common: hypertension, hypotension, infusion site reactions
Interactions
- Little to no CYP450 metabolism; inhibition or induction of P450 metabolism unlikely
- No relevant interaction with warfarin, probenecid or aztreonam
- Caution when co-administered with tobramycin
Pregnancy and breastfeeding
- No clinical data; not used during pregnancy unless clearly necessary
Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- Cubicin9583 · EMEA/H/C/000637
- Daptomycin Hospira · genericPfizer Europe MA EEIG · EMEA/H/C/004310
Source: European Medicines Agency (EMA), product information
Austria
- Daptomycin Accord HealthcareAccord Healthcare B.V. · 1 register entry
- Daptomycin AccordpharmaAccord Healthcare B.V. · 1 register entry
- Daptomycin BetapharmBetapharm Arzneimittel Gmbh · 1 register entry
- Daptomycin HikmaHikma Farmacêutica (Portugal), S.A. · 1 register entry
- Daptomycin MipMip Pharma Gmbh · 1 register entry
- Daptomycin NoramedaNorameda Uab · 1 register entry
- Daptomycin NoridemNoridem Enterprises Ltd · 1 register entry
- Daptomycin PanpharmaXellia Pharmaceuticals Aps · 2 register entries
- Daptomycin RokitanRokitan Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Germany
- Daptomycin AccordAccord Healthcare B.V. · 2 register entries
- Daptomycin AccordpharmaAccord Healthcare B.V. · 1 register entry
- Daptomycin AmaroxAmarox Pharma Gmbh · 1 register entry
- Daptomycin BetaBetapharm Arzneimittel Gmbh · 1 register entry
- Daptomycin CiplaCipla Europe Nv · 1 register entry
- Daptomycin EberthDr. Friedrich Eberth Arzneimittel Gmbh · 1 register entry
- Daptomycin Fosun PharmaFosun Pharma Sp. Z O.O. · 1 register entry
- Daptomycin HikmaHikma Farmacêutica (Portugal), S.A. · 1 register entry
- Daptomycin MipMip Pharma Gmbh · 1 register entry
- Daptomycin NoridemNoridem Enterprises Ltd · 1 register entry
- Daptomycin PanpharmaXellia Pharmaceuticals Aps · 1 register entry
- Daptomycin PurenEugia Pharma (Malta) Limited · 1 register entry
Show all 14 brand names
- Daptomycin TillomedTillomed Pharma Gmbh · 1 register entry
- XelltempraXellia Pharmaceuticals Aps · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28
Turkey
- CiosaABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
- DapacinHAVER TRAKYA İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
- DaptocinGENSENTA İLAÇ SANAYİ VE TİC. A.Ş. · 2 register entries
- DaptomaxVEM İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
- DaptopolPOLİFARMA İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
- DupcinDEVA HOLDİNG A.Ş. · 2 register entries
- XaptoCENTURİON İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 25 more European countries
- Belgium
- Daptomycine Hikma
- Bulgaria
- Даптомицин Mip
- Croatia
- Daptomicin Accord Healthcare, Daptomicin Accordpharma, Daptomicin Mip
- Cyprus
- Daptomycin Cooper, Daptomycin Noridem, Daptomycin Sapiens
- Czechia
- Daptomycin Accordpharma
- Denmark
- Daptomycin "hameln", Daptomycin Accord Healthcare, Daptomycin Accordpharma, Daptomycin Mip, Daptomycin Noridem, Xelltempra
- Estonia
- Daptomycin Norameda
- Finland
- Daptomycin Accord Healthcare, Daptomycin Accordpharma, Daptomycin Advanz Pharma, Daptomycin Hameln, Daptomycin Mip Pharma, Daptomycin Norameda, Daptomycin Noridem, Daptomycin Reddy
- France
- Daptomycin Fosun Pharma, Daptomycin Tillomed, Daptomycine Accord, Daptomycine Accordpharma, Daptomycine Arrow, Daptomycine Hikma, Daptomycine Medac, Daptomycine Noridem, Daptomycine Reddy Pharma, Daptomycine Tillomed, Daptomycine Xellia, Xelltempra
- Greece
- Daptomycin Accord Healthcare, Daptomycin Accordpharma, Daptomycin Anfarm, Daptomycin Cooper, Daptomycin Demo, Zepraxen, Zolbifen
- Hungary
- Daptomycin Anfarm, Daptomycin Hameln
- Iceland
- Cubicin, Daptomycin Hameln, Daptomycin Hospira, Daptomycin Mip, Xelltempra
- Ireland
- Daptomycin Accord Healthcare, Daptomycin Accordpharma, Daptomycin N.A., Daptomycin Noridem, Daptomycin Reddy Holding, Daptomycin Xellia
- Italy
- Daptomicina Accord, Daptomicina Accordpharma, Daptomicina Aurobindo, Daptomicina Dr. Reddy’s, Daptomicina Fosun Pharma, Daptomicina Hameln, Daptomicina Hikma, Daptomicina Noridem, Daptomicina Tillomed, Daptomicina Xellia, Xelltempra Xellia
- Liechtenstein
- Cubicin, Daptomycin Hospira
- Luxembourg
- Daptomycin Eberth, Daptomycine Hikma
- Malta
- Daptomycin Anfarm, Daptomycin Dr. Reddys, Daptomycin Melita Pharm, Zepraxen
- Netherlands
- Daptomicin Accord Healthcare, Daptomicine Accord Healthcare, Daptomycin Hikma, Daptomycine Accordpharma, Daptomycine Amarox, Daptomycine Hikma
- Norway
- Cubicin, Daptomycin Accord Healthcare, Daptomycin Accordpharma, Daptomycin Hameln, Daptomycin Hospira, Daptomycin Mip, Daptomycin Noridem, Xelltempra Xellia
- Poland
- Daptomicina Fosun Pharma, Daptomycin Accord Healthcare, Daptomycin Accordpharma, Daptomycin Fosun Pharma
- Portugal
- Daptomicina Accord Healthcare, Daptomicina Accordpharma, Daptomicina Be Pharma, Daptomicina Cipla, Daptomicina Eugia, Daptomicina Hikma, Daptomicina Noridem, Daptomicina Normon, Daptomicina Reddy
- Romania
- Daptomicină Dr. Reddy’s, Daptomicină Mip
- Slovenia
- Daptomicin Accord Healthcare, Daptomicin Accordpharma
- Spain
- Daptomicin Tarbis, Daptomicina Accord, Daptomicina Accordpharma, Daptomicina Avalon, Daptomicina Cipla, Daptomicina Dr. Reddys, Daptomicina Eugia, Daptomicina Hikma, Daptomicina Noridem, Daptomicina Normon, Daptomicina Sala, Daptomicina Tillomed, Daptomicina Xellia, Xelltempra Xellia Pharmaceuticals
- Sweden
- Daptomycin Accord Healthcare, Daptomycin Accordpharma, Daptomycin Advanz Pharma, Daptomycin Hameln, Daptomycin Hikma, Daptomycin Mip, Daptomycin Noridem, Daptomycin Reddy, Xelltempra
EMA – Article 57 product data (EU/EEA), 2026-10-28
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Sources
- European Medicines Agency. Cubicin – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/cubicin-epar-product-information_en.pdf
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.