Daptomycin (Cubicin)

Trade Name : Cubicin

Merck Sharp & Dohme Corp.

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Strength 500 mg/10mL

DAPTOMYCIN Lipopeptide Antibacterial [EPC],Lipopeptides [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Daptomycin (Cubicin) which is also known as Cubicin and Manufactured by Merck Sharp & Dohme Corp.. It is available in strength of 500 mg/10mL per ml. Read more

Daptomycin (Cubicin) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • CUBICIN is a lipopeptide antibacterial indicated for the treatment of:
  • Limitations of Use:
  • To reduce the development of drug-resistant bacteria and maintain the effectiveness of CUBICIN and other antibacterial drugs, CUBICIN should be used to treat infections that are proven or strongly suspected to be caused by bacteria. ()
  • Adult Patients
  • Pediatric Patients
  • For Injection: 500 mg daptomycin as a sterile, pale yellow to light brown lyophilized powder for reconstitution in a single-dose vial.
  • For Injection: 500 mg lyophilized powder for reconstitution in a single-dose vial ()
  • CUBICIN is contraindicated in patients with known hypersensitivity to daptomycin.
  • Known hypersensitivity to daptomycin ()
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  • Anaphylaxis/hypersensitivity reactions (including life-threatening): Discontinue CUBICIN and treat signs/symptoms. ()
  • Myopathy and rhabdomyolysis: Monitor CPK levels and follow muscle pain or weakness; if elevated CPK or myopathy occurs, consider discontinuation of CUBICIN. ()
  • Eosinophilic pneumonia: Discontinue CUBICIN and consider treatment with systemic steroids. ()
  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): Discontinue CUBICIN and institute appropriate treatment. ()
  • Tubulointerstitial Nephritis (TIN): Discontinue CUBICIN and institute appropriate treatment. ()
  • Peripheral neuropathy: Monitor for neuropathy and consider discontinuation. ()
  • Potential nervous system and/or muscular system effects in pediatric patients younger than 12 months: Avoid use of CUBICIN in this age group. ()
  • Clostridioides difficileu2013
  • Persisting or relapsing bacteremia/endocarditis: Perform susceptibility testing and rule out sequestered foci of infection. ()
  • Decreased efficacy was observed in adult patients with moderate baseline renal impairment. ()
  • The following adverse reactions are described, or described in greater detail, in other sections:
  • To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Adult cSSSI Patients:
  • Pediatric cSSSI Patients:
  • Adult bacteremia/endocarditis Patients:n- S. aureus
  • Pediatric bacteremia Patients:
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  • In the event of overdosage, supportive care is advised with maintenance of glomerular filtration. Daptomycin is cleared slowly from the body by hemodialysis (approximately 15% of the administered dose is removed over 4 hours) and by peritoneal dialysis (approximately 11% of the administered dose is removed over 48 hours). The use of high-flux dialysis membranes during 4 hours of hemodialysis may increase the percentage of dose removed compared with that removed by low-flux membranes.
  • CUBICIN (daptomycin for injection) contains daptomycin, a cyclic lipopeptide antibacterial agent derived from the fermentation of . The chemical name is -decanoyl-L-tryptophyl-D-asparaginyl-L-aspartyl-L-threonylglycyl-L-ornithyl-L-aspartyl-D-alanyl-L-aspartylglycyl-D-seryl--3-methyl-L-glutamyl-3-anthraniloyl-L-alanine u03b5-lactone. The chemical structure is:
  • The empirical formula is CHNO; the molecular weight is 1620.67. CUBICIN is supplied in a single-dose vial as a sterile, preservative-free, pale yellow to light brown, lyophilized cake containing approximately 500 mg of daptomycin for intravenous (IV) use following reconstitution with 0.9% sodium chloride injection The only inactive ingredient is sodium hydroxide, which is used for pH adjustment. Freshly reconstituted solutions of CUBICIN range in color from pale yellow to light brown.
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  • CUBICIN (daptomycin for injection) is supplied as a sterile pale yellow to light brown lyophilized cake in a single-dose 10 mL vial containing 500 mg of daptomycin: Package of 1 (NDC 67919-011-01).
  • Store original packages at refrigerated temperatures, 2 to 8u00b0C (36 to 46u00b0F); avoid excessive heat n
  • Advise patients that allergic reactions, including serious allergic reactions, could occur and that serious reactions require immediate treatment. Patients should report any previous allergic reactions to daptomycin. n
  • Advise patients to report muscle pain or weakness, especially in the forearms and lower legs, as well as tingling or numbness. n
  • Advise patients to report any symptoms of cough, breathlessness, or fever. n
  • Advise patients that diarrhea is a common problem caused by antibacterials that usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterials, patients can develop watery and bloody stools (with or without stomach cramps and fever), even as late as 2 or more months after having received the last dose of the antibacterial. If this occurs, patients should contact their physician as soon as possible. n
  • Counsel patients that antibacterial drugs, including CUBICIN, should be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When CUBICIN is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be administered exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by CUBICIN or other antibacterial drugs in the future.
  • Distributed by: Merck Sharp & Dohme Corp., a subsidiary ofn Whitehouse Station, NJ 08889, USA
  • For patent information: www.merck.com/product/patent/home.html
  • The trademarks depicted herein are owned by their respective companies.
  • Copyright u00a9 2015-2020 Merck Sharp & Dohme Corp., a subsidiary of n All rights reserved.
  • uspi-mk3009-i-2008r010
  • NDC 67919-011-01
  • Cubicinn- 500 mg per vial
  • MUST BE REFRIGERATED
  • For Intravenous Infusion.
  • Use 0.9% Sodium ChlorideInjection for reconstitutiononly.
  • Single-dose vial u2013Discard Unused Portion
  • Rx only

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