Mupirocin Calcium (Bactroban)

Trade Name : BACTROBAN

GlaxoSmithKline LLC

OINTMENT

Strength 20 mg/g

MUPIROCIN CALCIUM RNA Synthetase Inhibitor Antibacterial [EPC],RNA Synthetase Inhibitors [MoA]

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Disclaimer

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 Mupirocin Calcium (Bactroban) which is also known as BACTROBAN and Manufactured by GlaxoSmithKline LLC. It is available in strength of 20 mg/g per ml. Read more

Mupirocin Calcium (Bactroban) 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.

Read more
  • No data
  • BACTROBAN nasal ointment is indicated for the eradication of nasal colonization with methicillinu2011resistant (MRSA) in adult and pediatric patients (aged 12 years and older) and healthcare workers as part of a comprehensive infection control program to reduce the risk of infection among patients at high risk of MRSA infection during institutional outbreaks of infections with this microorganism.
  • BACTROBAN nasal ointment is an RNA synthetase inhibitor antibacterial indicated for the eradication of nasal colonization with methicillin-resistant (MRSA) in adult and pediatric patients (aged 12 years and older) and healthcare workers as part of a comprehensive infection control program to reduce the risk of infection among patients at high risk of MRSA infection during institutional outbreaks of infections with this microorganism ()
  • 1
  • Staphylococcus aureus (S. aureus)
  • No data
  • BACTROBAN nasal ointment is a white to off-white ointment that contains 20 mg (2% w/w) of mupirocin in a soft white ointment base supplied in single-use 1u2011gram tubes.
  • Nasal ointment: 20 mg (2% w/w) of mupirocin in single-use 1-gram tubes. ()
  • BACTROBAN nasal ointment is contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of BACTROBAN nasal ointment.
  • Known hypersensitivity to mupirocin or any of the excipients of BACTROBAN nasal ointment. ()
  • No data
  • Clostridium difficile-
  • The following adverse reactions are discussed in more detail in other sections of the labeling:
  • The most frequent adverse reactions (at least 1% in U.S. trials) were headache, rhinitis, respiratory disorders, pharyngitis, taste perversion, burning/stinging, cough, and pruritus. ()
  • No data
  • BACTROBAN (mupirocin) nasal ointment, 2% contains the dihydrate crystalline calcium hemiu2011salt of the RNA synthetase inhibitor antibacterial, mupirocin. Chemically, it is (u03b1,2,3,4,5)-5-[(2,3,4,5)-2,3-epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4-dihydroxy-u03b2-methyl-2-pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid, calcium salt (2:1), dihydrate.
  • The molecular formula of mupirocin calcium is (CHO)Cau20222HO, and the molecular weight is 1075.3. The molecular weight of mupirocin free acid is 500.6. The structural formula of mupirocin calcium is:
  • Each gram of BACTROBAN nasal ointment contains 20 mg (2% w/w) of mupirocin equivalent to 21.5 mg (2.15% w/w) of mupirocin calcium. The inactive ingredients are paraffin and a mixture of glycerin esters (SOFTISANu00a0649).
  • No data
  • Longu2011term studies in animals to evaluate carcinogenic potential of mupirocin calcium have not been conducted.
  • Results of the following studies performed with mupirocin calcium or mupirocin sodium in vitro and in vivo did not indicate a potential for genotoxicity: rat primary hepatocyte unscheduled DNA synthesis, sediment analysis for DNA strand breaks, reversion test (Ames), mutation assay, metaphase analysis of human lymphocytes, mouse lymphoma assay, and bone marrow micronuclei assay in mice.
  • In a fertility/reproductive performance study (with dosing through lactation), mupirocin administered subcutaneously to male and female rats at doses up to 100 mg per kg per day, which is 41u00a0times the human intranasal dose (approximately 20u00a0mg mupirocin per day) based on calculations of dose divided by the entire body surface area, did not result in impaired fertility or impaired reproductive performance attributable to mupirocin.
  • All adequate and well-controlled trials of this product were vehicle-controlled; therefore, no data from direct, head-to-head comparisons with other products are available. The safety and effectiveness of applications of this medication for greater than 5 days have not been established. There are no human clinical or pre-clinical animal data to support the use of this product in a chronic manner or in manners other than those described in this prescribing information.
  • In clinical trials, 210 domestic (US) and 2,130 foreign adult subjects received BACTROBAN nasal ointment. Greater than 90% of subjects in clinical trials had eradication of nasal colonization 2 to 4 days after therapy was completed. Approximately 30% recolonization was reported in 1 domestic trial within 4 weeks after completion of therapy. These eradication rates were clinically and statistically superior to those reported in subjects in the vehicle-treated arms of the adequate and well-controlled trials. Those treated with vehicle had eradication rates of 5% to 30% at 2 to 4 days post-therapy with 85% to 100% recolonization within 4 weeks.
  • No data
  • BACTROBAN nasal ointment is a white to off-white ointment that contains 20 mg (2% w/w) of mupirocin.
  • BACTROBAN nasal ointment, 2% is supplied in single-use 1u2011gram tubes.
  • NDC 0029-1526-03 Single-use 1u2011gram tube in Package of 10: NDC 0029-1526-11.
  • Store between 20u00b0C and 25u00b0C (68u00b0F and 77u00b0F); excursions permitted to 15u00b0Cu00a0tou00a030u00b0C (59u00b0Fu00a0tou00a086u00b0F). Do not refrigerate.
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Advise the patient to administer BACTROBAN nasal ointment as follows:
  • BACTROBAN is owned by or licensed to the GSK group of companies. The other brand listed is a trademark owned by or licensed to its owner and is not owned by or licensed to the GSK group of companies. The maker of this brand is not affiliated with and does not endorse the GSK group of companies or its products.
  • GlaxoSmithKline
  • Research Triangle Park, NC 27709
  • u00a92020 GSK group of companies or its licensor.
  • BBN:8PI
  • PHARMACISTu2011DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT
  • No data
  • PRINCIPAL DISPLAY PANEL
  • NDC 0029-1526-11
  • Arrayn- BACTROBAN
  • Arrayn- (mupirocin nasal ointment, 2%
  • 10 x 1.0 gram Single-Use Tubes
  • This shrink-wrapped unit represents one 5-day course of therapy.
  • Store at 20- 25C (68 u2013 77F); excursions permitted 15 - 30C (59 u2013 86F).. Do not refrigerate.
  • Do not use if seal on tube nozzle is broken.
  • Usual Dosage:
  • GlaxoSmithKline
  • Research Triangle Park, NC 27709

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