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Mupirocin Calcium (Bactroban)

Trade Name : BACTROBAN

GlaxoSmithKline LLC

CREAM

Strength 20 mg/g

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

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Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

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.

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  • No data
  • BACTROBAN cream is indicated for the treatment of secondarily infected traumatic skin lesions (up to 10u00a0cm in length or 100u00a0cm in area) due to susceptible isolates of and .
  • BACTROBAN cream is an RNA synthetase inhibitor antibacterial indicated for the treatment of secondarily infected traumatic skin lesions (up to 10u00a0cm in length or 100u00a0cmin area) due to susceptible isolates of and ()
  • No data
  • BACTROBAN cream is a white cream that contains 20 mg (2% w/w) of mupirocin per gram in an oil- and wateru2011based emulsion, supplied in 15-gram and 30-gram tubes.
  • Cream: 20 mg (2% w/w) of mupirocin per gram in 15-gram and 30-gram tubes. ()
  • BACTROBAN cream is contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of BACTROBAN cream.
  • Known hypersensitivity to mupirocin or any of the excipients of BACTROBAN cream. ()
  • 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%) were headache, rash, and nausea. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or
  • No data
  • BACTROBAN (mupirocin) cream, 2% contains the dihydrate crystalline calcium hemi-salt 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 cream contains 20 mg (2% w/w) of mupirocin equivalent to 21.5 mg (2.15% w/w) of mupirocin calcium. The inactive ingredients are benzyl alcohol, cetomacrogol 1000, cetyl alcohol, mineral oil, phenoxyethanol, purified water, stearyl alcohol, and xanthan gum.
  • 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 14 times the human topical dose (approximately 60 mg 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.
  • The efficacy of topical BACTROBAN cream for the treatment of secondarily infected traumatic skin lesions (e.g., lacerations, sutured wounds, and abrasions not more than 10u00a0cm in length or 100u00a0cm in total area) was compared with that of oral cephalexin in 2 randomized, doubleu2011blind, doubleu2011dummy clinical trials. Clinical efficacy rates at followu2011up in the per-protocol populations (adults and pediatric subjects included) were 96.1% for BACTROBAN cream (nu00a0=u00a0231) and 93.1% for oral cephalexin (nu00a0=u00a0219). Pathogen eradication rates at followu2011up in the per-protocol populations were 100% for both BACTROBAN cream and oral cephalexin.
  • Pediatrics
  • There were 93 pediatric subjects aged 2u00a0weeks to 16u00a0years enrolled per protocol in the secondarily infected skin lesion trials, although only 3 were younger than 2u00a0years of age in the population treated with BACTROBAN cream. Subjects were randomized to either 10u00a0days of topical BACTROBAN cream 3u00a0times daily or 10u00a0days of oral cephalexin (250u00a0mg 4u00a0times daily for subjects greater than 40u00a0kg or 25 mg per kg per day oral suspension in 4 divided doses for subjects less than or equal to 40u00a0kg). Clinical efficacy at followu2011up (7 to 12u00a0days post-therapy) in the per-protocol populations was 97.7% (43u00a0ofu00a044) for BACTROBAN cream and 93.9% (46u00a0ofu00a049) for cephalexin.
  • No data
  • BACTROBAN cream is a white cream that contains 20 mg (2% w/w) of mupirocin per gram in an oil- and water-based emulsion.
  • BACTROBAN cream, 2% is supplied in 15u2011gram and 30u2011gram tubes.
  • NDC 0029-1527-22 (15-gram tube)
  • NDC 0029-1527-25 (30-gram tube)
  • Store at or below 25u00b0C (77u00b0F). Do not freeze.
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Advise the patient to administer BACTROBAN cream as follows:
  • Trademarks are owned by or licensed to the GSK group of companies.
  • GlaxoSmithKline
  • Research Triangle Park, NC 27709
  • u00a92020 GSK group of companies or its licensor.
  • BBC:5PI
  • PHARMACISTu2011DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT
  • No data
  • PRINCIPAL DISPLAY PANEL
  • NDC 0029-1527-22
  • Arrayn- BACTROBAN
  • Arrayn- (mupirocin) cream, 2%, for topical use
  • Arrayn- 15 grams
  • R only
  • Do not use if seal on tube nozzle is broken
  • Made in England
  • u00a92019 the GSK group of companies

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