Mupirocin (Mupirocin)

Trade Name : Mupirocin

E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

OINTMENT

Strength 20 mg/g

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

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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 Mupirocin (Mupirocin) which is also known as Mupirocin and Manufactured by E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.. It is available in strength of 20 mg/g per ml. Read more

Mupirocin (Mupirocin) 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

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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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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
  • Mupirocin ointment is indicated for the topical treatment of impetigo due to susceptible isolates of u00a0 and .
  • Mupirocin ointment is an RNA synthetase inhibitor antibacterial indicated for the topical treatment of impetigo due to susceptible isolates of and ()
  • No data
  • Each gram of Mupirocin Ointment USP, 2% contains 20u00a0mg mupirocin in a water-miscible ointment base supplied in 22-gram tubes.
  • u2022
  • 3
  • Mupirocin ointment is contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of Mupirocin ointment.
  • u2022
  • 4
  • No data
  • Clostridium difficile-
  • The following adverse reactions are discussed in more detail in other sections of the labeling:
  • To report SUSPECTED ADVERSE REACTIONS, contact Fougera Pharmaceuticals Inc. at 1-800-645-9833 or FDA at 1-800-FDA-1088 or
  • u2022
  • 6.1
  • No data
  • Mupirocin Ointment USP, 2% contains the RNA synthetase inhibitor antibacterial, mupirocin. The chemical name is ()-(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 9u2011hydroxynonanoic acid.
  • The molecular formula of mupirocin is CHO and the molecular weight is 500.6. The structural formula of mupirocin is:
  • Figure 1. Structure of Mupirocin
  • Each gram of Mupirocin Ointment USP, 2% contains 20u00a0mg mupirocin in a water-miscible ointment base (polyethylene glycol ointment, N.F.) consisting of polyethylene glycol 400 and polyethylene glycol 3350.
  • No data
  • Longu2011term studies in animals to evaluate carcinogenic potential of mupirocin have not been conducted.
  • Results of the following studies performed with mupirocin calcium or mupirocin sodium and 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 14u00a0times the human topical dose (approximately 60u00a0mg 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 Mupirocin ointment in impetigo was tested in 2 trials. In the first, subjects with impetigo were randomized to receive either Mupirocin ointment or vehicle placebo 3 times daily for 8 to 12u00a0days. Clinical efficacy rates at end of therapy in the evaluable populations (adults and pediatric subjects included) were 71% for Mupirocin ointment (nu00a0=u00a049) and 35% for vehicle placebo (nu00a0=u00a051). Pathogen eradication rates in the evaluable populations were 94% for Mupirocin ointment and 62% for vehicle placebo.
  • In the second trial, subjects with impetigo were randomized to receive either Mupirocin ointment 3 times daily or 30 to 40u00a0mgu00a0peru00a0kg oral erythromycin ethylsuccinate per day (this was an unblinded trial) for 8u00a0days. There was a followu2011up visit 1u00a0week after treatment ended. Clinical efficacy rates at the follow-up visit in the evaluable populations (adults and pediatric subjects included) were 93% for Mupirocin ointment (nu00a0=u00a029) and 78.5% for erythromycin (nu00a0=u00a028). Pathogen eradication rates in the evaluable populations were 100% for both test groups.
  • Pediatrics
  • There were 91 pediatric subjects aged 2u00a0months to 15u00a0years in the first trial described above. Clinical efficacy rates at end of therapy in the evaluable populations were 78% for Mupirocin ointment (nu00a0=u00a042) and 36% for vehicle placebo (nu00a0=u00a049). In the second trial described above, all subjects were pediatric except 2 adults in the group receiving Mupirocin ointment. The age range of the pediatric subjects was 7u00a0months to 13u00a0years. The clinical efficacy rate for Mupirocin ointment (nu00a0=u00a027) was 96%, and for erythromycin it was unchanged (78.5%).
  • No data
  • Mupirocin Ointment USP, 2% is supplied in 22u2011gram tubes.
  • Each gram of Mupirocin Ointment USP, 2% contains 20u00a0mg mupirocin in a water-miscible ointment base.
  • NDC 0168-0352-22 (22-gram tube)
  • Store at controlled room temperature 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F). [See USP Controlled Temperature.]
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Advise the patient to administer Mupirocin ointment as follows:
  • PATIENT INFORMATION
  • Mupirocin Ointment
  • (myoo-PEER-oh-sin)
  • What is Mupirocin ointment?
  • Mupirocin ointment is a prescription medicine used on the skin (topical use) to treat a skin infection called impetigo that is caused by bacteria called Staphylococcus aureus and Streptococcus pyogenes.
  • It is not known if Mupirocin ointment is safe and effective in children under 2 months of age.
  • Who should not use Mupirocin ointment?
  • Do not use Mupirocin ointment if:
  • u2022 you are allergic to mupirocin or any of the ingredients in Mupirocin ointment. See the end of this Patient Information leaflet for a complete list of the ingredients in Mupirocin ointment.
  • What should I tell my healthcare provider before using Mupirocin ointment?
  • Before using Mupirocin ointment, tell your healthcare provider about all of your medical conditions including if you:
  • u2022 have kidney problems
  • u2022 are pregnant or plan to become pregnant. It is not known if Mupirocin ointment will harm your unborn baby.
  • u2022 are breastfeeding or plan to breastfeed. It is not known if Mupirocin ointment passes into your breast milk. You and your healthcare provider should decide if you can use Mupirocin ointment while breastfeeding.
  • Tell your healthcare provider about all of the medicines you take,
  • How should I use Mupirocin ointment?
  • u2022 Mupirocin ointment is for use on the skin (topical).
  • u2022 Use Mupirocin ointment exactly as your healthcare provider tells you to use it.
  • u2022 Apply a small amount of Mupirocin ointment, with a cotton swab or gauze pad, to the affected area 3 times each day.
  • u2022 It is important that you take the full course of Mupirocin ointment. Do not stop early because your symptoms may disappear before the infection is fully cleared.
  • u2022 Wash your hands applying Mupirocin ointment.
  • u2022 After applying Mupirocin ointment, you may cover the treated area with a clean gauze pad, unless your healthcare provider has told you to leave it uncovered.
  • u2022 Talk to your healthcare provider if your skin does not improve after 3 to 5 days of treatment with Mupirocin ointment.
  • u2022 If you are breastfeeding and use Mupirocin ointment on your breast or nipple, wash the area well before breastfeeding your child.
  • What are the possible side effects of Mupirocin ointment?
  • Mupirocin ointment may cause serious side effects, including:
  • u2022 Stop using Mupirocin ointment and call your healthcare provider or go to the nearest emergency room right away if you have any of the following signs or symptoms of a severe allergic reaction:
  • u2218 hives
  • u2218 swelling of your face, lips, mouth, or tongue
  • u2218 a rash over your whole body
  • u2218 trouble breathing or wheezing
  • u2218 dizziness, fast heartbeat or pounding in your chest
  • u2022 Do not get Mupirocin ointment in your eyes. If Mupirocin ointment gets in your eyes, rinse your eyes well with water.
  • u2022 . Stop using Mupirocin ointment and call your healthcare provider if you develop an irritation, severe itching, or a rash while using Mupirocin ointment.
  • u2022 CDAD may happen in people who use or have used medicine to treat bacterial infections. The severity of CDAD can range from mild diarrhea to severe diarrhea that may cause death (fatal colitis). Call your healthcare provider or go to the nearest emergency room right away if you have diarrhea while using or after you stop using Mupirocin ointment.
  • u2022 Mupirocin ointment contains polyethylene glycol, which in large amounts can cause kidney damage. You should not apply Mupirocin ointment to open skin wounds or damaged skin, especially if you have kidney problems.
  • u2022 Mupirocin ointment should not be used on skin that is near an IV (intravenous) site.
  • The most common side effects of Mupirocin ointment include:
  • u2022 burning
  • u2022 stinging or pain
  • u2022 itching
  • These are not all the possible side effects of Mupirocin ointment. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store Mupirocin ointment?
  • u2022 Store Mupirocin ointment at room temperature between 68u00b0F to 77u00b0F (20u00b0C to 25u00b0C).
  • u2022 Keep Mupirocin ointment and all medicines out of the reach of children
  • General information about the safe and effective use of Mupirocin ointment
  • Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Mupirocin ointment for a condition for which it was not prescribed. Do not give Mupirocin ointment to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Mupirocin ointment that is written for health professionals.
  • What are the ingredients in Mupirocin ointment?
  • Active Ingredient:
  • Inactive Ingredients:
  • 46218959A
  • R01/18#122
  • This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: March 2017
  • PACKAGE LABEL u2013 PRINCIPAL DISPLAY PANEL u2013 22 G CONTAINER
  • NDC
  • Fougerau00ae
  • MUPIROCINn- OINTMENT USP, 2%
  • Rx
  • NET WT 22 grams
  • NDC
  • Rx
  • FOUGERAn- u00a0u00a0u00a0
  • MUPIROCIN OINTMENT USP, 2%
  • WARNING: Keep out of reach of children.
  • NET WT 22 grams

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