Mupirocin (Mupirocin)

Trade Name : Mupirocin

Teva Pharmaceuticals USA, Inc.

OINTMENT

Strength 20 mg/g

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

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You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

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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 Teva Pharmaceuticals USA, 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

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
  • Mupirocin ointment is indicated for the topical treatment of impetigo due to susceptible isolates of and n
  • Mupirocin ointment is an RNA synthetase inhibitor antibacterial indicated for the topical treatment of impetigo due to susceptible isolates of and . ()
  • No data
  • For Topical Use Only. ()
  • Apply a small amount of mupirocin ointment, with a cotton swab or gauze pad, to the affected area 3 times daily for up to 10 days. ()
  • Re-evaluate patients not showing a clinical response within 3 to 5 days. ()
  • Not for intranasal, ophthalmic, or other mucosal use. ()
  • Each gram of mupirocin ointment USP contains 20 mg mupirocin in a water-miscible ointment base supplied in 22-gram tubes.
  • Ointment: Each gram contains 20 mg mupirocin in a water-miscible ointment base supplied in 22-gram tubes. ()
  • Mupirocin ointment is contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of mupirocin ointment.
  • Known hypersensitivity to mupirocin or any of the excipients of mupirocin ointment. ()
  • No data
  • Severe Allergic Reactions: Anaphylaxis, urticaria, angioedema, and generalized rash have been reported in patients treated with formulations of mupirocin, including mupirocin ointment. ()
  • Eye Irritation: Avoid contact with eyes. ()
  • Local Irritation: Discontinue in the event of sensitization or severe local irritation. ()
  • Clostridium difficile
  • Potential for Microbial Overgrowth: Prolonged use may result in overgrowth of nonsusceptible microorganisms, including fungi. ()
  • Risk Associated with Mucosal Use: Mupirocin ointment is not formulated for use on mucosal surfaces. A separate formulation, mupirocin nasal ointment, is available for intranasal use. ()
  • Risk of Polyethylene Glycol Absorption: Mupirocin ointment should not be used where absorption of large quantities of polyethylene glycol is possible, especially if there is evidence of moderate or severe renal impairment. ()
  • Risk Associated with Use at Intravenous Sites: Mupirocin ointment should not be used with intravenous cannulae or at central intravenous sites because of the potential to promote fungal infections and antimicrobial resistance. ()
  • The following adverse reactions are discussed in more detail in other sections of the labeling:
  • To report SUSPECTED ADVERSE REACTIONS, contact
  • TEVA USA, PHARMACOVIGILANCE at 1-866-832-8537
  • or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • The most frequent adverse reactions (at least 1%) were burning, stinging or pain, and itching. ()
  • 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 9-hydroxynonanoic acid. The chemical structure is:
  • CHO M.W. 500.63
  • Each gram of mupirocin ointment USP, 2% contains 20 mg mupirocin in a water-miscible ointment base (polyethylene glycol ointment, N.F.) consisting of polyethylene glycol 400 and polyethylene glycol 3350.
  • No data
  • Long-term 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 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 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 12 days. Clinical efficacy rates at end of therapy in the evaluable populations (adults and pediatric subjects included) were 71% for mupirocin ointment (n = 49) and 35% for vehicle placebo (n = 51). 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 40 mg per kg oral erythromycin ethylsuccinate per day (this was an unblinded trial) for 8 days. There was a follow-up visit 1 week 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 (n = 29) and 78.5% for erythromycin (n = 28). Pathogen eradication rates in the evaluable populations were 100% for both test groups.
  • Pediatrics
  • There were 91 pediatric subjects aged 2 months to 15 years in the first trial described above. Clinical efficacy rates at end of therapy in the evaluable populations were 78% for mupirocin ointment (n = 42) and 36% for vehicle placebo (n = 49). 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 7 months to 13 years. The clinical efficacy rate for mupirocin ointment (n = 27) was 96%, and for erythromycin it was unchanged (78.5%).
  • No data
  • Each gram of Mupirocin Ointment USP, 2% contains 20 mg mupirocin in a water-miscible ointment base.
  • Mupirocin Ointment USP, 2% is supplied in 22 gram tubes (NDC 0093-1010-42).
  • Store at 20 to 25C (68 to 77F) [See USP Controlled Room Temperature].
  • Advise the patient to read the FDA-approved patient labeling (Patient Information).
  • Advise the patient to administer mupirocin ointment as follows:
  • All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA, Inc.
  • Manufactured In Croatia By:
  • Pliva Hrvatska d.o.o.
  • Zagreb, Croatia
  • Manufactured For:
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. K 5/2017
  • 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 and 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:
  • 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:
  • Tell your healthcare provider about all of the medicines you take,
  • How should I use mupirocin ointment?
  • What are the possible side effects of mupirocin ointment?
  • Mupirocin ointment may cause serious side effects, including:
  • The most common side effects of mupirocin ointment include:
  • 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?
  • 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 USP?
  • Active Ingredient:
  • Inactive Ingredients:
  • For more information call 888-838-2872.
  • This Patient Information has been approved by the U.S. Food and Drug Administration.
  • Manufactured In Croatia By:
  • Pliva Hrvatska d.o.o.
  • Zagreb, Croatia
  • Manufactured For:
  • Teva Pharmaceuticals USA, Inc.
  • North Wales, PA 19454
  • Rev. B 5/2017
  • No data

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