BACTROBAN 2% Mupirocin 20mg / g Ointment 15g
NONRXDRUG-DRP-4193-15
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Features
Brand
Bactroban
Full Details
Dosage Strength
20 mg / g (2% w/w)
Drug Ingredients
- Mupirocin
Drug Packaging
Ointment 15g
Generic Name
Mupirocin
Dosage Form
Ointment
Registration Number
DRP-4193
Drug Classification
Over-The-Counter (OTC)
Description
Indications/Uses
Mupirocin (Bactroban) 2% Ointment is indicated for the topical treatment of primary and secondary bacterial skin infections.
Primary skin infections: Impetigo, folliculitis, furunculosis and ecthyma.
Secondary infections: Infected dermatoses e.g., infected eczema. Infected traumatic lesions e.g., abrasions, insect bites, minor (not requiring hospitalisation) wounds and burns.
Prophylaxis: Mupirocin may be used to avoid bacterial contamination of small wounds, incisions and other clean lesions, and to prevent infection of abrasions and small cuts and wounds.
Primary skin infections: Impetigo, folliculitis, furunculosis and ecthyma.
Secondary infections: Infected dermatoses e.g., infected eczema. Infected traumatic lesions e.g., abrasions, insect bites, minor (not requiring hospitalisation) wounds and burns.
Prophylaxis: Mupirocin may be used to avoid bacterial contamination of small wounds, incisions and other clean lesions, and to prevent infection of abrasions and small cuts and wounds.
Dosage/Direction for Use
Populations: Adults/Children/Elderly/Hepatically impaired: 2 to 3 times a day for up to 10 days, depending on the response.
Renally impaired: See Precautions.
Method of administration: A small quantity of cream should be applied to the affected area with a piece of clean cotton wool or gauze swab.
The treated area may be covered by a dressing.
Do not mix with other preparations as there is a risk of dilution, resulting in a reduction in the antibacterial activity and potential loss of stability of the mupirocin in the cream/ointment.
Renally impaired: See Precautions.
Method of administration: A small quantity of cream should be applied to the affected area with a piece of clean cotton wool or gauze swab.
The treated area may be covered by a dressing.
Do not mix with other preparations as there is a risk of dilution, resulting in a reduction in the antibacterial activity and potential loss of stability of the mupirocin in the cream/ointment.
Overdosage
Symptoms and Signs: There is currently limited experience with overdosage of mupirocin.
Treatment: There is no specific treatment for an overdose of mupirocin. In the event of overdose, the patient should be treated supportively with appropriate monitoring as necessary. Further management should be as clinically indicated or as recommended by the national poison center, where available.
Treatment: There is no specific treatment for an overdose of mupirocin. In the event of overdose, the patient should be treated supportively with appropriate monitoring as necessary. Further management should be as clinically indicated or as recommended by the national poison center, where available.
Contraindications
Mupirocin (Bactroban 2%) Ointment should not be given to patients with a history of hypersensitivity to mupirocin or any of the constituents of the preparations.
Special Precautions
In the rare event of a possible sensitisation reaction or severe local irritation occurring with the use of Mupirocin (Bactroban) 2% Cream/Ointment, treatment should be discontinued, the product should be washed/wiped off and appropriate alternative therapy for the infection instituted.
As with other antibacterial products, prolonged use may result in overgrowth of non-susceptible organisms.
Pseudomembranous colitis has been reported with the use of antibiotics and may range in severity from mild to life-threatening. Therefore, it is important to consider its diagnosis in patients who develop diarrhoea during or after antibiotic use. Although this is less likely to occur with topically applied mupirocin, if prolonged or significant diarrhoea occurs or the patient experiences abdominal cramps, treatment should be discontinued immediately and the patient investigated further.
Avoid contact with the eyes. If contaminated, the eyes should be thoroughly irrigated with water until the ointment residues have been removed.
Renal impairment: Polyethylene glycol can be absorbed from open wounds and damaged skin and is excreted by the kidneys. In common with other polyethylene glycol based ointments, mupirocin (Bactroban) 2% ointment should not be used in conditions where absorption of large quantities of polyethylene glycol is possible, especially if there is evidence of moderate or severe renal impairment. This mupirocin ointment formulation is not suitable for: ophthalmic use, intranasal use, use in conjunction with cannulae and at the site of central venous cannulation.
Ability to perform tasks that require judgement, motor or cognitive skills: No adverse effects on the ability to drive or operate machinery have been identified.
As with other antibacterial products, prolonged use may result in overgrowth of non-susceptible organisms.
Pseudomembranous colitis has been reported with the use of antibiotics and may range in severity from mild to life-threatening. Therefore, it is important to consider its diagnosis in patients who develop diarrhoea during or after antibiotic use. Although this is less likely to occur with topically applied mupirocin, if prolonged or significant diarrhoea occurs or the patient experiences abdominal cramps, treatment should be discontinued immediately and the patient investigated further.
Avoid contact with the eyes. If contaminated, the eyes should be thoroughly irrigated with water until the ointment residues have been removed.
Renal impairment: Polyethylene glycol can be absorbed from open wounds and damaged skin and is excreted by the kidneys. In common with other polyethylene glycol based ointments, mupirocin (Bactroban) 2% ointment should not be used in conditions where absorption of large quantities of polyethylene glycol is possible, especially if there is evidence of moderate or severe renal impairment. This mupirocin ointment formulation is not suitable for: ophthalmic use, intranasal use, use in conjunction with cannulae and at the site of central venous cannulation.
Ability to perform tasks that require judgement, motor or cognitive skills: No adverse effects on the ability to drive or operate machinery have been identified.
Use In Pregnancy & Lactation
Fertility: There are no data on the effects of mupirocin on human fertility. Studies in rats showed no effects on fertility (see Pharmacologic Properties: Toxicology: Non-Clinical Information under Actions).
Use in Pregnancy: Adequate human data on use during pregnancy are not available. Studies in animals do not indicate reproductive toxicity (see Pharmacologic Properties: Toxicology: Non-Clinical Information under Actions).
Bactroban Cream: Mupirocin should only be used in pregnancy when the potential benefits outweigh the potential risks associated with treatment.
Use in Lactation: Adequate human and animal data on use during lactation are not available.
If a cracked nipple is to be treated, it should be thoroughly washed prior to breast-feeding.
Use in Pregnancy: Adequate human data on use during pregnancy are not available. Studies in animals do not indicate reproductive toxicity (see Pharmacologic Properties: Toxicology: Non-Clinical Information under Actions).
Bactroban Cream: Mupirocin should only be used in pregnancy when the potential benefits outweigh the potential risks associated with treatment.
Use in Lactation: Adequate human and animal data on use during lactation are not available.
If a cracked nipple is to be treated, it should be thoroughly washed prior to breast-feeding.
Adverse Reactions
Adverse reactions are listed as follows by system organ class and frequency. Frequencies are defined as: very common (greater than or equal to 1/10), common (greater than or equal to 1/100, less than 1/10), uncommon (greater than or equal to 1/1000, less than 1/100), rare (greater than or equal to 1/10,000, less than 1/1000), very rare (less than 1/10,000), including isolated reports.
Common and uncommon adverse reactions were determined from pooled safety data from a clinical trial population of 1573 treated patients encompassing 12 clinical studies. Very rare adverse reactions were primarily determined from post-marketing experience data and therefore refer to reporting rate rather than true frequency.
Immune system disorders: Very rare: Systemic allergic reactions including anaphylaxis, generalised rash, urticaria and angioedema have been reported with mupirocin ointment.
Skin and subcutaneous tissue disorders: Common: Burning localised to the area of application.
Uncommon: Itching, erythema, stinging and dryness localised to the area of application. Cutaneous sensitisation reactions to mupirocin or the ointment base.
Common and uncommon adverse reactions were determined from pooled safety data from a clinical trial population of 1573 treated patients encompassing 12 clinical studies. Very rare adverse reactions were primarily determined from post-marketing experience data and therefore refer to reporting rate rather than true frequency.
Immune system disorders: Very rare: Systemic allergic reactions including anaphylaxis, generalised rash, urticaria and angioedema have been reported with mupirocin ointment.
Skin and subcutaneous tissue disorders: Common: Burning localised to the area of application.
Uncommon: Itching, erythema, stinging and dryness localised to the area of application. Cutaneous sensitisation reactions to mupirocin or the ointment base.
Caution For Usage
Incompatibilities: None identified/reported.
Instructions for Use/Handling: Any product remaining at the end of treatment should be discarded.
Wash hands after application.
Instructions for Use/Handling: Any product remaining at the end of treatment should be discarded.
Wash hands after application.
Storage
Store at temperatures not exceeding 25°C.
Action
Pharmacology: Pharmacodynamics: Mechanism of Action: Mupirocin is a novel antibiotic produced through fermentation of Pseudomonas fluorescens. Mupirocin inhibits isoleucyl transfer-RNA synthetase, thereby arresting bacterial protein synthesis.
Due to this particular mode of action, and its unique chemical structure, mupirocin does not show any cross-resistance with other clinically available antibiotics.
Mupirocin has bacteriostatic properties at minimum inhibitory concentrations and bactericidal properties at the higher concentrations reached when applied locally.
Pharmacodynamic Effects: Activity: Mupirocin is a topical antibacterial agent showing in vivo activity against Staphylococcus aureus (including methicillin-resistant strains), S. epidermidis and beta-haemolytic Streptococcus species.
The in vitro spectrum of activity includes the following bacteria: Commonly Susceptible Species: Staphylococcus aureus1,2, Staphylococcus epidermidis1,2, Coagulase-negative staphylococci1,2, Streptococcus species1, Haemophilus influenzae, Neisseria gonorrhoeae, Neisseria meningitides, Moraxella catarrhalis, Pasteurella multocida.
1Clinical efficacy has been demonstrated for susceptible isolates in approved clinical indications.
2Including beta-lactamase producing strains and methicillin-resistant strains.
Resistant Species: Corynebacterium species, Enterobacteriaceae, Gram negative non-fermenting rods, Micrococcus species, Anaerobes.
Mupirocin susceptibility (MIC) breakpoints for Staphylococcus spp.: Ointment and Cream: Susceptible: less than or equal to 1 microgram/mL.
Intermediate: 2 to 256 micrograms/mL.
Resistant: greater than 256 micrograms/mL.
Resistance mechanisms: Low-level resistance in staphylococci (MICs 8 to 256 micrograms/mL) has been shown to be due to changes in the native isoleucyl tRNA synthetase enzyme. High-level resistance in staphylococci (MICs greater than or equal to 512 micrograms/mL) has been shown to be due to a distinct, plasmid encoded isoleucyl tRNA synthetase enzyme. Intrinsic resistance in Gram-negative organisms such as the Enterobacteriaceae could be due to poor penetration into the bacterial cell.
Pharmacokinetics: Absorption: Mupirocin is poorly absorbed through intact human skin.
Metabolism: Mupirocin is suitable only for topical application. Following i.v. or oral administration, or if mupirocin is absorbed (e.g. through broken/diseased skin) mupirocin is rapidly metabolised to inactive monic acid.
Elimination: Mupirocin is rapidly eliminated from the body by metabolism to its inactive metabolite monic acid which is rapidly excreted by the kidney.
Special Patient Population: Elderly patients: No restrictions unless there is evidence of moderate or severe renal impairment (see Precautions).
Toxicology: Non-Clinical Information: Carcinogenesis/Mutagenesis: Carcinogenesis: Carcinogenicity studies with mupirocin have not been conducted.
Genotoxicity: Mupirocin was not mutagenic in Salmonella typhimurium or Escherichia coli (Ames assay). In a Yahagi assay, small increases in Salmonella typhimurium TA98 were observed at highly cytotoxic concentrations. In an in vitro mammalian gene mutation assay (MLA), no increase in mutation frequency was observed in the absence of metabolic activation. In the presence of metabolic activation, small increases in mutation frequency were observed at highly cytotoxic concentrations. However, no effects were observed in, yeast cell assays for gene conversion/mutation, an in vitro human lymphocyte assay or in an in vitro unscheduled DNA synthesis (UDS) assay. Furthermore, an in vivo mouse micronucleus assay (chromosome damage) and a rat Comet assay (DNA strand breakage) were negative, indicating the small increases observed at highly cytotoxic concentrations in vitro do not translate to the in vivo situation.
Reproductive Toxicology: Fertility: Mupirocin administered subcutaneously to male rats 10 weeks prior to mating and to female rats 15 days prior to mating until 20 days post coitum at doses up to 100 mg/kg/day had no effect on fertility.
Pregnancy: In embryo-foetal development studies in rats there was no evidence of developmental toxicity at subcutaneous doses up to 375 mg/kg/day.
In an embryo-foetal development study in rabbits at subcutaneous doses up to 160 mg/kg/day, maternal toxicity (impaired weight gain and severe injection site irritation) at the high dose resulted in abortion or poor litter performance. However, there was no evidence of developmental toxicity in foetuses of rabbits maintaining pregnancy to term.
Due to this particular mode of action, and its unique chemical structure, mupirocin does not show any cross-resistance with other clinically available antibiotics.
Mupirocin has bacteriostatic properties at minimum inhibitory concentrations and bactericidal properties at the higher concentrations reached when applied locally.
Pharmacodynamic Effects: Activity: Mupirocin is a topical antibacterial agent showing in vivo activity against Staphylococcus aureus (including methicillin-resistant strains), S. epidermidis and beta-haemolytic Streptococcus species.
The in vitro spectrum of activity includes the following bacteria: Commonly Susceptible Species: Staphylococcus aureus1,2, Staphylococcus epidermidis1,2, Coagulase-negative staphylococci1,2, Streptococcus species1, Haemophilus influenzae, Neisseria gonorrhoeae, Neisseria meningitides, Moraxella catarrhalis, Pasteurella multocida.
1Clinical efficacy has been demonstrated for susceptible isolates in approved clinical indications.
2Including beta-lactamase producing strains and methicillin-resistant strains.
Resistant Species: Corynebacterium species, Enterobacteriaceae, Gram negative non-fermenting rods, Micrococcus species, Anaerobes.
Mupirocin susceptibility (MIC) breakpoints for Staphylococcus spp.: Ointment and Cream: Susceptible: less than or equal to 1 microgram/mL.
Intermediate: 2 to 256 micrograms/mL.
Resistant: greater than 256 micrograms/mL.
Resistance mechanisms: Low-level resistance in staphylococci (MICs 8 to 256 micrograms/mL) has been shown to be due to changes in the native isoleucyl tRNA synthetase enzyme. High-level resistance in staphylococci (MICs greater than or equal to 512 micrograms/mL) has been shown to be due to a distinct, plasmid encoded isoleucyl tRNA synthetase enzyme. Intrinsic resistance in Gram-negative organisms such as the Enterobacteriaceae could be due to poor penetration into the bacterial cell.
Pharmacokinetics: Absorption: Mupirocin is poorly absorbed through intact human skin.
Metabolism: Mupirocin is suitable only for topical application. Following i.v. or oral administration, or if mupirocin is absorbed (e.g. through broken/diseased skin) mupirocin is rapidly metabolised to inactive monic acid.
Elimination: Mupirocin is rapidly eliminated from the body by metabolism to its inactive metabolite monic acid which is rapidly excreted by the kidney.
Special Patient Population: Elderly patients: No restrictions unless there is evidence of moderate or severe renal impairment (see Precautions).
Toxicology: Non-Clinical Information: Carcinogenesis/Mutagenesis: Carcinogenesis: Carcinogenicity studies with mupirocin have not been conducted.
Genotoxicity: Mupirocin was not mutagenic in Salmonella typhimurium or Escherichia coli (Ames assay). In a Yahagi assay, small increases in Salmonella typhimurium TA98 were observed at highly cytotoxic concentrations. In an in vitro mammalian gene mutation assay (MLA), no increase in mutation frequency was observed in the absence of metabolic activation. In the presence of metabolic activation, small increases in mutation frequency were observed at highly cytotoxic concentrations. However, no effects were observed in, yeast cell assays for gene conversion/mutation, an in vitro human lymphocyte assay or in an in vitro unscheduled DNA synthesis (UDS) assay. Furthermore, an in vivo mouse micronucleus assay (chromosome damage) and a rat Comet assay (DNA strand breakage) were negative, indicating the small increases observed at highly cytotoxic concentrations in vitro do not translate to the in vivo situation.
Reproductive Toxicology: Fertility: Mupirocin administered subcutaneously to male rats 10 weeks prior to mating and to female rats 15 days prior to mating until 20 days post coitum at doses up to 100 mg/kg/day had no effect on fertility.
Pregnancy: In embryo-foetal development studies in rats there was no evidence of developmental toxicity at subcutaneous doses up to 375 mg/kg/day.
In an embryo-foetal development study in rabbits at subcutaneous doses up to 160 mg/kg/day, maternal toxicity (impaired weight gain and severe injection site irritation) at the high dose resulted in abortion or poor litter performance. However, there was no evidence of developmental toxicity in foetuses of rabbits maintaining pregnancy to term.
MedsGo Class
Topical Antibiotics
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