BACTIFREE Mupirocin 2.0% Ointment 10g
RXDRUG-DRP-1138-10
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Features
Brand
Bactifree
Full Details
Dosage Strength
20mg /g (2% w/w)
Drug Ingredients
- Mupirocin
Drug Packaging
Ointment 10g
Generic Name
Mupirocin
Dosage Form
Ointment
Registration Number
DRP-1138
Drug Classification
Prescription Drug (RX)
Description
Indications/Uses
For the topical treatment of primary and secondary bacterial skin infections due to susceptible organisms: Primary skin infections: Impetigo, folliculitis, furunculosis, and ecthyma.
Secondary skin infections: Secondary infected dermatoses, such as eczema, psoriasis, atopic dermatitis, herpes, epidermolysis bullosa, ichthyosis, and infected traumatic lesions such as skin ulcers, minor burns, cuts, abrasions, small lacerations, sutured wounds, biopsy sites, surgical incisions, and insect bites.
Prophylaxis: Mupirocin may be used to prevent bacterial contamination in minor burns, biopsy sites, incisions and other clean lesions. For abrasions, minor cuts and wounds, the prophylactic use of mupirocin may prevent the development of infection and permit wound healing.
Secondary skin infections: Secondary infected dermatoses, such as eczema, psoriasis, atopic dermatitis, herpes, epidermolysis bullosa, ichthyosis, and infected traumatic lesions such as skin ulcers, minor burns, cuts, abrasions, small lacerations, sutured wounds, biopsy sites, surgical incisions, and insect bites.
Prophylaxis: Mupirocin may be used to prevent bacterial contamination in minor burns, biopsy sites, incisions and other clean lesions. For abrasions, minor cuts and wounds, the prophylactic use of mupirocin may prevent the development of infection and permit wound healing.
Dosage/Direction for Use
Wash hands before and after each application unless mupirocin is used to treat a hand condition.
Clean the affected and adjacent area with mild soap and water.
Rinse thoroughly and pat dry.
Apply a small amount of mupirocin ointment on the affected area three times daily for up to 10 days, or as prescribed by a physician. The treated area may be covered with gauze dressing if needed.
Re-assess patients not showing a clinical response within 3 to 5 days.
Do not apply concurrently with other topical medications, as there is a potential risk of dilution, resulting in reduction in antibacterial activity and potential loss of stability of mupirocin.
Clean the affected and adjacent area with mild soap and water.
Rinse thoroughly and pat dry.
Apply a small amount of mupirocin ointment on the affected area three times daily for up to 10 days, or as prescribed by a physician. The treated area may be covered with gauze dressing if needed.
Re-assess patients not showing a clinical response within 3 to 5 days.
Do not apply concurrently with other topical medications, as there is a potential risk of dilution, resulting in reduction in antibacterial activity and potential loss of stability of mupirocin.
Special Precautions
For external use on the skin only.
Avoid contact with the eyes. If the ointment comes in contact with the eyes, rinse out promptly and thoroughly with water.
Do not use at the site of central venous cannulation.
As with other polyethylene glycol-based ointments, do not use mupirocin ointment in conditions where large amounts of polyethylene glycol may be absorbed (e.g., in open wounds, extensive burns, broken skin), particularly in patients with moderate or severe renal impairment.
In cases of sensitivity or severe local irritation, discontinue mupirocin treatment and consult a physician.
As with other antibacterial products, long-term use may result in overgrowth of non-susceptible organisms, including fungi.
Avoid contact with the eyes. If the ointment comes in contact with the eyes, rinse out promptly and thoroughly with water.
Do not use at the site of central venous cannulation.
As with other polyethylene glycol-based ointments, do not use mupirocin ointment in conditions where large amounts of polyethylene glycol may be absorbed (e.g., in open wounds, extensive burns, broken skin), particularly in patients with moderate or severe renal impairment.
In cases of sensitivity or severe local irritation, discontinue mupirocin treatment and consult a physician.
As with other antibacterial products, long-term use may result in overgrowth of non-susceptible organisms, including fungi.
Adverse Reactions
Infections and infestations: Cellulitis, pharyngitis, secondary wound infection, upper respiratory tract infection.
Immune system disorders: Angioedema, application site hypersensitivity reactions, systemic allergic reactions.
Nervous system disorders: Dizziness, headache.
Gastrointestinal disorders: Abdominal pain, diarrhea, nausea, ulcerative stomatitis.
Skin and subcutaneous tissue disorders: Burning sensation, contact dermatitis, cutaneous sensitization reactions (to mupirocin or the ointment base), erythema, exfoliative dermatitis, furunculosis, hives, itching, pain, pruritus, rash, skin dryness, stinging, urticaria.
General disorders and administration site conditions: Fever, increased exudates, injury, pain or bleeding secondary to eczema, swelling, tenderness.
Immune system disorders: Angioedema, application site hypersensitivity reactions, systemic allergic reactions.
Nervous system disorders: Dizziness, headache.
Gastrointestinal disorders: Abdominal pain, diarrhea, nausea, ulcerative stomatitis.
Skin and subcutaneous tissue disorders: Burning sensation, contact dermatitis, cutaneous sensitization reactions (to mupirocin or the ointment base), erythema, exfoliative dermatitis, furunculosis, hives, itching, pain, pruritus, rash, skin dryness, stinging, urticaria.
General disorders and administration site conditions: Fever, increased exudates, injury, pain or bleeding secondary to eczema, swelling, tenderness.
Action
Pharmacologic Classification: Antibacterial.
Pharmacology: Mupirocin is a naturally occurring antibiotic produced by fermentation using the microorganism Pseudomonas fluorescens. It inhibits bacterial protein synthesis by reversibly and specifically binding to bacterial isoleucyl transfer-RNA synthetase. Due to its unique mode of action, mupirocin shows no cross resistance with other classes of antibiotics including erythromycin, fusidic acid, gentamicin, lincomycin, methicillin, neomycin, novobiocin, penicillin, streptomycin, chloramphenicol, or tetracycline.
Mupirocin is bactericidal at concentrations achieved with topical application. The minimum bactericidal concentration (MBC) of the drug against Staphylococcus aureus is usually eight to 32 times higher than the minimum inhibitory concentration (MIC) of the drug. The effect of wound secretions on the MICs of mupirocin has not been determined.
Based on in vitro studies, mupirocin's antibacterial activity is enhanced at a slightly acidic pH than at neutral or alkaline pH. It is inactivated at pH less than 4 or greater than 9. The normal skin pH (approximately 5.5) presumably contributes to the activity of mupirocin when applied topically to the skin.
Pharmacokinetics: Bioavailability: Mupirocin does not appear to be appreciably absorbed into the systemic circulation after topical application to intact skin. However, when the drug is applied to broken or diseased skin, the drug may be absorbed into deeper epidermis and possibly into the systemic circulation.
About 95% to 97% of mupirocin is highly bound to serum proteins in vitro.
Any systemically absorbed mupirocin is eliminated from the body by de-esterification of the drug to its inactive metabolite, monic acid, which is rapidly excreted in the urine.
Pharmacology: Mupirocin is a naturally occurring antibiotic produced by fermentation using the microorganism Pseudomonas fluorescens. It inhibits bacterial protein synthesis by reversibly and specifically binding to bacterial isoleucyl transfer-RNA synthetase. Due to its unique mode of action, mupirocin shows no cross resistance with other classes of antibiotics including erythromycin, fusidic acid, gentamicin, lincomycin, methicillin, neomycin, novobiocin, penicillin, streptomycin, chloramphenicol, or tetracycline.
Mupirocin is bactericidal at concentrations achieved with topical application. The minimum bactericidal concentration (MBC) of the drug against Staphylococcus aureus is usually eight to 32 times higher than the minimum inhibitory concentration (MIC) of the drug. The effect of wound secretions on the MICs of mupirocin has not been determined.
Based on in vitro studies, mupirocin's antibacterial activity is enhanced at a slightly acidic pH than at neutral or alkaline pH. It is inactivated at pH less than 4 or greater than 9. The normal skin pH (approximately 5.5) presumably contributes to the activity of mupirocin when applied topically to the skin.
Pharmacokinetics: Bioavailability: Mupirocin does not appear to be appreciably absorbed into the systemic circulation after topical application to intact skin. However, when the drug is applied to broken or diseased skin, the drug may be absorbed into deeper epidermis and possibly into the systemic circulation.
About 95% to 97% of mupirocin is highly bound to serum proteins in vitro.
Any systemically absorbed mupirocin is eliminated from the body by de-esterification of the drug to its inactive metabolite, monic acid, which is rapidly excreted in the urine.
MedsGo Class
Topical Antibiotics
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