Bactoderm

Bactoderm

mupirocin

Manufacturer:

Ikapharmindo
Full Prescribing Info
Contents
Mupirocin.
Description
Cream: Each gram of cream contains: Mupirocin calcium equivalent to Mupirocin 20 mg.
Ointment: Each gram of ointment contains: Mupirocin 20 mg.
A presentation of Mupirocin 2% w/w in a white translucent, water soluble Polyethylene Glycol base.
Action
Pharmacology: Cream: Mechanism of Drug Action: Mupirocin is produced by fermentation using the organism Pseudomonas fluorencens. Mupirocin inhibits bacterial protein synthesis by reversibly and specifically binding to bacterial isoleucyl transfer RNA synthetase. Due to this mode of action, Mupirocin demonstrates no in vitro cross-resistance with fusidic acid, chloramphenicol, erythromycin, gentamicin, lincomycin, methicillin, neomycin, novabiocin, penicillin, streptomycin and tetracycline.
Ointment: Mupirocin is a topical antibacterial agent, active against those organisms responsible for the majority of skin infections e.g. Staphylococcus aureus, including methicillin-resistant strains, other staphylococci, and streptococci. It is also active against Gram-negative organisms such as Escherichia coli and Haemophilus influenzae.
Pharmacokinetics: Absorption and Excretion: BACTODERM ointment penetrates into human skin but the rate of systemic penetration appears to be low. Systemically absorbed, BACTODERM is rapidly metabolized to the inactive metabolite, monic acid, and quickly excreted by the kidneys.
Indications/Uses
Cream: Acute primary skin infections such as impetigo, folliculitis, furunculosis.
Ointment: Acute primary and secondary bacterial skin infections such as impetigo, pyoderma, folliculitis, furunculosis, abcess, wound infections, trauma, post surgery wounds, burns, etc.
Dosage/Direction for Use
Cream: Adults and children: Bactoderm cream should be applied to the affected area three times daily.
The area treated may be covered with gauze dressing if necessary.
Patients not showing a clinical response without 3 to 5 days should be re-evaluated.
Ointment: Adults and children: BACTODERM ointment should be applied to the affected area up to three times a day, for up to 10 days. The area may be covered with a dressing or occluded with a dressing if desired.
Contraindications
Cream: Bactoderm Cream is contraindicated in patients with known hypersensitivity to any of the constituents of the product.
Ointment: Hypersensitivity to Mupirocin or Polyethylene Glycol.
Special Precautions
Cream: Avoid contact with the eyes.
Use with caution if signs of renal impairment develop.
Use with caution during pregnancy.
Caution should be exercised the drug is administered to a nursing woman.
In the event of a sensitization or severe local irritation, usage should be discontinued immediately, and appropriate alternative therapy instituted.
Prolonged use of the drug may result in overgrowth of nonsusceptible microorganisms.
The drug is not formulated for use on mucosal surfaces.
Polythylene glycol (PEG) can be absorbed from open wounds and skin damage, which is then excreted renally. Therefore caution should be exercised when absorption of large quantities of PEG is possible, particularly in patients known to have moderate to severe renal impairment.
Ointment: When BACTODERM ointment is used on the face, care should be taken to avoid the eyes.
BACTODERM ointment should be used with caution if there is evidence of moderate or severe renal impairment.
Use in pregnancy: studies in experimental animals have shown Mupirocin has no teratogenic effects. However, there is inadequate evidence of safety to recommend the use of BACTODERM ointment during pregnancy.
Use with caution during pregnancy.
Use In Pregnancy & Lactation
Cream: Use with caution during pregnancy.
Caution should be exercised the drug is administered to a nursing woman.
Ointment: Use in pregnancy: studies in experimental animals have shown Mupirocin has no teratogenic effects. However, there is inadequate evidence of safety to recommend the use of BACTODERM ointment during pregnancy.
Use with caution during pregnancy.
Adverse Reactions
Cream: Rash, burning and pruritus.
Ointment: Burning, stinging and itching.
Storage
Store in a dry place below 25°C.
MIMS Class
ATC Classification
D06AX09 - mupirocin ; Belongs to the class of other topical antibiotics used in the treatment of dermatological diseases.
Presentation/Packing
Cream 2% x 5 g x 1's, 10 g x 1's. Oint 2% x 10 g x 1's.
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