Muprivex

Mupirocin.

Off white homogenous soft mass ointment.
Mupirocin is white to off-white crystalline powder. It is freely soluble in Acetone, in Chloroform, in Dehydrated alcohol and in Methanol, slightly soluble in Ether and very slightly soluble in Water. It has Molecular formula of C₂₆H₄₄O₉ and Molecular weight is 500.62.
Each gram contains: Mupirocin 20 mg.

Pharmacological Classification: Antibacterial (Antibiotic for Topical Use). ATC code: D06AX09.
Pharmacology: Pharmacodynamics: Mechanism of action: Mupirocin is a novel antibiotic produced through fermentation by Pseudomonas fluorescens. Mupirocin inhibits isoleucyl transfer-RNA synthetase, thereby arresting bacterial protein synthesis. Mupirocin has bacteriostatic properties at minimum inhibitory concentrations and bactericidal properties at the higher concentrations reached when applied locally.
Pharmacokinetics: After topical application of Mupirocin Ointment, mupirocin is only very minimally absorbed systemically and that which is absorbed is rapidly metabolised to the antimicrobially inactive metabolite, monic acid. Penetration of mupirocin into the deeper epidermal and dermal layers of the skin is enhanced in traumatised skin and under occlusive dressings.
Elderly: No restrictions unless there is evidence of moderate or severe renal impairment.

Mupirocin is indicated in adults and children.
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, streptococci. It is also active against Gram-negative organisms such as Escherichia coli and Haemophilus influenzae. Mupirocin Ointment is used for skin infections, e.g. impetigo, folliculitis, furunculosis.

Adults (including elderly) and Paediatric population: Mupirocin 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 if desired.
Method of administration: Topical.
Do not mix with other preparations as there is a risk of dilution, resulting in a reduction of the antibacterial activity and potential loss of stability of the mupirocin in the ointment.

Symptoms: There is currently limited experience with overdosage of mupirocin.
Management: The toxicity of mupirocin is very low. In the event of accidental ingestion of the ointment, symptomatic treatment should be given.
In case of erroneous oral intake of large quantities of the ointment, renal function should be closely monitored in patients with renal insufficiency because of the possible side effects of polyethylene glycol. 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 poisons centre, where available.

Hypersensitivity to the active substance(s) or to any of the excipients listed in Description.
This Mupirocin Ointment formulation is not suitable for ophthalmic or intranasal use.

For external use only.

Should a possible sensitisation reaction or severe local irritation occur with the use of Mupirocin Ointment, treatment should be discontinued, the product should be washed off and appropriate therapy 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.
Mupirocin Ointment is not suitable for: ophthalmic use; intranasal use (in neonates or infants); use in conjunction with cannulae; at the site of central venous cannulation.
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 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.

Pregnancy: Reproduction studies on mupirocin in animals have revealed no evidence of harm to the foetus. As there is no clinical experience on its use during pregnancy, Mupirocin Ointment should only be used in pregnancy when the potential benefits outweigh the possible risks of treatment.
Breast-feeding: It is unknown whether mupirocin is excreted in human milk. If a cracked nipple is to be treated, it should be thoroughly washed prior to breast-feeding.
Fertility: There are no data on the effects of mupirocin on human fertility. Studies in rats showed no effects on fertility.

Adverse reactions are listed as follows by system organ class and frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<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. (See table.)

Click on icon to see table/diagram/image

No interaction studies have been performed.

Store at a temperature below 30°C.
Keep the tube tightly closed after use.
Shelf Life: 24 months.

Topical Antibiotics

D06AX09 - mupirocin ; Belongs to the class of other topical antibiotics used in the treatment of dermatological diseases.

Non-Rx