Foskina Cream

Foskina Cream

mupirocin

Manufacturer:

Glenmark

Distributor:

Glenmark
Full Prescribing Info
Contents
Mupirocin.
Description
Each gram of Cream contains Mupirocin Calcium, USP 21.5 mg in a mineral oil cream base.
List of excipients: The inactive ingredients are benzyl alcohol, glyceryl monostearate, mineral oil, phenoxyethanol, polyoxyl 20 cetostearyl ether, purified water and xanthan gum.
Action
Pharmacotherapeutic group: Dermatologicals. ATC code: D06AX09, Antibiotics and chemotherapeutics for dermatological use.
Pharmacology: Pharmacodynamics: Mode of action: Mupirocin is an antibiotic produced through fermentation of Pseudomonas fluorescens and inhibits bacterial protein synthesis by binding to bacterial isoleucyl t-RNA synthetase.
Mupirocin has bacteriostatic properties at minimum inhibitory concentrations and bactericidal properties at the higher concentrations reached when applied locally.
Mechanism of Resistance: Low-level resistance in staphylococci is thought to result from point mutations within the usual staphylococcal chromosomal gene (ileS) for the target isoleucyl tRNA synthetase enzyme. High-level resistance in staphylococci 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 of the outer membrane of the Gram-negative bacterial cell wall.
Due to its particular mode of action, and its unique chemical structure, mupirocin does not show any cross-resistance with other clinically available antibiotics.
Microbiological Susceptibility: The prevalence of acquired resistance may vary geographically and with time for selected species, and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infection is questionable. (See table.)

Click on icon to see table/diagram/image

Pharmacokinetics: Absorption: Systemic absorption of mupirocin through intact human skin is low although it may occur through broken/diseased skin. However, clinical trials have shown that when given systemically, it is metabolised to the microbiologically inactive metabolite monic acid and rapidly excreted.
Excretion: Mupirocin is rapidly eliminated from the body by metabolism to its inactive metabolite monic acid which is rapidly excreted by the kidney.
Toxicology: Preclinical safety data: Pre-clinical effects were seen only at exposures which give no cause for concern for man under normal conditions of clinical use. Mutagenicity studies revealed no risks to man.
Indications/Uses
Mupirocin Cream is indicated for the topical treatment of secondary infected traumatic lesions such as small lacerations, sutured wounds or abrasions (up to 10 cm in length or 100 cm2 in area) due to susceptible strains of Staphylococcus aureus and Staphylococcus pyogenes.
Dosage/Direction for Use
Adults/children ≥ 1 year/elderly: 3 times a day for up to 10 days, depending on the response.
Patients not showing a clinical response within 3 to 5 days should be re- evaluated.
The duration of treatment should not exceed 10 days.
Children <1 year: Mupirocin Cream has not been studied in infants under 1 year old and therefore it should not be used in these patients until further data become available.
Patients with hepatic impairment: No dosage adjustment is necessary.
Patients with renal impairment: No dosage adjustment is necessary.
Method of Administration: A thin layer 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.
Overdosage
Symptoms: There is currently limited experience with overdosage of mupirocin cream.
Management: There is no specific treatment for an overdose of mupirocin cream. 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.
Contraindications
Hypersensitivity to mupirocin or any of the excipients.
Special Precautions
Should a possible sensitisation reaction or severe local irritation occur with the use of mupirocin cream, 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.
The mupirocin cream formulation is not suitable for ophthalmic use and intranasal use.
Avoid contact with eyes. If contaminated, the eyes should be thoroughly irrigated with water until the cream residues have been removed.
Effects on ability to drive and use machines: 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.
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 should only be used in pregnancy when the potential benefits outweigh the possible risks of treatment.
Breast-feeding: There is no information on the excretion of mupirocin in milk. If a cracked nipple is to be treated, it should be thoroughly washed prior to breast feeding.
Adverse Reactions
Data from clinical trials was used to determine the frequency of very common to rare undesirable effects. Very rare adverse reactions were primarily determined from post-marketing experience data and therefore refer to reporting rate rather than true frequency.
The following convention has been used for the classification of frequency: - very common >1/10, common >1/100 and <1/10, uncommon >1/1000 and <1/100, rare >1/10,000 and <1/1000, very rare <1/10,000.
Immune system disorders: Very rare: Systemic allergic reactions including anaphylaxis, generalised rash, urticaria and angioedema.
Skin and subcutaneous tissue disorders: Common: Application site hypersensitivity reactions including urticaria, pruritus, erythema, burning sensation, contact dermatitis, rash.
Skin dryness and erythema have been reported in irritancy studies in volunteers.
Drug Interactions
No drug interactions have been identified.
Caution For Usage
Incompatibilities: Not applicable.
Special precautions for disposal and other handling: No special requirements.
Storage
Store at temperatures not exceeding 25°C.
Do not freeze.
Shelf life: 24 Months.
MIMS Class
ATC Classification
D06AX09 - mupirocin ; Belongs to the class of other topical antibiotics used in the treatment of dermatological diseases.
Presentation/Packing
Cream (tube) 20 mg/g (2% w/w) (white soft homogeneous cream) x 15 g.
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