1. Name Of The Medicinal Product
Brulidine Cream
Lloyds Antiseptic Cream
2. Qualitative And Quantitative Composition
Dibrompropamidine isethionate 0.15%w/w
3. Pharmaceutical Form
Cream
4. Clinical Particulars
4.1 Therapeutic Indications
Indications
(a) First aid dressing for minor burns, scalds, abrasions and other open injuries and their routine treatment
(b) For the treatment of surface infections due to susceptible organisms, particularly in cases with penicillin resistant Staphylococci or certain Gram-negative bacilli
(c) Treatment of ringworm of the scalp (Microsporum canis) and other superficial fungal infections
(d) Treatment of pyodermias, including sycosis barbae
(e) Treatment of otitis externa
(f) Treatment of nappy rash
4.2 Posology And Method Of Administration
Adults: apply to the affected area, either directly or on a light dressing, two or three times a day.
Elderly and children: no specific recommendations.
4.3 Contraindications
Brulidine Cream should not be used in patients with known hypersensitivity to dibrompropamidine or any of the other ingredients.
4.4 Special Warnings And Precautions For Use
Prolonged use may interfere with healing and cause skin necrosis in infants.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
None known
4.6 Pregnancy And Lactation
There is no evidence of the drug's safety in human use nor is there any evidence from animal work that it is free from hazard. Avoid unless considered essential.
4.7 Effects On Ability To Drive And Use Machines
None
4.8 Undesirable Effects
There is always the possibility, although rare, of a sensitisation reaction or contact dermatitis occurring: in such an event, treatment should be discontinued immediately.
4.9 Overdose
The 25g tube of Brulidine Cream contains 37.5mg of dibrompropamidine and the 30g contains 45mg.
No toxic effects are likely to occur even if the contents of a full tube are accidentally ingested. Similarly, the ingredients of the base are unlikely to have toxic effects in the quantities present.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Dibrompropamidine isethionate is an antibacterial agent active against pathogenic Streptococci and Staphylococci, including penicillin resistant strains, and has some activity against a number of Gram negative bacilli. Its antibacterial action in not inhibited by pus, blood or p-aminobenzoic acid. In addition, it has useful activity against certain species of pathogenic fungi. Brulidine Cream is well tolerated and rarely gives rise to sensitisation reactions or contact dermatitis.
5.2 Pharmacokinetic Properties
No data available
5.3 Preclinical Safety Data
No relevant data
6. Pharmaceutical Particulars
6.1 List Of Excipients
Caster oil, virgin
Cetostearyl alcohol
Polyethylene glycol 600 monostearate
Methyl parahydroxybenzoate
Silicone MS antifoam A
Purified water
6.2 Incompatibilities
Not applicable
6.3 Shelf Life
36 months
6.4 Special Precautions For Storage
Store below 25°C
6.5 Nature And Contents Of Container
Collapsible aluminium internally lacquered tube with extended nozzle containing 25g or 30g cream
Polythene plug seal cap
6.6 Special Precautions For Disposal And Other Handling
Not applicable
7. Marketing Authorisation Holder
Manx Pharma Ltd
Taylor Group House
Wedgnock Lane
Warwick
CV34 5YA
United Kingdom
8. Marketing Authorisation Number(S)
PL 15833/0002
9. Date Of First Authorisation/Renewal Of The Authorisation
1 September 1997 / 30 May 2002
10. Date Of Revision Of The Text
September 2010
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