SMTL Dressings Datacard



Product Name: Flamazine
Classification Name: Silver-sulphadiazine cream
Manufacturer: Smith & Nephew Pharmaceuticals Limited

Description

Flamazine consists of a white hydrophilic cream containing micronised silver sulphadiazine 1% w/w in a semi-solid oil in water emulsion. Other ingredients include glycerol monostearate, polysorbates, cetyl alcohol, liquid paraffin, propylene glycol and purified water.

Indications

Flamazine is used for the prophylaxis and treatment of soft tissue infections in a variety of wound types. It is specifically indicated for burn wounds, as an aid to the short-term treatment of infection in leg ulcers and pressure ulcers, and as an aid to the prophylaxis of infection in skin graft donor sites and extensive abrasions. It is also used for the conservative management of finger-tip injuries where pulp, nail loss and/or partial loss of the distal phalanx has occurred.

Contra-indications

Flamazine should not be used on patients who are known to be hypersensitive to silver sulphadiazine or other ingredients of the preparation. As sulphonamides can cause kernicterus, Flamazine cream should not be used at or near term in pregnancy, or on premature or newborn infants.

Method of use

A layer of Flamazine cream at least 3-5mm thick should be applied to the base of a previously cleansed wound or ulcer bed, and covered with a suitable absorbent dressing held in place with tape or an appropriate bandage.

In the treatment of burns to the hands or digits, once dressed with cream, the hand may be placed in a clear plastic bag or glove, which is then closed at the wrist. During this treatment hand and finger movement should be encouraged.

For fingertip injuries, once haemostasis is achieved, a 3-5mm layer of cream should be applied and covered either with a conventional dressing or a finger removed from a plastic glove, held in place with waterproof adhesive tape.

Frequency of Change

In the treatment of conventionally dressed burns, it is recommended that the cream be replaced at least every 24 hours; more frequently if the volume of exudate is large. Hand burns dressed with Flamazine in bags should be changed when an excessive amount of exudate has accumulated.

In the treatment of ulcers and other injuries the dressing should be changed every 2-3 days unless the production of exudate is excessive when the dressing should be changed more frequently.

Warnings

Flamazine cream should be used with caution in the presence of significant hepatic or renal impairment.

It has also been reported that the use of Flamazine cream may delay separation of burn eschar.

Safety of use of Flamazine in pregnancy has not been established. It should therefore only be used in pregnancy if the benefit is likely to be greater than possible risk to foetus.

Local reactions such as burning, itching and skin rash may occur in about 2% of patients. Leucopenia has been reported in 3-5% of burns patients treated with silver sulphadiazine cream. It is usually self-limiting and therapy does not usually need to be discontinued. Systemic absorption of silver sulphadiazine may very rarely result in any of the adverse reactions attributable to systemic sulphonamide therapy or clinical argyria.

Presentation

Flamazine is presented in collapsible tubes and jars.

Storage

All presentations of Flamazine should be stored below 25C and protected from light. When stored correctly the cream has a shelf life of 36 months.

The contents of one container are for the treatment of one person only. Jars of Flamazine should be discarded 24hrs after opening and the tubes seven days after opening.

Sizes

Flamazine is available as follows:

Legal Category

Flamazine is a Prescription Only Medicine (POM), and is the subject of a Product Licence (PL 13374/0006)

Bibliography

1. Salman H., Leakey A., Smith & Nephew Data on File, 2001

2. Edwards J, Flamazine Product Focus, Journal of Community Nursing, Feb 2002, 16, issue 2.

3. Bishop J.B et al, A prospective randomised evaluator-blinded trial of two potential wound healing agents for the treatment of venous stasis ulcers, Journal of Vascular Surgery 1992, 16: 251-7.

Availability

Further information on obtaining Smith & Nephew products is available on the Smith & Nephew web site.


Revision Details

Revision AuthorDr S. Thomas
Revision No 1.1
Revision date2002/01/29

This datacard has been prepared from data provided by the manufacturer and/or from published literature.



All materials copyright © 1992-2007 by the Surgical Materials Testing Lab. unless otherwise stated.

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Last Modified: Tuesday, 16-Jul-2002 08:23:28 BST