Flamazine cream is indicated for the prophylaxis and treatment of infection in burn wounds. Flamazine cream may also be used as an aid to the short-term treatment of infection in leg ulcers and pressure sores, and as an aid to the prophylaxis of infection in skin graft donor sites and extensive abrasions

Flamazine cream is also indicated for the conservative management of fingertip injuries where pulp, nail loss and/or partial loss of the distal phalanx has occurred

To be applied topically

Burns

The burn wound should be cleaned and Flamazine cream applied over all the affected areas to a depth of 3-5mm

This application is best achieved with a sterile gloved hand and/or sterile spatula. Where necessary, the cream should be re-applied to any area from which it has been removed by patient activity

In burns, Flamazine cream should be re-applied at least every 24 hours, or more frequently if the volume of exudate is large

Hand burns

Flamazine cream can be applied to the burn and the whole hand enclosed in a clear plastic bag or glove, which is then closed at the wrist

The patient should be encouraged to move the hand and fingers. The dressing should be changed when an excessive amount of exudate has accumulated in the bag

Leg Ulcers/Pressure Sores

The cavity of the ulcer should be filled with Flamazine Cream to a depth of at least 3-5mm. As Flamazine Cream can cause maceration of normal skin on prolonged contact, care should be taken to prevent spread onto non-ulcerated areas

Application of Flamazine Cream should be followed by an absorbent pad or gauze dressing, with further application of pressure bandaging as appropriate for the ulcer

The dressings should normally be changed daily but for wounds which are less exudative, less frequent changes (every 48 hours) may be acceptable

Cleansing and debriding should be performed before application of Flamazine cream

Flamazine cream is not recommended for use in leg or pressure ulcers that are very exudative

Finger-Tip Injuries

Haemostasis of the injury should be achieved prior to the application of a 3- 5mm layer of Flamazine cream

A conventional finger dressing may be used

Alternatively the finger of a plastic or unsterile surgical glove can be used and fixed in place with waterproof adhesive tape. Dressings should be changed every 2-3 days

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

Caution of use is required in patients known to be sensitive to systemic sulphonamides and in individuals known to have glucose-6-phosphate dehydrogenase deficiency

Use of Flamazine cream may delay separation of burn eschar and may alter the appearance of the burn wounds

As silver may inactivate enzymatic debriding agents, their concomitant use may be inappropriate

In large-area burns where serum sulphadiazine levels may approach therapeutic levels, it should be noted that the effects of systemically administered drugs may be altered

This can especially apply to oralhypoglycaemic agents and to phenytoin. In the case of these drugs, it is recommended that blood levels should be monitored as their effects can be potentiated

For Flamazine cream no clinical data on exposed pregnancies are available, although animal studies have not shown any hazard. Since all sulphonamides increase the risk of kernicterus, Flamazine cream should not be used in pregnant females at term and caution is required in nursing mothers. Systemically absorbed sulphadiazine can be excreted in breast milk although at concentrations 15-35% of those found in serum

None Known

Undesirable Effects

o   Blood & lymphatic Tissue Disorders

Common: Leukopenia

Leukopenia has been reported in 3-5% of burns patients treated with Flamazine

This may be a drug related effect, and often manifests itself 2-3 days after treatment has commenced. It is usually self-limiting and therapy with Flamazine cream does not usually need to be discontinued, although the blood count must be monitored to ensure that it returns to normal within a few days

o   General Disorders & Administration Site Conditions

Common: Application site burning

o   Renal & Urinary Disorders

Very rare: Renal failure

Skin & Subcutaneous Tissue Disorders

Common: Pruritis

(Common: Application site rash (including eczema and contact dermatitis

Rare: Argyria

There is evidence that in large area wounds and/or after prolonged application, systemic absorption of silver can occur causing clinical argyria

To report any side effects

(National Pharmacovigilance and Drug Safety Center (NPC

o Fax: +966-11-205-7662

o To call the executive management of vigilance and crisis management: +966-11 2038222 ext.: 2353 – 2356 – 2317 – 2354 – 2334 – 2340

o Toll-free: 8002490000

o E-mail: npc.drug@sfda.gov.sa

o Website: www.sfda.gov.sa/npc

Not likely to occur with normal usage

Silver Sulphadiazine has bacteriostatic and bactericidal properties. This combination provides a wide spectrum of antimicrobial activity

There is evidence that in large area wounds and/or after prolonged application, systemic absorption of silver can occur causing clinical argyria

The sulphadiazine readily diffuses across wounds and enters the general circulation

The degree of uptake will significantly depend upon the nature of the wound and the dosing regime. Sulphadiazine is excreted in the urine

None Stated

Polysorbate 60
Polysorbate 80
Glycerol Monostearate
Cetyl Alcohol
Propylene Glycol
Liquid Paraffin
Water for injection

None Known

Flamazine should be stored below 30°C.

Protect from light.

50g plastic tube with plastic screw cap

Tubes of Flamazine should be discarded 7 days after opening