Drugs List

Therapeutic Indications

Uses

Prophylaxis and treatment of infection in burn wounds.

Short-term treatment of infected leg ulcers and pressure sores, and as an aid to the prophylaxis of infection in skin graft donor sites and extensive abrasions.

Conservative management of finger-tip injuries where pulp, nail loss and/or partial loss of the distal phalanx has occurred.

Administration

For topical administration to affected area(s) only.

A depth of cream of at least 3mm - 5mm is recommended.

Apply with a sterile spatula or with a sterile gloved hand.

Handling

The contents of one container should be reserved for the treatment of one patient only.

Pots of cream should be discarded 24 hours after opening. Tubes should be discarded 7 days after opening.

Incompatibilities

Contraindications

Pregnancy - near term (see Pregnancy section)
Neonates
Premature infants

Precautions and Warnings

Significant hepatic or renal impairment
Pregnancy (see Pregnancy section)
Breastfeeding (see Lactation section)
Glucose-6-phosphate deficiency

When applied to large areas or after prolonged application, sufficient systemic absorption of sulfadiazine may occur for blood levels to approach therapeutic levels. The side effects and interactions of systemic sulfonamides may then become significant. This especially applies to oral hypoglycaemic agents and to phenytoin. With these drugs, it is recommended that blood levels should be monitored. Argyria may also occur after prolonged application or if applied to large areas of the skin.
If blood disorders or skin rashes occur, treatment should be stopped immediately.

Leucopenia has been reported after the first 2 or 3 days treatment of burns. It is usually self-limiting, but discontinue treatment if blood count remains abnormal after a few days.
Monitor patient for leucopenia throughout treatment.

The use of silver sulfadiazine cream may lead to delayed separation of burn eschar and the appearance of the burn wound may be altered.

Silver may inactivate enzymatic debriding agents.

Manufacturer recommends that the use of silver sulfadiazine cream for the treatment of leg or pressure ulcers that are highly exudative should be avoided.

Pregnancy and Lactation

Pregnancy

Contraindicated in pregnancy near term.

Animal studies have not shown silver sulfadiazine to be hazardous, however the safety in human pregnancy has not been established.

All sulfonamides increase the risk of kernicterus. Briggs suggests because of the risk of potential toxicity to the new born, sulfonamides should be avoided near term.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use with caution as safety not established.

Systemically sulfadiazine can be excreted in breast milk although at concentrations 15-35% of those found in serum.

There is a risk of kernicterus in susceptible infants, and of haemolysis in G6PD-deficient infants. Briggs suggests sulfonamide excretion into breast milk does not pose a significant risk to a healthy, full-term neonate. Exposure should be avoided in ill, stressed or premature infants.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Rash
Burning sensation (local)
Itching
Hypersensitivity reactions
Argyria
Leucopenia
Blood disorders
Maceration (wound edge)
Renal failure
Pruritus

Presentation

Cream containing 1% w/w silver sulfadiazine.

Drugs List

Therapeutic Indications

Uses

Prophylaxis and treatment of infection in burn wounds.

Short-term treatment of infected leg ulcers and pressure sores, and as an aid to the prophylaxis of infection in skin graft donor sites and extensive abrasions.

Conservative management of finger-tip injuries where pulp, nail loss and/or partial loss of the distal phalanx has occurred.

Dosage

Application is best achieved with a sterile gloved hand and/or sterile spatula.

Cleansing and/or debriding should be performed before application where appropriate.

Adults

Elderly

Children

Neonates

Patients with Renal Impairment

Patients with Hepatic Impairment

Additional Dosage Information

Administration

For topical administration to affected area(s) only.

A depth of cream of at least 3mm - 5mm is recommended.

Apply with a sterile spatula or with a sterile gloved hand.

Handling

The contents of one container should be reserved for the treatment of one patient only.

Pots of cream should be discarded 24 hours after opening. Tubes should be discarded 7 days after opening.

Incompatibilities

Contraindications

Pregnancy - near term (see Pregnancy section)
Neonates
Premature infants

Precautions and Warnings

Significant hepatic or renal impairment
Pregnancy (see Pregnancy section)
Breastfeeding (see Lactation section)
Glucose-6-phosphate deficiency

When applied to large areas or after prolonged application, sufficient systemic absorption of sulfadiazine may occur for blood levels to approach therapeutic levels. The side effects and interactions of systemic sulfonamides may then become significant. This especially applies to oral hypoglycaemic agents and to phenytoin. With these drugs, it is recommended that blood levels should be monitored. Argyria may also occur after prolonged application or if applied to large areas of the skin.
If blood disorders or skin rashes occur, treatment should be stopped immediately.

Leucopenia has been reported after the first 2 or 3 days treatment of burns. It is usually self-limiting, but discontinue treatment if blood count remains abnormal after a few days.
Monitor patient for leucopenia throughout treatment.

The use of silver sulfadiazine cream may lead to delayed separation of burn eschar and the appearance of the burn wound may be altered.

Silver may inactivate enzymatic debriding agents.

Manufacturer recommends that the use of silver sulfadiazine cream for the treatment of leg or pressure ulcers that are highly exudative should be avoided.

Pregnancy and Lactation

Pregnancy

Contraindicated in pregnancy near term.

Animal studies have not shown silver sulfadiazine to be hazardous, however the safety in human pregnancy has not been established.

All sulfonamides increase the risk of kernicterus. Briggs suggests because of the risk of potential toxicity to the new born, sulfonamides should be avoided near term.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use with caution as safety not established.

Systemically sulfadiazine can be excreted in breast milk although at concentrations 15-35% of those found in serum.

There is a risk of kernicterus in susceptible infants, and of haemolysis in G6PD-deficient infants. Briggs suggests sulfonamide excretion into breast milk does not pose a significant risk to a healthy, full-term neonate. Exposure should be avoided in ill, stressed or premature infants.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Rash
Burning sensation (local)
Itching
Hypersensitivity reactions
Argyria
Leucopenia
Blood disorders
Maceration (wound edge)
Renal failure
Pruritus

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Shelf Life and Storage

Store below 25 degrees C
Protect from light

Further Information

Last Full Review Date: January 2012

Reference Sources

British National Formulary, 62nd Edition (2011) Pharmaceutical Press, London.

BNF for Children (2011-2012) Pharmaceutical Press, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

Summary of Product Characteristics: Flamazine cream. Smith and Nephew Pharmaceuticals Ltd. Revised January 2007.