Silver Sulfadiazine

Silver sulfadiazine is a prescription cream used with other treatments to help prevent and treat wound infections in patients with serious burns. Silver sulfadiazine works by stopping the growth of bacteria that may infect an open wound. This helps to decrease the risk of the bacteria spreading to surrounding skin, or to the blood where it can cause a serious blood infection (sepsis). Silver sulfadiazine belongs to a class of drugs known as sulfa antibiotics. Silver sulfadiazine must not be used on premature babies or on newborns during the first 2 months of life because of the risk of serious side effects.

Silver sulfadiazine is available under the following different brand names: Silvadene, Thermazene, and SSD Cream.

Adult and Pediatric:

Cream

• 1%

Burn wound infections (2nd degree/3rd degree)

Adult:

• 1% cream: apply daily every 12 hours to burn

Pediatric:

• Infants under 2 months: contraindicated
• Infants over 2 months (1% cream): Apply daily every 12 hours to burn

Common side effects of Silver Sulfadiazine include:

• pain
• burning
• itching
• rash
• cell death of the skin
• localized eruption of the skin
• transient skin discoloration
• destruction of red blood cells (in patients with G6PD deficiency)
• deficiency of granulocytes in the blood
• discontinued production of blood cells
• low blood platelet count
• low white blood cell count
• dermatologic and hypersensitivity reactions (Stevens-Johnson syndrome, TEN)
• adverse gastrointestinal effects
• inflammation of the liver (hepatitis)
• toxic injury to the liver
• adverse nervous system effects
• acute kidney failure
• swelling in the kidney
• burning sensation
• presence of harmful bacteria via infection of a wound (sepsis)

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

Silver sulfadiazine has no known severe interactions with other drugs.

Silver sulfadiazine has no known serious interactions with other drugs.

Moderate interactions of silver sulfadiazine include:

• collagenase
• papain
• trypsin

Mild interactions of silver sulfadiazine include:

• collagenase
• papain
• trypsin

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns or for more information about this medicine.

Warnings

This medication contains silver sulfadiazine. Do not take Silvadene, Thermazene, or SSD Cream if you are allergic to silver sulfadiazine or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Sulfa allergy.
• G6PD deficiency.
• Hypersensitivity.
• Suflanomides may increase possibility of kernicterus; therefore, do not use during near-term pregnancy, in premature infants, or in infants below age 2 months.

Effects of Drug Abuse

• No information available

Short-Term Effects

• See "What Are Side Effects Associated with Using Silver Sulfadiazine?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Silver Sulfadiazine?"

Cautions

• Not recommended for use in pregnant women unless the burned area covers more than 20% of body surface or therapeutic benefits to patient outweigh the possible risks to the fetus.
• Although silver sulfadiazine is minimally absorbed, it reacts with body fluids to release sulfadiazine, which is absorbed and may reach substantial serum concentrations.
• Absorption of silver sulfadiazine varies depending on the percent of body surface area and the extent of the tissue damage; it is possible that any adverse reaction associated with sulfonamides may occur including blood dyscrasias, dermatologic and allergic reactions (including life-threatening cutaneous reactions [Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), exfoliative dermatitis]), gastrointestinal reactions, hepatitis and hepatocellular necrosis, central nervous system reactions, and toxic nephrosis.
• Hepatic/renal impairment.
• For topical use only; avoid contact with eye.

Pregnancy and Lactation

• Use silver sulfadiazine during pregnancy with caution if benefits outweigh risks. Animal studies show risk and human studies are not available, or neither animal nor human studies were done.
• Do not use silver sulfadiazine near term of pregnancy.
• It is unknown if silver sulfadiazine is distributed into breast milk; use caution if breastfeeding and consult your physician.