Uses

This medication is 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.

Other Uses

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used for other skin and wound infections (such as skin ulcers).

How To Use

Read the Patient Information Leaflet if available from your pharmacist before you start using silver sulfadiazine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is for use on the skin only. Avoid using this medication around your eyes unless directed to do so by your doctor.

Your health care professional will clean and remove the dead tissue from the wound to help the healing process.

Apply this medication to the wound using sterile technique (such as wearing sterile gloves and using sterile application tools), as directed by your doctor, usually 1 to 2 times daily. The layer of medication should be about one-sixteenth of an inch (1-2 millimeters) thick or as directed. The wound should be covered with the cream at all times. Dressings may be applied over the cream, but only if needed. If some of the cream rubs off the wound, reapply it immediately. The cream should also be reapplied immediately after hydrotherapy.

Treatment usually continues until the wound is completely healed or until the site is ready for skin grafting.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time(s) each day.

Tell your doctor if your condition lasts or if it gets worse.

Side Effects

Pain, burning, or itching of the treated skin may occur. Skin and mucous membranes (such as the gums) may become blue/gray in color. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• signs of infection (such as sore throat that doesn't go away, fever, chills)
• easy bruising/bleeding
• signs of anemia (such as unusual tiredness/weakness, rapid breathing, fast heartbeat)
• signs of kidney problems (such as change in the amount of urine, pink/bloody urine)
• signs of liver problems (such as nausea that doesn't stop, stomach/abdominal pain, vomiting, dark urine, yellowing eyes/skin)
• mental/mood changes

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using silver sulfadiazine, tell your doctor or pharmacist if you are allergic to it; or to other sulfa antibiotics (such as sulfamethoxazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• a certain enzyme deficiency (G6PD or glucose-6-phosphate dehydrogenase deficiency)
• kidney problems
• liver problems
• low white blood cell count

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. This medication must not be used near the expected delivery date because of possible harm to the unborn baby. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. However, similar drugs pass into breast milk and may harm nursing infants who are ill, premature, less than 2 months old, or who have certain disorders (such as jaundice, high blood levels of bilirubin, G6PD deficiency). Breast-feeding while using this drug is not recommended in infants with these conditions. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• skin products containing sodium sulfacetamide
• enzyme products used to break down and remove dead skin/tissue from burns and wounds (such as collagenase, papain, trypsin)

An inactive ingredient in some brands of this medication (propylene glycol) may be absorbed and may interfere with certain laboratory tests, possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Overdose

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 9-1-1. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Do not smoke or go near open flames while using this medication. Doing so may increase the risk of severe burns. Fabric (such as clothing, bedding, dressings) that has been in contact with this medication burns more easily and may be a fire hazard. Washing clothing and bedding may reduce the build-up of product but will not remove all of it.

Lab and/or medical tests (such as white blood cell count, kidney function, blood tests) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

If you miss a dose, use it as soon as you remember. This medicine should be on the wounds at all times as directed by your doctor.

Storage

Store the US product at room temperature. Store the Canadian product between 46-77 degrees F (8-25 degrees C). To ensure that the medication is sterile, the Canadian 250- and 500-gram jars should be discarded 24 hours after opening. The Canadian tubes should be discarded 7 days after opening. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.