Silvadene

DRUG DESCRIPTION

SILVADENE (silver sulfadiazine) Cream 1% is a soft, white, water-miscible cream containing the antimicrobial agent silver sulfadiazine in micronized form, which has the following structural formula:

SILVADENE (silver sulfadiazine) structural formula illustration

Each gram of SILVADENE Cream 1% contains 10 mg of micronized silver sulfadiazine. The cream vehicle consists of white petrolatum, stearyl alcohol, isopropyl myristate, sorbitan monooleate, polyoxyl 40 stearate, propylene glycol, and water, with methylparaben 0.3% as a preservative. SILVADENE Cream 1% (silver sulfadiazine) spreads easily and can be washed off readily with water.

What are the possible side effects of silver sulfadiazine topical (Silvadene, SSD, SSD AF, Thermazene)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • fever, chills, body aches, flu symptoms;
  • easy bruising or bleeding, unusual weakness;
  • pale or yellowed skin, dark colored urine;
  • ulcers on treated skin areas;
  • blood in your urine;
  • urinating less than...

Read All Potential Side Effects and See Pictures of Silvadene

What are the precautions when taking silver sulfadiazine (Silvadene)?

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...

Read All Potential Precautions of Silvadene


Silvadene Consumer (continued)

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 persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she 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 immediately if any of these rare but serious side effects occur: signs of infection (such as fever, chills, persistent sore throat), easy bruising/bleeding, signs of anemia (such as unusual tiredness/weakness, rapid breathing, fast heartbeat), change in the amount of urine, pink/bloody urine, signs of liver problems (such as stomach/abdominal pain, persistent nausea, vomiting, dark urine, yellowing eyes/skin), mental/mood changes.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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.

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). Therefore, breast-feeding while using this drug is not recommended in infants with these conditions. Consult your doctor before breast-feeding.


Silvadene Patient Information Including Side Effects

Brand Names: Silvadene, SSD, SSD AF, Thermazene

Generic Name: silver sulfadiazine topical (Pronunciation: SIL ver SUL fa DYE a zeen TOP ik al)

  • What is silver sulfadiazine topical (Silvadene)?
  • What are the possible side effects of silver sulfadiazine topical (Silvadene)?
  • What is the most important information I should know about silver sulfadiazine topical (Silvadene)?
  • What should I discuss with my healthcare provider before using silver sulfadiazine topical (Silvadene)?
  • How should I use silver sulfadiazine topical (Silvadene)?
  • What happens if I miss a dose (Silvadene)?
  • What happens if I overdose (Silvadene)?
  • What should I avoid while using silver sulfadiazine topical (Silvadene)?
  • What other drugs will affect silver sulfadiazine topical (Silvadene)?
  • Where can I get more information?

What is silver sulfadiazine topical (Silvadene)?

Silver sulfadiazine is an antibiotic. It fights bacteria and fungus on the skin.

Silver sulfadiazine topical (for the skin) is used to treat or prevent infections on areas of burned skin.

Silver sulfadiazine topical may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of silver sulfadiazine topical (Silvadene)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • fever, chills, body aches, flu symptoms;
  • easy bruising or bleeding, unusual weakness;
  • pale or yellowed skin, dark colored urine;
  • ulcers on treated skin areas;
  • blood in your urine;
  • urinating less than usual or not at all;
  • drowsiness, confusion, mood changes, nausea and vomiting;
  • swelling, weight gain; or
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.

Less serious side effects may include:

  • brown or gray discoloration of treated skin;
  • mild itching or burning; or
  • upset stomach.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about silver sulfadiazine topical (Silvadene)?

You should not use this medication if you are allergic to silver sulfadiazine or another sulfa medication.

Before using this medication, tell your doctor if you have liver disease, kidney disease, or an enzyme deficiency called glucose-6-phosphate dehydrogenase deficiency (G6PD).

The person applying this medication to burn wounds should wear sterile disposable gloves. Take care to keep the treatment area as clean as possible to prevent further infection.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

Avoid exposing treated skin areas to sunlight, sunlamps, or tanning beds. Silver sulfadiazine can make your skin more sensitive to sunlight, and a sunburn may result. Wear protective clothing when you are outdoors.

Call your doctor at once if you have a serious side effect such as fever, chills, flu symptoms, easy bruising or bleeding, unusual weakness, pale or yellowed skin, dark colored urine, ulcers on treated skin areas, swelling or weight gain, urinating less than usual, or a severe blistering or peeling red skin rash.

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