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silver sulfadiazine (Rx)

Brand and Other Names:Silvadene, Thermazene, more...SSD Cream

Dosing & Uses

AdultPediatric
ADULT

Dosage Forms & Strengths

cream

  • 1%

Burn Wound Infections (2°/3°)

1% cream: Apply to thickness of 1/16 inch qDay-q12hr to burn

Dosing Considerations

Reapply as necessary; burn should be covered with cream at all times; continue use until healed or the burn site is ready for grafting; continue therapy if possibility of infection exists unless significant adverse reaction has occurred

Dosing Modifications

Renal impairment: Use with caution; drug accumulation possible

Hepatic impairment: Use with caution; drug accumulation possible

PEDIATRIC

Dosage Forms & Strengths

cream

  • 1%

Burn Wound Infections (2°/3°)

<2 months: Contraindicated

>2 months (1% cream): Apply qDay-q12hr to burn

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Interactions

Interaction Checker

and silver sulfadiazine

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (1)

              • allogeneic cultured keratinocytes and fibroblasts

                silver sulfadiazine decreases effects of allogeneic cultured keratinocytes and fibroblasts by Other (see comment). Avoid or Use Alternate Drug. Comment: Silver-containing antimicrobials and dressings may decrease viability of keratinocytes and human dermal fibroblasts. .

              Monitor Closely (3)

              • collagenase

                silver sulfadiazine decreases effects of collagenase by Other (see comment). Use Caution/Monitor. Comment: Heavy metal ions inactivate enzymes.

              • papain

                silver sulfadiazine decreases effects of papain by Other (see comment). Use Caution/Monitor. Comment: Heavy metal ions inactivate enzymes.

              • trypsin

                silver sulfadiazine decreases effects of trypsin by Other (see comment). Use Caution/Monitor. Comment: Heavy metal ions inactivate enzymes.

              Minor (3)

              • collagenase

                collagenase decreases effects of silver sulfadiazine by pharmacodynamic antagonism. Minor/Significance Unknown.

              • papain

                papain decreases effects of silver sulfadiazine by pharmacodynamic antagonism. Minor/Significance Unknown.

              • trypsin

                trypsin decreases effects of silver sulfadiazine by pharmacodynamic antagonism. Minor/Significance Unknown.

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              Adverse Effects

              Frequency Not Defined

              Pain

              Burning

              Itching

              Rash

              Necrosis of the skin

              Erythema multiforme

              Transient skin discoloration

              Hemolytic anemia (in patients with G6PD deficiency)

              Agranulocytosis

              Aplastic anemia

              Thrombocytopenia

              Leukopenia

              Dermatologic and hypersensitivity reactions (eg, Stevens-Johnson syndrome, TEN)

              Adverse GI effects

              Hepatitis and hepatocellular necrosis

              Adverse nervous system effects

              Toxic nephrosis

              Interstitial nephritis

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              Warnings

              Contraindications

              Sulfa allergy

              Hypersensitivity

              Pregnant women at term or near term; premature infants, or in infants 2 months or younger

              Cautions

              Use caution in G6PD deficiency; hemolysis may occur

              For topical use only; avoid contact with eyes

              Prolonged use may result in bacterial or fungal superinfection

              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]), GI reactions, hepatitis and hepatocellular necrosis, CNS reactions, and toxic nephrosis

              Use caution in hepatic/renal impairment

              For topical use only; avoid contact with eye

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              Pregnancy & Lactation

              Pregnancy category: C, X (near term)

              Lactation: Not known if distributed into breast milk; use caution

              Pregnancy Categories

              A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

              B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

              C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

              D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

              X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

              NA: Information not available.

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              Pharmacology

              Mechanism of Action

              Acts on cell membrane and cell wall

              Absorption

              Peak plasma time: 3-11 days

              Elimination

              Half-life: 10 hr

              Excretion: Urine (50%)

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              Images

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              Patient Handout

              Patient Education
              Silver Sulfadiazine topical

              COMMON BRAND NAME(S): Silvadene; SSD; Thermazene

              USES: What is silver sulfadiazine used for? Topical silver sulfadiazine is commonly used to treat and prevent wound infections in people with severe burns.  Topical silver sulfadiazine may not be appropriate for the infection listed above, depending on which germs are causing the infection. Bacteria in some locations may have developed resistance to topical silver sulfadiazine, which will make it less effective. Topical silver sulfadiazine may also be used for other conditions as determined by your healthcare provider. How does silver sulfadiazine work (mechanism of action)? Topical silver sulfadiazine kills certain types of bacteria by affecting their cell wall or membrane. How is silver sulfadiazine supplied (dosage forms)? Topical silver sulfadiazine is available as Silvadene, SSD, Thermazene, and silver sulfadiazine generic in the following dosage form that is applied to the skin. 1% cream How should I store silver sulfadiazine? Topical silver sulfadiazine should be stored at room temperature,  between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C), for shorter periods of time, such as when transporting it. Store in a cool, dry place. Keep tightly closed.

              HOW TO USE: cream that is applied to the skin

              SIDE EFFECTS: What are the most common side effects of silver sulfadiazine? The most common side effects of topical silver sulfadiazine are listed below. Tell your healthcare provider if you have any of these side effects that bother you. Pain, burning, itching, rashes, and skin discoloration  Low white blood cells ( leukopenia ) Reduced need to pee Swelling in your face, feet, ankles, or legs Sudden weight gain There may be other side effects of topical silver sulfadiazine that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at http://www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at http://www.health.gc.ca/medeffect or by calling 866-234-2345. What are the serious side effects of silver sulfadiazine? While less common, the most serious side effects of topical silver sulfadiazine are described below, along with what to do if they happen. Severe Allergic Reactions. Topical silver sulfadiazine can cause allergic reactions , which can be serious. Stop using topical silver sulfadiazine and get help right away if you have any of the following symptoms of a serious allergic reaction. Breathing problems or wheezing Racing heart Fever or general ill feeling Swollen lymph nodes Swelling of the face, lips, mouth, tongue, or throat Trouble swallowing or throat tightness Itching, skin rash, or pale red bumps on the skin called hives Nausea or vomiting Dizziness, feeling lightheaded, or fainting Stomach cramps Joint pain Severe Skin Reactions. Topical silver sulfadiazine can cause severe skin reactions called Stevens-Johnson syndrome (SJS) , toxic epidermal necrolysis (TEN) , and exfoliative dermatitis that can lead to death if not treated. If you develop a rash, stop topical silver sulfadiazine and call your healthcare provider right away. Get emergency help right away if you have any of the following symptoms of SJS, TEN, or exfoliative dermatitis. Painful red or purple skin that looks burned and peels off Flat red rash or blisters on your skin, mouth, nose, and genitals Red, painful, watery eyes Liver Damage. Liver damage, also called hepatotoxicity , can happen when using topical silver sulfadiazine. Call your healthcare provider right away if you have any of the following symptoms of liver damage. Nausea or vomiting Stomach pain Fever Weakness or unusual tiredness Itching Loss of appetite Light colored poop Dark colored urine Your skin or the whites of your eyes turning yellowish in color ( jaundice ) Kidney Damage. Kidney damage can happen when using topical silver sulfadiazine. Call your healthcare provider right away if you have any of the following symptoms of kidney damage. Reduced need to pee Swelling in your feet, ankles, or legs  Weakness or unusual tiredness Difficulty catching your breath or chest pain/pressure Confusion Nausea Seizures Blood Disorders. Topical silver sulfadiazine can cause blood disorders such as agranulocytosis , aplastic anemia , hemolytic anemia , low platelets ( thrombocytopenia ), and low white blood cell count ( leukopenia ). Stop using topical silver sulfadiazine and get help right away if you have any of the following symptoms of blood disorders. Fever Shortness of breath Pale or yellowish skin Easy bruising or bleeding Frequent infection Unusual weakness or tiredness Dizziness, lightheadedness, or feeling like you are about to pass out Headache Fast or abnormal heartbeat Another Infection. Using topical silver sulfadiazine may lead to an infection with another type of germ, such as fungi. Call your healthcare provider if your wound infection does not improve or gets worse.

              PRECAUTIONS: Who should not use silver sulfadiazine? Allergies to Ingredients. People who are allergic to any of the following should not use topical silver sulfadiazine. silver sulfadiazine Silvadene SSD Thermazene Any of the ingredients in the specific product dispensed Your pharmacist can tell you all of the ingredients in the specific topical silver sulfadiazine products they stock. Term or Near Term Pregnancy. Do not use topical silver sulfadiazine if you are pregnant and at or near your delivery date.  See the Pregnancy section below for more details. Premature Babies or Newborns Younger than 2 Months Old. Premature babies or newborn infants during the first 2 months of life should not use topical silver sulfadiazine because of a possible serious side effect called kernicterus . Kernicterus is a condition when a substance called bilirubin builds up in your blood and causes brain damage.  What should I know about silver sulfadiazine before using it? Do not use topical silver sulfadiazine unless it has been prescribed to you by a healthcare provider. Use it as prescribed. Do not share topical silver sulfadiazine with other people, even if they have the same condition as you. It may harm them. Keep topical silver sulfadiazine out of the reach of children. Topical silver sulfadiazine is only for use on the skin. Do not get topical silver sulfadiazine in your eyes. You should continue to use silver sulfadiazine until the area is healed or until the site is ready for grafting.  What should I tell my healthcare provider before using silver sulfadiazine? Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if topical silver sulfadiazine is right for you. In particular, make sure that you discuss any of the following. Current and Past Health Conditions. Tell your healthcare provider if you have any of the following health conditions. Glucose-6-phosphate dehydrogenase deficiency Known allergy to a type of medicine called a sulfonamide  Kidney problems Liver problems Pregnancy. It is not known if or how topical silver sulfadiazine could affect pregnancy or harm an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. Your healthcare provider will advise you if you should use topical silver sulfadiazine while you are pregnant or trying to get pregnant. Severe side effects can occur in a baby if the mother uses topical silver sulfadiazine near her delivery date.  Breastfeeding. It is not known if topical silver sulfadiazine passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Severe side effects can occur in a baby who is fed by a mother who is using topical silver sulfadiazine. Talk with your healthcare provider about stopping either breastfeeding or topical silver sulfadiazine. 

              DRUG INTERACTIONS: Does silver sulfadiazine interact with foods or drinks? There are no known interactions between topical silver sulfadiazine and foods or drinks. It is unknown if drinking alcohol will affect topical silver sulfadiazine. Does silver sulfadiazine interact with other medicines (drug interactions)? Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. In particular, make sure that you discuss any other medicines that may be applied to the same area of your skin as topical silver sulfadiazine.

              OVERDOSE: What should I do if I accidentally use too much silver sulfadiazine? If you or someone else has used too much topical silver sulfadiazine, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222. What should I do if I miss a dose of silver sulfadiazine? If you miss a dose, use it as soon as you remember. If it is almost time for your next dose, skip the missed dose, and use only the next dose. Do not use double or extra doses. It is important to complete your prescribed course of topical silver sulfadiazine, even if your symptoms get better or go away. This will reduce the risk that future infections are not resistant to topical silver sulfadiazine or other similar medicines.

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              Formulary

              FormularyPatient Discounts

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              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
              QL Quantity Limits
              Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
              ST Step Therapy
              Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
              OR Other Restrictions
              Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.