Silvadene cream  … for Burns, ulcers, sores, and wounds

Composition

Silvadene cream:

  • Active Ingredients:  Silver sulfadiazine  1 %  (in a water washable base).
  • Pharmaceutical Forms: Cream.
 Silvadene cream

Therapeutic Activity

Topical antimicrobial (antibacterial and antifungal).

Pharmacological Action

 Silver sulfadiazine has been introduced to replace silver nitrate in the topical treatment of extensive burns. It readily penetrates the eschar. Its solubility is low enough that insufficient silver ions are released to precipitate significant amounts of chloride ions and proteins. Hypochloremia, hyponatremia and eschars that adhere to dressings are thus avoided. Despite its low solubility, silver sulfadiazine exerts a prominent antibacterial action against pseudomonas. Furthermore, unlike silver nitrate, it does not cause argyrols staining of wounds or bed linens. The compound is painless upon application.

Pharmacokinetics

  • Absorption: Limited absorption with topical use. 
  • Distribution: None.
  • Metabolism: None.
  • Excretion: Excreted in urine.

Indications

Silvadene Cream: Topical antimicrobial drug for prevention and treatment of sepsis in second and third degree of burns.

When should not the product be used

  • In patients with known hypersensitivity to sulfa drugs or any other ingredient of the drug.
  • In premature infants during the first few months of life and newborn infants younger than two months of age. 
  • Do not use if you are pregnant approaching or at term. 

Dosage

  • The usual dose: According to the physician’s instructions. The cream should be applied on the affected area approximately as a 3-5 mm thin layer.  
  • Missed dose: Apply as soon as you remember the missed dose, but never use if almost time for the next application.

Side Effects

In addition to the desired effects of Silvadene, some side effects may occur during the course of treatment such as:

  • Burning feeling on the treated area, itching, pain, and skin rash. 
  • Increased sensitivity of the skin to sunlight.
  • Transient brownish.
  • gray skin discoloration.
  • May cause blood dyscrasias. 

Drug Interactions

Concomitant use of any of the following medications with Silvadene may lead to drug interactions. Example:  Cimetidine, phenytoin, and topical enzyme preparations that contain collagenase, papain, or sutilains. 

Pregnancy and Lactation

  • Pregnancy: This drug should be used during pregnancy only if clearly justified especially in pregnant women approaching or at term.
  • Lactation: Avoid breast feeding during and for several days after therapy.

Warning

Do not take this medicine without consulting a physician before starting treatment:

  • If you are pregnant, or breast feeding, or you think about becoming pregnant.
  • If you suffer from G6PD deficiency.
  • If you suffer from kidney or liver diseases. 

Precautions 

  • Keep the medicine out of the reach of children.
  • If a child swallowed the medication accidentally, seek help at an emergency and take the remaining medicine with you. 
  • Do not induce vomiting without consulting the physician.
  • Do not take your medication in the dark, always read the label and make sure you are using the right medication.
  • Always notice the expiry date and never use medicines after that date.
  • Avoid exposure of the drug to excessive heat and humidity during storage.
  • Take the drug only as prescribed and do not exceed the prescribed dose.  

Attention: For External Use Only. 

Directions for Use

  • Always wear sterile, disposable gloves before applying Silvadene.
  • Clean the area requested to be covered with the cream, then apply approximately a 3-5 mm thin layer and spread gently.
  • Continue the treatment until cure or injury is healed.
  • Do not open the container except when use. 
  • A separate container should be reserved for each patient. Any remaining cream should be discarded on the completion of the treatment.  

For Arabic Information

  سلفادين كريم – معلومات باللغة العربية

Package and Storage

  • Packing: Aluminium tube of 20 g.
  • Storage: Store at temperature below 30°C.

Instruction of Patients

  •  Avoid drug contact with eyes and mucous membrane.
  •  Burned area should be covered with cream at all times.