Silver Sulphadiazine Cream

Silver Sulphadiazine Cream

Read this leaflet carefully before you start taking this medicine.  (DOWNLOAD)

  • Keep this leaflet. You may need to read it again. 
  • If you have any further questions, ask your health care provider.
  • This medicine has been prescribed for you. Do not pass it on to others. It  may harm them, even if their symptoms are the same as yours. If any of the side effects become serious, or if you notice any side effects  not listed in this leaflet, please tell your health care provider.

In this leaflet:  

  1. What Silver Sulphadaizine Cream is and what it is used for 2. Before you use Silver Sulphadaizine Cream 
  2. How to use Silver Sulphadaizine Cream 
  3. Possible side effects 
  4. How to store Silver Sulphadaizine Cream 
  5. Further information 

 

  1. WHAT SILVER SULPHADAIZINE CREAM IS AND WHAT IT IS USED  FOR 

Silver Sulphadaizine belongs to a group of medicines called antibacterial  which are used for the prophylaxis and treatment of infection in burn wounds.

2. BEFORE YOU USE SILVER SULPHADAIZINE CREAM Do not use Silver Sulphadaizine Cream 

  • If you are allergic (hypersensitive) to the active substance(s) or any of the  other ingredients of Silver Sulphadaizine Cream. 
  • For preterm infants or newborns under 2 months. 
  • If you are pregnant and approaching term. 

Warnings and Precautions 

  • Caution of use is required in individuals known to have Glucose-6- phosphate dehydrogenase deficiency; hemolysis may occur. Hepatic or renal impairment; accumulation may occur; discontinuation  may be necessary blood dyscrasias (e.g. agranulocytosis, aplastic  anemia, thrombocytopenia, leukopenia, hemolytic anemia) may occur. CNS reactions may occur. 
  • Cross-sensitivity with other sulfonamides may occur; if allergic reactions  occur, consider potential hazards of continuing therapy. 
  • Cutaneous reactions, life-threatening (e.g. Stevens-Johnson syndrome,  Toxic Epidermal Necrolysis [TEN], exfoliative dermatitis), may occur. Fungal proliferation, in or below the eschar, may occur. 
  • Gastrointestinal reactions may occur. 
  • Hepatitis or hepatocellular necrosis may occur. 
  • Toxic nephrosis may occur. 
  • Discontinue treatment with this drug immediately if skin rash or any sign  of adverse reaction occurs. 
  • Fatalities associated with the administration of sulphonamides and  trimethoprim, either alone or in combination, have occurred due to severe  reactions, including Steven-Johnson syndrome, toxic epidermal  necrolysis and other reactions. The drug should be discontinued at the  first appearance of skin rash or any sign of adverse reaction. 
  • Urinalyses may be required prior to and periodically during treatment to  detect crystalluria and/or urinary calculi formation in patients on long-term  or high-dose therapy and in patients with impaired renal function. 
  • If allergic reactions or hepatic or renal function impairment with decreased  elimination occurs, discontinuation of therapy with the medication should  be considered. 

Effects on the ability to drive and use machines  

Unlikely to impair a patient’s ability to drive or use machinery. 

Interactions with Other Medicaments  

Concurrent application of papain and silver salt-containing formulations such  as silver sulfadiazine may result in the inactivation of the enzymatic debriding  action of papain. 

Pregnancy and breast-feeding 

Ask your health care provider for advice before taking any medicine.

3. HOW TO USE SULPHADIAZINE CREAM 

Silver sulfadiazine 1% cream should be applied with a sterile, gloved hand to  the burn surface once or twice daily to a thickness of approximately 1/16th  inch (1.5mm), and continued until satisfactory healing occurs, until the burn  site is ready for grafting. Silver sulfadiazine should be applied more frequently  to burn areas which might allow easier removal of the cream by movement of  the patient. Dressings can be applied over the cream, but this is usually not  necessary. 

Renal Failure: No specific dosage adjustment of silver sulfadiazine is  necessary. Although silver is not readily absorbed, sulfadiazine can be  absorbed in significant quantities following prolonged treatment of extensive  burns, and measurement of sulfadiazine levels may be indicated in patients  with impaired renal function 

Hepatic Insufficiency: No specific dosage adjustment of silver sulfadiazine is  necessary. However, large amounts of sulfadiazine may be absorbed  following prolonged treatment of extensive burns, and serum sulfonamide  levels should be monitored during prolonged use of the drug in patients with  impaired hepatic function. 

Use in children 

Safety and effectiveness not established in children 

Mode of Administration 

Topical. 

Contact with the eyes should be avoided. In case of accidental contact with  the eyes, rinse the eyes thoroughly with running water. 

If you use more Silver Sulphadaizine Cream than you should Management of over dosage is usually symptomatic and supportive. If you have any further questions on the use of this product, ask your health  care provider. 

  1. POSSIBLE SIDE EFFECTS 

Like all medicines, Silver Sulphadaizine Cream can cause side effects,  although not everybody gets them. 

  • Dermatologic: Local reactions such as burning, pruritus, rash, skin  irritation, skin necrosis, erythema multiforme and skin discoloration may  occur. 
  • Hematologic: Disorder of hematopoietic structure (rare), Leukopenia  (rare) 
  • If any of the side effects gets serious, or if you notice any side effects not  listed in this leaflet, please tell your health care provider. 

Reporting of side effects 

If you get any side effects, talk to your healthcare provider. This includes any  possible side effects not listed in this leaflet. You can also report side effects  directly to Fidson Healthcare Plc. By reporting side effects, you can help  provide more information on the safety of this medicine.

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Read this leaflet carefully before you start taking this medicine.  (DOWNLOAD) Keep this leaflet. You may need to read it again.  If you have any further questions, ask your health care provider. • This medicine has been prescribed for you. Do not pass it on to others. It  may harm

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