INTRODUCTION

BURNOSAF PLUS CREAM contains Silver sulphadiazine which belongs to the group of medicines called Sulfonamides. BURNOSAF PLUS CREAM is used in the prophylaxis and treatment of infection in burn wounds, leg ulcers and/or pressure sores caused by sensitive micro-organisms in affected individuals.

BURNOSAF PLUS CREAM is also indicated for use in the conservative management of finger-tip injuries (which involves pulp, nail loss and/or partial loss of the distal phalanx (finger bones) in affected individuals.

BURNOSAF PLUS CREAM is not recommended for use in patients allergic (hypersensitive) to silver sulphadiazine/sulphonamide, cetyl alcohol, and/or propylene glycol.

Before applying BURNOSAF PLUS CREAM, inform your doctor if you suffer from glucose-6-phosphate dehydrogenase-deficiency (genetic disorder that affects red blood cells), and/or have lung problems (such as respiratory impairment), kidney problems (such as renal impairment), and liver problems (such as hepatic impairment).

BURNOSAF PLUS CREAM is advised to be used with caution in pregnant and breast feeding women only if it is clearly necessary.

BURNOSAF PLUS CREAM is not recommended for use in premature infants/new-born infants (aged below 3 months) and is advised to be used with caution in elderly patients (aged 65 years/above) after consulting the doctor.

The most common side effects of applying BURNOSAF PLUS CREAM are leukopenia (low white blood cell count), application site reaction (such as burning, skin rash), and/or pruritis (itching). Consult your doctor if any of these symptoms worsens.

USES OF BURNOSAF PLUS CREAM

• Aids in the prophylaxis and treats infection associated with burn wounds, leg ulcers and/or pressure sores caused by sensitive micro-organisms
• Aids in the conservative management of finger-tip injuries (that involves pulp, nail loss and/or partial loss of the distal phalanx (finger bones) in affected individuals

HOW BURNOSAF PLUS CREAM WORKS

BURNOSAF PLUS CREAM works by inhibiting bacterial enzyme dihydropteroate synthetase (enzyme responsible for folic acid synthesis in bacteria) which leads to blockade of DNA synthesis in bacteria resulting in prevention and synthesis of bacterial growth in burn wounds, leg ulcers and/or pressure sores in affected individuals.  

DIRECTIONS FOR USE

Apply BURNOSAF PLUS CREAM as advised by your physician. It is for external use only. Wash your hands before and after use. The burn wounds should be cleansed and debrided. While applying BURNOSAF PLUS CREAM to burn wounds wear sterile disposable gloves. Apply required quantity of cream over the wound area and cover the applied site with a sterile dressing or leave the area uncovered. The cream may also be applied with a conventional finger dressing when used on the finger-tip injuries. Your doctor will decide the exact dose and duration of treatment for the child depending on child’s age, body weight and disease condition.

SIDE EFFECTS OF BURNOSAF PLUS CREAM

HOW TO MANAGE SIDE EFFECTS

Itchy Skin:

Try to pat or tap your skin instead of scratching it. Hold a damp towel to cool your skin. Wear loose clothing and avoid tight clothes, or clothes made from wool or synthetic fabrics. Avoid using perfumed soaps, deodorants or moisturizers and use a skin softener regularly.

WARNING & PRECAUTIONS

INTERACTIONS

A. Drug-Drug interactions:

• enzymatic debriding agents (used to remove necrotic material from pressure ulcers, leg ulcers, wounds) Ex. trypsin, subtilisin
• oral-hypoglycaemic agents (medicines used to treat diabetes) Ex. metformin, glimepiride
• phenytoin (medicine used for fits)

Overdosage:

If you or anyone else accidentally apply too much of BURNOSAF PLUS CREAM, consult your doctor immediately or visit the nearby hospital to manage overdose symptoms.

SYNOPSIS

MORE INFORMATION

• Keep BURNOSAF PLUS CREAM out of the sight and reach of children
• Do not store BURNOSAF PLUS CREAM above 25°C

FAQs ABOUT BURNOSAF PLUS CREAM

What is BURNOSAF PLUS CREAM used for?

BURNOSAF PLUS CREAM is used in the prophylaxis and treatment of infection in burn wounds, leg ulcers and/or pressure sores caused by sensitive micro-organisms in affected individuals. It is also indicated for use in the conservative management of finger-tip injuries (which involves pulp, nail loss and/or partial loss of the distal phalanx (finger bones) in affected individuals.

What are the common side effects associated with the use of BURNOSAF PLUS CREAM?

The most common side effects of applying BURNOSAF PLUS CREAM are leukopenia (low white blood cell count), application site reaction (such as burning, skin rash), and/or pruritis (itching). Consult your doctor if any of these symptoms worsens.

How BURNOSAF PLUS CREAM works?

BURNOSAF PLUS CREAM works by inhibiting bacterial enzyme dihydropteroate synthetase (enzyme responsible for folic acid synthesis in bacteria) which leads to blockade of DNA synthesis in bacteria resulting in prevention and synthesis of bacterial growth in burn wounds, leg ulcers and/or pressure sores in affected individuals.

How BURNOSAF PLUS CREAM should be applied?

Apply BURNOSAF PLUS CREAM as advised by your physician. It is for external use only. Wash your hands before and after use. The burn wounds should be cleansed and debrided. While applying BURNOSAF PLUS CREAM to burn wounds wear sterile disposable gloves. Apply required quantity of cream over the wound area and cover the applied site with a sterile dressing or leave the area uncovered. The cream may also be applied with a conventional finger dressing when used on the finger-tip injuries. Your doctor will decide the exact dose and duration of treatment for the child depending on child’s age, body weight and disease condition.

Can BURNOSAF PLUS CREAM be applied in pregnant and breastfeeding women?

Yes, BURNOSAF PLUS CREAM can be used but with caution in pregnant and breastfeeding women only if it is clearly necessary. Consult your doctor before applying the medicine.

REFERENCES

1. K.D. Tripathi. Sulfonamides, Cotrimoxazole and Quinolones. Essentials of Medical Pharmacology. Seventh Edition. 2013. Page - 706.

2. Rosemary J. Oaks; Renford Cindass.Silver Sulfadiazine. NIH National Library of Medicine. National Center for Biotechnology Information. StatPearls [Internet]. May 2022. [Accessed on 1st September 2022] https://www.ncbi.nlm.nih.gov/books/NBK556054/

3. King Pharmaceuticals, Inc. U.S. Food and Drug Administration (USFDA). [Revised in September 2012] [Accessed on 1st September 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017381s050lbl.pdf

4. Smith & Nephew GmbH. Health Products Regulatory Authority (HPRA). [Revised in July 2021] [Accessed on 1st September 2022] https://www.hpra.ie/img/uploaded/swedocuments/Licence_PA22696-002-001_19072021112637.pdf

USEFUL DIAGNOSTIC TESTS

• Kidney function test
• Complete blood count