Usage
This combination medication is primarily used to treat first and second-degree burns. It is also indicated for skin ulcers (incisions, abrasions, minor cuts, wounds), and diabetic foot ulcers.
Pharmacological Classification: Topical antibacterial, antiseptic, and growth factor.
Mechanism of Action: This medication combines three active ingredients that work synergistically: rhEGF stimulates cell growth and regeneration, chlorhexidine gluconate acts as an antiseptic and antibacterial agent, and silver sulfadiazine provides broad-spectrum antimicrobial action.
Alternate Names
How It Works
Pharmacodynamics: rhEGF binds to EGF receptors, stimulating cell proliferation, migration, and differentiation, leading to accelerated tissue regeneration. Chlorhexidine disrupts bacterial cell walls. Silver sulfadiazine hinders bacterial folic acid synthesis, and silver ions bind to bacterial DNA and membranes.
Pharmacokinetics: Primarily topical action. Minimal systemic absorption with intact skin, but absorption increases with large burns or open wounds. Silver sulfadiazine metabolizes to sulfadiazine, which is excreted renally. Chlorhexidine has poor absorption through intact skin, but systemic absorption may occur from broken skin.
Mode of Action: rhEGF activates the MAP kinase pathway, leading to the phosphorylation of transcription factors that promote cell proliferation. Chlorhexidine causes leakage of intracellular components, leading to bacterial death. Silver sulfadiazine competes with para-aminobenzoic acid (PABA) to inhibit bacterial dihydrofolic acid synthesis. Silver ions also damage bacterial DNA.
Elimination Pathways: Silver sulfadiazine is metabolized to sulfadiazine and excreted renally.
Dosage
Standard Dosage
Adults:
Apply a thin layer (approximately 1/16 inch or 1.5 mm) to the cleansed and debrided area 1-2 times daily, or as directed by the physician. Reapply at least every 24 hours, and to any area where the cream has been removed.
Children:
Use and dose must be determined by a doctor for children older than 2 months. Not recommended for premature infants and infants 2 months and younger.
Special Cases:
- Elderly Patients: Use with caution and monitor for adverse reactions.
- Patients with Renal Impairment: Use with caution; drug accumulation possible.
- Patients with Hepatic Dysfunction: Use with caution; drug accumulation possible.
- Patients with Comorbid Conditions: Use with caution in patients with G6PD deficiency as hemolysis may occur. Caution in patients with porphyria.
Clinical Use Cases
Dosage in these situations should be determined by the treating physician based on individual patient needs. For hand burns, apply the cream and enclose the hand in a plastic bag or glove, changing the dressing every three days or as needed.
- Intubation: N/A
- Surgical Procedures: May be used on surgical incisions.
- Mechanical Ventilation: N/A
- Intensive Care Unit (ICU) Use: Dosage as per physician’s recommendation.
- Emergency Situations: N/A
Dosage Adjustments
Adjustments may be needed based on patient response, wound/burn characteristics, and complicating factors. Close monitoring is essential, especially with renal or hepatic impairment, G6PD deficiency, and porphyria.
Side Effects
Common Side Effects
- Itching
- Pain, burning, or stinging at the application site
- Rash
- Skin irritation, redness
- Dryness
Rare but Serious Side Effects
- Allergic reactions (rash, swelling, difficulty breathing, dizziness, nausea)
- Leukopenia
- Argyria (bluish-gray skin discoloration)
- Hemolysis (particularly in patients with G6PD deficiency)
Long-Term Effects
With prolonged use, monitor for silver toxicity (argyria) and blood cell count changes.
Adverse Drug Reactions (ADR)
Severe allergic reactions require immediate medical attention. Monitor for wound site infections.
Contraindications
- Hypersensitivity to any component
- Pregnant women at term, premature infants, neonates in the first month of life
- G6PD deficiency
- Severe hepatic or renal impairment
Drug Interactions
- Cimetidine: May increase leukopenia risk in large burns.
- Sodium nitrite: May increase methemoglobinemia risk.
- Proteolytic enzymes (collagenase, papain, sutilains): May be inactivated by silver.
- Topical antiseptics (e.g., hydrogen peroxide): May interact and cause irritation.
- Corticosteroids (e.g., hydrocortisone): May increase skin irritation.
- Oral hypoglycemic agents and phenytoin: Their action may be potentiated.
Pregnancy and Breastfeeding
Pregnancy Safety Category: C, X (near term). Unsafe during pregnancy. Avoid use in pregnant females at term, premature infants, or in newborn infants in the first month of life (due to the risk of kernicterus).
Not known if distributed in breast milk. Use with caution.
Drug Profile Summary
- Mechanism of Action: rhEGF promotes cell growth, chlorhexidine is antiseptic/antibacterial, and silver sulfadiazine is antimicrobial.
- Side Effects: Itching, pain, rash, irritation, allergic reactions, leukopenia, argyria, hemolysis.
- Contraindications: Hypersensitivity, pregnancy/lactation, G6PD deficiency, severe hepatic/renal impairment.
- Drug Interactions: Cimetidine, sodium nitrite, proteolytic enzymes, topical antiseptics, corticosteroids.
- Pregnancy & Breastfeeding: Contraindicated near term and in neonates. Caution during breastfeeding.
- Dosage: Thin layer 1-2 times daily. Adjust based on individual needs.
- Monitoring Parameters: Wound healing progress, signs of infection, blood cell counts, signs of silver toxicity.
Popular Combinations
This medication itself is a combination product. Avoid concurrent use of other topical products on the same area.
Precautions
- General Precautions: Screen for allergies, metabolic disorders, and organ dysfunction.
- Specific Populations: As described above.
- Lifestyle Considerations: Alcohol interaction unknown. Driving ability not affected.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Chlorhexidine Gluconate + Recombinant Human Epidermal Growth Factor + Silver Sulfadiazine?
A: Apply a thin layer (1/16 inch or 1.5mm) to the cleansed area 1-2 times daily for adults. Pediatric dosage should be determined by a physician.
Q2: What are the common side effects?
A: Common side effects include itching, pain, rash, and irritation at the application site.
Q3: Is this medication safe to use during pregnancy or breastfeeding?
A: No. It is contraindicated near term and in neonates. Use with caution during breastfeeding.
Q4: What should I do if a patient experiences an allergic reaction?
A: Discontinue use immediately and provide appropriate medical care. Severe reactions require urgent attention.
Q5: Can this medication be used on all types of burns?
A: It is primarily indicated for first and second-degree burns. Its use on third-degree burns should be under the guidance of a physician.
Q6: Are there any drug interactions I should be aware of?
A: Yes. It can interact with cimetidine, sodium nitrite, proteolytic enzymes, and some topical medications.
Q7: How should this medication be stored?
A: Store in a cool, dry place away from sunlight at 10°C to 25°C.
Q8: How does rhEGF contribute to wound healing?
A: rhEGF stimulates cell proliferation, migration, and differentiation, promoting faster healing.
Q9: What is the role of silver sulfadiazine in this combination?
A: Silver sulfadiazine provides broad-spectrum antimicrobial activity, preventing wound infections.
