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Brand Name :
Regranex Gel
Synonyms :
becaplermin
Class :
Metabolic and Endocrine, Wound Care
Brand Name :
Regranex Gel
Synonyms :
becaplermin
Class :
Metabolic and Endocrine, Wound Care
Dosage Forms & Strengths
Topical gel
0.01%
The formula in inches based on tube size as follows:
For 2 g tube: Length of ulcer × width × 1.3 is equal to length of gel in inches
For 15 g tube: Length of ulcer × width × 0.6 is equal to length of gel in inches
The formula in centimeters based on tube size as follows:
For 2 g tube: Length of ulcer × width ÷ 2 is equal Length of gel in cm
For 15 g tube: Length of ulcer × width ÷ 4 is equal to length of gel in cm
Dosing Considerations
In treatment of venous stasis ulcers and pressure ulcers the efficacy is not determined
In humans the effects on exposed joints, bone, tendons and ligaments are not established
Safety and efficacy not determined
Refer to adult dosing
Actions and Spectrum
becaplermin works by stimulating the migration and proliferation of cells involved in wound healing. It stimulates the production of fibroblasts, endothelial cells, and granulation tissue, which are essential for wound healing processes. The spectrum of becaplermin is focused on the treatment of chronic, non-healing diabetic ulcers.
Frequency defined
<1%
Ulcer infection
Local pain
Tunneling of ulcer
Skin ulceration
1-10%
Skin rash
Erythema
Post marketing Reports
Burning sensation at site of application
None
Contraindication:
Caution:
Pregnancy consideration:
Pregnancy category: N/A
Lactation: Excretion into human milk is unknown
Pregnancy Categories:
Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester.
Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.
Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
Category N: There is no data available for the drug under this category.
Pharmacology
becaplermin should not be applied to wounds that show signs of clinically significant infections. It stimulates the production of granulation tissue and encourages the chemotactic recruitment and proliferation of cells involved in wound healing.
Pharmacodynamics
Human platelet-derived growth factor (rPDGF-BB), which encourages fibroblast proliferation and differentiation to speed up wound healing and accelerates the development of new granulation tissue, also stimulates angiogenesis.
Pharmacokinetics
Absorption
The absorption of becaplermin through intact skin is minimal.
Distribution
It does not distribute extensively throughout the body.
Metabolism
Not known
Elimination and excretion
Not known
becaplermin is administered topically as a gel directly to the surface of the chronic and non-healing diabetic ulcer.
Generic Name: becaplermin
Why do we use becaplermin?
becaplermin is used for the treatment of chronic, non-healing diabetic ulcers.
It is typically used as an adjunctive therapy alongside measures such as wound debridement and infection control.
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