REGRANEX is for topical use; it is not for oral, ophthalmic or intravaginal use.

The amount of REGRANEX to be applied depends upon the size of the ulcer area. To calculate the length of gel to apply to the ulcer, measure the greatest length of the ulcer by the greatest width of the ulcer in either inches or centimeters. To calculate the length of gel in inches, use the formula shown below in Table 1, and to calculate the length of gel in centimeters, use the formula shown below in Table 2.

Using the calculation, each square inch of ulcer surface will require approximately 2/3 inch length of gel squeezed from a 15 g tube. For example, if the ulcer measures 1 inch by 2 inches, then a 1 1/4 inch length of gel should be used for 15 g tubes (1 × 2 × 0.6 = 1 1/4).

Using the calculations for ulcer size in centimeters, each square centimeter of ulcer surface will require approximately a 0.25 centimeter length of gel squeezed from a 15 g tube. For example, if the ulcer measures 4 cm by 2 cm, then a 2 cm length of gel should be used for a 15 g tube [(4 × 2) ÷ 4 = 2].

The amount of REGRANEX to be applied should be recalculated by the physician or wound caregiver at weekly or biweekly intervals depending on the rate of change in ulcer area. The weight of REGRANEX from 15 g tubes is 0.65 g per inch length and 0.25 g per centimeter length.

To apply REGRANEX, the calculated length of gel should be squeezed on to a clean measuring surface, e.g., wax paper, and measured to the correct length with a ruler. The measured REGRANEX is transferred from the clean measuring surface using an application aid and then spread over the entire cleaned ulcer area to yield a thin continuous layer of approximately 1/16 of an inch thickness. The site(s) of application should then be covered by a saline moistened gauze dressing and left in place for approximately 12 hours. The dressing should then be removed and the ulcer rinsed with saline or water to remove residual gel and covered again with a moist primary dressing (without REGRANEX gel) for the remainder of the day. REGRANEX should be applied once daily to the ulcer until complete healing has occurred. If the ulcer does not decrease in size by approximately 30% after 10 weeks of treatment or complete healing has not occurred in 20 weeks, continued treatment with REGRANEX should be reassessed. The step-by-step instructions for applying REGRANEX in a home care setting can be found in the FDA-approved Instructions for Use.