A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Regranex Indications, Dosage, Storage, Stability - Becaplermin
Regranex Indications, Dosage, Storage, Stability - Becaplermin
INDICATIONS
REGRANEX Gel is indicated for the treatment of lower extremity
diabetic neuropathic ulcers
that extend into the subcutaneous
tissue or beyond and have an adequate blood
supply. When used as an adjunct to, and not a substitute
for, good ulcer care practices
including initial sharp debridement, pressure
relief and infection
control, REGRANEX Gel increases
the incidence of complete
healing of diabetic
ulcers.
The efficacy of REGRANEX
Gel for the treatment of diabetic
neuropathic ulcers that do not extend
through the dermis into subcutaneous
tissue (Stage I or II, IAET
staging classification) or
ischemic diabetic ulcers has not been evaluated.
DOSAGE AND ADMINISTRATION
The amount of REGRANEX Gel to be applied will vary depending 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 2, and to calculate the length
of gel in centimeters, use the
formula shown below in Table
3.
Table 2: Formula to Calculate Length of Gel in Inches
to be Applied Daily
INCHES
| Tube Size |
Formula |
| 15 or 7.5g tube |
length X width X 0.6 |
| 2g tube |
length X width X 1.3 |
Using the calculation, each square inch of ulcer
surface will
require approximately 2+3 inch length
of gel squeezed from a 15g or
7.5g tube, or approximately 1 1/3inch length
of the gel from a 2g 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 15g
or 7.5g tubes (1 X 2 X 0.6=1 1/4)and 2 3/4 inch gel
length should be used for 2g
t.b. (1 X 2 X 1.3=2 3/4).
Table 3: Formula to Calculate Length of Gel in Centimeters to be Applied
Daily
CENTIMETERS
| Tube Size |
Formula |
| 15 or 7.5g tube |
length X width divided by 4 |
| 2g tube |
length X width divided by 2 |
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 15g or
7.5g tube, or approximately a 0.5 centimeter
length of gel
from a 2g tube. For example, if the ulcer measures 4 cm
by 2 cm, then a 2 centimeter
length of gel
should be used for 15g or 7.5g t.b.
[(4 X 2) divided by 4=2] and a 4 centimeter
length of gel should be used for
2g t.b. [(4 X 2) divided by 2=4].
The amount of REGRANEX Gel to be applied should be recalculated by the
physician or wound
care giver at weekly or biweekly intervals depending on the rate
of change in ulcer area. The
weight of REGRANEX Gel from 7.5g and 15g tubes is 0.65g per
inch length and 0.25g per centimeter
length.
To apply REGRANEX Gel, the calculated length of gel
should be squeezed on to a clean measuring surface, e.g., wax paper. The
measured REGRANEX Gel is transferred from the clean measuring surface
using an application aid and then
spread over the entire 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 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 second moist dressing
(without REGRANEX Gel) for the remainder of the day. REGRANEX Gel 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 Gel should be reassessed. The step-by-step instructions
for applying REGRANEX Gel for home administration
are described under "Information for Patients".
HOW SUPPLIED
REGRANEX (becaplermin) Gel, supplied as a clear, colorless to straw-colored
preserved gel containing 100µg
of becaplermin per gram
of gel, is available in multi-use tubes in the following sizes:
| 2g tubes |
NDC 0045-0810-02 |
| 7.5g tubes |
NDC0045-0810-07 |
| 15g tubes |
NDC 0045-0810-15 |
REGRANEX Gel is for external
use only.
Storage
Store refrigerated, 2-8º C (36-46º F). DO NOT FREEZE. DO
NOT USE THE GEL AFTER THE EXPIRATION DATE AT THE BOTTOM OF THE TUBE.
Caution: Federal (USA) law prohibits
dispensing without prescription.
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