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
Penlac Nail Lacquer Patient, Information, Instructions - Ciclopirox
Penlac Nail Lacquer Patient, Information, Instructions - Ciclopirox
PATIENT INFORMATION
Patients should have detailed instructions regarding the use of PENLAC™
NAIL LACQUER Topical Solution, 8%, as a component of a comprehensive management
program for onychomycosis in order to achieve maximum benefit with the
use of this product.
The patient should be told to:
- Use PENLAC™ NAIL LACQUER Topical Solution, 8%, as directed by a health
care professional. Avoid contact with the eyes and mucous membranes.
Contact with skin other than skin immediately surrounding the treated
nail(s) should be avoided. PENLAC™ NAIL LACQUER Topical Solution, 8%,
is for external use only.
- PENLAC™ NAIL LACQUER Topical Solution, 8%, should be applied evenly
over the entire nail plate and 5 mm of surrounding skin. If possible,
PENLAC™ NAIL LACQUER Topical Solution, 8%, should be applied to the
nail bed, hyponychium, and the under surface of the nail plate when
it is free of the nail bed (e.g., onycholysis). Contact with the surrounding
skin may produce mild, transient irritation (redness).
- Removal of the unattached, infected nail, as frequently as monthly,
by a health care professional is needed with use of this medication.
- Inform a health care professional if the area of application shows
signs of increased irritation (redness, itching, burning, blistering,
swelling, oozing).
- Up to 48 weeks of daily applications with PENLAC™ NAIL LACQUER Topical
Solution, 8%, and professional removal of the unattached, infected nail,
as frequently as monthly, are considered the full treatment needed to
achieve a clear or almost clear nail (defined as 10% or less residual
nail involvement).
- Six months of therapy with professional removal of the unattached,
infected nail may be required before initial improvement of symptoms
is noticed.
- A completely clear nail may not be achieved with use of this medication.
In clinical studies less than 12% of patients were able to achieve either
a completely clear or almost clear toenail.
- Do not use the medication for any disorder other than that for which
it is prescribed.
- Do not use nail polish or other nail cosmetic products on the treated
nails.
- Avoid use near heat or open flame, because product is flammable.
Patients should have detailed instructions regarding the use of PENLAC™
NAIL LACQUER Topical Solution, 8%, as a component of a comprehensive management
program for onychomycosis in order to achieve maximum benefit with the
use of this product. Discuss your treatment plan with your health care
professional for regular removal of the unattached, infected nail.
Before using this medication, tell your doctor if you:
- Are pregnant or nursing
- Are an insulin dependent diabetic or have diabetic neuropathy
- Have a history of immunosuppression
- Are immunocompromised (e.g., received an organ transplant, etc.)
- Require medication to control epilepsy
- Use or require topical corticosteroids on a repeated monthly basis
- Use steroid inhalers on a regular basis
Patient Information:
- Use PENLAC™ NAIL LACQUER Topical Solution, 8%, as directed by your
health care professional.
- PENLAC™ NAIL LACQUER Topical Solution, 8%, is for external use only.
- Contact with skin other than skin immediately surrounding the treated
nail(s) should be avoided.
- Avoid contact with the eyes and mucous membranes.
- Removal of the unattached, infected nail, as frequently as monthly,
by your health care professional is needed with use of this medication
to obtain maximal benefit with use of this product.
- Inform your health care professional if the area of application shows
signs of increased irritation (redness, itching, burning, blistering,
swelling, oozing).
- Up to 48 weeks of daily applications with PENLAC™ NAIL LACQUER Topical
Solution, 8%, and professional removal, as frequently as monthly, of
the unattached, infected nail are considered the full treatment time
to achieve a clear or almost clear nail (defined as 10% or less residual
nail involvement). Six months of therapy with professional removal of
the unattached, infected nail may be required before initial improvement
of symptoms is noticed.
- A completely clear nail may not be achieved with use of this medication.
In clinical studies less than 12% of patients were able to achieve either
a clear or almost clear toenail.
- Do not use nail polish or other nail cosmetic products on the treated
nails.
- Avoid use near heat or open flame, because product is flammable.
Patient Instructions
- Before starting treatment, remove any loose nail or nail material
using nail clippers or nail files.
- Apply PENLAC™ NAIL LACQUER Topical Solution, 8%, once daily (preferably
at bedtime) to all affected nails with the applicator brush provided.
Apply the lacquer evenly over the entire nail. Where possible, nail
lacquer should also be applied to the underside of the nail and to the
skin beneath it. Allow lacquer to dry (approximately 30 seconds) before
putting on socks or stockings. After applying medication, wait 8 hours
before taking a bath or shower.
- Apply PENLAC™ NAIL LACQUER Topical Solution, 8%, daily over the previous
coat.
- Once a week, remove the PENLAC™ NAIL LACQUER Topical Solution, 8%,
with alcohol. Remove as much as possible of the damaged nail using nail
clippers, or nail files.
- Repeat process (steps 2 through 4).
Please Note:
- To prevent screw cap from sticking to the bottle, do not allow solution
to get into the bottle threads.
- To prevent the solution from drying out, bottle should be closed
tightly after every use.
- To protect from light, replace bottle into carton after each use.
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