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PENLAC
Penlac is a topical prescription treatment for mild to moderate fungal infections of the fingernails and toenails. |
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PENLAC DRUG INFO
IMPORTANT NOTE:
The following information is intended to supplement,
not substitute for, the expertise and judgment of
your physician, pharmacist or other healthcare professional.
It should not be construed to indicate that use of
the drug is safe, appropriate, or effective for you.
Consult your healthcare professional before using
this drug.
(ciclopirox) Topical Solution, 8%
COMMON BRAND NAME(S):
Penlac
USES:
PENLAC NAIL LACQUER (ciclopirox) Topical Solution, 8%, as a component of a
comprehensive management program, is indicated as topical treatment in
immunocompetent patients with mild to moderate onychomycosis of fingernails and
toenails without lunula involvement, due to Trichophyton rubrum. The comprehensive
management program includes removal of the unattached, infected nails as frequently as
monthly, by a health care professional who has special competence in the diagnosis and
treatment of nail disorders, including minor nail procedures.
HOW TO USE:
Before starting treatment, remove any loose nail or nail material using nail clippers or nail files.
Apply a thin layer of Penlac once daily (preferably at bedtime) to all affected nails with the
applicator brush provided. Apply the thin layer of 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 daily over the previous coat. Once a week, remove the
Penlac with alcohol. Remove as much as possible of the damaged nail using scissors, nail clippers or nail files.
Repeat process.
SIDE EFFECTS: The most common side effects were
rash-related adverse events: periungual erythema and erythema of the proximal nail fold were reported more
frequently in patients treated with PENLAC NAIL LACQUER (ciclopirox) Topical Solution, 8%. Other TEAEs
thought to be causally related included nail disorders such as shape change, irritation, ingrown toenail,
and discoloration. If you notice other effects not listed above, contact your doctor or pharmacist.
PRECAUTIONS:
If a reaction suggesting sensitivity or chemical irritation should occur with the use of
PENLAC NAIL LACQUER (ciclopirox) Topical Solution, 8%, treatment should be
discontinued and appropriate therapy instituted.
So far there is no relevant clinical experience with patients with insulin dependent
diabetes or who have diabetic neuropathy. The risk of removal of the unattached,
infected nail, by the health care professional and trimming by the patient should be
carefully considered before prescribing to patients with a history of insulin dependent
diabetes mellitus or diabetic neuropathy.
DRUG INTERACTIONS:
Tell your doctor of all prescription and nonprescription medication you use.
No studies have been conducted to determine whether ciclopirox might reduce the
effectiveness of systemic antifungal agents for onychomycosis. Therefore, the
concomitant use of 8% ciclopirox topical solution and systemic antifungal agents for
onychomycosis is not recommended. especially of: other nasal products.
Do not start or stop any medicine without doctor or pharmacist approval.
OVERDOSE: If overdose is suspected, contact your local poison
control center or emergency room immediately.
NOTES: If a reaction suggesting sensitivity or
chemical irritation should occur with the use of PENLAC NAIL LACQUER (ciclopirox) Topical Solution, 8%,
treatment should be discontinued and appropriate therapy instituted. So far there is no relevant clinical
experience with patients with insulin dependent diabetes or who have diabetic neuropathy. The risk of
removal of the unattached, infected nail, by the health care professional and trimming by the patient should be
carefully considered before prescribing to patients with a history of insulin dependent diabetes mellitus or
diabetic neuropathy.
MISSED DOSE:
If you miss a dose, use it as soon as remembered; do not use if it is almost time for the next dose, instead,
skip the missed dose and resume your usual dosing schedule. Do not "double-up" the dose to catch up.
STORAGE: Store at room temperature between 36 and 77 degrees F
(2 -25 degrees C) away from light and moisture. Avoid freezing.
Disclaimer
This information is not intended
to substitute for professional medical advice. Be
sure to contact your physician, pharmacist or other
health care provider for more information about this
medication.
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