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 Indications, Dosage, Storage, Stability - Ciclopirox
Penlac Nail Lacquer Indications, Dosage, Storage, Stability - Ciclopirox
INDICATIONS
(To understand fully the indication for this product, please read
the entire INDICATION AND USAGE section of the labeling.)
PENLAC® NAIL LACQUER 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 4 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.
- 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.
- PENLAC® NAIL LACQUER Topical Solution, 8%, should be used only under
medical supervision as described above.
- The effectiveness and safety of PENLAC® NAIL LACQUER Topical Solution,
8%, in the following populations has not been studied. The clinical
trials with use of PENLAC® NAIL LACQUER Topical Solution, 8%, excluded
patients who: were pregnant or nursing, planned to become pregnant,
had a history of immunosuppression (e.g., extensive, persistent, or
unusual distribution of dermatomycoses, extensive seborrheic dermatitis,
recent or recurring herpes zoster, or persistent herpes simplex), were
HIV seropositive, received organ transplant, required medication to
control epilepsy, were insulin dependent diabetics or had diabetic neuropathy.
Patients with severe plantar (moccasin) tinea pedis were also excluded.
- The safety and efficacy of using PENLAC® NAIL LACQUER Topical Solution,
8%, daily for greater than 48 weeks have not been established.
Clinical Trials Data
The results of use of PENLAC® NAIL LACQUER Topical Solution, 8%, in treatment
of onychomycosis of the toenail without lunula involvement were obtained
from two double-blind, placebo-controlled studies conducted in the US.
In these studies, patients with onychomycosis of the great toenails without
lunula involvement were treated with ciclopirox topical solution, 8%,
in conjunction with monthly removal of the unattached, infected toenail
by the investigator. PENLAC® NAIL LACQUER Topical Solution, 8%, was applied
for 48 weeks. At baseline, patients had 20-65% involvement of the target
great toenail plate. Statistical significance was demonstrated in one
of two studies for the endpoint "complete cure" (clear nail and negative
mycology), and in two studies for the endpoint "almost clear" (£10%
nail involvement and negative mycology) at the end of study. These results
are presented below.
|
At Week 48 (plus Last Observation Carried Forward)
for the Intent-to-Treat (ITT) Population
|
| |
Study 312 |
Study 313
|
| Active |
Vehicle |
Active |
Vehicle |
| Complete Cure* |
6/110 (5.5%) |
1/109 (0.9%) |
10/118 (8.5%) |
0/117 (0%)
|
| Almost Clear** |
7/107 (6.5%) |
1/108 (0.9%) |
14/116 (12%) |
1/115 (0.9%) |
| Negative Mycology Alone*** |
30/105 (29%) |
12/106 (11%) |
41/115 (36%) |
10/114 (9%) |
| * Clear nail
and negative mycology |
| **
£10% nail involvement and negative mycology |
| *** Negative KOH and negative
culture |
The summary of reported patient outcomes for the ITT population at 12
weeks following the end of treatment are presented below. Note that post-treatment
efficacy assessments were scheduled only for patients who achieved a complete
cure.
|
Post-treatment Week 12 Data for Patients Who
Achieved Complete Cure at Week 48
|
| |
Study 312 |
Study 313 |
| Active |
Vehicle |
Active |
Vehicle |
| Number of Treated Patients |
112 |
111 |
119 |
118 |
| Complete Cure at Week 48 |
6 |
1 |
10 |
0 |
| Post-treatment Week 12 Outcomes: |
| Patients Missing All Week 12 Assessments |
2 |
0 |
2 |
0 |
| Patients with Week 12 Assessments |
4 |
1 |
8 |
0 |
| Complete Cure |
3 |
1 |
4 |
0 |
| Almost Clear |
2* |
1 |
1* |
0 |
|
Negative Mycology
|
3 |
1 |
5 |
0 |
*Four patients (from studies 312 and 313) who were completely cured did
not have post-treatment Week 12 planimetry data.
DOSAGE AND ADMINISTRATION
PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, should be used as a component of a comprehensive
management program for onychomycosis. Removal of the unattached, infected nail, as frequently as monthly, by a
health care professional, weekly trimming by the patient, and daily application of the medication are all integral parts
of this therapy. Careful consideration of the appropriate nail management program should be given to patients with
diabetes (see PRECAUTIONS).
Nail Care By Health Care Professionals:
Removal of the unattached, infected nail, as frequently as monthly, trimming of onycholytic nail, and filing of excess
horny material should be performed by professionals trained in treatment of nail disorders.
Nail Care By Patient
Patients should file away (with emery board) loose nail material and trim nails, as required, every seven days after
PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, is removed with alcohol.
PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, should be applied once daily (preferably at bedtime or
eight hours before washing) to all affected nails with the applicator brush provided. The PENLAC® NAIL LACQUER
(ciclopirox) Topical Solution, 8%, should be applied evenly over the entire nail plate.
If possible, PENLAC® NAIL LACQUER (ciclopirox) 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).
The PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, should not be removed on a daily basis. Daily applications
should be made over the previous coat and removed with alcohol every seven days. This cycle should be
repeated throughout the duration of therapy.
HOW SUPPLIED
PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, is supplied in
3.3 mL (NDC 0088-2200-13) glass bottles with screw caps which are fitted
with brushes.
Protect from light (e.g., store the bottle in the carton after every
use).
PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, should be stored
at room temperature between 59° and 86°F (15° and 30°C).
CAUTION: Flammable. Keep away from heat and flame.
Rx ONLY
REFERENCES
1. Dittmar W., Lohaus G. 1973. HOE296, A new antimycotic
compound with a broad antimicrobial spectrum. Arzneim-Forsch/Drug Res.
23:670-674.
2. Niewerth et. al., 1998. Antimicrobial susceptibility
testing of dermatophytes: Comparison of the agar macrodilution and broth
micro dilution tests. Chemotherapy. 44:31-35.
3. Yang et. al. 1997. A new simulation model for
studying in vitro topical penetration of antifungal drugs into hard keratin.
J. Mycol. Med. 7:195-98.
Prescribing Information as of December 2003.
Manufactured for:
Dermik Laboratories
A Division of Aventis Pharmaceuticals Inc.
Berwyn, PA 19312 USA
by: Aventis Pharma Deutschland GmbH
D-65926 Frankfurt am Main
Germany
©2003 Dermik Laboratories
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