1. PENLACTM
8% CICLOPIROX SOLUTION AVENTIS PHARMACEUTICALS INC.
1 | P a g e
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to
use Penlac safely and effectively. See full prescribing
information for Penlac.
PENLAC 8% (Ciclopirox) SOLUTION
Initial US Approval: 1998
---------------INDICATIONS AND USAGE----------------
Penlac Nail Lacquer (8%) Topical Solution is indicated as
topical treatment for:
 Immunocompetent patients with mild to moderate
onychomycosis of fingernails and toenails without
lunula involvement due to T.rubrum.(1.2)
 Removal of unattached, infected nails, as frequently as
monthly by health care professional competent in
diagnosis and treatment of nail disorders.(1.1, 5.3)
 Application of the topical solution must be under the
supervision of medical professional.(1.2, 5.3)
 Not to be used with a nail polish, or nail remover.(1.1)
-----------DOSAGE AND ADMINISTRATION----------
 Must be used as a component of comprehensive
management program for Onychomycosis.(2.1)
 Frequent removal of infected nail by the patient
necessary every month and trimming of onycholytic
nail by health professional concurrently.(2.2, 1.1, 5.3)
 Daily application of the solution to every integral part
of the nail, including the nail bed, hyponychium and
under the surface of the nail bed where it is free of the
nail bed (onycholysis). Must be evenly applied on the
nail plate and up to 5 mm of surrounding skin.(2.3, 5.3)
 Up to 48 weeks of daily application of the solution, and
consecutive infected nail removal needed to achieve a
clear nail or almost clear nail (defined as 10% or less
residual nail involvement). (2.4, 5.3)
-------------DOSAGE FORMS AND STRENGTH--------
Depending on severity of disease, it is recommended to
used over the infected nail of toes and fingers (3, 5.2)
-----------------CONTRAINDICATIONS-------------------
 Hypersensitive patients to display a series of physical
reaction towards the drug. (4)
 Predicament for patients with a history of
immunosuppression : extensive, persistent, or unusual
distribution of dermatomycoses, extensive seborrheic
dermatitis, HIV seropositive, received organ transplant,
diabetic neuropathic, severe plantar (moccasin) tinea
pedis. (1)
-------------WARNINGS AND PRECAUTIONS----------
 Not for ophthalmic, oral or intravaginal use, but for
nails and immediate adjacent skin only. (5.1)
 Any irritation, burning, itching, swelling, ooze or
sensitivity must be followed by discontinuation of the
dosage, and appropriate therapy should be
instituted.(5.2, 1)
 The risk of removal of the unattached, infected nail, by
health care professional and trimming by the patient,
should be carefully considered before prescribing to
patients with a history of diabetes mellitus and diabetic
neuropathy. (5.2)
 Do not use medication of any other disorder and nail
polish or other cosmetics on the nail plate. (5.3)
 Avoid use near heat or open flame, because the product
is flammable.(5.3)
----------------ADVERSE REACTIONS---------------------
 Rash related adverse events: periungual erythema and
erythema of the proximal nail fold. (Incidence 1% -
5%) & Site reactions / burning of skin. (Incidence 1%)
(6)
To report suspected ADVERSE REACTIONS, contact (manufacturer) at (phone #
and web address) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
----------------DRUG INTERACTIONS---------------------
Systemic antifungal agents for onychomycosis:
Discontinue prior using this solution. (7.1)
-----------USE IN SPECIFIC POPULATIONS-----------
Dose needs to be carefully administered for
hypersensitive patients. Safety not established for
pediatric, geriatric, pregnant and lactating populations.
(4, 8.1, 8.2, 8.3, 8.4)
See 17 for PATEINT COUNSELING INFORMATION and
FDA approved patient labeling.
REVISED: 05/13
WARNING: POTENTIAL FOR ALLERGIC REACTIONS
See full prescribing information for complete boxed warning.
 Not to be used for patients with a history of
immunosuppression. (4, 1)
 Not for eyes, oral or intravaginal use. (5.1)
 Must be prescribed and advised by a health care
professional. Discontinue if redness, swelling, oozing, or
burning occurs. (1, 5.2, 5.3)

2. PENLACTM
8% CICLOPIROX SOLUTION AVENTIS PHARMACEUTICALS INC.
2 | P a g e
FULL PRESCRIBING INFORMATION:
CONTENTS *
1 INDICATIONS AND USAGE
1.1 Moderate Onychomycosis
1.2 Generalized Use
2 DOSAGE AND ADMINISTRATION
2.1 Recommended dosage
2.2 Dosage Discontinuation
2.3 Nail care by Health Care Professional
2.4 Nail care by Patient
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNING AND PRECAUTIONS
5.1 Warning
5.2 Precautions
5.3 Information for patients
5.4 Guide for Health Care Professionals
6 ADVERSE REACTIONS
6.1 Clinical Studies experience
6.2 Post Marketing experience
7 DRUG INTERACTIONS
7.1 Other systemic anti fungal drug therapy
7.2 Drugs that are not clinically significant with Penlac
7.3 Allergic Drugs and their interaction with Penlac
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Nursing Mothers
8.3 Pediatric use
8.4 Geriatric use
8.5 Immunosuppressed patients
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Pharmacokinetics
12.2 Microbiology
12.2.1 Mechanism of Action
12.2.2 In vivo / ex vivo Activity
12.2.3 Susceptibility testing for T.rubrum sp.
12.2.4 Resistance
12.3 Antifungal Drug Interactions
12.4 Pharmacokinetics
13 NON CLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, and Impairment of
fertility
14 CLINICAL STUDIES
14.1 Clinical Trial Description
14.2 Double-blind Placebo-controlled studies
14.3 48 week results for Intent to Treat (ITT)
population.
15 REFERENCES
16 HOW SUPPLIED / STORAGE & HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 Patient Information
17.2 Instructions
17.3 Adverse Reactions Reporting
* Sections or subsections omitted from the full
prescribing information are not listed.

3. REFERENCES
1) “Penlac Nail Lacquer: Food And Drug Adminstration”; www.accessdata.fda.gov; Accessed
09/15/2015
2) “Introduction to drug labeling.pdf”; RGA 6201; Blackboad; www.myneu.edu ; Accessed 11/19/2015