Brand Name Drug: Penlac Nail Lacquer
Active Ingredient Drug: ciclopirox
Indication: Topical treatment of onchomycosis (nail fungus)
Company Name: Dermik Laboratories, a division of Aventis Pharmaceuticals
Availability: Approved by the FDA on December 27, 1999 and made available in the US in March 2000
Introduction
Millions of Americans, particularly those between 40 and 60, suffer from onychomycosis, a persistent fungal infection of the nails. It occurs when dermatophyte fungi, usually Trichophyton rubrum, invade the nail bed. Men and senior people are afflicted most often, although the infection can strike all ages and women as well.
Onychomycosis of the toenails occurs four times more frequently than that of the fingernails due to the moist environment in shoes that promotes dermatophyte proliferation. In addition to causing embarrassment for its sufferers, onychomycosis can also cause discomfort and pain, particularly during walking, as the infection pushes up the infected nail. Nail fungus can lead to more severe infections in people with diabetes.
Until recently, such infections have been treated using oral preparations, such as terbinafine and itraconazole, but many patients cannot or prefer not to take these drugs. Penlac Nail Lacquer (ciclopirox) is now available in the US for these patients – the first topical agent approved in the US for this disorder. The lacquer was approved by the FDA on December 27, 1999, and made available in March 2000. Ciclopirox nail lacquer has been available for several years in Germany under the brand name Batrafen.
Manufactured by Dermik Laboratories, a division of Aventis Pharmaceuticals, Penlac is applied like nail polish and should be used once daily, preferably at bedtime or eight hours before washing.
What Is Penlac Nail Lacquer Topical Solution?
Penlac Nail Lacquer Topical Solution, also known as ciclopirox, is a medication used to treat fungal infections of the toenails and fingernails. It is a topical antifungal medication that works by inhibiting the growth of fungi.
Penlac’s active ingredient is ciclopirox, an antifungal agent with broad-spectrum activity against various fungi.
Penlac is indicated for treating onychomycosis, a fungal infection of the nails. It is used explicitly for infections caused by dermatophytes and yeast.
Penlac is a topical solution that is applied directly to the affected nails. It is typically used once daily.
Penlac Nail Lacquer (ciclopirox): Clinical Study Results
Penlac Nail Lacquer (ciclopirox) ‘s efficacy for treating onychomycosis was established in two double-blind, placebo-controlled studies in the US. The research is expected to be published later this year. One study included 219 patients (study 312), while the other involved 235 patients (study 313); all patients had onychomycosis of the great toenails without lunula involvement. Patients were treated with either Penlac or a placebo every day for 48 weeks, with monthly removal of the unattached, infected toenail by the investigators.
At 48 weeks, 5.5% of patients in study 312 and 8.5% of patients in study 313 treated with Penlac achieved a complete cure (defined as a clear nail with negative mycology), compared to 0.9% and 0% of placebo patients, respectively. The corresponding rates for an almost-clear outcome (10% or less nail involvement and negative mycology) were 6.5% and 12% for Penlac patients, compared to 0.9% and 0.9% for placebo patients, respectively. Negative mycology alone was achieved by 29% of the Penlac patients in study 312 and 36% of Penlac patients in study 313, compared to 11% and 9% of placebo patients, respectively.
How It Works
Penlac Nail Lacquer Topical Solution 8% contains ciclopirox, a synthetic broad-spectrum antifungal agent that inhibits the growth of dermatophytes. In vitro studies suggest that ciclopirox may act by chelation of polyvalent cations, resulting in the inhibition of metal-dependent enzymes responsible for the degradation of peroxides within the fungal cell.
How to Use
The treatment duration with Penlac can be several months, as it takes time for the healthy nail to grow and replace the infected nail. It is crucial to continue the treatment as prescribed by the healthcare provider.
Before applying Penlac, the affected nails should be cleaned and dried. The solution is then applied evenly over the entire nail and surrounding skin using the provided applicator brush.
Penlac is for external use only. It is not intended for use on the surrounding skin or in the eyes, nose, mouth, or vagina.
Regular follow-up appointments with a healthcare provider may be necessary to monitor the progress of the treatment and make any adjustments if needed.
What the Patient Should Know
The most common side effect reported by patients using Penlac was redness at the nail fold. Some patients reported a change in nail shape, ingrown toenails, and nail discoloration. Patients who experience increased irritation (redness, itching, burning, blistering, swelling, or oozing) should inform their healthcare professionals. Penlac Nail Lacquer is for external use only.
Daily applications of Penlac should be made over the previous coat and removed with alcohol every seven days. A healthcare professional should remove the unattached, infected nail as frequently as monthly to obtain the maximum benefit of the product. Patients should also trim their nails weekly. Six months of treatment may be required before initial improvement of symptoms is noticed; full treatment time may be as long as 48 weeks.
Patients should not use nail polish or other cosmetic nail products on nails treated with Penlac. Because no studies have been conducted to determine whether Penlac might reduce the effectiveness of systemic antifungal agents for onychomycosis, the concomitant use of Penlac and systemic antifungal agents is not recommended.
Interactions
Since it is applied externally, its interactions with other medications are generally minimal compared to systemic medications. However, it’s still important to consider certain factors:
- Other Topical Medications: While Penlac is applied directly to the nails, it’s a good practice to inform your healthcare provider about any other topical medications, ointments, or creams you use. This includes over-the-counter products and prescription topicals.
- Nail Polish and Cosmetics: It’s advisable to avoid using nail polish or other cosmetic products on the treated nails while using Penlac. These products can interfere with the absorption of the medication.
- Nail Trauma: Inform your healthcare provider if there is any significant trauma or damage to the treated nails. This may affect the efficacy of Penlac.
- Allergic Reactions: If you have known allergies to any ingredients in Penlac or other topical products, it’s important to communicate this to your healthcare provider.
As Penlac is primarily used topically, the risk of systemic drug interactions is low. However, individual reactions can vary, and it’s essential to follow the application instructions provided by your healthcare provider.
Always inform your healthcare provider about all medications (including over-the-counter and herbal supplements) and any existing medical conditions to ensure a comprehensive understanding of your health and to avoid potential interactions or complications. If you have specific concerns or questions about interactions, discussing them with your healthcare provider is best.
Side Effects
Penlac Nail Lacquer Topical Solution (ciclopirox) is generally well-tolerated when used as directed, but like any medication, it may cause side effects in some individuals. Common side effects are usually mild and may include:
- Nail Changes: Some individuals may experience changes in the treated nails’ color, texture, or appearance.
- Nail Disorders: The treated nails may become brittle, discolored, or loose.
- Burning or Stinging: There might be a burning sensation or stinging at the application site.
- Skin Redness or Irritation: The skin around the treated nails may become red or irritated.
- Itching: Itching at the application site can occur.
It’s important to note that these side effects are generally local and related to the application site. If you experience severe or persistent side effects, it’s advisable to contact your healthcare provider.
Systemic severe side effects are rare with topical medications like Penlac, as the drug is primarily applied externally. However, seek immediate medical attention if you experience any signs of an allergic reaction (such as rash, itching, swelling, severe dizziness, or difficulty breathing).
If you have concerns about side effects or experience any unusual symptoms during the use of Penlac Nail Lacquer, it’s essential to contact your healthcare provider. They can guide you on whether to continue the treatment or consider alternative options based on your response.
Jennifer is a clinical pharmacologist. She helps doctors of all medical specialties choose medications. Jennifer consults about drug dosage, interactions, and side effects.