Onychomycosis. It’s a mouthful, but it simply means a fungal infection of the nail. These infections are usually caused by dermatophytes, yeasts, or molds, and they’re surprisingly common. Beyond just being unsightly, nail fungus can really impact your quality of life.
That’s where Penlac (ciclopirox) comes in. Penlac Nail Lacquer (ciclopirox) Topical Solution, 8% is a topical antifungal medication designed to treat mild to moderate onychomycosis, affecting both fingernails and toenails, similar to Loceryl Nail Lacquer. It’s an alternative to oral antifungal medications, which can sometimes have more significant side effects throughout your body. While there is not currently a penlac generic available, the medication itself offers a solid treatment option, but it’s important to consider the cost with insurance.
The goal of this article is to give you a clear picture of Penlac, diving into how it works, how to use it, how well it works, what the safety considerations are, and other important information you should know. It’s based on research and prescribing information, so you can be sure you’re getting reliable facts.
It’s also important to remember that getting rid of nail fungus often takes more than just medication. A comprehensive management program is often needed for successful treatment, so be sure to talk to your doctor about all your options.
How it works
Like most medications, ciclopirox has a specific mechanism of action to address fungal infections.
How it works
Ciclopirox is an antifungal. It works by grabbing certain metal ions, which stops enzymes that depend on those metals from working correctly. These enzymes are essential for fungal growth. By stopping these enzymes, ciclopirox disrupts the transport of essential elements inside the fungal cell.
In vitro activity
Ciclopirox has been shown to work against a wide range of fungi in lab tests. The specific amount of ciclopirox needed to stop fungal growth (MIC value) varies depending on the type of fungus. For common fungi like Trichophyton rubrum and Trichophyton mentagrophytes, MIC values range from 1 to 20 mcg/mL in lab settings.
Pharmacokinetics
When you apply ciclopirox topically, very little of it gets absorbed into your bloodstream. Studies show that less than 5% of the applied dose gets absorbed into the body.
Serum levels
After topical application, ciclopirox serum levels were found to range from 12 to 80 ng/mL in one study. The average maximum serum level of ciclopirox after two months of daily use was 31.28 ng/mL.
Indications and Usage
So, what’s Penlac used for, exactly? The FDA has approved it for:
- Treating mild to moderate onychomycosis (nail fungus) on fingernails and toenails.
However, it’s important to understand the limitations:
- Penlac should be part of a complete management plan for nail fungus, not a standalone treatment.
- Don’t get it in your eyes, mouth, or vagina. It’s for nails only!
- If you have a weakened immune system, Penlac’s safety and effectiveness are unknown.
A few other things to keep in mind:
- Your doctor will need to professionally remove any infected nail parts. You’ll also need to take care of your nails as directed.
- Don’t use Penlac at the same time as oral antifungal medications.
Dosage and administration
Penlac (ciclopirox) is for external use on fingernails and toenails. It’s crucial to follow the directions carefully to get the best results.
How to apply
Apply Penlac once a day, preferably at bedtime, to all affected nails. The following steps will help you apply it correctly:
- Remove any loose nail or debris from the affected nail with nail clippers or nail file.
- Wash and dry the affected nails.
- Use the brush applicator to apply Penlac evenly over the entire nail plate. If possible, apply to the underside of the nail and the skin surrounding it.
- Wait about 30 seconds for the medicine to dry before putting on socks or stockings or going to bed.
- After applying the medicine, wait at least eight hours before taking a bath or shower.
- Use rubbing alcohol to remove Penlac from your nails once a week. At the same time, file away any loose nail material with nail clippers or a nail file.
Nail care by health professionals
It’s important to have a health professional remove any unattached, infected nail frequently to help the medication reach the nail bed. Talk with your doctor about whether you need professional nail debridement.
Nail care by patients
You’ll also need to file your nails regularly to remove any loose, infected material. Trim them carefully, and talk with your doctor about the best way to care for your nails if you have diabetes or neuropathy.
What did clinical trials show about the effectiveness of Penlac?
Two double-blind, placebo-controlled studies in the U.S. looked at how well Penlac worked to treat onychomycosis. In these studies, people applied Penlac topical solution, 8%, to their toenails. They also had the unattached, infected part of their nail removed once a month.
How well did Penlac work?
It’s important to note that the “complete cure” rates in the clinical trials were pretty low:
- Study 312: 6 out of 110 people (5.5%)
- Study 313: 10 out of 118 people (8.5%)
The “almost clear” rates were also fairly low:
- Study 312: 7 out of 107 people (6.5%)
- Study 313: 14 out of 116 people (12%)
A slightly higher percentage of people achieved “negative mycology,” meaning that lab tests no longer detected a fungal infection:
- Study 312: 30 out of 105 people (29%)
- Study 313: 41 out of 115 people (36%)
What are some things to keep in mind about these clinical trials?
The clinical trials excluded certain people, including those who were pregnant or nursing, people with weakened immune systems, and certain types of diabetics.
Also, the data suggests that Penlac works best when it’s used as part of a complete treatment plan, not as a standalone fix.
Contraindications, warnings, and precautions
Like all medications, the generic version of Penlac has some contraindications, warnings, and precautions you should know about before you use it.
Contraindications
You should not use this medication if you know you are allergic or sensitive to any of its ingredients.
Warnings
This medication is only for external use. Don’t get it in your eyes, mouth, or vagina.
Precautions
Before you use this medication, keep the following in mind:
- This medication is flammable. Keep it away from heat and open flames.
- Don’t get this medication in your eyes or on other mucous membranes.
- Tell your doctor if you have diabetes or any kind of numbness.
- Remember that you’ll get the best results if you follow all of your doctor’s instructions for managing your condition.
Adverse reactions and side effects
Like any medication, Penlac can cause side effects. In clinical trials, around 9% of patients taking Penlac reported side effects, versus 7% of patients taking the vehicle (placebo).
Common side effects
The most common side effects with Penlac are skin-related. These include:
- Mild rash
- Periungual erythema (redness and irritation around the nail)
- Nail disorders
In clinical trials, 5% of patients taking Penlac had periungual erythema, or redness of the proximal nail fold.
Patient monitoring
When starting Penlac, you’ll want to watch for signs of irritation or allergic reactions. Talk to your doctor if you develop a rash or any other new skin symptoms.
Special Populations
It’s important to consider how medications may affect particular groups of people.
Pregnancy
Penlac is classified as Pregnancy Category B. Animal studies haven’t revealed any major fetal malformations. However, there aren’t enough well-designed studies in pregnant women to be certain. Penlac should only be used during pregnancy if the potential benefit outweighs the potential risk to the fetus.
Nursing Mothers
We don’t know if ciclopirox (the active ingredient in Penlac) passes into breast milk. If you’re nursing, talk with your doctor about the risks and benefits before using Penlac.
Children
The safety and effectiveness of Penlac in children haven’t been studied.
Older Adults
Clinical trials of Penlac didn’t include enough people over 65 to know if they respond differently to the medication compared to younger adults.
Drug interactions and resistance
As with any medication, you’ll want to keep in mind the potential for interactions with other medications or the possibility of developing resistance to the drug.
Drug interactions
You should not use Penlac at the same time as you’re taking a systemic antifungal medication.
Resistance
It’s possible that a fungus could become resistant to Penlac.
So far, no studies have looked at whether T. rubrum becomes resistant to ciclopirox when exposed to the 8% topical solution in Penlac.
Also, there’s no standard, validated method for labs to use when testing fungi to see if they are susceptible to ciclopirox.
If you’re concerned about drug interactions or the possibility of resistance, be sure to discuss these concerns with your doctor or pharmacist.
Putting It All Together
Penlac (ciclopirox) Topical Solution, 8% is a prescription treatment for mild to moderate toenail fungus. It’s a topical antifungal medication that you paint on your affected toenails.
For Penlac to work, you’ll need to follow a comprehensive treatment plan that includes professional nail care and consistent use of the medication. This means regular visits to a podiatrist or other healthcare provider who can trim and file your nails to help the medication penetrate the nail bed. It also means diligently applying the medication as directed.
It’s important to have realistic expectations about how well Penlac will work. Clinical trials have shown that it doesn’t cure toenail fungus in everyone who uses it. It also has potential side effects, although most are mild.
To get the best results from Penlac, it’s important to understand how to use it correctly and to stick to your treatment plan. Talk to your doctor or pharmacist if you have any questions about Penlac or how to use it.