Penlac
- Generic Name: ciclopirox topical solution
- Brand Name: Penlac
- Drug Class: Antifungals, Topical
Penlac (Ciclopirox Topical Solution) side effects drug center
Penlac Nail Lacquer (ciclopirox) Topical Solution, 8% is a topical (for the skin) antifungal medication used to treat fungal infections of the toenails and fingernails. Penlac Nail Lacquer is available in generic form. Common side effects of Penlac Nail Lacquer include:
- redness,
- burning, or
- itching of treated skin, or
- changes in shape/color of nail.
Tell your doctor if you have unlikely but serious side effects of Penlac Nail Lacquer including:
- blistering,
- swelling, or
- oozing at the application site.
Penlac Nail Lacquer Topical Solution, 8%, should be applied once daily (preferably at bedtime or eight hours before washing) to all affected nails and over the entire nail plate with the applicator brush provided. The unattached, infected nail should be removed as frequently as monthly by a health care professional, and trimmed weekly by the patient, along with daily application of the medication. Penlac Nail Lacquer may interact with other topical products. Do not use nail polish, artificial nails, or other cosmetic nail products on the nails treated with Penlac Nail Lacquer. Other drugs may interact with Penlac Nail Lacquer. Tell your doctor all prescription or over-the-counter medicines and supplements you use. During pregnancy, Penlac Nail Lacquer should be used only when prescribed. It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.
Our Penlac Nail Lacquer (ciclopirox) Topical Solution Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using this medicine and call your doctor at once if you have:
- unusual or severe itching, redness, burning, dryness, or irritation of treated skin; or
- discoloration or other changes in the nails.
Common side effects may include:
- mild burning, itching, or redness.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Penlac (Ciclopirox Topical Solution)
SIDE EFFECTS
In the vehicle-controlled clinical trials conducted in the US, 9% (30/327) of patients treated with PENLAC ®NAIL LACQUER (ciclopirox) Topical Solution, 8%, and 7% (23/328) of patients treated with vehicle reported treatment-emergent adverse events (TEAE) considered by the investigator to be causally related to the test material. The incidence of these adverse events, within each body system, was similar between the treatment groups except for Skin and Appendages: 8% (27/327) and 4% (14/328) of subjects in the ciclopirox and vehicle groups reported at least one adverse event, respectively. The most common 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%, (5% [16/327]) than in patients treated with vehicle (1% [3/328]). Other TEAEs thought to be causally related included nail disorders such as shape change, irritation, ingrown toenail, and discoloration.
The incidence of nail disorders was similar between the treatment groups (2% [6/327] in the PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, group and 2% [7/328] in the vehicle group). Moreover, application site reactions and/or burning of the skin occurred in 1% of patients treated with PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, (3/327) and vehicle (4/328).
A 21-Day Cumulative Irritancy study was conducted under conditions of semi-occlusion. Mild reactions were seen in 46% of patients with the PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, 32% with the vehicle and 2% with the negative control, but all were reactions of mild transient erythema. There was no evidence of allergic contact sensitization for either the PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, or the vehicle base. In a separate study of the photosensitization potential of PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8% in a maximized test design that included the occluded application of sodium lauryl sulfate, no photoallergic reactions were noted. In four subjects localized allergic contact reactions were observed. In the vehicle-controlled studies, one patient treated with PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, discontinued treatment due to a rash, localized to the palm (causal relation to test material undetermined).
Use of PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, for 48 additional weeks was evaluated in an open-label extension study conducted in patients previously treated in the vehicle-controlled studies. Three percent (9/281) of subjects treated with PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, experienced at least one TEAE that the investigator thought was causally related to the test material. Mild rash in the form of periungual erythema (1% [2/281]) and nail disorders (1% [4/281]) were the most frequently reported. Four patients discontinued because of TEAEs. Two of the four had events considered to be related to test material: one patient's great toenail "broke away" and another had an elevated creatine phosphokinase level on Day 1 (after 48 weeks of treatment with vehicle in the previous vehicle-controlled study).
Read the entire FDA prescribing information for Penlac (Ciclopirox Topical Solution)
© Penlac Patient Information is supplied by Cerner Multum, Inc. and Penlac Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.