Penlac

DRUG DESCRIPTION

PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, contains a synthetic antifungal agent, ciclopirox. It is intended for topical use on fingernails and toenails and immediately adjacent skin.

Each gram of PENLAC® NAIL LACQUER (ciclopirox) Topical Solution, 8%, contains 80 mg ciclopirox in a solution base consisting of ethyl acetate, NF; isopropyl alcohol, USP; and butyl monoester of poly[methylvinyl ether/maleic acid] in isopropyl alcohol. Ethyl acetate and isopropyl alcohol are solvents that vaporize after application.

PENLAC ®NAIL LACQUER (ciclopirox) Topical Solution, 8%, is a clear, colorless to slightly yellowish solution.

The chemical name for ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridone, with the empirical formula C12H17NO2 and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0]. The chemical structure is:

Penlac® Nail Lacquer (ciclopirox) Structural Formula Illustration

What are the possible side effects of ciclopirox topical (Loprox, Penlac Nail Lacquer)?

Serious side effects of ciclopirox topical use are not expected to occur. Stop using ciclopirox topical and contact your doctor if you experience unusual or severe itching, redness, burning, dryness, or irritation of the skin or discoloration or other changes in the nails.

Mild burning, itching, or redness may occur with use of ciclopirox topical shampoo.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You...

Read All Potential Side Effects and See Pictures of Penlac »

What are the precautions when taking ciclopirox topical solution (Penlac)?

Before using ciclopirox, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, numbness in fingers/toes (such as diabetic neuropathy).

Before having surgery, tell your doctors or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk....

Read All Potential Precautions of Penlac »


Penlac Consumer (continued)

SIDE EFFECTS: Redness/burning of treated skin or changes in shape/color of nail may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: blistering/swelling/oozing at the application site.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using ciclopirox, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, numbness in fingers/toes (such as diabetic neuropathy).

Before having surgery, tell your doctors or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.


Penlac Patient Information Including Side Effects

Brand Names: Loprox, Penlac Nail Lacquer

Generic Name: ciclopirox topical (Pronunciation: sye kloe PEER ox)

  • What is ciclopirox topical (Penlac)?
  • What are the possible side effects of ciclopirox topical (Penlac)?
  • What is the most important information I should know about ciclopirox topical (Penlac)?
  • What should I discuss with my healthcare provider before using ciclopirox topical (Penlac)?
  • How should I use ciclopirox topical (Penlac)?
  • What happens if I miss a dose (Penlac)?
  • What happens if I overdose (Penlac)?
  • What should I avoid while using ciclopirox topical (Penlac)?
  • What other drugs will affect ciclopirox topical (Penlac)?
  • Where can I get more information?

What is ciclopirox topical (Penlac)?

Ciclopirox is an antifungal medication. Ciclopirox topical prevents fungus from growing.

Ciclopirox topical cream and lotion formulations are used to treat skin infections such as athlete's foot, jock itch, ringworm, and yeast infections. Ciclopirox shampoo is used to treat seborrheic dermatitis (inflammatory skin condition) of the scalp. Ciclopirox topical nail lacquer is used to treat fungal infections of the toenails and fingernails.

Ciclopirox topical may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of ciclopirox topical (Penlac)?

Serious side effects of ciclopirox topical use are not expected to occur. Stop using ciclopirox topical and contact your doctor if you experience unusual or severe itching, redness, burning, dryness, or irritation of the skin or discoloration or other changes in the nails.

Mild burning, itching, or redness may occur with use of ciclopirox topical shampoo.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about ciclopirox topical (Penlac)?

Avoid getting ciclopirox topical in the eyes, nose, or mouth.

Do not use bandages or dressings that do not allow air to circulate (occlusive dressings) on areas treated with ciclopirox cream or lotion, unless otherwise directed by your doctor. Wear loose-fitting clothing (preferably cotton).

Use ciclopirox topical nail lacquer on nails and immediately surrounding skin only.

Ciclopirox topical nail lacquer is flammable, keep it away from heat and flame.

Use ciclopirox topical for the full amount of time prescribed by your doctor. Your symptoms may improve before the infection is completely healed however, it is important to use the medication for the full amount of time.

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