Understanding Toenail
Fungal Infections

What causes it?

Onychomycosis is truly a fungus among us! Fungi are fond of warm, damp areas. So you can easily pick up toenail fungus by:

  • walking barefoot in a shower, in a locker room, or around a swimming pool
  • wearing shoes or socks that have become wet
  • wearing shoes that don’t fit properly or crunch your toes, such as high heels

Having athlete’s foot, another fungal infection, may increase your risk of toenail fungus.

Injuring your toe or having certain health conditions—such as diabetes, circulatory problems, or a weakened immune system—may also increase your risk of getting toenail fungus.

What happens if toenail fungus is untreated?

Having discolored or thickened toenails may be embarrassing. But toenail fungus is not just cosmetic. Without treatment, it won’t go away. It can actually spread and may get worse. Here are some problems that toenail fungus can cause:

  • Nails can become so thick that they are difficult to cut
  • Thickened nails may make wearing shoes uncomfortable
  • An infection can develop into a painful swelling under the nail
  • Nails may begin to crumble, eventually leading to an entire nail being lost

Think you may have toenail fungus? Talk with your doctor.

If your toenails are discolored, or if they have thickened, you may think it’s clear that you have toenail fungus. But just looking at your nails isn’t enough.

That’s because toenail fungus may be mistaken for something else, such as:

  • nail injury
  • a nail-bed tumor
  • peripheral vascular disease (a disease of the blood vessels)
  • psoriasis or other skin condition

Your podiatrist or dermatologist may take a nail scraping and send it to a lab to rule out nonfungal causes and to confirm that it is toenail fungus.

What should I know about treatment?

It may be easy to get toenail fungus, but it sure is tough to get rid of! Putting off treatment may even make things worse, giving the fungal infection more of a chance to grow. This may cause more damage to your toenails.

The earlier you seek professional medical help, the greater chance you have of clearing up your toenail fungus—and keeping it from spreading. Treatment options include topical treatments (such as antifungal cream, lotion, or polish), laser treatment, and oral treatments, such as ONMEL® (itraconazole).

What are treatment options?

Topical treatments

Topical treatments are applied to the nail surface over a period of time. That treatment period is typically 48 weeks.

Oral treatments

Antifungal pills attack the fungal infection from inside the body. The treatment period is typically 12 weeks. But be patient; it may take several months before you see a difference. That’s because it takes time (between 12 and 18 months) for the healthy nail to grow back completely.

Your healthcare provider may order blood tests to check your liver function before prescribing an oral antifungal medication.

Everyday foot care

Keeping your feet and toes clean and dry is your best defense against nail fungus. Here are 10 tips to keep fungus from coming back.

Keep your feet dry.

After your bath or shower, dry your feet well— especially between your toes.

Don’t wear the same shoes every day.

Switch footwear so your shoes dry and air out before you wear them again.

Choose good shoes.

Go for lighter, “breathable” materials that keep your feet well ventilated. Footwear made of vinyl, rubber, or other synthetic material can trap moisture (and fungus).

Wash your hands.

After touching infected nails, wash up to avoid spreading nail fungus.

Use antifungal powder.

Make it a part of your daily routine.

Practice good nail care.

Clip toenails straight across and file down thickened areas. Be sure to disinfect toenail clippers or home pedicure tools.

Carry a spare pair of socks.

Change into a fresh pair whenever you’re active and your feet sweat a lot.

Take care at nail salons.

If you go for a manicure or pedicure, make sure the nail salon sterilizes its instruments—or bring your own.

Protect your feet.

By the pool, in the shower room, at the gym, or in other public areas, wear waterproof sandals or shoes.

Don’t cover up your nails.

Avoid wearing nail polish and artificial nails, which can worsen an infection.

Effective toenail fungus treatment delivered in a single, once-daily tablet

ONMEL® (itraconazole)

200-mg tablets

How does ONMEL work?

ONMEL is an FDA-approved antifungal treatment; it stops the growth of toenail fungus. Clinical studies showed that many more patients who received ONMEL had a complete cure of their toenail fungus than those patients who received placebo—a treatment without the active medicine.

How is ONMEL different?

ONMEL works inside the body to attack and fight the toenail fungal infection. ONMEL uses Meltrex® Technology to allow the controlled release of medicine in just one 200-mg tablet.

ONMEL offers easy dosing.

Set up your medicine routine with ONMEL.

How do I take ONMEL?

Tips for staying on track with ONMEL:

ONMEL works best when taken with a full meal at the same time of day.

If you forget to take or miss doses of ONMEL, skip that dose and take the next dose at your regular time. Do not make up missed doses.

Remember, treatment with ONMEL takes 12 weeks. Be sure to finish all of your ONMEL as prescribed by your healthcare provider.

Your healthcare provider should do blood tests before you start and while you take ONMEL, especially if you have liver problems.

What to expect when taking ONMEL.

For best results, it is important to take your medicine for the full 12-week treatment period.

Good to know:

You may see some change in the base of your toenail during that time. But be patient because it may take longer for your toenail to grow out.

Always make sure you keep your healthcare provider informed about your treatment progress. Treating toenail fungus may vary from person to person. Your healthcare provider may also suggest other treatments while you are using ONMEL to help your toenails improve.

Save money on your prescription

ONMEL® (itraconazole)

200-mg tablets

ONMEL Co-Pay Savings Program

Eligible patients can receive great savings on their ONMEL prescriptions at participating pharmacies. Download and print the savings offer and take it with you when you fill your prescription. Please see full terms and conditions on the savings offer printout.

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Indications and Usage

ONMEL is a prescription medicine used to treat fungal infections of the toenails.
It is not known if ONMEL is safe and effective in children under the age of 18.

Important Safety Information for ONMEL

ONMEL can cause serious life-threatening side effects, including:

1. Heart Failure. Do not take ONMEL if you have had heart failure, including congestive heart failure. Stop taking ONMEL and call your doctor right away if you have any of these symptoms of congestive heart failure:

  • shortness of breath
  • swelling of your feet, ankles, or legs
  • sudden weight gain
  • increased tiredness
  • coughing up white or pink phlegm
  • fast heartbeat
  • waking up at night more than normal for you

2. Serious cardiovascular effects. Do not take ONMEL if you also take the following medicines:

  • cisapride (Propulsid®)
  • felodipine, nisoldipine (Lexxel®, Plendil®, Sular®)
  • pimozide (Orap®)
  • triazolam (Halcion®)
  • quinidine (Quinidine Gluconate, Quinidine Sulfate)
  • lovastatin (Mevacor®, Advicor®, Altoprev®)
  • dofetilide (Tikosyn®)
  • simvastatin (Zocor®, Simcor®, Vytorin®)
  • levomethadyl (Oralaam®)
  • methadone (Dolophine®)
  • midazolam (Versed®)
  • ergot alkaloids (Migranal®, Ergonovine®, Cafergot®, Methergine®, Dihydroergotamine Mesylate, Methylergonovine)
  • This is not a complete list of medicines that can interact with ONMEL.
  • The product names used herein are for identification purposes only. All product names, trademarks and registered trademarks are the property of their respective owners.
  • Before taking ONMEL, tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
  • Talk to your doctor or pharmacist before you start any new medicine. They can tell you if it is safe to take ONMEL with your other medicines.
    • Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

Who should not take ONMEL?

Do not take ONMEL if you:

  • have or had heart failure, including congestive heart failure.
  • take certain medicines.
  • are taking fentanyl. Taking fentanyl, a strong opioid narcotic pain medicine with ONMEL could cause serious breathing problems that can lead to death.
  • are pregnant or plan to become pregnant. ONMEL can harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
  • are breast-feeding or plan to breast-feed. ONMEL can pass into your breastmilk and may harm your baby.
  • have ever had an allergic reaction to itraconazole or any of the other ingredients in ONMEL. Ask your doctor or pharmacist for a list of these ingredients.

What are the possible side effects of ONMEL?

ONMEL can cause serious side effects, including:

  • liver failure and death. Stop taking ONMEL and call your doctor right away if you have symptoms of liver failure including:
    • unusually tired
    • lose your appetite
    • nausea
    • abdominal pain
    • vomiting
    • yellow change in the color of your skin or eyes
    • dark colored urine
    • pale stools (bowel movements)
  • nerve damage (neuropathy). Call your doctor right away if you have tingling or numbness in your hands or feet. You may need to stop taking ONMEL if this happens.
  • hearing loss. Hearing loss can happen for a short time or permanently in some people who take ONMEL with other medications. Stop taking ONMEL and call your doctor right away if you have any changes in your hearing.

Common side effects of ONMEL include:

  • increased liver enzyme in blood test results
  • upper respiratory infection or cold
    (runny nose, cough, and sneeze)
  • urinary tract infection (burning and painful urination)
  • stomach pain
  • diarrhea
  • nausea
  • headache
  • tiredness
  • throat pain
  • back pain

These are not all of the possible side effects of ONMEL. Tell your doctor if you have any side effect that bothers you or that does not go away. For more information, ask your doctor.

Thank you for visiting ONMEL.com

Sebela is committed to advancing treatment in antifungal therapy.
For other information, please contact:

Sebela Pharmaceuticals Inc.
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Roswell, GA 30076
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References: 1. ONMEL [package insert]. Greensboro, NC: Merz Pharmaceuticals, LLC; 2012. 2. Data on file. Raleigh, NC. Merz Pharmaceuticals, LLC. 3. Rodgers P, Bassler M. Treating onychomycosis. Am Fam Physician. 2001;63:663-672. 4. Breitenbach J. Melt extrusion: from process to drug delivery technology. Eur J Pharm Biopharm. 2002;54(2):107-117. 5. Maddin S, Quiring J, Bulger L. Randomized, placebo-controlled, phase 3 study of itraconazole for the treatment of oncyhomycosis. J Drugs Dermatol. 2013;12(7):758-763.