Onmel

Onmel is a prescription medication used to treat fungal infections of the toenails. Onmel belongs to a group of drugs triazoles. It works by slowing the growth of fungi that cause infection.

This medication comes in tablet form. It is usually taken once a day for 12 weeks.

Common side effects of Onmel are infections of the upper respiratory tract and high liver test results. 

Onmel is a prescription medication used to treat fungal infections of the toenails.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Merz Pharmaceuticals, LLC

Serious side effects have been reported with Onmel. See the “Onmel Precautions” section.

Common side effects of Onmel include the following:

• 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

This is not a complete list of Onmel side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor and pharmacist the name of all the prescription and non-prescription medicines you are taking, including dietary supplements and herbal remedies. 

Never take Onmel if you:

• are taking any of the medicines listed below. Dangerous or even life-threatening abnormal heartbeats could result:
  • quinidine (such as Cardioquin, Quinaglute, Quinidex)
  • dofetilide (such as Tikosyn)
  • cisapride (such as Propulsid)
  • pimozide (such as Orap)
  • methadone (such as Dolophine)
  • levacetylmethadol (such as Orlaam)
• are taking any of the following medicines:
  • lovastatin (such as Mevacor, Advicor, Altocor)
  • simvastatin (such as Zocor)
  • triazolam (such as Halcion)
  • midazolam (such as Versed)
  • nisoldipine (such as Sular)
  • felodipine (such as Plendil)
  • ergot alkaloids (such as Migranal, Ergonovine, Cafergot, Methergine)
• 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.

Taking Onmel with certain other medicines could lead to serious or life-threatening medical problems. For example, taking fentanyl, a strong opioid narcotic pain medicine, with Onmel could cause serious side effects, including trouble breathing, that may be life-threatening. Tell your doctor and pharmacist the name of all the prescription and non-prescription medicines you are taking. Your doctor will decide if Onmel is the right treatment for you.

Onmel is used to treat fungal toenail infections. However, Onmel is not for everyone. 

Serious side effects have been reported with Onmel including the following: 

• 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.

Do not take Onmel if you:

• are allergic to Onmel or any of its ingredients
• have or have had heart failure, including congestive heart failure.
• are pregnant or plan to become pregnant
• are taking any of these medications: cisapride, dofetilide, ergot alkaloids such as dihydroergotamine, ergotamine, ergometrine (ergonovine), and methylergometrine (methylergonovine); felodipine, levacetylmethadol (levomethadyl), lovastatin, methadone, oral midazolam, nisoldipine, pimozide, quinidine, simvastatin, and triazolam

Before taking Onmel, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have or had heart failure, including congestive heart failure.
• have lung, liver or kidney problems
• have any other medical conditions
• are pregnant or planning to become pregnant
• are breast-feeding or plan to breastfeed. Onmel can pass into your breast milk and may harm your baby. Talk to your doctor about the best way to feed your baby if you take Onmel.
• have ever had an allergic reaction to Onmel. Ask your doctor or pharmacist for a list of these ingredients.

​Tell your doctor and pharmacist the name of all the prescription and non-prescription medicines you are taking, including dietary supplements and herbal remedies. 

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Onmel falls into category C. There are no adequate and well-controlled clinical trials in the pregnant women with Onmel.

Females who can become pregnant should use effective birth control during treatment with Onmel and for 2 months after you stop treatment with Onmel. Talk to your doctor about the type of birth control that is best for you while taking Onmel.

Tell your doctor if you are breastfeeding or plan to breastfeed. Onmel is excreted in human breast milk. Therefore, the expected benefits of Onmel therapy for the mother should be weighed against the potential risk from exposure of Onmel to the infant. Talk to your doctor about the best way to feed your baby if you take Onmel.

Take Onmel exactly as prescribed.

This medication comes in tablet form. It is usually taken once a day for 12 weeks.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully

The recommended dose of Onmel for fungus of the toenail is 200 mg (one tablet) once daily for 12 consecutive weeks.

If you think you took too much Onmel, call your doctor or local poison control center, or go to the nearest hospital emergency room right away.

Store Onmel at room temperature in a dry place away from light.

Keep all medicines, including Onmel, out of the reach of children.

WARNING: CONGESTIVE HEART FAILURE, CARDIAC EFFECTS AND DRUG INTERACTIONS

• Do not administer for the treatment of onychomycosis in patients with evidence of ventricular dysfunction such as congestive heart failure (CHF) or a history of CHF.
• If signs or symptoms of congestive heart failure occur during administration, discontinue administration. 
• Negative inotropic effects were seen when itraconazole was administered intravenously to dogs and healthy human volunteers.
• Drug Interactions: Co-administration of certain drugs is contraindicated. See complete boxed warning. 
• May increase plasma concentrations of drugs metabolized by the cytochrome P450 3A4 isoenzyme system (CYP3A4) pathway. 
• Serious cardiovascular events, including QT prolongation, torsades de pointes, ventricular tachycardia, cardiac arrest, and/or sudden death have occurred in patients using certain drugs. See complete boxed warning.