Onmel

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

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.

Take Onmel exactly as prescribed.

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

Onmel comes in a 14 tablet blisterpack container.

Your doctor should do blood tests to check your liver function before you start and while you take Onmel, especially if you have liver problems.

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.

Itraconazole is an antifungal medication that fights infections caused by fungus.

Itraconazole is used to treat infections caused by fungus, which can invade any part of the body including the lungs, mouth or throat, toenails, or fingernails.

Itraconazole may also be used for purposes not listed in this medication guide.

In the U.S.

• Onmel
• Sporanox

Available Dosage Forms:

• Solution
• Capsule
• Tablet

Therapeutic Class: Antifungal

Chemical Class: Triazole

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies on the relationship of age to the effects of itraconazole have not been performed in the pediatric population. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of itraconazole have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have temporary or permanent hearing loss or have kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving itraconazole.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Alfuzosin
• Alprazolam
• Amifampridine
• Amisulpride
• Astemizole
• Bepridil
• Cisapride
• Colchicine
• Conivaptan
• Dabigatran Etexilate
• Dihydroergotamine
• Disopyramide
• Dofetilide
• Dronedarone
• Eletriptan
• Eliglustat
• Eplerenone
• Ergonovine
• Ergotamine
• Felodipine
• Fesoterodine
• Flibanserin
• Fluconazole
• Irinotecan
• Irinotecan Liposome
• Isavuconazonium Sulfate
• Ivabradine
• Levomethadyl
• Lomitapide
• Lovastatin
• Lurasidone
• Maraviroc
• Mesoridazine
• Methadone
• Methylergonovine
• Methysergide
• Midazolam
• Naloxegol
• Nelfinavir
• Nisoldipine
• Pimozide
• Piperaquine
• Posaconazole
• Quinidine
• Ranolazine
• Silodosin
• Simvastatin
• Solifenacin
• Sparfloxacin
• Telithromycin
• Terfenadine
• Thioridazine
• Ticagrelor
• Tolvaptan
• Triazolam
• Venetoclax
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Ado-Trastuzumab Emtansine
• Afatinib
• Aliskiren
• Amiodarone
• Anagrelide
• Apixaban
• Aprepitant
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Atorvastatin
• Avanafil
• Axitinib
• Bedaquiline
• Betrixaban
• Boceprevir
• Bosutinib
• Bretylium
• Brexpiprazole
• Brigatinib
• Bromocriptine
• Buserelin
• Cabazitaxel
• Cabozantinib
• Calcifediol
• Carbamazepine
• Cariprazine
• Ceritinib
• Cilostazol
• Citalopram
• Clarithromycin
• Clozapine
• Cobicistat
• Cobimetinib
• Crizotinib
• Cyclosporine
• Dabrafenib
• Daclatasvir
• Dasatinib
• Deflazacort
• Degarelix
• Delamanid
• Deslorelin
• Deutetrabenazine
• Digoxin
• Docetaxel
• Domperidone
• Donepezil
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Efavirenz
• Elvitegravir
• Erlotinib
• Escitalopram
• Eszopiclone
• Everolimus
• Fentanyl
• Fluoxetine
• Fluticasone
• Fosaprepitant
• Foscarnet
• Fosphenytoin
• Gonadorelin
• Goserelin
• Halofantrine
• Haloperidol
• Histrelin
• Hydrocodone
• Hydroxychloroquine
• Hydroxyzine
• Ibrutinib
• Ibutilide
• Idelalisib
• Iloperidone
• Ivacaftor
• Ixabepilone
• Lapatinib
• Leuprolide
• Levofloxacin
• Levomilnacipran
• Lumacaftor
• Macitentan
• Manidipine
• Metronidazole
• Midostaurin
• Mifepristone
• Morphine
• Morphine Sulfate Liposome
• Moxifloxacin
• Nafarelin
• Netupitant
• Nevirapine
• Nifedipine
• Nilotinib
• Olaparib
• Ondansetron
• Oxycodone
• Palbociclib
• Panobinostat
• Pasireotide
• Pazopanib
• Phenytoin
• Pimavanserin
• Pitolisant
• Pixantrone
• Ponatinib
• Quetiapine
• Reboxetine
• Regorafenib
• Repaglinide
• Retapamulin
• Ribociclib
• Rifampin
• Risperidone
• Rivaroxaban
• Romidepsin
• Ruxolitinib
• Salmeterol
• Sevoflurane
• Sildenafil
• Simeprevir
• Sirolimus
• Sonidegib
• Sotalol
• St John's Wort
• Sulpiride
• Sunitinib
• Suvorexant
• Tacrolimus
• Tadalafil
• Tamsulosin
• Temsirolimus
• Thiotepa
• Topotecan
• Toremifene
• Trabectedin
• Triptorelin
• Valbenazine
• Vandetanib
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vilazodone
• Vincristine
• Vincristine Sulfate Liposome
• Vinflunine
• Vorapaxar
• Warfarin
• Zolpidem
• Zuclopenthixol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol
• Anisindione
• Buspirone
• Busulfan
• Ciprofloxacin
• Dicumarol
• Didanosine
• Indinavir
• Meloxicam
• Micafungin
• Phenprocoumon
• Ritonavir
• Rosuvastatin
• Saquinavir
• Tolterodine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• food
• Grapefruit Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Chronic obstructive pulmonary disease (COPD) or
• Edema (body swelling or fluid retention) or
• Heart attack, history of or
• Heart disease (eg, ischemic disease, valve problems) or
• Heart rhythm problems—Use with caution. May increase the risk for more serious side effects.

• Congestive heart failure, or history of—Should not be used to treat fungal infection of the fingernails or toenails in patients with this condition.

• Cystic fibrosis or
• Hypochlorhydria (low level of acid in the stomach) in HIV-infected patients—Absorption from the stomach may change.

• Elevated liver enzymes or
• Kidney disease or
• Liver disease, active or history of—Use with caution. May make these conditions worse.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Convulsions
• decreased urine
• dry mouth
• fever
• increased thirst
• irregular heartbeat
• loss of appetite
• mood changes
• muscle pain or cramps
• nausea or vomiting
• numbness or tingling in the hands, feet, or lips
• trouble breathing
• unusual tiredness or weakness

• Abdominal or stomach cramps or pain
• blurred vision
• chest pain
• chills
• clay-colored stools
• cloudy urine
• cold sweats
• confusion
• cough
• dark urine
• decrease in urine output or decrease in urine-concentrating ability
• diarrhea
• dizziness
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• drowsiness
• feeling unusually cold
• headache
• itching or rash
• light-colored stools
• mental changes
• muscle cramps in the hands, arms, feet, legs, or face
• muscle spasms (tetany) or twitching
• nervousness
• noisy, rattling breathing
• numbness and tingling around the mouth or fingertips
• pounding in the ears
• shivering
• slow, fast, or pounding heartbeat or pulse
• sneezing
• sore throat
• sweating
• swelling of the fingers, hands, feet, or lower legs
• tightness in the chest
• trembling
• troubled breathing at rest
• unpleasant breath odor
• vomiting of blood
• weight gain
• yellow eyes or skin

• Abdominal or stomach tenderness
• black, tarry stools
• bleeding gums
• blistering, peeling, or loosening of the skin
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blood in the urine or stools
• blue lips and fingernails
• burning, crawling, itching, numbness, painful, prickling, "pins and needles", or tingling feelings
• continuing ringing or buzzing or other unexplained noise in the ears
• coughing that sometimes produces a pink frothy sputum
• cracks in the skin
• decreased appetite
• difficulty with swallowing
• dilated neck veins
• disturbed color perception
• double vision
• extreme fatigue
• fast or irregular breathing
• feeling of discomfort
• general feeling of tiredness or weakness
• halos around lights
• hearing loss
• hives or welts
• inflammation of the joints
• joint pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of heat from the body
• loss of vision
• lower back or side pain
• night blindness
• overbright appearance of lights
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid weight gain
• red skin lesions, often with a purple center
• red, irritated eyes
• red, swollen skin
• scaly skin
• sores, ulcers, or white spots on the lips or in the mouth
• stomach pain, continuing
• swollen lymph glands
• tingling of the hands or feet
• tunnel vision
• unsteadiness or awkwardness
• unusual bleeding or bruising
• unusual weight gain or loss
• upper right abdominal or stomach pain
• weakness in the arms, hands, legs, or feet

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Decreased interest in sexual intercourse
• difficulty having a bowel movement (stool)
• difficulty with moving
• discouragement
• feeling of constant movement of self or surroundings
• feeling sad or empty
• inability to have or keep an erection
• indigestion
• irritability
• loss in sexual ability, desire, drive, or performance
• loss of interest or pleasure
• muscle aching or stiffness
• pain or tenderness around the eyes and cheekbones
• passing of gas
• sensation of spinning
• sleepiness or unusual drowsiness
• soreness of the skin
• stomach fullness or discomfort
• stuffy or runny nose
• swollen joints
• tiredness
• trouble concentrating
• trouble sleeping

• Acid or sour stomach
• belching
• change in taste
• hair loss or thinning of the hair
• heartburn
• increased need to urinate
• increased sensitivity of the eyes to sunlight
• increased sensitivity of the skin to sunlight
• loss of bladder control
• loss of taste
• menstrual changes
• passing urine more often
• redness or other discoloration of the skin
• severe sunburn
• stomach fullness, discomfort, or upset

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

• Store at room temperature. Do not freeze.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the adverse reaction rate observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Patients in the trial for toenail onychomycosis were treated with a dosing regimen of 200 mg once daily for 12 consecutive weeks.

The most commonly reported adverse reaction leading to discontinuation of Onmel was increased hepatic enzyme (6 subjects, 1.0%), followed by dizziness (3 subjects, 0.5%). No other adverse reaction leading to discontinuation occurred in more than one subject.

The table below lists all adverse reactions reported by at least 1% of patients who received Onmel during 12 weeks of treatment:

Post Marketing Experience

The following adverse reactions have been identified during post-approval use of itraconazole (all formulations) and are listed in Table 2 below. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establishing a causal relationship to drug exposure.

Common side effects of Onmel include: nausea. Other side effects include: vomiting. See below for a comprehensive list of adverse effects.