Generic Name: itraconazole (IT-ra-KON-a-zole)
Brand Name: Onmel
Onmel should not be used to treat a fungal infection of the toenail or fingernail (onychomycosis) in patients with heart failure or a history of heart failure. Contact your doctor immediately if you experience symptoms of congestive heart failure, such as swelling of the hands, ankles, or feet; shortness of breath; or sudden, unexplained weight gain.
Use of Onmel along with certain other medicines may increase the risk of their side effects. This may include serious and sometimes fatal heart problems (eg, irregular heartbeat). Do not take Onmel if you are also taking cisapride, disopyramide, dofetilide, dronedarone, eplerenone, ergot alkaloids (eg, dihydroergotamine, ergotamine, methylergonovine), felodipine, irinotecan, lovastatin, lurasidone, methadone, oral midazolam, nisoldipine, pimozide, quinidine, ranolazine, simvastatin, ticagrelor, or triazolam. If you have kidney or liver problems, do not take Onmel if you are also taking fesoterodine, solifenacin, telithromycin, or a medicine that contains colchicine.
Onmel is used for:
Treating fungal infections of the toenail in certain patients. It may also be used for other conditions as determined by your doctor.
Onmel is an azole antifungal. It works by killing sensitive fungi.
Do NOT use Onmel if:
- you are allergic to any ingredient in Onmel
- you are pregnant or planning to become pregnant
- you have heart failure or a history of heart failure
- you are taking cisapride, disopyramide, dofetilide, dronedarone, eplerenone, an ergot alkaloid (eg, dihydroergotamine, ergotamine, methylergonovine), felodipine, irinotecan, lovastatin, lurasidone, methadone, oral midazolam, nisoldipine, pimozide, quinidine, ranolazine, simvastatin, ticagrelor, or triazolam
- you have kidney or liver problems and you are also taking fesoterodine, solifenacin, telithromycin, or a medicine that contains colchicine
Contact your doctor or health care provider right away if any of these apply to you.
Before using Onmel:
Some medical conditions may interact with Onmel. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you are allergic to other azole antifungals (eg, ketoconazole)
- if you have HIV infection, a weakened immune system, low white blood cell levels, cystic fibrosis, kidney or liver problems, abnormal liver function tests, lung or breathing problems (eg, chronic obstructive pulmonary disease [COPD]), low stomach acid (eg, hypochlorhydria), nerve problems, problems with swelling or retaining fluid
- if you have an irregular heartbeat or other heart problems (eg, congestive heart failure, coronary artery disease, heart valve problems)
- if you have had serious liver problems caused by Onmel or other medicines
Some MEDICINES MAY INTERACT with Onmel. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Many prescription and nonprescription medicines (eg, used for abortion; allergies; anxiety, depression, or other mental or mood problems; asthma or other lung or breathing problems; blood thinning; blood vessel problems; cancer; Cushing syndrome; cystic fibrosis; diabetes; erectile dysfunction; gout; heartburn; hepatitis C virus infection; high blood pressure; high cholesterol; HIV infection; hormonal birth control, such as birth control pills; immune system suppression; infections; inflammation; irregular heartbeat or other heart problems; migraine headaches; narcotic dependence; nausea and vomiting; overactive bladder or other urinary problems; pain; parathyroid gland problems; prostate problems; seizures; sleep; stomach or bowel problems; Tourette syndrome), multivitamin products, and herbal or dietary supplements because they may interact with Onmel. Ask your doctor or pharmacist if you are unsure if any of your medicines might interact with Onmel
This may not be a complete list of all interactions that may occur. Ask your health care provider if Onmel may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Onmel:
Use Onmel as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Onmel. Talk to your pharmacist if you have questions about this information.
- Take Onmel with a full meal. If you have low stomach acid or you take medicine to reduce stomach acid, take Onmel with an acidic beverage (eg, non-diet cola).
- If you take antacids, didanosine, H2 blockers (eg, famotidine), or proton pump inhibitors (PPIs) (eg, omeprazole), ask your doctor or pharmacist how to take it with Onmel.
- To clear up your infection completely, take Onmel for the full course of treatment. Keep taking it even if you feel better in a few days. Do not miss any doses.
- Onmel works best if it is taken at the same time each day.
- If you miss a dose of Onmel, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Onmel.
Important safety information:
- Tell your doctor or dentist that you take Onmel before you receive any medical or dental care, emergency care, or surgery.
- Onmel may cause dizziness or vision changes. These effects may be worse if you take it with alcohol or certain medicines. Use Onmel with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it. If you have dizziness or vision changes, do not drive or perform other possibly unsafe tasks.
- Rarely, Onmel has been associated with serious and sometimes fatal liver problems, including some cases within the first week of treatment. Contact your doctor right away if you notice dark urine; loss of appetite; pale stools; severe stomach pain; unusual tiredness, nausea, or vomiting; or yellowing of the skin or eyes.
- Hearing loss has been reported in patients taking Onmel. Many of these cases have occurred when Onmel has been taken along with quinidine. The hearing loss usually goes away when Onmel is stopped but may persist in some patients. Discuss any questions or concerns with your doctor.
- Onmel only works against fungi; it does not treat viral infections (eg, the common cold).
- Be sure to use Onmel for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The fungus could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
- Onmel may interact with many other medicines. This includes how well Onmel works or increased side effects. Sometimes this may lead to life-threatening effects or sudden death. Be sure your doctor and pharmacist know all of the medicines that you take.
- Do not switch to other forms of Onmel (eg, capsules, oral solution) without checking with your doctor. Effectiveness and side effects of these forms of Onmel may be different even at the same dose.
- Diabetes patients - Onmel may increase the risk of low blood sugar from your diabetes medicine. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Hormonal birth control (eg, birth control pills) may not work as well while you are using Onmel. To prevent pregnancy, use an extra form of birth control (eg, condoms).
- Women who are able to become pregnant should use an effective form of birth control while taking Onmel and for 2 months after stopping Onmel. Talk with your doctor about effective forms of birth control.
- Lab tests may be performed while you use Onmel. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Onmel with caution in the ELDERLY; they may be more sensitive to its effects, especially loss of hearing.
- PREGNANCY and BREAST-FEEDING: It is not known if Onmel can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Onmel while you are pregnant. Onmel is found in breast milk. If you are or will be breast-feeding while you use Onmel, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Onmel:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Back or throat pain; cold symptoms (eg, runny nose, coughing, sneezing); diarrhea; dizziness; headache; mild stomach pain; nausea; tiredness.
Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); burning or painful urination; changes in the amount of urine produced or uncontrolled urination; coughing up white or pink mucus; decreased sexual ability; fast, slow, or irregular heartbeat; joint pain; loss of hearing; menstrual problems; muscle pain, weakness, or cramping; numbness, burning, or tingling of the hands, arms, legs, or feet; red, swollen, blistered, or peeling skin; ringing in the ears; sensitivity to sunlight; severe stomach or back pain (with or without nausea or vomiting); shortness of breath; sudden, unexplained weight changes; swelling of the hands, ankles, or feet; symptoms of liver problems (eg, dark urine; loss of appetite; pale stools; severe stomach pain; unusual tiredness, nausea, or vomiting; yellowing of the skin or eyes); unusual tiredness; vision problems (eg, blurred vision, double vision); waking up at night more than normal.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Onmel:
Store Onmel at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Onmel out of the reach of children and away from pets.
- If you have any questions about Onmel, please talk with your doctor, pharmacist, or other health care provider.
- Onmel is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Onmel or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Onmel. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Onmel. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Onmel.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.