Antifungal, azole (Oral route, parenteral route)

Brand Names:

2 in 1 Dandruff
3 Day Vaginal Cream
Abelcet
Ambisome
Amphocin
Amphotec
Ancobon
Bio-Statin
Blis-To-Sol
Caldesene
Cancidas
Derma Cidol 2000
Diflucan
Eraxis
Ertaczo
Exelderm
Fulvicin P/G
Fungoid
Grifulvin V
Gynazole-1
Lamisil
Loprox
Mentax
Monistat 1
Monistat I.V.
Mycamine
Myco-Nail
Naftin
Natacyn
Nizoral
Noxafil
Oxistat
Spectazole
Sporanox
Terazol 3
Tinactin
Vfend
Vusion
Mycostatin Suspension
Nadostine
Nadostine Sucrose-Free
Nilstat Drops
Nilstat Powder
Nyaderm
Pms-Nystatin

Dosage Forms:

Capsule
Solution
Tablet
Packet
Suspension
Powder for Suspension

Uses of This Medicine:

Azole antifungals are used to treat serious fungus infections that may occur in different parts of the body. These medicines may also be used for other problems as determined by your doctor.

These medicines are available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, azole antifungals are used in certain patients with the following medical conditions:

Cryptococcosis
Cushing's syndrome
Fungus infections in newborns
Hirsutism
Histoplasmosis
Paronychia (infection of the tissue surrounding the nail)
Penicillium marneffei infection
Pneumonia caused by fungus
Prostate cancer
Ringworm of the beard, hand, or scalp
Septicemia (infection of the blood) caused by fungus
Skin infection (including leishmaniasis and sporotrichosis)

Before Using This Medicine:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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.

Children

A small number of children have been safely treated with azole antifungals. Be sure to discuss with your child's doctor the use of these medicines in children.

Older adults

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of azole antifungals in the elderly with use in other age groups.

Pregnancy

Studies have not been done in pregnant women. However, studies in some animals have shown that azole antifungals, taken in high doses, may cause harm to the mother and the fetus. They have caused birth defects in animals. During clinical practice of itraconazole, cases of birth defects including skeletal, GI tract, heart, and eye malformations and genetic malformations have been reported. Itraconazole should not be given to pregnant women or women who may become pregnant for the treatment of onychomycosis. Women who could become pregnant should use birth control while taking itraconazole and for 2 months after itraconazole treatment is stopped. Before taking these medicines, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding

Azole antifungals pass into breast milk. Mothers who are taking these medicines and who wish to breast-feed should discuss this with their doctors.

Other medicines

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

Alfuzosin
Alprazolam
Amobarbital
Aprobarbital
Astemizole
Bepridil
Butabarbital
Carbamazepine
Cisapride
Conivaptan
Dihydroergotamine
Dofetilide
Eplerenone
Ergoloid Mesylates
Ergonovine
Ergotamine
Eterobarb
Halofantrine
Heptabarbital
Hexobarbital
Levomethadyl
Lovastatin
Mephobarbital
Mesoridazine
Methylergonovine
Methysergide
Midazolam
Pentobarbital
Phenobarbital
Pimozide
Quinidine
Ranolazine
Rifabutin
Rifampin
Ritonavir
Secobarbital
Simvastatin
Sirolimus
St John's Wort
Terfenadine
Thioridazine
Triazolam
Ziprasidone

Using medicines in this class 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.

Acecainide
Acenocoumarol
Ajmaline
Alosetron
Alprazolam
Amiodarone
Amisulpride
Amitriptyline
Amoxapine
Anisindione
Aprepitant
Aprindine
Arsenic Trioxide
Atorvastatin
Azimilide
Bretylium
Cerivastatin
Chloral Hydrate
Chloroquine
Chlorpromazine
Cimetidine
Clarithromycin
Cyclosporine
Darunavir
Dasatinib
Delavirdine
Desipramine
Diazepam
Dibenzepin
Dicumarol
Digoxin
Disopyramide
Dolasetron
Doxepin
Droperidol
Efavirenz
Enflurane
Eplerenone
Erythromycin
Etravirine
Fentanyl
Flecainide
Fluoxetine
Fluticasone
Foscarnet
Fosphenytoin
Gemifloxacin
Halofantrine
Haloperidol
Halothane
Hydroquinidine
Ibutilide
Imipramine
Irinotecan
Isoflurane
Isoniazid
Isradipine
Ixabepilone
Lapatinib
Levofloxacin
Levomethadyl
Lidoflazine
Lorcainide
Lovastatin
Mefloquine
Midazolam
Nevirapine
Nilotinib
Nitrofurantoin
Nortriptyline
Octreotide
Pentamidine
Phenindione
Phenprocoumon
Phenytoin
Pirmenol
Prajmaline
Probucol
Procainamide
Prochlorperazine
Propafenone
Quetiapine
Quinidine
Repaglinide
Rifabutin
Rifampin
Risperidone
Salmeterol
Sematilide
Sertindole
Simvastatin
Sirolimus
Sotalol
Spiramycin
Sulfamethoxazole
Sultopride
Sunitinib
Tacrolimus
Tedisamil
Telithromycin
Temsirolimus
Topotecan
Triazolam
Trifluoperazine
Trimethoprim
Trimipramine
Varicella Virus Vaccine
Vasopressin
Vinblastine
Vincamine
Vincristine
Vincristine Liposome
Vindesine
Vinorelbine
Warfarin
Zidovudine
Zolmitriptan
Zotepine

Other interactions

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 medicines in this class with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use your medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Other medical problems

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

Achlorhydria (absence of stomach acid) or
Hypochlorhydria (decreased amount of stomach acid) Itraconazole and ketoconazole may not be absorbed from the stomach as well in patients who have low levels of or no stomach acid.

Alcohol abuse (or history of) or
Liver disease Alcohol abuse or liver disease may increase the chance of side effects caused by azole antifungals.

Congestive heart failure or
Other heart problems Itraconazole may make these conditions worse.

Kidney disease The effects of fluconazole may be increased in patients with kidney disease.

Proper Use of This Medicine:

Ketoconazole and the capsule form of itraconazole should be taken with a full meal. The oral solution form of itraconazole should be taken on an empty stomach. If you have any questions about the antifungal medicine you are taking, check with your health care professional.

For patients taking the oral liquid form of fluconazole, itraconazole, or ketoconazole:

Use a specially marked measuring spoon or other device to measure each dose accurately. The average household teaspoon may not hold the right amount of liquid.

If you have achlorhydria (absence of stomach acid) or hypochlorhydria (decreased amount of stomach acid), and you are taking itraconazole or ketoconazole, your doctor may want you to take your medicine with an acidic drink. You may dissolve your medicine in cola or seltzer water and drink the solution, or your may take your medicine with a glass of cola or seltzer water. Your doctor may suggest that you dissolve each capsule or tablet in a teaspoonful of weak hydrochloric acid solution to help you absorb the medicine better. Your health care professional can prepare the solution for you. After you dissolve the tablet in the acid solution, add this mixture to a small amount (1 or 2 teaspoonfuls) of water in a glass. Drink the mixture through a plastic or glass drinking straw. Place the straw behind your teeth, as far back in your mouth as you can. This will keep the acid from harming your teeth. Be sure to drink all the liquid to get the full dose of medicine. Next, swish around in your mouth about one-half glass of water and then swallow it. This will help wash away any acid that may remain in your mouth or on your teeth.

To help clear up your infection completely, it is very important that you keep taking this medicine for the full time of treatment , even if your symptoms begin to clear up or you begin to feel better after a few days. Since fungus infections may be very slow to clear up, you may have to continue taking this medicine every day for as long as 6 months to a year or more. Some fungus infections never clear up completely and require continuous treatment. If you stop taking this medicine too soon, your symptoms may return.

This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses . Also, it is best to take each dose at the same time every day. If you need help in planning the best time to take your medicine, check with your health care professional.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For fungus infections:
- For oral dosage form (capsule):
  - Adults 150 milligrams (mg) as a single dose to treat vaginal yeast infections.
  - Children up to 18 years of age Dose must be determined by your doctor.
- For oral dosage forms (suspension and tablets):
  - Adults and teenagers 200 to 400 mg on the first day, then 100 to 400 mg once a day for weeks or months, depending on the medical problem being treated. A vaginal yeast infection is treated with a single dose of 150 mg.
  - Children 6 months of age and older 6 to 12 mg per kilogram (mg/kg) (2.7 to 5.4 mg per pound) of body weight on the first day, then 3 to 12 mg/kg (1.35 to 5.4 mg per pound) of body weight once a day for weeks or months, depending on the medical problem being treated.
  - Infants and children up to 6 months of age Dose must be determined by your doctor.
- For injection dosage form:
  - Adults and teenagers 200 to 400 mg on the first day, then 100 to 400 mg once a day, injected into a vein, for weeks or months, depending on the medical problem being treated.
  - Children 6 months of age and older 6 to 12 mg per kilogram (mg/kg) (2.7 to 5.4 mg per pound) of body weight on the first day, then 3 to 12 mg/kg (1.35 to 5.4 mg per pound) of body weight once a day, injected into a vein, for weeks or months, depending on the medical problem being treated.
  - Infants and children up to 6 months of age Dose must be determined by your doctor.

For fungus infections:
- For oral dosage form (capsule):
  - Adults and teenagers 200 milligrams (mg) once a day, which may be increased up to 400 mg once a day for weeks or months, depending on the medical problem being treated. Fingernail and toenail infections are treated with 200 mg one or two times a day for weeks or months.
  - Children up to 16 years of age Dose must be determined by your doctor.
- For oral dosage form (solution):
  - Adults and teenagers 200 milligrams (mg) once a day, which may be increased up to 400 mg once a day for weeks or months, depending on the medical problem being treated. Fingernail and toenail infections are treated with 200 mg one or two times a day for weeks or months.
  - Children up to 16 years of age Dose must be determined by your doctor.
- For injection dosage form:
  - Adults and teenagers 100 to 200 mg once a day for days or weeks, depending on the medical problem being treated.
  - Children up to 12 years of age Dose must be determined by your doctor.
For febrile neutropenia (low white blood cell count with a fever):
- For oral dosage form (solution):
  - Adults and teenagers 200 milligrams (mg) twice a day until your doctor tells you to stop taking this medicine. Your doctor will have you use itraconazole for injection before being switched to oral solution.
  - Children up to 16 years of age Dose must be determined by your doctor.
- For injection dosage form:
  - Adults 200 milligrams (mg) twice a day for 4 doses, then 200 mg once a day for up to 14 days. Your doctor will have you start taking oral solution after you have completed your treatment with this injection dosage form.
  - Children Dose must be determined by your doctor.

For fungus infections:
- For oral dosage form (suspension and tablets):
  - Adults and teenagers 200 to 400 milligrams (mg) once a day for days or weeks, depending on the medical problem being treated.
  - Children over 2 years of age 3.3 to 6.6 mg per kilogram (1.5 to 3 mg per pound) of body weight once a day for days or weeks, depending on the medical problem being treated.
  - Infants and children up to 2 years of age Dose must be determined by your doctor.

Missed dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Keep the oral liquid form of this medicine from freezing.

Precautions While Using This Medicine:

It is important that your doctor check your progress at regular visits. This will allow your doctor to check for any unwanted effects.

If your symptoms do not improve within a few weeks (or months for some infections), or if they become worse, check with your doctor.

These medicines should not be taken with astemizole (e.g., Hismanal), cisapride (e.g., Propulsid), dofetilide (e.g., Tikosyn) or terfenadine (e.g., Seldane). Doing so may increase the risk of serious side effects affecting the heart.

Liver problems may be more likely to occur if you drink alcoholic beverages while you are taking ketoconazole. Alcoholic beverages may also cause stomach pain, nausea, vomiting, headache, or flushing or redness of the face. Other alcohol-containing preparations (for example, elixirs, cough syrups, tonics) may also cause problems. These problems may occur for at least a day after you stop taking ketoconazole. Therefore, you should not drink alcoholic beverages or use alcohol-containing preparations while you are taking this medicine and for at least a day after you stop taking it.

If you are taking antacids, cimetidine (e.g., Tagamet), famotidine (e.g., Pepcid), nizatidine (e.g., Axid), omeprazole (e.g., Prilosec), or ranitidine (e.g., Zantac) while you are taking itraconazole or ketoconazole, take the other medicine at least 2 hours after you take itraconazole or ketoconazole . If you take these medicines at the same time that you take itraconazole or ketoconazole, they will keep your antifungal medicine from working properly.

Ketoconazole may cause your eyes to become more sensitive to light than they are normally. Wearing sunglasses and avoiding too much exposure to bright light may help lessen the discomfort.

Side Effects of This Medicine:

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:

Less common: Fever and chills; skin rash or itching

Rare: Dark or amber urine; fever and sore throat; pale stools; reddening, blistering, peeling, or loosening of skin and mucous membranes; stomach pain; unusual bleeding or bruising; unusual tiredness or weakness; yellow eyes or skin

Incidence not known Itraconazole: Abdominal pain; black, tarry stools; blistering, peeling or loosening of skin; bloating or swelling of face, arms, hands, lower legs, or feet; blue lips and fingernails; blurred vision; burning, numbness, tingling, or painful sensations; chest pain; chills; continuing vomiting; convulsions; cough; coughing that sometimes produces a pink frothy sputum; decreased urine output; difficult, fast, noisy breathing, sometimes with wheezing; difficulty swallowing; dilated neck veins; dry mouth; extreme fatigue; fast heartbeat; fatigue; flushed, dry skin; fruit-like breath odor; general feeling of tiredness or weakness; hives or welts; increased hunger; increased sweating; increased thirst; increased urination; irregular breathing; irregular heartbeat; itching skin; joint or muscle pain; large amount of triglyceride in the blood; large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs; light-colored stools; lower back or side pain; mood changes; muscle pain or cramps; numbness or tingling in hands, feet, or lips; painful or difficult urination; pale skin; pale stools; puffiness; rapid weight gain; red skin lesions, often with a purple center; red, irritated eyes; redness of skin; shortness of breath; skin rash or itching; sores, ulcers, or white spots in mouth or on lips; sweating; swelling in legs and ankles; swelling of face, fingers, feet, or lower legs; swelling of the eyelids or around the eyes, face, lips, or tongue; tightness in chest; tingling of hands or feet; troubled breathing; unexplained weight loss; unsteadiness or awkwardness; unusual weight gain or loss; upper right abdominal pain; weakness in arms, hands, legs, or feet; weight gain; wheezing

Incidence not known Fluconazole: Black, tarry, stools; chest pain or discomfort; cough; decreased urine; diarrhea; dry mouth; fainting; increased thirst; irregular or slow heartbeat; joint or muscle pain; large amount of cholesterol in the blood; large amount of triglyceride in the blood; large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs; loss of bladder control; lower back or side pain; mood changes; muscle pain or cramps; muscle spasm or jerking of all extremities; nausea or vomiting; numbness or tingling in hands, feet, or lips; painful or difficult urination; pale skin; red irritated eyes; red skin lesions, often with a purple center; shortness of breath; sore throat; sores, ulcers, or white spots in mouth or on lips; sudden loss of consciousness

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:

Less common: Constipation; diarrhea; dizziness; drowsiness; headache; nausea; vomiting

Rare: Decreased sexual ability in males; enlargement of the breasts in males; increased sensitivity of the eyes to light; menstrual irregularities

Incidence not known Fluconazole: Acid or sour stomach; bad unusual or unpleasant taste in mouth; belching; change in taste; hair loss; heartburn; swelling of face; thinning of hair

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

Last Updated: 6/12/2013

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