Generic Name: Ketoconazole (kee-toe-KOE-na-zole)
Brand Name: Nizoral A-D

Ketoconazole Shampoo is used for:

Treating scaling associated with dandruff. It may also be used for other conditions as determined by your doctor.

Ketoconazole Shampoo is an imidazole antifungal. It works by killing sensitive fungi by interfering with the formation of the fungal cell membrane and weakening it. The weakened cell membrane allows the cell contents to leak out and results in the death of the fungus.

Do NOT use Ketoconazole Shampoo if:

• you are allergic to any ingredient in Ketoconazole Shampoo

Contact your doctor or health care provider right away if any of these apply to you.

Before using Ketoconazole Shampoo:

Some medical conditions may interact with Ketoconazole Shampoo. 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 have low blood sugar levels, liver disease, or porphyria (a blood disease), sulfite sensitivity, or you drink more than 3 alcohol-containing drinks a day

Some MEDICINES MAY INTERACT with Ketoconazole Shampoo. Because little, if any, of Ketoconazole Shampoo is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Ketoconazole Shampoo 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 Ketoconazole Shampoo:

Use Ketoconazole Shampoo as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Moisten hair and scalp with water. Apply enough shampoo to wash your scalp and hair. Gently massage the entire scalp, leaving the shampoo on for about 5 minutes. Rinse thoroughly, then dry your hair as you normally do.
• Keep Ketoconazole Shampoo out of your eyes, nose, and mouth. If this occurs, wash with water and contact your doctor, nurse, or pharmacist.
• If you miss a dose of Ketoconazole Shampoo, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Ketoconazole Shampoo.

Important safety information:

• Be sure to use Ketoconazole Shampoo for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
• If you use topical products too often, your condition may become worse.
• If your symptoms do not improve or if they become worse, check with your doctor.
• Some of these products contain sulfites. Sulfites may cause an allergic reaction in some patients (eg, asthma patients). If you have ever had an allergic reaction to sulfites, ask your pharmacist if your product has sulfites in it.
• Talk to your doctor before you take Ketoconazole Shampoo if you drink more than 3 drinks with alcohol per day.
• Using Ketoconazole Shampoo on hair that has been permanently waved may cause a loss of the curl.
• Ketoconazole Shampoo should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Ketoconazole Shampoo while you are pregnant. If you are or will be breast-feeding while you use Ketoconazole Shampoo, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Ketoconazole Shampoo:

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:

Itching; mild irritation or stinging; oiliness and dryness of hair and scalp.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); increased or abnormal hair loss; reddening, blistering, peeling, itching, or burning of your skin.

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Proper storage of Ketoconazole Shampoo:

Store Ketoconazole Shampoo between 59 and 77 degrees F (15 and 25 degrees C). Store in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ketoconazole Shampoo out of the reach of children and away from pets.

General information:

• If you have any questions about Ketoconazole Shampoo, please talk with your doctor, pharmacist, or other health care provider.
• Ketoconazole Shampoo 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.

This information is a summary only. It does not contain all information about Ketoconazole Shampoo. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: Ketoconazole (KEE-toe-KON-a-zole)
Brand Name: Xolegel

Ketoconazole Gel is used for:

Treating a skin condition called seborrheic dermatitis.

Ketoconazole Gel is an antifungal agent. It works by killing the fungus causing the skin condition.

Do NOT use Ketoconazole Gel if:

• you are allergic to any ingredient in Ketoconazole Gel

Contact your doctor or health care provider right away if any of these apply to you.

Before using Ketoconazole Gel:

Some medical conditions may interact with Ketoconazole Gel. 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 have a weakened immune system, liver problems, or the blood disease porphyria

Some MEDICINES MAY INTERACT with Ketoconazole Gel. Because little, if any, of Ketoconazole Gel is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Ketoconazole Gel 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 Ketoconazole Gel:

Use Ketoconazole Gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Ketoconazole Gel. Talk to your pharmacist if you have questions about this information.
• Wash your hands before and immediately after using Ketoconazole Gel.
• Spread a thin layer of Ketoconazole Gel onto the affected area with the tips of your fingers. Gently rub it in. Be sure to cover the entire affected area and the healthy skin around it.
• Do not touch your eyes or nose while you are applying Ketoconazole Gel.
• Wait for at least 20 minutes after you apply Ketoconazole Gel before you apply makeup or sunscreen.
• Do not wash the area where you applied Ketoconazole Gel for at least 3 hours after you apply it.
• If you miss a dose of Ketoconazole Gel, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Ketoconazole Gel.

Important safety information:

• Ketoconazole Gel is for external use only. Do not get it in your eyes, nose, or mouth. If you get it in your eyes, rinse at once with cool tap water. Do not get Ketoconazole Gel in your vagina.
• Do not use Ketoconazole Gel for other skin conditions at a later time.
• Ketoconazole Gel is flammable. Do not store or use near an open flame. Do not smoke during or right after use of Ketoconazole Gel.
• Ketoconazole Gel should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Ketoconazole Gel while you are pregnant. It is not known if Ketoconazole Gel is found in breast milk after topical use. If you are or will be breast-feeding while you use Ketoconazole Gel, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Ketoconazole Gel:

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:

Mild burning at the application site.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blisters, irritation, pain, redness, or severe burning at the application site.

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Proper storage of Ketoconazole Gel:

Store Ketoconazole Gel at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do NOT store near an open flame. Keep Ketoconazole Gel out of the reach of children and away from pets.

General information:

• If you have any questions about Ketoconazole Gel, please talk with your doctor, pharmacist, or other health care provider.
• Ketoconazole Gel 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.

This information is a summary only. It does not contain all information about Ketoconazole Gel. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Generic Name: telithromycin (Oral route)

tel-ith-roe-MYE-sin

Commonly used brand name(s):

In the U.S.

• Ketek
• Ketek Pak

Available Dosage Forms:

• Tablet

Therapeutic Class: Antibiotic

Chemical Class: Ketolide

Uses For Ketek Pak

Telithromycin is used to treat a lung infection called community-acquired pneumonia (CAP). It belongs to the family of medicines called antibiotics. Antibiotics are medicines used in the treatment of infections caused by bacteria. They work by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections .

This medicine is available only with your doctor’s prescription .

Before Using Ketek Pak

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

No information is available on the relationship of age to the effects of telithromycin in the pediatric population. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of telithromycin in the elderly. However, elderly patients are more likely to have age-related renal and liver function impairment, which may require an adjustment in the dose for patients receiving telithromycin .

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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

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.

• Bepridil
• Cisapride
• Dronedarone
• Mesoridazine
• Pimozide
• Silodosin
• Terfenadine
• Thioridazine
• Tolvaptan
• 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.

• Acecainide
• Ajmaline
• Amiodarone
• Amisulpride
• Amitriptyline
• Amoxapine
• Aprindine
• Arsenic Trioxide
• Astemizole
• Atorvastatin
• Azimilide
• Bretylium
• Chloral Hydrate
• Chloroquine
• Chlorpromazine
• Clarithromycin
• Colchicine
• Dasatinib
• Desipramine
• Dibenzepin
• Dihydroergotamine
• Disopyramide
• Dofetilide
• Dolasetron
• Doxepin
• Droperidol
• Encainide
• Enflurane
• Ergoloid Mesylates
• Ergotamine
• Erythromycin
• Everolimus
• Flecainide
• Fluconazole
• Fluoxetine
• Fluticasone
• Foscarnet
• Halofantrine
• Haloperidol
• Halothane
• Hydroquinidine
• Ibutilide
• Iloperidone
• Imipramine
• Isoflurane
• Isradipine
• Ixabepilone
• Lapatinib
• Levomethadyl
• Lidoflazine
• Lorcainide
• Lovastatin
• Mefloquine
• Methadone
• Methylergonovine
• Nilotinib
• Nortriptyline
• Octreotide
• Ondansetron
• Pazopanib
• Pentamidine
• Pirmenol
• Prajmaline
• Probucol
• Procainamide
• Prochlorperazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Ranolazine
• Rifampin
• Risperidone
• Romidepsin
• Salmeterol
• Sematilide
• Sertindole
• Simvastatin
• Sotalol
• Spiramycin
• Sulfamethoxazole
• Sultopride
• Sunitinib
• Tadalafil
• Tamsulosin
• Tedisamil
• Telavancin
• Temsirolimus
• Trifluoperazine
• Trimethoprim
• Trimipramine
• Vasopressin
• Venlafaxine
• Verapamil
• Zotepine

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.

• Carbamazepine
• Cyclosporine
• Digoxin
• Fosphenytoin
• Hexobarbital
• Itraconazole
• Ketoconazole
• Metoprolol
• Midazolam
• Phenobarbital
• Phenytoin
• Repaglinide
• Sirolimus
• Tacrolimus
• Theophylline

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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:

• Bradycardia (slow heartbeat) or
• Heart rhythm problems or
• Hypokalemia (low potassium in the blood) or
• Hypomagnesemia (low magnesium in the blood) or
• QTc prolongation (rare heart rhythm problem)—May cause these conditions to become worse .

• Hepatitis or
• Jaundice or
• Myasthenia gravis—Should not use in patients with these conditions .

• Kidney disease—May cause side effects to become worse .

Proper Use of telithromycin

This section provides information on the proper use of a number of products that contain telithromycin. It may not be specific to Ketek Pak. Please read with care.

Telithromycin may be taken with or without food. Swallow the tablet whole. Do not crush, break, or chew it .

To help clear up your infection completely, keep taking telithromycin for the full time of treatment, even if you begin to feel better after a few days. If you stop taking this medicine too soon, your symptoms may return.

Take this medicine at the same time every day. Do not take more than one dose in 24 hours .

Dosing

The dose of this medicine 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 this medicine. 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 oral dosage form (tablets):
  • For community-acquired pneumonia:
    • Adults—800 milligrams (mg) once a day for 7 to 10 days .
    • Children—Use and 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

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Ketek Pak

Telithromycin should not be taken with pimozide (Orap®). Doing so may increase the risk of serious side effects .

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

Stop taking telithromycin and contact your doctor immediately if you experience symptoms of liver disease. These symptoms include tiredness, body aches, loss of appetite, nausea, yellow skin and eyes, dark urine, light-colored stools, itchy skin, or severe stomach pains. Severe liver problems and liver failure have been reported, and in some cases, liver injury developed quickly and after only a few doses .

This medicine may cause fainting, blurred vision, or other vision problems. If any of these occur, do not drive, use machines, or do anything else that could be dangerous if you are not able to see well or if you feel a lightheaded. If these side effects occur and they bother you, check with your doctor .

This medicine may cause you to have severe diarrhea. Ask your doctor before taking any medicine to stop the diarrhea .

Ketek Pak Side Effects

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:

Rare

• Abdominal pain
• blistering, peeling, or loosening of skin
• blurred vision
• chest pain or discomfort
• chills
• confusion
• convulsions
• cough
• dark urine
• decreased urine
• difficulty with breathing, chewing, swallowing, or talking
• dizziness
• double vision
• drooping eyelids
• dry mouth
• fainting
• faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• fast, slow, or irregular heartbeat
• fever with or without chills
• increased thirst
• itching
• joint pain
• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• light-colored stools
• loss of appetite
• mood changes
• muscle pain or cramps
• muscle weakness
• nausea
• nervousness
• numbness or tingling in hands, feet, or lips
• red, irritated eyes
• shortness of breath
• skin rash
• sores, ulcers, or white spots in the mouth or on the lips or tongue
• stomach cramps, tenderness, or pain
• sweating
• tightness in chest
• unusual tiredness or weakness
• upper right abdominal pain
• vomiting
• watery or bloody diarrhea
• weakness or heaviness of the legs
• wheezing
• yellow eyes and skin

Incidence not known

• Black, tarry stools
• clay-colored stools
• continuous vomiting
• dark-colored urine
• decreased appetite
• general feeling of tiredness or weakness
• swelling of feet or lower legs
• unpleasant breath odor
• vomiting of blood

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:

More Common

• Diarrhea

Less common

• Abnormal dreams
• acid or sour stomach
• belching
• bloated, full feeling, or pressure in the stomach
• burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
• burning feeling in chest or stomach
• change in color, amount, or odor of vaginal discharge
• change in sense of smell
• change in taste
• difficulty focusing eyes
• difficulty having a bowel movement (stool)
• disturbed attention span
• dry lips
• dry skin
• excess air or gas in stomach or intestines
• feeling of constant movement of self or surroundings
• feeling of warmth, redness of the face, neck, arms and occasionally, upper chest
• frequent urination
• headache
• heartburn
• increased amount of pale, dilute urine
• indigestion
• itching of the vagina or outside genitals
• lack or loss of strength
• lightheadedness
• loose stools
• loss of appetite
• loss of sense of taste
• pain during sexual intercourse
• pain or tenderness around the eyes and cheekbones
• passing gas more often than usual
• redness of skin
• redness, swelling, or soreness of the tongue
• sensation of spinning
• shakiness in the legs, arms, hands, or feet
• skin rash, encrusted, scaly and oozing
• sleeplessness
• sore mouth or tongue
• sore throat
• stomach upset or pain
• stuffy or runny nose
• swelling or puffiness of the face
• tenderness in the stomach area
• thick, white curd-like vaginal discharge, without odor or with mild odor
• tooth discoloration
• trouble sleeping
• weight loss
• white patches in the mouth and on the tongue

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.

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Generic Name: ketoconazole (KEE toe KON a zole)
Brand Names: Nizoral

What is ketoconazole?

Ketoconazole is an antifungal antibiotic.

Ketoconazole is used to treat infections caused by fungus, which can invade any part of the body including the mouth, throat, esophagus, lungs, bladder, or skin.

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

What is the most important information I should know about ketoconazole?

You should not use this medication if you are allergic to ketoconazole, or if you are also taking triazolam (Halcion).

Before taking ketoconazole, tell your doctor if you have liver disease, kidney disease, a heart rhythm disorder, decreased stomach acid (achlorhydria), or a history of “Long QT syndrome.”

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Ketoconazole will not treat a viral infection such as the common cold or flu.

Avoid taking antacids or stomach acid reducers (Tagamet, Pepcid, Axid, Zantac, and others) for at least 2 hours after you have taken your dose of ketoconazole. These medications can make it harder for the ketoconazole tablet to dissolve in your stomach.

Avoid drinking alcohol. It may cause unpleasant side effects while you are taking ketoconazole.

What should I discuss with my healthcare provider before taking ketoconazole?

You should not use this medication if you are allergic to ketoconazole, or if you are also taking triazolam (Halcion).

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take ketoconazole:

• decreased stomach acid (achlorhydria);

• liver disease;

• kidney disease;

• a heart rhythm disorder; or

• a personal or family history of “Long QT syndrome.”

FDA pregnancy category C. It is not known whether ketoconazole is harmful to an unborn baby. Before you take this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. Ketoconazole may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take ketoconazole?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Ketoconazole works best if you take it with food. Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Ketoconazole will not treat a viral infection such as the common cold or flu.

To be sure this medication is not causing harmful effects, your liver function may need to be checked with blood tests on a regular basis. Do not miss any scheduled appointments.

Store ketoconazole at room temperature away from moisture and heat.

See also: Ketoconazole dosage in more detail

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a ketoconazole overdose are not known.

What should I avoid while taking ketoconazole?

Avoid taking antacids or stomach acid reducers (Tagamet, Pepcid, Axid, Zantac, and others) for at least 2 hours after you have taken your dose of ketoconazole. These medications can make it harder for the ketoconazole tablet to dissolve in your stomach.

Avoid drinking alcohol. It may cause unpleasant side effects while you are taking ketoconazole.

Ketoconazole side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• dizziness, fainting, fast or pounding heartbeat;

• easy bruising or bleeding, unusual weakness;

• numbness or tingly feeling;

• severe depression, confusion, or thoughts of hurting yourself; or

• nausea, stomach pain, low fever, loss of appetite, weakness, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• mild nausea, vomiting, or stomach pain;

• mild itching or skin rash;

• headache;

• dizziness;

• breast swelling; or

• impotence or loss of interest in sex.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ketoconazole Dosing Information

Usual Adult Dose for Oral Thrush:

Initial dose: 200 mg orally once a day.
May be increased to 400 mg once a day for more severe or resistant infections. Treatment should be continued for 1-2 weeks.

Usual Adult Dose for Dermatophytosis:

Initial dose: 200 mg orally once a day.
May be increased to 400 mg once a day for more severe or resistant infections. Treatment should be continued for 4 weeks.

Usual Adult Dose for Blastomycosis:

Initial dose: 200 mg orally once a day.
May be increased to 400 mg once a day for more severe or resistant infections. Treatment should be continued for at least 6 months.

Usual Adult Dose for Coccidioidomycosis:

Initial dose: 200 mg orally once a day.
May be increased to 400 mg once a day for more severe or resistant infections. Treatment should be continued for at least 6 months.

Usual Adult Dose for Histoplasmosis:

Initial dose: 200 mg orally once a day.
May be increased to 400 mg once a day for more severe or resistant infections. Treatment should be continued for at least 6 months.

Usual Adult Dose for Paracoccidioidomycosis:

Initial dose: 200 mg orally once a day.
May be increased to 400 mg once a day for more severe or resistant infections. Treatment should be continued for at least 6 months.

Usual Adult Dose for Chronic Mucocutaneous Candidiasis:

Initial dose: 200 mg orally once a day.
May be increased to 400 mg once a day for more severe or resistant infections. Treatment should be continued for 3-12 months. Patients usually require maintenance therapy.

Usual Adult Dose for Esophageal Candidiasis:

Initial dose: 200 mg orally once a day.
May be increased to 400 mg once a day for more severe or resistant infections. Treatment should be continued for 2-3 weeks.

Usual Adult Dose for Onychomycosis — Fingernail:

Initial dose: 200 mg orally once a day.
May be increased to 400 mg once a day for more severe or resistant infections. Treatment should be continued for 6-12 months.

Usual Adult Dose for Onychomycosis — Toenail:

Initial dose: 200 mg orally once a day.
May be increased to 400 mg once a day for more severe or resistant infections. Treatment should be continued for 6-12 months.

Usual Adult Dose for Vaginal Candidiasis:

Initial dose: 200 mg orally once a day.
May be increased to 400 mg once a day for more severe or resistant infections. Treatment should be continued for approximately 1 to 2 weeks and until tests indicate the resolution of the infection.

What other drugs will affect ketoconazole?

Many drugs can interact with ketoconazole. Below is just a partial list. Tell your doctor if you are using:

• acetaminophen (Tylenol);

• cyclosporine (Gengraf, Sandimmune, Neoral);

• clopidogrel (Plavix);

• digoxin (digitalis, Lanoxin);

• tacrolimus ((Prograf);

• loratadine (Alavert, Claritin, Tavist ND);

• methylprednisolone (Medrol);

• phenytoin (Dilantin);

• rifampin (Rifadin, Rifater, Rifamate, Rimactane);

• diabetes medication you take by mouth;

• a sedative such as midazolam (Versed);

• a blood thinner such as warfarin (Coumadin);

• cancer medications;

• birth control pills or hormone replacement therapy;

• methotrexate (Rheumatrex, Trexall);

• cholesterol medications such as niacin (Advicor), atorvastatin (Lipitor), lovastatin (Altocor, Mevacor), simvastatin (Zocor), and others; or

• medications to treat HIV or AIDS.

This list is not complete and there are many other drugs that can interact with ketoconazole. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about ketoconazole.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 9.01. Revision Date: 11/18/2009 10:22:12 AM.

kee-toe-KON-a-zole

Commonly used brand name(s):

In the U.S.

• Extina
• Nizoral
• Nizoral A-D
• Xolegel

In Canada

• Ketoderm

Available Dosage Forms:

• Shampoo
• Foam
• Gel/Jelly
• Solution
• Cream

Therapeutic Class: Antifungal

Chemical Class: Imidazole

Uses For ketoconazole

Ketoconazole is used to treat infections caused by a fungus or yeast. It works by killing the fungus or yeast or preventing its growth.

Ketoconazole cream is used to treat:

• Athlete’s foot (tinea pedis; ringworm of the foot);
• Ringworm of the body (tinea corporis);
• Ringworm of the groin (tinea cruris; jock itch);
• Seborrheic dermatitis;
• “Sun fungus” (tinea versicolor; pityriasis versicolor); and
• Yeast infection of the skin (cutaneous candidiasis).

Ketoconazole gel or foam is used to treat seborrheic dermatitis (scaly areas on your skin or scalp).

Ketoconazole 1% shampoo is used to treat dandruff.

Ketoconazole 2% shampoo is used to treat “sun fungus” (tinea versicolor; pityriasis versicolor).

ketoconazole may also be used for other fungus infections of the skin as determined by your doctor.

Most forms of ketoconazole are available only with your doctor’s prescription. Some forms are available without a prescription. However, your doctor may have special instructions on the proper use for your medical condition.

Before Using ketoconazole

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 ketoconazole, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to ketoconazole 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 have not been performed on the relationship of age to the effects of topical ketoconazole in children below the age of 12 years. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of topical ketoconazole in the elderly. However, some elderly patients may be more sensitive to the adverse effects of ketoconazole.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of ketoconazole

ketoconazole should be used only on the skin. Do not get it in your eyes, nose, mouth, or vagina.

For patients using the cream form of ketoconazole:

• Apply enough ketoconazole cream to cover the affected and surrounding skin areas, and rub in gently.
• To help clear up your infection completely, it is very important that you keep using ketoconazole cream for the full time of treatment, even if your symptoms begin to clear up after a few days. Since fungus or yeast infections may be very slow to clear up, you may have to continue using ketoconazole every day for up to several weeks. If you stop using ketoconazole too soon, your symptoms may return. Do not miss any doses.

For patients using the foam form of ketoconazole:

• Wash your hands before and after using ketoconazole.
• Do not spray the foam directly on your hand because it will begin to melt as soon as it touches your skin. Instead, spray the foam into the cap of the medicine can or other cool surface. Then dip your fingertips into the foam to pick up small amounts of the medicine, and apply to the affected skin areas. Gently massage the foam into your skin until it disappears.
• If you are treating skin areas with hair, such as your scalp, move any hair away so the foam can be applied directly to the affected skin.
• ketoconazole is flammable. Do not use it near heat, an open flame, or while smoking. Do not puncture, break, or burn the medicine can.

For patients using the gel form of ketoconazole:

• Wash your hands before and after using ketoconazole.
• Apply enough ketoconazole gel to cover the affected and surrounding skin areas, and rub in gently with your fingertips.
• After applying ketoconazole, do not wash the affected area for at least 3 hours.
• Cosmetics (makeup or sunscreens) may be used on the treated skin areas no sooner than 20 minutes after ketoconazole is applied.
• ketoconazole may be flammable. Do not use it near heat, an open flame, or while smoking.

For patients using the 1% shampoo form of ketoconazole:

• Wet your hair and scalp well with water.
• Apply enough shampoo to work up a good lather and gently massage it over your entire scalp.
• Rinse your hair and scalp with warm water.
• Repeat application.
• Rinse your hair and scalp well with warm water, and dry your hair.

For patients using the 2% shampoo form of ketoconazole:

• Wet your hair and scalp well with water.
• Apply the shampoo to the skin of the affected area and a wide margin surrounding this area.
• Work up a good lather and leave it in place for 5 minutes.
• Rinse your hair and scalp well with warm water, and dry your hair.

Dosing

The dose of ketoconazole 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 ketoconazole. 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 cream dosage form:
  • For cutaneous candidiasis, tinea corporis, tinea cruris, tinea pedis, or pityriasis versicolor:
    • Adults—Apply once a day to the affected skin and surrounding area.
    • Children—Use and dose must be determined by your doctor.
  • For seborrheic dermatitis:
    • Adults—Apply two times a day to the affected skin and surrounding area.
    • Children—Use and dose must be determined by your doctor.
• For foam dosage form:
  • For seborrheic dermatitis:
    • Adults—Apply two times a day to the affected skin and surrounding area for 4 weeks.
    • Children—Use and dose must be determined by your doctor.
• For gel dosage form:
  • For seborrheic dermatitis:
    • Adults—Apply once a day to the affected skin and surrounding area for 2 weeks.
    • Children—Use and dose must be determined by your doctor.
• For 1% shampoo dosage form:
  • For dandruff:
    • Adults—Use every 3 or 4 days for up to 8 weeks. Then use only as needed to keep dandruff under control.
    • Children—Use and dose must be determined by your doctor.
• For 2% shampoo dosage form:
  • For pityriasis versicolor:
    • Adults—Use once.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of ketoconazole, apply 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.

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using ketoconazole

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and check you for any problems or unwanted effects that may be caused by ketoconazole.

Do not use ketoconazole for a skin problem that has not been checked by your doctor.

If your skin problem does not improve within 2 weeks for cutaneous candidiasis, pityriasis versicolor, tinea corporis, or tinea cruris; or 4 weeks for seborrheic dermatitis; or 4 to 6 weeks for tinea pedis, or if it becomes worse, check with your doctor.

Good health habits are also required for patients using the cream form of ketoconazole to help clear up your infection completely and to help make sure it does not return.

For patients using the cream for athlete’s foot (tinea pedis; ringworm of the foot), the following instructions will help keep the feet cool and dry:

• Avoid wearing socks made from wool or synthetic materials (e.g., rayon or nylon). Instead, wear clean, cotton socks and change them daily or more often if your feet sweat a lot.
• Wear sandals or well-ventilated shoes (e.g., shoes with holes).
• Use a bland, absorbent powder (e.g., talcum powder) or an antifungal powder between the toes, on the feet, and in socks and shoes one or two times a day. It is best to use the powder between the times you use the cream.
• If you have any questions about these instructions, check with your doctor.

For patients using the cream for ringworm of the groin (tinea cruris; jock itch), the following instructions will help reduce chafing and irritation and will also help keep the groin area cool and dry:

• Avoid wearing underwear that is tight-fitting or made from synthetic materials (e.g., rayon or nylon). Instead, wear loose-fitting, cotton underwear.
• Use a bland, absorbent powder (e.g., talcum powder) or an antifungal powder on the skin. It is best to use the powder between the times you use ketoconazole cream.
• If you have any questions about these instructions, check with your doctor.

The foam form of ketoconazole may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

ketoconazole may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using ketoconazole.

Tell your doctor if you have the following symptoms while using the ketoconazole 2% shampoo: hair discoloration, abnormal hair texture, removal of the curl from permanently waved hair, hair loss, itching, burning sensation of the skin, or blistering, peeling, or redness of the skin.

ketoconazole Side Effects

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—For cream, shampoo, foam, or gel

• Itching, stinging, burning, or irritation not present before use of ketoconazole

Rare—For cream, foam, or gel

• Acne
• bleeding from sore in the mouth
• burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
• discoloration of the fingernails or toenails
• dizziness
• eye dryness, irritation, or swelling
• red rash with watery, yellow-colored, or pus filled blisters with or without thick yellow to honey-colored crusts
• skin dryness, pain, rash, redness, or swelling
• sore in the mouth or on the gums
• swelling of the face

Rare—For shampoo

• Hair loss and irritation

Incidence not known—For shampoo

• Blistering, burning, crusting, dryness, or flaking of the skin
• burning sensation of the skin
• burning, itching, redness, skin rash, swelling, or soreness at the application site
• discoloration of the hair
• dry skin
• fast heartbeat
• fever
• hives
• hoarseness
• irritation
• itching, scaling, severe redness, or soreness of the skin
• joint pain, stiffness, or swelling
• rash
• shortness of breath
• swelling of the eyelids, face, lips, hands, or feet
• thinning of the hair
• tightness in the chest
• troubled breathing or swallowing
• wheezing

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—For shampoo or gel

• Dryness or oiliness of the hair and scalp
• headache

Rare—For shampoo

• Abnormal hair texture
• mild dryness of the skin
• scalp pustules

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.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided “AS IS” and “as available” for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

kee-toe-KON-a-zole

Commonly used brand name(s):

In the U.S.

• Nizoral

Available Dosage Forms:

• Tablet

Therapeutic Class: Antifungal

Chemical Class: Imidazole

Uses For ketoconazole

Ketoconazole is used to treat serious fungal or yeast infections, such as candidiasis (thrush, oral thrush), blastomycosis (Gilchrist’s disease), coccidioidomycosis (Valley fever, San Joaquin Valley fever), histoplasmosis (Darling’s disease), chromoblastomycosis (chromomycosis), or paracoccidioidomycosis (South American blastomycosis, Lutz-Splendore-Almeida disease). ketoconazole works by killing the fungus or yeast, or preventing its growth .

Ketoconazole is also used to treat parasitic fungal infections on the skin (such as athlete’s foot or ringworm) that cannot be treated with topical medicine or griseofulvin, or for patients who cannot take griseofulvin .

ketoconazole is available only with your doctor’s prescription .

Before Using ketoconazole

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 ketoconazole, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to ketoconazole 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 have not been performed on the relationship of age to the effects of ketoconazole in children below 2 years of age. Safety and efficacy have not been established .

Geriatric

No information is available on the relationship of age to the effects of ketoconazole in geriatric patients .

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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

Using ketoconazole 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
• Astemizole
• Cisapride
• Conivaptan
• Dihydroergotamine
• Dofetilide
• Dronedarone
• Eplerenone
• Ergoloid Mesylates
• Ergonovine
• Ergotamine
• Methylergonovine
• Methysergide
• Pimozide
• Ranolazine
• Silodosin
• Terfenadine
• Tolvaptan
• Triazolam

Using ketoconazole 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.

• Amiodarone
• Aprepitant
• Atorvastatin
• Bretylium
• Cerivastatin
• Clopidogrel
• Colchicine
• Dasatinib
• Erythromycin
• Etravirine
• Everolimus
• Fentanyl
• Fluticasone
• Ibutilide
• Iloperidone
• Irinotecan
• Ixabepilone
• Lapatinib
• Levomethadyl
• Lovastatin
• Mefloquine
• Midazolam
• Nilotinib
• Pazopanib
• Romidepsin
• Salmeterol
• Simvastatin
• Sirolimus
• Sotalol
• Sunitinib
• Tadalafil
• Tamsulosin
• Temsirolimus
• Topotecan

Using ketoconazole 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
• Aliskiren
• Almotriptan
• Alosetron
• Amlodipine
• Amprenavir
• Anisindione
• Aripiprazole
• Bexarotene
• Bortezomib
• Bosentan
• Budesonide
• Chlordiazepoxide
• Cilostazol
• Cinacalcet
• Conjugated Estrogens
• Cyclosporine
• Darifenacin
• Darunavir
• Delavirdine
• Dicumarol
• Didanosine
• Dutasteride
• Efavirenz
• Eletriptan
• Erlotinib
• Escitalopram
• Esterified Estrogens
• Estradiol
• Estriol
• Estrone
• Estropipate
• Eszopiclone
• Felodipine
• Fesoterodine
• Fosamprenavir
• Fosaprepitant
• Galantamine
• Gefitinib
• Imatinib
• Indinavir
• Isoniazid
• Isradipine
• Lopinavir
• Maraviroc
• Methylprednisolone
• Mometasone
• Nevirapine
• Nicardipine
• Nifedipine
• Nisoldipine
• Oxybutynin
• Paricalcitol
• Phenprocoumon
• Pioglitazone
• Praziquantel
• Prednisone
• Quetiapine
• Quinidine
• Rabeprazole
• Ramelteon
• Reboxetine
• Repaglinide
• Rifampin
• Rifapentine
• Ritonavir
• Saquinavir
• Sildenafil
• Solifenacin
• Tacrolimus
• Telithromycin
• Tolbutamide
• Tolterodine
• Trazodone
• Tretinoin
• Trimetrexate
• Valdecoxib
• Warfarin
• Zolpidem

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 ketoconazole 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 ketoconazole, 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 ketoconazole. Make sure you tell your doctor if you have any other medical problems, especially:

• Achlorhydria (absence of stomach acid)—May not be absorbed from the stomach in patients with this condition .

• Liver disease—Use with caution. May make this condition worse .

Proper Use of ketoconazole

Keep using ketoconazole for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon .

Dosing

The dose of ketoconazole 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 ketoconazole. 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 oral dosage form (tablets):
  • For fungal infections:
    • Adults—At first, 200 milligrams (mg) once a day. Your doctor may increase your dose if needed.
    • Children over 2 years of age—Dose is based on body weight and must be determined by your doctor.
    • Children up to 2 years of age—Use and dose must be determined by your doctor .

Missed Dose

If you miss a dose of ketoconazole, 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

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using ketoconazole

It is very important that your doctor check your progress at regular visits to make sure ketoconazole is working properly. Blood tests may be needed to check for unwanted effects .

Ketoconazole should not be taken with astemizole (e.g., Hismanal), cisapride (e.g., Propulsid), or terfenadine (e.g., Seldane). Doing so may increase the risk of serious side effects that affect the heart .

Liver problems may occur while you are taking ketoconazole. Check with your doctor right away if you are having more than one of these symptoms: abdominal pain or tenderness; clay-colored stools; dark urine; decreased appetite; fever; headache; itching; loss of appetite; nausea and vomiting; skin rash; swelling of the feet or lower legs; unusual tiredness or weakness; or yellow eyes or skin .

If your symptoms do not improve, or if they become worse, check with your doctor. You may need to take ketoconazole for several months before your infection gets better .

ketoconazole Side Effects

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:

Rare

• Back, leg, or stomach pains
• black, tarry stools
• bleeding gums
• blood in the urine or stools
• blurred vision
• burning, crawling, itching, numbness, prickling, “pins and needles,” or tingling feelings
• change in color vision
• change in the ability to see colors, especially blue or yellow
• chest pain
• chills
• confusion
• cough
• dark urine
• difficulty breathing
• difficulty seeing at night
• difficulty swallowing
• dizziness
• fast heartbeat
• fever
• general body swelling
• headache
• hives
• hoarseness
• increased sensitivity of the eyes to sunlight
• irritation
• itching
• joint pain, stiffness or swelling
• light-colored stools
• loss of appetite
• mood or mental changes
• nausea or vomiting, severe
• nosebleeds
• 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
• redness of the skin
• shortness of breath
• skin rash
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swelling of the eyelids, face, lips, hands, or feet
• swollen glands
• tightness in the chest
• trouble sleeping
• troubled breathing or swallowing
• unusual bleeding or bruising
• unusual tiredness or weakness
• vision changes
• wheezing
• yellow eyes or skin

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:

Rare

• Change in number of sperm and their ability to move
• decreased interest in sexual intercourse
• diarrhea
• hair loss or thinning of hair
• inability to have or keep an erection
• loss in sexual ability, desire, drive, or performance
• sleepiness or unusual drowsiness
• swelling of the breasts or breast soreness for both female and male

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.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided “AS IS” and “as available” for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

Pronunciation: (KEE-ta-meen HYE-droe-KLOR-ide)
Class: General anesthetic

Trade Names:
Ketalar
- Injection, solution 10 mg/mL
- Injection, solution 50 mg/mL
- Injection, solution 100 mg/mL

Trade Names:
Ketamine
- Injection, solution 10 mg/mL
- Injection, solution 50 mg/mL
- Injection, solution 100 mg/mL

Pharmacology

Produces rapid-acting anesthetic state with profound analgesia, normal pharyngeal-laryngeal reflexes, normal or slightly enhanced skeletal muscle tone, cardiovascular and respiratory stimulation, and, occasionally, transient and minimal respiratory depression.

Pharmacokinetics

Absorption

Ketamine is rapidly absorbed. Mean C _max is 0.75 mcg/mL. T _max is 1 h.

Distribution

Distribution half-life is approximately 10 to 15 min.

Metabolism

Undergoes N-dealkylation, hydroxylation of cyclohexone ring, conjugation with glucuronic acid, and dehydration of the hydroxylated metabolites to form the cyclohexene derivative. The metabolite is about one-third as active as ketamine.

Elimination

The beta phase half-life of ketamine is 2.5 h. Approximately 91% is excreted in urine and 3% in feces.

Onset

Onset is 30 sec (IV) and 3 to 4 min (IM).

Duration

Duration is 5 to 10 min (IV) and 12 to 25 min (IM).

Indications and Usage

Diagnostic and surgical procedures that do not require skeletal muscle relaxation; induction of anesthesia; supplementation of low-potency agents, such as nitrous oxide.

Unlabeled Uses

Prevention of anesthesia-induced shivering.

Contraindications

Patients in whom significant BP elevation would be a serious hazard; hypersensitivity to the drug.

Dosage and Administration

Induction of Anesthesia
Adults and Children 16 yr of age and older

IV Initial: 1 to 4.5 mg/kg via slow infusion (over 60 sec); usual dose for 5- to 10-min anesthesia: 2 mg/kg. Alternatively, 1 to 2 mg/kg at a rate of 0.5 mg/kg/min, augmented with diazepam IV 2 to 5 mg. Maintenance: One-half to full induction dose, repeated as needed. Alternatively, adults induced with ketamine augmented with IV diazepam may receive 0.1 to 0.5 mg/min by slow microdrip infusion, augmented with diazepam 2 to 5 mg IV as needed. IM Initial: 6.5 to 13 mg/kg. Maintenance: One-half to full induction dose, repeated as needed.

General Advice

• The 100 mg/mL concentration should not be injected IV without proper dilution. It is recommended that the drug be diluted with an equal volume of sterile water for injection, isotonic sodium chloride solution, or dextrose 5% in water.
• Because of rapid induction following the initial IV injection, the patient should be in a supported position during administration.
• Administer IV slowly (over a period of 60 sec). More rapid administration may result in respiratory depression and enhanced pressor response.
• To prepare a dilute solution containing 1 mg/mL, transfer 10 mL (50 mg/mL concentration) or 5 mL (100 mg/mL concentration) to 500 mL of dextrose 5% injection or sodium chloride 0.9% injection and mix well. If fluid restriction is required, add ketamine as described previously to a 250 mL infusion to provide a final concentration of 2 mg/mL.
• Ketamine 10 mg/mL is not recommended for dilution.
• Ketamine is physically incompatible with diazepam and barbiturates.
• Give atropine, scopolamine, or another drying agent at an appropriate interval prior to induction.

Storage/Stability

Store vials at controlled room temperature (68° to 77°F). Protect from light.

Drug Interactions

Halothane

Decreased cardiac output, BP, and pulse.

Tubocurarine and other nondepolarizing muscle relaxants

Increased neuromuscular effects, resulting in prolonged respiratory depression.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Arrhythmia, bradycardia, elevated blood pressure and heart rate, hypotension.

CNS

Enhanced skeletal muscle tone manifested by tonic and clonic movement.

Emergence reaction

Confusion, delirium, excitement, hallucinations, irrational behavior, pleasant dream-like state, vivid imagery.

Dermatologic

Morbilliform rash, transient erythema.

EENT

Diplopia, increased intraocular pressure, nystagmus.

GI

Anorexia, nausea, vomiting.

Local

Local pain and exanthema at injection site.

Respiratory

Apnea after rapid injection, laryngospasm, other airway obstruction, respiratory stimulation, severe respiratory depression.

Precautions

Warnings Emergence reactions Emergence reactions occur in approximately 12% of patients. The incidence is least frequent in elderly (older than 65 yr of age) patients and also less frequent with IM use. Psychological manifestations Severity varies between pleasant dream-like states, vivid imagery, hallucinations, and emergence delirium, sometimes accompanied by confusion, excitement, and irrational behavior. The duration is ordinarily a few hours; however, recurrences have been seen up to 24 h postoperatively. No residual psychological effects are known. The incidence may be reduced by using lower dosages with IV diazepam. These reactions may be reduced if verbal, tactile, and visual patient stimulation is minimized during recovery. This does not preclude monitoring vital signs. Management To terminate a severe emergence reaction, a small hypnotic dose of a short-acting or ultra short-acting barbiturate may be required. When used on an outpatient basis, do not release patient until recovery from anesthesia is complete. Patients should be accompanied by an adult.

Monitor Continually monitor cardiac function during procedures in patients with hypertension or cardiac decompensation aseptically.

Pregnancy

Category B .

Lactation

Undetermined.

Children

Safety and efficacy in children younger than 16 yr of age have not been established.

Elderly

Use with caution, usually starting at the low end of the dosing range.

Alcohol

Use with caution in chronic alcoholic and acutely alcohol-intoxicated patients.

Cerebrospinal fluid pressure

Cerebrospinal fluid pressure increase has been reported following administration.

Hypertension or cardiac decompensation

In patients with these conditions, monitor function continuously during procedure.

Respiratory effects

May occur with overdosage or too rapid a rate of administration.

Respiratory surgery/diagnostic procedures

Do not use in surgery or diagnostic procedures of the pharynx, larynx, or bronchial tree. Do not administer ketamine alone because pharyngeal and laryngeal reflexes are usually active. Muscle relaxants, with proper attention to respiration, may be required.

Visceral pain

In surgical procedures involving visceral pain pathways, supplement with an agent that obtunds visceral pain.

Overdosage

Symptoms

Respiratory depression.

Patient Information

• Advise patient that neurologic effects may persist for 24 h after anesthesia. Advise patient to use caution during this period while driving or performing other tasks requiring mental alertness.

Copyright © 2009 Wolters Kluwer Health.

Generic name: Telithromycin Brand names: Ketek Why is Ketek prescribed? Ketek is a new type of antibiotic known as a ketolide. It is used to treat bacterial infections in the lungs and sinuses, specifically: Acute (severe or sudden) flare-ups of chronic bronchitis Acute sinusitis Pneumonia Most important fact about Ketek Like all antibiotics, Ketek could cause a severe inflammation of the colon (known as pseudomembranous colitis). It results from bacterial overgrowth in the colon and ranges in severity from mild to life-threatening. Contact your doctor right away if you develop any of the following: Abdominal cramps Watery diarrhea Frequent bowel movements Low-grade fever Bloody stools How should you take Ketek? Try to take Ketek at the same time every day. It may be taken with or without food. Your doctor will only prescribe Ketek to treat a bacterial infection; it will not cure a viral infection, such as the common cold. It’s important to take the full dosage schedule of Ketek, even if you’re feeling better in a few days. Not completing the full dosage schedule may decrease the drug’s effectiveness and increase the chances that the bacteria may become resistant to Ketek and other antibiotics. –If you miss a dose… Take the forgotten dose as soon as you remember. However, if it is almost time for your next dose, skip the one you missed and return to your regular schedule. Do not take two doses at once. –Storage instructions… Store at room temperature. Ketek side effects Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe to continue using Ketek. Side effects may include: Diarrhea, nausea, headache, dizziness Why should Ketek not be prescribed? You should not use Ketek if you have ever had an allergic reaction to it or to macrolide antibiotics such as erythromycin (E-Mycin, Erytab, Erythrocin, and others), Zithromax, and Biaxin. You should not use Ketek if you are currently taking the medications pimozide (Orap) or cisapride. Special warnings about Ketek Use Ketek with caution if you have myasthenia gravis. The drug can worsen your symptoms and cause severe–and even life-threatening–reactions. Be sure to tell your doctor if you have this illness. Ketek may cause visual problems, including blurred vision or difficulty focusing. These episodes can last for several hours. Problems with vision are most likely to occur after the first or second dose, although they can occur any time during treatment. If visual problems occur, avoid driving a motor vehicle, operating heavy machinery, or engaging in other hazardous activities. Also avoid looking quickly from one object to another. If you have vision problems that interfere with your daily activities, notify your doctor. Ketek could potentially affect heart rhythm and cause changes on an electrocardiogram (ECG or EKG). Tell the doctor if you develop an irregular heartbeat or if you faint while taking the drug. Use Ketek cautiously, if at all, if you have a condition that makes you susceptible to heartbeat irregularities, such as low potassium or magnesium levels, a severely slow heartbeat, or a congenital heart rhythm disturbance. There have been reports of liver function problems in people taking Ketek. Use Ketek cautiously if you’ve ever had liver problems, including hepatitis or jaundice (yellowing of the skin or whites of the eyes). Possible food and drug interactions when taking Ketek Ketek should never be combined with the drugs pimozide (Orap) or cisapride. Ketek could alter levels of certain cholesterol-lowering drugs, including atorvastatin (Lipitor), lovastatin (Mevacor, Altocor), and simvastatin (Zocor). This could increase the risk of drug-induced muscle damage. Therapy with these cholesterol drugs should generally be stopped until treatment with Ketek is finished. Ketek should also be avoided if you’re taking medication to correct an abnormal heart rhythm. Examples include quinidine, procainamide (Procanbid), and dofetilide (Tikosyn). When Ketek is taken together with certain other drugs, the effects of either could be increased, decrease, or altered. It is especially important to check with your doctor before combining Ketek with the following: Carbamazepine (Tegretol) Cyclosporine (Sandimmune) Digoxin (Lanoxin) Diuretics (water pills) such as furosemide (Lasix) or hydrochlorothiazide (HydroDIURIL, Esidrix) Ergot-containing drugs such as Cafergot Hexobarbital Itraconazole (Sporanox) Ketoconazole (Nizoral) Metoprolol (Lopressor, Toprol-XL) Midazolam (Versed) Phenytoin (Dilantin) Rifampin (Rifadin, Rifamate, Rimactane) Sirolimus (Rapamune) Tacrolimus (Prograf) Theophylline (Theo-Dur) Special information if you are pregnant or breastfeeding The effects of Ketek during pregnancy have not been adequately studied. Ketek should be used only if the benefits outweigh the potential risks to the baby. Notify your doctor right away if you become pregnant or plan to become pregnant while taking Ketek. It is not known whether Ketek appears in human breast milk. However, it did appear when given to breastfeeding animals. If Ketek is essential to your health, the doctor may advise you to stop breastfeeding until your treatment is finished. Recommended dosage for Ketek ADULTS 18 YEARS AND OLDER The usual dose is two 400-milligram tablets (for a total of 800 milligrams) taken once a day at the same time. For acute flare-ups of chronic bronchitis or acute sinusitis, treatment lasts 5 days. For pneumonia, treatment lasts 7 to 10 days. Safety and effectiveness in children have not been studied. Overdosage Although no specific information on Ketek overdose is available, any medication taken in excess can have serious consequences. If you suspect an overdose, seek emergency treatment immediately.

Generic Name: ketamine (KET a meen)
Brand Names: Ketalar

What is Ketalar (ketamine)?

Ketamine is an anesthetic medication.

Ketamine is used as a general anesthetic to prevent pain and discomfort during certain medical tests or procedures, or minor surgery.

Ketamine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Ketalar (ketamine)?

Before you receive ketamine, tell your doctor if you are allergic to any drugs, or if you have a history of alcoholism.

It may take you longer to recover from anesthesia with ketamine if you have recently used a barbiturate such as phenobarbital (Luminal) or secobarbital (Seconal), or a narcotic medication such as fentanyl (Actiq, Duragesic), hydrocodone (Lortab, Vicodin), oxycodone (OxyContin), propoxyphene (Darvocet, Darvon), and others.

Ketamine may be harmful to an unborn baby. Before you receive ketamine, tell your doctor if you are pregnant.

You may feel strange or slightly confused when you first come out of anesthesia. Tell your caregivers if these feelings are severe or unpleasant.

Ketamine can cause side effects that may impair your thinking or reactions for 24 hours or longer. Be careful if you drive or do anything that requires you to be awake and alert. You will probably not be allowed to drive yourself home after your surgery or medical procedure.

Follow your doctor’s instructions about any restrictions on food, beverages, or activity after you recover from anesthesia.

What should I discuss with my health care provider before receiving Ketalar (ketamine)?

Before you receive ketamine, tell your doctor if you are allergic to any drugs, or if you have a history of alcoholism.

Ketamine may be harmful to an unborn baby. Before you receive ketamine, tell your doctor if you are pregnant.

How is ketamine given?

Ketamine is given as an injection through a needle placed into a vein or muscle. You will receive this injection in a clinic or hospital setting.

Your caregivers will monitor your heart function, blood pressure, and breathing while you are under the effects of ketamine.

You may feel strange or slightly confused when you first come out of anesthesia. Tell your caregivers if these feelings are severe or unpleasant.

What happens if I miss a dose?

Since ketamine is usually given for anesthesia, you are not likely to be on a dosing schedule.

What happens if I overdose?

An overdose of ketamine is unlikely to occur since the medication is given by a doctor. Your vital signs will be closely watched while you are under anesthesia to make sure the medication is not causing any harmful effects.

What should I avoid after receiving Ketalar (ketamine)?

Ketamine can cause side effects that may impair your thinking or reactions for 24 hours or longer. Be careful if you drive or do anything that requires you to be awake and alert. You will probably not be allowed to drive yourself home after your surgery or medical procedure.

Follow your doctor’s instructions about any restrictions on food, beverages, or activity after you recover from anesthesia.

Ketalar (ketamine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Tell your caregivers at once if you have any of these serious side effects within 24 hours after you receive ketamine:

• severe confusion;

• hallucinations;

• unusual thoughts; or

• extreme fear.

Less serious side effects may include:

• dream-like feeling;

• double vision;

• jerky muscle movements;

• dizziness, drowsiness;

• nausea, vomiting, loss of appetite; or

• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Ketalar (ketamine)?

Before you receive ketamine, tell your doctor if you have recently used any of the following:

• a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or

• narcotic medication such as fentanyl (Actiq, Duragesic, Ionsys), hydrocodone (Lortab, Vicodin), hydromorphone (Dilaudid, Palladone), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin, Oramorph), oxycodone (OxyContin, Percocet, Roxicodone), propoxyphene (Darvocet, Darvon), and others.

If you are using any of these drugs, it may take you longer to recover from anesthesia with ketamine.

There may be other drugs that can affect ketamine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your doctor or pharmacist can provide more information about ketamine.

• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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