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ketorolac

30/06/10

Generic Name: ketorolac (KEE toe ROLE ak)
Brand Names: Toradol, Toradol IM, Toradol IV/IM

What is ketorolac?

Ketorolac is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Ketorolac works by reducing hormones that cause inflammation and pain in the body.

Ketorolac is used short-term (5 days or less) to treat moderate to severe pain.

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

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

This medicine can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use ketorolac. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking ketorolac. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Do not drink alcohol while taking ketorolac. Alcohol can increase the risk of stomach bleeding caused by ketorolac.

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

Do not use this medication if you are allergic to ketorolac, aspirin, or other NSAIDs, or if you have:

severe kidney disease;
a bleeding or blood clotting disorder;
a closed head injury or bleeding in your brain;
a stomach ulcer or a history of stomach or intestinal bleeding; or
if you are breast-feeding a baby.

Do not take ketorolac if you are also taking pentoxifylline (Trental) or probenecid (Benemid). Do not take ketorolac with aspirin or other NSAIDs such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Voltaren), diflunisal (Dolobid), etodolac (Lodine), flurbiprofen (Ansaid), indomethacin (Indocin), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), or piroxicam (Feldene).

Taking an NSAID can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use an NSAID. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

NSAIDs can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking an NSAID. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Before taking ketorolac, tell your doctor if you are allergic to any drugs, or if you have:

a history of heart attack, stroke, or blood clot;
heart disease, congestive heart failure, high blood pressure;
liver or kidney disease,
ulcerative colitis or Crohn’s disease;
asthma;
polyps in your nose;
if you have recently had surgery; or
if you smoke.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take ketorolac.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Taking ketorolac during labor can increase the risk of bleeding during childbirth. Do not take ketorolac during pregnancy unless your doctor has told you to.

This medication can affect fertility (your ability to have children). Do not take ketorolac while you are trying to get pregnant.

Ketorolac can pass into breast milk and may harm a nursing baby. Do not take this medicine without telling your doctor if you are breast-feeding a baby. Do not give this medicine to anyone younger than 18 years old.

How should I take ketorolac?

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. Ketorolac is not for treating minor aches and pains.

Ketorolac is usually given first as an injection, and then as an oral (by mouth) medicine. Ketorolac injection is given through a needle into a muscle or a vein. Your doctor, nurse, or other healthcare provider will give you this injection.

The ketorolac tablet should be taken with a full glass of water. Ketorolac is normally given for 5 days or less, including both the injection and oral forms combined. Long-term use of ketorolac can damage your kidneys or cause bleeding. If you need to have any type of surgery, tell the surgeon ahead of time if you have recently used ketorolac. Store ketorolac tablets at room temperature away from moisture and heat.

See also: Ketorolac dosage in more detail

What happens if I miss a dose?

Since ketorolac is taken as needed for pain, you may not be on a dosing schedule. And if you receive ketorolac injection in a hospital setting, it is not likely that you will miss a dose.

If you are taking the medication regularly, 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.

Overdose symptoms may include nausea, vomiting, stomach pain, drowsiness, black or bloody stools, coughing up blood, urinating less than usual, shallow breathing, and fainting.

What should I avoid while taking ketorolac?

Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain aspirin or other medicines similar to ketorolac (such as ibuprofen, ketoprofen, or naproxen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, ketoprofen, or naproxen. Do not drink alcohol while taking ketorolac. Alcohol can increase the risk of stomach bleeding caused by ketorolac.

Ketorolac 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. Stop taking ketorolac and seek medical attention or call your doctor at once if you have any of these serious side effects:

chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
black, bloody, or tarry stools;
coughing up blood or vomit that looks like coffee grounds;
swelling or rapid weight gain;
urinating less than usual or not at all;
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
the first sign of any mouth sores or skin rash, no matter how mild;
pale skin, easy bruising, severe tingling, numbness, pain, muscle weakness; or
fever, headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions).

Less serious side effects may include:

upset stomach, mild nausea or vomiting, diarrhea, constipation;
mild heartburn, stomach pain, bloating, gas;
dizziness, headache, drowsiness;
sweating; or
ringing in your ears.

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.

Ketorolac Dosing Information

Usual Adult Dose for Pain:

In adults, the use of oral ketorolac is only indicated as continuation therapy to IV or IM dosing of ketorolac. The manufacturer recommends that the oral formulation should not be given as an initial dose.

Parenteral:

Single dose administration:

IM: Patients less than 65 years of age: one dose of 60 mg. Patients who are renally impaired, and/or less than 50 kg (110 pounds): one dose of 30 mg.

IV: Patients less than 65 years of age: one dose of 30 mg. Patients who are renally impaired, and/or less than 50 kg (110 pounds): One dose of 15 mg.

Multiple dose administration:

Patients less than 65 years of age: 30 mg IM or IV every 6 hours as needed. The maximum daily dose should not exceed 120 mg.

Patients who are renally impaired, and/or less than 50 kg (110 pounds): 15 mg IM or IV every 6 hours as needed. The maximum dose should not exceed 60 mg.

Oral:

10 mg orally 4 times a day as needed. The maximum daily dose should not exceed 40 mg.

Patients less than 50 kg: The maximum daily dose should not exceed 40 mg.

Usual Geriatric Dose for Pain:

Parenteral:

Single dose administration:

IM: Patients greater than or equal to 65 years of age, renally impaired, and/or less than 50 kg (110 pounds): one dose of 30 mg.

IV: Patients greater than or equal to 65 years of age, renally impaired, and/or less than 50 kg (110 pounds): One dose of 15 mg.

Multiple dose administration:

Patients greater than or equal to 65 years of age, renally impaired, and/or less than 50 kg (110 pounds): 15 mg IM or IV every 6 hours as needed. The maximum dose should not exceed 60 mg.

Oral:

10 mg orally 4 times a day as needed. The maximum daily dose should not exceed 40 mg.

Usual Pediatric Dose for Pain:

2 to 16 years:
IM dosing: a single dose of 1 mg/kg up to a maximum of 30 mg.
IV dosing: a single dose of 0.5 mg/kg up to a maximum of 15 mg.

Study (n=54)
Greater than or equal to 3 years: 0.6 mg/kg IV once post surgery.

What other drugs will affect ketorolac?

Tell your doctor if you are taking an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor). Taking any of these drugs with ketorolac may cause you to bruise or bleed easily.

Before taking ketorolac, tell your doctor if you are taking any of the following drugs:

a blood thinner such as warfarin (Coumadin);
lithium (Eskalith, Lithobid);
methotrexate (Rheumatrex, Trexall);
thiothixene (Navane);
alprazolam (Xanax);
diuretics (water pills) such as furosemide (Lasix);
muscle relaxers;
steroids (prednisone and others);
seizure medications such as carbamazepine (Carbatrol, Tegretol) or phenytoin (Dilantin);
a heart or blood pressure medication such as candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro, Avalide), losartan (Cozaar, Hyzaar), valsartan (Diovan), telmisartan (Micardis), or olmesartan (Benicar); or
aspirin or other NSAIDs such as etodolac (Lodine), flurbiprofen (Ansaid), indomethacin (Indocin), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others; or
an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), ramipril (Altace), and others.

This list is not complete and there may be other drugs that can interact with ketorolac. 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 ketorolac.

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.

Concise,K

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ketoconazole topical

30/06/10

Generic Name: ketoconazole topical (kee toe KOE na zole)
Brand Names: Extina, Kuric, Nizoral A-D, Nizoral Topical, Xolegel

What is ketoconazole topical?

Ketoconazole topical is an antifungal medication. Ketoconazole topical prevents fungus from growing on your skin.

Ketoconazole topical is used to treat fungal infections of the skin such as athlete’s foot, jock itch, ringworm, and seborrhea (dry, flaking skin).

Ketoconazole topical is available as a cream, gel, and as a shampoo. The shampoo is used for the treatment of dandruff.

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

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

Use this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Do not use bandages or dressings over the treated skin areas, unless your doctor has told you to. Avoid getting this medication in your eyes, nose, or mouth.

Wait at least 20 minutes after applying this medicine before you use cosmetics or sunscreen on the treated skin area. Do not wash the treated skin for at least 3 hours after applying ketoconazole topical.

Call your doctor if your condition does not improve within 2 weeks, or if your symptoms get worse.

Stop using ketoconazole topical and call your doctor if you have severe burning, irritation, redness, pain, or oozing where the medicine is applied. Ketoconazole topical gel is flammable. Do not use it while you are smoking or near an open flame. Do not use this medication on a child younger than 12 years old.

What should I discuss with my healthcare provider berfore using ketoconazole topical?

Do not use this medication if you are allergic to ketoconazole. FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether ketoconazole topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not use this medication on a child younger than 12 years old.

How should I apply ketoconazole topical?

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

Do not use this medication for any skin condition that has not been diagnosed by a doctor.

Wash your hands before and after using this medication.

Clean and dry the affected area. Apply a thin layer of the cream or gel to the affected skin area as directed. This medicine is usually used for only 2 to 4 weeks.

Do not use bandages or dressings over the treated skin areas, unless your doctor has told you to.

Use the shampoo twice per week, unless your doctor has told you otherwise. Apply enough shampoo to create a lather and massage the scalp for 1 minute. Rinse thoroughly and repeat, leaving the lather on for an additional 3 minutes. Then rinse it off completely. Allow at least 3 days to pass between uses of ketoconazole shampoo.

Use this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated.

Call your doctor if your condition does not improve within 2 weeks, or if your symptoms get worse.

Store ketoconazole topical at room temperature away from moisture and heat. Ketoconazole topical gel is flammable. Do not use it while you are smoking or near an open flame.

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use 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, or if anyone has accidentally swallowed it.

An overdose of ketoconazole topical applied to the skin is not expected to produce life-threatening symptoms.

What should I avoid while using ketoconazole topical?

Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water.

Avoid covering treated skin areas with tight-fitting, synthetic clothing (such as nylon or polyester) that doesn’t allow air to circulate to your skin. If you are treating your feet, wear clean cotton socks and sandals or shoes that allow for air circulation. Keep your feet as dry as possible.

Avoid using other skin or hair products that can cause irritation, such as harsh soaps or shampoos or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime. Do not use other medicated skin products unless your doctor has told you to.

Ketoconazole topical 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. Stop using ketoconazole topical and call your doctor if you have any of these serious side effects:

severe itching, burning, or irritation where the medicine is applied;
oily or dry scalp, mild hair loss;
redness, pain, or oozing of treated skin areas; or
eye redness, swelling, or irritation.

Less serious side effects include:

mild skin itching or irritation;
dry skin; or
headache.

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.

Ketoconazole topical Dosing Information

Usual Adult Dose for Cutaneous Candidiasis:

2% Cream: Apply to the affected and surrounding area once to twice a day for 2 weeks.

Usual Adult Dose for Tinea Corporis:

2% Cream: Apply to the affected and surrounding area once to twice a day for 2 weeks.

Usual Adult Dose for Tinea Cruris:

2% Cream: Apply to the affected and surrounding area once to twice a day for 2 weeks.

Usual Adult Dose for Tinea Pedis:

2% Cream: Apply to the affected and surrounding area once to twice a day for 6 weeks.

Usual Adult Dose for Tinea Versicolor:

2% Cream: Apply to the affected and surrounding area once a day for 2 weeks.

2% Shampoo: Apply to damp skin of the affected area and a wide margin surrounding this area. One application should be sufficient; however, an application once a day for 3 days has also been used.

Ketoconazole shampoo should be lathered, left in place for 5 minutes, and then rinsed off with water.

Usual Adult Dose for Seborrheic Dermatitis:

2% Cream: Apply to affected areas twice a day for 4 weeks or until clinical clearing.
2% Foam: Apply to affected areas twice a day for 4 weeks.
2% Gel: Apply to affected areas once a day for 2 weeks.

Usual Adult Dose for Dandruff:

1% Shampoo: Apply every 3 or 4 days for up to 8 weeks. Then apply as needed to control dandruff.

Ketoconazole shampoo should be used in sufficient quantity to produce lather, left on the scalp for 1 minute, and then rinsed. The application should be repeated, left on scalp for an additional 3 minutes, and then rinsed.

Usual Pediatric Dose for Seborrheic Dermatitis:

12 years or older:
2% Foam: Apply to affected areas twice a day for 4 weeks.
2% Gel: Apply to affected areas once a day for 2 weeks.

Usual Pediatric Dose for Dandruff:

12 years or older:
1% Shampoo: Apply every 3 or 4 days for up to 8 weeks. Then apply as needed to control dandruff.

Usual Pediatric Dose for Tinea Corporis:

2% Cream: Apply to the affected area once to twice a day.

What other drugs will affect ketoconazole topical?

There may be other drugs that can affect ketoconazole topical. 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.

Concise,K

Comments (0)

30/06/10

Ketoconazole/

Hydrocortisone Gel

Generic Name: Ketoconazole/Hydrocortisone (KEE-toe-KON-a-zole/HYE-droe-KOR-ti-sone)
Brand Name: Xolegel CorePak

Ketoconazole/Hydrocortisone Gel is used for:

Treating a skin condition called seborrheic dermatitis. It may also help to reduce itching, redness, and swelling.

Ketoconazole/Hydrocortisone Gel kit contains an antifungal medicine and a topical corticosteroid. The antifungal works by killing the fungus causing the skin condition. The corticosteroid works by reducing skin inflammation, which helps relieve redness, swelling, itching, and irritation.

Do NOT use Ketoconazole/Hydrocortisone Gel if:

you are allergic to any ingredient in Ketoconazole/Hydrocortisone Gel

Contact your doctor or health care provider right away if this applies to you.

Before using Ketoconazole/Hydrocortisone Gel:

Some medical conditions may interact with Ketoconazole/Hydrocortisone 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
if you have a skin infection, measles, thinning of the skin, tuberculosis (TB), chickenpox, shingles, a positive TB skin test, or have recently had a vaccination

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

Ask your health care provider if Ketoconazole/Hydrocortisone 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/Hydrocortisone Gel:

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

An extra patient leaflet is available with Ketoconazole/Hydrocortisone Gel. Talk to your pharmacist if you have questions about this information.
Wash your hands before and immediately after using Ketoconazole/Hydrocortisone Gel.
To use the antifungal: Spread a thin layer of the medicine 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/Hydrocortisone Gel.
Wait for at least 20 minutes after you apply Ketoconazole/Hydrocortisone Gel before you apply makeup or sunscreen.
Do not wash the area where you applied Ketoconazole/Hydrocortisone Gel for at least 3 hours after you apply it.
To use the topical corticosteroid: Apply a small amount of medicine to the affected area. Gently rub it in until it is evenly distributed.
Do not bandage or wrap the affected area unless directed otherwise by your doctor.
If you miss a dose of Ketoconazole/Hydrocortisone 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/Hydrocortisone Gel.

Important safety information:

Ketoconazole/Hydrocortisone 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/Hydrocortisone Gel in your vagina.
Do not use Ketoconazole/Hydrocortisone Gel for other skin conditions at a later time.
Ketoconazole/Hydrocortisone Gel is flammable. Do not store or use near an open flame. Do not smoke during or right after use of Ketoconazole/Hydrocortisone Gel.
Check with your doctor before receiving vaccinations while you are using Ketoconazole/Hydrocortisone Gel.
Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Ketoconazole/Hydrocortisone Gel, especially if the child is using a large amount of it or using it for a long period of time.
Ketoconazole/Hydrocortisone 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/Hydrocortisone Gel while you are pregnant. It is not known if Ketoconazole/Hydrocortisone Gel is found in breast milk after topical use. If you are or will be breast-feeding while you use Ketoconazole/Hydrocortisone Gel, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Ketoconazole/Hydrocortisone 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 skin irritation or dryness; mild, temporary burning or stinging 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); infection; new or worsening irritation, pain, redness, blistering, or severe burning at the application site; skin thinning or discoloration.

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/Hydrocortisone Gel:

Store Ketoconazole/Hydrocortisone 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/Hydrocortisone Gel out of the reach of children and away from pets.

General information:

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

Issue Date: May 5, 2010

Database Edition 10.2.1.002

K,Med-facts

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Ketoderm

30/06/10

Generic Name: ketoconazole (Topical route)

kee-toe-KON-a-zole

Oral routeTablet

Coadministration of terfenadine with ketoconazole tablets is contraindicated. Rare cases of serious cardiovascular adverse events, including death, ventricular tachycardia and torsades de pointes have been observed in patients taking ketoconazole tablets concomitantly with terfenadine, due to increased terfenadine concentrations induced by ketoconazole tablets.

Pharmacokinetic data indicate that oral ketoconazole inhibits the metabolism of astemizole, resulting in elevated plasma levels of astemizole and its active metabolite desmethylastemizole which may prolong QT intervals. Coadministration of astemizole with ketoconazole tablets is therefore contraindicated.

Coadministration of cisapride with ketoconazole is contraindicated. Serious cardiovascular adverse events including ventricular tachycardia, ventricular fibrillation and torsades de pointes have occurred in patients taking ketoconazole concomitantly with cisapride .

When used orally, ketoconazole has been associated with hepatic toxicity, including some fatalities. Patients receiving this drug should be informed by the physician of the risk and should be closely monitored. Coadministration of ketoconazole with terfenadine, astemizole, and cisapride is contraindicated due to the inhibition of metabolism of these drugs by ketoconazole. Coadministration of these drugs with ketoconazole may result in serious cardiovascular events, including death, ventricular tachycardia, ventricular fibrillation, torsades de pointes, and prolongation of the QT interval .

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 Ketoderm

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).

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

Most forms of this medicine 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 Ketoderm

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

Allergies

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

Pediatric

Appropriate studies 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 this medicine.

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

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

This medicine 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 this medicine:

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 this medicine every day for up to several weeks. If you stop using this medicine too soon, your symptoms may return. Do not miss any doses.

For patients using the foam form of this medicine:

Wash your hands before and after using this medicine.
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.
This medicine 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 this medicine:

Wash your hands before and after using this medicine.
Apply enough ketoconazole gel to cover the affected and surrounding skin areas, and rub in gently with your fingertips.
After applying this medicine, 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 this medicine is applied.
This medicine may be flammable. Do not use it near heat, an open flame, or while smoking.

For patients using the 1% shampoo form of this medicine:

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 this medicine:

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 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 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 this medicine, 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 Ketoderm

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 this medicine.

Do not use this medicine 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 this medicine 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 this medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

This medicine 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 this medicine.

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.

Ketoderm 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 this medicine

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.

Advanced,K

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ketoprofen

30/06/10

Generic Name: ketoprofen (kee toe PROE fen)
Brand names: Actron, Orudis KT, Orudis, Oruvail

What is ketoprofen?

Ketoprofen is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Ketoprofen works by reducing hormones that cause inflammation and pain in the body.

Ketoprofen is used to treat pain or inflammation caused by arthritis. It is also used to treat menstrual pain.

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

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

This medicine can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking ketoprofen. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

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

You should not use this medication if you are allergic to ketoprofen, or to aspirin or other NSAIDs.

Before taking ketoprofen, tell your doctor if you are allergic to any drugs, or if you have:

a history of heart attack, stroke, or blood clot;
heart disease, congestive heart failure, high blood pressure;
a history of stomach ulcers or bleeding, bowel problems, diverticulosis;
liver or kidney disease;
asthma;
polyps in your nose; or
if you smoke.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

FDA pregnancy category C. It is not known whether ketoprofen is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether ketoprofen passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medicine to a child without the advice of a doctor.

How should I take ketoprofen?

Take this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Ketoprofen should not be used to treat minor aches and pains.

If you take ketoprofen for a long period of time, your doctor may want to check you on a regular basis to make sure this medication is not causing harmful effects. Do not miss any scheduled visits to your doctor.

Store ketoprofen at room temperature, away from moisture, heat, and light.

See also: Ketoprofen dosage in more detail

What happens if I miss a dose?

Since ketoprofen is sometimes taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, 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. Overdose symptoms may include nausea, vomiting, dizziness, drowsiness, black or bloody stools, coughing up blood, urinating less than usual or not at all, shallow breathing, fainting, seizure (convulsion), or coma.

What should I avoid while taking ketoprofen?

Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain medicines similar to ketoprofen (such as aspirin, ibuprofen, or naproxen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, or naproxen. Do not drink alcohol while taking ketoprofen. Alcohol can increase the risk of stomach bleeding.

Ketoprofen 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. Stop taking ketoprofen and seek medical attention or call your doctor at once if you have any of these serious side effects:

chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;
confusion, tremors or shaking;
urinating less than usual or not at all;
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
bruising, severe tingling, numbness, pain, muscle weakness.

Less serious side effects may include:

upset stomach, mild heartburn or stomach pain, diarrhea, constipation; bloating, gas;
dizziness, headache, nervousness;
skin itching or rash;
dry mouth;
increased sweating, runny nose;
blurred vision; or
ringing in your ears.

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.

Ketoprofen Dosing Information

Usual Adult Dose for Osteoarthritis:

Ketoprofen: 75 mg orally 3 times a day or 50 mg orally 4 times a day.
The recommended maximum is 300 mg/day.

Ketoprofen Extended-release: 200 mg orally once daily.

Usual Adult Dose for Rheumatoid Arthritis:

Ketoprofen: 75 mg orally 3 times a day or 50 mg orally 4 times a day.
The recommended maximum is 300 mg/day.

Ketoprofen Extended-release: 200 mg orally once daily.

Usual Adult Dose for Acute Gout:

Ketoprofen: 100 mg orally one time, followed by 50 mg every 6 hours until the acute gouty attack has resolved, usually 2 to 3 days.

Usual Adult Dose for Pain:

Ketoprofen: 25 to 50 mg orally every 6 to 8 hours. Dose may be increased up to a maximum of 75 mg.

Usual Adult Dose for Fever:

Ketoprofen: 12.5 mg orally every 4 to 6 hours. An additional dose may be given if the fever does not improve within 1 hour.

The maximum daily dose should not exceed 75 mg.

Usual Adult Dose for Dysmenorrhea:

Ketoprofen: 25 to 50 mg orally every 6 to 8 hours as needed for pain relief. The dose should be titrated to patient response and should not exceed 300 mg/24 hours.

What other drugs will affect ketoprofen?

Before taking ketoprofen, tell your doctor if you are taking any of the following drugs:

cyclosporine (Gengraf, Neoral, Sandimmune);
lithium (Eskalith, Lithobid);
methotrexate (Rheumatrex, Trexall);
probenecid (Benemid);
a blood thinner such as warfarin (Coumadin), or an anti-platelet medication such as clopidogrel (Plavix), dipyridamole (Persantine), ticlopidine (Ticlid), and others;
steroids (prednisone and others);
aspirin, or other NSAIDs such as diclofenac (Voltaren), etodolac (Lodine), fenoprofen (Nalfon), flurbiprofen (Ansaid), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others.

This list is not complete and there may be other drugs that can interact with ketoprofen. 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 ketoprofen.

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.

Concise,K

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ketoprofen (Oral route)

30/06/10

kee-toe-PROE-fen

Oral routeTabletCapsuleCapsule, Extended Release

CARDIOVASCULAR RISK
- NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk

Ketoprofen is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery .

GASTROINTESTINAL RISK
- NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events .

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Ketoprofen is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs can also cause an increased risk of serious gastrointestinal adverse events especially in the elderly, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal .

Commonly used brand name(s):

In the U.S.

Orudis
Orudis KT
Oruvail

Available Dosage Forms:

Tablet, Extended Release
Tablet
Capsule, Extended Release
Capsule
Tablet, Enteric Coated

Therapeutic Class: Analgesic

Pharmacologic Class: NSAID

Chemical Class: Propionic Acid (class)

Uses For ketoprofen

Ketoprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain, and helps to relieve symptoms of arthritis (osteoarthritis and rheumatoid arthritis), such as inflammation, swelling, stiffness, and joint pain. ketoprofen does not cure arthritis and will help you only as long as you continue to take it .

In addition, ketoprofen can be used to treat menstrual cramps and other conditions as determined by your doctor .

ketoprofen is available only with your doctor’s prescription .

Before Using ketoprofen

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 ketoprofen, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to ketoprofen 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 ketoprofen in children below 18 years of age. 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 ketoprofen in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require adjustment of dosage in patients receiving ketoprofen .

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

Interactions with Medicines

Using ketoprofen 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.

Ketorolac

Using ketoprofen 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.

Ardeparin
Aspirin
Beta Glucan
Certoparin
Dalteparin
Danaparoid
Desirudin
Enoxaparin
Ginkgo
Methotrexate
Nadroparin
Parnaparin
Pemetrexed
Reviparin
Tacrolimus
Tinzaparin
Warfarin

Using ketoprofen 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.

Acetohexamide
Alacepril
Amiloride
Azosemide
Bemetizide
Benazepril
Bendroflumethiazide
Benzthiazide
Bumetanide
Buthiazide
Candesartan Cilexetil
Canrenoate
Captopril
Chlorothiazide
Chlorpropamide
Chlorthalidone
Cilazapril
Citalopram
Clopamide
Clopidogrel
Clovoxamine
Cyclopenthiazide
Cyclosporine
Cyclothiazide
Delapril
Desvenlafaxine
Duloxetine
Enalaprilat
Enalapril Maleate
Eprosartan
Escitalopram
Ethacrynic Acid
Femoxetine
Flesinoxan
Fluoxetine
Fluvoxamine
Fosinopril
Furosemide
Gliclazide
Glimepiride
Glipizide
Gliquidone
Glyburide
Hydrochlorothiazide
Hydroflumethiazide
Imidapril
Indapamide
Irbesartan
Lisinopril
Lithium
Losartan
Methyclothiazide
Metolazone
Milnacipran
Moexipril
Nefazodone
Olmesartan Medoxomil
Paroxetine
Pentopril
Perindopril
Piretanide
Polythiazide
Quinapril
Quinethazone
Ramipril
Sertraline
Spirapril
Spironolactone
Tasosartan
Telmisartan
Temocapril
Tolazamide
Tolbutamide
Torsemide
Trandolapril
Triamterene
Trichlormethiazide
Valsartan
Venlafaxine
Xipamide
Zimeldine
Zofenopril

Interactions with Food/Tobacco/Alcohol

Proper Use of ketoprofen

For safe and effective use of ketoprofen, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your doctor. Taking too much of ketoprofen may increase the chance of unwanted effects, especially in elderly patients .

When used for severe or continuing arthritis, ketoprofen must be taken regularly as ordered by your doctor in order for it to help you. ketoprofen usually begins to work within one week, but in severe cases up to two weeks or even longer may pass before you begin to feel better. Also, several weeks may pass before you feel the full effects of ketoprofen.

To lessen stomach upset, you may take ketoprofen with food, milk, or antacid unless your doctor tells you otherwise .

Dosing

The dose of ketoprofen 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 ketoprofen. If your dose is different, do not change it unless your doctor tells you to do so.

For oral dosage form (capsules):
- For osteoarthritis and rheumatoid arthritis:
  - Adults—At first, 75 milligrams (mg) three times a day or 50 mg four times a day. Your doctor may increase your dose, if necessary, up to a total of 300 mg a day.
  - Children—Use and dose must be determined by your doctor .
- For mild to moderate pain or menstrual cramps:
  - Adults—25 to 50 mg every six to eight hours as needed. Some people may need to take as much as 75 mg every six to eight hours. Doses larger than 75 mg are not likely to give better relief.
  - Children—Use and dose must be determined by your doctor .
For oral dosage form (extended-release capsules):
- For osteoarthritis and rheumatoid arthritis:
  - Adults—200 mg once a day, in the morning or evening. Take the medicine at the same time every day.
  - Children—Use and dose must be determined by your doctor .

Missed Dose

If you miss a dose of ketoprofen, 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.

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using ketoprofen

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 to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects .

ketoprofen may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use ketoprofen for a long time might also have a higher risk .

ketoprofen may cause bleeding in your stomach or intestines. These problems can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years old, if you are in poor health, or if you are using certain other medicines (a steroid or a blood thinner) .

Serious skin reactions can occur during treatment with ketoprofen. Check with your doctor right away if you have any of the following symptoms while taking ketoprofen: blistering, peeling, loosening of skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red skin lesions, sore throat, sores, ulcers, white spots in mouth or on lips, or unusual tiredness or weakness .

Possible warning signs of some serious side effects that can occur during treatment with ketoprofen may include swelling of the face, fingers, feet, and/or lower legs; severe stomach pain, black, tarry stools, and/or vomiting of blood or material that looks like coffee grounds; unusual weight gain; yellow skin or eyes; decreased urination; bleeding or bruising; and/or skin rash. Also, signs of serious heart problems could occur such as chest pain, tightness in chest, fast or irregular heartbeat, unusual flushing or warmth of skin, weakness, or slurring of speech. Stop taking ketoprofen and check with your doctor immediately if you notice any of these warning signs.

ketoprofen may also cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur often in patients who are allergic to aspirin or other nonsteroidal anti-inflammatory drugs. Anaphylaxis requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, wheezing, or fainting. Other signs may include changes in skin color of the face; very fast but irregular heartbeat or pulse; hive-like swellings on the skin; and puffiness or swelling of the eyelids or around the eyes. If these effects occur, get emergency help at once .

Using ketoprofen while you are pregnant can harm your unborn baby. If you think you have become pregnant while using ketoprofen, tell your doctor right away .

ketoprofen 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:

More common

Abdominal pain
bloody urine
decreased frequency or amount of urine
headache
increased blood pressure
increased thirst
loss of appetite
lower back or side pain
nausea
swelling of face, fingers, feet, or lower legs
troubled breathing
unusual tiredness or weakness
vomiting
weight gain

Less common

Bladder pain
cloudy urine
difficult, burning, or painful urination
frequent urge to urinate
rash
swelling or inflammation of the mouth

Rare

Back pain
bleeding from rectum
bleeding gums
blistering, peeling, loosening of skin
blood in vomit
bloody nose
bloody, black, or tarry stools
blurred vision
body aches or pain
burning feeling in chest or stomach
burning, dry or itching eyes
change in color of eye
chest pain
chills
clay-colored stools
cold hands and feet
coma
confusion
congestion
constipation
convulsions
cough or hoarseness
coughing or spitting up blood
cracks in the skin
dark urine
decreased urination
decreased vision or other changes in vision
diarrhea
difficult or labored breathing
difficulty swallowing
dilated neck veins
discharge, excessive tearing
dryness or soreness of throat
extreme fatigue
fast, irregular, pounding, or racing heartbeat or pulse
feeling faint, dizzy, or lightheadedness
feeling of warmth or heat
fever with or without chills
flushing or redness of skin, especially on face and neck
general tiredness and weakness
heartburn
hives or welts
increased sensitivity of skin to sunlight
indigestion
itching
joint or muscle pain
light-colored stools
loss of heat from the body
muscle pain or cramps
nervousness
noisy breathing
pale or blue lips, fingernails, or skin
pale skin
pinpoint red or purple spots on skin
pounding in the ears
problems with bleeding or clotting
puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
red skin lesions, often with a purple center
red, irritated eyes
red, swollen skin
redness or other discoloration of skin
redness or soreness around fingernails or loosening of the fingernails
redness, pain, swelling of eye, eyelid, or inner lining of eyelid
runny nose
scaly skin
severe abdominal cramping
severe or continuing stomach pain
severe sunburn
shortness of breath
skin rash, encrusted, scaly and oozing
slow heartbeat
slow or irregular breathing
sores, ulcers, or white spots on lips or in mouth
stomach pain or upset
sweating
swelling of face, ankles, or hands
tender, swollen glands in neck
tenderness in stomach area
tightness in chest
trouble in swallowing
troubled breathing with exertion
unpleasant breath odor
unusual bleeding or bruising
upper right abdominal pain
voice changes
vomiting of blood
vomiting of material that looks like coffee grounds, severe and continuing
wheezing
yellow eyes or skin

Symptoms of overdose

Dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
fast or shallow breathing
pain or discomfort in chest, upper stomach, or throat
unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness

More common

Acid or sour stomach
belching
bloated
discouragement
dreams
excess air or gas in stomach or intestines
excitation
feeling sad or empty
full feeling
general feeling of discomfort or illness
irritability
lack of appetite
loss of interest or pleasure
passing gas
sleepiness
sleeplessness
trouble concentrating
trouble sleeping
unable to sleep

Less common

Continuing ringing or buzzing or other unexplained noise in ears
disturbed color perception
double vision
halos around lights
hearing loss
loss of vision
night blindness
overbright appearance of lights
tunnel vision
weight loss

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.

Advanced,K

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Ketoconazole Foam

30/06/10

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

Ketoconazole Foam is used for:

Treating seborrheic dermatitis (a skin condition). It may also be used for other conditions as determined by your doctor.

Ketoconazole Foam is an imidazole antifungal. Exactly how it works to treat seborrheic dermatitis is not known. Ketoconazole Foam kills sensitive fungi.

Do NOT use Ketoconazole Foam if:

you are allergic to any ingredient in Ketoconazole Foam

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

Before using Ketoconazole Foam:

Some medical conditions may interact with Ketoconazole Foam. 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

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

Ask your health care provider if Ketoconazole Foam 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 Foam:

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

An extra patient leaflet is available with Ketoconazole Foam. Talk to your pharmacist if you have questions about this information.
Wash your hands in cool water and dry well before you use Ketoconazole Foam. If your fingers are too warm, the medicine will begin to melt right away when it touches your skin.
To use Ketoconazole Foam, hold the can upright. Dispense the medicine into the cap or onto a cool surface. Do not dispense the medicine directly onto your skin or hands because it will melt too soon. If the can seems warm or the foam seems runny, hold the can under cold running water to cool it.
Using your fingertips, gently massage Ketoconazole Foam into the affected areas until the foam disappears. To treat your scalp or other skin areas with hair, move your hair away so that the medicine can be applied to the affected skin.
After you use Ketoconazole Foam, wipe any excess foam off of the container.
Wash your hands immediately after you use Ketoconazole Foam, unless your hands are part of the treated area.
To clear up your infection completely, use Ketoconazole Foam for the full course of treatment. Keep using it even if you feel better in a few days.
If you miss a dose of Ketoconazole Foam, 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 Foam.

Important safety information:

Ketoconazole Foam is for external use only. Do not get it in your eyes, nose, vagina, or mouth. If you get it in any of these areas, rinse at once with cool tap water.
Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.
If your symptoms do not get better within 4 weeks or if they get worse, check with your doctor.
Do not use Ketoconazole Foam for other skin conditions at a later time.
Talk with your doctor before you use any other medicines or cleansers on your skin.
Ketoconazole Foam may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Ketoconazole Foam. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
Ketoconazole Foam is flammable. Do not store or use near an open flame. Do not smoke during or right after use of Ketoconazole Foam.
Ketoconazole Foam 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 Foam while you are pregnant. It is not known if Ketoconazole Foam is found in breast milk after topical use. If you are or will be breast-feeding while you use Ketoconazole Foam, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Ketoconazole Foam:

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, temporary burning or stinging.

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); redness, irritation, or severe burning of the skin.

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 Foam:

Store Ketoconazole Foam at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Avoid temperatures above 120 degrees F (49 degrees C). Do not refrigerate or freeze. Store away from heat and direct sunlight. Do not puncture, break, or burn the canister even if it appears to be empty. Keep Ketoconazole Foam out of the reach of children and away from pets.

General information:

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

Issue Date: May 5, 2010

Database Edition 10.2.1.002

K,Med-facts

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Ketoconazole Gel and Pyrithione Zinc Shampoo Gel

30/06/10

Generic Name: Ketoconazole Gel and Pyrithione Zinc Shampoo (KEE-toe-KON-a-zole/PIR-i-THYE-one zink)
Brand Name: Xolegel Duo

Ketoconazole Gel and Pyrithione Zinc Shampoo Gel is used for:

Treating and preventing itching, flaking, and scaling of the skin and scalp caused by seborrheic dermatitis and dandruff.

Ketoconazole Gel and Pyrithione Zinc Shampoo Gel is a convenience pack containing an antifungal gel and antiseborrheic shampoo. The antifungal works by killing the fungus causing the skin condition. The antiseborrheic works by slowing the production of skin cells, which helps to reduce flakiness.

Do NOT use Ketoconazole Gel and Pyrithione Zinc Shampoo Gel if:

you are allergic to any ingredient in Ketoconazole Gel and Pyrithione Zinc Shampoo Gel

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

Before using Ketoconazole Gel and Pyrithione Zinc Shampoo Gel:

Some medical conditions may interact with Ketoconazole Gel and Pyrithione Zinc Shampoo 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 condition that covers a large area of the body
if you have a weakened immune system, liver problems, or the blood disease porphyria

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

Ask your health care provider if Ketoconazole Gel and Pyrithione Zinc Shampoo 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 and Pyrithione Zinc Shampoo Gel:

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

FOR THE GEL: Wash your hands before and right after using Ketoconazole Gel and Pyrithione Zinc Shampoo Gel. Spread a thick layer of Ketoconazole Gel and Pyrithione Zinc Shampoo Gel onto the affected skin 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 and Pyrithione Zinc Shampoo Gel.
Wait for at least 20 minutes after you apply the gel before you apply makeup or sunscreen.
Do not wash the area where you applied the gel for at least 3 hours after you apply it.
FOR THE SHAMPOO: Shake well before each use. Wet hair thoroughly. Apply the shampoo and work it into a lather. Rinse thoroughly. You may repeat if desired unless your doctor tells you otherwise.
For best results, use the shampoo at least 2 times per week or as directed by your doctor. Do not use more often than once daily.
IF YOU MISS A DOSE OF THE 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. IF YOU MISS A DOSE OF THE SHAMPOO, use the dose when you remember. Continue to use Ketoconazole Gel and Pyrithione Zinc Shampoo Gel as directed by your doctor or the package labeling.

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

Important safety information:

Ketoconazole Gel and Pyrithione Zinc Shampoo Gel is for external use only. Do not get it in your eyes, nose, or mouth. If you get it in any of these areas, rinse at once with cool tap water. Do not get Ketoconazole Gel and Pyrithione Zinc Shampoo Gel in your vagina.
Check with your doctor before you use Ketoconazole Gel and Pyrithione Zinc Shampoo Gel if your condition covers a large area of your body.
If your symptoms do not improve with regular use or if they become worse, consult your doctor.
Do not use Ketoconazole Gel and Pyrithione Zinc Shampoo Gel for other skin conditions at a later time.
The gel in this convenience pack is flammable. Do not store or use near an open flame. Do not smoke during or right after use of Ketoconazole Gel and Pyrithione Zinc Shampoo Gel.
Ketoconazole Gel and Pyrithione Zinc Shampoo 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 and Pyrithione Zinc Shampoo Gel while you are pregnant. It is not known if Ketoconazole Gel and Pyrithione Zinc Shampoo Gel is found in breast milk after topical use. If you are or will be breast-feeding while you use Ketoconazole Gel and Pyrithione Zinc Shampoo Gel, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Ketoconazole Gel and Pyrithione Zinc Shampoo 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.

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. Ketoconazole Gel and Pyrithione Zinc Shampoo Gel is harmful if swallowed.

Proper storage of Ketoconazole Gel and Pyrithione Zinc Shampoo Gel:

Store Ketoconazole Gel and Pyrithione Zinc Shampoo Gel at room temperature, at 77 degrees F (25 degrees C). Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do NOT store near an open flame. Keep Ketoconazole Gel and Pyrithione Zinc Shampoo Gel out of the reach of children and away from pets.

General information:

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

Issue Date: May 5, 2010

Database Edition 10.2.1.002

K,Med-facts

Comments (0)

Ketoconazole Tablets

30/06/10

Dosage Form: tablet

Ketoconazole Tablets, USP
200 mg

Rx only

Warning

Coadministration of terfenadine with Ketoconazole Tablets is contraindicated. Rare cases of serious cardiovascular adverse events, including death, ventricular tachycardia and torsades de pointes have been observed in patients taking Ketoconazole Tablets concomitantly with terfenadine, due to increased terfenadine concentrations induced by Ketoconazole Tablets. (See CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS sections.)

Ketoconazole Tablets Description

Ketoconazole is a synthetic broad-spectrum antifungal agent available in scored white tablets, each containing 200 mg ketoconazole base for oral administration. In addition, each tablet also contains the following inactive ingredients: colloidal silicon dioxide, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and starch (corn). Ketoconazole is cis – 1 – acetyl – 4 – [4 - [[2 - (2,4 - dichlorophenyl) - 2 - (1H - imidazol - 1 - ylmethyl) - 1,3 - dioxolan - 4 - yl]methoxyl]phenyl]piperazine.

Ketoconazole is a white to slightly beige, odorless powder, soluble in acids, with a molecular weight of 531.44. Ketoconazole’s structural formula and molecular formula are as follows:

C26H28Cl2N4O4

Ketoconazole Tablets – Clinical Pharmacology

Mean peak plasma levels of approximately 3.5 mcg/mL are reached within 1 to 2 hours, following oral administration of a single 200 mg dose taken with a meal. Subsequent plasma elimination is biphasic with a half-life of 2 hours during the first 10 hours and 8 hours thereafter. Following absorption from the gastrointestinal tract, ketoconazole is converted into several inactive metabolites. The major identified metabolic pathways are oxidation and degradation of the imidazole and piperazine rings, oxidative O-dealkylation and aromatic hydroxylation. About 13% of the dose is excreted in the urine, of which 2 to 4% is unchanged drug. The major route of excretion is through the bile into the intestinal tract. In vitro, the plasma protein binding is about 99% mainly to the albumin fraction. Only a negligible proportion of ketoconazole reaches the cerebral-spinal fluid. Ketoconazole is a weak dibasic agent and thus requires acidity for dissolution and absorption.

Ketoconazole Tablets are active against clinical infections with Blastomyces dermatitidis, Candida spp., Coccidioides immitis, Histoplasma capsulatum, Paracoccidioides brasiliensis, and Phialophora spp. Ketoconazole Tablets are also active against Trichophyton spp., Epidermophyton spp., and Microsporum spp. Ketoconazole is also active in vitro against a variety of fungi and yeast. In animal models, activity has been demonstrated against Candida spp., Blastomyces dermatitidis, Histoplasma capsulatum, Malassezia furfur, Coccidioides immitis, and Cryptococcus neoformans.

Mode of Action

In vitro studies suggest that ketoconazole impairs the synthesis of ergosterol, which is a vital component of fungal cell membranes.

Indications and Usage for Ketoconazole Tablets

Ketoconazole Tablets are indicated for the treatment of the following systemic fungal infections: candidiasis, chronic mucocutaneous candidiasis, oral thrush, candiduria, blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. Ketoconazole Tablets should not be used for fungal meningitis because it penetrates poorly into the cerebral-spinal fluid.

Ketoconazole Tablets are also indicated for the treatment of patients with severe recalcitrant cutaneous dermatophyte infections who have not responded to topical therapy or oral griseofulvin, or who are unable to take griseofulvin.

Contraindications

Coadministration of terfenadine or astemizole with Ketoconazole Tablets is contraindicated. (See BOX WARNING, WARNINGS, and PRECAUTIONS sections.)

Concomitant administration of Ketoconazole Tablets with cisapride is contraindicated. (See BOX WARNING, WARNINGS and PRECAUTIONS sections.)

Concomitant administration of Ketoconazole Tablets with oral triazolam is contraindicated. (See PRECAUTIONS section.)

Ketoconazole is contraindicated in patients who have shown hypersensitivity to the drug.

Warnings

Hepatotoxicity, primarily of the hepatocellular type, has been associated with the use of Ketoconazole Tablets, including rare fatalities. The reported incidence of hepatotoxicity has been about 1:10,000 exposed patients, but this probably represents some degree of under-reporting, as is the case for most reported adverse reactions to drugs. The median duration of ketoconazole tablet therapy in patients who developed symptomatic hepatotoxicity was about 28 days, although the range extended to as low as 3 days. The hepatic injury has usually, but not always, been reversible upon discontinuation of ketoconazole tablet treatment. Several cases of hepatitis have been reported in children.

Prompt recognition of liver injury is essential. Liver function tests (such as SGGT, alkaline phosphatase, SGPT, SGOT and bilirubin) should be measured before starting treatment and at frequent intervals during treatment. Patients receiving Ketoconazole Tablets concurrently with other potentially hepatotoxic drugs should be carefully monitored, particularly those patients requiring prolonged therapy or those who have had a history of liver disease.

Most of the reported cases of hepatic toxicity have to date been in patients treated for onychomycosis. Of 180 patients worldwide developing idiosyncratic liver dysfunction during ketoconazole tablet therapy, 61.3% had onychomycosis and 16.8% had chronic recalcitrant dermatophytoses.

Transient minor elevations in liver enzymes have occurred during treatment with Ketoconazole Tablets. The drug should be discontinued if these persist, if the abnormalities worsen, or if the abnormalities become accompanied by symptoms of possible liver injury.

In rare cases anaphylaxis has been reported after the first dose. Several cases of hypersensitivity reactions including urticaria have also been reported.

Coadministration of Ketoconazole Tablets and terfenadine has led to elevated plasma concentrations of terfenadine which may prolong QT intervals, sometimes resulting in life-threatening cardiac dysrhythmias. Cases of torsades de pointes and other serious ventricular dysrhythmias, in rare cases leading to fatality, have been reported among patients taking terfenadine concurrently with Ketoconazole Tablets. Coadministration of Ketoconazole Tablets and terfenadine is contraindicated.

Coadministration of astemizole with Ketoconazole Tablets is contraindicated. (See BOX WARNING, CONTRAINDICATIONS, and PRECAUTIONS sections.)

Concomitant administration of Ketoconazole Tablets with cisapride is contraindicated because it has resulted in markedly elevated cisapride plasma concentrations and prolonged QT interval, and has rarely been associated with ventricular arrhythmias and torsades de pointes. (See BOX WARNING, CONTRAINDICATIONS and PRECAUTIONS sections.)

In European clinical trials involving 350 patients with metastatic prostatic cancer, eleven deaths were reported within two weeks of starting treatment with high doses of Ketoconazole Tablets (1200 mg/day). It is not possible to ascertain from the information available whether death was related to ketoconazole therapy in these patients with serious underlying disease. However, high doses of Ketoconazole Tablets are known to suppress adrenal corticosteroid secretion.

In female rats treated three to six months with ketoconazole at dose levels of 80 mg/kg and higher, increased fragility of long bones, in some cases leading to fracture, was seen. The maximum “no-effect” dose level in these studies was 20 mg/kg (2.5 times the maximum recommended human dose). The mechanism responsible for this phenomenon is obscure. Limited studies in dogs failed to demonstrate such an effect on the metacarpals and ribs.

Precautions

General

Ketoconazole Tablets have been demonstrated to lower serum testosterone. Once therapy with ketoconazole has been discontinued, serum testosterone levels return to baseline values. Testosterone levels are impaired with doses of 800 mg per day and abolished by 1600 mg per day. Ketoconazole Tablets also decrease ACTH induced corticosteroid serum levels at similar high doses. The recommended dose of 200 mg to 400 mg daily should be followed closely.

In four subjects with drug-induced achlorhydria, a marked reduction in ketoconazole absorption was observed. Ketoconazole Tablets require acidity for dissolution. If concomitant antacids, anticholinergics, and H2-blockers are needed, they should be given at least two hours after administration of Ketoconazole Tablets. In cases of achlorhydria, the patients should be instructed to dissolve each tablet in 4 mL aqueous solution of 0.2 N HCl. For ingesting the resulting mixture, they should use a drinking straw so as to avoid contact with the teeth. This administration should be followed with a cup of tap water.

Information for Patients

Patients should be instructed to report any signs and symptoms which may suggest liver dysfunction so that appropriate biochemical testing can be done. Such signs and symptoms may include unusual fatigue, anorexia, nausea and/or vomiting, jaundice, dark urine or pale stools (see WARNINGS section).

Drug Interactions

Ketoconazole is a potent inhibitor of the cytochrome P450 3A4 enzyme system. Coadministration of Ketoconazole Tablets and drugs primarily metabolized by the cytochrome P450 3A4 enzyme system may result in increased plasma concentrations of the drugs that could increase or prolong both therapeutic and adverse effects. Therefore, unless otherwise specified, appropriate dosage adjustments may be necessary. The following drug interactions have been identified involving Ketoconazole Tablets and other drugs metabolized by the cytochrome P450 enzyme system.

Ketoconazole Tablets inhibit the metabolism of terfenadine, resulting in an increased plasma concentration of terfenadine and a delay in the elimination of its acid metabolite. The increased plasma concentration of terfenadine or its metabolite may result in prolonged QT intervals. (See BOX WARNING, CONTRAINDICATIONS, and WARNINGS sections.)

Human pharmacokinetics data indicate that oral ketoconazole potently inhibits the metabolism of cisapride resulting in a mean eight-fold increase in AUC of cisapride. Data suggest that coadministration of oral ketoconazole and cisapride can result in prolongation of the QT interval on the ECG. Therefore concomitant administration of Ketoconazole Tablets with cisapride is contraindicated. (See BOX WARNING, CONTRAINDICATIONS, and WARNINGS sections.)

Ketoconazole Tablets may alter the metabolism of cyclosporine, tacrolimus, and methylprednisolone, resulting in elevated plasma concentrations of the latter drugs. Dosage adjustment may be required if cyclosporine, tacrolimus, or methylprednisolone are given concomitantly with Ketoconazole Tablets.

Coadministration of Ketoconazole Tablets with midazolam or triazolam has resulted in elevated plasma concentrations of the latter two drugs. This may potentiate and prolong hypnotic and sedative effects, especially with repeated dosing or chronic administration of these agents. These agents should not be used in patients treated with Ketoconazole Tablets. If midazolam is administered parenterally, special precaution is required since the sedative effect may be prolonged.

Rare cases of elevated plasma concentrations of digoxin have been reported. It is not clear whether this was due to the combination of therapy. It is, therefore, advisable to monitor digoxin concentration in patients receiving ketoconazole.

When taken orally, imidazole compounds like ketoconazole may enhance the anticoagulant effect of coumarin-like drugs. In simultaneous treatment with imidazole drugs and coumarin drugs, the anticoagulant effect should be carefully titrated and monitored.

Because severe hypoglycemia has been reported in patients concomitantly receiving oral miconazole (an imidazole) and oral hypoglycemic agents, such a potential interaction involving the latter agents when used concomitantly with Ketoconazole Tablets (an imidazole) can not be ruled out.

Concomitant administration of Ketoconazole Tablets with phenytoin may alter the metabolism of one or both of the drugs. It is suggested to monitor both ketoconazole and phenytoin.

Concomitant administration of rifampin with Ketoconazole Tablets reduces the blood levels of the latter. INH (Isoniazid) is also reported to affect ketoconazole concentrations adversely. These drugs should not be given concomitantly.

After the coadministration of 200 mg oral ketoconazole twice daily and one 20 mg dose of loratadine to 11 subjects, the AUC and Cmax of loratadine averaged 302% (± 142 S.D.) and 251% (± 68 S.D.), respectively, of those obtained after co-treatment with placebo. The AUC and Cmax of descarboethoxyloratadine, an active metabolite, averaged 155% (± 27 S.D.) and 141% (± 35 S.D.), respectively. However, no related changes were noted in the QTc on ECG taken at 2, 6, and 24 hours after the coadministration. Also, there were no clinically significant differences in adverse events when loratadine was administered with or without ketoconazole.

Rare cases of a disulfiram-like reaction to alcohol have been reported. These experiences have been characterized by flushing, rash, peripheral edema, nausea, and headache. Symptoms resolved within a few hours.

Carcinogenesis, Mutagenesis, Impairment of Fertility

The dominant lethal mutation test in male and female mice revealed that single oral doses of ketoconazole as high as 80 mg/kg produced no mutation in any stage of germ cell development. The Ames Salmonella microsomal activator assay was also negative. A long term feeding study in Swiss Albino mice and in Wistar rats showed no evidence of oncogenic activity.

Pregnancy

Teratogenic Effects. Pregnancy Category C

Ketoconazole has been shown to be teratogenic (syndactylia and oligodactylia) in the rat when given in the diet at 80 mg/kg/day (10 times the maximum recommended human dose). However, these effects may be related to maternal toxicity, evidence of which also was seen at this and higher dose levels.

There are no adequate and well controlled studies in pregnant women. Ketoconazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects

Ketoconazole has also been found to be embryotoxic in the rat when given in the diet at doses higher than 80 mg/kg during the first trimester of gestation.

In addition, dystocia (difficult labor) was noted in rats administered oral ketoconazole during the third trimester of gestation. This occurred when ketoconazole was administered at doses higher than 10 mg/kg (higher than 1.25 times the maximum human dose).

It is likely that both the malformations and the embryotoxicity resulting from the administration of oral ketoconazole during gestation are a reflection of the particular sensitivity of the female rat to this drug. For example, the oral LD50 of ketoconazole given by gavage to the female rat is 166 mg/kg whereas in the male rat the oral LD50 is 287 mg/kg.

Nursing Mothers

Since ketoconazole is probably excreted in the milk, mothers who are under treatment should not breast feed.

Pediatric Use

Ketoconazole Tablets have not been systematically studied in children of any age, and essentially no information is available on children under 2 years. Ketoconazole should not be used in pediatric patients unless the potential benefit outweighs the risks.

Adverse Reactions

In rare cases, anaphylaxis has been reported after the first dose. Several cases of hypersensitivity reactions including urticaria have also been reported. However, the most frequent adverse reactions were nausea and/or vomiting in approximately 3%, abdominal pain in 1.2%, pruritus in 1.5%, and the following in less than 1% of the patients: headache, dizziness, somnolence, fever and chills, photophobia, diarrhea, gynecomastia, impotence, thrombocytopenia, leukopenia, hemolytic anemia, and bulging fontanelles. Oligospermia has been reported in investigational studies with the drug at dosages above those currently approved. Oligospermia has not been reported at dosages up to 400 mg daily, however sperm counts have been obtained infrequently in patients treated with these dosages. Most of these reactions were mild and transient and rarely required discontinuation of Ketoconazole Tablets. In contrast, the rare occurrences of hepatic dysfunction require special attention (see WARNINGS section).

In worldwide postmarketing experience with Ketoconazole Tablets there have been rare reports of alopecia, paresthesia, and signs of increased intracranial pressure including bulging fontanelles and papilledema. Hypertriglyceridemia has also been reported but a causal association with ketoconazole is uncertain.

Neuropsychiatric disturbances, including suicidal tendencies and severe depression, have occurred rarely in patients using Ketoconazole Tablets.

Ventricular dysrhythmias (prolonged QT intervals) have occurred with the concomitant use of terfenadine with Ketoconazole Tablets. (See BOX WARNING, CONTRAINDICATIONS, and WARNINGS sections.) Data suggest that coadministration of Ketoconazole Tablets and cisapride can result in prolongation of the QT interval and has rarely been associated with ventricular arrhythmias. (See CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS sections.)

Overdosage

In the event of accidental overdosage, supportive measures, including gastric lavage with sodium bicarbonate, should be employed.

Ketoconazole Tablets Dosage and Administration

Adults

The recommended starting dose of Ketoconazole Tablets is a single daily administration of 200 mg (one tablet). In very serious infections or if clinical responsiveness is insufficient within the expected time, the dose of ketoconazole may be increased to 400 mg (two tablets) once daily.

Children

In small numbers of children over 2 years of age, a single daily dose of 3.3 to 6.6 mg/kg has been used. Ketoconazole Tablets have not been studied in children under 2 years of age.

There should be laboratory as well as clinical documentation of infection prior to starting ketoconazole therapy. Treatment should be continued until tests indicate that active fungal infection has subsided. Inadequate periods of treatment may yield poor response and lead to early recurrence of clinical symptoms. Minimum treatment for candidiasis is one or two weeks. Patients with chronic mucocutaneous candidiasis usually require maintenance therapy. Minimum treatment for the other indicated systemic mycoses is six months.

Minimum treatment for recalcitrant dermatophyte infections is four weeks in cases involving glabrous skin. Palmar and plantar infections may respond more slowly. Apparent cures may subsequently recur after discontinuation of therapy in some cases.

How is Ketoconazole Tablets Supplied

Ketoconazole Tablets, USP are available containing 200 mg of ketoconazole. The 200 mg tablets are white to off-white, round, flat-faced, beveled edge tablets debossed with M above the score and 261 below the score on one side of the tablet and blank on the other side. They are available as follows:

NDC 0179-055-70
Box, Unit-Dose of 30 tablets

STORE AT ROOM TEMPERATURE

15° TO 30°C (59° TO 86°F).

PROTECT FROM MOISTURE.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Manufactured by:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505

REV SEPTEMBER 1999
KTCZ:R1

Repackaged by:
Kaiser Foundation Hospitals
Livermore, CA 94551

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KETOCONAZOLE
ketoconazole tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0179-0055 (00378-0261)
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Ketoconazole (Ketoconazole)	Ketoconazole	200 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
STARCH, CORN

Product Characteristics
Color	WHITE (white to off-white)	Score	2 pieces
Shape	ROUND	Size	10mm
Flavor		Imprint Code	M;261
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0179-0055-70	30 TABLET In 1 BOX, UNIT-DOSE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075597	03/02/2010

Labeler - KAISER FOUNDATION HOSPITALS (053052619)

Establishment
Name	Address	ID/FEI	Operations
KAISER FOUNDATION HOSPITALS		053052619	repack

Revised: 04/2010KAISER FOUNDATION HOSPITALS

K,Professional

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Ketoconazole Cream

30/06/10

Generic Name: Ketoconazole (kee-toe-KOE-na-zole)
Brand Name: Kuric and Nizoral

Ketoconazole Cream is used for:

Treating certain fungal infections of the skin.

Ketoconazole Cream 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 Cream if:

you are allergic to any ingredient in Ketoconazole Cream

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

Before using Ketoconazole Cream:

Some medical conditions may interact with Ketoconazole Cream. 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 Cream. Because little, if any, of Ketoconazole Cream is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Ketoconazole Cream 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 Cream:

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

Clean the affected area with soap and water and dry thoroughly. Apply enough medicine to cover the affected area. Rub in gently. Do not cover unless directed otherwise by your doctor. Wash your hands immediately after using Ketoconazole Cream, unless your hands are part of the treated area.
Keep Ketoconazole Cream out of your eyes, nose, and mouth. If this occurs, wash with water and contact your doctor, nurse, or pharmacist.
To clear up your infection completely, use Ketoconazole Cream for the full course of treatment. Keep using it even if you feel better in a few days.
If you miss a dose of Ketoconazole Cream, 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 Cream.

Important safety information:

Be sure to use Ketoconazole Cream 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 Cream if you drink more than 3 drinks with alcohol per day.
Ketoconazole Cream should not be used 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 Cream while you are pregnant. It is not known if Ketoconazole Cream is found in breast milk. Do not breast-feed while using Ketoconazole Cream.

Possible side effects of Ketoconazole Cream:

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.

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); reddening, blistering, peeling, itching, or burning of your skin.

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 Cream:

Store Ketoconazole Cream 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 Cream out of the reach of children and away from pets.

General information:

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

Issue Date: May 5, 2010

Database Edition 10.2.1.002

K,Med-facts

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