Kericort 10

Generic Name: hydrocortisone (Topical application route)

hye-droe-KOR-ti-sone

Commonly used brand name(s)

In the U.S.

• Ala-Cort


• Ala-Scalp HP


• Anusol HC


• Aquanil HC


• Beta HC


• Caldecort


• Cetacort


• Corta-Cap


• Cortagel Extra Strength


• Cortaid


• CortAlo With Aloe


• Corticaine


• Corticool Maximum Strength


• Cortizone-10


• Cortizone-5


• Cotacort


• Delacort


• Dermarest


• Dermtex-HC


• Foille Cort


• Gly-Cort


• Hydrozone Plus


• Hytone


• Instacort-10


• Ivy Soothe


• IvyStat


• Keratol HC


• Kericort 10


• Lacticare-HC


• Locoid


• Locoid Lipocream


• Medi-Cortisone Maximum Strength


• Microcort


• Mycin Scalp


• Neutrogena T/Scalp


• NuCort


• Nupercainal HC


• Nutracort


• Pandel


• Pediaderm HC Kit


• Preparation H Hydrocortisone


• Proctocream-HC


• Recort Plus


• Sarnol-HC Maximum Strength


• Scalacort


• Scalpcort


• Summer's Eve Specialcare


• Texacort


• Therasoft Anti-Itch & Dermatitis


• U-Cort


• Westcort

In Canada

• Barriere-Hc


• Cortate


• Cort-Eze


• Cortoderm Mild Ointment


• Cortoderm Regular Ointment


• Emo-Cort


• Emo-Cort Scalp Solution


• Hydrocortisone Cream


• Novo-Hydrocort


• Novo-Hydrocort Cream


• Prevex Hc


• Sarna Hc

Available Dosage Forms:

• Solution


• Cream


• Spray


• Lotion


• Ointment


• Pad


• Liquid


• Gel/Jelly


• Kit


• Foam


• Stick


• Paste

Therapeutic Class: Corticosteroid, Weak

Pharmacologic Class: Adrenal Glucocorticoid

Uses For Kericort 10

Hydrocortisone topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions. This medicine is a corticosteroid (cortisone-like medicine or steroid).

This medicine is available both over-the-counter (OTC) and with your doctor's prescription.

Before Using Kericort 10

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of hydrocortisone topical in the pediatric population. However, because of this medicine's toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor's instructions very carefully.

Geriatric

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

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.

Other Medical Problems

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

• Cushing's syndrome (adrenal gland disorder) or


• Diabetes or


• Hyperglycemia (high blood sugar) or


• Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.

• Infection of the skin at or near the place of application or


• Large sores, broken skin, or severe skin injury at the place of application—The chance of side effects may be increased.

Proper Use of hydrocortisone

This section provides information on the proper use of a number of products that contain hydrocortisone. It may not be specific to Kericort 10. Please read with care.

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it in your eyes. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

To use:

• Wash your hands with soap and water before and after using this medicine.


• Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.


• With the lotion, shake it well before using.


• Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.


• If the medicine is applied to the diaper area of an infant, do not use tight-fitting diapers or plastic pants unless directed to do so by your doctor.


• If your doctor ordered an occlusive dressing or airtight covering to be applied over the medicine, make sure you know how to apply it. Occlusive dressings increase the amount of medicine absorbed through your skin, so use them only as directed. If you have any questions about this, check with your doctor.

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 redness, itching, and swelling of the skin:
  
  • For topical dosage form (cream):
    
    • Adults—Apply to the affected area of the skin two or three times per day.
    
    
    • Children—Apply to the affected area of the skin two or three times per day.
    
    
  
  
  • For topical dosage form (lotion):
    
    • Adults—Apply to the affected area of the skin two to four times per day.
    
    
    • Children—Apply to the affected area of the skin two to four times per day.
    
    
  
  
  • For topical dosage form (ointment):
    
    • Adults—Apply to the affected area of the skin three or four times per day.
    
    
    • Children—Apply to the affected area of the skin three or four times per day.
    
    
  
  
  • For topical dosage form (solution):
    
    • Adults—Apply to the affected area of the skin three or four times per day.
    
    
    • Children—Apply to the affected area of the skin three or four times per day.
    
    
  
  

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 Kericort 10

It is very important that your doctor check your or your child's progress at regular visits for any unwanted effects that may be caused by this medicine.

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

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.

Do not use cosmetics or other skin care products on the treated areas.

Kericort 10 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:

Incidence not known

• Blistering, burning, crusting, dryness, or flaking of the skin


• irritation


• itching, scaling, severe redness, soreness, or swelling of the skin


• redness and scaling around the mouth


• thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g. between the fingers)


• thinning, weakness, or wasting away of the skin

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

Incidence not known

• Acne or pimples


• burning and itching of the skin with pinhead-sized red blisters


• burning, itching, and pain in hairy areas, or pus at the root of the hair


• increased hair growth on the forehead, back, arms, and legs


• lightening of normal skin color


• lightening of treated areas of dark skin


• reddish purple lines on the arms, face, legs, trunk, or groin


• softening of the skin

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.

More Kericort 10 resources

• Kericort 10 Use in Pregnancy & Breastfeeding
• Kericort 10 Drug Interactions
• Kericort 10 Support Group
• 15 Reviews for Kericort0 - Add your own review/rating

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Ophthalmic Surgical Staining Medications

Drugs associated with Ophthalmic Surgical Staining

The following drugs and medications are in some way related to, or used in the treatment of Ophthalmic Surgical Staining. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Drug List:

Membraneblue

Visionblue

Kionex

Dosage Form: oral / rectal suspension
Kionex®

Sodium Polystyrene Sulfonate, USP

Cation-Exchange Resin

Kionex Description

Kionex®brand of sodium polystyrene sulfonate is a benzene, diethenyl- polymer with ethenylbenzene, sulfonated, sodium salt and has the following structural formula:

The drug is a cream to light brown finely ground, powdered form of sodium polystyrene sulfonate, a cation-exchange resin prepared in the sodium phase with anin vitroexchange capacity of approximately 3.1 mEq (in vivoapproximately 1 mEq) of potassium per gram. The sodium content is approximately 100 mg (4.1 mEq) per gram of the drug. It can be administered orally or in an enema.

Kionex - Clinical Pharmacology

As the resin passes along the intestine or is retained in the colon after administration by enema, the sodium ions are partially released and are replaced by potassium ions. For the most part, this action occurs in the large intestine, which excretes potassium ions to a greater degree than does the small intestine. The efficiency of this process is limited and unpredictably variable. It commonly approximates the order of 33 percent but the range is so large that definitive indices of electrolyte balance must be clearly monitored. Metabolic data are unavailable.

INDICATION AND USAGE

Kionex®is indicated for the treatment of hyperkalemia.

Contraindications

Kionex®is contraindicated in the following conditions: patients with hypokalemia, patients with a history of hypersensitivity to polystyrene sulfonate resins, obstructive bowel disease, neonates with reduced gut motility (postoperatively or drug induced) and oral administration in neonates (seePRECAUTIONS).

Warnings

Colonic Necrosis:

Cases of colonic necrosis and other serious gastrointestinal adverse events (bleeding, ischemic colitis, perforation) have been reported in association with sodium polystyrene sulfonate use. The majority of these cases reported the concomitant use of sorbitol. Risk factors for gastrointestinal adverse events were present in many of the cases including prematurity, history of intestinal disease or surgery, hypovolemia, and renal insufficiency and failure. Concomitant administration of sorbitol is not recommended (seePRECAUTIONS, Drug Interactions).

Alternative Therapy in Severe Hyperkalemia:

Since effective lowering of serum potassium with Kionex®may take hours to days, treatment with this drug alone may be insufficient to rapidly correct severe hyperkalemia associated with states of rapid tissue breakdown (e.g., burns and renal failure) or hyperkalemia so marked as to constitute a medical emergency. Therefore, other definitive measures, including dialysis, should always be considered and may be imperative.

Hypokalemia:

Serious potassium deficiency can occur from therapy with Kionex®. The effect must be carefully controlled by frequent serum potassium determinations within each 24 hour period. Since intracellular potassium deficiency is not always reflected by serum potassium levels, the level at which treatment with Kionex®should be discontinued must be determined individually for each patient. Important aids in making this determination are the patient's clinical condition and electrocardiogram. Early clinical signs of severe hypokalemia include a pattern of irritable confusion and delayed thought processes.

Electrocardiographically, severe hypokalemia is often associated with a lengthened Q-T interval, widening, flattening, or inversion of the T wave, and prominent U waves. Also, cardiac arrhythmias may occur, such as premature atrial, nodal, and ventricular contractions, and supraventricular and ventricular tachycardias. The toxic effects of digitalis are likely to be exaggerated. Marked hypokalemia can also be manifested by severe muscle weakness, at times extending into frank paralysis.

Electrolyte Disturbances:

Like all cation-exchange resins, Kionex®Sodium Polystyrene Sulfonate is not totally selective (for potassium) in its actions, and small amounts of other cations such as magnesium and calcium can also be lost during treatment. Accordingly, patients receiving Kionex®should be monitored for all applicable electrolyte disturbances.

Systemic Alkalosis:

Systemic alkalosis has been reported after cation-exchange resins were administered orally in combination with nonabsorbable cation-donating antacids and laxatives such as magnesium hydroxide and aluminum carbonate. Magnesium hydroxide should not be administered with Kionex®. One case of grand mal seizure has been reported in a patient with chronic hypocalcemia of renal failure who was given sodium polystyrene sulfonate with magnesium hydroxide as laxative. (SeePRECAUTIONS, Drug Interactions.)

Precautions

Caution is advised when Kionex®is administered to patients who cannot tolerate even a small increase in sodium loads (i.e., severe congestive heart failure, severe hypertension, or marked edema). In such instances compensatory restriction of sodium intake from other sources may be indicated.

In the event of clinically significant constipation, treatment with Kionex®should be discontinued until normal bowel motion is resumed. Magnesium-containing laxatives or sorbitol should not be used (seePRECAUTIONS, Drug Interactions).

The patient should be positioned carefully when ingesting the resin, in order to avoid aspiration, which may lead to bronchopulmonary complications.

Drug Interactions

Antacids:

The simultaneous oral administration of Kionex®with nonabsorbable cation-donating antacids and laxatives may reduce the resin's potassium exchange capability.

Non-absorbable cation-donating antacids and laxatives:

Systemic alkalosis has been reported after cation-exchange resins were administered orally in combination with nonabsorbable cation-donating antacids and laxatives such as magnesium hydroxide and aluminum carbonate. Magnesium hydroxide should not be administered with Kionex®. One case of grand mal seizure has been reported in a patient with chronic hypocalcemia of renal failure who was given sodium polystyrene sulfonate with magnesium hydroxide as a laxative.

Intestinal obstruction due to concretions of aluminum hydroxide when used in combination with sodium polystyrene sulfonate has been reported.

Digitalis:

The toxic effects of digitalis on the heart, especially various ventricular arrhythmias and A-V nodal dissociation, are likely to be exaggerated by hypokalemia, even in the face of serum digoxin concentrations in the "normal range". (SeeWARNINGS.)

Sorbitol:

Concomitant use of sorbitol with sodium polystyrene sulfonate has been implicated in cases of colonic necrosis. Therefore, concomitant administration is not recommended. (SeeWARNINGS.)

Lithium:

Kionex®may decrease absorption of lithium.

Thyroxine:

Kionex®may decrease absorption of thyroxine.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Studies have not been performed.

Pregnancy Category C

Animal reproduction studies have not been conducted with Kionex®(Sodium Polystyrene Sulfonate, USP). It is also not known whether Kionex®can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Kionex®should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Kionex®is administered to a nursing woman.

Pediatric Use:

The effectiveness of Kionex®in pediatric patients has not been established. In neonates, Kionex®should not be given by the oral route. In both children and neonates, particular care should be observed with rectal administration, as excessive dosage or inadequate dilution could result in impaction of the resin.

Due to the risk of digestive hemorrhage or colonic necrosis, particular care should be observed in premature infants or low birth weight infants.

Adverse Reactions

Kionex®Sodium Polystyrene Sulfonate may cause some degree of gastric irritation. Anorexia, nausea, vomiting, and constipation may occur especially if high doses are given. Also, hypokalemia, hypocalcemia, and significant sodium retention, and their related clinical manifestations, may occur (seeWARNINGS). Occasionally diarrhea develops. Large doses in elderly individuals may cause fecal impaction (seePRECAUTIONS). Rare instances of colonic necrosis have been reported. Intestinal obstruction due to concretions of aluminum hydroxide, when used in combination with sodium polystyrene sulfonate, has been reported.

The following events have been reported from worldwide post marketing experience:

• Fecal impaction following rectal administration, particularly in children;


• Gastrointestinal concretions (bezoars) following oral administration;


• Gastrointestinal tract ulceration or necrosis which could lead to intestinal perforation; and,


• Rare cases of acute bronchitis and/or bronchopneumonia associated with inhalation of particles of polystyrene sulfonate.

Overdosage

Biochemical disturbances resulting from overdosage may give rise to clinical signs and symptoms of hypokalemia, including: irritability, confusion, delayed thought processes, muscle weakness, hyporeflexia, which may progress to frank paralysis and/or apnea. Electrocardiographic changes may be consistent with hypokalemia or hypercalcemia; cardiac arrhythmias may occur. Hypocalcemic tetany may occur. Appropriate measures should be taken to correct serum electrolytes (potassium, calcium), and the resin should be removed from the alimentary tract by appropriate use of laxatives or enemas.

Kionex Dosage and Administration

Suspension of this drug should be freshly prepared and not stored beyond 24 hours.

The average daily adult dose of the resin is 15 g to 60 g. This is best provided by administering 15 g (approximately 4levelteaspoons)of Kionex®one to four times daily. One gram of Kionex®contains 4.1 mEq of sodium; one level teaspoon contains approximately 3.5 g of Kionex®and 15 mEq of sodium. (A heaping teaspoon may contain as much as 10 g to 12 g of Kionex®.) Since thein vivoefficiency of sodium-potassium exchange resins is approximately 33 percent, about one third of the resin's actual sodium content is being delivered to the body.

In smaller children and infants, lower doses should be employed by using as a guide a rate of 1 mEq of potassium per gram of resin as the basis for calculation.

Each dose should be given as a suspension in a small quantity of water or, for greater palatability, in syrup. The amount of fluid usually ranges from 20 mL to 100 mL, depending on the dose, or may be simply determined by allowing 3 mL to 4 mL per gram of resin.

The resin may be introduced into the stomach through a plastic tube and, if desired, mixed with a diet appropriate for a patient in renal failure.

The resin may also be given, although with less effective results, in an enema consisting (for adults) of 30 g to 50 g every six hours. Each dose is administered as a warm emulsion (at body temperature) in 100 mL of aqueous vehicle. The emulsion should be agitated gently during administration. The enema should be retained as long as possible and followed by a cleansing enema.

After an initial cleansing enema, a soft, large size (French 28) rubber tube is inserted into the rectum for a distance of about 20 cm, with the tip well into the sigmoid colon, and taped in place. The resin is then suspended in the appropriate amount of aqueous vehicle at body temperature and introduced by gravity, while the particles are kept in suspension by stirring. The suspension is flushed with 50 mL or 100 mL of fluid, following which the tube is clamped and left in place. If back leakage occurs, the hips are elevated on pillows or a knee-chest position is taken temporarily. A somewhat thicker suspension may be used, but care should be taken that no paste is formed, because the latter has a greatly reduced exchange surface and will be particularly ineffective if deposited in the rectal ampulla. The suspension is kept in the sigmoid colon for several hours, if possible. Then, the colon is irrigated with nonsodium containing solution at body temperature in order to remove the resin. Two quarts of flushing solution may be necessary. The returns are drained constantly through a Y tube connection. While the use of sorbitol is not recommended, particular attention should be paid to this cleansing enema if sorbitol has been used.

The intensity and duration of therapy depend upon the severity and resistance of hyperkalemia.

Kionex®should not be heated for to do so may alter the exchange properties of the resin.

How is Kionex Supplied

Kionex®is available as a cream to light brown, finely ground powder in jars of 1 pound.

Store at 20 to 25 C (68 to 77 F) [see USP Controlled Room Temperature]

Kionex®(Sodium Polystyrene Sulfonate, USP) is available as a powder in containers of:

454 grams (One Pound)

NDC 0574-2004-16

Packaged by:

Paddock Laboratories, Inc.

Minneapolis, MN 55427

(02-10)

PRINCIPAL DISPLAY PANEL - 454 gram Bottle Label

NDC 0574-2004-16

Kionex®

Sodium Polystyrene Sulfonate, USP

Rx ONLY

AVERAGE ADULT DOSE:15 g (approximately 4level

teaspoons) one to four times daily in water. See

complete prescribing information.

The effect must be carefully controlled by frequent

serum potassium determinations within each 24

hour period. Sodium content approximately 60 mEq

per 15 g.

Suspension should be freshly prepared and not stored

beyond 24 hours. Dispense in tight, light-resistant

containers as defined in the USP.

STORAGE:Store at 20 to 25 C (68 to 77 F) [see USP

Controlled Room Temperature]

Read package insert.

NET WEIGHT 454 GRAMS (1 LB)

Paddock

Laboratories, Inc.

Kionex  sodium polystyrene sulfonate  powder, for suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0574-2004 Route of Administration ORAL, RECTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM POLYSTYRENE SULFONATE (SODIUM CATION) SODIUM CATION 4.1 meq  in 1 g

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color BROWN (cream to light brown) Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0574-2004-16 454 g In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA040029	02/01/1998

Labeler - Paddock Laboratories, LLC (967694121)

Establishment
Name	Address	ID/FEI	Operations
Paddock Laboratories, LLC		967694121	PACK

Establishment
Name	Address	ID/FEI	Operations
ROHM AND HAAS FRANCE SAS		763647914	API MANUFACTURE

Revised: 01/2012Paddock Laboratories, LLC

ketoconazole Topical

kee-toe-KON-a-zole

Commonly used brand name(s)

In the U.S.

• Extina


• Nizoral


• Nizoral A-D


• Xolegel

In Canada

• Ketoderm

Available Dosage Forms:

• Shampoo


• Foam


• Gel/Jelly


• Solution


• Cream

Therapeutic Class: Antifungal

Chemical Class: Imidazole

Uses For ketoconazole

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

Ketoconazole cream is used to treat:

• Athlete's foot (tinea pedis; ringworm of the foot);


• Ringworm of the body (tinea corporis);


• Ringworm of the groin (tinea cruris; jock itch);


• Seborrheic dermatitis;


• "Sun fungus" (tinea versicolor; pityriasis versicolor); and


• Yeast infection of the skin (cutaneous candidiasis).

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

Ketoconazole 1% shampoo is used to treat dandruff.

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

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

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

Before Using ketoconazole

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

Allergies

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

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ketoconazole topical in children younger than 12 years of age. 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 ketoconazole topical in the elderly. However, some elderly patients may be more sensitive to the side effects of ketoconazole.

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of ketoconazole

It is very important that you use ketoconazole only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

ketoconazole is for use on the skin only. Do not get it in your eyes, nose, mouth, or vagina. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

For patients using the cream:

• Apply enough 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 the cream for the full time of treatment, even if your symptoms begin to clear up after a few days. Since fungus or yeast infections may be very slow to clear up, you may have to continue using ketoconazole every day for up to several weeks. If you stop using ketoconazole too soon, your symptoms may return. Do not miss any doses.

For patients using the foam:

• Wash your hands before and after using ketoconazole.


• Do not spray the foam directly on your hand because it will begin to melt as soon as it touches your skin. Instead, spray the foam into the cap of the medicine can or other cool surface. Then dip your fingertips into the foam to pick up small amounts of the medicine, and apply to the affected skin areas. Gently massage the foam into your skin until it disappears.


• If you are treating skin areas with hair, such as your scalp, move any hair away so the foam can be applied directly to the affected skin.


• ketoconazole is flammable. Do not use it near heat, an open flame, or while smoking. Do not puncture, break, or burn the medicine can.

For patients using the gel:

• Wash your hands before and after using ketoconazole.


• Apply enough ketoconazole gel to cover the affected and surrounding skin areas, and rub in gently with your fingertips.


• After applying ketoconazole, do not wash the affected area for at least 3 hours.


• Cosmetics (makeup or sunscreens) may be used on the treated skin areas no sooner than 20 minutes after ketoconazole is applied.


• ketoconazole may be flammable. Do not use it near heat, an open flame, or while smoking.

For patients using the 1% shampoo:

• 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:

• Wet your hair and scalp well with water.


• Apply the shampoo to the skin of the affected area and a wide margin surrounding this area.


• Work up a good lather and leave it in place for 5 minutes.


• Rinse your hair and scalp well with warm water, and dry your hair.

Dosing

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

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

• For cream dosage form:
  
  • For cutaneous candidiasis, tinea corporis, tinea cruris, tinea pedis, or pityriasis versicolor:
    
    • Adults—Apply to the affected area of the skin and the surrounding area once a day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For seborrheic dermatitis:
    
    • Adults—Apply to the affected area of the skin and the surrounding area two times per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  


• For foam dosage form:
  
  • For seborrheic dermatitis:
    
    • Adults—Apply to the affected area of the skin and the surrounding area two times per day for 4 weeks.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  


• For gel dosage form:
  
  • For seborrheic dermatitis:
    
    • Adults, teenagers, and children 12 years of age and older—Apply to the affected area of the skin and the surrounding area once a day for 2 weeks.
    
    
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.
    
    
  
  


• For 1% shampoo dosage form:
  
  • For dandruff:
    
    • Adults—Use every 3 or 4 days for up to 8 weeks. Then use only as needed to keep dandruff under control.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  


• For 2% shampoo dosage form:
  
  • For pityriasis versicolor:
    
    • Adults—Use once.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of ketoconazole, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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

Precautions While Using ketoconazole

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

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

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

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

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

• Avoid wearing socks made from wool or synthetic materials (e.g., rayon or nylon). Instead, wear clean, cotton socks and change them daily or more often if your feet sweat a lot.


• Wear sandals or well-ventilated shoes (e.g., shoes with holes).


• Use a bland, absorbent powder (e.g., talcum powder) or an antifungal powder between the toes, on the feet, and in socks and shoes one or two times a day. It is best to use the powder between the times you use the cream.


• If you have any questions about these instructions, check with your doctor.

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

• Avoid wearing underwear that is tight-fitting or made from synthetic materials (e.g., rayon or nylon). Instead, wear loose-fitting, cotton underwear.


• Use a bland, absorbent powder (e.g., talcum powder) or an antifungal powder on the skin. It is best to use the powder between the times you use ketoconazole cream.


• If you have any questions about these instructions, check with your doctor.

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

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

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

Stop using ketoconazole and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.

ketoconazole Side Effects

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

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

Less common—For cream, shampoo, foam, or gel

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

Rare—For cream, foam, or gel

• Acne


• bleeding from sore in the mouth


• blistering, crusting, irritation, itching, or reddening of the skin


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• cracked, dry, or scaly skin


• 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 gel

• Pain

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.

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More ketoconazole Topical resources

• Ketoconazole Topical Use in Pregnancy & Breastfeeding
• Ketoconazole Topical Support Group
• 10 Reviews for Ketoconazole Topical - Add your own review/rating

• Extina Foam MedFacts Consumer Leaflet (Wolters Kluwer)


• Extina Prescribing Information (FDA)


• Extina Consumer Overview


• Kuric Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Nizoral A-D Shampoo MedFacts Consumer Leaflet (Wolters Kluwer)


• Xolegel Prescribing Information (FDA)


• Xolegel Gel MedFacts Consumer Leaflet (Wolters Kluwer)


• Xolegel Consumer Overview

Compare ketoconazole Topical with other medications

• Cutaneous Candidiasis
• Dandruff
• Seborrheic Dermatitis
• Tinea Corporis
• Tinea Cruris
• Tinea Pedis
• Tinea Versicolor

Oxapen

Oxapen may be available in the countries listed below.

Ingredient matches for Oxapen

Oxacillin

Oxacillin is reported as an ingredient of Oxapen in the following countries:

• Tunisia

International Drug Name Search

Macmiror

Macmiror may be available in the countries listed below.

Ingredient matches for Macmiror

Nifuratel

Nifuratel is reported as an ingredient of Macmiror in the following countries:

• Bulgaria


• Czech Republic


• Georgia


• Hong Kong


• Italy


• Lithuania


• Mexico


• Poland


• Romania


• Russian Federation


• Slovakia


• Taiwan

Nystatin

Nystatin is reported as an ingredient of Macmiror in the following countries:

• Slovakia

International Drug Name Search

Nicergoline

In some countries, this medicine may only be approved for veterinary use.

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

C04AE02

CAS registry number (Chemical Abstracts Service)

0027848-84-6

Chemical Formula

C24-H26-Br-N3-O3

Molecular Weight

484

Therapeutic Category

Vasodilator

Chemical Name

Ergoline-8-methanol, 10-methoxy-1,6-dimethyl-, 5-bromo-3-pyridinecarboxylate (ester), (8ß)-

Foreign Names

• Nicergolinum (Latin)
• Nicergolin (German)
• Nicergoline (French)
• Nicergolina (Spanish)

Generic Names

• Nicergolina (OS: DCIT)
• Nicergoline (OS: JAN, DCF, USAN, BAN)
• FI 6714 (IS)
• MNE (IS)
• Nicergoline (PH: BP 2010, Ph. Franç. Xe édit, Ph. Eur. 6)
• Nicergolinum (PH: Ph. Eur. 6)

Brand Names

• Adavin
  Lek, Bosnia & Herzegowina; Lek, Poland



• Albotyl
  Help, Greece



• Bieluzon S
  Yoshindo, Japan



• Celgotin S
  Towa Yakuhin, Japan



• Cereid S
  Kyorin Rimedio, Japan



• Cergodun
  Duncan, Argentina



• Circulat
  Polpharma, Poland; Polpharma, Vietnam



• Dasovas
  Pfizer, Peru



• Ergobel
  Kwizda, Germany



• Ergotop
  Ivax, Czech Republic; Kwizda, Austria; Kwizda, Hungary



• Fitergol (veterinary use)
  Merial, Austria; Merial, France; Merial, United Kingdom; Merial, Italy; Merial, Netherlands; Merial, Norway; Merial Australia, Australia; Merial Portuguesa Lda, Portugal



• Hirubulin
  N Nichi-Iko PharmaceuticalJMA, Japan



• Lestmart N
  Taiyo Pharmaceutical, Japan



• Lexilin
  Rotam Reddy, China



• Marileon N
  Taisho Yakuhin, Japan



• Marion
  Li Ta, Taiwan



• Nicergin
  Rösch & Handel, Austria



• Nicergobeta
  Betapharm, Germany



• Nicergolin
  Filofarm, Poland



• Nicergolina Angenerico
  Angenerico, Italy



• Nicergolina L.CH.
  Chile, Chile



• Nicergolina LPH
  Labormed Pharma, Romania



• Nicergolina Ratiopharm
  Ratiopharm, Italy



• Nicergolina Sandoz
  Sandoz, Italy



• Nicergolin-CT
  CT Arzneimittel, Germany



• Nicergoline Biogaran
  Biogaran, France



• Nicergoline EG
  EG Labo, France



• Nicergoline Mylan
  Mylan, France



• Nicergoline Qualimed
  Qualimed, France



• Nicergoline RPG
  RPG, France



• Nicergoline Teva
  Teva Santé, France



• Nicergolin-neuraxpharm
  Neuraxpharm, Germany



• Nicerin
  Biovena, Poland



• Nicerium
  Hexal, Germany; Hexal, Luxembourg; Hexal, Romania; Sandoz, Lithuania; Sandoz, Latvia



• Nilogrin
  Polfa, Romania; Polfa Pabianice, Poland; PZF Polfa, Vietnam



• Salumosin
  Nipro PharmaNipurofama, Japan



• Sawachion
  Sawai Seiyaku, Japan



• Selphamin
  Tatsumi Kagaku, Japan



• Sergolin
  United Pharmaceutical, United Arab Emirates; United Pharmaceutical, Bahrain; United Pharmaceutical, Iraq; United Pharmaceutical, Libya; United Pharmaceutical, Qatar; United Pharmaceutical, Saudi Arabia; United Pharmaceutical, Sudan; United Pharmaceutical, Yemen



• Sermion
  Actavis, Bulgaria; Carlo Erba, Turkey; Pfizer, Argentina; Pfizer, Austria; Pfizer, Bulgaria; Pfizer, Brazil; Pfizer, Chile; Pfizer, China; Pfizer, Costa Rica; Pfizer, Czech Republic; Pfizer, Spain; Pfizer, Georgia; Pfizer, Guatemala; Pfizer, Hong Kong; Pfizer, Honduras; Pfizer, Hungary; Pfizer, Lithuania; Pfizer, Latvia; Pfizer, Myanmar; Pfizer, Mexico; Pfizer, Nicaragua; Pfizer, Panama; Pfizer, Philippines; Pfizer, Poland; Pfizer, Portugal; Pfizer, Russian Federation; Pfizer, El Salvador; Pfizer, Thailand; Pfizer, Taiwan; Pfizer, Venezuela; Pharmacia, Ghana; Pharmacia, Greece; Pharmacia, Kenya; Pharmacia, Liberia; Pharmacia, Poland; Pharmacia, Romania; Pharmacia, Serbia; Pharmacia, Sierra Leone; Pharmacia, Tanzania; Pharmacia, Uganda; Pharmacia, Zimbabwe; Pharmacia Upjohn, Oman; Programmi Sanitari, Italy; Sanofi-Aventis, France; Tanabe Mitsubishi, Japan



• Serolin
  Kalbe, Indonesia



• Sinergolin
  Sintofarm, Romania



• Socwarl
  NNisshin Seiyaku - Yamagata, Japan



• Varson
  Almirall, Spain



• Vasogoline S
  Kyowa Yakuhin, Japan



• Wincl N
  Ohara Yakuhin, Japan

International Drug Name Search

Glossary

BAN	British Approved Name
DCF	Dénomination Commune Française
DCIT	Denominazione Comune Italiana
IS	Inofficial Synonym
JAN	Japanese Accepted Name
OS	Official Synonym
PH	Pharmacopoeia Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.