Pronunciation:

hye-droe-KOR-ti-sone AS-e-tate, eye-oh-doe-KWIN-ol

Brand Names:

• Vytone

Dosage Forms:

• Cream

Classifications:

Therapeutic—

Anti-Infective/Anti-Inflammatory Combination

Pharmacologic—

Hydrocortisone

Chemical—

Halogenated Hydroxyquinoline

Uses of This Medicine:

Hydrocortisone and iodoquinol is a combined anti-infective and cortisone-like medicine. Hydrocortisone and iodoquinol topical cream is used to treat infections of the skin and to help provide relief from the redness, itching, and discomfort of many skin problems.

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

Before Using This Medicine:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of hydrocortisone and iodoquinol topical cream in children younger than 12 years of age. Safety and efficacy have not been established.

Older adults—

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

Other 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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

• Desmopressin
• Rotavirus Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Aldesleukin
• Aspirin
• Atazanavir
• Balofloxacin
• Bemiparin
• Besifloxacin
• Bupropion
• Carbamazepine
• Ciprofloxacin
• Clarithromycin
• Cobicistat
• Conivaptan
• Cosyntropin
• Darunavir
• Enoxacin
• Fedratinib
• Fexinidazole
• Fleroxacin
• Flumequine
• Fosnetupitant
• Gatifloxacin
• Gemifloxacin
• Itraconazole
• Lenacapavir
• Levofloxacin
• Lomefloxacin
• Lutetium Lu 177 Dotatate
• Macimorelin
• Mavacamten
• Moxifloxacin
• Nadifloxacin
• Nadroparin
• Netupitant
• Norfloxacin
• Ofloxacin
• Omaveloxolone
• Pazufloxacin
• Pefloxacin
• Phenobarbital
• Primidone
• Prulifloxacin
• Rufloxacin
• Sargramostim
• Somatrogon-ghla
• Sparfloxacin
• Tosufloxacin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alcuronium
• Atracurium
• Auranofin
• Colestipol
• Gallamine
• Hexafluorenium
• Licorice
• Metocurine
• Rifapentine
• Saiboku-To

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. 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:

• 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 This Medicine:

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, nose, lips, 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.

To help clear up your skin problem completely, it is very important that you keep using this medicine for the full time of treatment.

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.
• Do not bandage or otherwise wrap the area of the skin being treated unless directed to do so by 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 topical dosage form (cream):
  • For bacterial and fungus infections:
    • Adults and children 12 years of age and older—Apply to the affected area of the skin three to four times a day.
    • Children younger than 12 years of age—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 This Medicine:

It is very important that your doctor check the progress of you or your child 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 weeks, or if they becomes worse, check with your doctor.

This medicine may stain your skin, hair, or clothes. Talk to your doctor if you have concerns about this.

Avoid using tight-fitting diapers or plastic pants on a child if this medicine is being used on the child's diaper area. Plastic pants and tight-fitting diapers may increase the chance of absorption of the medicine through the skin and the chance of side effects.

Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.

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

Side Effects of This Medicine:

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

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

Incidence not known

Blistering, burning, crusting, dryness, flaking, scaling, severe redness, soreness, or swelling of the skin

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

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

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

redness and scaling around the mouth

softening of the skin

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

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

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

lightening of normal skin color

lightening of the treated areas of dark 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.