Brand Name
US Brand Name
Dermasorb AF Complete Kit
Canadian Brand Name
Vioform Hydrocortisone
Vioform Hydrocortisone Mild
Description
Clioquinol and hydrocortisone is a combined anti-infective and cortisone-like medicine. Clioquinol and hydrocortisone topical preparation 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.
This product is available in the following dosage forms:
- Cream
Before Using
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 clioquinol and hydrocortisone topical cream in children 2 years of age and older. 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. Use of clioquinol and hydrocortisone topical cream is not recommended in infants or in children up to 2 years of age.
Geriatric
No information is available on the relationship of age to the effects of clioquinol and hydrocortisone topical cream in geriatric patients.
Breastfeeding
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.
Drug Interactions
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
- Avacopan
- Balofloxacin
- Bemiparin
- Besifloxacin
- Bupropion
- Carbamazepine
- Ciprofloxacin
- Clarithromycin
- Cobicistat
- Conivaptan
- Cosyntropin
- Darunavir
- Desogestrel
- Dienogest
- Drospirenone
- Enoxacin
- Estradiol
- Ethinyl Estradiol
- Ethynodiol
- Fedratinib
- Fexinidazole
- Fleroxacin
- Flumequine
- Fosnetupitant
- Gatifloxacin
- Gemifloxacin
- Gestodene
- Insulin Aspart, Recombinant
- Itraconazole
- Lenacapavir
- Letermovir
- Levofloxacin
- Levonorgestrel
- Lomefloxacin
- Lutetium Lu 177 Dotatate
- Macimorelin
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
- Mavacamten
- 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:
- 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.
- Infections (eg, herpes simplex, vaccinia, varicella)—Should not be used in patients with these conditions.
- 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
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, 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.
To help clear up your skin problem completely, it is very important that you keep using this medicine for the full time of treatment. Do not miss any doses.
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.
Do not use this medicine on the face, groin, or underarms, or have skin thinning unless directed to do so by your doctor.
To use the cream, lotion, or ointment:
- 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 forms (cream, lotion, or ointment):
- For bacterial and fungus infections:
- Adults and children 2 years of age or older—Apply to the affected area of the skin two to four times a day.
- Children up to 2 years of age—Use is not recommended.
- For bacterial and fungus infections:
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
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 1 to 2 weeks, or if they becomes worse, check with your doctor.
This medicine may stain clothing, skin, hair, and nails yellow. Avoid getting this medicine on your clothing. Bleaching may not remove the stain.
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.
This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.
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.
Do not use cosmetics or other skin care products on the treated skin areas.
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
- 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
- darkening of the skin
- diarrhea
- dizziness
- dryness
- fainting
- fast heartbeat
- fever
- hives, itching, or rash
- hoarseness
- irritation
- itching, scaling, severe redness, soreness, or swelling of the skin
- joint pain, stiffness, or swelling
- loss of appetite
- mental depression
- nausea
- reddish purple lines on the arms, face, legs, trunk, or groin
- redness and scaling around the mouth
- softening of the skin
- swelling of the eyelids, face, lips, hands, or feet
- thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (eg, between the fingers)
- tightness in the chest
- troubled breathing or swallowing
- unusual tiredness or weakness
- vomiting
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.
CON-XXXXXXXX
