Pronunciation:

kloe-TRIM-a-zole, bay-ta-METH-a-sone dye-PROE-pee-oh-nate

Brand Names:

• Lotrisone
• Lotriderm
• Pms-Clotrimazole And Betamethasone

Dosage Forms:

• Cream
• Lotion

Classifications:

Therapeutic—

Anti-Infective/Anti-Inflammatory Combination

Pharmacologic—

Betamethasone

Chemical—

Imidazole

Uses of This Medicine:

Clotrimazole and betamethasone topical combination is used to treat fungus infections. Clotrimazole works by killing the fungus or preventing its growth. Betamethasone, a corticosteroid (cortisone-like medicine or steroid), is used to help relieve redness, swelling, itching, and other discomfort of fungus infections.

Clotrimazole and betamethasone topical cream or lotion is applied to the skin to treat:

• Ringworm of the foot (tinea pedis or athlete's foot),
• Ringworm of the groin (tinea cruris or jock itch), and
• Ringworm of the body (tinea corporis).

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—

Use of clotrimazole and betamethasone topical combination cream is not recommended in children younger than 17 years of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of clotrimazole and betamethasone topical combination in the elderly. However, elderly patients are more likely to have a thinning skin or skin ulcers, which may require caution in patients receiving clotrimazole and betamethasone topical combination.

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

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.

• Aldesleukin
• Aspirin
• Atazanavir
• Balofloxacin
• Bedaquiline
• Bemiparin
• Besifloxacin
• Bupropion
• Carbamazepine
• Ciprofloxacin
• Cobicistat
• Colchicine
• Cosyntropin
• Darunavir
• Desogestrel
• Dienogest
• Dihydroergotamine
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Drospirenone
• Enoxacin
• Ergoloid Mesylates
• Ergonovine
• Ergotamine
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Fleroxacin
• Flumequine
• Gatifloxacin
• Gemifloxacin
• Gestodene
• Levofloxacin
• Levonorgestrel
• Lisuride
• Lomefloxacin
• Lutetium Lu 177 Dotatate
• Macimorelin
• Meperidine
• Mestranol
• Metergoline
• Methylergonovine
• Methysergide
• Moxifloxacin
• Nadifloxacin
• Nadroparin
• Nicergoline
• Nirmatrelvir
• Nomegestrol
• Norethindrone
• Norfloxacin
• Norgestimate
• Norgestrel
• Ofloxacin
• Paclitaxel
• Paclitaxel Protein-Bound
• Pazufloxacin
• Pefloxacin
• Prulifloxacin
• Ritonavir
• Rufloxacin
• Sargramostim
• Somatrogon-ghla
• Sparfloxacin
• Tacrolimus
• Tosufloxacin
• Upadacitinib

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
• Fosphenytoin
• Gallamine
• Hexafluorenium
• Licorice
• Metocurine
• Phenobarbital
• Phenytoin
• Primidone
• Rifampin
• Rifapentine
• Saiboku-To
• Trimetrexate

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:

• Bacteria infections of the skin or
• Skin diseases causing impaired circulation (eg, stasis dermatitis) or
• Tuberculosis (TB) of the skin—Betamethasone may make these condition worse.

• Cataracts or
• Cushing's syndrome (adrenal gland disorder) or
• Diabetes or
• Glaucoma or
• Hyperglycemia (high blood sugar) or
• Intracranial hypertension (increased pressure in the head)—Use with caution. May make these conditions worse.

• Diaper dermatitis (diaper rash)—Use is not recommended in patients with this condition.

• Herpes or
• Vaccinia (cowpox) or
• Varicella (chickenpox) or
• Other virus infections of the skin—Betamethasone may speed up the spread of virus infections.

• 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 or
• Liver failure—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 should come with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This medicine is for use on the skin only. Do not get it into your eyes, nose, mouth, or vagina, or apply it on your face or under your arms.

To help clear up your skin infection completely, it is very important that you keep using this medicine 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 several weeks or more. If you stop using this medicine too soon, your symptoms may return. Do not miss any doses.

To use:

• Wash your hands 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 skin being treated unless directed to do so by your doctor.
• Do not cover, wrap, or wear tight fitting clothes over your treated skin areas unless directed by your doctor. Allow the medicine to dry before putting on your clothes.
• Do not use the cream to treat tinea cruris and tinea corporis for more than 2 weeks, and for tinea pedis for more than 4 weeks unless your doctor has told you to.

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 or lotion):
  • For tinea cruris and tinea corporis:
    • Adults and children 17 years of age and older—Apply to the affected skin area(s) 2 times a day, in the morning and evening, for 1 week.
    • Children younger than 17 years of age—Use is not recommended.
  • For tinea pedis:
    • Adults and children 17 years of age and older—Apply to the affected skin area(s) 2 times a day, in the morning and evening, for 2 weeks.
    • Children younger than 17 years of age—Use is not recommended.

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:

If your skin infection does not improve within 1 week for jock itch or ringworm of the body, and 2 weeks for athlete's foot, or if it becomes 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 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.

Check with your doctor right away if you have a skin rash, burning, stinging, swelling, redness, or irritation on the skin.

Check with your doctor right away if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).

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

To help clear up your skin infection completely and to help make sure it does not return, the following good health habits are important:

• For patients using this medicine for athlete's foot:
  • Carefully dry the feet, especially between the toes, after bathing.
  • Avoid wearing socks made from wool or synthetic materials (eg, rayon or nylon). Instead, wear clean, cotton socks and change them daily or more often if your feet sweat freely.
  • Wear well-ventilated shoes (eg, shoes with holes) or sandals.
  • Use a bland, absorbent powder (eg, talcum powder) or an antifungal powder freely between the toes, on the feet, and in socks and shoes once or twice a day. Be sure to use the powder after clotrimazole and betamethasone combination cream has been applied and has disappeared into the skin. Do not use the powder as the only treatment for your fungus infection.
  These measures will help keep the feet cool and dry.
• For patients using this medicine for jock itch:
  • Carefully dry the groin area after bathing.
  • Avoid wearing underwear that is tight-fitting or made from synthetic materials (eg, rayon or nylon). Instead, wear loose-fitting, cotton underwear.
  • Use a bland, absorbent powder (eg, talcum powder) or an antifungal powder freely once or twice a day. Be sure to use the powder after clotrimazole and betamethasone combination cream has been applied and has disappeared into the skin. Do not use the powder as the only treatment for your fungus infection.
  These measures will help reduce chafing and irritation and will also help keep the groin area cool and dry.
• For patients using this medicine for ringworm of the body:
  • Carefully dry yourself after bathing.
  • Avoid too much heat and humidity if possible. Try to keep moisture from building up on affected areas of the body.
  • Wear well-ventilated clothing.
  • Use a bland, absorbent powder (eg, talcum powder) or an antifungal powder freely once or twice a day. Be sure to use the powder after clotrimazole and betamethasone combination cream has been applied and has disappeared into the skin. Do not use the powder as the only treatment for your fungus infection.
  These measures will help keep the affected areas cool and dry.

If you have any questions about this, check with your doctor.

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:

Less common

Blistering, burning, itching, peeling, dryness, redness, or other signs of skin irritation not present before use of this medicine

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

hives

Rare

Chills

cough

fever

hoarseness

lower back or side pain

painful or difficult urination

rash

stinging

swelling

Incidence not known

Blindness

blurred vision

change in vision

decreased vision

dry mouth

eye pain

full or round face, neck, or trunk

headache

irritability

nausea

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

redness and scaling around the mouth

softening of the skin

stomach pain

tearing

unusual tiredness or weakness

vomiting

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.