Lotrisone

DRUG DESCRIPTION

LOTRISONE® (clotrimazole and betamethasone) Cream and Lotion contain combinations of clotrimazole, a synthetic antifungal agent, and betamethasone dipropionate, a synthetic corticosteroid, for dermatologic use.

Chemically, clotrimazole is 1–(o-chloro-?,?-diphenylbenzyl) imidazole, with the empirical formula C22H17CIN2, a molecular weight of 344.84, and the following structural formula:

Clotrimazole Structural Formula Illustration

Clotrimazole is an odorless, white crystalline powder, insoluble in water and soluble in ethanol.

Betamethasone dipropionate has the chemical name 9-fluoro-11?,17,21-trihydroxy-16?-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.59, and the following structural formula:

Betamethasone dipropionate is a white to creamy white, odorless crystalline powder, insoluble in water.

Each gram of LOTRISONE (clotrimazole and betamethasone) Cream contains 10 mg clotrimazole and 0.643 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone), in a hydrophilic cream consisting of purified water, mineral oil, white petrolatum, cetyl alcohol plus stearyl alcohol, ceteareth-30, propylene glycol, sodium phosphate monobasic monohydrate, and phosphoric acid; benzyl alcohol as preservative.

LOTRISONE (clotrimazole and betamethasone) Cream may contain sodium hydroxide. LOTRISONE (clotrimazole and betamethasone) Cream is smooth, uniform, and white to off-white in color.

Each gram of LOTRISONE (clotrimazole and betamethasone) Lotion contains 10 mg clotrimazole and 0.643 mg betamethasone dipropionate (equivalent to 0.5 mg betamethasone), in a hydrophilic base of purified water, mineral oil, white petrolatum, cetyl alcohol plus stearyl alcohol, ceteareth-30, propylene glycol, sodium phosphate monobasic monohydrate, and phosphoric acid; benzyl alcohol as a preservative.

LOTRISONE (clotrimazole and betamethasone) Lotion may contain sodium hydroxide. LOTRISONE (clotrimazole and betamethasone) Lotion is opaque and white in color.

What are the possible side effects of betamethasone and clotrimazole topical (Lotrisone)?

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 this medication and call your doctor at once if you have any of these signs that you may be absorbing betamethasone topical through your skin or gums:

  • swelling, redness, or any signs of new infection;
  • severe burning or stinging of treated skin;
  • weight gain, rounding of the face;
  • increased thirst...

Read All Potential Side Effects and See Pictures of Lotrisone »

What are the precautions when taking clotrimazole and betamethasone (Lotrisone)?

Before using this medication, tell your doctor or pharmacist if you are allergic to clotrimazole or betamethasone; or to other azole antifungals (e.g., ketoconazole) or corticosteroids (e.g., triamcinolone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: immune system problems, poor blood circulation.

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially thinning skin.

Rarely, using corticosteroid medications for a long time or over large areas of skin can make it...

Read All Potential Precautions of Lotrisone »


Lotrisone Consumer (continued)

SIDE EFFECTS: Burning, tingling, dry skin, or stinging may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: extreme hair growth, skin thinning/discoloration, acne, stretch marks, "hair bumps" (folliculitis).

Rarely, it is possible this medication will be absorbed from the skin into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children, and in people who use this medication for a long time or over large areas of the skin. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to clotrimazole or betamethasone; or to other azole antifungals (e.g., ketoconazole) or corticosteroids (e.g., triamcinolone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: immune system problems, poor blood circulation.

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially thinning skin.

Rarely, using corticosteroid medications for a long time or over large areas of skin can make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months.

Though it is unlikely, this medication may slow down a child's growth if used for a long time. The effect on final adult height is unknown. See the doctor regularly so your child's height can be checked.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk when applied to the skin. Similar medications pass into breast milk when taken by mouth. Consult your doctor before breast-feeding.


Lotrisone Patient Information Including Side Effects

Brand Names: Lotrisone

Generic Name: betamethasone and clotrimazole topical (Pronunciation: bay ta METH a sone and kloe TRIM a zole)

  • What is betamethasone and clotrimazole topical (Lotrisone)?
  • What are the possible side effects of betamethasone and clotrimazole topical (Lotrisone)?
  • What is the most important information I should know about betamethasone and clotrimazole topical (Lotrisone)?
  • What should I discuss with my healthcare provider before using betamethasone and clotrimazole topical (Lotrisone)?
  • How should I use betamethasone and clotrimazole topical (Lotrisone)?
  • What happens if I miss a dose (Lotrisone)?
  • What happens if I overdose (Lotrisone)?
  • What should I avoid while using betamethasone and clotrimazole topical (Lotrisone)?
  • What other drugs will affect betamethasone and clotrimazole topical (Lotrisone)?
  • Where can I get more information?

What is betamethasone and clotrimazole topical (Lotrisone)?

Clotrimazole is an antifungal antibiotic that treats or prevents infection caused by fungus.

Betamethasone is a topical steroid that reduces itching, swelling, and redness of the skin.

The combination of betamethasone and clotrimazole topical is used to treat fungal skin infections such as athlete's foot, jock itch, and ringworm.

Betamethasone and clotrimazole topical may also be used for other purposes not listed in this medication guide.

What are the possible side effects of betamethasone and clotrimazole topical (Lotrisone)?

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 this medication and call your doctor at once if you have any of these signs that you may be absorbing betamethasone topical through your skin or gums:

  • swelling, redness, or any signs of new infection;
  • severe burning or stinging of treated skin;
  • weight gain, rounding of the face;
  • increased thirst or hunger, urinating more than usual; or
  • anxiety, depressed mood.

Less serious side effects may include:

  • mild skin itching or irritation;
  • dry skin;
  • changes in skin color;
  • increased acne; or
  • scarring or thinning of the skin.

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.

What is the most important information I should know about betamethasone and clotrimazole topical (Lotrisone)?

Do not cover treated skin areas with a bandage or tight clothing, unless your doctor has told you to.

Do not use this medication on a child younger than 17 years old. Children are more likely to absorb the steroid through the skin. Never use betamethasone and clotrimazole to treat diaper rash.

It may take up to 1 or 2 weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your groin symptoms do not improve after 1 week, or if your foot symptoms do not improve after 2 weeks of treatment.

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