A/T/S

Erythromycin topical preparations are used on the skin to help control acne . They may be used alone or with one or more other medicines that are applied to the skin or taken by mouth for acne . They may also be used for other problems, such as skin infections, as determined by your doctor .

Erythromycin is available only with your doctor`s prescription.

This product is available in the following dosage forms:

• Pad


• Gel/Jelly


• Ointment


• Solution


• Swab


• Lotion

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

Erythromycin topical solution has been tested in children 12 years of age and older and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people . Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of topical erythromycin in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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.

Proper Use

Before applying this medicine, thoroughly wash the affected area with warm water and soap, rinse well, and pat dry. After washing or shaving, it is best to wait 30 minutes before applying the pledget (swab), topical gel, or topical liquid form . The alcohol in them may irritate freshly washed or shaved skin .

For patients using the pledget (swab), topical gel, or topical liquid form of erythromycin:

• These forms contain alcohol and are flammable. Do not use near heat, near open flame, or while smoking.


• It is important that you do not use this medicine more often than your doctor ordered. It may cause your skin to become too dry or irritated.


• Also, you should avoid washing the acne-affected areas too often. This may dry your skin and make your acne worse. Washing with a mild, bland soap 2 or 3 times a day should be enough, unless you have oily skin . If you have any questions about this, check with your doctor .


• To use:
  
  
  
  • The topical liquid form of this medicine may come in a bottle with an applicator tip, which may be used to apply the medicine directly to the skin . Use the applicator with a dabbing motion instead of a rolling motion (not like a roll-on deodorant, for example). If the medicine does not come in an applicator bottle, you may moisten a pad with the medicine and then rub the pad over the whole affected area. Or you may also apply this medicine with your fingertips. Be sure to wash the medicine off your hands afterward.
  
  
  • Apply a thin film of medicine, using enough to cover the affected area lightly. You should apply the medicine to the whole area usually affected by acne, not just to the pimples themselves. This will help keep new pimples from breaking out.
  
  
  • The pledget (swab) form should be rubbed over the whole affected area. You may use extra pledgets (swabs), if needed, to cover larger areas.
  
  
  • Since these medicines contain alcohol, they may sting or burn. Therefore, do not get these medicines in the eyes, nose, mouth, or on other mucous membranes. Spread the medicine away from these areas when applying. If these medicines do get in the eyes, wash them out immediately, but carefully, with large amounts of cool tap water . If your eyes still burn or are painful, check with your doctor .
  
  
  
  

This medicine will not cure your acne . However, to help keep your acne under control, keep using this medicine for the full time of treatment, even if your symptoms begin to clear up after a few days. You may have to continue using this medicine every day for months or even longer in some cases. If you stop using this medicine too soon, your symptoms may return. It is important that you do not miss any doses.

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 acne:
  
  
  
  • For gel dosage form:
    
    
    
    • Adultsa€”Apply to the affected area(s) of the skin two times a day, morning and evening.
    
    
    • Childrena€”Dose must be determined by your doctor .
    
    
    
    
  
  
  • For ointment dosage form:
    
    
    
    • Adults, teenagers, and childrena€”Apply to the affected area(s) of the skin two times a day, morning and evening.
    
    
    
    
  
  
  • For pledgets dosage form:
    
    
    
    • Adults, teenagers, and childrena€”Apply to the affected area(s) of the skin two times a day.
    
    
    
    
  
  
  • For topical solution dosage form:
    
    
    
    • Adults, teenagers, and children 12 years of age and overa€”Apply to the affected area(s) of the skin two times a day, morning and evening.
    
    
    • Children up to 12 years of agea€”Dose must be determined by your doctor .
    
    
    
    
  
  
  
  

Missed Dose

If you miss a dose of this medicine, take 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. Do not double doses.

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.

Precautions

If your acne does not improve within 3 to 4 weeks, or if it becomes worse, check with your health care professional . However, treatment of acne may take up to 8 to 12 weeks before you see full improvement.

For patients using the pledget (swab), topical gel, or topical liquid form of erythromycin:

• If your doctor has ordered another medicine to be applied to the skin along with this medicine, it is best to wait at least 1 hour before you apply the second medicine. This may help keep your skin from becoming too irritated. Also, if the medicines are used too close together, they may not work properly.


• After application of this medicine to the skin, mild stinging or burning may be expected and may last up to a few minutes or more.


• This medicine may also cause the skin to become unusually dry, even with normal use. If this occurs, check with your doctor .


• You may continue to use cosmetics (make-up) while you are using this medicine for acne . However, it is best to use only ``water-base`` cosmetics. Also, it is best not to use cosmetics too heavily or too often. They may make your acne worse. If you have any questions about this, check with your doctor .

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 .

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:

For erythromycin ointmentLess common

• Peeling


• Redness

For erythromycin pledget (swab), topical gel, or topical liquid form More common

• Dry or scaly skin


• Irritation


• Itching


• Stinging or burning feeling

Less common

• Peeling


• Redness

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.