Earsol-HC

Otic corticosteroids are available only with your doctor`s prescription.

This product is available in the following dosage forms:

• Oil


• Solution

Before Using

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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

There is no specific information about the use of otic corticosteroids in children. Children born to mothers taking otic corticosteroid therapy during their pregnancy should be observed for decrease in growth and for hypoadrenalism (anorexia, low blood pressure, and weakness).

Geriatric

Although there is no specific information about the use of otic corticosteroids in the elderly, they are not expected to cause different side effects or problems in older people than they do in younger adults.

Pregnancy

Studies with otic corticosteroids have not been done in pregnant women. However, in animal studies, corticosteroids have been shown to cause birth defects. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant .

Breastfeeding

Corticosteroids pass into breast milk. Be sure you have discussed the risks to the child and benefits of the medicine with your doctor .

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.

Other Medical Problems

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Type 2 diabetes mellitus or


• Epilepsya€”Using otic corticosteroids may worsen this condition.

• Fungal infections or


• Tuberculosis or


• Viral infections or


• Otitis media, chronic or


• Any other ear infection or condition (or history of)a€”Otic corticosteroids may worsen existing infections or cause new infections.

• Glaucoma or


• High blood pressurea€”Otic corticosteroids may increase the pressure in the blood vessels of the eye and throughout the body .

• Heart diseasea€”Irregular heartbeat and change in blood pressure are more likely to occur.

• Osteoporosisa€”Otic corticosteroids increase the risk of bone fractures.

• Punctured ear druma€”Using otic corticosteroids with a punctured ear drum may damage the ear.

Proper Use

To use ear drops:

• Lie down or tilt the head so that the affected ear faces up. Gently pull the earlobe up and back for adults (down and back for children) to straighten the ear canal. Drop the medicine into the ear canal. Keep the ear facing up for several (about 5) minutes to allow the medicine to run to the bottom of the ear canal. A sterile cotton plug may be gently inserted into the ear opening to prevent the medicine from leaking out. At first, your doctor may want you to put more medicine on the cotton plug during the day to keep it moist.

To keep the medicine as germ-free as possible, do not touch the dropper or applicator tip to any surface (including the ear). Also, keep the container tightly closed.

Do not use corticosteroids more often or for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Do not use any leftover medicine for future ear problems without first checking with your doctor . This medicine should not be used if certain kinds of infections are present. To do so may make the infection worse.

Dosing

The dose medicines in this class 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 these medicines. 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 betamethasone

• For redness, itching, and swelling:
  
  
  
  • Adults and childrena€”Use two or three drops in the ear every two or three hours. After symptoms are relieved, your doctor may lower the dose .
  
  
  
  

For dexamethasone

• For redness, itching, and swelling:
  
  
  
  • Adults and childrena€”Use three or four drops in the ear two or three times a day. After symptoms are relieved, your doctor may lower the dose .
  
  
  
  

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

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions

If your condition does not improve within 5 to 7 days, or if it becomes worse, check with your doctor .

While you are being treated with otic corticosteroids, and after you stop treatment, do not have any immunizations (vaccinations) without your doctor`s approval. Otic corticosteroids may lower your body`s resistance and there is a chance you might get the infection the immunization is trying to prevent. In addition, other persons living in your household should not take or have recently taken oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid other persons who have taken oral polio vaccine . Do not get close to them, and do not stay in the same room with them for very long . If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth .

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:

Less common

• Anorexia


• Black or tarry stools


• Bone fractures


• Breathing difficulties


• Burning or stinging of the ear


• Chest pain


• Continual stomach pain or burning


• Decreased or blurred vision


• Excess hair growth in females


• Fainting


• Flushing


• Frequent urination


• Headache


• High blood pressure


• Impaired wound healing


• Impotence in males


• Increased sweating


• Increased thirst


• Irregular heartbeat


• Low blood pressure


• Menstrual changes


• Muscle cramps


• Muscle wasting


• Nausea or vomiting


• Persistent fungal infections of the ear


• Rapid weight gain


• Seizures


• Stomach bloating


• Suppressed growth in children


• Suppressed reaction to skin tests


• Swelling of feet or lower legs


• Thin fragile skin


• Tingling in arms and lower legs or feet


• Vertigo


• Weight loss

There have not been any other common or important side effects reported with this medicine.

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.