Betnesol Otic

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|Betnesol Otic

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CORTICOSTEROIDS (Otic)

Some commonly used brand names are:

In the U.S.—

  • Decadron 2

In Canada—

  • Betnesol 1
  • Decadron 2

Note:

For quick reference, the following corticosteroids are numbered to match the corresponding brand names.

This information applies to the following medicines:
1. Betamethasone (bay-ta-METH-a-sone)*
2. Dexamethasone (dex-a-METH-a-sone)
* Not commercially available in the U.S.
‡ Generic name product may be available in the U.S.

Category

  • Corticosteroids, otic—Betamethasone; Dexamethasone
  • Anti-inflammatory, steroidal, otic—Betamethasone; Dexamethasone

Description

Otic corticosteroids (kor-ti-koe-STE-roids) (cortisone-like medicines) are used in the ear to relieve the redness, itching, and swelling caused by certain ear problems.

Otic corticosteroids are available only with your doctor"s prescription, in the following dosage forms:

  • Otic
  • Betamethasone
    • Solution (Canada)
  • Dexamethasone
    • Solution (U.S. and Canada)

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 otic corticosteroids, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to corticosteroids. Also tell your health care professional if you are allergic to any other substances, such as certain preservatives or dyes.

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.

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

Children—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).

Older adults—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.

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 may occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking otic corticosteroids, it is especially important that your doctor and pharmacist know if you are taking the following:

  • Phenytoin (e.g., Dilantin)

Other medical problems—The presence of other medical problems may affect the use of otic corticosteroids. Make sure you tell your doctor if you have any other medical problems, especially:

  • Type 2 diabetes mellitus or
  • Epilepsy—Using otic corticosteroids may worsen this condition
  • Heart disease—Irregular heartbeat and change in blood pressure are more likely to occur
  • Glaucoma or
  • High blood pressure—Otic corticosteroids may increase the pressure in the blood vessels of the eye and throughout the body
  • Osteoporosis—Otic corticosteroids increase the risk of bone fractures
  • Fungal infections or
  • Tuberculosis or
  • Viral infections or
  • Otitis media, chronic or
  • Any other ear infection or condition (or history of)—Otic corticosteroids may worsen existing infections or cause new infections
  • Punctured ear drum—Using otic corticosteroids with a punctured ear drum may damage the ear

Proper Use of This Medicine

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 of otic corticosteroids 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 otic corticosteroids. If your dose is different, do not change it unless your doctor tells you to do so.

  • For betamethasone
  • For redness, itching, and swelling:
    • Adults and children—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 children—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, use it as soon as you remember. 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—To store this medicine:

  • Keep out of the reach of children.
  • Store away from heat and direct light.
  • Keep the medicine from freezing.
  • Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

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 of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. The following side effects usually do not need medical attention and may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

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. However, if you notice any unusual effects, check with your doctor.

Revised: 08/21/2000

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