Otazem – Fluocinolone Acetonide Uses, Dose, And Side Effects


Otazem 250 micrograms/ml Ear Drops, Fluocinolone acetonide Solution in Single Dose Containers.

What Is Otazem And What Otazem Used For?

Otazem is a solution for use in the ear. It contains fluocinolone acetonide, a corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties. Otazem used for eczema in the ear canal in adults with intact eardrums.

What You Need To Know Before You Use Otazem

Do Not Use Otazem

  • If you are allergic to fluocinolone acetonide or any of the other ingredients of this medicine (listed in section 6).

Warnings And Cautions

  • Avoid getting the medicine in your eye.
  • Talk to your doctor before using Otazem if you have or may have damaged (cracked) eardrum.
  • If, at the start of treatment, you develop urticaria ( hives ), skin rash or other allergic symptoms (eg sudden swelling of the face, neck or eyelids or difficulty breathing), you should stop treatment immediately and consult a doctor. Severe hypersensitivity reactions may require immediate emergency care.
  • If your doctor has also diagnosed you with a bacterial or fungal infection, you must also use the complementary treatment for infection one. Failure to do so may aggravate the infection . To reduce the side effects , use this medicine with the lowest dose and only for as long as your doctor tells you.

Contact a doctor if you experience blurred vision or other visual disturbances.

Children And Young People

The use of fluocinolone acetonide for treating ear canal eczema in children and adolescents has not been studied. Therefore, Otazem can not be recommended for children and adolescents.

Other Medicines And Otazem

Tell your doctor or pharmacist if you are taking, have recently taken, or might take other medicines.

Pregnancy, Breastfeeding And Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Otazem has not been studied in pregnant women with Otazem.

Therefore, this medicine should be used with caution during pregnancy. Caution should be exercised when administering Otazem to a breastfeeding woman, as it is unknown whether fluocinolone acetonide is excreted in human milk.

Driving And Using Machines

Otazem does not affect the ability to drive or use dangerous machines. Otazem contains. Polysorbate 80, glycrol, povidone K90F, lactic acid, sodium hydroxide 1N and water are ingredients.

How To Use Otazem?

  • Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
  • The recommended dose is a single-dose container in the affected ear twice daily for 7 days.
  • Only use this medicine in both ears if your doctor tells you to. Your doctor will tell you how long your treatment with Otazem should last.

Instructions for use:

The person giving Otazem should wash their hands.

  1. Remove a single-dose container from the package (Fig. 1).
  2. Heat the drops by holding the single-dose container (Fig. 2).
  3. Turn off the single-dose container lid (Fig. 3).
  4. Tilt your head to one side so that the ear to be treated is facing upwards (Fig. 4).
  5. Empty the entire contents of the single-dose container into the ear (Fig. 5). Gently pull the ear up and back. This causes the ear drops to flow into the ear canal.
  6. Hold the head in the same position for 1 minute so the medicine can flow into the ear (Fig. 6). Dispose of the single-dose container after administration.
  7. Repeat if necessary for the other ear.
Instructions for use of Cetraxal Comp

It is important to follow these instructions to get the good effect of the drug in your ear. If the head is kept upright or if you move the head too quickly when the Otazem ear drops are given, the medicine will flow out of the ear and will not reach the ear canal as intended.

If You Use More Otazem Than You Should: 

Symptoms of overdose are unknown. If you have ingested too much medicine or if e.g. If a child has ingested the medicine, contact a doctor, hospital for assessment of the risk and advice.

If You Forget To Use Otazem:

Do not take a double dose to make up for a forgotten dose. Take the next dose as usual.

If You Stop Using Otazem:

Do not stop using it without consulting your doctor or pharmacist. It is very important to use Otazem ear drops for the time your doctor prescribes, even if your symptoms improve.

Ask your doctor or pharmacist if you have any further questions about using this product.

Possible Otazem Side Effects:

This medicine can cause side effects like all medicines, although not everybody gets them.

Common (may affect up to 1 in 10 people):

  • Burning
  • Itching
  • Irritation
  • Dryness and discomfort where the medicine is applied.

Uncommon (may affect up to 1 in 100 people): 

Folliculitis ( inflammation of the hair follicles)

Rare (may affect up to 1 in 1,000 people):

  • Skin atrophy (skin thinning)
  • Stretch marks
  • Rash
  • Infection
  • Blurred vision has been reported (occurs in an unknown number of users).

How To Store Otazem?

  • Keep this medicine out of sight and reach of children.
  • Do not use this medicine after the expiry date stated on the single-dose container, sachet and carton after “EXP.” The expiration date is the last day of the specified month.
  • Store below 25 ° C and in the original package. Sensitive to light.
  • After opening the bag: 3 months. Discard 3 months after first opening the aluminum bag.
  • Dispose of the single-dose container once the medicine has been given.
  • Do not use this medicine if you notice that the product is not clear to a slightly yellowish clear solution.

Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.

Contents Of The Pack And Other Information

Content Declaration

  • The active substance is fluocinolone acetonide.
  • 1 ml solution contains 250 micrograms fluocinolone acetonide.
  • Each single-dose container containing 0.40 ml of solution contains 100 micrograms of fluocinolone acetonide.
  • The other ingredients are polysorbate 80, glycerol , povidone K90F, lactic acid , sodium hydroxide 1N and water.

What The Medicine Looks Like And Contents Of The Pack?

  • Otazem is a clear solution packaged in single-dose containers containing 0.40 ml.
  • The single-dose containers are in a protective aluminum foil bag and a carton.
  • Each single-dose container contains approximately 100 micrograms of fluocinolone acetonide.
  • Each pack contains 15 or 30 single-dose containers. Not all pack sizes may be marketed.

Marketing Authorisation Holder


Laboratorios SALVAT, SA

C / Gall, 30-36.
08950 Llobregat Services

Barcelona (Spain)

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