Otixal: Uses, Side Effects and Dosage

What is OTIXAL used for?

OTIXAL is used to treat infection caused by certain bacteria in the middle ear of children 6 months and older who have a tube in the ear drum.

Antibacterial drugs like OTIXAL treat only bacterial infections. They do not treat viral infections. OTIXAL contains an antibacterial ingredient called ciprofloxacin, and it should be used exactly as directed and until the 7 days of treatment is completed. Misuse or overuse of OTIXAL could lead to the growth of bacteria that will not be killed by ciprofloxacin. This means that OTIXAL or other medicines that contain ciprofloxacin may not work for you in the future. Do not share your medicine.

How does OTIXAL work?

OTIXAL ear drops contain ciprofloxacin hydrochloride and fluocinolone acetonide. Ciprofloxacin hydrochloride kills bacteria. This treats the infection. Fluocinolone acetonide reduces the substances which inflame tissues. Together they treat the ear infection and swelling.

What are the ingredients in OTIXAL?

Medicinal ingredients: Ciprofloxacin hydrochloride and fluocinolone acetonide. Non-medicinal ingredients: polysorbate 80, glycerin, povidone K90F and purified water.

OTIXAL comes in the following dosage forms:

OTIXAL is a sterile, preservative-free ear drop solution supplied in translucent single-use 0.25 mL vials. Vials are packaged in a protective foil pouch.

Do not use OTIXAL if:

• You/your child are allergic (hypersensitive) to ciprofloxacin or to other quinolone antibiotics.
• You/your child are allergic to fluocinolone acetonide or to other steroids.
• Children are younger than 6 months old.
• You/your child have an ear infection caused by a virus or fungus.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take OTIXAL. Talk about any health conditions or problems you may have, including if:

• You have/your child has 2 or more ear infections within 6 months.

• You are breast-feeding a baby. It is not known if the active ingredients in these ear drops pass into breast milk.

Other warnings you should know about:

Contact your doctor:

• If you/your child develop:

  • A swelling
  • A serious skin rash
  • A pain or discharge lasting for a few days
• Before stopping OTIXAL treatment. Do not stop treatment on your own. These conditions may be caused by bacteria, yeast, or fungus resistant to the drug.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

How to take OTIXAL:

See the step-by-step instructions for using OTIXAL below.

It is important that the person giving OTIXAL follows these instructions carefully to make sure that the drug is most effective.

1. 1.

   The person giving OTIXAL should wash his or her

   hands with soap and water.

1. 2. Gently clean any discharge that can be removed easily from the outer ear. DO NOT INSERT ANY OBJECT OR SWAB INTO THE EAR CANAL.
2. 3.

   Detach the vial from the pack.

   1. 4. Warm the ear drops by holding the vial in your hands for 1 or 2 minutes.
   2. 5. Twist off the vial cap.

1. 6. Tilt your/your child’s head to one side to keep the affected ear up.
2. 7. Instill the contents of 1 vial in the ear.
3. 8. Pump the tragus (the small piece of cartilage found in front of the ear canal) 4 times by pushing inward to allow the medicine to penetrate the middle ear. This will allow the drops to pass through the tube in the eardrum and into the middle ear.
4. 9.

   Keep the patient’s head tilted sideways for

   approximately 1 minute to allow the medicine time to penetrate the ear. When instilling ear drops, raising the head to the vertical position or moving too rapidly may cause part of the medicine to leak out of the ear canal. This should be avoided as it may prevent the medicine from reaching the full depth of the ear canal.

   Discard the vial after the administration.

5. 10. Repeat steps, if necessary, for the opposite ear.

Usual dose:

• Instill the contents of 1 single-use vial into the affected ear twice daily for 7 days. Use approximately every 12 hours, for example at 8 AM and 8 PM.
• Use this dosing routine for patients of all ages.
• Do not use OTIXAL unless your/your child’s doctor has told you how to use it and you understand the explanation. Ask your/your child’s doctor or pharmacist if you have any questions.
• Use OTIXAL exactly as your/your child’s doctor has told you.
• Use the ear drops for as long as the doctor has instructed, even if the symptoms improve.
• Do not start or stop using OTIXAL without talking to your/your child’s doctor first.

Overdose:

If OTIXAL is accidentally swallowed or if you think you have instilled too much into your ear, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

If you/your child miss a dose of OTIXAL, it should be given as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule. Do not use a double dose unless your/your child’s doctor has instructed you to do so. If the infection is not improved after 1 week, you should consult your/your child’s doctor.

What are possible side effects from using OTIXAL?

Common side effects with OTIXAL include:

• Itching, pain, discharge or swelling in the ear.

Tell your/your child’s doctor if you have any side effects that bother you or do not go away.

These are not all the possible side effects you may feel when taking OTIXAL. If you experience any side effects not listed here, contact your healthcare professional.

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report:

• Online at MedEffect;
• By calling 1-866-234-2345 (toll-free);

• By completing a Consumer Side Effect Reporting Form and sending it by:

  • Fax to 1-866-678-6789 (toll-free), or

  • Mail to: Canada Vigilance Program

    Health Canada, Postal Locator 1908C Ottawa, ON

    K1A 0K9

    Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Keep out of reach and sight of children, preferably in a locked cupboard.

• Do not use after the expiry date that is stated on the carton and the vial.
• Store at room temperature (15°C to 30°C). Protect from light; store unused vials in the protective foil pouch and discard 7 days after opening the pouch. Do not open until ready to use.
• After using the full contents of the vial, discard the empty vial in a secure location.

If you want more information about OTIXAL:

• Talk to your healthcare professional.
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the manufacturer’s website www.otixal.ca, or by calling 1-877-663-3987.

OTIXAL is a trademark from Laboratorios SALVAT, S.A., Spain and is distributed in Canada by Medexus under licence from Laboratorios SALVAT, S.A., Spain.

Last Revised: JAN 23, 2023