OFLOXACIN (Page 2 of 3)

ADVERSE REACTIONS SECTION

Subjects with Otitis Externa

In the phase III clinical trials performed in support of once-daily dosing, 799 subjects with otitis externa and intact tympanic membranes were treated with Ofloxacin Otic Solution. The studies, which served as the basis for approval, were 020 (pediatric, adolescents and adults), 016 (adolescents and adults) and 017 (pediatric). The following treatment-related adverse events occurred in two or more of the subjects.

Incidence Rate

Adverse Event Studies 002/003+
BID
(N=229) Studies 016/017+
QD
(N=310) Studies 002+
QD
(N=489)
Application Site Reaction 3% 16.8% 0.6%
Pruritus 4% 1.2% 1.0%
Earache 1% 0.6% 0.8%
Dizziness 1% 0.0% 0.6%
Headache 0% 0.3% 0.2%
Vertigo 1% 0.0% 0.0%

+Studies 002/003 (BID) and 016/017 (QD) were active-controlled and comparative. Study 020 (QD) was open and non-comparative.

An unexpected increased incidence of application site reaction was seen in studies 016/017 and was similar for both ofloxacin and the active control drug (neomycin-polymyxin B sulfate-hydrocortisone). This finding is believed to be the result of specific questioning of the subjects regarding the incidence of application site reactions.

In once daily dosing studies, there were also single reports of nausea, seborrhea, transient loss of hearing, tinnitus, otitis externa, otitis media, tremor, hypertension and fungal infection.

In twice daily dosing studies, the following treatment-related adverse events were each reported in a single subject: dermatitis, eczema, erythematous rash, follicular rash, hypoaesthesia, tinnitus, dyspepsia, hot flushes, flushing and otorrhagia.

Subjects with Acute Otitis Media with Tympanostomy Tubes (AOM TT) and Subjects with Chronic Suppurative Otitis Media (CSOM) with Perforated Tympanic Membranes In phase III clinical trials which formed the basis for approval, the following treatment-related adverse events occurred in 1% or more of the 656 subjects with non-intact tympanic membranes in AOM TT or CSOM treated twice-daily with Ofloxacin Otic Solution:

Adverse Event

Incidence (N=656)

Taste Perversion 7%
Earache 1%
Pruritus 1%
Paraesthesia 1%
Rash 1% Dizziness 1%

Other treatment-related adverse reactions reported in subjects with non-intact tympanic membranes included: diarrhea (0.6%), nausea (0.3%), vomiting (0.3%), dry mouth (0.5%), headache (0.3%), vertigo (0.5%), otorrhagia (0.6%), tinnitus (0.3%), fever (0.3%). The following treatment-related adverse events were each reported in a single subject: application site reaction, otitis externa, urticaria, abdominal pain, dysaesthesia, hyperkinesia, halitosis, inflammation, pain, insomnia, coughing, pharyngitis, rhinitis, sinusitis, and tachycardia.

Post-marketing Adverse Events

Cases of uncommon transient neuropsychiatric disturbances have been included in spontaneous post-marketing reports. A causal relationship with Ofloxacin Otic Solution, 0.3% is unknown.

DOSAGE & ADMINISTRATION SECTION

Otitis Externa: The recommended dosage regimen for the treatment of otitis externa is:

For pediatric patients (from 6 months to 13 years old): Five drops (0.25 mL, 0.75 mg ofloxacin) instilled into the affected ear once daily for seven days.

For patients 13 years and older: Ten drops (0.5 mL, 1.5 mg ofloxacin) instilled into the affected ear once daily for seven days.

The solution should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness which may result from the instillation of a cold solution. The patient should lie with the affected ear upward, and then the drops should be instilled. This position should be maintained for five minutes to facilitate penetration of the drops into the ear canal. Repeat, if necessary, for the opposite ear.

Acute Otitis Media in pediatric patients with tympanostomy tubes: The recommended dosage regimen for the treatment of acute otitis media in pediatric patients (from 1 to 12 years old) with tympanostomy tubes is:

Five drops (0.25 mL, 0.75 mg ofloxacin) instilled into the affected ear twice daily for ten days. The solution should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness which may result from the instillation of a cold solution. The patient should lie with the affected ear upward, and then the drops should be instilled. The tragus should then be pumped 4 times by pushing inward to facilitate penetration of the drops into the middle ear. This position should be maintained for five minutes. Repeat, if necessary, for the opposite ear.

Chronic Suppurative Otitis Media with perforated tympanic membranes:

The recommended dosage regimen for the treatment of chronic suppurative otitis media with perforated tympanic membranes in patients 12 years and older is:

Ten drops (0.5 mL, 1.5 mg ofloxacin) instilled into the affected ear twice daily for fourteen days. The solution should be warmed by holding the bottle in the hand for one or two minutes to avoid dizziness which may result from the instillation of a cold solution. The patient should lie with the affected ear upward, before instilling the drops. The tragus should then be pumped 4 times by pushing inward to facilitate penetration into the middle ear. This position should be maintained for five minutes. Repeat, if necessary, for the opposite ear.

HOW SUPPLIED SECTION

  • Ofloxacin Otic Solution, 0.3% is supplied in a *DROP-TAINER® dispenser containing 5 mL in an 8 mL bottle and 10 mL in a 10 mL bottle.

    5 mL NDC 61314-015-05

    10 mL NDC 61314-015-10

    STORAGE CONDITIONS: Store at 20° — 25°C (68° — 77°F), excursions permitted to 15° — 30°C (59° — 86°F). Protect from light.

    Rx Only

    *DROP-TAINER® is a registered trademark of Alcon Manufacturing, Ltd.

    Dist. By:

    FALCON Pharmaceuticals, Ltd.

    Fort Worth, Texas 76134 USA

    Mfd. By:

    ALCON LABORATORIES, INC.

    Fort Worth, Texas 76134 USA

    Printed in USA

    9004982-0909

    PATIENT INFORMATION

    IMPORTANT PATIENT INFORMATION AND INSTRUCTIONS. READ BEFORE USE.

    What is Ofloxacin Otic Solution?

    Ofloxacin Otic Solution is an antibiotic in a sterile solution used to treat ear infections caused by certain bacteria found in:

    • patients (12 years and older) who have a middle ear infection and have a hole in the eardrum

    • pediatric patients (between 1 and 12 years of age) who have a middle ear infection and have a tube in the eardrum

    • patients (6 months and older) who have an infection in the ear canal.

    Middle ear infection: A middle ear infection is a bacterial infection behind the eardrum. People with a hole or a tube in the eardrum may notice a discharge (fluid draining) from the ear canal.

    Ear canal infection: An ear canal infection (also known as “Swimmer’s Ear”) is a bacterial infection of the ear canal. The ear canal and the outer part of the ear may swell, turn red, and be painful. Also, a fluid discharge may appear in the ear canal.

    Who should NOT use Ofloxacin Otic Solution?

    • Do not use this product if you are allergic to ofloxacin or to other quinolone antibiotics.

    • Do not give this product to pediatric patients who:

    • have an ear canal infection and are less than 6 months of age because no data were collected from this population.

    • have a middle ear infection and have a tube in the eardrum and are less than one year of age because no data were collected from this population.

    • have a middle ear infection and have a hole in the eardrum and are less than 12 years of age because no data were collected from this population.

    How should Ofloxacin Otic Solution be given?

    • Close
    • 1. Wash hands

      The person giving Ofloxacin Otic Solution should wash his/her hands with soap and water.

    • 2. Clean ear & warm bottle

      Gently clean any discharge that can be removed easily from the outer ear. DO NOT INSERT ANY OBJECT OR SWAB INTO THE EAR CANAL. Hold the bottle of Ofloxacin Otic Solution, in the hand for one or two minutes to warm the solution.

    • 3. Add drops

      For a Middle Ear Infection: The person receiving Ofloxacin Otic Solution should lie on his/her side with the infected ear up. Patients (12 and older) should have 10 drops of Ofloxacin Otic Solution put into the infected ear. Pediatric patients under 12 should have 5 drops put into the infected ear. The tip of the bottle should not touch the fingers or the ear or any other surfaces.

      For an Ear Canal Infection (“Swimmer’s Ear”):

      The person receiving Ofloxacin Otic Solution should lie on his/her side with the infected ear up. Patients (13 and older) should have 10 drops of Ofloxacin Otic Solution put into the infected ear. Pediatric patients under 13 should have 5 drops put into the infected ear. The tip of the bottle should not touch the fingers or the ear or any other surfaces.

      BE SURE TO FOLLOW THE INSTRUCTIONS BELOW FOR THE PATIENT’S SPECIFIC EAR INFECTION.

    • 4. Press ear or pull ear

      For a Middle Ear Infection:

      While the person receiving Ofloxacin Otic Solution lies on his/her side, the person giving the drops should gently press the TRAGUS (see diagram) 4 times in a pumping motion. This will allow the drops to pass through the hole or tube in the eardrum and into the middle ear.

      For an Ear Canal Infection (“Swimmer’s Ear”):

      While the person receiving the drops lies on his/her side, the person giving the drops should gently pull the outer ear upward and backward. This will allow the ear drops to flow down into the ear canal.

    • 5. Stay on side

      The person who received the ear drops should remain on his/her side for at least 5 minutes. Repeat Steps 2-5 for the other ear if both ears are infected.

    • How often should Ofloxacin Otic Solution, 0.3% be given?

      In patients with an Ear Canal Infection (“Swimmer’s Ear”), Ofloxacin Otic ear drops should be given once daily at about the same time each day (for example, 8 AM or 8 PM) in each infected ear unless the doctor has instructed otherwise. In patients with a Middle Ear Infection, Ofloxacin Otic ear drops should be given 2 times each day (about 12 hours apart, for example 8 AM and 8 PM) in each infected ear unless the doctor has instructed otherwise. The best times to use the ear drops are in the morning and at night.

      It is very important to use the ear drops for as long as the doctor has instructed, even if the symptoms improve. If Ofloxacin Otic Solution, 0.3% ear drops are not used for as long as the doctor has instructed, the infection may be more likely to return.

    • What if a dose is missed?

      In patients with an Ear Canal Infection (“Swimmer’s Ear”), it is important that you take the drops every day. If you miss a dose which may have been scheduled for earlier in the day, (for example, 8 AM), you should take that day’s dose as soon as possible and then go back to your regular daily dosing schedule.

      In patients with a Middle Ear Infection, if a dose of Ofloxacin Otic is missed, 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 the doctor has instructed you to do so. If the infection is not improved after one week, you should consult your doctor. If you have two or more episodes of drainage within six months, it is recommended that you see your doctor for further evaluation.

    • What activities should be avoided while using Ofloxacin Otic Solution?

      It is important that the infected ear(s) remain clean and dry. When bathing, avoid getting the infected ear(s) wet. Avoid swimming unless the doctor has instructed otherwise.

    • What are some of the possible side effects of Ofloxacin Otic Solution?

      During the testing of Ofloxacin Otic in external ear infections, the most common side effect was discomfort upon application which happened in 7% of patients. If the pain is severe, the medication should be stopped and you should contact your doctor. Other side effects were: itching (1%), earache (0.8%), and dizziness (0.4%).

      During testing of Ofloxacin Otic Solution in middle ear infections, the most common side effect was a bitter taste which happened in 7% of patients with a middle ear infection. This may occur when some of the drops pass from the middle ear to the back of the mouth. This side effect is not serious and there is no need to stop the medicine if this should happen. Other side effects which were found in 1% of the patients were: earache, itching, abnormal sensation, rash and dizziness.

      Call your doctor about these or other side effects if they occur.

      If a rash or an allergic reaction to Ofloxacin Otic occurs, stop using the product and contact your doctor.

      DO NOT TAKE OFLOXACIN OTIC SOLUTION BY MOUTH.

      If Ofloxacin Otic is accidentally swallowed or an overdose occurs, call the doctor immediately. This medicine is available only with a doctor’s prescription. Use only as directed. Do not use this medicine if outdated.

      If you wish to learn more about Ofloxacin Otic, ask the doctor or pharmacist.

      See accompanying insert.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.