OFLOXACIN OTIC- ofloxacin solution

Ofloxacin Otic by

Drug Labeling and Warnings

Ofloxacin Otic by is a Prescription medication manufactured, distributed, or labeled by RPK Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Acute Otitis Media in Pediatric Patients with Tympanostomy Tubes

The recommended dosage regimen for the treatment of acute otitis media in pediatric patients (from one 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 that 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 that 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

    Product: 53002-2604

    NDC: 53002-2604-1 5 mL in a BOTTLE, DROPPER

  • PATIENT INFORMATION

    Rx Only

    Ofloxacin Otic Solution, 0.3%

    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:

    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) in 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?

    How should Ofloxacin Otic Solution be given?

    1. Wash hands


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

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    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.

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    Hold the bottle of Ofloxacin Otic Solution in the hand for one or two minutes to warm the solution.

    Before using the medication for the first time, be sure the white plastic sealing tape between the bottle and the cap is unbroken.

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    To break the seal and open the bottle, unscrew the cap by turning as indicated by the arrow.

    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.

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    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.

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    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.

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    5. Stay on side


    The person who received the ear drops should remain on his/her side for at least 5 minutes.

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    Repeat Steps 2-5 for the other ear if both ears are infected.

    How often should Ofloxacin Otic Solution be given?

    In patients with an Ear Canal Infection ("Swimmer’s Ear"), Ofloxacin Otic Solution 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 Solution 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 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 Solution 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 Solution 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 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 Solution occurs, stop using the product and contact your doctor.

    DO NOT TAKE OFLOXACIN OTIC SOLUTION BY MOUTH.

    If Ofloxacin Otic Solution is accidentally swallowed or 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 Solution ask the doctor or pharmacist. Complete Prescribing Information is available from your doctor or pharmacist upon request.

    HOW SUPPLIED

    Bottles containing 5 mL and 10 mL.

    Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from light.

    This Patient Information has been approved by the U.S. Food and Drug Administration.

    Manufactured by:Manufactured for:
    Apotex Inc.Apotex Corp.
    Toronto, OntarioWeston, FL
    Canada33326
    M9L 1T9

    000000                    September 2015

  • Ofloxacin Otic Solution

    Label Image
  • INGREDIENTS AND APPEARANCE
    OFLOXACIN OTIC 
    ofloxacin solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 53002-2604(NDC:60505-0363)
    Route of AdministrationAURICULAR (OTIC)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OFLOXACIN (UNII: A4P49JAZ9H) (OFLOXACIN - UNII:A4P49JAZ9H) OFLOXACIN3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 53002-2604-15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product10/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07652705/14/2004
    Labeler - RPK Pharmaceuticals, Inc. (147096275)
    Establishment
    NameAddressID/FEIBusiness Operations
    RPK Pharmaceuticals, Inc.147096275RELABEL(53002-2604)

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