Application Information

This drug has been submitted to the FDA under the reference 020799/001.

Names and composition

"FLOXIN OTIC" is the commercial name of a drug composed of OFLOXACIN.

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
020799/001 FLOXIN OTIC OFLOXACIN SOLUTION/DROPS/OTIC 0.3% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
019735/001 FLOXIN OFLOXACIN TABLET/ORAL 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
019735/002 FLOXIN OFLOXACIN TABLET/ORAL 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
019735/003 FLOXIN OFLOXACIN TABLET/ORAL 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
019921/001 OCUFLOX OFLOXACIN SOLUTION/DROPS/OPHTHALMIC 0.3%
020087/001 FLOXIN IN DEXTROSE 5% OFLOXACIN INJECTABLE/INJECTION 400MG per 100ML
020087/002 FLOXIN OFLOXACIN INJECTABLE/INJECTION 20MG per ML
020087/003 FLOXIN OFLOXACIN INJECTABLE/INJECTION 40MG per ML
020087/004 FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER OFLOXACIN INJECTABLE/INJECTION 4MG per ML
020087/005 FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER OFLOXACIN INJECTABLE/INJECTION 400MG per 100ML
020799/001 FLOXIN OTIC OFLOXACIN SOLUTION/DROPS/OTIC 0.3% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
075762/001 OFLOXACIN OFLOXACIN INJECTABLE/INJECTION 40MG per ML
076093/001 OFLOXACIN OFLOXACIN TABLET/ORAL 200MG
076093/002 OFLOXACIN OFLOXACIN TABLET/ORAL 300MG
076093/003 OFLOXACIN OFLOXACIN TABLET/ORAL 400MG
076128/001 OFLOXACIN OFLOXACIN SOLUTION/DROPS/OTIC 0.3%
076182/001 OFLOXACIN OFLOXACIN TABLET/ORAL 200MG
076182/002 OFLOXACIN OFLOXACIN TABLET/ORAL 300MG
076182/003 OFLOXACIN OFLOXACIN TABLET/ORAL 400MG
076220/001 OFLOXACIN OFLOXACIN TABLET/ORAL 200MG
076220/002 OFLOXACIN OFLOXACIN TABLET/ORAL 300MG
076220/003 OFLOXACIN OFLOXACIN TABLET/ORAL 400MG
076231/001 OFLOXACIN OFLOXACIN SOLUTION/DROPS/OPHTHALMIC 0.3%
076407/001 OFLOXACIN OFLOXACIN SOLUTION/DROPS/OPHTHALMIC 0.3%
076513/001 OFLOXACIN OFLOXACIN SOLUTION/DROPS/OPHTHALMIC 0.3%
076527/001 OFLOXACIN OFLOXACIN SOLUTION/DROPS/OTIC 0.3%
076615/001 OFLOXACIN OFLOXACIN SOLUTION/DROPS/OPHTHALMIC 0.3%
076616/001 OFLOXACIN OFLOXACIN SOLUTION/DROPS/OTIC 0.3%
076622/001 OFLOXACIN OFLOXACIN SOLUTION/DROPS/OPHTHALMIC 0.3%
076830/001 OFLOXACIN OFLOXACIN SOLUTION/DROPS/OPHTHALMIC 0.3%
076848/001 OFLOXACIN OFLOXACIN SOLUTION/DROPS/OPHTHALMIC 0.3%
077098/001 OFLOXACIN OFLOXACIN TABLET/ORAL 200MG
077098/002 OFLOXACIN OFLOXACIN TABLET/ORAL 300MG
077098/003 OFLOXACIN OFLOXACIN TABLET/ORAL 400MG
078222/001 OFLOXACIN OFLOXACIN SOLUTION/DROPS/OTIC 0.3%
078559/001 OFLOXACIN OFLOXACIN SOLUTION/DROPS/OPHTHALMIC 0.3%
090395/001 OFLOXACIN OFLOXACIN SOLUTION/DROPS/OTIC 0.3%
091656/001 OFLOXACIN OFLOXACIN TABLET/ORAL 200MG
091656/002 OFLOXACIN OFLOXACIN TABLET/ORAL 300MG
091656/003 OFLOXACIN OFLOXACIN TABLET/ORAL 400MG
202692/001 OFLOXACIN OFLOXACIN SOLUTION/DROPS/OPHTHALMIC 0.3%

Ask a doctor

A licensed doctor will try to answer your question for free as quickly as possible. Free of charge during the beta period.

Answered questions

What do i do if i get Floxin Otic in my eye?
well this morning my eye was really red, i think it is pink eye but whatever not the point. my mom comes in and says here put these in your eye. i asked her are you sure and she said yes. so i took the drops and put it in. I immediatly dropped to the floor kicking around and screaming. it was burning sooooooooooooo... Asked by Jarred Ashby 1 year ago.

well this morning my eye was really red, i think it is pink eye but whatever not the point. my mom comes in and says here put these in your eye. i asked her are you sure and she said yes. so i took the drops and put it in. I immediatly dropped to the floor kicking around and screaming. it was burning sooooooooooooo badly like putting acid in your eyes. my mom looked and it said Floxin Otic-FOR EARS ! like really mom ? so am i gonna be okay cause right now my eye is stinging worse than ever. Answered by Corey Cracolici 1 year ago.

splash water in your eye if it doesnt help go to a doctor or a&e Answered by Beverley Galavis 1 year ago.

Flush you eyes then stop writing on the internet. Maybe drop by the emergency ward to be sure Peter Answered by Laureen Hosack 1 year ago.


Can i use floxin otic (ofloxacin) for an ear infection when taking penicillin?
this is for my girlfriend who has mono like symptoms, and a strep throat, which is why she is taking penicillin. but she says her ears hurt. and when i had mono my ears hurt too. so i am just wondering if she can mix without harm? Asked by Loretta Keeny 1 year ago.

I think your intentions are well-meaning, but you're also not a medical provider either. I've never seen someone with Mono AND Strep Throat in all my years caring for patients. Not to mention, it is a BIG "NO-NO" to use antibiotics with Mono. I would think the doctor said this to convey the "symptoms," because they can often be rather similar. Hold off on the drops. Strep commonly affects the ears to cause pain, but the drops will be useless because they will NOT work past the eardrum. She will be better off taking some Aleve or Advil to reduce her pain. Best of luck! Answered by January Pelini 1 year ago.

Never, ever self-medicate or share prescription medications. For one thing, it is illegal to share any prescription medications. Also, you said your girlfriend has "mono like symptoms" and strep throat. What do you mean by "mono like"? Was the doctor informed of this at the time of the strep throat diagnosis and penicillin administration? If the mono like symptoms are a new development, she should return to her doctor. If the doctor was aware of those symptoms, then he is probably thinking that the penicillin will cover all of that. Your girlfriend should start to feel better by day 3 or 4 but must finish her medication until it is gone or as instructed by her doctor. Penicillin remains the drug of choice for treating strep throat. Do not give her your floxin. Your otic floxin is specific for ear infections. You do not know that she really has an ear infection. Since it is an antibiotic, it will kill any bugs that are susceptible to it. We all have bacteria colonizing us everywhere. Indiscriminate use of antibiotics kills off a lot of our "good" and normal bacteria. This leaves plenty of room for the bad bacteria to grow. You could, in fact, make things worse instead of better. Don't disrupt the balance unless its for an infection and under the direction of a doctor. Answered by Dedra Goldfarb 1 year ago.

NEVER EVER mix prescription drugs without first talking to a health care provider. You could cause more harm than good. Answered by Caridad Hannemann 1 year ago.


I have fluid in my ear and what my doctor gave me isn't working has anyone ever had this problem?
What can I use to get the fluid out of my ear because everytime I swallow I hear a loud popping inside my ear Asked by Rubie Bunge 1 year ago.

Yes i have had ear problims ask ur doctor about floxin otic they are ear drops and at the same time u take the ear drops ask ur doc about takeing amoxicillin i had the same problem and when i was on this medication My ear problem went away in 7 days my ear was dry.And the flixin octic is pretty expensive but oh man does it work and the drops dont hurt when they go in your ear eigther. Answered by Berniece Chaix 1 year ago.

i don't know. but, see your doctor because if you don't get it out you end up having a big problem. i did, and now can only smile fully on one side! Answered by Jolanda Pigram 1 year ago.


Any doctors out there that can answer a fairly simple question?
The name of the med by the way is Floxin Otic singles (ofloxacin otic) each tube contains 0.25mL Asked by Dorathy Bohm 1 year ago.

For starters I have already been to see my doctor. I have two very nasty ear infections (one of which promted a second visit because it started to bleed). I have been prescribed what feels like a ton of meds to help clear them up. My question being for one of my Rx. I was prescribed ear drop antibiotics to go along with an oral antibiotic, but I am to take what they call "singles" (little tubes filled with the med) . 2 in each ear once a day. I don't understand why only once a day with two in each ear, do you? and Why can't I take one in each ear twice a day? I am not overly concerned about it I was just curious to know and seeing how I can barely hear anything it is easier to type then to call the doctor again. Answered by Jenine Mabray 1 year ago.

Otitis externa is an inflammatory process of the external auditory canal. The unique structure of the external auditory canal contributes to the development of otitis externa. It is the only skin-lined cul-de-sac in the human body. The external auditory canal is warm, dark and prone to becoming moist, making it an excellent environment for bacterial and fungal growth. The skin is very thin and the lateral third overlies cartilage, while the rest has a base of bone. The canal is easily traumatized. The exit of debris, secretions and foreign bodies is impeded by a curve at the junction of the cartilage and bone. The presence of hair, especially the thicker hair common in older men, can be a further impediment. Fortunately, the external auditory canal has some special defenses. Cerumen creates an acidic coat containing lysozymes and other substances that probably inhibit bacterial and fungal growth. The lipid-rich cerumen is also hydrophobic and prevents water from penetrating to the skin and causing maceration. Too little cerumen can predispose the ear canal to infection, but cerumen that is excessive or too viscous can lead to obstruction, retention of water and debris, and infection. Additionally, the canal is defended by a unique epithelial migration that occurs from the tympanic membrane outward, carrying any debris with it. However, as evidenced by your condition, this does not always prevent an infection - otitis externa. The dose of the drops contained in the ‘singles’ that you describe, is likely insufficient to deliver a satisfactory dose which will affect the cause of the infection, therefore your doctor has prescribed two single doses for each ear. (if, for example, the required dose is 500 mg for each ear, and the dose contained in a ‘single’ is only 250mg, then you would need two ‘singles’ in each ear to make the required dose of 500mg) The reason for this being a ‘once a day’ dose is because that is the required dose to fight the infection each day. You will have a certain dose of oral (by mouth) tablets to take at certain intervals during the day which will ‘add up’ to the required dose for the whole day. The fact that the dose is split up during the day is to endeavour to keep the level of the antibiotic relatively high throughout the day. If you were to take all the medication at one time, then the medication would reach a peak and gradually ‘drop off’. The oral antibiotics compliment the aural ones instilled into your ears by the ‘singles’. Hope this helps Matador 89 Answered by Lillian Rumford 1 year ago.

Not an MD but an RN you have a bacterial infection and it's best with this medicine to take it at the same time each day - for the course of treatment to get rid of the infection (how most antibiotics work) thus the importance of the time of day to take and follow directions. It's to hit the infection to the ear drum. If you just had a middle ear infection you'd do one drop twice a day. There is no ryme or reason other then this is what works best for your type of serious (painful) infection. Rest. Feel better soon! Answered by Thelma Terstage 1 year ago.

You know you would be best to ask your Pharmacists. They can be very very informative when it comes to Rx's, and may even be able to give you an answer to that question. As for the dosage I am not sure why you should have them both at the same time. That may in fact just be the size of the dose needed and they have to break it into two smaller tubes for administration. Much like cough medicine, yes you need two table spoons, not one now and one later, but a table spoon is a easy to take measurement. I hope that helps out, and best of luck with those ear infections. Just a little FYI did you know that second hand smoke can actually cause severe and reoccurring ear infections. Answered by Elvira Kowallis 1 year ago.

Most likely would be the antibiotic milligram dosage in the small single use tubes.For instance if your MD ordered the ear drops to have 500mg of antibiotic in each ear,and it only came in 250milligrams in each tube,then the proper dose would be 2 tubes in each ear twice a day,total of 500mg/ 2x a day in each ear,along with the antibiotics by mouth. You can call your pharmacy to make sure.Take care. SW RNP Answered by Darrin Conlisk 1 year ago.

Your question is reasonable.Details of medication are not mentioned . I am sure you can use your antibiotic ear drops twice a day& continue oral antibiotic as prescribed. DrB.Kovvali. Answered by Janita Langeveld 1 year ago.

the 2 ampules- once a day give enough strength of the med to hopefully kill the bacteria 1 ampule twice a day only "wounds" the crud 2 times a day a knockout punch is better Answered by Roseann Luneau 1 year ago.

you need to take one so if can thin the wax of the ear, you then take it later because the wax builds up, to much, and you burn your ear cannal Answered by Hassie Myhr 1 year ago.


Feels like something is stuck in my eye...?
I got something in my eye yesterday, i flushed it out with cold water, saline rinse but nothing worked, had a hard time sleeping last night cause when i closed my eyes I could really feel it, got up and put some antibiotic eye drops in it thru the nite or so what i though was eye drops, comes to find out it was... Asked by Curtis Manco 1 year ago.

I got something in my eye yesterday, i flushed it out with cold water, saline rinse but nothing worked, had a hard time sleeping last night cause when i closed my eyes I could really feel it, got up and put some antibiotic eye drops in it thru the nite or so what i though was eye drops, comes to find out it was ear drops floxin otic. Whatever was in my eye is gone but it feels like really brusied and throbbing pain in it today. Could these drops have made it worse and if this happens again any recommendations on what to do because the cold water and rinse didn't work good. Thanks, Tee Answered by Dania Sirmon 1 year ago.

Sound like you scratched your cornea, throbbing red, murky looking. Go to your eye doc, this can cause permanent eye damage if not treated. Answered by Theodora Brummet 1 year ago.

I have scratched my eyes 2 times and had super glue in them once, I have also burned my cornea with a curling iron! Other than the burn, I had to flush my eyes out with water and an anti-bacterial rinse. The pain will go away within a few days if you don't rub your eyes. best of luck! Answered by Barry Giessinger 1 year ago.

Please, go see your eye doctor. Answered by Dana Roberto 1 year ago.


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