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Ofloxacin 0.3% Otic Sol 5 Ml

  • Manufacturer Name : Amneal
  • MFG # : 69238161503
  • NDC : 69238161503
  • Distributor Name : AmeriSource Bergen
PID UOM Price Qty
418692 1BT/EA
$12.32
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Additional Information

Product NameOfloxacin 0.3% Ear Drops 5 mL
ApplicationAntibiotic
Generic Drug NameOfloxacin
Mechanism of ActionInhibits bacterial DNA gyrase and topoisomerase IV.
Strength0.3%
TypeOtic
Volume5 mL
Onset of ActionRapid, localized effect
Duration of ActionProlonged effect due to minimal systemic absorption.
Side EffectsEar discomfort, itching, mild dizziness.
PrecautionsAvoid contact with eyes, discontinue if rash occurs.
Pregnancy CategoryCategory C (use with caution).
Pediatric UseSafe for children above 1 year under medical guidance.
Instructions for UseWarm bottle slightly, apply as directed by a physician.
Storage ConditionsBelow 25°C, protect from light, tightly closed.
PackagingSterile 5 mL dropper bottle.
UsesTreats otitis externa and otitis media caused by bacteria.

Description

Ofloxacin 0.3% ear drops are an otic solution formulated to treat bacterial infections of the ear, such as otitis externa and otitis media. The active ingredient, ofloxacin, is a fluoroquinolone antibiotic known for its broad-spectrum activity against gram-positive and gram-negative bacteria. It works by inhibiting bacterial DNA gyrase and topoisomerase IV, enzymes essential for DNA replication and transcription, thereby stopping bacterial growth and proliferation.

The solution is supplied in a 5 mL dropper bottle, ensuring precise and convenient administration. It is clear and colorless, free from particulates, and designed to provide effective therapeutic action directly at the infection site. The preparation ensures minimal systemic absorption, reducing the risk of systemic side effects and drug interactions, making it suitable for localized ear infections.

Ofloxacin 0.3% ear drops are commonly used to alleviate symptoms such as ear pain, swelling, and discharge caused by bacterial infections. It is especially effective against pathogens like Pseudomonas aeruginosa and Staphylococcus aureus, which are frequently implicated in ear infections.

Product Properties:

Description N
Description N
Description -
DESI Drug Ind -
DESI Drug Ind -; -
DESI Drug Ind -; -
DESI2 Drug Ind -
Drug Category N
Drug Category USES: Ofloxacin is used to treat outer ear infections (swimmer's ear or ear canal infections) and middle ear infections. It works by stopping the growth of bacteria. This medication belongs to a class of drugs called quinolone antibiotics. This medication treats only bacterial ear infections. It will not work for other types of ear infections. Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.
Drug Category USES: Ofloxacin is used to treat outer ear infections (swimmer's ear or ear canal infections) and middle ear infections. It works by stopping the growth of bacteria. This medication belongs to a class of drugs called quinolone antibiotics. This medication treats only bacterial ear infections. It will not work for other types of ear infections. Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.
Drug Type Code COMMON BRAND NAME(S): Floxin
Drug Type Code 1
Drug Type Code COMMON BRAND NAME(S): Floxin
FDA Approval Date 08/30/2019
FDA Therap Equiv AT
HCPCS -
HCPCS 1
HCPCS 1
Market Entry Date 05/04/2020
Medical Coverage -
Medical Coverage -
Medical Coverage -
Termination Date (oh-FLOX-a-sin)
Termination Date -
Termination Date (oh-FLOX-a-sin)
Unit ML
Units Per Pkg 5
Active Ingredients 3563 ofloxacin 82419361
Active Ingredients 3563 ofloxacin 82419361
Active Ingredients 3563 ofloxacin 82419361
AHFS Class 52040400 ANTIBACTERIALS (EENT)
AHFS Class 52040400 ANTIBACTERIALS (EENT)
AHFS Class 52040400 ANTIBACTERIALS (EENT)
DEA Class NC
DEA Class NC
DEA Class NC
Dose Form DROPS
Dose Form DROPS
Dose Form DROPS
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 48292 ofloxacin OTIC (EAR) DROPS 0.3 %
Gen Code and Des 48292 ofloxacin OTIC (EAR) DROPS 0.3 %
Gen Code and Des 48292 ofloxacin OTIC (EAR) DROPS 0.3 %
Inactive Ingredients 3141 benzalkonium chloride 8001545
Inactive Ingredients 3141 benzalkonium chloride 8001545
Inactive Ingredients 3141 benzalkonium chloride 8001545
OMP Family -
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength 0.3%
Strength 0.3%
Strength 0.3%
Common Brand Name -
Common Brand Name -
Common Brand Name COMMON BRAND NAME(S): Floxin
Drug Interaction -
Drug Interaction -
Drug Interaction DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Allocation Period -
Allocation Period -
Allocation Period -
Case Quantity 48
Case Quantity 48
Case Quantity 48
Drug Form Pack Size 5
Drug Form Pack Size 5
Drug Form Pack Size 5
Form SOLUTION
Form SOLUTION
Form SOLUTION
Hazard Code -
Hazard Code -
Hazard Code -
Listed Chemical -
Listed Chemical -
Listed Chemical -
NIOSH Code -
NIOSH Code -
NIOSH Code -
Orange Book AT Topical products therapeutically equivalent in same dosage form.
Orange Book AT Topical products therapeutically equivalent in same dosage form.
Orange Book AT Topical products therapeutically equivalent in same dosage form.
Retail Pack Quantity 1
Retail Pack Quantity 1
Retail Pack Quantity 1
Returnable Status Returnable
Returnable Status Returnable
Returnable Status Returnable
Special Storage Cond 00 None
Special Storage Cond 00 None
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Temp Zone 10 Room Temperature
Temp Zone 10 Room Temperature
Unit EA
Unit EA
Unit EA
Unit Size 5
Unit Size 5
Unit Size 5
How to Use -
How to Use HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using ofloxacin and each time you get a refill. If you have any questions, ask your doctor or pharmacist. For accuracy and to avoid contamination, have another person give the drops if possible. Hold the container in your hand for a few minutes to warm it. This will minimize dizziness. To apply ear drops, wash your hands first. To avoid contamination, do not touch the dropper tip or let it touch your ear or any other surface. Lie on your side or tilt the affected ear upward. Place the dropper directly over your ear and administer the prescribed number of drops. If you are using the single-use containers, empty the contents of the prescribed number of containers into your ear. For outer ear infections, to help the drops roll into the ear, adults should hold the earlobe up and back. In children, hold the earlobe down and back. For middle ear infections, gently press down several times on the cartilage that partially covers your ear opening to allow the drops to enter your middle ear (see Patient Information Leaflet). Keep your head tilted for about 5 minutes, or insert a soft cotton plug if so directed. Repeat the above steps for your other ear if so directed. Do not rinse the dropper. Replace the dropper cap on the bottle after each use. If you are using the single-dose containers, discard any unused solution after each application. Do not reuse. Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time(s) each day. Continue using it for the full time prescribed, even if symptoms disappear after a few days. Stopping this medication too early may allow bacteria to continue to grow, which may result in a relapse of the infection. Inform your doctor if your condition does not improve in 1 week. Report any ear discharge that occurs after the treatment period is completed. Do not use in the eye.
How to Use -
Missed Dose 5
Missed Dose 5
Missed Dose MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.
Notes NOTES: Do not share this medication with others. This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor tells you to. It is important to keep the infected ear(s) clean and dry. Try not to get the infected ear(s) wet when bathing. Avoid swimming unless your doctor tells you otherwise.
Notes ML
Notes ML
Overdose AT
Overdose AT
Overdose OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. This medicine may be harmful if swallowed.
Phonetic Pronunciation -
Phonetic Pronunciation -
Phonetic Pronunciation (oh-FLOX-a-sin)
Precautions -
Precautions -
Precautions PRECAUTIONS: Before using ofloxacin, tell your doctor or pharmacist if you are allergic to it; or to other quinolone antibiotics (such as ciprofloxacin, levofloxacin); or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: other ear problems, two or more ear infections within 6 months. This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. However, it is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.
Side Effects -
Side Effects -
Side Effects SIDE EFFECTS: Mild irritation/discomfort in the ear, dizziness, headache, earache, or changes in taste may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: tingling/numbness, hearing changes. Use of this medication for prolonged or repeated periods may result in a new fungal ear infection. Do not use it for longer than prescribed. Contact your doctor if you notice new or worsening symptoms. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Storage 08/30/2019
Storage 08/30/2019
Storage STORAGE: Store at room temperature away from light. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Uses -
Uses -
Uses USES: Ofloxacin is used to treat outer ear infections (swimmer's ear or ear canal infections) and middle ear infections. It works by stopping the growth of bacteria. This medication belongs to a class of drugs called quinolone antibiotics. This medication treats only bacterial ear infections. It will not work for other types of ear infections. Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.

Frequently Asked Questions(FAQs)

The cost of Ofloxacin 0.3% Otic Sol 5 Ml is $12.32 .
Ofloxacin 0.3% Otic Sol 5 Ml is manufactured by Amneal.
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