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Ofloxacin 0.3% Otic Sol 10 Ml

  • Manufacturer Name : LIFESTAR PHARMA LLC
  • MFG # : 70756061030
  • NDC : 70756061030
  • Distributor Name : AmeriSource Bergen
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Product Properties:

Description -
DESI Drug Ind -
DESI2 Drug Ind AT
Drug Category -
Drug Type Code N
FDA Approval Date 09/22/2022
FDA Therap Equiv ML
HCPCS -
Market Entry Date -
Medical Coverage -
Termination Date 1
Unit 10
Units Per Pkg 07/14/2022
Active Ingredients 3563 ofloxacin 82419361
AHFS Class 52040400 ANTIBACTERIALS (EENT)
DEA Class NC
Dose Form DROPS
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 48292 ofloxacin OTIC (EAR) DROPS 0.3 %
Inactive Ingredients 3141 benzalkonium chloride 8001545
OMP Family -
Product Category RX Pharmaceuticals
Strength 0.3%
Common Brand Name COMMON BRAND NAME(S): Floxin
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 -
Case Quantity 48
Drug Form Pack Size 10
Form SOLUTION
Hazard Code -
Listed Chemical -
NIOSH Code -
Orange Book AT Topical products therapeutically equivalent in same dosage form.
Retail Pack Quantity 1
Returnable Status Returnable
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Unit EA
Unit Size 10
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.
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.
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 (oh-FLOX-a-sin)
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: 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 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: 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.

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Ofloxacin 0.3% Otic Sol 10 Ml is manufactured by LIFESTAR PHARMA LLC.
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