Ofloxacin

What is ofloxacin used for?

Ofloxacin is a prescription medicine that is used to treat eye infections.

Description

Ofloxacin otic solution, 0.3% is a sterile aqueous anti-infective (anti-bacterial) solution for otic use.

Chemically, ofloxacin has three condensed 6-membered rings made up of a fluorinated carboxyquinolone with a benzoxazine ring. The chemical name of ofloxacin is: (±)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid. The molecular formula of ofloxacin is C18H20FN3O4 and its molecular weight is 361.37. The structural formula is:

Ofloxacin, USP is white to off-white or pale yellow crystalline powder. It is soluble in glacial acetic acid; sparingly soluble in chloroform and in 0.1N sodium hydroxide; sparingly soluble to slightly soluble in methylene chloride; slightly soluble in dimethylformamide and very slightly soluble in methyl alcohol and water.

Ofloxacin otic solution contains 0.3% (3 mg/mL) ofloxacin, USP with benzalkonium chloride (0.0025%), sodium chloride (0.9%), and water for injection. Hydrochloric acid and sodium hydroxide are added to adjust the pH between 6.0 and 7.0.

Before taking ofloxacin, tell your doctor:

• If you are allergic to ofloxacin; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are breast-feeding or plan to breast-feed.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take ofloxacin with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take ofloxacin?

• Tell all of your health care providers that you take ofloxacin. This includes your doctors, nurses, pharmacists, and dentists.
• Use care when driving or doing other tasks that call for clear eyesight.
• Bright lights may bother you. Wear sunglasses.
• Do not use longer than you have been told. A second infection may happen.
• Very bad and sometimes deadly allergic reactions have rarely happened with other forms of ofloxacin as well as drugs like this one. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using ofloxacin while you are pregnant.

How is ofloxacin best taken?

Use ofloxacin as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Use as you have been told, even if your signs get better.
• Use ofloxacin at the same time of day.
• For the eye only.
• Wash your hands before and after use.
• Do not touch the container tip to the eye, lid, or other skin.
• When using, tilt your head back.
• Gently pull down the lower lid and squeeze in how much the doctor told you to use.
• After use, keep your eyes closed. Put pressure on the inside corner of the eye. Do this for 1 to 2 minutes. This keeps the drug in your eye.
• Avoid wearing contacts unless told to wear them by your doctor.

What do I do if I miss a dose?

• Use a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses at the same time or extra doses.

What are the side effects of ofloxacin that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Change in eyesight, eye pain, or very bad eye irritation.
• Joint pain or swelling.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

What are some other side effects of ofloxacin?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Burning.
• Eye irritation.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out ofloxacin?

• Store at room temperature. Do not freeze.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PRINCIPAL DISPLAY PANEL

• NDC 69238-1616-6
• Ofloxacin Otic Solution, 0.3% (10 mL)
• Rx Only
• Amneal Pharmaceuticals LLC

• NDC 69238-1615-3
• Ofloxacin Otic Solution, 0.3% (5 mL)
• Rx Only
• Amneal Pharmaceuticals LLC

SRC: NLM .