Floxin

Black Box Warnings

Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together including: tendinitis and tendon rupture, peripheral neuropathy, and CNS effects

Discontinue the drug immediately and avoid use of systemic fluoroquinolones in patients who experience any of these serious adverse reactions

May exacerbate muscle weakness in patients with myasthenia gravis; avoid fluoroquinolones with known history of myasthenia gravis

Serious adverse effects and limitations-of-use

• Both oral and injectable fluroquinolones are associated with disabling side effects involving tendons, muscles, joints, nerves and the central nervous system
• These side effects can occur hours to weeks after exposure to fluoroquinolones and may potentially be permanent
• Because the risk of these serious side effects generally outweighs the benefits for patients with acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated UTIs, that fluoroquinolones should be reserved for use in patients with these conditions who have no alternative treatment options
• For some serious bacterial infections, including anthrax, plague, and bacterial pneumonia among others, the benefits of fluoroquinolones outweigh the risks and it is appropriate for them to remain available as a therapeutic option

Contraindications

Documented hypersensitivity

Cautions

May produce false-positive urine opiate screening

No longer recommended for gonorrhea due to widespread resistance in the US

In prolonged therapy, perform periodic evaluations of organ system functions (eg, renal, hepatic, hematopoietic); adjust dose in renal function impairment; superinfections may occur with prolonged or repeated antibiotic therapy

Not drug of first choice in pediatrics due to increased incidence of adverse events compared to controls, including arthropathy; no data exist for dose for pediatric patients with renal impairment (ie, CrCl <50 mL/min)

Convulsions, increased intracranial pressure (including pseudotumor cerebri), and toxic psychosis reported with fluoroquinolones

Acute onset of retinal detachment increased 4.5-fold with oral fluoroquinolones in a single case-controlled study - JAMA 2012;307(13):1414-1419; another study disputes these findings (relative risk, 1.29) - JAMA 2013;310(20):2184-2190

Peripheral neuropathy

• Peripheral neuropathy may occur rapidly after initiating therapy and may potentially become permanent
• Development of peripheral neuropathy appears to be unrelated to the duration of therapy or the age of the patient
• If peripheral neuropathy develops, discontinue the fluoroquinolone and treat with an alternative non-fluoroquinolone antibacterial drug, unless the benefit of continued treatment with a fluoroquinolone outweighs the risk

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Floxin is part of the drug class:

• Otological Antiinfectives

Serious side effects have been reported with Floxin. See the “Floxin Precautions” section.

Common side effects of Floxin include the following:

• nausea
• diarrhea
• constipation
• gas
• vomiting
• stomach pain or cramps
• change in ability to taste food
• loss of appetite
• dry mouth
• headache
• dizziness
• excessive tiredness
• pain, swelling, or itching of the vagina

This is not a complete list of Floxin side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• Store Floxin tablets at room temperature.
• Avoid prolonged exposure to the sun while taking Floxin.
• Do not take antacids within 2 hours of taking Floxin.
• Keep this and all medicines out of the reach of children.

Ofloxacin is in a group of antibiotics called fluoroquinolones (flor-o-KWIN-o-lones). Ofloxacin fights bacteria in the body.

Ofloxacin is used to treat bacterial infections that cause bronchitis, pneumonia, chlamydia, gonorrhea, skin infections, urinary tract infections, and infections of the prostate.

Ofloxacin may also be used for purposes not listed in this medication guide.

You should not use this medication if you have a history of myasthenia gravis, or if you are allergic to ofloxacin or similar antibiotics such as ciprofloxacin (Cipro), gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), and others.

To make sure you can safely take ofloxacin, tell your doctor if you have any of these other conditions:

• heart rhythm disorder, especially if you take quinidine (Quin-G), disopyramide (Norpace), bretylium (Bretylol), procainamide (Pronestyl, Procan SR), amiodarone (Cordarone, Pacerone), or sotalol (Betapace);
• a history of allergic reaction to an antibiotic;
• muscle weakness or trouble breathing;
• joint problems;
• kidney or liver disease;
• epilepsy or a history of seizures;
• diabetes;
• low levels of potassium in your blood (hypokalemia); or
• a personal or family history of Long QT syndrome.

Ofloxacin can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using ofloxacin.

FDA pregnancy category C. It is not known whether ofloxacin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Ofloxacin may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the Achilles' tendon of the heel. These effects may be more likely to occur if you are over 60, if you take steroid medication, or if you have had a kidney, heart, or lung transplant. Stop taking ofloxacin and call your doctor at once if you have sudden pain, swelling, tenderness, stiffness, or movement problems in any of your joints. Rest the joint until you receive medical care or instructions.

Do not share this medication with another person (especially a child), even if they have the same symptoms you have.

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Ofloxacin is used to treat certain bacterial infections in many different parts of the body. It may also be used for other problems as determined by your doctor. Ofloxacin may mask or delay the symptoms of syphilis. It is not effective against syphilis infections.

Ofloxacin belongs to the class of drugs known as fluoroquinolone antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

This medicine is available only with your doctor's prescription.

Floxin®Otic (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 empirical formula of ofloxacin is C18H20FN3O4and its molecular weight is 361.38. The structural formula is:

Floxin®Otic contains 0.3% (3mg/ml) ofloxacin with benzalkonium chloride (0.0025%), sodium chloride (0.9%), and water for injection. Hydrochloric acid and sodium hydroxide are added to adjust the pH to 6.5 ± 0.5.

Floxin®Otic (ofloxacin otic solution) 0.3% is contraindicated in patients with a history of hypersensitivity to ofloxacin, to other quinolones, or to any of the components in this medication.

Floxin®Otic (ofloxacin otic solution) 0.3% is supplied in plastic dropper bottles containing 5 ml and 10 ml.

NDC 63395-101-05 Floxin®Otic 5ml

NDC 63395-101-10 Floxin®Otic 10 ml

Note: Store at 25 C (77 F), excursions permitted to 15-30 (59-86 F). Protect from light.

Rx Only

Daiichi Sankyo Pharma Development, a division of Daiichi Sankyo, Inc.

Edison, NJ 08837

Revised: November 2006

Covered by U.S. Patent No. 5,401,741

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

LactMed Record Number

204

Last Revision Date

20170808

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