Floxin

DRUG DESCRIPTION

FLOXIN® (ofloxacin tablets) Tablets is a synthetic broad-spectrum antimicrobial agent for oral administration. Chemically, ofloxacin, a fluorinated carboxyquinolone, is the racemate, (±)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid. The chemical structure is:

FLOXIN® (ofloxacin) Structural Formula Illustration

Its empirical formula is C18H20FN3O4, and its molecular weight is 361.4 Ofloxacin is an off-white to pale yellow crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine. The relative solubility characteristics of ofloxacin at room temperature, as defined by USP nomenclature, indicate that ofloxacin is considered to be soluble in aqueous solutions with pH between 2 and 5. It is sparingly to slightly soluble in aqueous solutions with pH 7 (solubility falls to 4 mg/mL) and freely soluble in aqueous solutions with pH above 9. Ofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order: Fe+3 > Al+3 > Cu +2 > Ni+2 > Pb+2 > Zn+2 > Mg+2 > Ca+2 > Ba+2.

FLOXIN® (ofloxacin) Tablets contain the following inactive ingredients: anhydrous lactose, modified corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 80, sodium starch glycolate, titanium dioxide and may also contain synthetic yellow iron oxide.

What are the possible side effects of ofloxacin (Floxin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using ofloxacin and call your doctor at once if you have any of these serious side effects:

  • diarrhea that is watery or bloody;
  • seizure (convulsions);
  • confusion, hallucinations, unusual thoughts or behavior;
  • dizziness, fainting, fast or pounding heartbeat;
  • sudden pain or swelling near your joints (especially in your arm...

Read All Potential Side Effects and See Pictures of Floxin »

What are the precautions when taking ofloxacin (Floxin)?

Before taking ofloxacin, tell your doctor or pharmacist if you are allergic to it; or to other quinolone antibiotics (e.g., ciprofloxacin, levofloxacin); or if you have any other allergies. This product may contain inactive ingredients, 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: seizure disorder, conditions that increase your risk of seizures (e.g., brain/head injury, brain tumors), nervous system disorders (e.g., peripheral neuropathy), kidney disease, liver disease, myasthenia gravis, joint/tendon problems (e.g., tendonitis, bursitis).

Ofloxacin may cause a condition that affects the heart rhythm (QT prolongation). QT...

Read All Potential Precautions of Floxin »


Floxin Consumer (continued)

SIDE EFFECTS: See also Warning section.

Upset stomach, nausea, diarrhea, headache, dizziness, lightheadedness, or trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she 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 immediately if any of these unlikely but serious side effects occur: sunburn-like skin reaction (sun sensitivity), shaking, mental/mood changes (e.g., nervousness, confusion, hallucinations, rare thoughts of suicide).

Tell your doctor immediately if any of these rare but very serious side effects occur: severe/persistent headache, vision problems, hearing changes, unsteadiness, seizures, persistent nausea/vomiting, stomach/abdominal pain, yellowing eyes/skin, dark urine, unusual tiredness, easy bruising/bleeding, signs of a new infection (e.g., fever, persistent sore throat), unusual change in the amount of urine.

Seek immediate medical attention if any of these rare but very serious side effects occur: severe dizziness, fainting, fast/irregular heartbeat.

Ofloxacin may rarely cause serious nerve problems that may be reversible if identified and treated early. Seek immediate medical attention if you develop any of the following symptoms: pain/numbness/burning/tingling/weakness in any part of the body, changes in how you sense touch/pain/temperature/body position/vibration.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, chest pain.

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.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking ofloxacin, tell your doctor or pharmacist if you are allergic to it; or to other quinolone antibiotics (e.g., ciprofloxacin, levofloxacin); or if you have any other allergies. This product may contain inactive ingredients, 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: seizure disorder, conditions that increase your risk of seizures (e.g., brain/head injury, brain tumors), nervous system disorders (e.g., peripheral neuropathy), kidney disease, liver disease, myasthenia gravis, joint/tendon problems (e.g., tendonitis, bursitis).

Ofloxacin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using ofloxacin, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using ofloxacin safely.

If you have diabetes, you may experience changes in blood glucose levels due to infection or use of ofloxacin. Symptoms of high blood sugar include increased thirst and urination. Symptoms of low blood sugar include nervousness, shaking, sweating, fast heartbeat, or hunger. Follow your doctor's instructions to treat your low blood sugar level (e.g., take glucose tablets or gel; eat a quick source of sugar such as table sugar, honey, or candy; drink a glass of orange juice or non-diet soda). Tell your doctor immediately if you experience symptoms of high or low blood sugar while taking this medication. Monitor your blood glucose levels as directed by your doctor.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Caution is advised when using this medication in children younger than 18 years of age because they may be at greater risk for joint/tendon problems. Discuss the risks and benefits with the doctor.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, the elderly may be at greater risk for tendon problems while using this drug, especially if they are also taking corticosteroids (e.g., prednisone, hydrocortisone). The elderly may also be more sensitive to the side effect of ofloxacin on the heart rhythm (QT prolongation).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Though there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.


Floxin Patient Information Including Side Effects

Brand Names: Floxin

Generic Name: ofloxacin (Pronunciation: oh FLOX a sin)

  • What is ofloxacin (Floxin)?
  • What are the possible side effects of ofloxacin (Floxin)?
  • What is the most important information I should know about ofloxacin (Floxin)?
  • What should I discuss with my healthcare provider before taking ofloxacin (Floxin)?
  • How should I take ofloxacin (Floxin)?
  • What happens if I miss a dose (Floxin)?
  • What happens if I overdose (Floxin)?
  • What should I avoid while taking ofloxacin (Floxin)?
  • What other drugs will affect ofloxacin (Floxin)?
  • Where can I get more information?

What is ofloxacin (Floxin)?

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 other purposes not listed in this medication guide.

What are the possible side effects of ofloxacin (Floxin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using ofloxacin and call your doctor at once if you have any of these serious side effects:

  • diarrhea that is watery or bloody;
  • seizure (convulsions);
  • confusion, hallucinations, unusual thoughts or behavior;
  • dizziness, fainting, fast or pounding heartbeat;
  • sudden pain or swelling near your joints (especially in your arm or ankle);
  • easy bruising or bleeding;
  • urinating less than usual or not at all;
  • numbness, burning, pain, or tingly feeling in your hands or feet;
  • pale or yellowed skin, dark colored urine, fever, weakness;
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
  • the first sign of any skin rash, no matter how mild.

Less serious side effects may include:

  • nausea, vomiting, stomach pain, constipation;
  • feeling restless or anxious;
  • headache, dizziness;
  • muscle pain;
  • sleep problems (insomnia), or nightmares;
  • vaginal itching or discharge; or
  • mild skin itching.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about ofloxacin (Floxin)?

You should not use this medication if you are allergic to ofloxacin or similar antibiotics such as ciprofloxacin (Cipro), levofloxacin (Levaquin), norfloxacin (Noroxin), lomefloxacin (Maxaquin), and others.

Before taking ofloxacin, tell your doctor if you have kidney or liver disease, joint problems, myasthenia gravis, seizures or epilepsy, diabetes, low levels of potassium in your blood (hypokalemia), or a personal or family history of "Long QT syndrome."

Avoid taking antacids, vitamin or mineral supplements, sucralfate (Carafate), or didanosine (Videx) powder or chewable tablets within 2 hours before or after you take ofloxacin. These other medicines can make ofloxacin much less effective when taken at the same time.

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 an oral 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.

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