Product Summary

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PRESCRIPTION REQUIRED

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs. OFLOXACIN - ORAL (oh-FLOX-uh-sin) COMMON BRAND NAME(S): Floxin WARNING: This medication may rarely cause tendon damage (e.g., tendinitis, tendon rupture) during or after treatment. Your risk for tendon problems is greater if you are over 60 years of age, if you are taking corticosteroids (such as prednisone), or if you have had a kidney, heart or lung transplant. Stop exercising, rest, and seek immediate medical attention if you develop joint/muscle/tendon pain or swelling. Ofloxacin should not be used in patients with myasthenia gravis. It may cause the condition to become worse. Seek immediate medical attention if you develop muscle weakness or trouble breathing.

USES: This medication is used to treat a variety of bacterial infections. Ofloxacin belongs to a class of drugs called quinolone antibiotics. It works by stopping the growth of bacteria. This antibiotic treats only bacterial infections. It will not work for viral infections (e.g., common cold, flu). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking ofloxacin and each time you get a refill. If you have any questions, consult your doctor or pharmacist. Take this medication by mouth with or without food, usually twice a day (in the morning and evening), or as directed by your doctor. Drink plenty of fluids while taking this medication unless your doctor tells you otherwise. The dosage and length of treatment is based on your medical condition and response to treatment. Take this medication 2 hours before or 2 hours after taking any medications containing magnesium, aluminum, or calcium. Some examples include quinapril, certain forms of didanosine (chewable/dispersible buffered tablets or pediatric oral solution), vitamins/minerals, and antacids. Sucralfate, bismuth subsalicylate, iron, and zinc are also included. These medications bind with ofloxacin preventing its full absorption. Antibiotics work best when the amount of medicine in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals. Continue to take this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection. Inform your doctor if your condition persists or worsens.

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. Your doctor may need to switch you to another antibiotic or adjust your diabetes medications if any reaction occurs. 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.

DRUG INTERACTIONS: See also How to Use section. Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first. This drug should not be used with the following medication because very serious interactions may occur: strontium ranelate. If you are currently using the medication listed above, tell your doctor or pharmacist before starting ofloxacin. Many drugs besides ofloxacin may affect the heart rhythm (QT prolongation), including dofetilide, pimozide, procainamide, amiodarone, quinidine, sotalol, macrolide antibiotics (such as erythromycin), among others. Therefore, before using ofloxacin, report all medications you are currently using to your doctor or pharmacist. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: corticosteroids (e.g., dexamethasone, prednisone), duloxetine, live bacterial vaccines, nonsteroidal anti-inflammatory drugs (NSAIDs such as ibuprofen, naproxen), probenecid, theophylline, warfarin. Also report the use of drugs which might increase seizure risk when combined with ofloxacin such as isoniazid (INH), phenothiazines (e.g., thioridazine), theophylline, or tricyclic antidepressants (e.g., amitriptyline), among others. Consult your doctor or pharmacist for details. Although most antibiotics probably do not affect hormonal birth control such as pills, patch, or ring, some antibiotics may decrease their effectiveness. This could cause pregnancy. Examples include rifamycins such as rifampin or rifabutin. Be sure to ask your doctor or pharmacist if you should use additional reliable birth control methods while using this antibiotic. This medication may interfere with certain laboratory tests (e.g., urine screening for opiates), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe dizziness.

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 told to do so by your doctor. A different medication may be necessary in that case. Laboratory and/or medical tests may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature at 77 degrees F (25 degrees C) in a tightly closed container away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines 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 for more details about how to safely discard your product. Information last revised June 2012. Copyright(c) 2012 First Databank, Inc.

Ofloxacin 300mg Tablet