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Ofloxacin 300 Mg Tab 100

  • Manufacturer Name : NIVAGEN PHARMAC
  • MFG # : 75834020001
  • NDC : 75834020001
  • Distributor Name : AmeriSource Bergen
PID UOM Price Qty
310615 UN
$1,629.30
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ofloxacin ORAL TABLET 300 MG

Product Properties:

Description -
Description -
DESI Drug Ind -
DESI Drug Ind -
DESI2 Drug Ind -
DESI2 Drug Ind AB
Drug Category N
Drug Category -
Drug Type Code 1
Drug Type Code N
FDA Approval Date 07/15/2016
FDA Approval Date 09/18/2014
FDA Therap Equiv AB
FDA Therap Equiv TAB
HCPCS -
HCPCS -
Market Entry Date 07/15/2016
Market Entry Date -
Medical Coverage -
Medical Coverage -
Termination Date -
Termination Date 1
Unit 100
Unit TAB
Units Per Pkg 100
Units Per Pkg 09/18/2014
Active Ingredients 3563 ofloxacin 82419361
Active Ingredients 3563 ofloxacin 82419361
AHFS Class 8121800 QUINOLONE ANTIBIOTICS
AHFS Class 8121800 QUINOLONE ANTIBIOTICS
DEA Class NC
DEA Class NC
Dose Form TABLET
Dose Form TABLET
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 15601 ofloxacin ORAL TABLET 300 MG
Gen Code and Des 15601 ofloxacin ORAL TABLET 300 MG
Inactive Ingredients -
Inactive Ingredients -
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength 300MG
Strength 300MG
Common Brand Name COMMON BRAND NAME(S): Floxin
Common Brand Name COMMON BRAND NAME(S): Floxin
Drug Interaction DRUG INTERACTIONS: See also Warning, How to Use, and Precautions sections. 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. Some products that may interact with this drug include: "blood thinners" (such as acenocoumarol, warfarin), strontium. Many drugs besides ofloxacin may affect the heart rhythm (QT prolongation), including dofetilide, procainamide, amiodarone, quinidine, sotalol, among others. Ofloxacin is very similar to levofloxacin. Do not use medications containing levofloxacin while using ofloxacin. This medication may interfere with certain laboratory tests (such as urine screening for opiates), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
Drug Interaction DRUG INTERACTIONS: See also Warning, How to Use, and Precautions sections. 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. Some products that may interact with this drug include: "blood thinners" (such as acenocoumarol, warfarin), strontium. Many drugs besides ofloxacin may affect the heart rhythm (QT prolongation), including dofetilide, procainamide, amiodarone, quinidine, sotalol, among others. Ofloxacin is very similar to levofloxacin. Do not use medications containing levofloxacin while using ofloxacin. This medication may interfere with certain laboratory tests (such as urine screening for opiates), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
Allocation Period -
Allocation Period -
Case Quantity 6
Case Quantity 6
Drug Form Pack Size 100
Drug Form Pack Size 100
Form TABLET
Form TABLET
Hazard Code -
Hazard Code -
Listed Chemical -
Listed Chemical -
NIOSH Code -
NIOSH Code -
Orange Book AB Products meeting necessary bioequivalence requirements.
Orange Book AB Products meeting necessary bioequivalence requirements.
Retail Pack Quantity 1
Retail Pack Quantity 1
Returnable Status Returnable
Returnable Status Returnable
Special Storage Cond 00 None
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Temp Zone 10 Room Temperature
Unit EA
Unit EA
Unit Size 100
Unit Size 100
How to Use 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, ask your doctor or pharmacist. Take this medication by mouth with or without food as directed by your doctor, usually twice a day (every 12 hours). The dosage and length of treatment is based on your medical condition and response to treatment. Drink plenty of fluids while taking this medication unless your doctor tells you otherwise. Take this medication at least 2 hours before or 2 hours after taking other products that may bind to it, decreasing its effectiveness. Ask your pharmacist about the other products you take. Some examples include: quinapril, sucralfate, vitamins/minerals (including iron and zinc supplements), and products containing magnesium, aluminum, or calcium (such as antacids, didanosine solution, calcium supplements). For the best effect, take this antibiotic at evenly spaced times. To help you remember, take this medication at the same time(s) every day. 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. Tell your doctor if your condition lasts or gets worse.
How to Use 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, ask your doctor or pharmacist. Take this medication by mouth with or without food as directed by your doctor, usually twice a day (every 12 hours). The dosage and length of treatment is based on your medical condition and response to treatment. Drink plenty of fluids while taking this medication unless your doctor tells you otherwise. Take this medication at least 2 hours before or 2 hours after taking other products that may bind to it, decreasing its effectiveness. Ask your pharmacist about the other products you take. Some examples include: quinapril, sucralfate, vitamins/minerals (including iron and zinc supplements), and products containing magnesium, aluminum, or calcium (such as antacids, didanosine solution, calcium supplements). For the best effect, take this antibiotic at evenly spaced times. To help you remember, take this medication at the same time(s) every day. 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. Tell your doctor if your condition lasts or gets worse.
Missed Dose 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. Take your next dose at the regular time. Do not double the dose to catch up.
Missed Dose 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. Take 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. Lab and/or medical tests may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.
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. Lab and/or medical tests may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.
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. Symptoms of overdose may include: severe dizziness.
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. Symptoms of overdose may include: severe dizziness.
Phonetic Pronunciation (oh-FLOX-uh-sin)
Phonetic Pronunciation (oh-FLOX-uh-sin)
Precautions PRECAUTIONS: See also Warning section. Before taking 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, 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 (such as brain/head injury, brain tumors), nerve problems (such as peripheral neuropathy), kidney disease, liver disease, mental/mood disorders (such as depression), myasthenia gravis, joint/tendon problems (such as tendonitis, bursitis), blood vessel problems (such as aneurysm or blockage of the aorta or other blood vessels, hardening of the arteries), high blood pressure, certain genetic conditions (Marfan syndrome, Ehlers-Danlos syndrome). Ofloxacin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using ofloxacin, tell your doctor or pharmacist of all the drugs you take and 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. This medication may rarely cause serious changes in blood sugar, especially if you have diabetes. Check your blood sugar regularly as directed and share the results with your doctor. Watch for symptoms of high blood sugar, such as increased thirst/urination. Also watch for symptoms of low blood sugar such as sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or by drinking fruit juice or non-diet soda. Tell your doctor right away about the reaction and the use of this product. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. 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. 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). Ofloxacin may cause live bacterial vaccines (such as typhoid vaccine) to not work well. Tell your health care professional that you are using ofloxacin before having any immunizations/vaccinations. This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Children may be more sensitive to the side effects of this drug, especially joint/tendon problems. Older adults may be at greater risk for tendon problems (especially if they are also taking corticosteroids such as prednisone or hydrocortisone), QT prolongation, and a sudden tear/break in the main blood vessel (aorta). 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. Consult your doctor before breast-feeding.
Precautions PRECAUTIONS: See also Warning section. Before taking 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, 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 (such as brain/head injury, brain tumors), nerve problems (such as peripheral neuropathy), kidney disease, liver disease, mental/mood disorders (such as depression), myasthenia gravis, joint/tendon problems (such as tendonitis, bursitis), blood vessel problems (such as aneurysm or blockage of the aorta or other blood vessels, hardening of the arteries), high blood pressure, certain genetic conditions (Marfan syndrome, Ehlers-Danlos syndrome). Ofloxacin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using ofloxacin, tell your doctor or pharmacist of all the drugs you take and 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. This medication may rarely cause serious changes in blood sugar, especially if you have diabetes. Check your blood sugar regularly as directed and share the results with your doctor. Watch for symptoms of high blood sugar, such as increased thirst/urination. Also watch for symptoms of low blood sugar such as sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or by drinking fruit juice or non-diet soda. Tell your doctor right away about the reaction and the use of this product. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. 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. 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). Ofloxacin may cause live bacterial vaccines (such as typhoid vaccine) to not work well. Tell your health care professional that you are using ofloxacin before having any immunizations/vaccinations. This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Children may be more sensitive to the side effects of this drug, especially joint/tendon problems. Older adults may be at greater risk for tendon problems (especially if they are also taking corticosteroids such as prednisone or hydrocortisone), QT prolongation, and a sudden tear/break in the main blood vessel (aorta). 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. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: See also Warning section. Upset stomach, nausea, diarrhea, headache, dizziness, lightheadedness, or trouble sleeping 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: easy bruising/bleeding, signs of a new infection (such as sore throat that doesn't go away, fever), signs of kidney problems (such as change in the amount of urine), signs of liver problems (such as nausea/vomiting that doesn't stop, unusual tiredness, stomach/abdominal pain, yellowing eyes/skin, dark urine). Get medical help right away if you have any very serious side effects, including: hearing changes, unsteadiness, severe dizziness, fainting, fast/irregular heartbeat, signs of a tear/break in the main blood vessel called the aorta (such as sudden/severe pain in the stomach/chest/back, shortness of breath). This medication may rarely cause a severe intestinal condition due to a bacteria called C. difficile. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop: diarrhea that doesn't stop, abdominal or stomach pain/cramping, blood/mucus in your stool. If you have these symptoms, do not use anti-diarrhea or opioid products because they may make symptoms worse. Use of this medication for prolonged or repeated periods may result in oral thrush or a new 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, 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.
Side Effects SIDE EFFECTS: See also Warning section. Upset stomach, nausea, diarrhea, headache, dizziness, lightheadedness, or trouble sleeping 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: easy bruising/bleeding, signs of a new infection (such as sore throat that doesn't go away, fever), signs of kidney problems (such as change in the amount of urine), signs of liver problems (such as nausea/vomiting that doesn't stop, unusual tiredness, stomach/abdominal pain, yellowing eyes/skin, dark urine). Get medical help right away if you have any very serious side effects, including: hearing changes, unsteadiness, severe dizziness, fainting, fast/irregular heartbeat, signs of a tear/break in the main blood vessel called the aorta (such as sudden/severe pain in the stomach/chest/back, shortness of breath). This medication may rarely cause a severe intestinal condition due to a bacteria called C. difficile. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop: diarrhea that doesn't stop, abdominal or stomach pain/cramping, blood/mucus in your stool. If you have these symptoms, do not use anti-diarrhea or opioid products because they may make symptoms worse. Use of this medication for prolonged or repeated periods may result in oral thrush or a new 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, 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 and moisture. Do not store in the bathroom. 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.
Storage STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. 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: 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 (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.
Uses 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 (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

Frequently Asked Questions(FAQs)

The cost of OFLOXACIN 300 MG TAB 100 is $ 1629.30.
OFLOXACIN 300 MG TAB 100 is manufactured by NIVAGEN PHARMAC.
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