GENERIC NAME(S): Gemifloxacin
OTHER NAME(S): Factive Tablet
Quinolone antibiotics (including gemifloxacin) may cause serious and possibly permanent tendon damage (such as tendonitis, tendon rupture), nerve problems in the arms and legs (peripheral neuropathy), and nervous system problems. Get medical help right away if you have any of the following symptoms: pain/numbness/burning/tingling/weakness in your arms/hands/legs/feet, changes in how you sense touch/pain/temperature/vibration/body position, severe/lasting headache, vision changes, shaking (tremors), seizures, mental/mood changes (such as agitation, anxiety, confusion, hallucinations, depression, rare thoughts of suicide).
Tendon damage may occur during or after treatment with this medication. Stop exercising, rest, and get medical help right away if you develop joint/muscle/tendon pain or swelling. 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 a kidney, heart, or lung transplant.
This medication may make a certain muscle condition (myasthenia gravis) worse. Tell your doctor right away if you have new or worsening muscle weakness (such as drooping eyelids, unsteady walk) or trouble breathing.
Discuss the risks and benefits with your doctor before using this medication.Show More
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.
How to use Factive
Take this medication by mouth with or without food as directed by your doctor, usually once daily. The dosage and length of treatment are based on your medical condition and response to treatment. Drink plenty of fluids while taking this drug unless your doctor tells you otherwise.
Take this medication at least 2 hours before or 3 hours after taking other products that may make it work less well. Examples include quinapril, sucralfate, vitamins/minerals (including iron, zinc), and products that contain magnesium or aluminum (such as antacids, didanosine solution), among others. Ask your pharmacist about all the products you take.
For the best effect, take this antibiotic at evenly spaced times. To help you remember, take this medication at the same time 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.
See also Warning section.
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: unusual bruising/bleeding, signs of kidney problems (such as change in the amount of urine), signs of liver problems (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine).
Get medical help right away if you have any very serious side effects, including: chest pain, 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.
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.
Gemifloxacin can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. The risk of developing a rash is higher in people younger than 40 years, in women (especially if on hormone replacement treatment), or when gemifloxacin is taken for longer than 7 days. Stop taking gemifloxacin and get medical help right away if you develop any rash.
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.
Before using gemifloxacin, 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: diabetes, joint/tendon problems (such as tendonitis, bursitis), kidney problems, mental/mood disorders (such as depression), a certain muscle condition (myasthenia gravis), nerve problems (such as peripheral neuropathy), seizure disorder, 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).
Gemifloxacin 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 gemifloxacin, 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 gemifloxacin 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).
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.
Gemifloxacin may cause live bacterial vaccines (such as typhoid vaccine) to not work well. Tell your health care professional that you are using gemifloxacin before having any immunizations/vaccinations.
Children may be at greater risk for joint/tendon problems while using this drug. Discuss the risks and benefits with the doctor.
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 drug passes into breast milk in small amounts. Consult your doctor before breast-feeding.
See also How to Use section.
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.
A product that may interact with this drug is: strontium.
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.
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 tests (such as kidney function, complete blood count, blood sugar, cultures) may be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments.
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.
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.Information last revised June 2022. Copyright(c) 2023 First Databank, Inc.
- GE 320, GE 320
- GE 320, GE 320
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