Generic Name: gemifloxacin (JEM-i-FLOX-a-sin)
Brand Name: Factive
Factive is associated with an increased risk of tendon problems. These include pain, swelling, inflammation, and possible breakage of tendons. The risk of tendon problems is greater in patients who are older than 60 years old, patients who take corticosteroids (eg, prednisone), or in those who have received kidney, heart, or lung transplants. The Achilles tendon in the back of the foot/ankle area is most often affected. However, problems may also occur in other tendons (eg, in the shoulder, arm, or hand). Problems may occur while you take Factive or up to several months after you stop taking it.
Signs of tendon problems may include pain, soreness, redness, or swelling of a tendon or joint; bruising right after an injury in a tendon area; hearing or feeling a snap or pop in a joint or tendon area; or inability to move or bear weight on a joint or tendon area. Tell your doctor right away if you experience any of these symptoms while you take Factive or within several months after you stop taking it.
Factive may worsen muscle weakness and breathing problems in patients with myasthenia gravis. Do not take Factive if you have a history of myasthenia gravis.
Factive is used for:
Treating infections caused by certain bacteria.
Factive is a fluoroquinolone antibiotic. It works by killing sensitive bacteria.
Do NOT use Factive if:
- you are allergic to any ingredient in Factive or to any other fluoroquinolone antibiotic (eg, ciprofloxacin)
- you have uncorrected blood electrolyte levels (eg, low potassium or magnesium)
- you have a history of myasthenia gravis or of a certain type of irregular heartbeat (eg, QT interval prolongation)
- you are taking certain medicines for heart rhythm problems (eg, amiodarone, procainamide, quinidine, sotalol)
Contact your doctor or health care provider right away if any of these apply to you.
Before using Factive:
Some medical conditions may interact with Factive. Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of diabetes, severe or persistent diarrhea, skin sensitivity to the sun, heart problems (eg, abnormal heart function tests, congestive heart failure, a heart attack, slow or irregular heartbeat), heart blood vessel problems, or low blood potassium or magnesium levels
- if you have a family history of irregular heartbeat (QT prolongation)
- if you have a stomach infection, brain or nervous system problems, increased pressure in the brain, Alzheimer disease, or brain blood vessel problems
- if you have a history of seizures or you are at risk of seizures
- if you have a history of joint or tendon problems; rheumatoid arthritis; liver problems; kidney problems or decreased kidney function; or a heart, kidney, or lung transplant
- if you take hormone replacement therapy (HRT) or if you participate in strenuous physical work or exercise
Some MEDICINES MAY INTERACT with Factive. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Arsenic, astemizole, azole antifungals (eg, ketoconazole), cisapride, diuretics (eg, hydrochlorothiazide, furosemide), droperidol, haloperidol, ketolides (eg, telithromycin), macrolide antibiotics (eg, erythromycin), certain medicines for heart rhythm disturbances (eg, dofetilide, quinidine, procainamide, amiodarone, sotalol), phenothiazines (eg, thioridazine), pimozide, terfenadine, tricyclic antidepressants (eg, amitriptyline), ziprasidone, or any other medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval) because side effects, such as racing heartbeat, dizziness, fainting, or life-threatening irregular heartbeat leading to unconsciousness, may be increased by Factive. Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat
- Corticosteroids (eg, prednisone) because the risk of tendon problems may be increased
- Oral anticoagulants (eg, warfarin) because the risk of bleeding may be increased by Factive
- Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) or probenecid because they may increase the risk of Factive's side effects
- Sulfonylureas (eg, glyburide) because the risk of side effects, including low blood sugar, may be increased by Factive
This may not be a complete list of all interactions that may occur. Ask your health care provider if Factive may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Factive:
Use Factive as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Factive comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Factive refilled.
- Take Factive by mouth with or without food.
- Swallow Factive whole. Do not break, crush, or chew before swallowing.
- Take Factive with a full glass of water (8 oz/240 mL).
- Factive works best if it is taken at the same time each day.
- Drinking extra fluids while you are taking Factive is recommended. Check with your doctor for instructions.
- Avoid taking Factive with dairy products (eg, milk, yogurt) or calcium-fortified juices by themselves. However, taking Factive as part of a full meal that contains these products is permitted.
- If you are also taking aluminum or magnesium (eg, certain antacids), calcium, iron, zinc, multivitamins, or certain forms of didanosine (chewable/buffered tablets, pediatric powder for oral solution), do not take it within 3 hours before or 2 hours after you take Factive.
- If you are also taking sucralfate, take Factive at least 2 hours before taking sucralfate.
- To clear up your infection completely, take Factive for the full course of treatment. Keep taking it even if you feel better in a few days.
- Do not miss any doses of Factive. If you miss a dose, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take more than 1 dose in the same day.
Ask your health care provider any questions you may have about how to use Factive.
Important safety information:
- Factive may cause dizziness, drowsiness, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Factive with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Factive only works against bacteria; it does not treat viral infections (eg, the common cold).
- Be sure to use Factive for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
- Long-term or repeated use of Factive may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
- Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you take the antibiotic or within several months after you stop taking it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.
- Nerve problems in the arms, hands, legs, or feet can happen in people taking Factive. These nerve problems can happen soon after Factive is started and may be permanent. Call your doctor right away if you have symptoms or nerve problems (eg, not able to handle heat or cold; decreased sensation of touch; unusual burning, numbness, tingling, pain, or weakness of the arms, hands, legs, or feet).
- Tell your doctor right away if you experience pain or swelling of a tendon, or weakness or loss of use of a joint area. Rest the area and avoid exercise until your doctor gives you instructions.
- Factive may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Factive. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
- Some patients taking Factive have developed a rash. This may be more likely if you are younger than 40 years old, are a woman, are taking hormone replacement therapy, or take Factive for longer than 5 days. Contact your doctor if you develop a rash.
- Diabetes patients - Factive may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- Use Factive with caution in the ELDERLY; they may be more sensitive to its effects (eg, tendon problems), especially if they take corticosteroids (eg, prednisone). They may also be more sensitive to other effects (eg, irregular heartbeat).
- Factive should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed. They may also be more sensitive to the effects of Factive, including bone and joint problems.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Factive while you are pregnant. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you take Factive, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of Factive:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Diarrhea; dizziness; headache; mild stomach pain; nausea; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); bloody or tarry stools; chest pain or pounding in the chest; decreased urination; excessive hunger, thirst, or urination; fainting; fast or irregular heartbeat; fever, chills, sore throat, or unusual cough; fruit-like breath odor; hallucinations; inability to move or bear weight on a joint or tendon area; joint pain; moderate or severe sunburn; mood or mental changes (eg, new or worsening anxiety, agitation, confusion, depression, nervousness, paranoia, restlessness); muscle pain or weakness; nightmares; pain, soreness, redness, swelling, weakness, or bruising of a tendon or joint area; pale stools; red, swollen, blistered, or peeling skin; seizures; severe or persistent diarrhea; severe or persistent dizziness, headache, or light-headedness; shortness of breath or trouble breathing; sleeplessness; stomach pain or cramps; suicidal thoughts or actions; sweating; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, yellowing of the skin or eyes); tremors; unusual bruising or bleeding; unusual swelling or weight gain; unusual weakness or tiredness; vaginal odor or discharge; vision changes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Factive:
Store Factive at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Factive out of the reach of children and away from pets.
- If you have any questions about Factive, please talk with your doctor, pharmacist, or other health care provider.
- Factive is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Factive or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Factive. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Factive. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Factive.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.