Generic Name: Gemifloxacin
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 over 60 years old, take corticosteroids (eg, prednisone), or 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 it.
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 quinolone (eg, ciprofloxacin)
- you have abnormal blood electrolyte levels (eg, low potassium or magnesium) or a history of a certain type of irregular heartbeat (eg, QTc 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, heart attack, slow or irregular heartbeat), heart blood vessel problems, low blood potassium or magnesium levels, or a family history of heart problems
- if you have a stomach infection, brain or nervous system problems, muscle problems (eg, myasthenia gravis), increased pressure in the brain, Alzheimer disease, or brain blood vessel problems
- if you have a history of seizures or you are at risk for seizures
- if you have a history of joint or tendon problems; rheumatoid arthritis; liver problems; kidney problems or decreased kidney function; or heart, kidney, or lung transplant
- if you take hormone replacement therapy (HRT) or a corticosteroid (eg, prednisone), 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), certain medicines for heart rhythm disturbances (eg, quinidine, procainamide, amiodarone, sotalol), cisapride, diuretics (eg, hydrochlorothiazide, furosemide), dofetilide, droperidol, haloperidol, ketolides (eg, telithromycin), macrolide antibiotics (eg, erythromycin), phenothiazines (eg, thioridazine), pimozide, terfenadine, tricyclic antidepressants (eg, amitriptyline), ziprasidone, or other medicines that may affect your heartbeat because side effects, such as racing heartbeat, dizziness, fainting, or life-threatening irregular heartbeat leading to unconsciousness, may be increased by Factive . Ask your doctor if you are unsure if any of your medicines may affect your heartbeat
- Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) or probenecid because they may increase the risk of Factive 's side effects
- Oral anticoagulants (eg, warfarin) because the risk of bleeding may be increased by Factive
- Sulfonylureas (eg, glyburide) because the risk of side effects, including low blood sugar, may be increased by Factive
- Corticosteroids (eg, prednisone) because the risk of tendon problems may be increased
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.
- If you are also taking aluminum or magnesium (eg, antacids), calcium, iron, zinc, multivitamins, or buffered 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 lightheadedness. 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 use the antibiotic or within several months after you stop using 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.
- 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 further instruction from your doctor.
- 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 the medicine 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 using Factive while you are pregnant. It is not known if Factive is found in breast milk. If you are or will be breast-feeding while you use 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:
Diarrhea; dizziness; drowsiness; headache; nausea; stomach upset; vomiting.
Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bloody or tarry stools; burning, numbness, tingling, pain, or weakness of the arms, hands, legs, or feet; chest pain or pounding in the chest; dark urine; decreased urination; excessive hunger, thirst, or urination; fainting; fast or irregular heartbeat; fever, chills, sore throat, or unusual cough; "fruity"-smelling breath; hallucinations; hoarseness; 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, restlessness, sleeplessness); muscle pain or weakness; nervousness; pain, soreness, redness, swelling, weakness, or bruising of a tendon or joint area; red, swollen, blistered, or peeling skin; restlessness; seizures; severe or persistent diarrhea; severe or persistent dizziness or lightheadedness; shortness of breath; stomach pain/cramps; suicidal thoughts or actions; sweating; tremors; unusual bruising or bleeding; unusual swelling or weight gain; unusual weakness or tiredness; vaginal odor or discharge; vision changes; yellowing of the eyes or skin.
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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.Proper storage of Factive :
Store Factive at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. 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.
This information is a summary only. It does not contain all information about Factive . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
- Factive Prescribing Information (FDA)
- Factive Detailed Consumer Information (PDR)
- Factive Concise Consumer Information (Cerner Multum)
- Factive Advanced Consumer (Micromedex) - Includes Dosage Information