DrugindexOnline^{2nd edition}

Generic Name: Gemifloxacin (je-mi-FLOX-a-sin)
Brand Name: Factive

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 other quinolones (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 medicines for heart rhythm disturbances (eg, quinidine, procainamide, amiodarone, sotalol), or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen)

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 or a family history of heart problems (eg, slow or irregular heartbeat, congestive heart failure), lack of blood supply to your heart, heart attack, abnormal heart function tests, or low blood potassium or magnesium levels
• if you have a history of diabetes, kidney or liver problems, skin sensitivity to sunlight, or if you will be exposed to sunlight over a long period of time
• if you have Alzheimer disease, tendonitis, a history of seizures, or if you are at risk for seizures
• if you have nerve or brain disease, hardening or narrowing of the arteries in the brain, or increased pressure in the head

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.
• NSAIDs (eg, ibuprofen) because the risk of side effects, including seizures, may be increased
• Oral anticoagulants (eg, warfarin) because side effects, including 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

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 may be taken with or without food.
• Swallow 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 them within 3 hours before or 2 hours after Factive .
• If you are also taking sucralfate, take Factive at least 2 hours before taking sucralfate.
• To clear up your infection completely, continue using Factive for the full course of treatment 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. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Factive . Using Factive alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
• Factive is effective only against bacteria. It is not effective for treating viral infections (eg, the common cold).
• It is important to use Factive for the full course of treatment. Failure to do so may decrease the effectiveness of Factive and may increase the risk that the bacteria will no longer be sensitive to Factive and will not be able to be treated by this or certain other antibiotics in the future.
• Long-term or repeated use of Factive may cause a second infection. Your doctor may want to change your medicine to treat the second infection. Contact your doctor if signs of a second infection occur.
• If severe diarrhea, stomach pain/cramps or bloody stools occur, contact your doctor immediately. This could be a symptom of a serious side effect requiring immediate medical attention. Do not treat diarrhea without consulting your doctor.
• Factive may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Factive . Use a sunscreen or protective clothing if you must be outside for a prolonged period.
• Diabetes patients - Factive may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
• Factive is not recommended for use in CHILDREN younger than 18 years of age. Safety and effectiveness in this age group have not been confirmed. CHILDREN may be more sensitive to the effects of Factive , including bone and joint problems.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Factive during pregnancy. It is unknown if Factive is excreted in breast milk. If you are or will be breast-feeding while you are using Factive , check with your doctor or pharmacist to discuss the 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; mild diarrhea; nausea; stomachache; taste changes; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety; bloody stools; changes in mood or behavior; chest pain or pounding in the chest; confusion; dark urine; decreased urination; depression; excessive hunger, thirst, or urination; fainting; fast or irregular heartbeat; fever, chills, or sore throat; "fruity"-smelling breath; hallucinations; hoarseness; lightheadedness; muscle pain; nervousness; numbness or tingling of the skin; paranoia; red, swollen, blistered, or peeling skin; restlessness; seizures; severe or continuous diarrhea; sleeplessness; stomach pain/cramps; suicidal thoughts; sweating; tendon or joint pain or swelling; tremors; unusual bruising or bleeding; 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 or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or 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/findyour.htm), or emergency room immediately.

Proper storage of Factive :

Store Factive at 77 degrees F (25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep Factive out of the reach of children and away from pets.

General information:

• 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.