Gemifloxacin is a fluoroquinolone (flor-o-KWIN-o-lone) antibiotic that fights bacteria in the body.

Gemifloxacin is used to treat different types of bacterial infections in the lungs.

Fluoroquinolone antibiotics can cause serious or disabling side effects. Gemifloxacin should be used only for infections that cannot be treated with a safer antibiotic.

Gemifloxacin may also be used for purposes not listed in this medication guide.

Gemifloxacin can cause serious side effects, including tendon problems, nerve damage, serious mood or behavior changes, or low blood sugar.

Stop using this medicine and call your doctor at once if you have symptoms such as: headache, hunger, irritability, numbness, tingling, burning pain, confusion, agitation, paranoia, problems with memory or concentration, thoughts of suicide, or sudden pain or movement problems in any of your joints.

In rare cases, gemifloxacin may cause damage to your aorta, which could lead to dangerous bleeding or death. Get emergency medical help if you have severe and constant pain in your chest, stomach, or back.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take gemifloxacin with water, and drink extra fluids to keep your kidneys working properly while taking this medicine.

Take the medicine at the same time each day, with or without food.

Swallow the tablet whole and do not chew it.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses can increase your risk of infection that is resistant to medication. Gemifloxacin will not treat a viral infection such as the flu or a common cold.

Do not share this medicine with another person, even if they have the same symptoms you have.

Store at room temperature away from moisture, heat, and light.

Usual Adult Dose for Bronchitis:

320 mg orally once a day for 5 days

Comments:
-Since fluoroquinolones (including this drug) have been associated with serious side effects and acute bacterial exacerbation of chronic bronchitis (ABECB) is self-limiting for some patients, this drug should be saved for treatment of ABECB in patients with no alternative treatment options.

Use: For the treatment of ABECB due to susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, H parainfluenzae, or Moraxella catarrhalis

Usual Adult Dose for Pneumonia:

320 mg orally once a day

Duration of therapy:
-Due to known/suspected S pneumoniae, H influenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae infection: 5 days
-Due to known/suspected multi-drug resistant S pneumoniae (MDRSP), Klebsiella pneumoniae, or M catarrhalis infection: 7 days

Comments:
-MDRSP isolates are isolates resistant to at least 2 of the following antibacterials: penicillin (MIC at least 2 mcg/mL), second-generation cephalosporins (e.g., cefuroxime), macrolides, tetracyclines, and sulfamethoxazole-trimethoprim.

Use: For the treatment of mild to moderate community-acquired pneumonia due to susceptible isolates of S pneumoniae (including MDRSP), H influenzae, M catarrhalis, M pneumoniae, C pneumoniae, or K pneumoniae

You should not use gemifloxacin if you are allergic to gemifloxacin or other fluoroquinolones (ciprofloxacin, levofloxacin, moxifloxacin, ofloxacin, norfloxacin, and others).

Gemifloxacin may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the Achilles' tendon of the heel. This can happen during treatment or up to several months after you stop taking gemifloxacin. Tendon problems may be more likely to occur if you are over 60, if you take steroid medication, or if you have had a kidney, heart, or lung transplant.

Tell your doctor if you have ever had:

• tendon problems, arthritis or other joint problems;

• blood circulation problems, aneurysm, narrowing or hardening of the arteries;

• heart problems, high blood pressure;

• a genetic disease such as Marfan syndrome or Ehler's-Danlos syndrome;

• diabetes;

• a muscle or nerve disorder, such as myasthenia gravis;

• long QT syndrome (in you or a family member);

• trouble swallowing pills;

• liver or kidney disease;

• epilepsy or other seizure disorder; or

• low levels of magnesium or potassium in your blood.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant.

You should not breast-feed while using gemifloxacin.

Gemifloxacin is not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light and excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Make sure you drink plenty of water or other fluids every day while you are taking gemifloxacin.

Do not take gemifloxacin with dairy products such as milk or yogurt, or with calcium-fortified juice. You may eat or drink these products as part of a regular meal, but do not use them alone when taking gemifloxacin. They could make the medication less effective.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor before using anti-diarrhea medicine.

Gemifloxacin could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Tell your doctor if you have severe burning, redness, itching, rash, or swelling after being in the sun.

Avoid driving or hazardous activity until you know how gemifloxacin will affect you. Your reactions could be impaired.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Gemifloxacin can cause serious side effects, including tendon problems, side effects on your nerves (which may cause permanent nerve damage), serious mood or behavior changes (after just one dose), or low blood sugar (which can lead to coma).

Stop taking gemifloxacin and call your doctor at once if you have:

• low blood sugar--headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, or feeling anxious or shaky;

• nerve symptoms in your hands, arms, legs, or feet--numbness, weakness, tingling, burning pain;

• serious mood or behavior changes--nervousness, confusion, agitation, paranoia, hallucinations, memory problems, trouble concentrating, thoughts of suicide; or

• signs of tendon rupture--sudden pain, swelling, bruising, tenderness, stiffness, movement problems, or a snapping or popping sound in any of your joints (rest the joint until you receive medical care or instructions).

In rare cases, gemifloxacin may cause damage to your aorta, the main blood artery of the body. This could lead to dangerous bleeding or death. Get emergency medical help if you have severe and constant pain in your chest, stomach, or back.

Also, stop using gemifloxacin and call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody;

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);

• the first sign of any skin rash, no matter how mild;

• muscle weakness, breathing problems;

• jaundice (yellowing of the skin or eyes);

• a seizure (convulsions); or

• increased pressure inside the skull--severe headaches, ringing in your ears, vision problems, pain behind your eyes.

Common side effects of gemifloxacin may include:

• nausea, vomiting, stomach pain, diarrhea;

• headache;

• dizziness; or

• rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Some medicines can make gemifloxacin much less effective when taken at the same time. If you take any of the following medicines, take your gemifloxacin dose 2 hours before or 3 hours after you take the other medicine:

• antacids that contain magnesium or aluminum (such as Maalox, Mylanta, or Rolaids), or the ulcer medicine sucralfate (Carafate);

• didanosine (Videx) powder or chewable tablets; or

• vitamin or mineral supplements that contain aluminum, iron, magnesium, or zinc.

Gemifloxacin can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Tell your doctor about all your other medicines, especially:

• probenecid;

• a diuretic or "water pill";

• insulin or oral diabetes medicine (check your blood sugar regularly);

• a blood thinner--warfarin, Coumadin, Jantoven;

• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others; or

• steroid medicine--prednisone, methylprednisolone, and others.

This list is not complete. Other drugs may interact with gemifloxacin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to gemifloxacin. If you have diabetes, your doctor may ask you to check your blood sugar more often while taking gemifloxacin.

Do not let anyone else take your medication. Your prescription is probably not refillable. If you still have symptoms of infection after you finish taking gemifloxacin, call your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.