Gemifloxacin

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

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

Gemifloxacin is a prescription medication used to treat certain infections. It belongs to a class of drugs known as antibiotics, which work by stopping the growth of certain bacteria.

It comes in tablet form and is usually taken once a day by mouth, with or without food.

Common side effects include diarrhea, rash, and headache. Gemifloxacin can also cause dizziness. Do not drive or operate heavy machinery until you know how gemifloxacin affects you.
 

If you take too much gemifloxacin, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Gemifloxacin may cause swelling or tearing of a tendon, especially if you are over 60, if you take steroid medication, or if you have had a kidney, heart, or lung transplant.

Take gemifloxacin only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

gemifloxacin comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Gemifloxacin may be taken with or without food. The tablet must be swallowed whole. Do not break, crush, or chew the tablet.

Drink plenty of fluids while you are taking gemifloxacin. Drinking extra water will help prevent some unwanted effects of gemifloxacin.

gemifloxacin works best when there is a constant amount in the blood or urine. To help keep the amount constant, do not miss any doses. Try to take the medicine at the same time each day.

Do not take gemifloxacin alone with milk, yogurt, or other dairy products. Do not drink any juice with calcium added when you take gemifloxacin. It is okay to have dairy products or juice as part of a larger meal when you take gemifloxacin.

If you are taking aluminum or magnesium-containing antacids, iron supplements, multivitamins, didanosine (Videx®), sucralfate (Carafate®), or zinc, do not take them at the same time that you take gemifloxacin. It is best to take these medicines 3 hours before or 2 hours after taking gemifloxacin. These medicines may keep gemifloxacin from working properly.

Keep using gemifloxacin for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

Dosing

The dose of gemifloxacin will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of gemifloxacin. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For treatment of lung infections:
    • Adults— 320 milligrams (mg) once a day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of gemifloxacin, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how gemifloxacin affects you.
• Do not use longer than you have been told. A second infection may happen.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• Tell your doctor if you have signs of high or low blood sugar like breath that smells like fruit, dizziness, fast breathing, fast heartbeat, feeling confused, feeling sleepy, feeling weak, flushing, headache, more thirsty or hungry, passing urine more often, shaking, or sweating.
• If you are taking warfarin, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with this medicine.
• You may get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
• Drink lots of noncaffeine liquids after using gemifloxacin unless told to drink less liquid by your doctor.
• Very bad and sometimes deadly allergic side effects have rarely happened. Talk with your doctor.
• Rarely, very bad and sometimes deadly effects have happened with this medicine. These include muscle or joint, kidney, liver, blood, and other problems. Talk with the doctor if you have questions.
• If you are over the age of 60, use gemifloxacin with care. You could have more side effects.
• This medicine is not approved for use in children younger than 18 years of age. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Chest pain or pressure, a fast heartbeat, or passing out.
• A heartbeat that does not feel normal.
• Fever or chills.
• Ringing in ears.
• Shortness of breath.
• Any unexplained bruising or bleeding.
• Feeling very tired or weak.
• Shakiness.
• Trouble walking.
• Vaginal itching or discharge.
• Muscle pain or weakness.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
• It is common to have diarrhea when taking this medicine. Rarely, a very bad form of diarrhea called Clostridium difficile (C diff)–associated diarrhea (CDAD) may occur. Sometimes, this has led to a deadly bowel problem (colitis). CDAD may happen while you are taking gemifloxacin or within a few months after you stop taking it. Call your doctor right away if you have stomach pain or cramps, very loose or watery stools, or bloody stools. Do not try to treat loose stools without first checking with your doctor.

• Factive

Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together, including tendonitis and tendon rupture, peripheral neuropathy, and CNS effects. Discontinue gemifloxacin immediately and avoid use of fluoroquinolones in patients who experience any of these serious adverse reactions. Because fluoroquinolones have been associated with serious adverse reactions, reserve gemifloxacin for use in patients who have no alternative treatment options for acute bacterial exacerbation of chronic bronchitis.

Fluoroquinolones may exacerbate muscle weakness in individuals with myasthenia gravis. Avoid gemifloxacin in patients with known history of myasthenia gravis.

WBC, signs/symptoms of infection, renal function

CrCl 40 mL/min or less: 160 mg orally every 24 hours

US BOXED WARNING:
SERIOUS SIDE EFFECTS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CNS EFFECTS, AND EXACERBATION OF MYASTHENIA GRAVIS:
-Fluoroquinolones (including this drug) have been associated with disabling and potentially irreversible serious side effects that have occurred together (including tendinitis and tendon rupture, peripheral neuropathy, CNS effects). This drug should be discontinued immediately and use of fluoroquinolones (including this drug) should be avoided in patients with any of these serious side effects.
-Fluoroquinolones (including this drug) may exacerbate muscle weakness in patients with myasthenia gravis. This drug should be avoided in patients with known history of myasthenia gravis.
-Since fluoroquinolones (including this drug) have been associated with serious side effects, this drug should be reserved for use in patients with no alternative treatment options for acute bacterial exacerbation of chronic bronchitis.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.