GEMIFLOXACIN (Systemic)?
Some commonly used brand names are:
In the U.S.?
? Not commercially available in Canada.
Category
Description
Gemifloxacin (ji-mi-FLOX-a-sin) belongsto the class of medicines known as antibiotics. It is used to treat bronchitisand pneumonia caused by bacterial infections.
Gemifloxacin works by killing bacteria or preventing their growth. However,this medicine will not work for colds, flu, or other virus infections.
This medicine is available only with your doctor's prescription, in thefollowing dosage forms:
Before Using This Medicine
In decidingto use a medicine, the risks of taking the medicine must be weighed againstthe good it will do. This is a decision you and your doctor will make. Forgemifloxacin, the following should be considered:
Allergies?Tell your doctor if you have ever had any unusualor allergic reaction to gemifloxacin or to other fluoroquinolones (type ofantibiotics). Also tell your health care professional if you are allergicto any other substances, such as foods, preservatives, or dyes.
Pregnancy?Gemifloxacin has not been studied in pregnant women.However, this medicine has been shown to cause growth and development problemsin young animals. Discuss with your doctor whether or not this medicine shouldbe taken during pregnancy.
Breast-feeding?It is not known whether gemifloxacin passes intohuman breast milk. Discuss with your doctor whether to breast-feed duringtreatment with this medicine.
Children?Studies on this medicine have only been done inadult patients and there is no specific information comparing the use of gemifloxacinin children with use in other age groups. It is not recommended to use gemifloxacinin children up to 18 years of age because this medicine has been shown tocause bone development problems in young animals.
Older adults?There is no specific information comparing useof gemifloxacin in the elderly with use in other age groups. However, it hasbeen used in older people and has not been found to cause different side effectsor other problems than it does in younger adults.
Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription(over-the-counter [OTC]) medicines. When you are taking gemifloxacin, it isespecially important that your doctor and pharmacist know if you are takingany of the following:
- Antiarrhythmic agents (medicine for abnormal heart rhythm)
- Anti-psychotics (medicine for mental illness) or
- Cisapride (e.g., Propulsid) or
- Erythromycin (e.g., Ery-Tab) or
- Tricyclic antidepressants (medicine for depression) ?Gemifloxacinmay cause changes in heart rhythm when taken with these drugs
- Antacids, aluminum- or magnesium-containing or
- Didanosine (e.g., Videx) or
- Iron supplements or
- Multivitamins with zinc or other metals?These medicines mayreduce the effectiveness of gemifloxacin; they should not be taken at least3 hours before or 2 hours after you take your gemifloxacin.
- Sucralfate (e.g., Carafate)?This medicines may reduce the effectivenessof gemifloxacin; gemifloxacin should be taken at least 2 hours before youtake sucralfate.
Other medical problems?The presence of other medicalproblems may affect the use of gemifloxacin. Make sure you tell your doctorif you have any other medical problems, especially:
- Brain or spinal cord disease, epilepsy or other seizures? Gemifloxacinmay increase the chance of making these problems worse.
- Heart rhythm problems? Gemifloxacin should be used with cautionin patients with these conditions.
- Hypokalemia (not enough potassium in your blood) or
- Hypomagnesemia (not enough magnesium in your blood)? Theseconditions can increase your risk of having a fast, slow or irregular heartbeatwhen you are taking gemifloxacin.
- QTc prolongation (rare heart rhythm problem)?Gemifloxacin maycause this condition to become worse, especially with higher doses of gemifloxacin.
Proper Use of This Medicine
Gemifloxacinmay be taken with or without food. Tablet must be swallowed whole. Do notchew the tablet.
Drink plenty of fluids while you are being treated with this medicine.Drinking extra water will help to prevent some unwanted effects of gemifloxacin.
This medicine works best when there is a constant amount in the blood orurine. To help keep the amount constant, do not missany doses. Also, it is best to take the doses at evenly spaced times, dayand night. For example, if you are to take one dose a day, try to takeit at the same time each day.
It is important that you take this medicine exactlyas prescribed by your doctor. It is important for you to take thismedicine for as long as the doctor tells you to, even if you begin to feelbetter after a few days.
Dosing?The dose of gemifloxacin will be differentfor different patients. Follow your doctor's orders orthe directions on the label and do not take more medicine than prescribedby your doctor.. The following information includes only the averagedoses of gemifloxacin. If your dose is different, donot change it unless your doctor tells you to do so.
- For oral dosage form (tablets):
- For treatment of infection
- Adults? 320 milligrams (mg) once a day for five to seven days.
- Children?Use and dose must be determined by your doctor.
Missed dose?If you miss a dose of this medicine, take itas soon as possible. However, if it is almost time for your next dose, skipthe missed dose and go back to your regular dosing schedule. It is very importantthat you do not double doses and that you do not take more than one dose perday.
Storage?To store this medicine:
- Keep out of the reach of children.
- Do not store in the bathroom, near the kitchen sink, or in otherdamp places. Heat or moisture may cause the medicine to break down.
- Keep the medicine from freezing. Do not refrigerate.
- Do not keep outdated medicine or medicine no longer needed. Ask yourhealth care professional how you should dispose of any medicine you do notuse. Be sure that any discarded medicine is out of the reach of children.
Precautions While Using This Medicine
Ifyour symptoms do not improve within a few days, or if they become worse, checkwith your doctor.
Make sure your doctor knows if you recently had an episode of chest pain.
Tell your doctor right away if you have palpitations (pounding heartbeat)or fainting spells while taking this medicine.
Some people who take gemifloxacin may become more sensitive to sunlightthan they are normally. Exposure to sunlight, even for brief periods of time,may cause severe sunburn; skin rash, redness, itching, or discoloration; orvision changes. When you begin taking this medicine use caution when you arein the sun and do not use a tanning bed, booth or sunlamp. If you have a severe reaction from the sun, check with your doctor.
If you get a skin rash or other signs of an allergicreaction, stop taking gemifloxacin and check with your doctor immediately.
Gemifloxacin may cause some people to become dizzy, lightheaded, drowsy,or less alert than they are normally. Make sure you knowhow you react to this medicine before you drive, use machines, or do anythingelse that could be dangerous if you are dizzy or are not alert. Ifthese reactions are especially bothersome, check with your doctor.
This medicine may rarely cause inflammation or even tearing of a tendon(the cord that attaches muscles to bones). If you getsudden pain in a tendon after exercise (for example, in your ankle, back ofthe knee or leg, shoulder, elbow, or wrist), stop taking gemifloxacin andcheck with your doctor. Rest and do not exercise until the doctor hasmade sure that you have not injured or torn the tendon.
Tell your doctor if you have severe diarrhea that does not go away whiletaking this medicine or after you finish taking this medicine.
Side Effects of This Medicine
Along with its needed effects, a medicinemay cause some unwanted effects. Although not all of these side effects mayoccur, if they do occur they may need medical attention.
Other side effects mayoccur that usually do not need medical attention. These side effects may goaway during treatment as your body adjusts to the medicine. However, checkwith your doctor if any of the following side effects continue or are bothersome.
Rare
Abnormal urine; acid or sour stomach; back pain; bad unusualor unpleasant taste; belching; blistering, crusting, irritation, itching, or reddening of skin; blurred vision; change in taste; change in vision; cracked, dry, scalyskin; difficulty having a bowel movement (stool); difficulty in moving; dizziness or light-headedness; dry mouth; dryness or soreness of throat; feelingof constant movement of self or surroundings; feelingof warmth; fruit like breath odor; heartburn; hoarseness; increased hunger and thirst; increased sensitivityof skin to sunlight; increased urination; indigestion; lack or loss of strength; leg cramps; loss of appetite; muscle aching or cramping; muscle pain or stiffness; nervousness; pain; pain in joints; redness of the face, neck, arms and occasionally, upper chest; sensation of spinning; shakiness inlegs, arms, hands, feet; sleepiness or drowsiness; sleeplessness; stomachdiscomfort, upset or pain; sudden sweating
Other side effects not listed above may also occur in some patients. Ifyou notice any other effects, check with your doctor.
Developed: 12/18/2003
Revised: 11/15/2004
