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|Factive

GEMIFLOXACIN (Systemic)†

Some commonly used brand names are:

In the U.S.—

• Factive

† Not commercially available in Canada.

Category

• Antibacterial, systemic

Description

Gemifloxacin (ji-mi-FLOX-a-sin) belongs to the class of medicines known as antibiotics. It is used to treat bronchitis and 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 the following dosage forms:

• Oral
• Tablets (U.S.)

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For gemifloxacin, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to gemifloxacin or to other fluoroquinolones (type of antibiotics). Also tell your health care professional if you are allergic to 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 problems in young animals. Discuss with your doctor whether or not this medicine should be taken during pregnancy.

Breast-feeding—It is not known whether gemifloxacin passes into human breast milk. Discuss with your doctor whether to breast-feed during treatment with this medicine.

Children—Studies on this medicine have only been done in adult patients and there is no specific information comparing the use of gemifloxacin in children with use in other age groups. It is not recommended to use gemifloxacin in children up to 18 years of age because this medicine has been shown to cause bone development problems in young animals.

Older adults—There is no specific information comparing use of gemifloxacin in the elderly with use in other age groups. However, it has been used in older people and has not been found to cause different side effects or other problems than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines. When you are taking gemifloxacin, it is especially important that your doctor and pharmacist know if you are taking any 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) —Gemifloxacin may 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 may reduce the effectiveness of gemifloxacin; they should not be taken at least 3 hours before or 2 hours after you take your gemifloxacin.

• Sucralfate (e.g., Carafate)—This medicines may reduce the effectiveness of gemifloxacin; gemifloxacin should be taken at least 2 hours before you take sucralfate.

Other medical problems—The presence of other medical problems may affect the use of gemifloxacin. Make sure you tell your doctor if you have any other medical problems, especially:

• Brain or spinal cord disease, epilepsy or other seizures— Gemifloxacin may increase the chance of making these problems worse.

• Heart rhythm problems— Gemifloxacin should be used with caution in patients with these conditions.

• Hypokalemia (not enough potassium in your blood) or
• Hypomagnesemia (not enough magnesium in your blood)— These conditions can increase your risk of having a fast, slow or irregular heartbeat when you are taking gemifloxacin.

• QTc prolongation (rare heart rhythm problem)—Gemifloxacin may cause this condition to become worse, especially with higher doses of gemifloxacin.

Proper Use of This Medicine

Gemifloxacin may be taken with or without food. Tablet must be swallowed whole. Do not chew 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 or urine. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times, day and night . For example, if you are to take one dose a day, try to take it at the same time each day.

It is important that you take this medicine exactly as prescribed by your doctor. It is important for you to take this medicine for as long as the doctor tells you to, even if you begin to feel better after a few days.

Dosing—The dose of gemifloxacin will be different for different patients. Follow your doctor"s orders or the directions on the label and do not take more medicine than prescribed by your doctor. . 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.

• 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 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. It is very important that you do not double doses and that you do not take more than one dose per day.

Storage—To store this medicine:

• Keep out of the reach of children.
• Do not store in the bathroom, near the kitchen sink, or in other damp 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 your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

If your symptoms do not improve within a few days, or if they become worse, check with 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 sunlight than they are normally. Exposure to sunlight, even for brief periods of time, may cause severe sunburn; skin rash, redness, itching, or discoloration; or vision changes. When you begin taking this medicine use caution when you are in 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 allergic reaction, 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 know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert . If these 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 get sudden pain in a tendon after exercise (for example, in your ankle, back of the knee or leg, shoulder, elbow, or wrist), stop taking gemifloxacin and check with your doctor . Rest and do not exercise until the doctor has made sure that you have not injured or torn the tendon.

Tell your doctor if you have severe diarrhea that does not go away while taking this medicine or after you finish taking this medicine.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 12/18/2003
Revised: 11/15/2004

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