Gemifloxacin (Systemic)

Brand name(s): Factive

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.

Last Revised: 11/15/2004