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Factive®

Brand Name: Factive®
Active Ingredient:   gemifloxacin mesylate
Strength(s): 320mg
Dosage Form(s):   Tablet
Availability:         Prescription only
Company Name:    LG Life Sciences
*Date Approved by FDA: April 4, 2003
*Approval by FDA does not mean that the drug is available to consumers at this time.




What is Factive used for?

Factive is an antibiotic. It is used to treat adults 18 years or older with bronchitis or pneumonia (lung infections) caused by certain bacteria (germs). Factive does not treat germs called viruses. A virus causes the common cold.

Who should not take Factive?

Do not take Factive if you are allergic to any of the ingredients in Factive or to any antibiotic called a “quinolone”.

Special Warnings with Factive: 

  • Factive should not be used in children under the age of 18.
  • Factive may cause a rare heart problem called prolongation of the QTc interval in some people. This condition can cause an abnormal heartbeat and result in sudden death.
  • Factive can cause a condition called photoxicity. Photoxicity can make your skin sunburn easier. Do not use a sunlamp or tanning bed while taking Factive. Use a sunscreen and wear protective clothing if you must be out in the sun.

What should I tell my doctor or health care provider?

Tell your health care provider if you: 

  • are pregnant, planning to become pregnant, or are breast feeding. The effects of Factive on unborn children and nursing infants are unknown. 
  • or any family members have a rare heart condition known as congenital prolongation of the QTc interval. 
  • have low potassium or magnesium levels. 
  • have a slow heartbeat called bradycardia 
  • have had a recent heart attack. 
  • have had a history of convulsions (seizures or "fits"). 
  • have kidney problems. 

Tell your health care provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your health care provider if you take: 

  • medicines for your heart rhythm called “antiarrhythmics” 
  • erythromycin 
  • medicines for your mental health called “antipsychotics” or “tricyclic antidepressants” 
  • medicines called “corticosteroids”, taken by mouth or by injection 
  • medicines called diuretics such as furosemide and hydrochlorothiazide 
  • antacids that contain magnesium or aluminum 
  • ferrous sulfate (iron) 
  • multivitamin that contains zinc or other metals 
  • Videx (didanosine) 
  • sucralfate 

These medicines may affect how Factive works, or Factive may affect how these medicines work.

What are some possible side effects of Factive? (This is NOT a complete list of side effects reported with Factive. Your health care provider can discuss with you a more complete list of side effects.)

Some signs of rare but serious side effects include: 

  • a rare heart problem known as prolongation of the QTc interval 
  • central nervous system problems including body shakes (tremors), restless feeling, lightheaded feelings, confusion, and hallucinations (seeing or hearing things that are not there) 
  • tendon problems including tendonitis or rupture (“tears”) of a tendon 
  • phototoxicity (making your skin sunburn easier) 

Factive and other quinolones may cause joint problems (arthropathy) in children. 

Some common side effects with Factive include: 

  • rash. If you get a rash while taking Factive, stop Factive and call your healthcare provider right away. 
  • diarrhea 
  • nausea 
  • headache 
  • vomiting 
  • stomach pain 
  • dizziness 
  • change in the way things taste in your mouth 

For more detailed information about Factive, ask your health care provider.

http://www.fda.gov/cder/foi/label/2003/21158_factive_lbl.pdf    Link to Factive's Approved Label

Posted 6/3/03

 

Back to Drug Side Effects


source: FDA


last update: December 2004





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