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Home >> Patients > Treatment of FACTIVE > How should I take FACTIVE

How should I take FACTIVE

How should I take FACTIVE?

FACTIVE should be taken once a day for 5-14 days depending on your prescription.

  • Take FACTIVE exactly as prescribed by your healthcare provider.
  • Take FACTIVE at about the same time each day.
  • FACTIVE can be taken with or without food.
  • Swallow FACTIVE whole, and drink plenty of fluids with it. Do not chew FACTIVE. Tell your healthcare provider if you are not able to swallow FACTIVE whole. You will need to take a different antibiotic medicine.

Do not skip any doses, or stop taking FACTIVE even if you begin to feel better, until you finish your prescribed treatment, unless:

  • you have a side effects
  • you have a serious allergic reaction
  • your healthcare provider tells you to stop.
  • This will help to make sure that all of the bacteria are killed and lower the chance that the bacteria will become resistant to FACTIVE. If this happens, FACTIVE and other antibiotic medicines may not work in the future.
  • Complete the course of medication even if you are feeling better.
  • If you miss a dose of FACTIVE, take it as soon as you remember. Do not take more than 1 dose of FACTIVE in one day.
  • If you take too much, call your healthcare provider or get medical help immediately.

How is FACTIVE administered?

Because of its relatively long half-life, FACTIVE is amenable to once-daily dosing so it is a convenient drug that will aid compliance with antibiotic treatment. FACTIVE is also effective in shorter courses than many other antibiotics due to its rapid bactericidal action. For example, in acute exacerbations of chronic bronchitis, a 5 day course of FACTIVE is sufficiently effective.

FACTIVE is available in an oral formulation and may be available as an intravenous preparation in the future.

REMEMBER

Take your dose of FACTIVE once a day.

Keep this medication out of the reach of children.

This information does not take the place of discussions with your doctor or health care professional about your medical condition or your treatment.

For more complete information about FACTIVE, request full prescribing information from your healthcare professional or pharmacist.

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Important Safety Information

THE SAFETY AND EFFECTIVENESS OF FACTIVE IN CHILDREN, ADOLESCENTS (<18 YEARS OF AGE), PREGNANT WOMEN, AND LACTATING WOMEN HAVE NOT BEEN ESTABLISHED.

FACTIVE is contraindicated in patients with a history of hypersensitivity to gemifloxacin, fluoroquinolone antibiotic agents, or any of the product components. Serious hypersensitivity and/or anaphylactic reactions have been reported in patients receiving fluoroquinolone therapy, including FACTIVE. Hypersensitivity reactions reported in patients receiving fluoroquinolone therapy have occasionally been fatal. These reactions may include serious, sometimes fatal skin reactions such as toxic epidermal necrolysis or Stevens-Johnson Syndrome; effects on the liver, including hepatitis, jaundice, and acute hepatic necrosis or failure; renal toxicities including interstitial nephritis and/or acute renal insufficiency or failure; and hematologic effects, including agranulocytosis, thrombocytopenia, and other hematologic abnormalities. These reactions may occur following the first dose or multiple doses. FACTIVE should be discontinued immediately at the first sign of an immediate type I hypersensitivity skin rash or any other manifestation of hypersensitivity reaction.

Fluoroquinolones, including FACTIVE, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart, or lung transplants. Call your healthcare professional right away at the first sign of tendon pain, swelling, or inflammation. You should stop taking FACTIVE until tendinitis or tendon rupture have been ruled out, and avoid exercise and using the affected area.

Fluoroquinolones may prolong the QT interval in some patients. FACTIVE should be avoided in patients with a history of prolongation of the QTc interval, patients with uncorrected electrolyte disorders (hypokalemia or hypomagnesemia), and patients receiving Class IA or Class III antiarrhythmic agents.

Rare cases of peripheral neuropathy have been reported in patients receiving quinolones.

In clinical studies with FACTIVE, central nervous system (CNS) effects have been reported infrequently. As with other fluoroquinolones, FACTIVE should be used with caution in patients with known or suspected CNS diseases. If CNS reactions occur, FACTIVE should be discontinued and appropriate measures instituted.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibiotic agents, including FACTIVE. If diarrhea occurs, evaluate for CDAD and treat appropriately.

In clinical trials, rash occurred more often with FACTIVE than therapy with comparator agents (2.8% vs. 0.6%). Increasing incidence of rash was associated with younger age (especially below 40), female gender, use of hormone replacement therapy, and longer duration of therapy.

Moderate to severe photosensitivity/phototoxicity reactions can be associated with the use of quinolones after sun or UV light exposure. Excessive exposure to the sun or UV light should be avoided.

Magnesium- and/or aluminum-containing antacids, products containing ferrous sulfate (iron), multivitamin preparations containing zinc or other cations, or Videx® (didanosine) chewable/buffered tablets or the pediatric powder for oral solution should not be taken within 3 hours before or 2 hours after FACTIVE. Sucralfate should not be taken within 2 hours of FACTIVE.

In clinical trials, the most common adverse drug reactions (≥2%) were diarrhea, rash, nausea, headache, abdominal pain, vomiting, and dizziness.

This product is available by prescription only.

* Videx® is a registered trademark of Bristol-Myers Squibb Company.

For US residents,
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

For Non-US residents,
You are encouraged to report negative side effects of prescription drugs, please click here or call 82-2-6924-3620.

Please note that the information contained on this site is intended for international health care providers and may not be appropriate for your country of origin. Please see the full FACTIVE prescribing information for your country for approved product indications, dosing, and important safety considerations. Click on the "Global Countries" tab above to learn how to obtain country-specific prescribing information.

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