Saturday, July 08, 2006

Factive

Factive

Generic Name: gemifloxacin (gem ih FLOCK sah sin)
Brand Names: Factive

What is the most important information I should know about gemifloxacin?

Take all of the gemifloxacin that has been prescribed for you even if you begin to feel better. Your symptoms may start to improve before the infection is completely treated.

Do not take gemifloxacin without first talking to your doctor if you or any member of your family have a heart condition known as prolongation of the QT interval. Also, do not take gemifloxacin if you are being treated for heart rhythm disturbances with drugs such as quinidine (Quinidex, Quinaglute, others), procainamide (Pronestyl, Procan SR, others), amiodarone (Cordarone, Pacerone, others), sotalol (Betapace), and others.

The following medicines should be taken at least 3 hours before or 2 hours after gemifloxacin: antacids that contain magnesium or aluminum (e.g. Rolaids, Maalox, others); vitamin or mineral supplements that contain zinc, magnesium or iron; didanosine chewable/ buffered tablets or pediatric powder for oral solution (ddI, Videx, Videx Pediatric, others). These medicines may decrease the effectiveness of gemifloxacin.

Gemifloxacin should be taken at least 2 hours before sucralfate (Carafate).

Avoid the use of sunlamps or tanning beds or prolonged exposure to sunlight while taking this medication. Gemifloxacin may increase the sensitivity of the skin to sunlight. Severe sunburn may result, even with minimal sun exposure. If exposure to the sun is unavoidable while taking gemifloxacin, wear protective clothing and use sunscreen. Call your doctor if you experience severe burning, redness, itching, rash, or swelling after exposure to the sun.

Use caution when driving, operating machinery, or performing other hazardous activities. Gemifloxacin may cause dizziness. If you experience dizziness, avoid these activities.


What is gemifloxacin?

Gemifloxacin is an antibiotic in the class of drugs called fluoroquinolones. It fights bacteria in the body.

Gemifloxacin is used to treat bacterial infections such as bronchitis and pneumonia.

Gemifloxacin may also be used for purposes other than those listed in this medication guide.
What should I discuss with my healthcare provider before taking gemifloxacin?

Do not take gemifloxacin without first talking to your doctor if you or any member of your family have a heart condition known as prolongation of the QT interval. Also, do not take gemifloxacin if you are being treated for heart rhythm disturbances with drugs such as quinidine (Cardioquin, Quinidex, Quinaglute, others), procainamide (Pronestyl, Procan SR, others), amiodarone (Cordarone, Pacerone, others), sotalol (Betapace), and others.

Before taking gemifloxacin, tell your doctor if you have

a low level of potassium or magnesium in your blood;

a slow heart rate (bradycardia);

heart disease or recent heart attack;

kidney disease;

liver disease; or

epilepsy or another seizure disorder.

You may not be able to take gemifloxacin or you may require a dosage adjustment or special monitoring during your treatment.

Gemifloxacin is in the FDA pregnancy category C. This means that it is not known whether gemifloxacin will be harmful to an unborn baby. Do not take gemifloxacin without first talking to your doctor if you are pregnant or could become pregnant during treatment.

It is unknown whether gemifloxacin passes into breast milk. Do not take gemifloxacin without first talking to your doctor if you are breast feeding a baby.

If you are over 60 years of age, you may be more likely to experience side effects from gemifloxacin. Your doctor may prescribe a lower dose of this medication.


How should I take gemifloxacin?

Take gemifloxacin exactly as directed by your doctor. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass (8 ounces) of water. Drink plenty of fluid while taking gemifloxacin.

Gemifloxacin can be taken with or without food.

Gemifloxacin is usually taken once a day. Take each dose at the same time every day. Follow your doctor's instructions.

Take all of the gemifloxacin that has been prescribed for you even if you begin to feel better. Your symptoms may start to improve before the infection is completely treated.

The following medicines should be taken at least 3 hours before or 2 hours after gemifloxacin: antacids that contain magnesium or aluminum (e.g. Rolaids, Maalox, others); vitamin or mineral supplements that contain zinc, magnesium or iron; didanosine chewable/ buffered tablets or pediatric powder for oral solution (ddI, Videx, Videx Pediatric, others). These medicines may decrease the effectiveness of gemifloxacin.

Gemifloxacin should be taken at least 2 hours before sucralfate (Carafate).

Store this medication at room temperature away from moisture and heat.
What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication.


What happens if I overdose?

Seek emergency medical attention.

Symptoms of a gemifloxacin overdose may include decreased activity, dizziness, tremors, and convulsions.
What should I avoid while taking gemifloxacin?

Avoid the use of sunlamps or tanning beds or prolonged exposure to sunlight while taking this medication. Gemifloxacin may increase the sensitivity of the skin to sunlight. Severe sunburn may result, even with minimal sun exposure. If exposure to the sun is unavoidable while taking gemifloxacin, wear protective clothing and use sunscreen. Call your doctor if you experience severe burning, redness, itching, rash, or swelling after exposure to the sun.

Use caution when driving, operating machinery, or performing other hazardous activities. Gemifloxacin may cause dizziness. If you experience dizziness, avoid these activities.
What are the possible side effects of gemifloxacin?

If you experience any of the following serious side effects, stop taking gemifloxacin and seek emergency medical attention or contact your doctor immediately:

an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

irregular or rapid heartbeats;

fainting;

seizures or tremors;

confusion or hallucinations (seeing or hearing things that are not there);

muscle or joint pain or swelling; or

a skin rash.

If you experience any of the following less serious side effects, continue taking gemifloxacin and talk to your doctor:

nausea, stomach pain, or diarrhea;

change in the way things taste in the mouth;

dizziness;

headache; or

increased sensitivity of the skin to sunlight.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.


What other drugs will affect gemifloxacin?

The following medicines should be taken at least 3 hours before or 2 hours after gemifloxacin: antacids that contain magnesium or aluminum (e.g. Rolaids, Maalox, others); vitamin or mineral supplements that contain zinc, magnesium or iron; didanosine chewable/ buffered tablets or pediatric powder for oral solution (ddI, Videx, Videx Pediatric, others). These medicines may decrease the effectiveness of gemifloxacin.

Gemifloxacin should be taken at least 2 hours before sucralfate (Carafate).

Do not take gemifloxacin without first talking to your doctor if you are taking any of the following drugs:

the heart medicines quinidine (Cardioquin, Quinidex, Quinaglute, others), procainamide (Pronestyl, Procan SR, others), amiodarone (Cordarone, Pacerone, others), sotalol (Betapace), and others;

a tricyclic antidepressant including amitriptyline (Elavil, Endep), amoxapine (Asendin), imipramine (Tofranil), nortriptyline (Pamelor), doxepin (Sinequan), and others;

an antipsychotic medication such as chlorpromazine (Thorazine), fluphenazine (Prolixin), perphenazine (Trilafon), mesoridazine (Serentil), thioridazine (Mellaril), haloperidol (Haldol), and others; or

erythromycin (E-Mycin, Ery-Tab, E.E.S., others).

Gemifloxacin and the drugs listed above may affect the rhythm of your heartbeats. You may not be able to take gemifloxacin, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

Before taking gemifloxacin, tell your doctor if you are taking:

warfarin (Coumadin);

probenecid (Benemid and others);

a steroid medication taken by mouth or injection such as cortisone (Cortone), methylprednisolone (Medrol), prednisone (Deltasone, Orasone, others), and others; or

a diuretic (water pill) such as furosemide (Lasix) or hydrochlorothiazide (HCTZ, Microzide, Hydrodiuril, others).

You may not be able to take gemifloxacin, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with gemifloxacin. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines including vitamins, minerals, and herbal products.


Where can I get more information?

Your pharmacist has additional information about gemifloxacin written for health professionals that you may read.


Drugs.com

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Antimicrobial treatment of lower respiratory tract infections in the hospital setting.

Antimicrobial treatment of lower respiratory tract infections in the hospital setting.

Grossman RF, Rotschafer JC, Tan JS.

University of Toronto, Toronto, Ontario, Canada.

Respiratory tract infections (RTIs) that may require hospitalization include acute exacerbations of chronic bronchitis (AECB), community-acquired pneumonia (CAP), and hospital-acquired pneumonia (HAP), which includes ventilator-associated pneumonia (VAP). Healthcare-associated pneumonia (HCAP) is treated similar to HAP and may be considered with HAP. For CAP requiring hospitalization, the current guidelines for the treatments of RTIs generally recommend either a beta-lactam and macrolide combination or a fluoroquinolone.

The respiratory fluoroquinolones (levofloxacin, gatifloxacin, moxifloxacin, and gemifloxacin) are excellent antibiotics due to high levels of susceptibility among gram-negative, gram-positive, and atypical pathogens. The fluoroquinolones are active against > 98% of Streptococcus pneumoniae, including penicillin-resistant strains. Fluoroquinolones are also recommended for AECB requiring hospitalization. Evidence from clinical trials suggests that levofloxacin monotherapy is as efficacious as combination ceftriaxone-erythromycin therapy in the treatment of patients hospitalized with CAP. For early-onset HAP, VAP, and HCAP without the risk of multidrug resistance, ceftriaxone, ampicillin-sulbactam, ertapenem, or one of the fluoroquinolones is recommended.

High-dose, short-course therapy regimens may offer improved treatment due to higher drug concentrations, more rapid killing, increased adherence, and the potential to reduce development of resistance. Recent studies have shown that short-course therapy with levofloxacin, azithromycin, or telithromycin in patients with CAP was effective, safe, and tolerable and may control the rate of resistance.

Am J Medicine - July 2005