Patient Medication Information: uses, side effects, how to take - Factive
ABOUT THIS MEDICATION
What the medication is used for:
FACTIVE™ is used to treat a certain type of bacterial lung infection called bronchitis. FACTIVE™ does not treat viral infections (e.g., the common cold).
What it does:
FACTIVE™ is an antibiotic. It kills many types of bacteria in the lung by interfering with bacterial enzymes to help stop bacterial growth and the infection.
When it should not be used:
Do not take FACTIVE™ if you are allergic to any
ingredient in the drug or to any antibiotic called “quinolone”. See “What the important nonmedicinal ingredients are.”
Do not take FACTIVE™ if you are receiving Class IA
(e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic agents.
What the medicinal ingredient is:
The medicinal ingredient is gemifloxacin mesylate.
What the important nonmedicinal ingredients are:
FACTIVE™ tablets contain: crospovidone, hydroxypropyl methylcellulose, magnesium stearate (vegetable origin), microcrystalline cellulose, polyethylene glycol, povidone, titanium dioxide.
What dosage forms it comes in:
FACTIVE™ is available as 320 mg tablets of gemifloxacin (as gemifloxacin mesylate) in a package of 5 tablets per blister.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
Serious hypersensitivity and/or anaphylactic reactions have been reported in patients receiving quinolone therapy, including FACTIVE™.
BEFORE you use FACTIVE™ talk to your doctor or pharmacist if:
- you are taking any other medications with FACTIVE™, including over-the-counter medications and dietary supplements.
- you are allergic to quinolone drug or any other non-medicinal ingredient in FACTIVE™.
- you have a history of convulsions. Convulsions have been reported in patients receiving certain antibiotics called quinolones.
$ you are pregnant, planning to become pregnant, or are breast feeding. The effects of FACTIVE™ on unborn children and nursing infants are unknown. $ you have kidney problems. You may require a lower dose and special monitoring during therapy.
$ you or any family member have a rare heart condition known as congenital prologation of the QTc interval (lengthened heartbeat). FACTIVE™ may produce changes in the electrocardiogram (QTc interval prolongation).
$ you have low potassium or magnesium levels. $ you have slow heart beat called bradycardia. $ you have recently had a heart attack.
$ you are on diuretics, e.g., furosemide, hydrochlorothiazide.
$ you are taking quinidine, procainamide, amidodorane or sotalol.
$ you are taking drug for abnormal heart rhythm
(antiarrhythmics).
$ you are taking erythromycin, antipsychotic, and tricyclic antidepressant, warfarin or coumadin.
FACTIVE™ has not been studied in children under the age of 18. Quinolones may cause joint problems (arthropathy) in children.
FACTIVE may be associated with allergic (hypersensitivity) reactions, even after a single dose. Stop taking the drug at the first sign of rash or other signs of the allergic reaction and tell your doctor.
Contact your doctor if the following develop while taking FACTIVETM:
- a) diarrhea
- b) peripheral neuropathy (nerve damage) with symptoms such as tingling, prickling, pain and weakness.
- c) depression, paranoia, rarely suicidal thoughts.
INTERACTIONS WITH THIS MEDICATION
Drugs that may interact with FACTIVE™ include:
Antacids: Do not take the following medicines within 3 hours before FACTIVE™ or 2 hours after FACTIVE™. They may interfere with the absorption of FACTIVE™ and may prevent it from working properly:
antacids containing magnesium and/or aluminum or
any medications containing calcium carbonate
- products containing ferrous sulfate (iron)
multivitamin preparations containing zinc or other
metals
VIDEX® (didanosine) chewable/buffered tablets or
the pediatric powder for oral solution
Sucralfate: FACTIVE™ should be taken at least 2 hours before sucralfate.
Warfarin: there have been reports of increased episodes of bleeding when warfarin and FACTIVE™ are taken together. Patients should notify their physicians if they are taking warfarin or its derivatives.
PROPER USE OF THIS MEDICATION
Usual adult dose:
The recommended dosage of FACTIVE™ for the treatment of bronchitis is one 320 mg tablet daily for 5 days. Take FACTIVE™ at the same time each day, with or without meals. Swallow the tablet whole with liberal amounts of liquid. Do not chew the tablet.
Overdose:
Contact your doctor or pharmacist if you have taken more than the recommended dose.
Missed Dose:
If you miss a dose, take it as soon as you remember unless it is almost time for the next dose. In that case, skip the missed dose and take the next one as directed. Do not take two doses at once.
Although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by FACTIVE™.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
FACTIVE™ is generally well tolerated. The most common side effects with FACTIVE™ include diarrhea, rash, nausea, headache, vomiting, stomach pain, dizziness, and a change in the way things taste in your mouth.
FACTIVE™ may be associated with serious allergic reactions, even after a single dose. Discontinue the drug and contact your doctor if allergic symptoms occur such as rapid pulse, difficulty in breathing, hives, swelling of the throat and tongue.
FACTIVE™ may cause dizziness; if this occurs, do not operate an automobile or machinery or engage in activities requiring mental alertness or coordination.
Discontinue FACTIVE™ and contact your doctor if you feel pain,
tenderness or rupture of a tendon. Rest and avoid exercise until you have seen a doctor.
Phototoxicity, the damage of skin by light, has been reported with certain antibiotics (quinolones) and the incidence has been low for FACTIVE™. Avoid excessive sunlight or artificial ultraviolet light (e.g., tanning beds). Contact your doctor if sunburn or a skin eruption occurs.
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | ||
Only if severe | In all cases | |||
| Common | Rash | T | T | |
| Uncommon | Allergic reaction* Dizziness Fainting spells Inflammation, pain or rupture of a tendon Palpitations (racing or irregular heartbeat) Persistent diarrhea, abdominal pain or blood/mucus in stool Skin eruption or sunburn-like reaction | T T T T T T T | T T T T T T T | |
| * Allergic reaction symptoms include rapid pulse, difficulty breathing, hives, swelling of the throat or tongue. | ||||
This is not a complete list of side effects. For any unexpected effects while taking FACTIVE™, contact your doctor or pharmacist.
HOW TO STORE IT
FACTIVE™ tablets should be stored between 15 and 25°C.
Keep out of reach of children.
REPORTING SUSPECTED SIDE EFFECTS
To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:
toll-free telephone: 866-234-2345 toll-free fax 866-678-6789
By email: cadrmp@hc-sc.gc.ca
By regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness Information Division
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found at: http://www.abbott.ca or by contacting the sponsor, Abbott Laboratories, Limited, at: 1-800-699-9948.