What is ACTIVE and what is it used for?
FACTIVE is offered in blister packs containing 5 and 7 film tablets, and each film tablet contains 320 mg Gemifloxacin mesylate 426.39 mg of Gemifloxacin equivalent to a free base.
FACTIVE is a broad-spectrum antibiotic that acts on many bacteria.
Used in the treatment of the following infections caused by FACTIVE-sensitive bacteria:
Acute bacterial exacerbation of chronic bronchitis (short term and sudden exacerbation)
Acquired pneumonia in society (pneumonia),
Sinusitis (Sine inflammation)
What are the Side Effects?
Like all drugs, there may be side effects in people who are sensitive to substances contained in ACTIVEin.
Stop using ACTIVE, if any of the following happens and report it to your doctor immediately or contact the emergency department of the nearest hospital to you.
These are all very serious side effects.
If you have one of these, you have a serious allergy to FACTIVE. You may need immediate medical attention or hospitalization.
All of these very serious side effects are quite rare.
Side effects are defined as shown in the following categories:
Very common:Public :
Uncommon:
Sparse:
Very rare:
10 At least lisin of the patient can be seen.
Less than one in 10 patients, but more than one in 100 patients. Less than one in 100 patients, but more than one in 1000 patients.
: less than one in 1,000 patients, but more than one in 10,000 patients
Less than one in 10,000 patients.
Common:
Uncommon:
Sparse:
Very rare:
How is ACTIVE Used?
The recommended dose of FACTIVE in adults is one tablet per day (320 mg), according to the table below.
ENDtCATION
Dosage
DURATION
Acute bacterial exacerbation of chronic bronchitis (short term and sudden exacerbation)
One tablet per day (320 mg)
5 Days
Acquired pneumonia (pneumonia) in the mild-to-moderate society
One tablet per day (320 mg)
7 Days
Sinusitis (Sine inflammation)
One tablet per day (320 mg)
5 Days
The recommended dose and duration of treatment for FACTIVE should not be exceeded.
FACTIVE should be swallowed without chewing with sufficient amount of liquid by mouth.
Different age groups:
Use in children
It should not be used in children and young people under the age of 18, as its safety and effectiveness are not determined.
Use in the elderly:
Dosage adjustment is not required.
Special use case:
Kidney failure: No dose adjustment is required in patients with creatinine clearance of >40 ml/min. Dosage change is recommended in patients with creatinine clearance of < 40 ml/min. The following table contains dosage recommendations for use in patients with kidney disorders:
Recommended Doses in Patients with Kidney Disorder:
Creatinine clearance (ml/min)
Dosage
<40
Usual Dose
<40
24 Mg every 160 hours
Patients requiring routine hemodialysis or continuous outpatient peritoneal dialysis should be given 24 mg every 160 hours.
Liver failure: Dosage adjustment is not recommended in patients with mild, moderate and severe liver impairment.
If you have an impression that the effect of FACTIVE is very strong or weak, talk to your doctor or pharmacist.
FACTIVE
What to Do in case of Overdose?
If you have used more than you need to use ACTIVE, talk to a doctor or pharmacist.
What Should I Do When I Forget to Use ACTIVE?
Do not take double doses to offset forgotten doses.
Effects that may occur when treatment with FACTIVE is terminated
Things to consider before using ACTIVE
WHO Should NOT Use ACTIVE?
What Should People Using ACTIVE Pay Attention to?
Gemifloxacin can cause heart rhythm disturbances to various degrees in some patients, and these rhythm changes can be seen in the electrocardiogram (ECG) taken. if you have a heart rhythm disorder (including palpitations) due to any cause, avoid using FACTIVE.
If you are taking a heart rhythm-regulating medication (kinidine, procainamide, amiodarone, sotalol), if you have an uncorrected electrolyte disorder (decreased potassium or magnesium levels in the blood), and if you have had a heart rhythm disorder in the past, avoid using FACTIVE.
If you are a patient of myasthenia gravis (a disease of the nervous-muscle systems that occurs in the form of weakness and rapid fatigue in the involuntary muscles.), avoid using FACTIVE. The use of ACTIVE can lead to the aggravation of your disease.
If you are taking medications such as erythromycin (antibiotics), antipsychotics (drugs used to treat severe mental disorders such as schizophrenia, paranoia), tricyclic antidepressants (drugs used to treat depression), use FACTIVEi with caution.
Patients taking fluoroquinolone group antibiotics have been reported to have severe and sometimes fatal hypersensitivity reactions. These reactions may occur following the first dose. If after the use of FACTIVE, itchy rashes appear with widespread redness on your skin, swelling or shortness of breath on your tongue and face, discontinue FACTIVE treatment and consult your doctor.
Patients receiving fluoroquinolone group antibiotics reported tendon inflammation (tendinitis) and shoulder, hand and Achilles tendon rupture (rupture) that required surgical repair or caused long-term incapacity. If you have tendon pain, inflammation or rupture, stop the FACTIVE treatment and consult your doctor.
It should be used with caution in patients with disorders of the central nervous system such as sara (epilepsy) or in patients who may develop seizures.
In the case of using fluoroquinolone group antibiotics, including gemifloxacin, disease processes have been reported that affect nerves such as pain, burning, stinging sensation, numbness and tingling, weakness. Findings may begin immediately after using gemifloxacin and may be irreversible. In the event of the appearance of symptoms such as pain, burning or stinging sensation, drowsiness or weakness during FACTIVE treatment, the use of gemifloxacin should be terminated urgently.
In patients taking almost all antibiotics, including FACTIVE, a special type of large intestine disorder called pseudomembranous colitis may occur, which manifests itself with severe diarrhea. Therefore, if you have serious diarrhea, consult your doctor.
Skin redness has been more common in young (especially under 40) women using FACTIVE and in women undergoing hormone replacement therapy and long-term treatment. If you develop redness on your skin during treatment, stop using FACTIVE and consult your doctor.
During the use of FACTIVE should not be exposed to strong sunlight or artificial UV rays (e.g., solar lamps, solariums), and broad-spectrum sunscreens should be used under bright sunlight.
Elevation in liver enzymes (AST and/or ALT) was observed during the use of FACTIVE. With the rise of enzymes, no symptoms occurred. With the cessation of treatment, liver incim increases have decreased. The recommended daily doses of FACTIVE therapy should not be exceeded and the FACTIVE treatment should not be extended beyond the recommended time.
In patients with impaired renal function, the dosage needs to be changed.
If these warnings apply to you, even at any time in the past, please consult your doctor.
Food and Beverage Consumption Together With ACTIVE
What are the foods and drinks that are inconvenient to be consumed with the specified medication? What should we eat or not eat?
FACTIVE tablets can be taken with or without food.
Is it Used During Pregnancy (Pregnancy) Period?
Consult your doctor or pharmacist before using the medicine.
It is not known whether gemifloxacin is safe to use in pregnancy. Therefore, as long as it is not certain that its benefits are much higher compared to its risks, then you should not use FACTIVE during pregnancy.
If you notice that you are pregnant during treatment, consult your doctor or pharmacist immediately.
Can it be Used During Breastfeeding?
Consult your doctor or pharmacist before using the medicine.
It is not known whether gemifloxacin urethra passes into breast milk.
Consult your doctor about whether you can use FACTIVE during breastfeeding.
Vehicle and machinery use
FACTIVE can cause dizziness, in which case the tool and machine should not be used or work that requires mental alertness or coordination should not be done.
What is the ACTIVE Active Agent?
No warning is required with regard to auxiliary substances contained in it.
Is It Used With Other Drugs?
In healthy volunteers treated for FACTIVE (a blood-thinning drug), warfarin had no significant effect on the anticoagulant (preventive of clotting) effect. However, because some quinolone group antibiotics have been reported to enhance the anticoagulant effects of warfarin or its derivatives in patients, when varfarin or its derivatives are also given a quinolone group antibiotic, the researchers said, appropriate tests should be performed, such as bleeding and clotting time.
The absorption of gemifloxacin in the body is significantly reduced by taking antacids (drug that reduces stomach acid), which also contains aluminum and magnesium. 3 Hours before taking FACTIVE tablets and within 2 hours after taking antacids containing magnesium and/or aluminum, products containing iron sulfate, multivitamin preparations containing zinc or other metals, or no paediatric powder should be taken for oral solution. FACTIVE should be taken at least 2 hours before sucralfate (a drug used to treat ulcers).
If you are taking probenecid (a drug used to treat chronic gout disease) with FACTIVE, this drug increases the effect of FACTIVE by 45. For this reason, if you have gout (a disease characterized by elevated uric acid levels in the blood) or if you are using probenecid for another reason, consult your doctor before using FACTIVE.
To download the FACTIVE prospectus as a PDF file here
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