Efficacy / Effect
Indication
Acute bacterial exacerbation of chronic bronchitis (ABECB)
Community-acquired pneumonia (of mild to moderate severity)
Acute Bacterial Sinusitis (ABS)
Effective strains
1. Gram-positive aerobic bacteria
Streptococcus, such as Streptococcus pneumoniae (including penicillin-resistant bacteria, macrolide-resistant bacteria, ofloxacin, levofloxacin, and quinolone-resistant bacteria and multidrug-resistant bacteria*)ㆍStreptococcus pyogenes (including macrolide-resistant bacteria)ㆍStreptococcus viridansㆍStreptococcus agalactiaeㆍStreptococcus milleriㆍStreptococcus anginosusㆍStreptococcus constellatusㆍStreptococcus mitis, Staphylococcus, such as Staphylococcus aureus (including strains susceptible to methicillin)ㆍStaphylococcus epidermidisㆍStaphylococcus saprophyticusㆍStaphylococcus hemolyticussuch, and Enterococcus, such as Enterococcus faecalisㆍEnterococcus faecium
* Multidrug-resistant organisms: Multi-drug resistant pneumococcus refers to a strain that is simultaneously resistant to two or more antimicrobials among penicillins, second generation cephalosporins (such as cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole.
2. Gram-negative aerobic bacteria
Haemophilus, such as Haemophilus influenza (including beta-lactamase positive and negative strains)ㆍHaemophilus parainfluenza, Moraxella such as Moraxella catarrhalis (including beta-lactamase positive and negative strains), Klebsiella such as Klebsiella pneumoniaeㆍKlebsiella oxytoca, Escherichia coli, Neisseria such as Neisseria gonorrhoeae, Acinetobacter such as Acinetobacter lwoffiiㆍAcinetobacter anitratusㆍAcinetobacter calcoaceticusㆍAcinetobacter haemolyticus, Citrobacter such as Citrobacter freundiiㆍCitrobacter koseri, Salmonella, Shigella, Enterococcus such as Enterobacter cloacaeㆍEnterobacter aerogenes, Serratia such as Serratia marcescens, Proteus such as Proteus mirabilisㆍProteus vulgaris, Providencia, Morganella such as Morganella morganii, Yersinia, Pseudomonas such as Pseudomonas aeruginosa, Bordetella such as Bordetella pertussis
3. Specific bacteria
Coxiella such as Coxiella burnetii, Mycoplasma such as Mycoplasma Pneumonia, Legionella such as Legionella pneumonia, Chlamydia such as Chlamydia pneumoniae
4. Anaerobic bacteria
Peptococcus, Clostridium, Fusobacterium, Porphyromonas, Prevotella, Clostridium non-perfringensㆍ Clostridium, Porphyromonas, Prevotella such as Clostridium perfringens
* Diseases for which medicine is efficacious
- Acute exacerbation of chronic respiratory disease (chronic bronchitis)
- Community-acquired pneumonia
- Rhinosinusitis
- Otitis media
Fluoroquinolone-based drugs, including this drug, are related to serious adverse events, so acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis are used in patients without other treatment options.
Dosage / Administration
FACTIVE® Tab. can be taken with or without food and should be swallowed whole with a liberal amount of liquid. The recommended dose of FACTIVE® Tab. is 320 mg daily, according to the following.
* Recommended Dosage Regimen of FACTIVE® Tab.
The clinical decision regarding the use of a 5 day or 7 day regimen should be guided by results of the initial sputum culture.
The recommended dose and duration of FACTIVE® Tab. should not be exceeded.
- Use in Renally Impaired Patients:
Dose adjustment in patients with creatinine clearance >40 mL/min is not required. Modification of the dosage is recommended for patients with creatinine clearance ≤40 mL/min.
- Use in Hepatically Impaired Patients:
No dosage adjustment is recommended in patients with mild (Child-Pugh Class A), moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment.
- Use in Elderly:
No dosage adjustment is recommended.
etc.
Appearance & Packaging Unit
White or almost white oval film-coated tablets
5 tablets(5 tablets/PTP packaging x 1), 30 tablets(5 tablets/PTP packaging x 6)
Active Ingredient and Capacity
Gemifloxacin Mesylate 320 mg
Storage
In a tight container, store at room temperature (1~30℃)
