Gemifloxacin Mesylate Tablets 320 mg
Gemflotab® is a synthetic broad-spectrum quinolone antibacterial agent for oral administration
MECHANISM OF ACTION & MICROBIOLOGY
The mechanism of action of quinolones, including gemifloxacin, is different from that of macrolides, beta-lactams, aminoglycosides, or tetracyclines; therefore, microorganisms resistant to these classes of drugs may be susceptible to gemifloxacin and other quinolones. There is no known cross-resistance between gemifloxacin and the above mentioned classes of antimicrobials.
The main mechanism of fluoroquinolone resistance is due to mutations in DNA gyrase and/or TOPO IV. Resistance to gemifloxacin develops slowly via multistep mutations and efflux in a manner similar to other fluoroquinolones. The frequency of spontaneous mutation is low (10-7 to < 10-10). Although cross-resistance has been observed between gemifloxacin and other fluoroquinolones, some microorganisms resistant to other fluoroquinolones may be susceptible to gemifloxacin.
GEMFLOTAB® is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below.
- Acute bacterial exacerbation of chronic bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.
- Community-acquired pneumonia (of mild to moderate severity) caused by Streptococcus pneumoniae (including multi-drug resistant strains [MDRSP])*, Haemophilus influenzae, Moraxella catarrhalis, Mycoplasma pneumoniae, Chlamydia pneumoniae, or Klebsiella pneumoniae.
- Typhoid fever (Enteric fever) caused by Salmonella typhi
- Gonorrhoea Infections:
- Uncomplicated urogenital gonorrhoea: (In combination with Azithromycin)
- Pharyngeal and rectal gonorrhoea: (In combination with Azithromycin)
GEMFLOTAB® is contraindicated in patients with a history of hypersensitivity to Gemifloxacin, fluoroquinolone agents, or any of the product components.
SIDE – EFFECTS
The most frequently reported adverse events include abdominal pain, diarrhoea, headache, nausea, rash and vomiting. The following side effects have been infrequently reported:-
Body as a whole: Fungal overgrowth
Central nervous system/Psychiatric: Dizziness and insomnia
Laboratory abnormalities: Asymptomatic transient elevation in liver enzymes.
Skin: Urticaria, pruritis and a maculopapular erythmatous skin rash. A diffuse maculopapular or erythematous skin rash was reported in some patients in the clinical trials. The rash occurred after one week, was generally mild to moderate and appeared to be a type IV hypersensitivity reaction. It is recommended that treatment with GEMFLOTAB® should be discontinued if a patient experiences rash.
Pregnancy & Lactation
GEMFLOTAB® should not be used in pregnant or lactating women. The safety and efficacy of GEMFLOTAB® in pregnant or lactating women have not been established. Animal studies have shown adverse effects on embryo-foetal development and gemifloxacin-related material is excreted in the milk of lactating rats.
Any signs or symptoms of overdosage should be treated symptomatically. No specific antidote is known. In the event of acute oral overdosage, the stomach should be emptied by inducing vomiting or by gastric lavage; the patients should be carefully observed and treated symptomatically with appropriate hydration maintained. Hemodialysis removes approximately 20 to 30 % of an oral dose of Gemifloxacin from plasma.
Store at a temperature not exceeding 30°C. Protect from light.
Keep medicine out of reach of children.
Alu – Alu Blister pack of 5 Tablets.
GEMFLOTAB® is the registered trademark of FilGap Healthcare Limited