Source: Υπουργείο Υγείας (CY) Revision Year: 2020 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Gyrablock is a broad spectrum quinolone bactericidal agent indicated for the treatment of acute and chronic, urinary tract infections caused by bacteria susceptible to norfloxacin.
Such infections include:
In uncomplicated acute cystitis Gyrablock should be used only when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the treatment of these infections.
Norfloxacin has a broad spectrum of antimicrobial activity against both Gram positive and Gram negative organisms. In vivo activity has been demonstrated against the following Gram negative organisms:
Alcaligenes sp., Citrobacter sp., Citrobacter diversus, Citrobacter freundii, Edwardsiella tarda, Enterobacter sp., Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter cloacae, Escherichia coli, Flavobacterium sp., Hafnia sp., Klebsiella sp., Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, indole positive Proteus sp., Proteus mirabilis, Proteus vulgaris, Providencia sp., Providencia rettgeri, Providencia stuartii, Pseudomonas aeruginosa, Pseudomonas cepacia, Pseudomonas fluorescens, Serratia sp., Serratia marcescens.
Norfloxacin is active against the following Gram positive organisms:
Enterococci, Staphylococcus sp., coagulase negative Staphylococcus, Staphylococcus aureus, including penicillinase producers and the majority of methicillin resistant strains, Staphylococcus epidermidis, Staphylococcus saphroyticus, Group B Streptococcus, Group D Streptococcus including Enterococcus faecalis, Group G Streptococcus and Streptococcus viridans.
Norfloxacin is also active against Bacillus cereus, Haemophilus influenzae, Neisseria gonorrhoea and Ureaplasma urealyticum. It has no activity against anaerobes with the exception of Clostridium perfringens.
Cross resistance between norfloxacin and other structurally unrelated antibacterial compounds does not exist.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
The causative agent of the infection should be tested for susceptibility to norfloxacin, but therapy may be started before the test results are available.
Urinary tract infections, uncomplicated: 400mg two times a day for three days.
Urinary tract infections, complicated: 400mg two times a day for seven to ten days.
Chronic urinary tract infections: 400mg two times a day for up to twelve weeks. If adequate clinical and bacteriological suppression is obtained in the first four weeks of therapy the dose may be reduced to 400 mg a day.
The half-life may be slightly prolonged, but no dosage adjustment is necessary unless renal impairment is also present.
In patients with renal impairment, creatinine clearance less than 30ml/minute, the half life of norfloxacin is approximately doubled to eight hours. It is recommended that the dose be either 200 mg two times a day or 400mg once a day.
There is no adequate data on use in hepatic impairment, caution is advised.
Safety for use in children has not been demonstrated. Use in children is contraindicated (see also section 4.3 and 4.4).
The tablets are for oral administration only. They should be taken one hour before or two hours after a meal or milk ingestion. Multivitamins with iron or zinc, antacids with magnesium and aluminium and sucralfate or didanosine containing products should not be taken within 2 hours of administration of norfloxacin. (See section 4.5).
In the event of overdose, symptomatic treatment should be implemented. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation.
If overdose is recent, the stomach should be emptied by emesis or gastric lavage and the patient kept under observation and treatment should be symptomatic and supportive. Maintain adequate hydration.
36 months.
Store below 25°C in the original package in order to protect from light and moisture.
Polypropelene securitainer packs, with a leaflet, in a carton. Securitainers of 14, 500 and 1000 tablets, blisters of 14, 20, 30, 50, 100 are available.
Not all pack sizes may be marketed.
No special requirements for disposal.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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