Loxone/Loxone T

Loxone/Loxone T

norfloxacin

Manufacturer:

Micro Labs

Distributor:

Zizawa Healthcare
Full Prescribing Info
Contents
Norfloxacin alone, or with tinidazole.
Description
Norfloxacin is 1-ethyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolone carboxylic acid.
Each Loxone T tablet contains tinidazole 400 mg and norfloxacin 600 mg.
Action
Antibacterial agent.
Pharmacology: Norfloxacin is a fluoroquinolone having a fluorine atom at position 6 which provides increased potency against gram-negative organisms. Position 7 carries a piperazine moiety which gives antipseudomonal activity. The fluorine also contributes to the electron stability of the molecule.
Norfloxacin inhibits the gyrase-mediated DNA supercoiling at concentrations that correlate well with those required to inhibit bacterial growth (0.1-10 mcg/mL). Eukaryotic cells contain type-II DNA topoisomerase in place of DNA gyrase. Norfloxacin inhibits this at very high concentrations (100-1000 mcg/mL).
Tinidazole is bactericidal against anaerobic organisms at a minimum concentration, which is generally the same as or twice, the respective inhibitory concentration. The specific mode of action of tinidazole against anaerobic bacteria is not clear, but it is probably the same as that of metronidazole. After entering the microorganism by diffusion, it is reduced to intermediate compounds, which cause cytotoxicity, probably by damaging DNA. Its selectively high activity against anaerobic organisms has suggested interference with electron transport form NADPH or other reduced substrates.
Microbiology: Norfloxacin is effective against a wide range of gram-positive and gram-negative organisms by inhibiting the synthesis of bacterial DNA gyrase with consequent loss of DNA supercoiling. The following bacteria have been found to be susceptible to norfloxacin in vitro, in urinary tract infections: Pseudomonas aeruginosa, Staphylococcus and Hafnia spp, E. coli, Morganella morganii, Proteus mirabilis, Citrobacter sp.
Norfloxacin has also been found to be effective against the Alcaligenes and Flavobacterium sp. Other species eg, Neisseria gonorrhoeae, Bacillus cereus, Shigella, Salmonella, Campylobacter, Vibrio parahaemolyticus have also been found to be susceptible.
Tinidazole is active in vitro against most obligate anaerobic bacteria.
Loxone T: Gram-Positive Aerobes: Enterococcus faecalis, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus saprophyticus, Streptococcus agalactiae.
Gram-Negative Aerobes: Citrobacter freundii, Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli, Klebsiella coli, Neisseria gonorrhoeae, Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa, Serratia marcescens.
Pharmacokinetics: Norfloxacin is absorbed rapidly from the gut with peak levels reached in 1 hr. Food delays absorption of norfloxacin. It is widely distributed and high levels are found in urine. It crosses the placenta but is not detectable in breast milk. It is partly metabolised and excreted in urine and bile. It has a half-life of 3 hrs, which increases with renal damage.
Indications/Uses
Loxone: Urinary tract infections, urethritis and/or cervicitis, bacterial enteric infections. Prophylaxis in granulocytopenic patients.
Loxone T: Treatment of diarrhoea and dysentery of amoebic, bacterial and mixed origins.
Dosage/Direction for Use
Loxone: Uncomplicated Lower Urinary Tract Infections: 400 mg twice daily for 3-10 days.
Urinary Tract Infections: 400 mg twice daily for 7-10 days.
Chronic Relapsing Urinary Tract Infections: 400 mg twice daily up to 12 weeks.
Gonococcal Urethritis or Cervicitis: A single dose of 800 mg.
Renal Impairment: Dosage should be modified in renal impairment by giving a 400-mg daily dosage.
Maximum Recommended Dose: 400 mg twice daily and should not be exceeded. Patients should take plenty of fluids.
Loxone T: Adults: 1 tab twice daily for 5-10 days, to be taken 1-2 hrs after a meal with liberal fluid intake.
Children: Not recommended.
Overdosage
The unabsorbed drug should be removed by a stomach wash or inducing vomiting. The patient should be observed carefully and managed with symptomatic supportive therapy. Patients should be well hydrated.
Contraindications
Hypersensitivity to norfloxacin or other quinolones.
Loxone T: Patients with neurological disorder and blood dyscrasias.
Special Precautions
Norfloxacin should be given with extreme care to patients with a history of seizures, severe cerebrovascular disease and severe renal damage. Anaphylactic reactions have been reported with quinolones. Patients should be instructed to take adequate amount of water. Exposure to sunlight should be avoided.
Use in pregnancy & lactation: There is no evidence that norfloxacin has any teratogenic effect. Restraint in the use of norfloxacin during pregnancy is recommended as a matter of principle, rather than because of demonstrated fetotoxicity. Tinidazole readily crosses the placenta and is distributed into breast milk. Tinidazole should not be given during the 1st trimester of pregnancy and is not recommended in lactation.
Use in children: The fluoroquinolones should preferably not be used in children and adolescents.
Use In Pregnancy & Lactation
There is no evidence that norfloxacin has any teratogenic effect. Restraint in the use of norfloxacin during pregnancy is recommended as a matter of principle, rather than because of demonstrated fetotoxicity. Tinidazole readily crosses the placenta and is distributed into breast milk. Tinidazole should not be given during the 1st trimester of pregnancy and is not recommended in lactation.
Adverse Reactions
Norfloxacin is well tolerated with a few adverse reactions. The most common adverse effects reported are nausea, vomiting, heartburn, constipation, diarrhoea, headache, dizziness, depression, insomnia and seizures; rash, dry mouth, fever, arthralgia and crystalluria. Nausea, vomiting, anorexia and a metallic or bitter taste in the mouth are the most common side effects. Malaise, vertigo, pruritus, headache, constipation and skin rashes have also been reported.
Drug Interactions
Concurrent use of iron and zinc, antacids and/or sucralfate may reduce norfloxacin's absorption capability. Norfloxacin may potentiate effects of oral anticoagulants, cyclosporine and theophylline. Nitrofurantoin antagonises the effects of norfloxacin in the urinary tract. Food delays absorption.
Storage
Store below 25°C, in a cool and dry place.
ATC Classification
J01RA13 - norfloxacin and tinidazole ; Belongs to the class of combinations of antibacterials. Used in the systemic treatment of infections.
J01MA06 - norfloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Presentation/Packing
Loxone: FC tab 400 mg x 10 x 10's.
Loxone T: Tab 10 x 2's.
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