NORFLOX ® Norfloxacin

NORFLOX © is a drug based on pivaloylssimethylester of norfloxacin

THERAPEUTIC GROUP: Antimicrobials - Antibiotics for systemic use

IndicationsAction mechanismStudies and clinical effectiveness Usage and dosage instructionsWarnings Pregnancy and lactationInteractionsContraindicationsUndesirable effects

Indications NORFLOX ® Norfloxacin

NORFLOX ® is used in medical clinics in the treatment of urinary tract infections sustained by pathogenic microorganisms sensitive to flurochinolones.

Mechanism of action NORFLOX ® Norfloxacin

NORFLOX ® is a drug based on an ester of norfloxacin, an antibiotic belonging to the second generation fluorichinolones category, and therefore has a broader spectrum of action which includes Gram-negative aerobic bacterial species and Gram-positive cocci.

The esterified form of Norfloxacin optimizes the pharmacokinetic properties guaranteeing an excellent bioavailability following oral administration and a greater persistence of the active form in the urinary tract, the main site of biological activity.

However, the antibiotic action is related to the ability of Norfloxacin to penetrate into bacterial cells interacting with specific enzymes involved in DNA duplication, and thus causing a proliferative arrest of these pathogens.

The imposing bacteriostatic action allows in just a few days of treatment to significantly reduce the proliferative rate of pathogenic microorganisms, thus controlling and limiting the accused symptomatology.

The efficacy of this antibiotic was observed both for enterobacteria and for pathogenic species generally more resistant to common antibiotic therapy such as Pseudomonas aeuriginosa.

Despite the powerful bacteriostatic activity, prolonged use of this antibiotic has been associated with the emergence of strains with resistive capacity represented by the expression of efflux pumps, inactivating enzymes and mutations of the target enzyme able to neutralize the efficacy therapeutic of Norfloxacin.

Studies carried out and clinical efficacy

1 .NORFLOXACINE AS AN ANTI-INFLAMMATORY IN THE COURSE OF CIRRHOSIS

Work that broadens the classic therapeutic indications of Norfloxacin, demonstrating how sub-therapeutic doses can reduce the inflammatory insult present in patients with cirrhosis, controlling the activation status of neutrophils.

2. NORFLOXACINE AND EPATORENAL SYNDROME

Work that evaluates the effectiveness of Norfloxacin in reducing endotoxemia characteristic of hepato-renal syndrome. Unfortunately, unlike when seen on experimental models, no particularly encouraging results were observed on patients.

3. RARE SIDE EFFECTS OF NORFLOXACINE

Interesting study that reveals a very rare side effect induced by Norfloxacin, represented by hypoglycemia in second-type diabetic patients treated with oral hypoglycemic agents and more precisely sulfonylureas. In the same, the appearance of dermatological reactions, and in particular of hives, was also observed.

Method of use and dosage

NORFLOX ®

540 mg tablets of Norfloxacin pivaloyloxymethyl ester equivalent to 400 mg of Norfloxacin;

Oral suspension at 5.4% of pivaloyloxymethyl ester of Norfloxacin.

The dosing schedule effective in the treatment of urinary tract infections both high and low, involves the administration of 400 mg of Norfloxacin twice a day for about 7 days.

Dosage adjustments may be necessary in particular conditions and in patients with renal and hepatic impairment.

Warnings NORFLOX ® Norfloxacin

The use of NORFLOX ® must necessarily be preceded by a careful medical examination useful to assess the prescriptive appropriateness and the possible presence of conditions incompatible with Flurochinolone-based therapy such as cardiac pathologies or severe renal function impairment.

Particular caution should therefore be reserved for these patients given the potential side effects of antibiotic therapy.

It is also important to avoid direct exposure to sunlight during Norfloxacin therapy given the potential photosensitizing activity, responsible for dermatitis and severe dermatological reactions.

PREGNANCY AND BREASTFEEDING

The high number of studies that revealed the presence of the active ingredient in therapeutic doses inside the umbilical cord, amniotic fluid and breast milk suggests avoiding the intake of NORFLOX ® during pregnancy and in the subsequent period of breastfeeding at otherwise.

Interactions

In order to avoid variations in the biological activity and the safety profile of the drugs used, the patient receiving NORFLOX ® should pay particular attention, always consulting first with their doctor, in case of simultaneous intake of:

Drugs or preparations based on divalent elements;
Pobenecid;
Anticonvulsant drugs;
Drugs capable of lengthening the QT interval;
Oral anticoagulants.

Contraindications NORFLOX ® Norfloxacin

The use of NORFLOX ® is contraindicated in case of hypersensitivity to the active substance or to one of its excipients, in patients of pediatric age or with a history of epileptic events.

Undesirable effects - Side effects

Although therapy with fluoroquinolones is generally well tolerated and free of particularly frequent side effects, it should be remembered that the administration of Norfloxacin, especially if continued for a long time, can determine the appearance of nausea, vomiting, diarrhea, abdominal pain, dyspepsia, pseudomembranous colitis, headache, irritability, fever, anxiety, and sometimes hepatic, renal, cardiac and neurological manifestations.