Norbactin tablets

Norbactin

  • Active Ingredient: Norfloxacin
  • 400 mg
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What is Norbactin?

The active ingredient of Norbactin brand is norfloxacin. The originating document has been archived. We cannot confirm the completeness, accuracy and currency of the content.

Used for

Norbactin is used to treat diseases such as: Bladder Infection, Campylobacter Gastroenteritis, Epididymitis, Non-Specific, Gonococcal Infection, Uncomplicated, Kidney Infections, Prostatitis, Salmonella Enteric Fever, Salmonella Gastroenteritis, Shigellosis, Traveler's Diarrhea, Urinary Tract Infection.

Side Effect

Possible side effects of Norbactin include: dry mouth; bloating; unusual weight loss; irritation or soreness of the mouth; headache; Abdominal or stomach cramps or tenderness; lower back or side pain; hives or welts, itching, or skin rash.

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Adverse reaction

Side effects of Norbactin are dizziness, nausea, headache, abdominal cramps, anorexia, diarrhea, constipation, dyspepsia, flatulence, tingling of the fingers, vomiting, tendonitis, tendon repture, liver toxicity, kidney toxicity.

Fluoroquinolones.

The fluoroquinolones ( Norbactin , ofloxacin, ciprofloxacin, levofloxacin, and moxifloxacin) are active against almost all aerobic gram-negative bacilli. Ciprofloxacin remains the most potent fluoroquinolone against P. aeruginosa. Levofloxacin and moxifloxacin are more active than the older fluoroquinolones against gram-positive cocci, although enterococci and methicillin-resistant S. aureus tend to be less susceptible than other gram-positive cocci. In addition, moxifloxacin is active against obligate anaerobes, in contrast to other fluoroquinolones. 211,212 Because of their ability to kill bacteria in the exponential and the stationary phases of growth, the fluoroquinolones are valuable antimicrobial agents for the treatment of intra-abdominal infections, including abscesses. However, fluoroquinolones should be used judiciously; especially because E. coli resistance has emerged internationally. 213 Fluoroquinolones have now been found to have plasmid-mediated resistance. When treating patients with community- or health care–acquired intra-abdominal infections of high severity, fluoroquinolone antibiotics should not be used unless local and hospital microbiologic surveys indicate greater than 90% of E. coli strains remain susceptible to these agents. 1

Currently, three fluoroquinolones (ciprofloxacin, levofloxacin, and moxifloxacin) are available for parenteral administration. These fluoroquinolones are also well absorbed after oral administration and are concentrated in tissues so that tissue levels greatly exceed the MICs of many sensitive pathogens. With current fluoroquinolone dosing regimens, serum levels may be inadequate to treat susceptible pathogens with relatively high MICs (e.g., >0.5 µg/mL of ciprofloxacin), which include some strains of P. aeruginosa, enterococci, and S. aureus, especially the methicillin-resistant strains. If such organisms can be anticipated (e.g., in nosocomial infections), additional antimicrobial agents may be necessary to broaden the spectrum of an empirical regimen. The addition of an antimicrobial agent active against anaerobic bacteria and aerobic or microaerophilic gram-positive cocci (e.g., clindamycin, ampicillin-sulbactam, amoxicillin-clavulanate acid) would be required if the use of ciprofloxacin were considered for secondary intra-abdominal infection. The use of levofloxacin, even combined with a second agent with reliable activity against anaerobic gram-negative bacilli for the treatment of intra-abdominal infections, does not have any published support, and perhaps this fluoroquinolone should be reserved for respiratory and urinary tract infections for which it may be better suited. 214 Moxifloxacin is the only fluoroquinolone that has been studied and approved as a single agent for the treatment of complicated intra-abdominal infections. It has been determined to be noninferior to β-lactam/lactamase inhibitors, cephalosporin-based regimens, and carbapenems in several comparator studies. 215-217 However, its use should be cautioned against in patients who have recently been treated with any fluoroquinolone antibiotic because these individuals may harbor moxifloxacin-resistant strains of B. fragilis as well as other fluoroquinolone-resistant microorganisms. 218

Administration

• Give with glass of water 1 hour before or 2 hours after a meal.

• Don't give antacids within 2 hours of Norbactin.

NOROXIN® (Norbactin) Tablets

SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS

  • Fluoroquinolones, including NOROXIN, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together, including:
  • Tendinitis and tendon rupture
  • Peripheral neuropathy
  • Central nervous system effects (see WARNINGS).Discontinue NOROXIN immediately and avoid the use of fluoroquinolones, including NOROXIN, in patients who experience any of these serious adverse reactions.
  • Fluoroquinolones, including NOROXIN, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid NOROXIN in patients with known history of myasthenia gravis (see WARNINGS).
  • Because fluoroquinolones, including NOROXIN, have been associated with serious adverse reactions (see WARNINGS), reserve NOROXIN for use in patients who have no alternative treatment options for uncomplicated urinary tract infections (including cystitis) (see INDICATIONS AND USAGE).

To reduce the development of drug-resistant bacteria and maintain the effectiveness of NOROXIN® and other antibacterial drugs, NOROXIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Antibiotic Regimens

Norbactin , a poorly absorbed fluoroquinolone, has been used to achieve selective intestinal decontamination in cirrhotic patients; Norbactin has several characteristics that make it suitable for prophylaxis. ▪

Poor absorption when taken orally

Effectiveness against enteric gram-negative organisms

Sparing of gram-positive and anaerobic organisms to maintain their protective role in the normal gut flora a.

Norbactin reduces the frequency of SBP, delays progression to hepatorenal syndrome, and improves overall survival.

In patients who have survived an episode of SBP: ▪

The recurrence rate can be as high as 68% at 1 year without antibiotic prophylaxis.

Norbactin, 400 mg orally daily, has been shown to decrease the probability of recurrent SBP to 20% at 1 year.

Norbactin prophylaxis is cost effective in reducing recurrent SBP.

However, Norbactin treatment does not alter the overall mortality in these patients.

Norbactin has not been available in the United States since 2014.

In patients with cirrhosis and gastrointestinal hemorrhage: ▪

The incidence of SBP can be as high as 45% to 66% at 1 year without antibiotic prophylaxis.

Antibiotic prophylaxis started immediately and continued for 7 days decreases the incidence of SBP to 10% to 20%.

Antibiotic prophylaxis may improve survival in these patients.

Intravenous ceftriaxone has been shown to be more effective than oral Norbactin for SBP prophylaxis in patients with advanced cirrhosis and gastrointestinal hemorrhage.

In hospitalized patients with ascitic flu > ▪

The overall probability of new-onset SBP is 20% in 1 year.

Prophylaxis with Norbactin 400 mg orally daily decreases in-hospital incidence of SBP from 22% to 0% without an effect on in-hospital mortality.

Trimethoprim-sulfamethoxazole, one double-strength tablet orally daily, has also been reported to be effective in preventing SBP and has supplanted Norbactin in the United States.

Gas Gas chromatography

Gas chromatography was used to analyze the res >Norbactin in pharmaceutical preparations . The analyte was dissolved in water, and the solution analyzed by GC on a fused-silica column (30 m×0.3 mm i.d.) coated with 5% cross-linked ph-Me silicone (3 μm). The temperature program consisted of an increase to 50°C, holding for 5 min, ramping to 180°C (ramp=15°C/min), and finally holding for 10 min at 180 5°C/min. Nitrogen was used as the carrier gas (flow rate of 1 mL/min), detection was effected using flame ionization. Piperazine was determined in the two mixtures by mixing for 10 min with cyclohexane, filtering, partitioning the filtrate with water, heating the aqueous phase at 45°C for 10 min, and then analyzing as above. The calibration graph was linear for 0.4–10 ppm piperazine, with a RSD (n=10) of 2.1% for 2 μg piperazine. The recovery from ciprofloxacin was 98.1–98.4%.

How does Norbactin work?

Norbactin is a type of medicine called a quinolone antibiotic. It works by interfering with a bacterial enzyme involved in replicating and repairing the genetic material (DNA) of bacteria. If this enzyme doesn't work, the bacteria cannot reproduce or repair themselves. This kills the bacteria and clears up the infection.

Your doctor may ask you for a urine sample to make sure the bacteria causing your infection are susceptible to Norbactin.

Resistance

Like other fluoroquinolones, resistance is mainly because of chromosomal mutation (Quinolone-Resistance Determining Regions ) forming a DNA gyrase or topoisomerase IV with reduced affinity for Norbactin. Another common mechanism is reduced permeability/increased efflux of Norbactin across bacterial membranes. Like other FQs Norbactin, FQ-resistant mutants are not easily selected hence resistance develops slowly to FQs.

Due to the unique mechanism of action of fluoroquinolones plasmid mediated transferable resistance perhaps does not occur. A Qnr protein has been seen that offers protection to the DNA gyrase from damage by the FQs. Also modification of Norbactin can be caused by a different type acetyltransferase which is similar to the one which modifies aminoglycoside.

Cross resistance is seen within the FQs.

Microorganisms like Klebsiella pneumoniae, acinetobacter and pseudomonas aeruginosa have developed the most resistance to Norbactin.

Norbactin is usually active against the microorganisms which are not sensitive to nalidixic acid.


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