In clinical trials involving 82 healthy subjects and 228 patients with gonorrhea, treated with a single dose of Norflodal, 6.5% reported drug-related adverse experiences. However, the following incidence figures were calculated without reference to drug relationship.
The most common adverse experiences ( > 1.0%) were: dizziness (2.6%), nausea (2.6%), headache (2.0%), and abdominal cramping (1.6%).
Additional reactions (0.3%-1.0%) were: anorexia, diarrhea, hyperhidrosis, asthenia, anal/rectal pain, constipation, dyspepsia, flatulence, tingling of the fingers, and vomiting.
Laboratory adverse changes considered drug-related were reported in 4.5% of patients/subjects. These laboratory changes were: increased AST (SGOT) (1.6%), decreased WBC (1.3%), decreased platelet count (1.0%), increased urine protein (1.0%), decreased hematocrit and hemoglobin (0.6%), and increased eosinophils (0.6%).
What are some things I need to know or do while I take Norflodal?
- Tell all of your health care providers that you take Norflodal. This includes your doctors, nurses, pharmacists, and dentists.
- Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how Norflodal affects you.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- High and low blood sugar has happened with drugs like this one. Most of the time, low blood sugar happened in people with diabetes who were taking drugs that lower blood sugar like insulin. Very low blood sugar has led to coma and sometimes death. Check blood sugar as you have been told by the doctor.
- Tell your doctor if you have signs of high or low blood sugar like breath that smells like fruit, dizziness, fast breathing, fast heartbeat, feeling confused, feeling sleepy, feeling weak, flushing, headache, more thirsty or hungry, passing urine more often, shaking, or sweating.
- This medicine may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking Norflodal with your other drugs.
- Do not use longer than you have been told. A second infection may happen.
- Tell your doctor if you take a drug that has caffeine, or you eat or drink products that have caffeine, like tea, coffee, cola, or chocolate.
- You may get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
- Drink lots of noncaffeine liquids every day unless told to drink less liquid by your doctor.
- Be careful if you have G6PD deficiency. Anemia may happen.
- A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
- If you are over the age of 60, use Norflodal with care. You could have more side effects.
- Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Norflodal while you are pregnant.
- Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
Norflodal is a synthetic, first generation broad-spectrum bactericidal fluoroquinolone antibiotic.
Urinary Tract Infections
Uncomplicated urinary tract infections (including cystitis) due to Enterococcus faecalis, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Staphylococcus epidermidis, Staphylococcus saprophyticus, Citrobacter freundii 1 , Enterobacter aerogenes 1 , Enterobacter cloacae 1 , Proteus vulgaris 1 , Staphylococcus aureus1, or Streptococcus agalactiae 1 .
Because fluoroquinolones, including NOROXIN, have been associated with serious adverse reactions (see WARNINGS), and for some patients uncomplicated urinary tract infection is self-limiting, reserve NOROXIN for treatment of uncomplicated urinary tract infections (including cystitis) in patients who have no alternative treatment options.
Complicated urinary tract infections due to Enterococcus faecalis, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, or Serratia marcescens 1 . Sexually transmitted diseases (see WARNINGS)
Uncomplicated urethral and cervical gonorrhea due to Neisseria gonorrhoeae.
Prostatitis due to Escherichia coli.
(See DOSAGE AND ADMINISTRATION for appropriate dosing instructions.)
Penicillinase production should have no effect on Norflodal activity.
Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to Norflodal. Therapy with Norflodal may be initiated before results of these tests are known; once results become available, appropriate therapy should be given. Repeat culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agents but also on the possible emergence of bacterial resistance.
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 susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Drug-drug. Antacids, bismuth, iron salts, subsalicylate, sucralfate, zinc salts: decreased Norflodal absorption
Antineoplastics: decreased Norflodal blood level
Cimetidine: interference with Norflodal elimination
Corticosteroids: increased risk of tendon rupture
Nitrofurantoin: antagonism of Norflodal's antibacterial effects in GU tract
Other fluoroquinolones: increased risk of nephrotoxicity
Probenecid: decreased renal elimination of Norflodal
Theophylline: increased theophylline blood level, greater risk of toxicity
Warfarin: increased anticoagulant effect
Drug-diagnostic tests. Alanine amino-transferase, alkaline phosphatase, aspartate aminotransferase, bilirubin, eosino-phils, lactate dehydrogenase, platelets: increased levels
Hemoglobin, hematocrit: decreased values
Drug-food. Caffeine: decreased hepatic metabolism of caffeine
Milk or yogurt (consumed alone): impaired drug absorption
Tube feedings: impaired drug absorption
Drug-herbs. Dong quai, St. John's wort: phototoxicity
Fennel: decreased drug absorption
Drug-behaviors. Sun exposure: phototoxicity
What are some other side effects of Norflodal?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Upset stomach or throwing up.
- Not hungry.
- Feeling sleepy.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
It is a Category C drug. Animal studies have not shown any teratogenic effect.
It is not known whether Norflodal is secreted during lactation.
There are no studies regarding the safety of Norflodal in persons aged
After oral intake about 30 to 40% of Norflodal is absorbed. Maximal plasma levels occur after one to two hours. The presence of food can delay absorption. The plasma protein binding is about 14%. It is extensively distributed. Norflodal has a unique property i.e. it penetrates well into tissues of the genitourinary tract. It crosses the placenta. Comparatively high concentrations are achieved in bile.
The t1/2 of Norflodal is three to four hours. Approximately 30% of a dose is eliminated unchanged in the urine within 24 hours, thus producing high urinary concentrations. Urinary excretion is mainly by tubular secretion and glomerular filtration and is decreased by probenecid, but plasma concentrations of Norflodal are usually not affected. Norflodal undergoes little metabolism, probably in the liver, and a number of metabolites have been reported in urine, some showing antibacterial activity. Approximately 30% of an oral dose is excreted in the faeces.
What is Norflodal? What is Norflodal used for?
Norflodal is a fluoroquinolone antibiotic. Other fluoroquinolones include ciprofloxacin (Cipro), levofloxacin (Levaquin), and ofloxacin (Floxin). Norflodal works by blocking DNA gyrase enzyme, which is responsible for production and repair of bacterial DNA. Blocking of DNA gyrase leads to bacteria death and prevents worsening of infection. Norflodal treats infections caused by gram-positive and gram-negative bacteria like Enterococcus faecalis, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus saprophyticus, Streptococcus agalactiae, Citrobacter freundii, Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli, Klebsiella pneumonia, Neisseria gonorrhoeae, Proteus mirabilis, Proteus vulgaris, Pseudomonas aeruginosa, and Serratia marcescens. FDA approved the brand name Norflodal (Noroxin) in October 1986.
NOROXIN® (Norflodal) 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.
DOSAGE AND ADMINISTRATION
Tablets NOROXIN should be taken at least one hour before or at least two hours after a meal or ingestion of milk and/or other dairy products. Multivitamins, other products containing iron or zinc, antacids containing magnesium and aluminum, sucralfate, or Videx® (Didanosine), chewable/buffered tablets or the pediatric powder for oral solution, should not be taken within 2 hours of administration of Norflodal. Tablets NOROXIN should be taken with a glass of water. Patients receiving NOROXIN should be well hydrated (see PRECAUTIONS).
Absorption and distribution
Norflodal displays linear kinetics. There is no significant accumulation with the recommended dosage of 400 mg every 12 h. Food slightly delays but does not otherwise impair absorption. Antacids reduce absorption. It is widely distributed, but concentrations in tissues other than those of the urinary tract are low; levels in the prostate are around 2.5 mg/g.
Renal excretion is significant with ciprofloxacin, Norflodal , and gatifloxacin, and doses of these agents should be halved if GFR is below 30 ml/min. 42,43 Moxifloxacin is only 20% renally excreted, and dose reduction is not required. Norflodal is well secreted by the kidney and thus useful in urinary tract infections. Quinolones are generally well tolerated but have been known to cause CNS effects (headache, dizziness, insomnia, depression, restlessness, and tremors), interstitial nephritis, and crystalluria. Fluids should be encouraged (if tolerated) and excessively alkaline urine avoided to prevent crystalluria. Quinolones show reduced absorption when they are coadministered with compounds containing metals such as magnesium, calcium, aluminum, and iron. As the timing of phosphate binders with meals is vital, quinolones should be administered away from meals and metallic phosphate binders. 9
Norflodal is given to treat urinary tract infections, such as cystitis and chronic prostatitis. It works by killing the bacteria which are the cause of the infection.