Norfloxacin

These indications are based on manufacturer information for both originator and generic products. For product specific registered indications, please refer to product specific manufacturer information

Registered South African indications:

• Complicated and uncomplicated upper and lower urinary tract infections, including cystitis, pyelitis, cystopyelitis and pyelonephritis
• Infections caused by Pseudomonas aeruginosa (an aminoglycoside must be administered concomitantly)

Contraindications

Registered South African contraindications

• Known hypersensitivity to the active substance, norfloxacin or any chemically related quinolone antibacterial or to any of the excipients
• Creatinine clearance of less than 30ml/min
• Moderate to severe renal impairment
• Coadministration with angiotensin-converting enzyme (ACE) inhibitors/renin-angiotensin blockers in patients with moderate to severe renal impairment
• Children or adolescents under the age of 18 years, as experimental evidence indicates that species variable, reversible lesions of the cartilage of weight-bearing joints has been seen in immature members of certain animal species
• Pregnancy
• Lactation
• Confirmed mitral valve and /aortic valve regurgitation unless no safer appropriate alternative antibiotic is available, has failed or is not well tolerated

Cautions

• Mild renal impairment
• Hepatic impairment
• Elderly
• History of QT prolongation or risk factors thereof
• Diabetes mellitus
• Exposure to sunlight
• History of peripheral neuropathy
• Known or suspected central nervous system disorder
• Risk factors that may predispose to seizures or lower the seizure threshold
• Prolonged use
• Patients with solid organ transplants
• Risk of fluoroquinolone-induced tendinitis and tendon rupture
• Risk of aortic aneurysm and dissection (particularly in the elderly)
• Marfan syndrome
• Vascular Ehlers-Danlos syndrome
• Takayasu arteritis
• Giant cell arteritis
• Behçet's disease
• Uncontrolled hypertension
• Atherosclerosis
• History of myasthenia gravis
• Rheumatoid arthritis
• Glucose-6-phosphate dehydrogenase deficiency

Forms avail. in SA and covered in this monograph: tab

Dosages below include:

• South African registered indications and dosages

South African registered indications and dosages

Infections caused by: Aerobic Gram-positive and Gram-negative aerobic organisms (broad spectrum)

Specific doses based on individual indications

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

Uncomplicated lower urinary tract infections (e.g. cystitis)

• Oral (tab): 400mg, 12hrly; Treatment duration: 3 days

Complicated urinary tract infections

• Oral (tab): 400mg, 12hrly; Treatment duration: 7-10 days

Susceptibility of the causative organisms to norfloxacin should be tested

The presence of food in the stomach may slightly decrease or delay the absorption of norfloxacin. Therefore, norfloxacin should preferably be taken with a full glass (240ml) of water on an empty stomach (either 1 hour before or 2 hours after meals or ingestion of milk)

Multivitamins, products containing iron or zinc, antacids containing magnesium and aluminium, sucralphate, or products containing didanosine should not be taken within 2 hours administration of norfloxacin

Contraindicated

Pregnancy

South African recommendations

• Contraindicated
• The safe use of norfloxacin in pregnant women has not been established
• Quinolones such as norfloxacin has been reported to cause arthropathy in immature animals and therefore its use during pregnancy is contraindicated

Breastfeeding

South African recommendations

• Contraindicated
• It is not known whether norfloxacin is excreted in human milk
• Administration to mothers breastfeeding their infants is contraindicated

Renal Impairment

South African recommendations

• Mild: Caution, dose adjustment recommended
  Doses may need to be reduced in renal impairment: 400mg once daily has been suggested when creatinine clearance is 30ml/minute
• Moderate to severe: Contraindicated

Hepatic Impairment

South African recommendations

• Caution; no dose adjustment recommended

Elderly

South African recommendations

• Caution; no dose adjustment recommended
  No geriatric-specific problems have been demonstrated
  However, elderly patients are more likely to have an age-related decrease in renal function, which may require an adjustment in dosage

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Dizziness 
• Headache 
• Drowsiness

Cardiovascular Disorders

• Mitral valve and/or aortic valve regurgitation

Gastrointestinal Disorders

• Nausea and vomiting
• Abdominal cramping
• Abdominal pain
• Anorectal pain
• Anorexia
• Constipation
• Diarrhea
• Dyspepsia
• Flatulence
• Loose stools
• Xerostomia

Hepatobiliary Disorders

• Elevated hepatic enzymes

Genitourinary Disorders

• Proteinuria 

Musculoskeletal Disorders

• Weakness 
• Back pain

Skin and Subcutaneous Tissue Disorders

• Hyperhidrosis
• Pruritus
• Rash

Immune, Blood and Lymphatic System Disorders

• Eosinophilia 
• Decreased white blood cell count
• Increased serum alkaline phosphatase
• Decreased platelet count
• Leukopenia 
• Thrombocytopenia
• Decreased haematocrit
• Decreased haemoglobin
• Fever

• Angiotensin-converting enzyme (ACE) inhibitors
• Renin-angiotensin blockers
• Corticosteroids
• Aminolevulinic acid
• Antacids
• Bacillus Calmette–Guérin vaccine
• Calcium salts
• Cholera vaccine
• Delamanid
• Didanosine
• Iron salts
• Lanthanum
• Magnesium salts
• Mifepristone
• Multivitamins
• Minerals 
• Nadifloxacin
• QT prolonging agents
• Quinapril
• Sevelamer
• Sodium picosulfate
• Strontium ranelate
• Sucralfate
• Theophylline derivatives
• Typhoid vaccine
• Zinc salts

• Full blood count

Specific cases may require

• Renal function
• Hepatic function

Risk of mitral and aortic regurgitation

• There is a possible increased risk for patients to develop mitral valve and/or aortic valve regurgitation (left sided heart valves) while on treatment with oral and injectable fluoroquinolones. The increased risk continues until about 60 days after completion of treatment
• A thorough cardiovascular examination, including an echocardiogram (ECG), should be performed, before oral or injectable fluoroquinolones are prescribed
• Fluoroquinolones should not be prescribed to patients with mitral valve and/or aortic valve regurgitation, unless no safer alternative antibiotic is available, has failed or is not well tolerated

The bactericidal action of norfloxacin results from inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV, which are required for bacterial DNA replication, transcription, repair, and recombination.

Spectrum of activity: Gram positive and Gram negative aerobic organisms

Tablet 400mg

• Floxin (Ranbaxy Pharmaceuticals)
• Norfloxacin Actor (Cipla)
• Utifloxa (Arrow)
• Utin-400 (Cipla)