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NORFLOXACIN is a brand name for Norfloxacin, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: NORFLOXACIN (norfloxacin tablets) is indicated for: The treatment of upper and lower urinary tract infections, specifically complicated and uncomplicated cystitis, pyelitis and pyelonephritis caused by susceptible strains of the following microorganisms: Escherichia coli Klebsiella pneumonia unspecified…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations In cases of uncomplicated acute bacterial cystitis, limit the use of NORFLOXACIN to circumstances where no other treatment options are available. A urine culture should be obtained prior to treatment to ensure norfloxacin tablets susceptibility.
Limit the use of NORFLOXACIN to patients where no other treatment options exist AND where norfloxacin tablets susceptibility is demonstrated, OR norfloxacin tablets susceptibility is highly likely, typically greater than or equal to 95%, based on local susceptibility patterns.
Appropriate culture and susceptibility studies should be carried out prior to initiation of therapy with norfloxacin tablets and if clinically indicated during treatment. Therapy may be initiated before obtaining results of these tests (see 15 MICROBIOLOGY), however, modification of such treatment may be required once the results become available.
2 Recommended Dose and Dosage Adjustment Adults The recommended dosage of NORFLOXACIN (norfloxacin tablets) for urinary tract infections is one 400 mg tablet twice a day taken with a glass of water at least 1 hour before, or 2 hours after a meal or milk ingestion for 7 to 10 days.
For women with uncomplicated acute cystitis, the duration of therapy can be reduced to three NORFLOXACIN (Norfloxacin Tablets) Page 6 of 42 (3) days. For adults with gonococcal urethritis or cervicitis, the recommended dosage of NORFLOXACIN is two 400 mg tablets (800 mg) given as a single dose.
Geriatrics The recommended dosage of NORFLOXACIN in elderly patients with normal renal function for their age is the same as given for adults above. 4 Geriatrics. Impaired Renal Function NORFLOXACIN may be used in the treatment of patients with renal insufficiency who do not require hemodialysis.
73 m2) the recommended dose is one 400 mg tablet once daily. See 7 WARNINGS AND PRECAUTIONS, Renal. When only the serum creatinine level is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance.
The serum creatinine should represent a steady state of renal function. 85 x above value. 01667. The administration of norfloxacin tablets to anuric patients is not recommended. Pediatrics The safety and efficacy of norfloxacin tablets in prepubertal children have not been established.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. NORFLOXACIN (norfloxacin tablets) is generally well tolerated. In controlled clinical trials involving 1,528 patients, the overall incidence of drug-related adverse reactions was approximately 3%.
The following adverse reactions were reported. 5 Post-Market Adverse Reactions The following additional adverse reactions have been reported since the drug was marketed: Blood and lymphatic system disorders: Hemolytic anemia, thrombocytopenia.
Abnormal adverse reactions observed rarely in clinical trials include leukopenia, eosinophilia, neutropenia.
Ear and labyrinth disorders:
Tinnitus. On very rare occasions, the following have been reported: transient hearing loss.
Eye disorders:
Conjunctivitis, eye pain/irritation, visual disturbances. On very rare occasions, the following have been reported: nystagmus, hemophthalmia.
General disorders and administration site conditions:
Asthenia/fatigue. On very rare occasions, the following have been reported: fever.
Gastrointestinal disorders:
Constipation, flatulence, pseudomembranous colitis, dysgeusia, pancreatitis (rare). On very rare occasions, the following have been reported: dry mouth.
, Cardiovascular 05/2025 7 WARNINGS AND PRECAUTIONS, Musculoskeletal 05/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ...........................................................................................
2 TABLE OF CONTENTS ............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .....................................................................
4 1 INDICATIONS .............................................................................................................. 1 Pediatrics...................................................................................................................
2 Geriatrics ................................................................................................................... 4 2 CONTRAINDICATIONS.................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. ........................................................... 5 4 DOSAGE AND ADMINISTRATION................................................................................. 1 Dosing Considerations ..............................................................................................
2 Recommended Dose and Dosage Adjustment ......................................................... 4 Administration .......................................................................................................... 5 Missed Dose ..............................................................................................................
6 5 OVERDOSAGE............................................................................................................. 7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 7 7 WARNINGS AND PRECAUTIONS ..................................................................................
NORFLOXACIN (norfloxacin tablets) is contraindicated in:
NORFLOXACIN (Norfloxacin Tablets) Page 5 of 42 Patients with known hypersensitivity to NORFLOXACIN, or to other quinolone antibacterial agents or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Norfloxacin tablets should not be used in patients in whom epiphyseal closure has not occurred. 3 Pediatrics. 4 Administration NORFLOXACIN tablets should be taken orally with a glass of water at least 1 hour before, or 2 hours after a meal or milk ingestion.
5 Missed Dose NORFLOXACIN (Norfloxacin Tablets) Page 7 of 42 If the patient misses a dose, inform the patient to skip the missed dose and take the next dose at the regular dosing schedule.
Hepatobiliary disorders:
Hepatitis, jaundice, including cholestatic jaundice.
Immune system disorders:
Anaphylaxis, angioedema.
Investigations:
Abnormal adverse reactions observed rarely in clinical trials include elevation of ALAT (SGPT), ASAT (SGOT), alkaline phosphatase, bilirubin, increased BUN, serum creatinine, and LDH, elevated creatine kinase (CK), and decreased hematocrit.
Musculoskeletal and connective tissue disorders:
Tendon rupture, possible exacerbation of myasthenia gravis, arthritis, myalgia.
Nervous system disorders:
Convulsions, paresthesia, polyneuropathy including Guillain-Barre syndrome, tremors, myoclonus, somnolence. On very rare occasions, the following have been reported: hypertonia, ataxia, dysarthria, dysphasia.
Psychiatric disorders:
Confusion, psychic disturbances including psychotic reactions.
Respiratory thoracic and mediastinal disorders:
On very rare occasions, the following have been reported: dyspnea.
Renal and urinary disorders:
Interstitial nephritis. Abnormal adverse reactions observed rarely in clinical trials include proteinuria. On very rare occasions, the following have been reported: renal failure.
Reproductive system and breast disorders:
Vaginal candidiasis. Skin and subcutaneous tissue disorders: photosensitivity, Stevens-Johnson syndrome, toxic NORFLOXACIN (Norfloxacin Tablets) Page 14 of 42 epidermal necrolysis, exfoliative dermatitis, erythema multiforme, pruritus, urticaria.
On very rare occasions, the following have been reported: periorbital erythema.
Vascular disorders:
Vasculitis. Others Although the following adverse reactions were not observed in these clinical trials with norfloxacin tablets, they have been reported following treatment with other quinolone antibacterial agents: Blood and lymphatic system disorders: Hemolytic anemia in patients with latent or actual defects in glucose-6-phosphate dehydrogenase (G6PD) activity.
Cardiac disorders:
Palpitation.
Ear and labyrinth disorders:
Vertigo.
Eye disorders:
Overbrightness of light, change in colour perception, difficulty in focusing, decrease in visual acuity and double vision.
Gastrointestinal disorders:
Soreness of the gums, metallic taste.
General disorders and administration site conditions:
Swelling of the extremities, edema.
Hepatobiliary disorders:
Cholestasis.
Metabolism and nutrition disorders:
Metabolic acidosis.
Musculoskeletal and connective tissue disorders:
Joint stiffness.
Nervous system disorders:
Signs and symptoms of increased intracranial pressure in infants and children which usually disappeared rapidly with no sequelae when treatment was discontinued.
Psychiatric disorders:
Restlessness; toxic psychosis (rare).
Reproductive system and breast disorders:
Perineal burning.
Skin and subcutaneous tissue disorders:
Bullae.
1 Special Populations ................................................................................................. 1 Pregnant Women ....................................................................................................
2 Breast-feeding ......................................................................................................... 3 Pediatrics.................................................................................................................
4 Geriatrics ................................................................................................................. 11 8 ADVERSE REACTIONS................................................................................................
2 Clinical Trial Adverse Reactions .............................................................................. 5 Post-Market Adverse Reactions.............................................................................. 13 9 DRUG INTERACTIONS ...............................................................................................
2 Drug Interactions Overview .................................................................................... 4 Drug-Drug Interactions ........................................................................................... 5 Drug-Food Interactions ...........................................................................................
6 Drug-Herb Interactions. .......................................................................................... 7 Drug-Laboratory Test Interactions.......................................................................... 16 10 CLINICAL PHARMACOLOGY .......................................................................................
1 Mechanism of Action .............................................................................................. 2 Pharmacodynamics .................................................................................................
3 Pharmacokinetics .................................................................................................... 18 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 23 12 SPECIAL HANDLING INSTRUCTIONS...........................................................................
23 PART II: SCIENTIFIC INFORMATION ...................................................................................... 24 13 PHARMACEUTICAL INFORMATION ........................................................................... 24 14 CLINICAL TRIALS .......................................................................................................
2 Comparative Bioavailability Studies ....................................................................... 24 15 MICROBIOLOGY .......................................................................................................
25 16 NON-CLINICAL TOXICOLOGY ..................................................................................... 30 PATIENT MEDICATION INFORMATION ................................................................................. 35 NORFLOXACIN (Norfloxacin Tablets) Page 4 of 42 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS NORFLOXACIN (norfloxacin tablets) is indicated for: The treatment of upper and lower urinary tract infections, specifically complicated and uncomplicated cystitis, pyelitis and pyelonephritis caused by susceptible strains of the following microorganisms: Escherichia coli Klebsiella pneumonia unspecified Klebsiella spp.
unspecified Enterobacter spp. unspecified Citrobacter spp. Proteus mirabilis Staphylococcus aureus Streptococcus faecalis Pseudomonas aeruginosa The treatment of […]