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Levofloxacin

FluoroquinoloneAntibacterial

Indications

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: 

  • Acute bacterial sinusitis due to H. influenzae, S. pneumoniae, S. aureus, M. catarrhalis and H. parainfluenzae
  • Acute exacerbations of chronic bronchitis due to H. influenzae, K. pneumoniae, methicillin-sensitive S. aureus, M. catarrhalis, E coli, H. parainfluenzae and S. pneumoniae
  • Community-acquired pneumonia due to H. influenzae, S. pneumoniae, methicillin-sensitive S. aureus, M. catarrhalis, H. parainfluenzae, K. pneumoniae, E. coli, Mycoplasma pneumoniae, Chlamydia pneumoniae and Legionella pneumophila
  • Hospital-acquired pneumonia due to H. influenzae, S. pneumoniae, and methicillin-sensitive S. aureus 
  • Chronic bacterial prostatitis due to Escherichia coli, Enterrococcus faecalis, Staphylococcus epidermidis, Staphylococcus haemolyticus, Streptococcus agalactiae, Streptococcus mitis
  • Complicated urinary tract infections and acute pyelonephritis due to E. coli, K. pneumoniae, S. faecalis, P. mirabilis, Enterobacter cloacae, P. aeruginosa
  • Uncomplicated urinary tract infections in women due to E.coli, K. pneumoniae
  • Uncomplicated skin and soft tissue infections due to methicillin-sensitive S. aureus, S. pyogenes, Acinetobacter calcoaceticus, E. cloacae, P. mirabilis, P. aeruginosa, E. coli, K. pneumoniae, S. faecalis
  • Complicated skin and skin structure infections: due to methicillin-sensitive S. aureus, S. pyogenes, P. mirabilis, E coli, K. pneumoniae, S. faecalis, E. cloacae, K. oxytoca
  • Intra-abdominal infections due to E. coli and anaerobic micro-organisms

In the treatment of infections caused by Pseudomonas aeruginosa, an aminoglycoside should be coadministered

Contraindications (ZA)

Registered South African contraindications

  • Hypersensitivity to the active ingredient or any of its excipients
  • Hypersensitivity to other quinolones
  • Epilepsy
  • Patients with history of tendon disorders associated with fluoroquinolone administration
  • Children or adolescents (under 18 years of age)
  • Pregnancy
  • Breastfeeding
  • Patients with confirmed mitral valve and aortic valve regurgitation unless no safer appropriate alternative is available, has failed or is not well tolerated
  • Coadministration of fluoroquinolones with angiotensin converting enzyme (ACE) inhibitors/angiotensin receptor blockers is contraindicated in patients with moderate to severe renal impairment

Warnings & precautions

  • Renal impairment
  • Elderly
  • Porphyria
  • Patients who have experienced serious adverse reactions in the past when using quinolone or fluoroquinolone containing products
  • Positive family history of aneurysm disease
  • Positive family history of congenital heart valve disease
  • Pre-existing heart valve disease
  • Presence of other risk factors or conditions predisposing for aortic both aneurysm and dissection and heart valve regurgitation/incompetence
    - Marfan syndrome
    - Vascular Ehlers-Danlos syndrome
    - Turner syndrome
    - Behçet's disease
    - Hypertension
    - Rheumatoid arthritis
  • Presence of other risk factors or conditions predisposing for aortic aneurysm and dissection (particularly in the elderly)
    - Takayasu arteritis
    - Giant cell arteritis
    - Known atherosclerosis
    - Sjögren's syndrome
  • Presence of other risk factors or conditions predisposing for heart valve regurgitation/incompetence
    - Infective endocarditis
  • Risk of fluoroquinolone-induced tendinitis and tendon rupture
  • Known or suspected Methicillin-resistant S. aureus infections
  • Solid organ transplant patients
  • Predisposed to seizures or epilepsy
  • Diabetic patients
  • Exposure to strong sunlight or to artificial UV rays
    - Sunray lamp
    - Solarium
  • Psychosis or history of psychiatric disease
  • QT prolongation or risk factors thereof
    - Congenital long QT syndrome
    - Coadministration with agents that are known to prolong the QT interval (e.g. Class IA and III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics)
    - Uncorrected electrolyte imbalance (e.g. hypokalemia, hypomagnesemia)
    - Elderly and women on QTc-prolonging medications
  • Cardiac disease
    - Heart failure
    - Myocardial infarction
    - Bradycardia
  • Severe underlying disease
    - Sepsis
  • History of myasthenia gravis
  • Mitral valve and/or aortic valve regurgitation
  • High doses
  • Coadministration with agents which lower the cerebral seizure threshold
  • Coadministration with vitamin K antagonists
  • Coadministration with systemic corticosteroids
  • Glucose-6-phosphate dehydrogenase deficiency
  • Sodium controlled diet (inj)
  • May impair ability to drive and operate machinery

Adult dosage

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

Dosages below include:

  • General dosing range
  • South African Standard Treatment Guideline indications and dosages
  • South African registered indications and dosages
  • Indications and dosages registered in other jurisdictions

Infections caused by: Some aerobic gram-positive bacteria, such as Bacillusanthracis, Staphylococcus aureus methi-S, Staphylococcus saprophyticus, Streptococci, group C and G, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes; Some aerobic gram negative bacteria, such as Eikenellacorrodens, Haemophilus influenzae, Haemophilus para-influenzae, Klebsiella oxytoca, Moraxella catarrhalis, Pasteurella multocida, Proteus vulgaris, Providencia rettgeri; Some anaerobic bacteria, such as Peptostreptococcus; Other susceptible organisms, such as Chlamydophila pneumoniae, Chlamydophila psittaci, Chlamydia trachomatis, Legionella pneumophila, Legionella sp., Mycoplasma pneumoniae, Mycoplasma hominis, Ureaplasma urealyticum; Kingella sp., Shigella sp., Y. enterocolitica

General dosing range

  • IV/ Oral (tab): 250-500mg, once or twice daily

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

South African Standard Treatment Guideline indications and dosages

Hepatitis in patients on antiretroviral therapy and anti-tuberculosis therapy (Additional agent(s) required)

  • Oral (tab): 750-1000mg, dly; Treatment duration: Stop at day 8 of rechallenge 
    (STG, Adult 2023)

Isoniazid mono-resistant tuberculosis (additional agent(s) required)

  • Oral (tab): 30-50kg: 750mg, dly; >50kg: 1000mg, dly; Treatment duration: ≥6 months
    (STG, Adult 2019; PHC 2020)

South African registered indications and dosages

Acute bacterial sinusitis
- Due to H. influenzae, S. pneumoniae, S. aureus, M. catarrhalis and H. parainfluenzae

  • IV/Oral (tab): 500mg, dly; Treatment duration: 10-14 days
    OR
  • IV/Oral (tab): 750mg, dly; Treatment duration: 5 days

Acute exacerbation of chronic bronchitis
- Due to H. influenzae, K. pneumoniae, methicillin-sensitive S. aureus, M. catarrhalis, E coli, H. parainfluenzae and S. pneumoniae

  • IV/Oral (tab): 500mg, dly: Treatment duration: 5-10 days
    OR
  • IV/Oral (tab): 750mg, dly; Treatment duration: 3-5 days

Community-acquired pneumoniae
- Due to H. influenzae, S. pneumoniae, methicillin-sensitive S. aureus, M. catarrhalis, H. parainfluenzae, K. pneumoniae, E. coli, Mycoplasma pneumoniae, Chlamydia pneumoniae and Legionella pneumophila

  • IV/Oral (tab): 500mg, 12-24hrly; Treatment duration: 10-14 days
    OR
  • IV/Oral (tab): 750mg, dly; Treatment duration: 5 days

Chronic bacterial prostatitis
- Due to Escherichia coli, Enterrococcus faecalis, Staphylococcus epidermidis, Staphylococcus haemolyticus, Streptococcus agalactiae, Streptococcus mitis

  • IV/Oral (tab): 500mg, dly; Treatment duration: 28 days

Complicated urinary tract infections and acute pyelonephritis
- Due to E. coli, K. pneumoniae, S. faecalis, P. mirabilis, Enterobacter cloacae, P. aeruginosa

  • IV/Oral (tab): 250mg, dly; Treatment duration: 10 days

Uncomplicated urinary tract infection
- Due to E.coli, K. pneumoniae

  • IV/Oral (tab): 250mg, dly; Treatment duration: 3 days

Complicated skin and skin structure infection
- Due to methicillin-sensitive S. aureus, S. pyogenes, P. mirabilis, E coli, K. pneumoniae, S. faecalis, E. cloacae, K. oxytoca

  • IV/Oral (tab): 500mg, 12hrly; Treatment duration: 10-14 days

Uncomplicated skin and skin structure infection
- Due to methicillin-sensitive S. aureus, S. pyogenes, Acinetobacter calcoaceticus, E. cloacae, P. mirabilis, P. aeruginosa, E. coli, K. pneumoniae, S. faecalis

  • IV/Oral (tab): 250-500mg, dly; Treatment duration: 7-10 days
    OR
    IV: 500mg, dly; Treatment duration: 10-14 days

Intra-abdominal infection (additional agent required)

  • IV/Oral (tab): 500mg, dly; Treatment duration: 10-14 days

Intra-abdominal infection: In combination with an antibiotic with anaerobic coverage

Above indications when bacteraemia and septicaemia are present

  • IV/Oral (tab): 500mg, 12hrly; Treatment duration: 10-14 days  

IV: Levofloxacin is only intended for slow IV infusion

Levofloxacin IV should be infused slowly over a period:
- ≥ 30mins for a dosage of 250mg, ≥60min for a dosage of 500mg and ≥90mins for a dosage of 750mg

The solution for infusion should be used immediately after perforation of the rubber stopper in order to prevent any bacterial contamination

See additional prescribing points

Tablets: Take 2hrs before iron salts, antacids, or sucralfate administration

Swallow whole, without crushing, and with sufficient amount of liquid

Continue treatment for 48-72hrs after the patient is afebrile

The time to switch from IV to oral treatment depends on the clinical situation

Indications and dosages registered in other jurisdictions

Acute bacterial sinusitis

  • Oral (tab): 500mg, dly; Treatment duration: 10-14 days

Acute bacterial exacerbations of chronic bronchitis

  • Oral (tab): 500mg, dly; Treatment duration: 7-10 days

Pyelonephritis

  • IV/Oral (tab): 500mg, dly; Treatment duration: 7-10 days

Community-acquired pneumonia
Complicated skin and soft tissue infections

  • IV/Oral (tab): 500mg, 12-24hrly; Treatment duration: 7-14 days

Uncomplicated cystitis

  • Oral (tab): 250mg, dly; Treatment duration: 3 days

Complicated urinary tract infections

  • Oral (tab): 500mg, dly; Treatment duration: 7-14 days
  • IV: 500mg, dly; Treatment duration: 7-14 days*

*Treatment duration includes IV plus oral treatment. The time to switch from IV to oral treatment depends on the clinical situation, but is normally 2-4 days

Chronic bacterial prostatitis

  • IV/Oral (tab): 500mg, dly; Treatment duration: 28 days

Inhalation anthrax

  • IV/Oral (tab): 500mg, dly; Treatment duration: 8 weeks

Levofloxacin solution is administered by slow IV infusion 12-24hrly. The infusion time must be ≥30 minutes for 250mg or 60mins for 500mg levofloxacin

The dosage depends in the type and severity of the infection and the susceptibility of the presumed causative pathogen. Treatment with levofloxacin after the initial use of the IV preparation may be completed with an appropriate oral levofloxacin presentation

Levofloxacin tablets should be swallowed without crushing and with sufficient amount of liquid

Levofloxacin tablets should be taken at least 2hrs before or after iron salts, zinc salts, magnesium-or aluminium containing antacids or didanosine (only didanosine formulations with aluminium or magnesium containing buffering agents), and sucralfate administration since reduction of absorption can occur

Paediatric dosage

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

Paed. dosages below include:

  • General dosing range
  • South African Standard Treatment Guideline indications and dosages
  • South African registered indications and dosages
  • Indications and dosages registered in other jurisdictions

Infections caused by: Some aerobic gram-positive bacteria, such as Bacillusanthracis, Staphylococcus aureus methi-S, Staphylococcus saprophyticus, Streptococci, group C and G, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes; Some aerobic gram negative bacteria, such as Eikenellacorrodens, Haemophilus influenzae, Haemophilus para-influenzae, Klebsiella oxytoca, Moraxella catarrhalis, Pasteurella multocida, Proteus vulgaris, Providencia rettgeri; Some anaerobic bacteria, such as Peptostreptococcus; Other susceptible organisms, such as Chlamydophila pneumoniae, Chlamydophila psittaci, Chlamydia trachomatis, Legionella pneumophila, Legionella sp., Mycoplasma pneumoniae, Mycoplasma hominis, Ureaplasma urealyticum; Kingella sp., Shigella sp., Y. enterocolitica

General dosing range

Younger than 28 days

  • No information available

Older than 28 days

  • IV/Oral (tab): 16-20mg/kg, dly, 12hrly; Max: 750mg/24hrs 

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

South African Standard Treatment Guideline indications and dosages

Multidrug-resistant tuberculosis - intensive phase and continuation phase (additional agent(s) required)

Younger than 8 years

  • Oral (tab): 15-20mg/kg, dly; Max: 1g/24hrs; Treatment duration: 18 months after the first date of sampling of a negative culture result
    (STG, Paed. 2017) 

Preventative therapy in case of MDR-TB contact (additional agent(s) required)

  • Oral (tab): 15-20mg/kg, dly; Treatment duration: 6 months
    (STG, Paed. 2017)

South African registered indications and dosages

Children and adolescents

  • Contraindicated

Indications and dosages registered in other jurisdictions

Younger than 18 years

  • Contraindicated

Special populations

Pregnancy

  • Contraindicated
  • A causal relationship with birth defects cannot be excluded
  • A review on the safety of fluoroquinolones concluded that these antibacterials should be avoided during pregnancy because of the difficulty in extrapolating animal mutagenicity results to humans and because the interpretation of this toxicity is still controversial
  • Some authors have also concluded that fluoroquinolones should be considered contraindicated in pregnancy, because safer alternatives are usually available
  • A 2013 review stated that fluoroquinolones are usually avoided in pregnancy because of concerns for foetal cartilage damage
  • There are limited amount of data from the use of levofloxacin in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity
  • However, in the absence of human data and due to the experimental risk of damage by fluoroquinolones to the weight-bearing cartilage of the growing organism, levofloxacin must not be used in pregnant women

Breastfeeding

  • Contraindicated
  • Levofloxacin is contraindicated in breastfeeding women
  • There is insufficient information on the excretion of levofloxacin in human milk; however other fluoroquinolones are excreted in breast milk. In the absence of human data and due to the experimental data suggest a risk of damage by fluoroquinolones to the weight-bearing cartilage of the growing organism, levofloxacin must not be used in breastfeeding women
  • Minimal levels of the drug were detectable 65 hours after the last dose
  • Studies to evaluate the carcinogenicity of ofloxacin in this manner have not been conducted

Fertility

  • Levofloxacin caused no impairment of fertility or reproductive performance in rats

Renal Impairment

  • eGFR ≥50ml/min/1.73m2: Caution; no dose adjustment recommended
  • eGFR <50ml//min/1.73m2: Caution; dose adjustment recommended
eGFR (ml/min/1.73m2) Dose and frequency
Loading doses should not be adjusted and must be administered in full
Dosage adjustment may vary depends on strength of levofloxacin (250, 500 or 750mg) formulation
50-80 No adjustment necessary; Limit use for acute infection antimicrobial therapy to 7-10 days
30-49 Limit therapy to the minimum duration required to achieve therapeutic effect  
20-29 Maintenance dose: Reduce by 50%; Administer 24hrly
 11-19
ESRD/ Haemodialysis		 Maintenance dose: Reduce by 50%; Administer 48hrly
≤10
ESRD/ Haemodialysis		 Maintenance dose: Reduce by 50%; Administer 3 times per week (72hrly)
If further deterioration in renal function is observed, discontinue treatment immediately

Hepatic Impairment

  • No dose adjustment recommended

Elderly

  • Caution; no dose adjustment recommended

Porphyria Information

  • Probably not porphyrinogenic (PNP)

Drugs in Sport

  • Permitted - No warnings

Adverse reactions

Central Nervous System Disorders

  • Headache
  • Dizziness
  • Somnolence
  • Tremor
  • Dysgeusia
  • Seizures
  • Paraesthesia
  • Peripheral sensory neuropathy
    - Pain
    - Burning
    - Tingling
    - Numbness
    - Weakness
  • Peripheral sensory motor neuropathy
  • Parosmia including anosmia
  • Dyskinesia
  • Extrapyramidal disorder
  • Ageusia
  • Syncope
  • Benign intracranial hypertension
  • Insomnia 1
  • Anxiety 21
  • Confusional states
  • Nervousness
  • Psychotic reactions
    - Hallucinations
    - Paranoia
  • Depression
  • Agitation
  • Abnormal dreams or nightmares
  • Psychotic disorders
    - Self-endangering behaviours
    - Suicidal ideation
    - Suicide attempt
  • Asthenia
  • Gait disturbance
  • Memory impairment
  • Sleep disorders

Cardiovascular Disorders 

  • Tachycardia
    - Ventricular tachycardia, which may result in cardiac arrest
  • Palpitation
  • Ventricular arrhythmia
  • Torsade de pointes
  • Prolonged QT electrocardiogram
  • Hypotension
  • Mitral valve and/or aortic valve regurgitation

Respiratory Disorders

  • Dyspnoea
  • Bronchospasm
  • Pneumonitis allergic

Gastrointestinal Disorders

  • Diarrhoea
  • Haemorrhagic diarrhoea
  • Nausea and vomiting
  • Abdominal pain
  • Dyspepsia
  • Flatulence
  • Constipation
  • Pancreatitis
  • Pseudomembranous colitis

Hepatobiliary Disorders

  • Increased hepatic enzymes
    - Increased alanine transaminase
    - Increased aspartate aminotransferase
    - Increased alkaline phosphatase
    - Increased Gamma-glutamyltransferase
  • Increased bilirubin
  • Jaundice
  • Severe hepatic injury
  • Fatal acute liver failure (primarily in patients with severe underlying diseases)
  • Hepatitis
  • Hepatic diseases
    - Anorexia
    - Jaundice
    - Dark urine
    - Pruritus
    - Tender abdomen
  • Porphyria

Genitourinary Disorders

  • Increased serum creatinine
  • Acute renal failure

Endocrine and Metabolic Disorders

  • Anorexia
  • Hypoglycaemia (particularly in diabetic patients)
  • Hyperglycaemia
  • Hypoglycaemic coma

Musculoskeletal Disorders

  • Arthralgia
  • Myalgia
  • Tendon disorders including tendinitis
    - Achilles tendon
  • Muscular weakness
  • Rhabdomyolysis
  • Tendon rupture
    - Achilles tendon
  • Ligament rupture
  • Muscle rupture
  • Arthritis

Skin and Subcutaneous Tissue Disorders

  • Rash
  • Pruritus
  • Urticaria
  • Hyperhidrosis
  • Toxic epidermal necrolysis
  • Stevens-Johnson syndrome
  • Erythema multiforme
  • Photosensitivity reaction
  • Leukocytoclastic vasculitis
  • Stomatitis

Immune, Blood and Lymphatic System Disorders

  • Fungal infection
    - Candida infection
  • Pathogen resistance
  • Leukopenia
  • Eosinophilia
  • Thrombocytopenia
  • Neutropenia
  • Pancytopenia
  • Agranulocytosis
  • Haemolytic anaemia
  • Angioedema
  • Hypersensitivity
  • Anaphylactic shock
  • Anaphylactoid shock
  • Pyrexia
  • Superinfection
    - Overgrowth of non-susceptible organisms

Sensory Disorders

  • Visual disturbances
  • Transient vision loss
  • Vertigo
  • Tinnitus
  • Impaired/ loss of hearing
  • Taste impairment
  • Smell impairment

Others

  • Pain (including pain in back, chest, and extremities)

Interactions

  • Corticosteroids
  • Iron salts
  • Zinc salts
  • Magnesium containing antacids
  • Aluminium containing antacids
  • Didanosine
  • Sucralfate
  • Theophylline
  • Non-steroidal anti-inflammatory agents
  • Seizure threshold lowering agents
  • Fenbufen
  • Probenecid
  • Cimetidine
  • Ciclosporin
  • Vitamin K antagonist
  • Warfarin
  • Agents that prolong QT interval
  • Class IA and III antiarrhythmics
  • Tricyclic antidepressants
  • Macrolides
  • Antipsychotics

Others

  • Certain laboratory tests (See additional prescribing points)

Monitoring

  • Renal function
  • Hepatic function
  • Full blood count
  • Mental status

Specific cases may require

  • Blood glucose
  • International Normalised Ratio (INR)
  • Prothrombin time
  • Electrocardiogram (ECG)

Additional observations

  • Signs of infection
  • Signs and symptoms of
    - Tendinopathy (such as tendon pain, swelling, inflammation or rupture)
    - Peripheral neuropathy
    - Disordered glucose regulation
    - Rash
    - Hypersensitivity reaction

Prescribing points

Tablet 250mg, 500mg - EML (Hospital)

Tablet 750mg, Injection 5mg/ml - Non EML

Additional administration instructions (IV)

  • Levofloxacin must not be mixed with heparin or alkaline solutions (e.g. sodium hydrogen carbonate)
  • Levofloxacin is compatible with the following solutions for infusion:
    - Sodium chloride 9 mg/ml (0.9%) solution
    - Dextrose 50 mg/ml (5%) injection
    - Dextrose 50 mg/ml (5%) in lactated Ringer's solution
    - Dextrose 25 mg/ml (2.5%) in Ringer's solution
    - Combination solutions for parenteral nutrition (amino acids, carbohydrates, electrolytes)

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

Interference with laboratory tests

  • In patients treated with levofloxacin, determination of opiates in urine may give false-positive results
  • It may be necessary to confirm positive opiate screens by more specific method. Levofloxacin may inhibit the growth of Mycobacterium tuberculosis and, therefore, may give false-negative results in the bacteriological diagnosis of tuberculosis

Mechanism of action

Levofloxacin is a synthetic antibacterial agent of the fluoroquinolone class and is the S (-) enantiomer of the racemic drug substance ofloxacin. Levofloxacin acts on the DNA-DNA-gyrase complex and topoisomerase IV.

Spectrum of activity: Some aerobic gram-positive bacteria, such as Bacillusanthracis, Staphylococcus aureus methi-S, Staphylococcus saprophyticus, Streptococci, group C and G, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes; Some aerobic gram negative bacteria, such as Eikenellacorrodens, Haemophilus influenzae, Haemophilus para-influenzae, Klebsiella oxytoca, Moraxella catarrhalis, Pasteurella multocida, Proteus vulgaris, Providencia rettgeri; Some anaerobic bacteria, such as Peptostreptococcus; Other susceptible organisms, such as Chlamydophila pneumoniae, Chlamydophila psittaci, Chlamydia trachomatis, Legionella pneumophila, Legionella sp., Mycoplasma pneumoniae, Mycoplasma hominis, Ureaplasma urealyticum; Kingella sp., Shigella sp., Y. enterocolitica

Dosage forms

  • Injection
  • Tablet
  • Film-coated tablet
  • Infusion

Formulation

Tablet 250mg

  • Artav (Watson Pharma) (Discontinued: 06/12/2021)
  • Litha levofloxacin 250mg (Litha Pharma)
  • Austell levofloxacin (Austell)
  • Levofloxacin-Winthrop (Winthrop) 
  • Macleods levofloxacin (Macleods)
  • Mylan levofloxacin (Xixia)
  • Sandoz levofloxacin (Sandoz)
  • Tavaloxx (Cipla Medpro)
  • Tavanic (Ranbaxy) originator
  • Zybact (Zydus)

Tablet 500mg

  • Artav (Watson Pharma) (Discontinued: 06/12/2021)
  • Litha levofloxacin 500mg (Litha Pharma)
  • Austell levofloxacin (Austell)
  • Avrokel 500 (Macleods)
  • Levojub (LeBasi Pharm)
  • Levonic (Pharma Dynamics)
  • Levofloxacin-Winthrop (Zentiva) 
  • Macleods levofloxacin (Macleods)
  • Mylan levofloxacin (Xixia)
  • Sandoz levofloxacin (Sandoz)
  • Spec levofloxacin (Specpharm)
  • Tavaloxx (Cipla Medpro)
  • Tavanic (Ranbaxy) originator
  • Zybact (Zydus)

Tablet 750mg

  • Artav (Watson Pharma) (Discontinued: 06/12/2021)
  • Levofloxacin-Winthrop (Winthrop)
  • Tavaloxx (Cipla Medpro)
  • Tavanic (Ranbaxy) originator

Injection (per ml) 5mg

  • Alefnic 500 IV (Arya Pharma)
  • Aspen levofloxacin (Litha)
  • Levofloxacin Fresenius (Fresenius Kabi)
  • Levofloxacin-Winthrop (Winthrop) 
  • Levonic (Pharma Dynamics)  
  • Levotav (Adcock Ingram)
  • Spec levofloxacin (Specpharm)
  • Tavanic (Ranbaxy) originator

References

1. SAMF_12th Edition_Page 300 2. SmPC: Levofloxacin 500 mg film-coated tablets, Generics UK T/A Mylan; Last updated on eMC: 16 Nov 2017; Downloaded online 03 Oct 2018 [https://www.medicines.org.uk/emc/product/8635/smpc] 3. SmPC: Levofloxacin 5 mg/ml solution for infusion, Bowmed Ibisqus Limited; Last updated on eMC: 121 Dec 2017; Downloaded online 03 Oct 2018 [https://www.medicines.org.uk/emc/product/8839/smpc] 4. https://drive.google.com/drive/folders/0B27NqM_vidrmSGJ3ckExNUJ2YTg (10/2007_Cipla_Tavaloxx_250,500,750mg_tab) 5. https://drive.google.com/drive/folders/0B27NqM_vidrmSGJ3ckExNUJ2YTg (18/04/2008_Ranbaxy_Tavanic_tab_inj) 6. https://drive.google.com/drive/folders/0B27NqM_vidrmSGJ3ckExNUJ2YTg (20/04/2012_Winthrop_Levofloxacin Winthrop_tab_inj) 7. https://drive.google.com/drive/folders/0B27NqM_vidrmSGJ3ckExNUJ2YTg (20/04/2012_Winthrop_Levofloxacin_250,500mg tab_250, 500 inj) 8. https://drive.google.com/drive/folders/0B27NqM_vidrmSGJ3ckExNUJ2YTg (5/06/2014_Fresenius_Levofloxacin_5mg/ml_inj) 9. https://webedition.sanfordguide.com/sanford-guide-online/drug-information/antibacterial-agents/fluoroquinolones/levofloxacin (as accessed on 19/3/2017) 10. Standard treatment guidelines and essential medicines list for South Africa, Hospital level, Paediatrics, 2017 11. U2D: Levofloxacin (systemic): Drug information, UpToDate; Downloaded online 03 Oct 2018 [https://www.uptodate.com/contents/levofloxacin-systemic-drug-information] 12. NAPOS The Drug Database for Acute Porphyria: J01MA12 Levofloxacin; Accessed online 03 Oct 2018 [http://www.drugs-porphyria.org/languages/UnitedKingdom/s3.php?atc_code=J01MA12&l=gbr] 13. South African Institute for Drug-Free Sport: Tavanic Tablets, Infusion; Accessed online 03 Oct 2018 [http://www.drugfreesport.org.za/online-medication-check/] 14. SmPC: Levofloxacin 5mg/ml solution for infusion, Consilient Health Ltd: Last updated on eMC: 21 Aug 2018; Downloaded online 09 Jan 2018 [https://www.medicines.org.uk/emc/product/9435/smpc] 15. Clinical Pharmacologist - Dr. M Irhuma (Renal impairment) [https://trello.com/c/uRBxmkts/179-levofloxacin-inj-tab-renal-impairment-dose-adjustments] 15.1 Chien S, et al. J Clin Pharmacol. 2005. 16. Clinical Pharmacologist - Dr. M Irhuma (pregnancy and breastfeeding) [https://trello.com/c/uRBxmkts/179-levofloxacin-inj-tab-renal-impairment-dose-adjustments] 16.1 Schaefer C, et al (ENTIS). Eur J Obstet Gynecol Reprod Bioi. 1996. 16.2 Cahill JB Jr, et al. Pharmacotherapy. 2005. 16.3 Briggs GG, Freeman RK, Yaffe SJ. Drugs in Pregnancy and Lactation.10th ed. Baltimore, MD: Lippincott Williams & Wilkins; 2015 (Page 794). 17. Important medicine safety information - Fluoroquinolone antibiotics – risk of mitral and aortic regurgitation associated with the use of oral and injectable fluoroquinolones, 29 May 2020. [https://drive.google.com/drive/folders/1zuy3IQ3MM1h75S2hBX0Iw2Fp8wn0Zhh5] 18. (1) EMG Clinical Pharmacologist - A/Prof(Dr) M Irhuma [https://trello.com/c/Vrd9p9qT/365-urgent-important-safety-information-fluoroquinolones] (2) DHCPL draft 3 to SAHPRA – Quinolones/fluoroquinolones – Group 1 (3) DHCPL draft 3 to SAHPRA – Quinolones/fluoroquinolones – Group 2 19. Standard Treatment Guidelines and Essential Medicines List for South Africa Hospital Level, Adults, 2019 Edition; South African Department of Health; Downloaded online: 01 Aug 2020 [https://drive.google.com/drive/folders/16eaaHNCltsFRDhPguYDuuX4FLJc9yH2y] 20. SmPC: Levofloxacin 250mg tablets, Ipca Laboratories UK Ltd; Last updated on eMC: 08 March 2021; Downloaded online 17 March 2021 [https://drive.google.com/drive/folders/1zuy3IQ3MM1h75S2hBX0Iw2Fp8wn0Zhh5] 21. SmPC: Levofloxacin 500mg tablets, Ipca Laboratories UK Ltd; Last updated on eMC: 08 March 2021; Downloaded online 17 March 2021 [https://drive.google.com/drive/folders/1zuy3IQ3MM1h75S2hBX0Iw2Fp8wn0Zhh5] 22. SmPC: Levofloxacin 5 mg/ml Solution for Infusions,Hospira UK Ltd; Last updated on eMC: 06 Jan 2021; Downloaded online 17 March 2021 [https://drive.google.com/drive/folders/1zuy3IQ3MM1h75S2hBX0Iw2Fp8wn0Zhh5] 23. PI: Tavanic IV, 750mg, Ranbaxy Pharmaceuticals: Date of Registration: March 2013 [https://drive.google.com/drive/folders/1zuy3IQ3MM1h75S2hBX0Iw2Fp8wn0Zhh5] 24. PI: Tavanic 750mg Tablets, Ranbaxy Pharmaceuticals: Date of Registration: 10 October 2013 [https://drive.google.com/drive/folders/1zuy3IQ3MM1h75S2hBX0Iw2Fp8wn0Zhh5] 25. Standard Treatment Guidelines and Essential Medicines List for South Africa Hospital Level, PHC, 2020 Edition 26. 19. Standard Treatment Guidelines and Essential Medicines List for South Africa Hospital Level, Adults, 2023 Edition; South African Department of Health; Downloaded online: 12 Jan 2023 27. Pharmacologist Recommendations - Levofloxacin (INJ/TAB/FCT/INF) - Prof Irhuma Accessed on trello 14 Oct 2024 [https://trello.com/c/85AtAi9E/973-levofloxacin-inj-tab-fct-inf-drupal-id-15645?search_id=00d79992-dd31-4521-98bb-0e154dd2f008] 27.1 LEVOFLOXACIN 250/ LEVOFLOXACIN 500 BIOTECH solution for infusion - PI. https://pi-pil-repository.sahpra.org.za/wp-content/uploads/2023/04/1.3.1.1-pi-Approved-Levofloxacin-Biotech-0004.pdf 27.2 LEVOFLOXACIN 5 mg/ml (100 ml) FRESENIUS solution for infusion - PI. https://pi-pil-repository.sahpra.org.za/wp-content/uploads/2023/02/Levofloxacin-5-mg-ml-100-ml_Approved-PI_10-Jan-2023.pdf 27.3 LEVOFLOXACIN TRINITY 250/LEVOFLOXACIN TRINITY 500 (Film coated tablets) - PI. https://pi-pil-repository.sahpra.org.za/wp-content/uploads/2024/05/pi-clean-ammended-levofloxacin-trinity-post-reg-insp-2023-08-16.pdf 27.4 LEVOFLOXACIN UNICORN 250/LEVOFLOXACIN UNICORN 500 film coated tablet - PI. https://pi-pil-repository.sahpra.org.za/wp-content/uploads/2023/12/pi-levofloxacinunicorn-jan2021.pdf 27.5 AUSTELL–LEVOFLOXACIN 250/AUSTELL–LEVOFLOXACIN 500 mg film-coated tablets - PI. https://pi-pil-repository.sahpra.org.za/wp-content/uploads/2021/09/1.3.1.1-Professional-information-Austell-Levofloxacin.pdf 27.6 Expert - Clinical Pharmacologist. 28. PI - LEVOFLOXACIN 250 BIOTECH & 500 BIOTECH solution for infusion, Biotech Laboratories (Pty) Ltd - DATE OF REVISION OF THE TEXT 06 March 2023 Downloaded online 15 October 2025 [https://pi-pil-repository.sahpra.org.za/wp-content/uploads/2023/04/1.3.1.1-pi-Approved-Levofloxacin-Biotech-0004.pdf] 29. PI - LEVOFLOXACIN UNICORN 250 & 500 film coated tablet, Unicorn Pharmaceuticals (Pty) Ltd - DATE OF FIRST AUTHORISATION 02 March 2021 Downloaded online 15 October 2025 [https://pi-pil-repository.sahpra.org.za/wp-content/uploads/2023/12/pi-levofloxacinunicorn-jan2021.pdf] GHANA REFERENCES GH1. Ministry of Health Ghana National Drugs Programme (GNDP) Standard Treatment Guidelines, 7th Edition, 2017 [https://drive.google.com/drive/folders/1EQKbcrtqOU9qM1DpWgsS35ERYS_WkO_w] GH2. Ministry of Health Ghana National Drugs Programme (GNDP) Essential Medicines List, 7th Edition, 2017 [https://drive.google.com/drive/folders/1EQKbcrtqOU9qM1DpWgsS35ERYS_WkO_w]

Brands & products

62 products · cached snapshot
Trade names (15)
  • Alefnic
  • Artav
  • Austell Levofloxacin
  • Levofloxacin-Winthrop
  • Levojub
  • Levonic
  • Litha levofloxacin
  • Macleods Levofloxacin
  • Mylan-Levofloxacin
  • Sandoz Levofloxacin
  • Spec Levofloxacin
  • Tavaloxx
  • Tavanic
  • Zybact
  • Avrokel 500

TABTablet· 34 products

from R40.63
ProductStrengthPackApplicantMin price
Lintrip 250discontinued250 mg5Dr Reddy's Laboratories (Pty) LtdR40.63
Lintrip 500discontinued500 mg5Dr Reddy's Laboratories (Pty) LtdR64.37
Sandoz Levofloxacin 250250 mg5Sandoz SA (Pty) LtdR84.92
Zybact 250mg250 mg5Zydus Healthcare SA (Pty) LtdR110.84
Avrokel 500500 mg5Macleods Pharmaceuticals SA (Pty) LtdR115.07
Levantrin 500 mg500 mg5Jubilant Pharma SA (Pty) LtdR116.47
Levofloxacin-Winthrop 250250 mg5Winthrop Pharmaceuticals (Pty) LtdR119.77
Tavanic 500500 mg5Ranbaxy S.A (Pty) LtdR122.57
Avrokel 250250 mg5Macleods Pharmaceuticals SA (Pty) LtdR122.59
Spec Levofloxacin 500500 mg5Specpharm (Pty) LtdR123.85
Levonic 500mg500 mg5Pharma Dynamics (Pty) LtdR125.30
Lintrip 500discontinued500 mg10Dr Reddy's Laboratories (Pty) LtdR128.73
Austell Levofloxacin 250mg250 mg5Austell Laboratories (Pty) LtdR136.38
Sandoz Levofloxacin 500500 mg5Sandoz SA (Pty) LtdR141.57
Tavanic 250250 mg5Ranbaxy S.A (Pty) LtdR147.95
Artav 750discontinued750 mg5Watson Pharma No. 1 (Pty) LtdR186.86
Zybact 500mg500 mg5Zydus Healthcare SA (Pty) LtdR187.48
Arylevo 500500 mg5Zydus Healthcare SA (PTY) LTDR197.33
Levofloxacin-Winthrop 500500 mg5Winthrop Pharmaceuticals (Pty) LtdR197.69
Levofloxacin Winthrop 750750 mg5Winthrop Pharmaceuticals (Pty) LtdR200.19
Tavaloxx 500500 mg5Cipla Medpro (Pty) LtdR228.92
Avrokel 500500 mg10Macleods Pharmaceuticals SA (Pty) LtdR230.17
Tavaloxx 750750 mg5Cipla Medpro (Pty) LtdR238.00
Tavanic 500500 mg10Ranbaxy S.A (Pty) LtdR245.11
Avrokel 250250 mg10Macleods Pharmaceuticals SA (Pty) LtdR245.16
Tavanic 750750 mg5Ranbaxy Pharmaceuticals (Pty) LtdR250.61
Levonic 500mg500 mg10Pharma Dynamics (Pty) LtdR250.62
Sandoz Levofloxacin 500500 mg10Sandoz SA (Pty) LtdR283.14
Zybact 500mg500 mg10Zydus Healthcare SA (Pty) LtdR374.98
Levofloxacin-Winthrop 500500 mg10Winthrop Pharmaceuticals (Pty) LtdR395.44
Tavaloxx 500500 mg10Cipla Medpro (Pty) LtdR457.84
Tavaloxx 250250 mg30Cipla Medpro (Pty) LtdR583.89
Avrokel 500500 mg30Macleods Pharmaceuticals SA (Pty) LtdR690.49
Avrokel 250250 mg30Macleods Pharmaceuticals SA (Pty) LtdR735.50

INFInfusion· 12 products

from R46.68
ProductStrengthPackApplicantMin price
Levofloxacin Fresenius 5mg/ml (100ml)500 mg/100ml100Fresenius Kabi South Africa (Pty) LtdR46.68
Alefnic 500 IV500 mg/100ml100Arya Pharma Pty LtdR47.91
Levofloxacin IV 5 mg/ml Austell500 mg/100ml100Austell Pharmaceuticals (Pty) LtdR54.22
Levonic IV 500500 mg/100ml100Pharma Dynamics (Pty) LtdR59.23
Spec Levofloxacin 250 IV250 mg/50ml50Specpharm (Pty) LtdR97.66
Tavanic I.V. 250250 mg/50ml50Ranbaxy S.A (Pty) LtdR99.39
Aspen Levofloxacin 5mg/ml500 mg/100ml100Acino Pharma (Pty) LtdR138.85
Tavanic I.V. 500500 mg/100ml100Ranbaxy Pharmaceuticals (Pty) LtdR156.15
Levotav IV 250250 mg/50ml50Adcock Ingram LimitedR164.93
Levotav IV 500500 mg/100ml100Adcock Ingram LimitedR187.37
Spec Levofloxacin 500 IV500 mg/100ml100Specpharm (Pty) LtdR195.39
Tavanic I.V. 750750 mg/150ml150Ranbaxy Pharmaceuticals (Pty) LtdR268.31

FCTFilm-coated tablet· 13 products

from R68.05
ProductStrengthPackApplicantMin price
Artav 250discontinued250 mg5Watson Pharma No. 1 (Pty) LtdR68.05
Litha Levofloxacin 250mg250 mg5Acino Pharma (Pty) LtdR69.77
Mylan Levofloxacin 250mg250 mg5Xixia Pharmaceuticals (Pty) LtdR80.40
Artav 500discontinued500 mg5Watson Pharma No. 1 (Pty) LtdR99.32
Levofloxacin Unicorn 500500 mg5Unicorn Pharmaceuticals (Pty) LtdR115.00
Litha Levofloxacin 500mg500 mg5Acino Pharma (Pty) LtdR115.78
Mylan Levofloxacin 500mg500 mg5Xixia Pharmaceuticals (Pty) LtdR121.42
Austell Levofloxacin 500mg500 mg5Austell Laboratories (Pty) LtdR122.59
Levojub 500500 mg5Jubilant Pharma SA (Pty) LtdR141.89
Artav 500discontinued500 mg10Watson Pharma No. 1 (Pty) LtdR198.66
Levofloxacin Unicorn 500500 mg10Unicorn Pharmaceuticals (Pty) LtdR230.00
Litha Levofloxacin 500mg500 mg10Acino Pharma (Pty) LtdR231.56
Mylan Levofloxacin 500mg500 mg10Xixia Pharmaceuticals (Pty) LtdR242.84

INJInjection· 3 products

from R79.62
ProductStrengthPackApplicantMin price
Levofloxacin Winthrop I.V. 250250 mg/50ml50Winthrop Pharmaceuticals (Pty) LtdR79.62
Levofloxacin Winthrop I.V. 500500 mg/100ml100Winthrop Pharmaceuticals (Pty) LtdR144.26
Levofloxacin Winthrop I.V. 750750 mg/150ml150Winthrop Pharmaceuticals (Pty) LtdR238.81

Medical aid coverage

data not yet integrated
Discovery Health
not yet integrated
  • Comprehensive Series—
  • Executive Plan—
  • KeyCare Series—
  • Priority Series—
  • Saver Series—

Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.

Bonitas Medical Fund
not yet integrated
  • BonClassic—
  • BonComprehensive—
  • BonEssential—
  • BonFit Select—
  • BonSave—
  • BonStart—

Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.

GEMS — Government Employees Medical Scheme
not yet integrated
  • Beryl—
  • Emerald—
  • Onyx—
  • Ruby—
  • Sapphire—
  • Tanzanite One—

Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.

POLMED — Police Medical Aid Scheme
not yet integrated
  • Aquarium Option—
  • Efficiency Option—
  • Marine Option—

Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.

Interacts with 9 known drugs

Check against other drugs →

Cited in 31 documents

NeoHealth® ID 15645 · updated 10/15/2025