neobookRx
DrugsLevel 4 LocalisationS4INJ · TAB · INF · FCTEML

Moxifloxacin

FluoriquinoloneAntibacterial

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: 

  • Respiratory tract infections
    - Acute exacerbations of chronic obstructive pulmonary disease (COPD) including chronic bronchitis (AECB) caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, methicillin-sensitive Staphylococcus aureus or Moraxella catarrhalis  (tab)
    - Community-acquired pneumonia (CAP) of mild to moderate severity caused by Streptococcus pneumonia (including CAP caused by penicillin-resistant strains and multi-drug resistant strains), Haemophilus influenzae, Mycoplasma pneumoniae, Chlamydophila pneumoniae, Klebsiella pneumoniae, methicillin-sensitive Staphylococcus aureus or Moraxella catarrhalis  (tab)
    - Acute sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis  (tab)
  • Uncomplicated pelvic inflammatory disease (i.e. infections of female upper genital tract, including salpingitis and endometritis) (not caused by Neisseria gonorrhoea)  (tab)
  • Severe and/or complicated skin and skin structure infections (including diabetic foot infections) caused by methicillin-sensitive Staphylococcus aureus, Streptococcus pyogenes, Enterococcus faecalis, Escherichia coli, Streptococcus agalactiae, Klebsiella pneumoniae, Proteus mirabilis, or Enterobacter cloacae (tab)
  • Severe and/or complicated intra-abdominal infections including polymicrobial infections such as abscesses (tab)
  • Severe and/or complicated community-acquired pneumonia (CAP), including CAP, caused by multi-drug resistant strains (inj)
  • Severe and/or complicated skin and skin structure infections (including diabetic foot infections) (inj)
  • Severe and/or complicated intra-abdominal infections including polymicrobial infections such as abscesses (inj)

Moxifloxacin is indicated for the treatment of severe and/or complicated infections caused by moxifloxacin-sensitive bacteria where other antimicrobials, approved for a similar indication and to which the causative bacteria are sensitive, were considered not to be an appropriate treatment option, have failed, are contraindicated, or not tolerated


Moxifloxacin is not indicated/approved for the initiation of treatment (first-line treatment) of infections described as mild/moderate/acute and uncomplicated, caused by bacteria sensitive to moxifloxacin, unless treatment with other appropriate antimicrobials, approved for a similar indication and to which the causative bacteria are sensitive, have failed, are contraindicated, or not tolerated

Cautions

Contraindications

  • Hypersensitivity to the active ingredient or any of its excipients
  • Hypersensitivity to other quinolones
  • History of tendon, muscle, joint, nerve, central nervous system or psychiatric disorders, especially those related to previous quinolone/fluoroquinolone use where alternative appropriate antibiotic choices are available
  • History of convulsions, epilepsy or difficult-to-control epilepsy disorders
  • Aortic aneurysm and/or dissection, or in patients with risk factors or conditions predisposing to aortic aneurysm and/or dissection, where alternative choices are available
  • Myasthenia gravis
  • Concomitant use of fluoroquinolones with angiotensin-converting enzyme (ACE) inhibitors/angiotensin-receptor blockers (ARBs) in patients with moderate to severe renal impairment (CrCl≤30ml/min) and in elderly patients
  • Patients below 18 years of age (there is evidence of damage to the cartilage of weight-bearing joints in immature animals)
  • Pregnancy
  • Lactation
  • Concomitant use with medicines that prolong the QT interval
  • Congenital or documented acquired QT prolongation
  • Clinically relevant heart failure with reduced left-ventricular ejection fraction
  • Electrolyte disturbances, particularly in uncorrected hypokalaemia
  • Clinically relevant bradycardia
  • Previous history of symptomatic dysrhythmias
  • Patients with confirmed mitral valve and/or aortic valve regurgitation unless no safer appropriate alternative antibiotic is available, has failed, or is not well tolerated
  • Severe hepatic insufficiency due to limited clinical data (Child-Pugh C)

Cautions

  • Hepatic impairment (Child-Pugh Class A&B)
  • Elderly patients (with renal impairment)
  • History of serious adverse reactions when using quinolone or fluoroquinolone containing products
  • Mitral valve and/or aortic regurgitation (See additional prescribing points)
  • Ongoing proarrhythmic conditions (especially women and elderly patients):
    - Acute myocardial ischaemia
    - QT prolongation
  • CNS disorders
  • Risk factors that may predispose to seizures or lower the seizure threshold
  • Psychotic patients
  • History of psychiatric disease
  • Myasthenia gravis
  • Solid organ transplant patients
  • Positive family history of aneurysm or congenital heart valve disease
  • Pre-existing aortic aneurysm and/or dissection
  • Pre-existing heart valve disease
  • Risk factors or conditions predisposing for both aortic aneurysm/dissection and heart valve regurgitation/incompetence:
    - Connective tissue disorders such as Marfan syndrome or Ehlers-Danlos syndrome
    - Turner syndrome
    - Behçet's disease
    - Hypertension
    - Rheumatoid arthritis
  • Vascular disorders
    - Takayasu arteritis
    - Giant cell arteritis
    - Known atherosclerosis
    - Sjögren's syndrome
  • Infective endocarditis
  • Dehydration
  • Diabetic patients
  • Severe burn infections
  • Fasciitis
  • Diabetic foot infections with osteomyelitis
  • Complicated pelvic inflammatory disease (e.g. associated with a tubo-ovarian or pelvic abscess) (tab)
  • UV irradiation
  • Extensive and/or strong sunlight exposure
  • Treatment of methicillin-resistant Staphylococcus aureus
  • Co-administration of medications that reduce potassium levels
  • Co-administration of medications associated with clinically significant bradycardia
  • Coadministration with corticosteroid treatment
  • Sodium restricted diet (inj)
  • Family history of or actual glucose-6-phosphate dehydrogenase deficiency
  • Galactose intolerance (tab)
  • Total lactase deficiency (tab)
  • Glucose-galactose malabsorption (tab)
  • May impair ability to drive or 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 Guidelines indications and dosages
  • South African registered indications and dosages
  • Indications and dosages registered in other jurisdictions

Infections caused by: Aerobic gram-positive microorganisms such as Gardnerella vaginalis; Staphylococcus aureus (methicillin-susceptible); Streptococcus agalactiae (Group B); Streptococcus milleri group (S. anginosus, S. constellatus and S. intermedius); Streptococcus pneumoniae; Streptococcus pyogenes (Group A); Streptococcus viridans group (S. viridans, S. mutans, S. mitis, S. sanguinis, S. salivarius, S. thermophilus); Aerobic gram-negative microorganisms such as Acinetobacter baumanii; Haemophilus influenzae; Haemophilus parainfluenzae; Legionella pneumophila; Moraxella (Branhamella) catarrhalis; Anaerobic microorganisms such as Fusobacterium spp.; Prevotella spp.; Other microorganisms such as Chlamydophila (Chlamydia) pneumoniae; Chlamydia trachomatis; Coxiella burnetii; Mycoplasma genitalium; Mycoplasma hominis; Mycoplasma pneumoniae

General dosing range

  • IV/Oral (tab): 400mg, dly

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 Guidelines indications and dosages

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

  • Oral (tab): 400mg, dly; Treatment duration: Stop at day 8 of rechallenge
    (STG, Adult 2023)

Uncomplicated pneumonia
- Severe penicillin allergy
Community-acquired pneumonia
- Severe penicillin allergy without features of severe pneumonia, without co-morbidity and patients <65 years
- Severe penicillin allergy without features of severe pneumonia, patients >65 years or co-morbidity (e.g. COPD, HIV, cardiac failure, diabetes) 

  • Oral (tab): 400mg, dly; Treatment duration: 5 days
    (STG, Adult 2019; PHC 2020) 

Community-acquired pneumonia - severe

  • IV: 400mg, dly; Switch to oral treatment if haemodynamically stable with respiratory rate <25 breaths/min and temperature <37.8oC
  • Oral (tab): 400mg, dly; Treatment duration: 5 days
    (STG, Adult 2019; PHC 2020)

Hospital-acquired pneumonia (Additional agent required)
- Severe penicillin allergy

  • IV/Oral (tab): 400mg, dly; Treatment duration: 10 days
    (STG, Adult 2019)

Bronchiectasis - severe
- Severe penicillin allergy

  • Oral (tab): 400mg, dly; Treatment duration: 7 days

OR

  • IV: 400mg, dly, as an infusion over 60min; Switch to oral once able to tolerate oral therapy (consult specialist)
    (STG, Adult 2019)

Lung abscess
- Severe penicillin allergy

  • IV: 400mg, dly, until apyrexial for 24hrs

THEN

  • Oral (tab): 400mg, dly; Treatment duration: Until no air-fluid level and reduction in size of abscess seen on repeat chest X-ray, usually 4-6 weeks
    (STG, Adult 2019)

Aspiration pneumonia
-  Severe penicillin allergy

  • IV: 400mg, dly, until apyrexial for 24hrs

THEN

  • Oral (tab): 400mg, dly; Treatment duration: Until there are no features of sepsis
    (STG, Adult 2019) 

Empyema
-  Severe penicillin allergy (and not a complication of pneumonia)

  • IV: 400mg, dly, until apyrexial for 24hrs

THEN

  • Oral (tab): 400mg, dly; Treatment duration: Until drainage complete
    (STG, Adult 2019)  

South African registered indications and dosages

Acute exacerbation of chronic obstructive pulmonary disease (COPD) including chronic bronchitis

  • Oral (tab): 400mg, dly; Treatment duration: 5 days

Acute sinusitis

  • Oral (tab): 400mg, dly; Treatment duration: 10 days

Community-acquired pneumonia

  • IV/Oral (tab): 400mg, dly; Treatment duration: 7-14 days

Uncomplicated skin and skin structure infections

  • Oral (tab): 400mg, dly; Treatment duration: 7 days

Complicated skin and skin structure infections

  • IV/Oral (tab): 400mg, dly; Treatment duration 7-21 days

Uncomplicated pelvic inflammatory disease

  • Oral (tab): 400mg, dly; Treatment duration: 14 days

Complicated intra-abdominal infections

  • IV/Oral (tab): 400mg, dly; Treatment duration: 5-14 days

Therapy may be initial intravenous administration, followed by oral administration of moxifloxacin tablets as soon as the oral route is feasible


Tablets to be swallowed whole with a glass of water


IV administration to be administered as an infusion over 60mins. See additional prescribing points for compatible infusion solutions


The recommended dose (400mg per day) and duration of therapy for the indication being treated should not be exceeded


Indications and dosages registered in other jurisdictions

Acute bacterial sinusitis

  • Oral (tab): 400mg, dly; Treatment duration: 7 days

Acute exacerbation of chronic obstructive pulmonary disease including bronchitis

  • Oral (tab): 400mg, dly; Treatment duration: 5-10 days

Mild to moderate pelvic inflammatory disease without associated tubo-ovarian or pelvic abscess

  • Oral (tab): 400mg, dly; Treatment duration: 14 days

Community-acquired pneumonia

  • IV/Oral (tab): 400mg, dly; Treatment duration: 7-14 days

Complicated skin and skin structure infections

  • IV/Oral (tab): 400mg, dly; Treatment duration: 7-21 days

IV therapy to be administered as a constant infusion over 60mins


Moxifloxacin should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections


In clinical studies with sequential therapy most patients switched from intravenous to oral therapy within 4 days (community-acquired pneumonia) or 6 days (complicated skin and skin structure infections). The recommended total duration of intravenous and oral treatment is 7-14 days for community-acquired pneumonia and 7-21 days for complicated skin and skin structure infections


The recommended dose (400mg per day) and duration of therapy for the indication being treated should not be exceeded

Paediatric dosage

Paed. forms avail. in SA and covered in this monograph: tab

Dosages below include:

  • South African Standard Treatment Guidelines indications and dosages
  • South African registered indications and dosages
  • Indications and dosages registered in other jurisdictions

Infections caused by:  Aerobic gram-positive microorganisms such as Gardnerella vaginalis; Staphylococcus aureus (methicillin-susceptible); Streptococcus agalactiae (Group B); Streptococcus milleri group (S. anginosus, S. constellatus and S. intermedius); Streptococcus pneumoniae; Streptococcus pyogenes (Group A); Streptococcus viridans group (S. viridans, S. mutans, S. mitis, S. sanguinis, S. salivarius, S. thermophilus); Aerobic gram-negative microorganisms such as Acinetobacter baumanii; Haemophilus influenzae; Haemophilus parainfluenzae; Legionella pneumophila; Moraxella (Branhamella) catarrhalis; Anaerobic microorganisms such as Fusobacterium spp.; Prevotella spp.; Other microorganisms such as Chlamydophila (Chlamydia) pneumoniae; Chlamydia trachomatis; Coxiella burnetii; Mycoplasma genitalium; Mycoplasma hominis; Mycoplasma pneumoniae

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 Guidelines indications and dosages

Multidrug-resistant tuberculosis (Additional agents required)
- Intensive and continuation phase

Younger than 8 years

  • Not established for use

Older than 8 years

  • <25kg: Oral (tab): 200mg, dly; Treatment duration: ≥6 months (exact duration of therapy for the intensive phase is 4 months after the first date of sampling of a negative culture result), total duration should be 18 months after the first date of sampling of a negative culture result
  • (STG, Paed. 2017) 
  • >25kg: Oral (tab): 400mg, dly; Treatment duration: ≥6 months (exact duration of therapy for the intensive phase is 4 months after the first date of sampling of a negative culture result), total duration should be 18 months after the first date of sampling of a negative culture result
     (STG, Paed. 2017) 

South African registered indications and dosages

  • Contraindicated
    The use of moxifloxacin in children and adolescents <18 years is contraindicated
    There is evidence of damage to the cartilage of weight-bearing joints in immature animals

Indications and dosages registered in other jurisdictions

  • Contraindicated
    Efficacy and safety of moxifloxacin in children and adolescents (<18 years) have not been established

Special populations

Pregnancy

  • Contraindicated
  • The safety of moxifloxacin in human pregnancy has not been evaluated
  • Animal studies have shown reproductive toxicity. The potential risk for humans is unknown
  • Due to the experimental risk of damage by fluoroquinolones to the weight-bearing cartilage of immature animals and reversible joint injuries described in children receiving some fluoroquinolones, moxifloxacin must not be used in pregnant women

Breastfeeding

  • Contraindicated
  • There is no data available in lactating or breastfeeding women
  • Preclinical data indicate that small amounts of moxifloxacin are secreted in milk
  • In the absence of human data and due to the experimental risk of damage by fluoroquinolones to the weight-bearing cartilage of immature animals, breastfeeding is contraindicated during moxifloxacin therapy

Fertility

  • Animal studies do not indicate impairment of fertility

Renal Impairment

Hepatic Impairment

Elderly

Porphyria Information

Drugs in Sport

  • Permitted - No warnings

Adverse reactions

Central Nervous System Disorders

  • Anxiety reactions
  • Psychomotor hyperactivity/agitation
  • Emotional lability
  • Depression
    - Self-injurious behaviour
    - Suicidal ideations/thoughts
    - Suicide attempts
  • Hallucination
  • Delirium
  • Depersonalization
  • Psychotic reactions
  • Headache
  • Dizziness
  • Paraesthesia
  • Dysaesthesia
  • Confusion
  • Disorientation
  • Sleep disorders (predominantly insomnia)
  • Tremor
  • Vertigo
  • Somnolence
  • Hypoaesthesia
  • Abnormal dreams
  • Disturbed coordination
    - Gait disturbances
  • Seizures
    - Grand mal convulsions
  • Disturbed attention
  • Speech disorders
  • Amnesia
  • Peripheral neuropathy  
  • Polyneuropathy
  • Hyperaesthesia
  • Fatigue
  • Increased intracranial pressure
  • Pseudotumour cerebri

Cardiovascular Disorders

  • QT prolongation
  • Palpitations
  • Tachycardia
  • Atrial fibrillation
  • Angina pectoris
  • Ventricular tachyarrhythmias
  • Syncope
  • Unspecified arrhythmias
  • Torsade de pointes
  • Cardiac arrest
  • Aortic aneurysm/dissection/rupture
  • Heart valve regurgitation/incomptence
  • Vasodilatation
  • Hypertension
  • Hypotension
  • Vasculitis
  • Mitral valve and/or aortic regurgitation (See additional prescribing points)

Respiratory Disorders

  • Dyspnoea (including asthmatic conditions)

Gastrointestinal Disorders

  • Nausea and vomiting
  • Gastrointestinal and abdominal pains
  • Diarrhoea
  • Constipation
  • Dyspepsia
  • Flatulence
  • Gastritis
  • Increased amylase
  • Dysphagia
  • Stomatitis
  • Antibiotic associated colitis
    - Pseudomembranous colitis

Hepatobiliary Disorders

  • Increase in transaminases
  • Hepatic impairment
    - Increased lactate dehydrogenase increase
  • Increase in bilirubin levels
  • Increase in gamma-glutamyl-transferase levels
  • Increase in blood alkaline phosphatase levels
  • Jaundice
  • Hepatitis (predominantly cholestatic)
  • Fulminant hepatitis
  • Liver failure

Genitourinary Disorders

  • Renal impairment
    - Increased blood urea nitrogen
    - Increased creatinine
  • Renal failure

Endocrine and Metabolic Disorders

  • Syndrome of inappropriate antidiuretic hormone secretion (SIADH)
  • Hyperlipidemia
  • Hyperglycemia
  • Hyperuricemia
  • Hypoglycaemia
  • Hypoglycaemic coma
  • Decreased appetite and food intake
  • Dehydration
  • Hypernatraemia
  • Hypercalcaemia

Musculoskeletal Disorders

  • Arthralgia
  • Myalgia
  • Tendonitis
  • Muscle cramp
  • Muscle twitching
  • Muscle weakness
  • Tendon rupture
  • Arthritis
  • Muscle rigidity
  • Exacerbation of symptoms of myasthenia gravis
  • Rhabdomyolysis
  • Painful conditions
    - Back pain
    - Chest pain
    - Pelvic pain
    - Pain in extremities

Skin and Subcutaneous Tissue Disorders

  • Pruritus
  • Rash
  • Urticaria
  • Dry skin
  • Bullous skin reactions
    - Stevens-Johnson syndrome
    - Toxic epidermal necrolysis
  • Acute generalised exanthematous pustulosis
  • Sweating

Immune, Blood and Lymphatic System Disorders

  • Superinfections due to resistant bacteria or fungi
    - Oral candidiasis
    - Vaginal candidiasis
  • Anaemia
  • Leucopenia/s
  • Neutropenia
  • Thrombocytopenia
  • Thrombocythemia
  • Blood eosinophilia
  • Prolonged prothrombin time
  • Increased/decreased INR
  • Increased prothrombin level
  • Agranulocytosis
  • Pancytopenia
  • Allergic reaction
  • Anaphylaxis including life-threatening shock
  • Allergic oedema
  • Angioedema
    - Laryngeal oedema (potentially life-threatening)
  • Haemolytic anaemia

Sensory Disorders

  • Taste disorders including ageusia
  • Smell disorders including anosmia
  • Visual disturbances
    - Diplopia
    - Blurred vision
  • Photophobia
  • Transient loss of vision
  • Uveitis
  • Bilateral acute iris transillumination
  • Tinnitus
  • Hearing impairment including deafness

Others

  • Feeling unwell
  • Prolonged (up to months or years), disabling and potentially irreversible serious drug reactions affecting several, sometimes multiple, system organ classes and senses
    - Tendonitis
    - Tendon rupture
    - Arthralgia
    - Pain in extremities
    - Gait disturbance
    - Neuropathies associated with paraesthesia
    - Depression
    - Fatigue
    - Memory impairment
    - Sleep disorders
    - Impairment of hearing, vision, taste and smell

Interactions

  • Agents that may prolong the QTc interval
  • Class IA antiarrhythmics
  • Quinidine
  • Hydroquinidine
  • Disopyramide
  • Class III antiarrhythmics
  • Amiodarone
  • Sotalol
  • Dofetilide
  • Ibutilide
  • Antipsychotics
  • Phenothiazines
  • Pimozide
  • Sertindole
  • Haloperidol
  • Sultopride
  • Tricyclic antidepressants
  • Certain antimicrobial agents
  • Saquinavir
  • Sparfloxacin
  • Erythromycin IV
  • Pentamidine
  • Antimalarials
  • Halofantrine
  • Certain antihistaminics
  • Terfenadine
  • Astemizole
  • Mizolastine
  • Cisapride
  • Vincamine IV
  • Bepridil
  • Diphemanil
  • Agents that reduce potassium levels
  • Loop diuretics
  • Thiazide-type diuretics
  • Laxatives (high doses)
  • Enemas (high doses)
  • Corticosteroids
  • Amphotericin B
  • Agents associated with clinically significant bradycardia
  • Agents containing bivalent or trivalent cations
  • Antacids containing magnesium or aluminium
  • Didanosine
  • Sucralfate
  • Agents containing iron or zinc
  • Charcoal
  • Oral anticoagulants

Other interactions

  • Mycobacterium spp. culture test

Monitoring

None routine. Specific cases may require

  • Full blood count
  • ECG
  • Blood glucose
  • International Normalised Ratio (when coadministered with anticoagulants)
  • Hepatic function
  • Renal function

Additional observations

  • Signs of infection
  • Signs and symptoms of disordered glucose regulation
  • Signs and symptoms of severe skin reactions

Prescribing points

Injection 400mg/250ml - EML (Hospital)

Tablet 400mg - EML (Primary) 


Administration directions (IV)

  • Constant infusion over 60mins is advised for intravenous administration. Intra-arterial administration should be avoided since preclinical studies demonstrated peri-arterial tissue inflammation following infusion by this route
  • If medically indicated, the solution for infusion can be administered via T-tube, together with compatible infusion solutions
  • Initial intravenous treatment may be followed by oral treatment with moxifloxacin 400mg tablets when clinically indicated

Infusion fluids

The following co-infusions were found to be compatible:

  • Water for injection
  • Sodium chloride 0.9%
  • Sodium chloride 1 molar
  • Glucose 5%/10%/40%
  • Xylitol 20%
  • Ringer's solution
  • Compound sodium lactate solution (Hartmann's Solution, Ringer-Lactate solution

The following solutions are incompatible:

  • Sodium chloride 10% and 20% solutions
  • Sodium bicarbonate 4.2% and 8.4% solutions
  • Co-infusion with other medicinal agents

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 biological tests

  • Moxifloxacin therapy may interfere with the Mycobacterium spp. culture test by suppression of mycobacterial growth causing false-negative results in samples taken from patients currently receiving moxifloxacin

Mechanism of action

The bactericidal action of moxifloxacin results from the inhibition of both type II topoisomerases (DNA gyrase and topoisomerase IV) required for bacterial DNA replication, transcription and repair. It appears that the C8-methoxy moiety contributes to enhanced activity and lower selection of resistant mutants of Gram-positive bacteria compared to the C8-H moiety. The presence of the bulky bicycloamine substituent at the C-7 position prevents active efflux, associated with the norA or pmrA genes seen in certain Gram-positive bacteria.

Spectrum of activity: Aerobic gram-positive microorganisms such as Gardnerella vaginalis; Staphylococcus aureus (methicillin-susceptible); Streptococcus agalactiae (Group B); Streptococcus milleri group (S. anginosus, S. constellatus and S. intermedius); Streptococcus pneumoniae; Streptococcus pyogenes (Group A); Streptococcus viridans group (S. viridans, S. mutans, S. mitis, S. sanguinis, S. salivarius, S. thermophilus); Aerobic gram-negative microorganisms such as Acinetobacter baumanii; Haemophilus influenzae; Haemophilus parainfluenzae; Legionella pneumophila; Moraxella (Branhamella) catarrhalis; Anaerobic microorganisms such as Fusobacterium spp.; Prevotella spp.; Other microorganisms such as Chlamydophila (Chlamydia) pneumoniae; Chlamydia trachomatis; Coxiella burnetii; Mycoplasma genitalium; Mycoplasma hominis; Mycoplasma pneumoniae

Dosage forms

  • Injection
  • Tablet
  • Infusion
  • Film-coated tablet

Formulation

Tablet 400mg

  • Avebact fct (Ranbaxy)
  • Avelon (Bayer) originator
  • Avoxa (Austell)
  • DRL Moxifloxacin (Dr Reddy's)
  • Litares (Pharmacare)
  • Lonxave 400 (Macleods Pharma)
  • Floxave (Hetero)
  • Mofloxx (Cipla)
  • Moxibay (Bayer) 
  • Moxifloxacin Macleods (Macleods Pharma)
  • Numoxx (Ranbaxy)
  • Ran-moxifloxacin (Ranbaxy)

Injection (per 250ml) 400mg

  • Austell Moxifloxacin (Austell)
  • Avelon (Bayer) originator
  • Moxifloxacin 400mg/250ml Fresenius (Fresenius Kabi SA)

Also available in the following form: Eye drop.

References

1. SAMF_12th Edition_Page 300 2. SmPC: Moxifloxacin 400 mg film-coated tablets, Rivopharm UK Ltd: Last updated on eMC: 22 Jun 2018; Downloaded online; 15 Aug 2018 https://www.medicines.org.uk/emc/medicine/32823 3. https://drive.google.com/drive/folders/0B27NqM_vidrmU1NFbDBmS2xsSFU (12/2009_Cipla_Numoxx_400mg_tab) 4. https://drive.google.com/drive/folders/0B27NqM_vidrmU1NFbDBmS2xsSFU (23/10/2008_Bayer_Avelon_tab_inj) 5. https://webedition.sanfordguide.com/sanford-guide-online/drug-information/antibacterial-agents/fluoroquinolones/moxifloxacin (as accessed on 19/3/2017) 5.1 Downloaded online: 17 March 2021 [https://drive.google.com/drive/folders/19WnJPFhSGGI0Q6PorvJR_2ykMshbTVrx] 6. SmPC: Avelox 400 mg/250 ml solution for infusion, Bayer plc: Last updated on eMC: 22 Oct 2018; Downloaded online; 29 Oct 2018 https://www.medicines.org.uk/emc/medicine/22827 7. Standard treatment guidelines and essential medicines list for South Africa, Hospital level, Paediatrics, 2017 8. U2D: Moxifloxacin (systemic): Drug information; Uptodate; Downloaded online; 29 Oct 2018 https://www.uptodate.com/contents/moxifloxacin-systemic-drug-information?search=moxifloxacin&source=panel_search_result&selectedTitle=1~91&usage_type=panel&display_rank=1 8.1 Downloaded online: 17 March 2021 [https://drive.google.com/drive/folders/19WnJPFhSGGI0Q6PorvJR_2ykMshbTVrx] 9. NAPOS The Drug Database for Acute Porphyria: Moxifloxacin; Accessed online 29 Oct 2018 http://www.drugs-porphyria.org/languages/UnitedKingdom/s3.php?atc_code=J01MA14&l=gbr 10. South African Institute for Drug-Free Sport: Avelon; Accessed online 29 Oct 2018 [http://www.drugfreesport.org.za/online-medication-check/] 11. 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/19WnJPFhSGGI0Q6PorvJR_2ykMshbTVrx] 12. AfriTox: Moxifloxacin; Last accessed online 21 July 2020 [https://www.afritox.co.za/hp/SingleToxin/SingleToxin.aspx?SingleToxinID=12184] 13. 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] 14. SmPC: Avelox 400mg film-coated tablets, Bayer plc; Last updated on eMC: 09 Nov 2020; Downloaded online: 17 March 2021 [https://drive.google.com/drive/folders/19WnJPFhSGGI0Q6PorvJR_2ykMshbTVrx] 15. SmPC: Avelox 400mg/250ml solution for infusion, Bayer plc; Last updated on eMC: 09 Nov 2020; Downloaded online: 17 March 2021 [https://drive.google.com/drive/folders/19WnJPFhSGGI0Q6PorvJR_2ykMshbTVrx] 16. SmPC: Moxifloxacin 400 mg film-coated tablets, Brown & Burk UK Ltd; Last updated on eMC: 25 Feb 2021; Downloaded online: 30 March 2021 [https://drive.google.com/drive/folders/19WnJPFhSGGI0Q6PorvJR_2ykMshbTVrx] 17. PI: Avelon 400mg, film-coated tablet, Avelon IV 400 mg/250 ml solution for Infusion: Date of Registration: 03 Sep 2020 [https://drive.google.com/drive/folders/19WnJPFhSGGI0Q6PorvJR_2ykMshbTVrx ] **Downloaded during QA** 18. PI: MOXIFLOXACIN DRL, Dr Reddy's: Date of Registration: Dec 2009 [https://drive.google.com/drive/folders/19WnJPFhSGGI0Q6PorvJR_2ykMshbTVrx] 19. Standard Treatment Guidelines and Essential Medicines List for South Africa Hospital Level, PHC, 2020 Edition 20. Standard Treatment Guidelines and Essential Medicines List for South Africa, Hospital Level, Adults, 2023 Edition; South African Department of Health 21. PI - MOXIFLOXACIN 400 mg/250 mL FRESENIUS solution for infusion, FRESENIUS KABI SOUTH AFRICA (PTY) LTD - Date of Revision 06 Aug 2024 downloaded from sahpra 11 Oct 2024 [https://pi-pil-repository.sahpra.org.za/wp-content/uploads/2024/08/MOXIFLOXACIN-FRESENIUS-pi_August2024.pdf] 22. PI - MOFLOXX (Tablets), CIPLA MEDPRO (PTY) LTD - Date of Revision 17 Jan 2021 Downloaded from sahpra 11 Oct 2024 [https://pi-pil-repository.sahpra.org.za/wp-content/uploads/2022/01/pi-final.pdf]

Brands & products

27 products · stale NAPPI snapshot · refreshed 5/29/2026 · 158 days old

infusionGeneric· 3 products

from R0.94/unit
ProductStrengthPackSchedSEPUnitDisp feeNAPPI
Moxifloxacin 400Mg/250Ml Fresenius 400 mg/250ml250S4R234.38R0.94R89.693004093001
Austell moxifloxacin iv solution for inf400 mg/250ml250S4R236.73R0.95R90.33724026001
Avelon iv solution for infusion 250ml400 mg/250ml250S4R298.78R1.20R107.40898511003

tabletGeneric· 17 products

from R49.02/unit
ProductStrengthPackSchedSEPUnitDisp feeNAPPI
Drl moxifloxacin400 mg10S4R490.16R49.02R156.57714104002
Drl moxifloxacin400 mg5S4R264.87R52.97R98.08714104001
Lonxave400 mg10S4R564.58R56.46R167.52721160002
Lonxave400 mg5S4R308.63R61.73R110.11721160001
Avebact400 mg10S4R650.23R65.02R180.12714067002
Litares400 mg10S4R705.10R70.51R188.19714361002
Numoxx400 mg10S4R711.54R71.15R189.14715250002
Ran-Moxifloxacin400 mg10S4R711.55R71.16R189.14714083002
Avebact400 mg5S4R359.05R71.81R123.98714067001
Mofloxx400 mg5S4R370.45R74.09R127.12721071001
Moxibay400 mg10S4R777.04R77.70R198.78715146002
Litares400 mg5S4R391.31R78.26R132.86714361001
Ran-Moxifloxacin400 mg5S4R395.09R79.02R133.90714083001
Numoxx400 mg5S4R395.09R79.02R133.90715250001
Moxibay400 mg5S4R433.63R86.73R144.50715146001
Avelon Tabs 10S400 mg10S4R1015.43R101.54R233.85881988014
Avelon400 mg5S4R557.20R111.44R166.43881988006

FctGeneric· 3 products

from R65.11/unit
ProductStrengthPackSchedSEPUnitDisp feeNAPPI
Avoxa400 mg10S4R651.08R65.11R180.253001369002
Floxave 400400 mg5S4R358.46R71.69R123.823000054001
Avoxa400 mg5S4R359.54R71.91R124.123001369001

dropsGeneric· 4 products

from R65.44/unit
ProductStrengthPackSchedSEPUnitDisp feeNAPPI
Ocucon5 mg/ml5S4R327.19R65.44R115.223005964001
Genfloc5 mg/ml5S4R337.16R67.43R117.963003572001
Avoxa Eye Drops5 mg/ml5S4R337.17R67.43R117.963006577001
Vigamox 5ml5 mg/ml5S4R432.71R86.54R144.25707883001
Trade names (14)
  • Austell Moxifloxacin
  • Avebact
  • Avelon
  • Avoxa
  • DRL Moxifloxacin
  • Floxave
  • Litares
  • Lonxave 400
  • Mofloxx
  • Moxibay
  • Moxifloxacin Fresenius
  • Moxifloxacin Tablets Macleods
  • Numoxx
  • Ran-Moxifloxacin

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 37 known drugs

Check against other drugs →

Cited in 28 documents

NeoHealth® ID 14681 · updated 10/11/2024