Chemical formula: C₂₁H₂₄FN₃O₄ Molecular mass: 401.431 g/mol PubChem compound: 152946
Moxifloxacin interacts in the following cases:
Co-administration of moxifloxacin with antacids and sulphacrate (ulcerative medicine), didanosine, zinc or iron should be taken 6 hours apart.
A large number of cases showing an increase in oral anticoagulant activity have been reported in patients receiving antibacterial agents, especially fluoroquinolones, macrolides, tetracyclines, cotrimoxazole and some cephalosporins. The infectious and inflammatory conditions, age and general status of the patient appear to be risk factors. Under these circumstances, it is difficult to evaluate whether the infection or the treatment caused the INR (international normalised ratio) disorder. A precautionary measure would be to more frequently monitor the INR. If necessary, the oral anticoagulant dosage should be adjusted as appropriate.
Moxifloxacin should be used with caution in patients who are taking medication that can reduce potassium levels (e.g. loop and thiazide-type diuretics, laxatives and enemas [high doses], corticosteroids, amphotericin B) or medication that is associated with clinically significant bradycardia.
Co-administration of moxifloxacin with activated carbon can inhibit the absorption of moxifloxacin and lead to a reduced systemic availability of more than 80%.
After repeated dosing in healthy volunteers, moxifloxacin increased Cmax of digoxin by approximately 30% without affecting AUC or trough levels. No precaution is required for use with digoxin.
In studies conducted in diabetic volunteers, concomitant administration of oral moxifloxacin with glibenclamide resulted in a decrease of approximately 21% in the peak plasma concentrations of glibenclamide. The combination of glibenclamide and moxifloxacin could theoretically result in a mild and transient hyperglycaemia. However, the observed pharmacokinetic changes for glibenclamide did not result in changes of the pharmacodynamic parameters (blood glucose, insulin). Therefore no clinically relevant interaction was observed between moxifloxacin and glibenclamide.
Patients with a family history of or actual glucose-6-phosphate dehydrogenase deficiency are prone to haemolytic reactions when treated with quinolones. Therefore, moxifloxacin should be used with caution in these patients.
Psychiatric reactions may occur even after the first administration of quinolones, including moxifloxacin. In very rare cases depression or psychotic reactions have progressed to suicidal thoughts and self-injurious behaviour such as suicide attempts. In the event that the patient develops these reactions, moxifloxacin should be discontinued and appropriate measures instituted. Caution is recommended if moxifloxacin is to be used in psychotic patients or in patients with history of psychiatric disease.
Cases of fulminant hepatitis potentially leading to liver failure (including fatal cases) have been reported with moxifloxacin. Patients should be advised to contact their doctor prior to continuing treatment if signs and symptoms of fulminant hepatic disease develop such as rapidly developing asthenia associated with jaundice, dark urine, bleeding tendency or hepatic encephalopathy.
Liver function tests/investigations should be performed in cases where indications of liver dysfunction occur.
Tendon inflammation and rupture (especially Achilles tendon), sometimes bilateral, may occur with quinolone therapy including moxifloxacin, even within 48 hours of starting treatment and have been reported up to several months after discontinuation of therapy. The risk of tendinitis and tendon rupture is increased in elderly patients and in those treated concurrently with corticosteroids. At the first sign of pain or inflammation, patients should discontinue treatment with moxifloxacin, rest the affected limb(s) and consult their doctor immediately in order to initiate appropriate treatment (e.g. immobilisation) for the affected tendon.
Antibiotic-associated diarrhoea (AAD) and antibiotic-associated colitis (AAC), including pseudomembranous colitis and Clostridium difficile-associated diarrhoea, has been reported in association with the use of broad spectrum antibiotics including moxifloxacin and may range in severity from mild diarrhoea to fatal colitis. Therefore it is important to consider this diagnosis in patients who develop serious diarrhoea during or after the use of moxifloxacin. If AAD or AAC is suspected or confirmed, ongoing treatment with antibacterial agents, including moxifloxacin, should be discontinued and adequate therapeutic measures should be initiated immediately. Furthermore, appropriate infection control measures should be undertaken to reduce the risk of transmission. Drugs inhibiting peristalsis are contraindicated in patients who develop serious diarrhoea.
Cases of bullous skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis have been reported with moxifloxacin. Patients should be advised to contact their doctor immediately prior to continuing treatment if skin and/or mucosal reactions occur.
As with all fluoroquinolones, disturbances in blood glucose, including both hypoglycemia and hyperglycemia have been reported with moxifloxacin. In moxifloxacin-treated patients, dysglycemia occurred predominantly in elderly diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (e.g. sulfonylurea) or with insulin. Cases of hypoglycaemic coma have been reported. In diabetic patients, careful monitoring of blood glucose is recommended.
Epidemiologic studies report an increased risk of aortic aneurysm and dissection after intake of fluoroquinolones, particularly in the older population. Therefore, fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other therapeutic options in patients with positive family history of aneurysm disease, or in patients diagnosed with pre-existing aortic aneurysm and/or dissection, or in presence of other risk factors or conditions predisposing for aortic aneurysm and dissection (e.g. Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis, Behcet’s disease, hypertension, known atherosclerosis)
In case of sudden abdominal, chest or back pain, patients should be advised to immediately consult a physician in an emergency department.
Quinolones have been shown to cause photosensitivity reactions in patients. However, studies have shown that moxifloxacin has a lower risk to induce photosensitivity. Nevertheless patients should be advised to avoid exposure to either UV irradiation or extensive and/or strong sunlight during treatment with moxifloxacin.
Cases of sensory or sensorimotor polyneuropathy resulting in paraesthesias, hypoaesthesias, dysaesthesias, or weakness have been reported in patients receiving quinolones including moxifloxacin. Patients under treatment with moxifloxacin should be advised to inform their doctor prior to continuing treatment if symptoms of neuropathy such as pain, burning, tingling, numbness, or weakness develop in order to prevent the development of an irreversible condition.
Quinolones are known to trigger seizures. Use should be with caution in patients with CNS disorders or in the presence of other risk factors which may predispose to seizures or lower the seizure threshold. In case of seizures, treatment with moxifloxacin should be discontinued and appropriate measures instituted.
Moxifloxacin should be used with caution in patients with myasthenia gravis because the symptoms can be exacerbated.
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.
There are no or limited amount of data from the use of moxifloxacin eye drops solution in pregnant women. However, no effects on pregnancy are anticipated since the systemic exposure to moxifloxacin is negligible. The medicinal product can be used during pregnancy.
There is no data available in lactating or nursing 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, breast-feeding is contraindicated during moxifloxacin therapy.
However, at therapeutic doses of moxifloxacin eye drops solution no effects on the suckling child are anticipated. The medicinal product can be used during breast-feeding.
Animal studies do not indicate impairment of fertility.
Studies have not been performed to evaluate the effect of ocular administration of moxifloxacin on fertility.
No studies on the effects of moxifloxacin on the ability to drive and use machines have been performed. However, fluoroquinolones including moxifloxacin may result in an impairment of the patient’s ability to drive or operate machinery due to CNS reactions (e.g. dizziness; acute, transient loss of vision) or acute and short lasting loss of consciousness (syncope). Patients should be advised to see how they react to moxifloxacin before driving or operating machinery.
Moxifloxacin eye drops solution has no or negligible influence on the ability to drive and use machines, however, as with any eye drops, temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs at instillation, the patient should wait until their vision clears before driving or using machinery.
Adverse reactions observed in clinical trials and derived from post-marketing reports with moxifloxacin 400 mg daily administered by the intravenous or oral route (intravenous only, sequential [IV/oral] and oral administration) sorted by frequencies are listed below:
Apart from nausea and diarrhoea all adverse reactions were observed at frequencies below 3%.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Frequencies are defined as: Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000).
Common: Superinfections due to resistant bacteria or fungi e.g. oral and vaginal candidiasis
Uncommon: Anaemia, Leucopenia(s), Neutropenia, Thrombocytopenia, Thrombocythemia, Blood eosinophilia, Prothrombin time prolonged/INR increased
Very Rare: Prothrombin level increased/INR decreased, Agranulocytosis
Uncommon: Allergic reaction
Rare: Anaphylaxis incl. very rarely life-threatening shock, Allergic oedema/angiooedema (incl. laryngeal oedema, potentially life-threatening)
Uncommon: Hyperlipidemia
Rare: Hyperglycemia, Hyperuricemia
Very Rare: Hypoglycemia
Uncommon: Anxiety reactions, Psychomotor hyperactivity/agitation
Rare: Emotional lability, Depression (in very rare cases potentially culminating in self-injurious behaviour, such as suicidal ideations/ thoughts, or suicide attempts), Hallucination
Very Rare: Depersonalization, Psychotic reactions (potentially culminating in self-injurious behaviour, such as suicidal ideations/thoughts, or suicide attempts)
Common: Headache, Dizziness
Uncommon: Par- and Dysaesthesia, Taste disorders (incl. ageusia in very rare cases), Confusion and disorientation, Sleep disorders (predominantly insomnia), Tremor, Vertigo, Somnolence
Rare: Hypoaesthesia, Smell disorders (incl. anosmia), Abnormal dreams, Disturbed coordination (incl. gait disturbances, esp. due to dizziness or vertigo), Seizures incl. grand mal convulsions, Disturbed attention, Speech disorders, Amnesia, Peripheral neuropathy and polyneuropathy
Very Rare: Hyperaesthesia
Uncommon: Visual disturbances incl. diplopia and blurred vision (especially in the course of CNS reactions)
Rare: Photophobia
Very Rare: Transient loss of vision (especially in the course of CNS reactions), Uveitis and bilateral acute iris transillumination
Rare: Tinnitus, Hearing impairment incl. deafness (usually reversible)
Common: QT prolongation in patients with hypokalaemia
Uncommon: QT prolongation, Palpitations, Tachycardia, Atrial fibrillation, Angina pectoris
Rare: Ventricular tachyarrhythmias, Syncope (i.e. acute and short lasting loss of consciousness)
Very Rare: Unspecified arrhythmias, Torsade de Pointes, Cardiac arrest
Uncommon: Vasodilatation
Rare: Hypertension, Hypotension
Very Rare: Vasculitis
Uncommon: Dyspnea (including asthmatic conditions)
Common: Nausea, Vomiting, Gastrointestinal and abdominal pains, Diarrhoea
Uncommon: Decreased appetite and food intake, Constipation, Dyspepsia, Flatulence, Gastritis, Increased amylase
Rare: Dysphagia, Stomatitis, Antibiotic-associated colitis (incl. pseudo-membranous colitis, in very rare cases associated with life-threatening complications)
Common: Increase in transaminases
Uncommon: Hepatic impairment (incl. LDH increase), Increased bilirubin, Increased gamma-glutamyl-transferase, Increase in blood alkaline phosphatase
Rare: Jaundice, Hepatitis (predominantly cholestatic)
Very Rare: Fulminant hepatitis potentially leading to life-threatening liver failure (incl. fatal cases)
Uncommon: Pruritus, Rash, Urticaria, Dry skin
Very Rare: Bullous skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis (potentially life-threatening)
Uncommon: Arthralgia, Myalgia
Rare: Tendonitis, Muscle cramp, Muscle twitching, Muscle weakness
Very Rare: Tendon rupture, Arthritis, Muscle rigidity, Exacerbation of symptoms of myasthenia gravis
Uncommon: Dehydration
Rare: Renal impairment (incl. increase in BUN and creatinine), Renal failure
Common: Injection and infusion site reactions
Uncommon: Feeling unwell (predominantly asthenia or fatigue), Painful conditions (incl. pain in back, chest, pelvic and extremities), Sweating, Infusion site (thrombo-) phlebitis
Rare: Oedema
The following undesirable effects have a higher frequency category in the subgroup of IV treated patients with or without subsequent oral therapy:
Common: Increased gamma-glutamyl-transferase.
Uncommon: Ventricular tachyarrhythmias, hypotension, oedema, antibiotic-associated colitis (incl. pseudomembranous colitis, in very rare cases associated with life-threatening complications), seizures incl. grand mal convulsions, hallucination, renal impairment (incl. increase in BUN and creatinine), renal failure.
There have been very rare cases of the following side effects reported following treatment with other fluoroquinolones, which might possibly also occur during treatment with moxifloxacin: increased intracranial pressure (including pseudotumor cerebri), hypernatraemia, hypercalcaemia, haemolytic anaemia, rhabdomyolysis, photosensitivity reactions.
In clinical studies involving 2,252 patients, moxifloxacin was administered up to 8 times a day, with over 1,900 of these patients receiving treatment 3 times daily. The overall safety population that received the medicinal product consisted of 1,389 patients from the United States and Canada, 586 patients from Japan and 277 patients from India. No serious ophthalmic or systemic undesirable effects related to the medicinal product were reported in any of the clinical studies. The most frequently reported treatment-related undesirable effects with the medicinal product were eye irritation and eye pain, occurring at an overall incidence of 1 to 2%. These reactions were mild in 96% of those patients who experienced them, with only 1 patient discontinuing therapy as a result.
The following adverse reactions are classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) or not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in decreasing order of seriousness.
Rare: haemoglobin decreased
Not known: Hypersensitivity
Uncommon: headache
Rare: paresthesia
Not known: dizziness
Common: eye pain, eye irritation
Uncommon: punctate keratitis, dry eye, conjunctival haemorrhage, ocular hyperaemia, eye pruritus, eyelid oedema, ocular discomfort,
Rare: corneal epithelium defect, corneal disorder, conjunctivitis, blepharitis, eye swelling, conjunctival oedema, vision blurred, visual acuity reduced, asthenopia, erythema of eyelid
Not known: endophthalmitis, ulcerative keratitis, corneal erosion, corneal abrasion, intraocular pressure increased, corneal opacity, corneal infiltrates, corneal deposits, eye allergy, keratitis, corneal oedema, photophobia, eyelid oedema, lacrimation increased, eye discharge, foreign body sensation in eyes
Not known: palpitations
Rare: nasal discomfort, pharyngolaryngeal pain, sensation of foreign body (throat)
Not known: dyspnoea
Uncommon: dysgeusia
Rare: vomiting
Not known: nausea
Rare: alanine aminotransferase increased, gamma-glutamyltransferase increased
Not known: erythema, rash, pruritus, urticaria
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following first dose, have been reported in patients receiving systemic quinolone therapy. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial oedema), airway obstruction, dyspnoea, urticaria and itching.
Ruptures of the shoulder, hand, Achilles, or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving systemic fluoroquinolones. Studies and post marketing experience with systemic quinolones indicate that a risk of these ruptures may be increased in patients receiving corticosteroids, especially geriatric patients and in tendons under high stress, including Achilles tendon.
In clinical trials, moxifloxacin has shown to be safe in paediatric patients, including neonates. In patients under 18 years old, the two most frequent adverse reactions were eye irritation and eye pain, both occurring at an incidence rate of 0.9%.
Based on data from clinical trials involving paediatric patients, including neonates, the type and severity of adverse reactions in the paediatric population are similar to those in adults.
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