Moloxin

Moloxin

moxifloxacin

Manufacturer:

KRKA

Distributor:

Uni Drug
Full Prescribing Info
Contents
Moxifloxacin hydrochloride.
Description
Each film-coated tablet contains 400 mg moxifloxacin (as hydrochloride).
Excipients/Inactive Ingredients: Tablet core: cellulose, microcrystalline; croscarmellose sodium; magnesium stearate.
Film coating: hypromellose 6 mPa·s; macrogol 4000; titanium dioxide (E171); ferric oxide red (E172).
Action
Pharmacotherapeutic group: Antibacterials for systemic use, quinolone antibacterials. ATC code: J01MA14.
Pharmacology: Pharmacodynamics: Mechanism of action: Moxifloxacin is a 8-methoxy-fluoroquinolone antibiotic with a broad spectrum of activity and bactericidal action. Moxifloxacin has in vitro activity against a wide range of gram-positive and gram-negative organisms, anaerobes, acid-fast bacteria, and atypicals eg. Mycoplasma spp., Chlamydia spp. and Legionella spp.
Moxifloxacin is effective against ß-lactam and macrolide resistant bacteria. Studies in animal models of infection have demonstrated the high in vivo activity.
Mechanism of resistance: Resistance mechanisms that inactivate penicillins, cephalosporins, aminoglycosides, macrolides and tetracyclines do not interfere with the antibacterial activity of moxifloxacin. There is no cross resistance between moxifloxacin and these agents. Plasmid-mediated resistance has not been observed to date. 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, a mechanism of fluoroquinolone resistance.
In vitro studies have demonstrated that resistance to moxifloxacin develops slowly by multiple step mutations. A very low overall frequency of resistance was demonstrated (10-7 - 10-10). Serial exposure of organisms to sub-MIC concentrations of moxifloxacin showed only a small increase in MIC values.
Cross resistance among quinolones has been observed. However, some gram-positive and anaerobic organisms resistant to other quinolones are susceptible to moxifloxacin.
Effect on the intestinal flora in humans: In two volunteer studies, the following changes in the intestinal flora were seen following oral dosing with moxifloxacin. E. coli, Bacillus spp., Bacteroides vulgatus, Enterococci, and Klebsiella spp. were reduced, as were the anaerobes Bifidobacterium, Eubacterium, and Peptostreptococcus. These changes returned to normal within two weeks. Clostridium difficile toxin was not found.
Moxifloxacin has been shown to be active against most strains of the following microorganisms both in vitro and in clinical infections as described in the "Indications" section. (See Tables 1 to 4.)

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The frequency of acquired resistance may vary geographically and with time for certain species. Local area information on resistance of organisms is desirable, particularly when treating severe infections. The previously mentioned information is provided as a guide on the probability of an organism being susceptible to moxifloxacin.
Comparison of PK/PD surrogates for intravenous and oral administration of a 400 mg moxifloxacin single dose. In patients requiring hospitalisation AUC/MIC90 parameters greater than 125 and Cmax / MIC90 of 8 - 10 is predictive for clinical cure (Schentag). In outpatients these surrogate parameters are generally smaller, i.e. AUC/MIC90 greater than 30-40 (Dudley and Ambrose).
The following table provides the respective PK/PD surrogates for intravenous and oral administration of 400 mg moxifloxacin calculated from single dose data: (See Table 5.)

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Pharmacokinetics: Absorption and Bioavailability: Following oral administration moxifloxacin is rapidly and almost completely absorbed. The absolute bioavailability amounts to approximately 91%.
Pharmacokinetics are linear in the range of 50 - 800 mg when given as a single dose and up to 600 mg when given once daily over 10 days. Following a 400 mg oral dose peak concentrations of 3.1 mg/l are reached within 0.5 - 4 h post administration. Peak and trough plasma concentrations at steady-state (400 mg once daily) were 3.2 and 0.6 mg/l, respectively. At steady-state the exposure within the dosing interval is approximately 30% higher than after the first dose.
Distribution: Moxifloxacin is distributed to extravascular spaces rapidly; after a dose of 400 mg an AUC of 35 m∙gh/l is observed. The steady-state volume of distribution (Vss) is approximately 2 l/kg. In vitro and ex vivo experiments showed a protein binding of approximately 40 - 42% independent of the concentration of the drug. Moxifloxacin is mainly bound to serum albumin.
The following peak concentrations (geometric mean) were observed following administration of a single oral dose of 400 mg moxifloxacin: (See Table 6.)

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Biotransformation: Moxifloxacin undergoes Phase II biotransformation and is excreted via renal and biliary/faecal pathways as unchanged drug as well as in the form of a sulpho-compound (M1) and a glucuronide (M2). M1 and M2 are the only metabolites relevant in humans, both are microbiologically inactive.
In clinical Phase I and in vitro studies no metabolic pharmacokinetic interactions with other drugs undergoing Phase I biotransformation involving cytochrome P450 enzymes were observed. There is no indication of oxidative metabolism.
Elimination: Moxifloxacin is eliminated from plasma with a mean terminal half life of approximately 12 hours. The mean apparent total body clearance following a 400 mg dose ranges from 179 to 246 ml/min. Renal clearance amounted to about 24 - 53 ml/min suggesting partial tubular reabsorption of the drug from the kidneys.
After a 400 mg dose, recovery from urine (approximately 19% for unchanged drug, approximately 2.5% for M1, and approximately 14% for M2) and faeces (approximately 25% of unchanged drug, approximately 36% for M1, and no recovery for M2) totalled to approximately 96%.
Concomitant administration of moxifloxacin with ranitidine or probenecid did not alter renal clearance of the parent drug.
Geriatric patients: Pharmacokinetics of moxifloxacin are not affected by age.
Gender: There was a 33% difference in the pharmacokinetics (AUC, Cmax) of moxifloxacin between male and female subjects. Drug absorption was unaffected by gender. These differences in the AUC and Cmax were attributable to the differences in body weight rather than gender. They are not considered as clinically relevant.
Renal impairment: The pharmacokinetic properties of moxifloxacin are not significantly different in patients with renal impairment (Including creatinine clearance < 30 ml/min/1.73m2) and in patients on chronic dialysis i. e. hemodialysis and continuous ambulatory peritoneal dialysis.
Hepatic impairment: On the basis of the pharmacokinetic studies carried out so far in patients with liver failure (Child Pugh A, B), it is not possible to determine whether there are any differences compared with healthy volunteers. There is insufficient experience in the clinical use of moxifloxacin in patients with severe hepatic impairment (Child Pugh C).
Ethnic differences: Possible interethnic differences were examined in Caucasian, Japanese, Black and other ethnic groups. No clinically relevant interethnic differences in pharmacokinetics could be detected.
Children and adolescents: Pharmacokinetics of moxifloxacin were not studied in paediatric patients.
Toxicology: Preclinical safety data: Effects on the haematopoetic system (slight decreases in the number of erythrocytes and platelets) were seen in rats and monkeys. As with other quinolones, hepatotoxicity (elevated liver enzymes and vacuolar degeneration) was seen in rats, monkeys and dogs. In monkeys CNS toxicity (convulsions) occurred. These effects were seen only after treatment with high doses of moxifloxacin or after prolonged treatment.
Moxifloxacin, like other quinolones, was genotoxic in in vitro tests using bacteria or mammalian cells. Since these effects can be explained by an interaction with the gyrase in bacteria and - at higher concentrations - by an interaction with the topoisomerase II in mammalian cells, a threshold concentration for genotoxicity can be assumed. In in vivo tests, no evidence of genotoxicity was found despite the fact that very high moxifloxacin doses were used. Thus, a sufficient margin of safety to the therapeutic dose in man can be provided. Moxifloxacin was non-carcinogenic in an initiation-promotion study in rats.
Many quinolones are photoreactive and can induce phototoxic, photomutagenic and photocarcinogenic effects. In contrast, moxifloxacin was proven to be devoid of phototoxic and photogenotoxic properties when tested in a comprehensive programme of in vitro and in vivo studies. Under the same conditions other quinolones induced effects.
At high concentrations, moxifloxacin is an inhibitor of the rapid component of the delayed rectifier potassium current of the heart and may thus cause prolongations of the QT interval. Toxicological studies performed in dogs using oral doses of ≥ 90 mg/kg leading to plasma concentrations ≥ 16 mg/l caused QT prolongations, but no arrhythmias. Only after very high cumulative intravenous administration of more than 50fold the human dose (> 300 mg/kg), leading to plasma concentrations of ≥ 200 mg/l (more than 40fold the therapeutic level), reversible, non-fatal ventricular arrhythmias were seen.
Quinolones are known to cause lesions in the cartilage of the major diarthrodial joints in immature animals. The lowest oral dose of moxifloxacin causing joint toxicity in juvenile dogs was four times the maximum recommended therapeutic dose of 400 mg (assuming a 50 kg bodyweight) on a mg/kg basis, with plasma concentrations two to three times higher than those at the maximum therapeutic dose.
Toxicity tests in rats and monkeys (repeated dosing up to six months) revealed no indication regarding an oculotoxic risk. In dogs, high oral doses (≥ 60 mg/kg) leading to plasma concentrations ≥ 20 mg/l caused changes in the electroretinogram and in isolated cases an atrophy of the retina.
Reproductive studies performed in rats, rabbits and monkeys indicate that placental transfer of moxifloxacin occurs. Studies in rats (p.o. and i.v.) and monkeys (p.o.) did not show evidence of teratogenicity or impairment of fertility following administration of moxifloxacin. A slightly increased incidence of vertebral and rib malformations was observed in foetuses of rabbits but only at a dose (20 mg/kg i.v.) which was associated with severe maternal toxicity. There was an increase in the incidence of abortions in monkeys and rabbits at human therapeutic plasma concentrations. In rats, decreased foetal weights, an increased prenatal loss, a slightly increased duration of pregnancy and an increased spontaneous activity of some male and female offspring was observed at doses which were 63 times the maximum recommended dose on a mg/kg basis with plasma concentrations in the range of the human therapeutic dose.
Indications/Uses
Moloxin 400 mg film-coated tablets are indicated for the treatment of the following bacterial infections caused by susceptible strains: Respiratory tract infection: Acute bacterial sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.
Acute bacterial exacerbations of chronic bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Staphylococcus aureus, or Moraxella catarrhalis.
Community acquired pneumonia (of mild to moderate severity) caused by Streptococcus pneumoniae, Haemophilus influenzae, Mycoplasma pneumoniae, Chlamydia pneumoniae, or Moraxella catarrhalis.
Uncomplicated skin and skin structure infections caused by Staphylococcus aureus or Streptococcus pyogenes.
Complicated skin and skin structure infections caused by methicillin-susceptible Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae or Enterobactercioacae.
Mild to moderate pelvic inflammatory disease (i.e. infections of female upper genital tract, including salpingitis and endometritis), without an associated tubo-ovarian or pelvic abscess.
Moloxin 400 mg film-coated tablets are not recommended for use in monotherapy of mild to moderate pelvic inflammatory disease but should be given in combination with another appropriate antibacterial agent (e.g. a cephalosporin) due to increasing moxifloxacin resistance of Neisseria gonorrhoeae.
Moloxin 400 mg film-coated tablets are indicated for the treatment of the above infections if they are caused by bacteria susceptible to moxifloxacin.
For a full list of susceptible strains, please refer to Pharmacology: Pharmacodynamics under Actions.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Dosage/Direction for Use
Posology: The recommended dose for Moloxin is 400 mg once daily (1 film-coated tablet) for the previously mentioned indications and should not be exceeded. The film-coated tablet should be swallowed whole with sufficient liquid and may be taken independent of meals.
For complicated skin and skin structure infections, therapy should usually be initiated with intravenous formulation. When switching from intravenous to oral dosage administration, no dosage adjustment is necessary. Patients whose therapy is started with Moloxin I.V. may be switched to Moloxin Tablets when clinically indicated at the discretion of the physician.
Duration of administration: The duration of treatment should be determined by the severity of the indication or clinical response. The following general recommendations are made: (See Table 7.)

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The recommended duration of therapy for the indication being treated should not be exceeded.
Moxifloxacin 400 mg film-coated tablets and moxifloxacin 400 mg solution for infusion have been studied in clinical trials for up to 21 days (in complicated skin and skin structure infections).
Children and adolescents: Efficacy and safety of Moloxin in children and adolescents have not been established (see Contraindications).
Geriatric patients: No adjustment of dosage is required in elderly.
Ethnic differences: No adjustment of dosage is required in ethnic groups.
Patients with hepatic impairment: No dosage adjustment is required in patients with mild or moderate impaired liver function. The use of moxifloxacin is not recommended in patients with severe hepatic impairment (Child Pugh C) (see Precautions).
Patients with renal impairment: No dose adjustment is required in patients with any degree of renal impairment (including creatinine clearance < 30 mL/min/1.73m2) and in patients on chronic dialysis i.e. hemodialysis and continuous ambulatory peritoneal dialysis.
Overdosage
No specific countermeasures after accidental overdose are recommended. In the event of overdose, symptomatic treatment should be implemented. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation. Concomitant administration of charcoal with a dose of 400 mg oral moxifloxacin will reduce systemic availability of the drug by more than 80%. The use of charcoal early during absorption may be useful to prevent excessive increase in the systemic exposure to moxifloxacin in cases of oral overdose.
Contraindications
Hypersensitivity to moxifloxacin, other quinolones or to any of the excipients listed in Description.
Pregnancy and lactation (see Use in Pregnancy & Lactation).
Patients below 18 years of age.
Patients with a history of tendon disease/disorder related to quinolone treatment.
Both in preclinical investigations and in humans, changes in cardiac electrophysiology have been observed following exposure to moxifloxacin, in the form of QT prolongation. For reasons of drug safety, moxifloxacin is therefore contraindicated in patients with: Congenital or documented acquired QT prolongation; Electrolyte disturbances, particularly in uncorrected hypokalaemia; Clinically relevant bradycardia; Clinically relevant heart failure with reduced left-ventricular ejection fraction; Previous history of symptomatic arrhythmias.
Moxifloxacin should not be used concurrently with other drugs that prolong the QT interval (see Interactions).
Due to limited clinical data, moxifloxacin is also contraindicated in patients with impaired liver function (Child Pugh C) and in patients with transaminases increase > 5fold ULN.
Special Precautions
The benefit of moxifloxacin treatment especially in infections with a low degree of severity should be balanced with the information contained in this section.
Prolongation of QTc interval and potentially QTc-prolongation-related clinical conditions: Moxifloxacin has been shown to prolong the QTc interval on the electrocardiogram in some patients. In the analysis of ECGs obtained in the clinical trial program, QTc prolongation with moxifloxacin was 6 msec ± 26 msec, 1.4% compared to baseline. As women tend to have a longer baseline QTc interval compared with men, they may be more sensitive to QTc-prolonging medications. Elderly patients may also be more susceptible to drug-associated effects on the QT interval.
Medication that can reduce potassium levels should be used with caution in patients receiving moxifloxacin (see Precautions and Interactions).
Moxifloxacin should be used with caution in patients with ongoing proarrhythmic conditions (especially women and elderly patients), such as acute myocardial ischaemia or QT prolongation as this may lead to an increased risk for ventricular arrhythmias (incl. torsade de pointes) and cardiac arrest (see Contraindications). The magnitude of QT prolongation may increase with increasing concentrations of the drug. Therefore, the recommended dose should not be exceeded. The benefit of moxifloxacin treatment especially in infections with a low degree of severity should be balanced with the information contained in the warnings and precautions section. If signs of cardiac arrhythmia occur during treatment with moxifloxacin, treatment should be stopped and an ECG should be performed.
Hypersensitivity/allergic reactions: Hypersensitivity and allergic reactions have been reported for fluoroquinolones including moxifloxacin after first administration. Anaphylactic reactions can progress to a life-threatening shock, even after the first administration. In these cases of clinical manifestations of severe hypersensitivity reactions moxifloxacin should be discontinued and suitable treatment (e.g. treatment for shock) initiated.
Severe liver disorders: Cases of fulminant hepatitis potentially leading to liver failure (including fatal cases) have been reported with moxifloxacin (see Adverse Reactions). 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.
Serious bullous skin reactions: Cases of bullous skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis have been reported with moxifloxacin (see Adverse Reactions). Patients should be advised to contact their doctor immediately prior to continuing treatment if skin and/or mucosal reactions occur.
Patients predisposed to seizures: 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.
Peripheral neuropathy: Cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving fluoroquinolones, including moxifloxacin. Symptoms may occur soon after initiation of moxifloxacin and may be irreversible. Moxifloxacin should be discontinued immediately if the patient experiences symptoms of peripheral neuropathy including pain, burning, tingling, numbness, and/or weakness or other alterations of sensation including light touch, pain, temperature, position sense, and vibratory sensation.
Psychiatric reactions: 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 (see Adverse reactions). 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.
Antibiotic-associated diarrhoea incl. colitis: 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.
Patients with myasthenia gravis: Fluoroquinolones, including moxifloxacin, have neuromuscular blocking activity and may exacerbate muscle weakness in persons with myasthenia gravis. Post-marketing serious adverse events, including deaths and requirement for ventilatory support, have been associated with fluoroquinolone use in persons with myasthenia gravis. Avoid moxifloxacin in patients with a known history of myasthenia gravis.
Tendon inflammation, tendon rupture: 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 (see Contraindications and Adverse reactions).
Patients with renal impairment: Elderly patients with renal disorders should use moxifloxacin with caution if they are unable to maintain adequate fluid intake, because dehydration may increase the risk of renal failure.
Vision disorders: If vision becomes impaired or any effects on the eyes are experienced, an eye specialist should be consulted immediately (see Effects on ability to drive and use machines as follows and Adverse Reactions).
Dysglycemia: 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. In diabetic patients, careful monitoring of blood glucose is recommended (see Adverse Reactions).
Prevention of photosensitivity reactions: 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.
Patients with glucose-6-phosphate dehydrogenase deficiency: 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.
Patients with pelvic inflammatory disease: For patients with complicated pelvic inflammatory disease (e.g. associated with a tubo-ovarian or pelvic abscess), for whom an intravenous treatment is considered necessary, treatment with Moloxin 400 mg film-coated tablets is not recommended.
Pelvic inflammatory disease may be caused by fluoroquinolone-resistant Neisseria gonorrhoeae. Therefore in such cases empirical moxifloxacin should be co-administered with another appropriate antibiotic (e.g. a cephalosporin) unless moxifloxacin-resistant Neisseria gonorrhoeae can be excluded. If clinical improvement is not achieved after 3 days of treatment, the therapy should be reconsidered.
Patients with special cSSSi: Clinical efficacy of intravenous moxifloxacin in the treatment of severe burn infections, fasciitis and diabetic foot infections with osteomyelitis has not been established.
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.
Patients with MRSA infections: Moxifloxacin is not recommended for the treatment of MRSA infections. In case of a suspected or confirmed infection due to MRSA, treatment with an appropriate antibacterial agent should be started (see Pharmacology: Pharmacodynamics under Actions).
Effects on ability to drive and use machines: 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, see Adverse reactions) or acute and short lasting loss of consciousness (syncope, see Adverse reactions). Patients should be advised to see how they react to moxifloxacin before driving or operating machinery.
Paediatric population: Due to adverse effects on the cartilage in juvenile animals (see Pharmacology: Toxicology under Actions) the use of moxifloxacin in children and adolescents < 18 years is contraindicated (see Contraindications).
Use In Pregnancy & Lactation
Pregnancy: The safety of moxifloxacin in human pregnancy has not been evaluated. Animal studies have shown reproductive toxicity (see Pharmacology: Toxicology under Actions). 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 (see Contraindications).
Breastfeeding: 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 (see Contraindications).
Fertility: Animal studies do not indicate impairment of fertility (see Pharmacology: Toxicology under Actions).
Adverse Reactions
Adverse reactions based on all clinical trials and derived from post-marketing reports with moxifloxacin 400 mg (oral and sequential therapy) sorted by frequencies are listed as follows: Apart from nausea and diarrhoea all adverse reactions listed under "common" 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); Not known (cannot be estimated from the available data). (See Table 8.)

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Drug Interactions
Interactions with medicinal products: An additive effect on QT interval prolongation of moxifloxacin and other medicinal products that may prolong the QTc interval cannot be excluded. This might lead to an increased risk of ventricular arrhythmias, including torsade de pointes. Therefore, co-administration of moxifloxacin with any of the following medicinal products is contraindicated (see Contraindications): anti-arrhythmics class IA (e.g. quinidine, hydroquinidine, disopyramide); anti-arrhythmics class III (e.g. amiodarone, sotalol, dofetilide, ibutilide); antipsychotics (e.g. phenothiazines, pimozide, sertindole, haloperidol, sultopride); tricyclic antidepressive agents; certain antimicrobial agents (saquinavir, sparfloxacin, erythromycin IV, pentamidine, antimalarials particularly halofantrine); certain antihistaminics (terfenadine, astemizole, mizolastine); others (cisapride, vincamine IV, bepridil, diphemanil).
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.
Concomitant ingestion of moxifloxacin together with antacids, minerals and multi-vitamins may result in impaired absorption of the drug due to formation of chelate complexes with the multi-valent cations contained in these preparations. This may lead to plasma concentrations considerably lower than desired. Hence, an interval of at least 4 hours before and 2 hours after should be given between administration of agents containing bivalent or trivalent cations (e.g. antacids containing magnesium or aluminium, didanosine tablets, sucralfate and agents containing iron or zinc) and administration of moxifloxacin.
Concomitant administration of charcoal with an oral dose of 400 mg moxifloxacin led to a pronounced prevention of drug absorption and a reduced systemic availability of the drug by more than 80%. Therefore, the concomitant use of these two drugs is not recommended (except for overdose cases, see also Overdosage).
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.
Changes in INR: 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.
Clinical studies have shown no interactions following concomitant administration of moxifloxacin with: ranitidine, probenecid, oral contraceptives, calcium supplements, morphine administered parenterally, theophylline, cyclosporine or itraconazole, atenolol and glibenclamide. No dose adjustment is necessary for these drugs.
Interaction with food: Moxifloxacin has no clinically relevant interaction with food including dairy products.
Storage
Do not store above 30°C.
Store in the original package in order to protect from moisture.
MIMS Class
ATC Classification
J01MA14 - moxifloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Presentation/Packing
FC tab 400 mg (dark pink, biconvex, capsule shaped) x 10's.
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