Avelox

Avelox

moxifloxacin

Manufacturer:

Bayer Indonesia
Full Prescribing Info
Contents
Moxifloxacin HCl.
Description
FC tab: 1 film-coated tablet contains 400 mg moxifloxacin (as hydrochloride).
Infusion: 1 single bottle of 250 mL infusion solution containing 400 mg moxifloxacin (as hydrochloride).
Action
Pharmacotherapeutic group: Quinolone antibacterials, fluoroquinolones. ATC Code: J01MA14.
Pharmacology: Pharmacodynamics: Moxifloxacin is a fluoroquinolone antibacterial.
Mechanism of action: In vitro, moxifloxacin has been shown to have activity against a wide range of Gram-positive and Gram-negative pathogens.
The bacterial action results from the interference with topoisomerase II (DNA Gyrase) and IV. Topoisomerases are essential enzymes which play a crucial part in the replication, transcription and repair of bacterial DNA. Topoisomerase IV is also known to influence bacterial chromosome division.
Kinetic investigations have demonstrated that moxifloxacin exhibits a concentration dependent killing rate. Minimum bacterial concentrations (MBC) were found to be the range of the minimum inhibitory concentration (MIC).
Infusion: See Table 1.


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Interference with culture test: Moxifloxacin therapy may give false negative culture results for Mycobacterium spp. By suppression of mycobacterial growth.
Effect on the intestinal flora in humans: The following changes in the intestinal flora were seen in volunteers following administration of moxifloxacin: E. coli, Bacillus spp., Enterococci, and Klebsiella spp. were reduced, as were the anaerobes Bacteroides vulgatus, Bifidobacterium, Eubacterium, and Peptostreptococcus. For B. fragilis there was an increase. These changes returned to normal within two weeks. There was no selection of Clostridium difficile (MIC90 2 mg/l) and its toxin under the administration of moxifloxacin. Moxifloxacin is not indicated for the treatment of Clostridium difficile.
The prevalence of resistance may vary geographically and with time for selected species and local area information on resistance is desirable, particularly when treating severe infections. The in vitro susceptibility information as follows gives only approximate guidance on probabilities whether micro-organisms will be susceptible to moxifloxacin or not.
In vitro Susceptible Data: Breakpoints S ≤1 mg/l, R >2 mg/l). (See Table 2.)


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Resistance: Resistance mechanisms which inactive penicillins, cephalosporins, aminoglycosides, macrolides and tetracyclines do not interfere with the antibacterial activity of moxifloxacin. Other resistance mechanisms such as permeation barriers (common, for example, in Pseudomonas aeruginosa) and efflux mechanisms may, however, also effect the sensitivity of corresponding bacteria to moxifloxacin. Apart from there is no cross-resistance between moxifloxacin and aforementioned compound classes. Plasmid-mediated resistance has not been observed. Laboratory tests on the development of resistance against moxifloxacin in Gram-positive bacteria revealed that resistance develops slowly by multiple step mutations and is mediated by target site modifications (i.e. in topoisomerase II and IV) and efflux mechanisms. The frequency of resistance development is low (rate 10-7-10-10).
Parallel resistance is observed with other quinolones. However, as moxifloxacin inhibits both topoisomerases (II & IV) in Gram-positive organisms, some Gram-positive bacteria and anaerobes that are resistant to other quinolones may be susceptible to moxifloxacin.
Pharmacokinetics: Absorption and Bioavailability: Following oral administration moxifloxacin is rapidly and almost completely absorbed. The absolute bioavailability amounts to approximately 90% after oral administration of a 400 mg dose.
Pharmacokinetics are linear in the range of 50-800 mg single dose and up to 600 mg once daily dosing 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 mg.h/l is observed. The steady-state volume 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 dose of 400 mg moxifloxacin: See Table 3.


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Metabolism: Moxifloxacin undergoes Phase II biotransformation and is excreted via renal and biliary/faecal pathways as unchanged drug as well as in the form of 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 under Phase I biotransformation involving Cytochrome P-450 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 range 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 (approx. 19% for unchanged drug, approx. 2.5% for M1, and approx. 14% for M2) and faeces (approx. 25% of unchanged drug, approx. 36% for M1, and no recover for M2) totalled to approximately 96%.
Concomitant administration of moxifloxacin with ranitidine or probenecid did not alter renal clearance of the parent drug.
Higher plasma concentrations are observed in healthy volunteers with low body weight (such as women) and in elderly volunteers.
The pharmacokinetic properties of moxifloxacin are not significantly different in patients with renal impairment (including creatinine clearance >20 ml/min/1.73 m2). As renal function decreases, concentrations of the M2 metabolite (glucuronide) increase by up to a factor of 2.5 (with a creatinine clearance of <30 mL/min/1.73 m2). No information is available on the use of moxifloxacin in patients with a creatinine clearance of <30 ml/min/1.73 m2 and renal dialysis patients.
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. Impaired liver function was associated with higher exposure to M1 in plasma, whereas exposure to parent drug was comparable to exposure in healthy volunteers.
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 effect were seen only after treatment with high doses of moxifloxacin or after prolonged treatment.
Carcinogenicity, Mutagenecity: Moxifloxacin, like other quinolones, was genotoxic in in vitro test using bacteria or mammalian cells. Since these effects can be explained by an interaction with 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 dose were used. Thus, a sufficient margin of safety to therapeutic dose in man can be provided. Moxifloxacin was non-carcinogenic in an initiation-promotion study in rats.
Phototoxicity: Many quinolones are photo-reactive and can induce phototoxic, photomutagenic and photocarcinogenic effects. In contrast, moxifloxacin was proven to be avoided 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.
ECG: At higher concentrations, moxifloxacin is an inhibitor 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 arrythmias. Only after very high cumulative intravenous administration of more than 50-fold the human dose (>300 mg/kg), leading to plasma concentrations of ≥200 mg/l (more than 40-fold the therapeutic level), reversible, non-fatal ventricular arrythmias were seen.
Anthrotoxicity: 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 indicating regarding an oculotoxic risk. In dogs, high oral doses (≥60 mg/kg) leading to plasma concentration ≥20 mg/l caused changes in the electroretinogram and isolated cases an atrophy of the retina.
Reprotoxicity: Reproductive studies performed in rats and monkeys indicate that placental transfer of moxifloxacin occurs. Studies in these species did not show evidence of teratogenicity or impairment of fertility following administration of moxifloxacin. Skeletal malformations were observed in rabbits that had been treated with an intravenous dose of 20 mg/kg. This study result is consistent with the known effects of quinolones on skeletal development. 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 pre-natal loss, a slightly increases duration of pregnancy and increases 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
Avelox 400 mg film coated tablets and infusion are indicated for the treatment of adults (≥18 years of age) for the following bacterial infections: Acute exacerbations of chronic bronchitis.
Community acquired pneumonia.
Acute bacterial sinusitis (adequately diagnosed).
Complicated skin and skin structure infections who require initial parenteral therapy; followed by oral; in patients who are intolerant to alternative agents (especially penicillin allergy), and when caused by organisms known to be susceptible to moxifloxacin.
Complicated intra-abdominal infections due to polymicrobial infections in patients who are intolerant to alternative agents, caused by organisms known to be susceptible to moxifloxacin.
FC tab: 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. Avelox 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. cephalosporin) due to increasing moxifloxacin resistance of Neisseria gonorrhoeae unless moxifloxacin-resistant Neisseria gonorrhoeae can be excluded.
Infusion: Avelox IV is only for patients that can not take oral administration or clinically proven have to take parenteral administration.
Avelox 400 mg film coated tablets and infusions are indicated for the treatment of the previously mentioned infections if they are caused by bacteria susceptible to moxifloxacin.
Consideration should be given on official guidance on the appropriate use of antibacterial agents.
Avelox may only be used on prescription and under the constant supervision of doctor.
Dosage/Direction for Use
FC tab: One 400 mg film coated tablet once daily.
Infusion: The recommended dose for Avelox is 400 mg once daily.
No adjustment of dosage is required in the elderly.
Efficacy and safety in children and adolescents have not been established (see Contraindications).
No dose adjustment in patient with any degree of renal impairment (including creatinine clearance ≤30 ml/min/1.73 m2).
For treatment of complicated skin and skin structure infections requiring initial intravenous therapy followed by oral tablet administration of 400 mg moxifloxacin tablet.
For treatment of complicated intra-abdominal infections requiring initial intravenous therapy followed by oral administration of 400 mg moxifloxacin tablet.
Method of administration: FC tab: The film-coated tablets should be swallowed whole with sufficient liquid and may be taken independent of meals.
Infusion: The infusion solution should be infused intravenously over 60 minutes.
It can be administered directly or together with compatible infusion solutions.
The following co-infusions were found to form stable mixtures over a period of 24 hours at room temperature with moxifloxacin infusion solution, and can therefore be considered as compatible: Water for Injections; Sodium Chloride 0.9%; Sodium Chloride 1 molar; Glucose 5%; Glucose 10%; Glucose 40%; Xylit 20%; Ringer Solution; Lactated Ringer Solution; Aminofusin 10% (manufacturer: Pharmacia & Upjohn); Jonosteril D5 (manufacturer: Fresenius Kabi).
If Avelox infusion solution is to be given with another drug, each drug should be given separately (see Incompatibilities under Cautions for Usage).
Only clear solutions are to be used.
Duration of administration: Avelox should be used for the following treatment durations: Acute exacerbations of chronic bronchitis: 5-10 days; Community acquired pneumonia: 10 days; Acute sinusitis: 7 days; Complicated skin and skin structure infections: 7-21 days (sequential IV/oral therapy); Complicated intra-abdominal infections: 5-14 days (sequential IV/oral therapy); Mild to moderate Pelvic Inflammatory disease: 14 days (FC tab).
In clinical trials in patients with complicated skin and skin structure infections the mean duration of intravenous therapy was approximately 6 days with an overall mean treatment duration of approximately 13 days.
The recommended dose (400 mg once daily) and duration of therapy for the indication being treated should not be exceeded.
Infusion: Moxifloxacin can be administered intravenously as initial intravenous administration, followed by oral tablet administration when allowed by the patient's condition.
Intravenous therapy may be limited for up to two to five days in therapy in the very ill patients and should be changed to oral therapy whenever possible as determined by the physician.
Overdosage
There is no experience with moxifloxacin in overdose. No specific countermeasures after accidental overdosage are recommended. General symptomatic therapy should be initiated.
FC tab: The use of charcoal early after oral administration may be useful to prevent excessive increase of systemic exposure to moxifloxacin in cases of overdosage.
Contraindications
Known hypersensitivity to any component of the infusions or other quinolones.
Pregnancy and lactation (see Use in Pregnancy & Lactation).
Patients below 18 years of age.
Patient with a history of tendon disease/disorder related to quinolone treatment.
Both in pre-clinical investigations and in humans, changes in cardiac electrophysiology have been observed following exposure to moxifloxacin, in the form of QT prolongation. For reason of the drug safety, Avelox is therefore contra-indicated in patients with: Congenital or documented acquired QT prolongation;
Electrolyte disturbances, particularly in hypokalaemia;
Clinically relevant bradycardia;
Clinically relevant heart failure with reduced left-ventricular ejection fraction;
Previous history of symptomatic arrythmias.
Avelox should not be used concurrently with other drugs that prolong the QT interval in particular Class IA (example: quinidine, procainamide) and Class III antiarrythmic agents (example: amiodarone, sotalol).
Due to a lack of data, Avelox is also contra-indicated in patients with impaired liver function (Child Pugh C) and in patients with transaminases increase >5-fold ULN and in patients with a creatinine clearance below 30 mL/min/1.73 m2 (serum creatinine >265 μmol/l) or undergoing renal dialysis.
Warnings
Fluoroquinolone are associated with an increased risk of tendonitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patient taking corticosteroid drug, and in patient with kidney, heart or lung transplants.
Special Precautions
Quinolones are known to trigger seizures. Use should be with caution in-patients with CNS disorders, which may predispose to seizures or lower the seizure threshold.
If vision becomes impaired or any effects on the eyes are experienced, an eye specialist should be consulted immediately.
Tendon inflammation and rupture may occur with quinolone therapy, particularly in elderly patients and in those treated concurrently with corticosteroids: cases occurring up to several months after completion of therapy have been reported. At the first sign of pain or inflammation, patient should discontinue treatment with Avelox and rest the affected limb(s).
Due to limited clinical data the use of moxifloxacin is not recommended in patients with severe hepatic impairment (Child Pugh C).
Moxifloxacin, as with some other quinolones and macrolides, has been shown to prolong the QTc interval. In the analysis of ECGs obtained in the clinical trial program the degree of mean ± SD QTc prolongation with moxifloxacin was small (6 msec, ± 26 msec, 1.4% compared to baseline). No statistically significant differences in the incidence of potentially relevant QTc prolongation between moxifloxacin and control groups including placebo were detected. Since there is only limited information available on patients who may be predisposed to develop cardiac arrythmias associated with QTc prolongation, moxifloxacin should be used with caution in patients using concomitant medication that can reduce potassium and magnesium level.
If signs of cardiac arrythmia occur during treatment with Avelox, treatment should be stopped and an ECG should be performed.
Liver function tests/investigations should be performed in cases where indications of liver dysfunction occur.
Pseudomembranous colitis has been reported with the use of broad-spectrum antibiotic; therefore it is important to consider this diagnosis in patients who develop serious diarrhoea during or after during Avelox. Drugs inhibiting peristalsis are contra-indicated in patients who develop serious diarrheoea.
Avelox should be used with caution in patients with myasthenia gravis because the symptoms can be exacerbated.
Patients with family history of, or actual defects in glucose-6-phosphate dehydrogenase deficiency are prone to haemolytic reactions when treated with quinolones. Therefore, Avelox should be used with caution in these patients.
Quinolone have been shown to cause photosensitivity reactions in patients. However, studies have been shown that Avelox has no substantive potential to induce photosensitivity. Nevertheless patient should be advised to avoid exposure to either UV irradiation or extensive sunlight during treatment with Avelox.
In some instances, the hypersensitivity and allergic reactions already occurred after the first administration and the doctor should be informed immediately. Anaphylactic reactions in very rare case instances can progress to a life threatening shock, in some instances after the first administration. In these cases the treatment with Avelox has to be discontinued, medical treatment (e.g. treatment for shock) is required.
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.
For patients with complicated pelvic disease (e.g. associated with a tubo ovarian or pelvic abscess), for whom an intravenous treatment is considered necessary,treatment with Avelox 400 mg film coated tablet is not recommended.
In patients for whom sodium intake is of medical concern (patients with congestive heart failure, renal failure, nephrotic syndrome, etc) the additional sodium load of the solution for infusion should be taken into account.
QT prolongation may lead to an increased risk for ventricular arrhythmias including torsades de pointes. No cardiovascular morbidity or mortality attributable to QTc prolongation occurred with Avelox treatment in clinical studies with more than 8000 patients, however certain predisposing conditions may increase the risk for ventricular arrhythmias.
In women and elderly patients who, both, may be more susceptible to QTc-prolonging drugs.
Cases of fulminant hepatitis potentially leading to liver failure (including fatal cases) have been reported with Avelox. Patients should be advised to contact their doctor immediately prior to continuing treatment if symptoms related to liver failure occur.
Cases of bullous skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis have been reported With Avelox. Patients should be advised to contact their doctor immediately prior to continuing treatment if skin and/or mucosal reactions occur.
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).
Moxifloxacin in vitro activity may interfere with the Mycobacterium spp. culture test by suppression of mycobacterial growth, causing false negative results in specimens from patients currently taking Avelox.
Cases of sensory or sensorimotor polyneuropathy, resulting in paraesthesias, hypoaesthesia, dysaesthesias, or weakness have been reported in patients receiving quinolones including Avelox. Patients under treatment with Avelox should be advised to inform their doctor prior to continuing treatment if symptoms of neuropathy such as pain, burning, tingling, numbness, or weakness develop (see Adverse Reactions).
Psychiatric reactions may occur even after the first administration of fluoroquinolones, including moxifloxacin. In very rare cases depression or psychotic reactions have progressed to suicidal thoughts and self-injurious behavior such as suicide attempts (see Adverse Reactions). In the event that the patient develops these reactions, Avelox should be discontinued and appropriate measures instituted. Caution is recommended if Avelox is to be used in psychotic patients or in patients with a history of psychiatric disease.
Because of the widespread and rising prevalence of fluoroquinolone-resistant Neisseria gonorrhoeae infections, monotherapy with moxifloxacin should be avoided in patients with pelvic inflammatory disease, unless fluoroquinolone-resistant N. gonorrhoeae can be excluded. If fluoroquinolone-resistant N. gonorrhoeae can not be excluded, the addition of an appropriate antibiotic which is regularly active against N. gonorrhoeae (e.g., a cephalosporin) to empirical moxifloxacin therapy, should be considered.
Dysglycemia: As with all fluoroquinolones, disturbances in blood glucose, including both hypoglycemia and hyperglycemia have been reported with Avelox. In Avelox-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).
Effects on ability to drive and use machines: Fluoroquinolones may result in an impairment of the patient's ability to drive or operate machinery due to CNS reactions (e.g. dizziness) and vision disorders (see Adverse Reactions). Patients should be advised to see how they react to moxifloxacin before driving or operating machinery.
FC tab: 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. 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 rare hereditary problems of galactose intolerance, the Lapp Lactose deficiency or glucose-galactose malabsorption should not take this medicine.
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.
Due to adverse effects on the cartilage in juvenile animals, the use of moxifloxacin in children and adolescents <18 years is contraindicated.
Use In Pregnancy & Lactation
The safety of use of Avelox in human pregnancy has not been evaluated. Reproduction studies performed in rats and monkeys did not reveal any evidence of teratogenecity or impairment of fertility. However, as with other quinolones, moxifloxacin has been shown to cause lesions in cartilage of the weight bearing joints of immature animals. Pre-clinical data indicate that moxifloxacin passes into milk. The use of Avelox in pregnancy and nursing mothers is contra-indicated (see Contraindications).
Adverse Reactions
Adverse drug reactions (ADRs) based on all clinical studies with moxifloxacin 400 mg (oral and sequential therapy) sorted by CIOMS III categories of frequency (overall n=17,951, including n=4,583 from sequential therapy studies; status: May 2010) are listed as follows: ADRs listed under "common" were observed with a frequency below 3% with the exception of nausea and diarrhea.
ADRs derived from post marketing reports (status: May 2010) are printed in bold italic.
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). (See Table 4.)


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The following undesirable effects have a higher frequency in the subgroup of IV/oral sequentially treated patients: Common: Increased gamma-glutamyl-transferase.
Uncommon: Ventricular tachyarrythmias, Hypotension, Edema, Antibiotic associated colitis (in very rare cases associated with life threatening complications), Seizures of various clinical manifestations (incl. grand mal convulsions), Hallucination, Renal impairment (which in some cases due to dehydration can lead to renal failure esp. in elderly with pre-existing renal disorders).
Drug Interactions
An interval of about 6 hours should be left between administration of agents containing bivalent or trivalent cations (e.g. antacids containing magnesium or aluminium, didanosine, sucralfate and agents containing iron or zinc) and administration of Avelox.
After repeated dosing in healthy volunteers moxifloxacin increased Cmax of digoxin approximately 30% without affecting AUC or trough levels.
In studies conducted in diabetic volunteers, concomitant administration of Avelox with glibenclamide resulted in a decrease of approximately 21% in the peak plasma concentrations of glibenclamide.
Concomitant use of drugs that induce bradycardia or hypokalaemia or drugs which induce QT prolongation (neuroleptic, certain anti-infective agents [some antimalarials, azole antimycotics, macrolides], certain antihistaminics [terfenadine, astemizole), cisapride) should be considered carefully (see Precautions). Antiarrythmic drugs class IA and III, are contra indicated (see Contraindications).
No interactions have been occurred following concomitant administration of moxifloxacin with: Warfarin, ranitidine, probenecid, oral contraceptives or theophylline.
In vitro studies with human P-450 enzymes support this data. Considering these results a metabolic interaction via P-450 enzymes is unlikely.
Note: The theophylline interaction study was conducted using a moxifloxacin dosage of 2 x 200 mg.
Changes in INR (International Normalized Ratio): Cases of increased anticoagulant activity have been reported in patients receiving anticoagulants concurrently with antibiotics, including Avelox.
FC tab: Concomitant ingestion of Avelox 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.
Avelox should not used concurrently with other drugs that prolong the QT interval: antiarrhythmic class IA (e.g. quinidine, hydroquinidine, disopyramide) or antiarrhytmics class III (e.g. amiodarone, sotalol, dofetilide, ibutilide), neuroleptics (e.g. phenothiazines, pimozide, sertindole, haloperidol, sultopride), tricyclic antidepressant agents, certain antimicrobials (sparfloxacin, erythromycin IV, bepridil, diphemanil). This effect might lead to an increased risk of ventricular arrhythmias, notably torsades de pointes. Therefore moxifloxacin is contraindicated in patients treated with these drugs.
Concomitant dosing of charcoal and 400 mg oral Avelox reduced the systemic availability of the drug by more than 80% by preventing absorption in vivo. The application of activated charcoal in the early absorption phase prevents further increase of systemic exposure in cases of overdose.
After intravenous drug administration carbo medicinalis only slightly reduces systemic exposure (approx. 20%).
Interaction with food: Moxifloxacin has no clinically relevant interaction with food including dairy products.
Caution For Usage
Infusion: Instruction for use/handling: At temperature below 15°C precipitation may occur, which will re-dissolve at room temperature (15°C-25°C). It is therefore recommended not to store the infusion solution in a refrigerator.
The product should be inspected visually for particles prior to administration. Only clear solution free from particles should be used.
Incompatibilities: The following coinfusions were found to be incompatible with Avelox solution for infusion: Sodium Chloride 10%; Sodium Chloride 20%; Sodium Hydrogen Carbonate 4.2%; Sodium Hydrogen Carbonate 8.4%.
Storage
FC tab: Store below 30°C. Store in the original package in order to protect from moisture.
Infusion: Do not store below 15°C.
Store in the original container.
Shelf life:
5 years.
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 x 5's. Infusion 400 mg/250 mL x 1's.
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