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Indications/Uses
Moxifloxacin (Avelox) 400 mg film-coated tablets are indicated for the treatment of the following bacterial infections caused by susceptible strains: Respiratory tract infections: Acute exacerbations of chronic bronchitis, Community acquired pneumonia (CAP) including CAP caused by multi-drug resistant strains*, Acute sinusitis.
Uncomplicated skin and skin structure infections.
Uncomplicated pelvic inflammatory disease (i.e. infections of female upper genital tract, including salpingitis and endometritis).
Complicated skin and skin structure infections (incl. diabetic foot infections).
Complicated intraabdominal infections including polymicrobial infections such as abscesses.
Moxifloxacin (Avelox) 400 mg solution for infusion is indicated for the treatment of the following bacterial infection caused by susceptible strains: Community acquired pneumonia (CAP) including CAP caused by multi-drug resistant strains*.
Complicated skin and skin structure infections (incl. diabetic foot infections).
Complicated intraabdominal infections including polymicrobial infections such as abscesses.
*) Multi-drug resistant Streptococcus pneumoniae (MDRSP) includes isolates known as PRSP (Penicillin-resistant S. pneumoniae), and strains resistant to two or more of the following antibiotics: penicillin (MIC ≥ 2 μg/mL), 2nd generation cephalosporins (e.g., cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Uncomplicated skin and skin structure infections.
Uncomplicated pelvic inflammatory disease (i.e. infections of female upper genital tract, including salpingitis and endometritis).
Complicated skin and skin structure infections (incl. diabetic foot infections).
Complicated intraabdominal infections including polymicrobial infections such as abscesses.
Moxifloxacin (Avelox) 400 mg solution for infusion is indicated for the treatment of the following bacterial infection caused by susceptible strains: Community acquired pneumonia (CAP) including CAP caused by multi-drug resistant strains*.
Complicated skin and skin structure infections (incl. diabetic foot infections).
Complicated intraabdominal infections including polymicrobial infections such as abscesses.
*) Multi-drug resistant Streptococcus pneumoniae (MDRSP) includes isolates known as PRSP (Penicillin-resistant S. pneumoniae), and strains resistant to two or more of the following antibiotics: penicillin (MIC ≥ 2 μg/mL), 2nd generation cephalosporins (e.g., cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Dosage/Direction for Use
Method of administration: Film-coated tablet: The film-coated tablet should be swallowed whole with sufficient liquid and may be taken independent of meals.
Solution for infusion: The solution for infusion should be infused intravenously over 60 minutes.
The solution for infusion can be administered directly or via a T-tube together with compatible infusion solutions.
The following confusions were found to form stable mixtures over a period of 24 hours at room temperature with Moxifloxacin (Avelox) solution for infusion, and can therefore be considered as compatible with Moxifloxacin (Avelox) solution for infusion: Water for Injections, Sodium Chloride 0.9%, Sodium Chloride 1 molar, Glucose 5%, Glucose 10%, Glucose 40%, Xylitol 20%, Ringer's Solution, Lactated Ringer's Solution.
If Moxifloxacin (Avelox) solution for infusion 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.
Dosage regimen: Dose (adults): The recommended dose for Moxifloxacin (Avelox) is 400 mg once daily (1 film-coated tablet and 250 mL solution for infusion, respectively) for the previously mentioned indications and should not be exceeded.
Duration of treatment: The duration of treatment should be determined by the severity of the indication or clinical response. The following general recommendations for the treatment of infections.
Solution for infusion: The solution for infusion should be infused intravenously over 60 minutes.
The solution for infusion can be administered directly or via a T-tube together with compatible infusion solutions.
The following confusions were found to form stable mixtures over a period of 24 hours at room temperature with Moxifloxacin (Avelox) solution for infusion, and can therefore be considered as compatible with Moxifloxacin (Avelox) solution for infusion: Water for Injections, Sodium Chloride 0.9%, Sodium Chloride 1 molar, Glucose 5%, Glucose 10%, Glucose 40%, Xylitol 20%, Ringer's Solution, Lactated Ringer's Solution.
If Moxifloxacin (Avelox) solution for infusion 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.
Dosage regimen: Dose (adults): The recommended dose for Moxifloxacin (Avelox) is 400 mg once daily (1 film-coated tablet and 250 mL solution for infusion, respectively) for the previously mentioned indications and should not be exceeded.
Duration of treatment: The duration of treatment should be determined by the severity of the indication or clinical response. The following general recommendations for the treatment of infections.
The recommended duration of treatment for the indication being treated should not be exceeded.
Moxifloxacin (Avelox) 400 mg film-coated tablets and Moxifloxacin (Avelox) 400 mg solution for infusion have been studied in clinical trials for up to 21 days (in complicated skin and skin structure infections).
Missed Dose: Film-coated tablet: If a dose is missed, it should be taken as soon as the patient remembers on the same day. Double doses should not be taken to compensate for a missed dose.
Additional information on special populations: Pediatric patients: The efficacy of Moxifloxacin (Avelox) in children and adolescents has not been established. Currently available data are described in Adverse Reactions, Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions. No recommendation on posology can be made.
The safety of Moxifloxacin (Avelox) in children below the age of 6 years has not been established. Currently available data are described in Adverse Reactions, Pharmacology: Pharmacodynamics, Pharmacokinetics and Toxicology: Preclinical safety data under Actions.
Moxifloxacin (Avelox) 400 mg film-coated tablets and Moxifloxacin (Avelox) 400 mg solution for infusion have been studied in clinical trials for up to 21 days (in complicated skin and skin structure infections).
Missed Dose: Film-coated tablet: If a dose is missed, it should be taken as soon as the patient remembers on the same day. Double doses should not be taken to compensate for a missed dose.
Additional information on special populations: Pediatric patients: The efficacy of Moxifloxacin (Avelox) in children and adolescents has not been established. Currently available data are described in Adverse Reactions, Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions. No recommendation on posology can be made.
The safety of Moxifloxacin (Avelox) in children below the age of 6 years has not been established. Currently available data are described in Adverse Reactions, Pharmacology: Pharmacodynamics, Pharmacokinetics and Toxicology: Preclinical safety data under Actions.
Overdosage
Only limited data on overdose are available. Single doses of up to 1200 mg and multiple doses of 600 mg moxifloxacin over 10 days were administered to healthy subjects without any significant undesirable effects. In the event of overdosage it is recommended that appropriate supportive care including ECG measurements should be instituted as dictated by the patient's clinical status.
The use of charcoal early after oral administration may be useful to prevent excessive increase of systemic exposure to moxifloxacin in cases of overdosage.
The use of charcoal early after oral administration may be useful to prevent excessive increase of systemic exposure to moxifloxacin in cases of overdosage.
Administration
May be taken with or without food: Swallow tab whole w/ sufficient liqd.
Contraindications
Known hypersensitivity to moxifloxacin or other fluoroquinolones or any of the excipients.
Pregnancy and lactation.
Pregnancy and lactation.
Special Precautions
Discontinue treatment in cases of anaphylactic reactions. Avoid treatment in patients w/ known prolongation of the QT interval & uncorrected hypokalemia; receiving class IA (eg, quinidine, procainamide) or class III (eg, amiodarone, sotalol) antiarrhythmic agents. Patients treated concomitantly w/ drugs that prolong the QT interval eg, cisapride, erythromycin, antipsychotics & TCAs; w/ ongoing proarrhythmic conditions eg, clinically significant bradycardia, acute myocardial ischemia, & liver cirrhosis; in women & elderly who are more susceptible to QTc-prolonging drugs. Fulminant hepatitis, symptoms related to liver failure. Patients w/ known or suspected CNS disorders (eg, lowered convulsion threshold, previous history of convulsion, reduced cerebral blood flow, altered brain structure or stroke), which may predispose to seizures or lower seizure threshold. Antibiotic-associated colitis; patients who develop serious diarrhoea in association w/ use. Myasthenia gravis. Tendinitis & tendon rupture in elderly, during strenuous physical activity, in patients treated concomitantly w/ corticosteroids, in patients w/ renal impairment including renal failure & patients w/ solid organ transplants. Not recommended for the treatment of MRSA infections. May interfere w/ Mycobacterium spp culture test. Peripheral neuropathy. Discontinue use if the patient develops psychiatric reactions. Psychotic patients or patients w/ history of psychiatric disease. Avoid in patients w/ pelvic inflammatory disease, unless fluoroquinolone-resistant N. gonorrhoeae can be excluded. Dysglycemia in elderly diabetic patients receiving concomitant treatment w/ oral hypoglycemic agent (eg, sulfonylurea) or w/ insulin. Careful monitoring of blood glucose in diabetic patients. Aortic aneurysm & dissection particularly in older population. May result in impairment of ability to drive or operate machinery due to CNS reactions & vision disorders. Adolescent & childn. Tab: Not recommended in patients w/ complicated pelvic inflammatory disease (eg, associated w/ tubo-ovarian or pelvic abscess). Soln for infusion: Na intake in patients w/ CHF, renal failure, nephrotic syndrome.
Use In Pregnancy & Lactation
Pregnancy: The safe use of Moxifloxacin (Avelox) in human pregnancy has not been established. Reversible joint injuries are described in children receiving some fluoroquinolones, however this effect has not been reported as occurring on exposed fetuses. Animal studies have shown reproductive toxicity. The potential risk for humans is unknown.
Consequently, the use of Moxifloxacin (Avelox) during pregnancy is contraindicated.
Lactation: As with other fluoroquinolones, Moxifloxacin (Avelox) has been shown to cause lesions in the cartilage of the weight bearing joints of immature animals. Preclinical evidence indicates that small amounts of moxifloxacin may be secreted in human milk. There is no data available in lactating or nursing women. Therefore, the use of Moxifloxacin (Avelox) in nursing mothers is contraindicated.
Consequently, the use of Moxifloxacin (Avelox) during pregnancy is contraindicated.
Lactation: As with other fluoroquinolones, Moxifloxacin (Avelox) has been shown to cause lesions in the cartilage of the weight bearing joints of immature animals. Preclinical evidence indicates that small amounts of moxifloxacin may be secreted in human milk. There is no data available in lactating or nursing women. Therefore, the use of Moxifloxacin (Avelox) in nursing mothers is contraindicated.
Adverse Reactions
Tabulated list of adverse reactions: Adverse drug reactions (ADRs) based on all clinical studies with moxifloxacin 400 mg (oral and sequential [IV/oral]/intravenous only administration) sorted by CIOMS III categories of frequency (overall n = 17,951, including n = 4,583 from sequential/intravenous 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).
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).
Drug Interactions
Antacids, minerals and multi-vitamins: Concomitant ingestion of Moxifloxacin (Avelox) together with antacids, minerals and multi-vitamins may result in impaired absorption of moxifloxacin after oral administration 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, antacids, anti-retroviral drugs (e.g. didanosine), and other preparations containing magnesium or aluminum, sucralfate and agents containing iron or zinc should be administered at least 4 hours before or 2 hours after ingestion of an oral moxifloxacin dose.
Warfarin: No interaction during concomitant treatment with warfarin on pharmacokinetics, prothrombin time and other coagulation parameters has been observed.
Changes in INR (International Normalized Ratio): Cases of increased anticoagulant activity have been reported in patients receiving anticoagulants concurrently with antibiotics, including Moxifloxacin (Avelox). The infectious disease (and its accompanying inflammatory process), age and general status of the patient are risk factors. Although an interaction between Moxifloxacin (Avelox) and warfarin was not demonstrated in clinical trials, INR monitoring should be performed and, if necessary, the oral anticoagulant dosage should be adjusted as appropriate.
Digoxin: The pharmacokinetics of digoxin are not significantly influenced by moxifloxacin and vice versa. After repeated dosing in healthy volunteers moxifloxacin increased Cmax of digoxin by approximately 30 % at steady state without affecting AUC or trough levels.
Charcoal: Concomitant dosing of charcoal and 400 mg oral Moxifloxacin (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%).
Food and dairy products: Absorption of moxifloxacin was not altered by food intake (including dairy products). Moxifloxacin (Avelox) can be taken independent from food intake.
Warfarin: No interaction during concomitant treatment with warfarin on pharmacokinetics, prothrombin time and other coagulation parameters has been observed.
Changes in INR (International Normalized Ratio): Cases of increased anticoagulant activity have been reported in patients receiving anticoagulants concurrently with antibiotics, including Moxifloxacin (Avelox). The infectious disease (and its accompanying inflammatory process), age and general status of the patient are risk factors. Although an interaction between Moxifloxacin (Avelox) and warfarin was not demonstrated in clinical trials, INR monitoring should be performed and, if necessary, the oral anticoagulant dosage should be adjusted as appropriate.
Digoxin: The pharmacokinetics of digoxin are not significantly influenced by moxifloxacin and vice versa. After repeated dosing in healthy volunteers moxifloxacin increased Cmax of digoxin by approximately 30 % at steady state without affecting AUC or trough levels.
Charcoal: Concomitant dosing of charcoal and 400 mg oral Moxifloxacin (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%).
Food and dairy products: Absorption of moxifloxacin was not altered by food intake (including dairy products). Moxifloxacin (Avelox) can be taken independent from food intake.
Caution For Usage
Incompatibilities: Film-coated tablets: Not applicable.
Solution for infusion: The following coinfusions were found to be incompatible with Moxifloxacin (Avelox) solution for infusion: Sodium Chloride 10%, Sodium Chloride 20%, Sodium Hydrogen Carbonate 4.2%, Sodium Hydrogen Carbonate 8.4%.
Instructions for use/handling: Film-coated tablet: Store in the original package in order to protect from moisture.
Solution for infusion: At temperatures 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.
Solution for infusion: The following coinfusions were found to be incompatible with Moxifloxacin (Avelox) solution for infusion: Sodium Chloride 10%, Sodium Chloride 20%, Sodium Hydrogen Carbonate 4.2%, Sodium Hydrogen Carbonate 8.4%.
Instructions for use/handling: Film-coated tablet: Store in the original package in order to protect from moisture.
Solution for infusion: At temperatures 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.
Storage
Film-coated tablet: Store at temperatures not exceeding 25°C.
Solution for infusion: Store at temperatures between 15°C - 30°C.
Store in the original container.
Solution for infusion: Store at temperatures between 15°C - 30°C.
Store in the original container.
Action
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 e.g. Chlamydia spp., Mycoplasma spp. and Legionella spp.
The bactericidal action results from the interference with topoisomerase II and IV. Topoisomerases are essential enzymes which control DNA topology and assist in DNA replication, repair and transcription.
Moxifloxacin exhibits concentration dependent bactericidal killing. Minimum bactericidal concentrations are generally similar to minimum inhibitory concentrations.
Moxifloxacin is effective against β-lactam and macrolide resistant bacteria. Studies in animal models of infection have demonstrated high in vivo activity.
Resistance: Resistance mechanisms which 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 fluoroquinolones has been observed. However, some gram-positive and anaerobic organisms resistant to other fluoroquinolones 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.
The bactericidal action results from the interference with topoisomerase II and IV. Topoisomerases are essential enzymes which control DNA topology and assist in DNA replication, repair and transcription.
Moxifloxacin exhibits concentration dependent bactericidal killing. Minimum bactericidal concentrations are generally similar to minimum inhibitory concentrations.
Moxifloxacin is effective against β-lactam and macrolide resistant bacteria. Studies in animal models of infection have demonstrated high in vivo activity.
Resistance: Resistance mechanisms which 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 fluoroquinolones has been observed. However, some gram-positive and anaerobic organisms resistant to other fluoroquinolones 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.
MedsGo Class
Quinolones
Features
Brand
Avelox
Full Details
Dosage Strength
400mg
Drug Ingredients
- Moxifloxacin
Drug Packaging
Film-Coated Tablet 1's
Generic Name
Moxifloxacin
Dosage Form
Film-Coated Tablet
Registration Number
DR-XY25608
Drug Classification
Prescription Drug (RX)
Product Questions
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