Avelox

Avelox

moxifloxacin

Manufacturer:

Bayer

Distributor:

Zuellig
Full Prescribing Info
Contents
Moxifloxacin HCl.
Description
Each tablet contains moxifloxacin HCl 436.8 mg equivalent to moxifloxacin 400 mg. It also contains croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, hypromellose, macrogol 4000, titanium dioxide (E171) and ferric oxide (E172) as inactive constituents.
Each 250 mL solution for infusion contain moxifloxacin HCl 436.8 mg equivalent to moxifloxacin 400 mg. It also contains sodium chloride, 1N hydrochloric acid, 2N sodium hydroxide and water for injection. The solution for infusion (250 mL) contains sodium 34 mmol.
Action
Microbiology: Moxifloxacin is a fluoroquinolone antibacterial 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, Chlamydia and Legionella spp.
Moxifloxacin is effective against β-lactam- and macrolide-resistant bacteria. Studies in animal models of infection have demonstrated the high in vitro activity.
Moxifloxacin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections.
Gram-Positive Microorganisms: Staphylococcus aureus (including methicillin-sensitive strains); Streptococcus pneumoniae (including penicillin- and macrolide-resistant strains); Streptococcus pyogenes (group A).
Gram-Negative Microorganisms: Haemophilus influenzae (including β-lactamase-negative and -positive strains); Haemophilus parainfluenzae; Klebsiella pneumoniae; Moraxella catarrhalis (including β-lactamase-negative and -positive strains; Escherichia coli; Enterobacter cloacae.
Atypicals: Chlamydia pneumoniae; Mycoplasma pneumoniae.
According to in vitro studies, the following organisms are sensitive to moxifloxacin, however, the safety and effectiveness of moxifloxacin in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials.
Gram-Positive Microorganisms: Streptococcus milleri, Streptococcus mitior, Streptococcus agalactiae, Streptococcus dysgalactiae, Staphylococcus cohnii, Staphylococcus epidermidis (including methicillin-sensitive strains), Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus saprophyticus, Staphylococcus simulans, Corynebacterium diphtheriae.
Gram-Negative Microorganisms: Bordetella pertussis, Klebsiella oxytoca, Enterobacter aerogenes, Enterobacter agglomerens, Enterobacter intermedius, Enterobacter sakazaki, Proteus mirabilis, Proteus vulgaris, Morganella morganii, Providencia rettgeri, Providencia stuartii.
Anaerobes: Bacteroides distasonis, Bacteroides eggerthii, Bacteroides fragilis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides uniformis, Fusobacterium and Porphyromonas spp, Porphyromonas anaerobius, Porphyromonas asaccharolyticus, Porphyromonas magnus, Prevotella and Propionibacterium spp, Clostridium perfringens, Clostridium ramosum.
Atypicals: Legionella pneumophila, Caxiella burnetii.
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.
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. A very low overall frequency of resistance was demonstrated (10-7 to 10-10). In vitro studies have demonstrated that resistance to moxifloxacin develops slowly by multiple-step mutations.
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.
Indications/Uses
Tablet: 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 multidrug resistant strains*, acute sinusitis, uncomplicated skin and skin structure infections, uncomplicated pelvic inflammatory disease (ie, infections of female upper genital tract, including salpingitis and endometritis), complicated skin and skin structure infections (including diabetic foot infections), complicated intraabdominal infections including polymicrobial infections eg, abscesses.
Infusion: Treatment of the following bacterial infections caused by susceptible strains: Community acquired pneumonia (CAP) including CAP caused by multidrug resistant strains*, complicated skin and skin structure infections (including diabetic foot infections), complicated intraabdominal infections including polymicrobial infections eg, abscesses.
Dosage/Direction for Use
Adults: The recommended dose of moxifloxacin for the previously mentioned indications is 400 mg once daily (1 film-coated tablet resp. 250 mL solution for infusion) 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 upper and lower respiratory tract infections are made:
Tablet: Bronchitis: Acute Exacerbation of Chronic Bronchitis: 5 days.
Pneumonia: Community-Acquired Pneumonia: 10 days.
Sinusitis: Acute Sinusitis: 7 days.
Uncomplicated Skin and Skin Structure Infections: 7 days.
Uncomplicated Pelvic Inflammatory Disease: 14 days.
Complicated Skin and Skin Structure Infections: Total treatment duration for sequential therapy (IV followed by oral therapy): 7-21 days.
Complicated Intra-abdominal Infections: Total treatment duration for sequential therapy (IV followed by oral therapy): 5-14 days.
The film-coated tablet should be swallowed whole with sufficient liquid and may be taken independent of meals.
Infusion: Therapy may be initial IV administration followed by oral administration of film-coated tablets when clinically indicated.
Pneumonia: Community-Acquired Pneumonia: Recommended total treatment duration for sequential administration (IV followed by oral therapy): 7-14 days.
Complicated Skin and Skin Structure Infections: Total treatment duration for sequential therapy (IV followed by oral therapy): 7-21 days.
Complicated Intra-abdominal Infections: Total treatment duration for sequential therapy (IV followed by oral therapy): 5-14 days.
The recommended duration of treatment for the indication being treated should not be exceeded.
Moxifloxacin 400 mg film-coated tablets and solution for infusion have been studied in clinical trials for up to 21 days (in complicated skin and skin structure infections).
Children: Efficacy and safety of moxifloxacin in children and adolescents have not been established.
Elderly: No dosage adjustment is required in the elderly.
Hepatic Impairment: No dosage adjustment is required in patients with impaired liver function.
Renal Impairment: No dose adjustment is required in patients with renal impairment (including creatinine clearance ≤30 mL/min/1.73 m2) and in patients on chronic dialysis ie, hemodialysis and continuous ambulatory peritoneal dialysis.
Inter-Ethnic Differences: No dosage adjustment is required in ethnic groups.
Administration: The solution for infusion should be infused IV over 60 min.
A statement "Infuse over a period of 60 min" should be given on the primary packaging material of the infusion solution.
The solution for infusion can be administered directly or via a T-tube together with compatible infusion solutions.
The following co-infusions were found to form stable mixtures over a period of 24 hrs at room temperature with moxifloxacin solution for infusion, and can therefore be considered as compatible with moxifloxacin solution for infusion: Water for injections, sodium chloride 0.9%, sodium chloride 1M, xylitol 20%, Ringer's solution, lactated Ringer's solution, glucose 5%, 10% and 40%.
If moxifloxacin solution for infusion is to be given with another drug, each drug should be given separately. Only clear solutions are to be used.
Overdosage
Only limited data on overdose are available. Single doses of up to 800 mg and multiple doses of 600 mg 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 should be instituted as dictated by the patient's clinical status.
Contraindications
Known hypersensitivity to moxifloxacin or other quinolones or any of the excipients of Avelox.
Pregnancy and lactation. Patients <18 years.
Use in pregnancy & lactation: Avelox is contraindicated in pregnant women.
As with other quinolones, moxifloxacin 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 in pregnancy and nursing mothers is contraindicated.
Special Precautions
In some instances, the hypersensitivity and allergic reactions already occurred after the 1st administration and the doctor should be informed immediately.
Seizures may occur with quinolone therapy. Moxifloxacin should be used with caution in patients with known or suspected CNS disorders which may predispose to seizures or lower the seizure threshold.
As no pharmacokinetic/pharmacodynamic data are available in severe hepatic impairment (Child-Pugh C), moxifloxacin should be used with caution in this patient group.
Moxifloxacin, as with some other quinolones and macrolides, has been shown to prolong the QTc interval. Treatment with moxifloxacin should be avoided due to the lack of clinical experience with the drug in these patients populations: Patients with known prolongation of the QT interval, uncorrected hypokalemia and those receiving class IA (eg, quinidine, procainamide) or class III (eg, amiodarone, sotalol) antiarrhythmic agents.
Moxifloxacin should be used with caution as an additive effect of moxifloxacin on the QT interval cannot be excluded for the following conditions: In patients treated concomitantly with drugs that prolong the QT interval eg, cisapride, erythromycin, antipsychotics and tricyclic antidepressants; patients with ongoing proarrhythmic conditions, eg clinically significant bradycardia, acute myocardial ischemia; patients with liver cirrhosis as preexisting QT prolongation in these patients cannot be excluded; 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 moxifloxacin. 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 eg, 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.
Tendon inflammation and rupture may occur with quinolone therapy, particularly in elderly patients and in those treated concurrently with corticosteroids. At the first sign of pain or inflammation, patients should discontinue treatment and rest the affected limb(s).
Antibiotic-associated colitis has been reported with the use of broad spectrum antibiotics including moxifloxacin; therefore, it is important to consider this diagnosis in patients who develop serious diarrhea in association with the use of moxifloxacin. In this clinical situation adequate therapeutic measures should be initiated immediately. Drugs inhibiting peristalsis are contraindicated in patients who develop serious diarrhea. Moxifloxacin should be used with caution in patients with myasthenia gravis because the symptoms can be exacerbated.
For patients with complicated pelvic inflammatory disease (eg, associated with a tubo-ovarian or pelvic abscess), for whom an IV treatment is considered necessary, treatment with moxifloxacin 400 mg film-coated tablets is not recommended.
In patients for whom sodium intake is of medical concern (patients with congestive heart failure, renal failure, nephrotic syndrome) the additional sodium load of the solution for infusion should be taken into account. For sodium chloride content of the solution for infusion see Description.
Use In Pregnancy & Lactation
Use in pregnancy & lactation: Avelox is contraindicated in pregnant women.
As with other quinolones, moxifloxacin 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 in pregnancy and nursing mothers is contraindicated.
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=12,984, including n=2535 for sequential therapy studies; status: December 2005) are listed in the table:
ADRs listed under "common" were observed with a frequency below 3% with the exception of nausea and diarrhea. (See table)

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

The following undesirable effects have a higher frequency in the subgroup of IV/oral sequentially treated patients: Common: Increased γ-glutamyl-transferase. Uncommon: Ventricular tachyarrhythmias, hypotension, edema, antibiotic-associated colitis (in very rare cases associated with life-threatening complications), seizures of various clinical manifestations (including grand mal convulsions), hallucinations, renal impairment and renal failure (due to dehydration especially in elderly with preexisting renal disorders).
Drug Interactions
For the following substances, absence of a clinically relevant interaction with moxifloxacin was proven: Atenolol, ranitidine, calcium supplements, theophylline, oral contraceptives, glibenclamide, itraconazole, digoxin, morphine, probenecid. No dose adjustment is necessary for these drugs.
Food and Dairy Products: Absorption of moxifloxacin was not altered by food intake. Therefore, moxifloxacin can be taken independent from food intake.
Antacids, Minerals and Multivitamins: Concomitant ingestion of moxifloxacin together with antacids, minerals and multivitamins may result in impaired absorption of the drug due to formation of chelate complexes with the multivalent cations contained in these preparations. This may lead to plasma concentrations considerably lower than desired. Hence, antacids, antiretroviral drugs and other preparations containing magnesium, aluminum and other minerals eg, iron, should be administered at least 4 hrs before or 2 hrs after ingestion of an oral moxifloxacin dose.
Warfarin: No interaction during concomitant treatment with warfarin on prothrombin time and other coagulation parameters has been observed.
Changes in International Normalized Ratio (INR): Cases of increased anticoagulant activity have been reported in patients receiving anticoagulants concurrently with antibiotics, including moxifloxacin. The infectious disease (and its accompanying inflammatory process), age and general status of the patient are risk factors. Although an interaction between moxifloxacin 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).
Charcoal: Concomitant dosing of charcoal and moxifloxacin 400 mg orally reduced the systemic availability of the drug by >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 IV drug administration, carbo medicinalis only slightly reduces systemic exposure (approximately 20%).
Storage
Tablet: Store at temperatures not exceeding 25°C.
Infusion: Store at temperatures between 15-30°C.
Avelox tablets should be stored 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 x 20's. Infusion 400 mg/250 mL (bag) x 1's.
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