Floxsafe/Floxsafe IV

Floxsafe: Moxifloxacin hydrochloride.
Floxsafe IV: Moxifloxacin.

Floxsafe: Caplet shaped brick red colored smooth film coated tablets plain on both sides.
Each Film coated tablet contains Moxifloxacin Hydrochloride Ph. Eur. equivalent to Moxifloxacin 400 mg.
Excipients/Inactive Ingredients: Lactose monohydrate, Povidone, Lactose anhydrous, Croscarmellose sodium, Colloidal silicon Dioxide, Magnesium Stearate.
Coating: Hypromellose, Polyethylene Glycol, Titanium Dioxide & Iron oxide Red.
Floxsafe IV: A transparent, yellow aqueous solution contained in a non-PVC bag.
Each 1 mL contains: Moxifloxacin 1.60 mg.

Pharmacotherapeutic group: Quinolone antibacterials, fluoroquinolones.
Floxsafe: ATC code: J01MA14.
Pharmacology: Pharmacodynamics: Mechanism of action: Moxifloxacin has in vitro activity against a wide range of Gram-positive and Gram-negative pathogens.
The bactericidal action of moxifloxacin results from the inhibition of both type II topoisomerases (DNA gyrase and topoisomerase IV) required for bacterial DNA replication, transcription and repair. 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, associated with the norA or pmrA genes seen in certain Gram-positive bacteria.
Pharmacodynamic investigations have demonstrated that moxifloxacin exhibits a concentration dependent killing rate. Minimum bactericidal concentrations (MBC) were found to be in the range of the minimum inhibitory concentrations (MIC).
Effect on the intestinal flora in humans: The following changes in the intestinal flora were seen in volunteers following oral administration of moxifloxacin: Escherichia coli, Bacillus spp., Enterococcus spp., and Klebsiella spp. were reduced, as were the anaerobes Bacteroides vulgatus, Bifidobacterium spp., Eubacterium spp., and Peptostreptococcus spp.. For Bacteroides fragilis there was an increase. These changes returned to normal within two weeks.
Mechanism of resistance: Resistance mechanisms that inactivate penicillins, cephalosporins, aminoglycosides, macrolides and tetracyclines do not interfere with the antibacterial activity of moxifloxacin. Other resistance mechanisms such as permeation barriers (common in Pseudomonas aeruginosa) and efflux mechanisms may also effect susceptibility to moxifloxacin.
In vitro resistance to moxifloxacin is acquired through a stepwise process by target site mutations in both type II topoisomerases, DNA gyrase and topoisomerase IV. Moxifloxacin is a poor substrate for active efflux mechanisms in Gram-positive organisms.
Cross-resistance is observed with other fluoroquinolones. However, as moxifloxacin inhibits both topoisomerase II and IV with similar activity in some Gram-positive bacteria, such bacteria may be resistant to other quinolones, but susceptible to moxifloxacin.
Break points: EUCAST clinical MIC and disk diffusion breakpoints for moxifloxacin (01.01.2011): See Table 1.

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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 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 steadystate (400 mg once daily) were 3.2 and 0.6 mg/L, respectively. At steadystate 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 steadystate 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 2.

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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 sulphocompound (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) totaled to approximately 96%.
Concomitant administration of moxifloxacin with ranitidine or probenecid did not alter renal clearance of the parent drug.
Elderly and patients with low body weight: Higher plasma concentrations are observed in healthy volunteers with low body weight (such as women) and in elderly volunteers.
Renal impairment: 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.
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. Impaired liver function was associated with higher exposure to M1 in plasma, whereas exposure to parent drug was comparable to exposure in healthy volunteers. There is insufficient experience in the clinical use of moxifloxacin in patients with impaired liver function.
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 noncarcinogenic 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 50 fold the human dose (>300 mg/kg), leading to plasma concentrations of ≥200 mg/L (more than 40fold the therapeutic level), reversible, nonfatal 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.
Microbiology: Microbiological Susceptibility: The prevalence of acquired resistance may vary geographically and with time for selected species and local information of resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought where the local prevalence of resistance is such that utility of the agent in at least some types of infections is questionable. (See Table 3.)

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Floxsafe IV: Pharmacology: Pharmacodynamics: Mechanism of action: Moxifloxacin inhibits bacterial type II topoisomerases (DNA gyrase and topoisomerase IV) that are required for bacterial DNA replication, transcription and repair.
Mechanism of resistance: Resistance to fluoroquinolones can arise through mutations in DNA gyrase and topoisomerase IV. Other mechanisms may include over-expression of efflux pumps, impermeability, and protein-mediated protection of DNA gyrase. Cross resistance should be expected between moxifloxacin and other fluoroquinolones. The activity of moxifloxacin is not affected by mechanisms of resistance that are specific to antibacterial agents of other classes.
Pharmacokinetics: Absorption and Bioavailability: After a single 400 mg intravenous 1 hour infusion peak plasma concentrations of approximately 4.1 mg/L were observed at the end of the infusion corresponding to a mean increase of approximately 26% relative to those seen after oral administration (3.1 mg/L). The AUC value of approximately 39 mg·h/L after i.v. administration is only slightly higher than that observed after oral administration (35 mg·h/L) in accordance with the absolute bioavailability of approximately 91%. In patients, there is no need for age or gender related dose adjustment on intravenous moxifloxacin. Pharmacokinetics are linear in the range of 50-1200 mg single oral dose, up to 600 mg single intravenous dose and up to 600 mg once daily dosing over 10 days.
Distribution: Moxifloxacin is distributed to extravascular spaces rapidly. 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. Maximum concentrations of 5.4 mg/kg and 20.7 mg/L (geometric mean) were reached in bronchial mucosa and epithelial lining fluid, respectively, 2.2 h after an oral dose. The corresponding peak concentration in alveolar macrophages amounted to 56.7 mg/kg. In skin blister fluid concentrations of 1.75 mg/L were observed 10 h after intravenous administration. In the interstitial fluid unbound concentration time profiles similar to those in plasma were found with unbound peak concentrations of 1.0 mg/L (geometric mean) reached approximately 1.8 h after an intravenous dose.
Biotransformation: Moxifloxacin undergoes Phase II biotransformation and is excreted via renal (approximately 40%) and biliary/faecal (approximately 60%) 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. Following a 400 mg intravenous infusion recovery of unchanged drug from urine was approximately 22% and from faeces approximately 26%. Recovery of the dose (unchanged drug and metabolites) totaled to approximately 98% after intravenous administration of the drug. Renal clearance amounted to about 24-53 mL/min suggesting partial tubular reabsorption of the drug from the kidneys. Concomitant administration of moxifloxacin with ranitidine or probenecid did not alter renal clearance of the parent drug.

Floxsafe: Moxifloxacin 400 mg film-coated tablets are indicated for the treatment of the following bacterial infections in patients of 18 years and older caused by bacteria susceptible to moxifloxacin. Moxifloxacin should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections or when these have failed: Acute bacterial sinusitis (adequately diagnosed).
Acute exacerbations of chronic bronchitis (adequately diagnosed).
Community acquired pneumonia, except severe cases.
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.
Moxifloxacin 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 unless moxifloxacin-resistant Neisseria gonorrhoeae can be excluded.
Moxifloxacin 400 mg film-coated tablets may also be used to complete a course of therapy in patients who have shown improvement during initial treatment with intravenous moxifloxacin for the following indications: Community acquired pneumonia; Complicated skin and skin structure infections.
Moxifloxacin 400 mg film-coated tablets should not be used to initiate therapy for any type of skin and skin structure infection or in severe community acquired pneumonia.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Floxsafe IV: Susceptible strains.
Gram-positive microorganisms: Enterococcus faecalis (many strains only moderately susceptible), Staphylococcus aureus (including methicillin-susceptible isolates), Streptococcus milleri group (Streptococcus anginosus, Streptococcus constellatus), Streptococcus pneumonia (including Penicillin and Macrolide resistant isolates), Streptococcus pyogenes (A group), Streptococcus mitior, Streptococcus agalactiae, Streptococcus dysgalactiae, Staphylococcus cohnii, Staphylococcus epidermidis (including methicillin-susceptible isolates), Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus saprophyticus, Staphylococcus simulans.
Gram-negative microorganisms: Haemophilus influenzae (includuing β-lactamase negative and positive strains), Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis (including β-lactamase negative and positive strains), E. coli, Enterobacter cloacae, Bordetella pertussis, Klebsiella oxytoca, Enterobacteraerogenes, Enterobacter intermedius, Enterobacter sakazaki, Proteus mirabilis, Proteus vulgaris, Morganella morganii, Providencia rettgeri.
Heterologous: Chlamydia pneumoniae, Mycoplasma pneumoniae, Legionella pneumophila, Coxiella burnettii.
Anaerobes: Bacteroides distasonis, Bacteroides fragilis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides uniformis, Fusobacterium spp., Porphyromonas spp., Porphyromonas anaerobius, Porphyromonas asaccharolyticus, Porphyromonas magnus, Prevotella spp., Clostridium perfringens, Peptostreptococcus species.
Respiratory infections: Acute sinusitis, Acute Exacerbation of Chronic Bronchitis, Pneumonia.
Skin and Skin Structure Infections.
Complicated Intra-Abdominal Infections.

Floxsafe: Posology (adults): The recommended dose is one 400 mg film-coated tablet once daily.
Renal/hepatic impairment: No adjustment of dosage is required in patients with mild to severely impaired renal function or in patients on chronic dialysis i.e. haemodialysis and continuous ambulatory peritoneal dialysis.
There is insufficient data in patients with impaired liver function.
Other special populations: No adjustment of dosage is required in the elderly and in patients with low bodyweight.
Paediatric population: Moxifloxacin is contraindicated in children and adolescents (<18 years). Efficacy and safety of moxifloxacin in children and adolescents have not been established.
Method of administration: The film-coated tablet should be swallowed whole with sufficient liquid and may be taken independent of meals.
Duration of administration: Moxifloxacin 400 mg film-coated tablets should be used for the following treatment durations: Acute exacerbation of chronic bronchitis: 5-10 days.
Community acquired pneumonia: 10 days.
Acute bacterial sinusitis: 7 days.
Mild to moderate pelvic inflammatory disease: 14 days.
Moxifloxacin 400 mg film-coated tablets have been studied in clinical trials for up to 14 days treatment.
Sequential (intravenous followed by oral) therapy: In clinical studies with sequential therapy most patients switched from intravenous to oral therapy within 4 days (community-acquired pneumonia) or 6 days (complicated skin and skin structure infections). The recommended total duration of intravenous and oral treatment is 7-14 days for community-acquired pneumonia and 7-21 days for complicated skin and skin structure infections.
The recommended dose (400 mg once daily) and duration of therapy for the indication being treated should not be exceeded.
Floxsafe IV: For adult, the recommended dose is 400 mg moxifloxacin, infused into vein over 60 minutes once daily.
Renal impairment (Creatinine Clearance <30 mL/min/1.73 m²): No adjustment of dosage is required.
Duration: The duration of therapy depends the severity of infection or clinical response. The recommended durations are as follows.
Sequential therapy for Acute Bacterial Sinusitis (orally or as intravenous infusion): 7-14 days.
Sequential therapy for Acute Bacterial Exacerbation of Chronic Bronchitis (orally or as an intravenous infusion): 5 days.
Sequential therapy for Pneumonia (orally or as an intravenous infusion): 7-14 days.
Sequential therapy for Uncomplicated Skin and Skin Structure Infections (orally or as an intravenous infusion): 7 days.
Sequential therapy for Complicated Skin and Skin Structure Infections (orally or as an intravenous infusion): 7-21 days.
Sequential therapy for Complicated Intra-Abdominal Infections (orally or as an intravenous infusion): 5-14 days.

Floxsafe: 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.
Floxsafe IV: Single doses up to 1200 mg and multiple doses of 600 mg over 10 days were administered to healthy subjects without any significant undesirable effects.
In the event of overdose, symptomatic treatment should be implemented including electrocardiogram (ECG) monitoring. The administration of activated charcoal after oral overdose may reduces systemic moxifloxacin exposure (approximately 20%), therefore the use of charcoal may be useful restrictively.

Floxsafe: Hypersensitivity to moxifloxacin, other quinolones or to any of the excipients listed in Description.
Pregnancy and 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.
Due to limited clinical data, moxifloxacin is also contraindicated in patients with impaired liver function (Child Pugh C) and in patients with transaminases increase >5 fold ULN.
Floxsafe IV: Patients with a history of hypersensitivity to moxifloxacin, other quinolones or to any of the excipients.
Pediatric patients and adolescents less than 18 years of age (Safety and effectiveness in pediatric patients and adolescents have not been established.)
Pregnant, women of child bearing potential, and lactating women.
Patients with severe hepatic insufficiency (the clinical data are limited).
Patient with high aminotransferase level (more than 5 times of normal value).
Patients with a history of tendon disorder related to quinolones treatment.
QT interval prolongation patient.
Electrolyte imbalance patient (especially patients with untreated hypokalemia).
Patients with bradycardia, and with a history of symptomatic arrhythmias.
Clinically relevant heart failure with reduced left-ventricular ejection fraction.
Patients receiving Class IA (e.g. quinidine, procainamide) or Class III (e.g. amiodarone, sotalol) antiarrhythmic agents, antipsychotics, tricyclic antidepressants, certain antimicrobial antimicrobial agents (saquinavir, sparfloxacin, erythromycin, pentamidine, antimalarials particularly halofantrine), certain antihistaminics (terfenadine, astemizole, mizolastine), cisapride, vincamine I.V, bepridil and diphemanil (concomitant use with moxifloxacin may increase the effect on QT interval prolongation).

Floxsafe IV: Tendinitis and tendon ruptures of the shoulder, the hand, the Achilles tendon or other tendons that may require surgical repair or may cause prolonged disability have been reported in patients administered quinolones including this drug. In the post-marketing surveillance, this risk has been increased in older patients, in patients taking corticosteroids, and in patients with kidney, heart or lung transplants. Factors that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Moxifloxacin should be discontinued if the patient experiences pain, inflammation, or rupture of a tendon. Patients should be advised to rest and refrain from exercise until the diagnosis of tendonitis or tendon rupture has been excluded. Tendon rupture can occur during or after completion of therapy.
Quinolones have neuromuscular blocking activity and may exacerbate muscle weakness in persons with myasthenia gravis. Post-marketing serious adverse events, including deaths and requirement for ventilator support, have been associated with quinolone use in persons with myasthenia gravis. [See as follows.]
Cases of fulminant hepatitis potentially leading to hepatic failure (including fatal cases) have been reported with moxifloxacin. Patients should discontinue moxifloxacin treatment and contact their doctor if signs and syndromes of fulminant hepatic disease develop such as rapidly developing asthenia associated with jaundice, dark urine, bleeding tendency or hepatic encephalopathy.
This drug should be used with caution in the following patients: Patients with known or suspected CNS disorders or in the presence of other risk factors that may predispose to seizure or lower the seizure threshold. (Quinolones may cause seizures).
This drug should be used with caution in following patients because the magnitude of QT interval prolongation may increase.
Patients with ongoing proarrhythmic conditions, such as acute myocardial ischemia.
Patients with liver cirrhosis who cannot be excluded the existing QT prolongation.
Women and the elderly people who may be more susceptible to drug-associated QTc-prolongation.
Patients with myasthenia gravis (the symptoms can be exacerbated).
Patients with glucose-6-phosphate dehydrogenase deficiency (patients are prone to haemolytic reactions when treated with quinolones.)

Floxsafe: 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.
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. The magnitude of QT prolongation may increase with increasing concentrations of the drug. Therefore, the recommended dose should not be exceeded.
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 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. 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. 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 polyneuropathy resulting in paraesthesias, hypoaesthesias, dysaesthesias, or weakness have been reported in patients receiving quinolones including moxifloxacin. Patients under treatment with moxifloxacin should be advised to inform their doctor prior to continuing treatment if symptoms of neuropathy such as pain, burning, tingling, numbness, or weakness develop.
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. 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: Moxifloxacin should be used with caution in patients with myasthenia gravis because the symptoms can be exacerbated.
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.
Vision disorders: If vision becomes impaired or any effects on the eyes are experienced, an eye specialist should be consulted immediately.
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.
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 galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
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 Moxifloxacin 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.
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.
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, or acute and short lasting loss of consciousness. Patients should be advised to see how they react to moxifloxacin before driving or operating machinery.
Use in Children: Due to adverse effects on the cartilage in juvenile animals the use of moxifloxacin in children and adolescents <18 years is contraindicated.
Floxsafe IV: To prevent the development of drug-resistant bacteria, it is desirable that moxifloxacin is used for a therapeutically minimum period after the confirmation of susceptibility.
It has been shown that moxifloxacin has an effect of QT interval prolongation as like other quinolones or macrolides. Females generally have longer QTc interval than males, so females response more sensibly to the drugs to prolong QTc interval. Elderly patients also response more sensibly to the drugs to have effects on the QT interval. The magnitude of QT prolongation may be increased with an increased plasma concentration of moxifloxacin. Therefore, the recommended dose should not be exceeded and the duration of infusion should not be less than the recommended 60 minutes for the administration of 400 mg. QT prolongation may lead to an increased risk for ventricular arrhythmias, including Torsades de pointes. No excess in cardiovascular morbidity or mortality attributable to QTc prolongation occurred with moxifloxacin treatment in over 8,000 patients (oral and parenteral administration), but QTc prolongation may lead to an increased risk for ventricular arrhythmias.
Cases of bullous skin reactions like mucocutaneous ocular syndrome (Stevens-Johnson syndrome) or toxic epidermal necrolysis (Lyell syndrome) 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.
Hypersensitivity and allergic reactions have been sometimes reported after first administration and in these cases patients should be advised to contact their doctor immediately. Anaphylactoid reactions can progress to a life-threatening shock after the first administration very rarely. In these cases moxifloxacin should be discontinued and suitable treatment (e.g. treatment for shock) initiated.
The risk of developing quinolone-associated tendinitis and tendon rupture is further increased in elderly patients, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Cases occurring up to several months after completion of therapy have been reported.
Moxifloxacin should be discontinued and patients should be advised to put their affected limb(s) at rest if the patient experiences pain or inflammation.
Antibiotic-associated colitis has been reported in association with the use of broad spectrum antibacterial agents, including moxifloxacin. Therefore it is important to consider this diagnosis in patients who develop serious diarrhea during or after the use of moxifloxacin. In this case, adequate therapeutic measures should be initiated immediately. Drugs inhibiting peristalsis are contraindicated in patients who develop serious diarrhea.
Quinolones have been shown to cause photosensitivity reactions in patients. However, no photosensitivity reactions have been reported in the preclinical and clinical studies which have been designed to confirm the photosensitivity of moxifloxacin. And any post-approval evidences have not been reported that moxifloxacin causes photosensitivity reactions. Nevertheless patients should be advised to avoid exposure to either UV irradiation or extensive and/or strong sunlight during treatment with moxifloxacin.
In patients whose sodium intake is to be considered medically (congestive cardiac failure, renal impairment, nephritic syndrome etc), the infused amount of sodium chloride should be considered.
This drug contains 34 mmol sodium per 250 mL.
Cases of sensory or sensorimotor axonal polyneuropathy resulting in paraesthesias, dysaesthesias, hypoesthesias or weakness have been reported in patients receiving quinolones including moxifloxacin. Patients under treatment with moxifloxacin should be advised to inform their doctor prior to continuing treatment if symptoms of neuropathy such as pain, burning, tingling, numbness, numbness, or weakness develop.
Psychiatric reactions may occur even after the first administration of fluoroquinolones including moxifloxacin. In very rare cases depression or psychotic reactions have culminated in self-injurious behavior, such as suicidal ideation/thoughts or suicide attempts. In the event that the patient develops these reactions, moxifloxacin should be discontinued and appropriate measures instituted. Caution is recommended if moxifloxacin is to be used in psychotic patients or in patients with history of psychiatric disease.
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.
In vitro activity of moxifloxacin 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.
Quinolones including moxifloxacin may result in an impairment of the patient's ability to drive or operate machinery due to CNS reactions and transient loss of vision.
Others: Like other quinolones, main organs involving toxicity of this drug are hematopoietic system (decrease of myelomonocytes in dogs and monkeys), CNS (convulsion in monkeys) and liver (increase of liver enzyme and necrosis of mono cell in rats, dogs and monkeys). Generally, such changes have been observed with overdose or long term use.
Reproductive studies performed in rats, rabbits and monkeys indicate that placental transfer of moxifloxacin occurs. Studies in rats (oral and I.V) and monkeys (oral) did not show evidence of teratogenicity or impairment of fertility following administration of moxifloxacin. Vertebral and rib malformations were observed in rabbits that had been treated with an I.V dose of 20 mg/kg. There was an increase in the incidence of a miscarriage in monkeys and rabbits at human therapeutic concentrations. In rates, decreased fetal 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 that are 63 times the maximum recommended human dose based upon plasma concentrations (mg/kg).
Animal studies to determine the carcinogenic potential of moxifloxacin have not been performed.
As the results of genotoxicity tests, negative response was obtained with moxifloxacin in in vivo micronucleus test using rodent hematopoietic cells, however positive responses were obtained in in vitro reverse mutagenic test using bacterial strains and in in vitro chromosome aberration assay using cultured mammalian cells regardless of metabolic activation.
Use in the Elderly: In clinical studies, the adverse reactions and its rate reported in the elderly patients are similar to those in non-elderly people. However, it should be carefully administered considering the condition of patient because physiological function of the elderly people is generally decreased. Especially in the elderly patients less than 40 kg body weight, it is easy to occur adverse reactions by the high plasma/tissue concentrations; therefore caution should be taken as using the low doses (200 mg). And the elderly people may be more susceptible to drug-associated QT interval prolongation.

Floxsafe: Pregnancy: The safety of moxifloxacin in human pregnancy has not been evaluated. Animal studies have shown reproductive toxicity. The potential risk for humans is unknown. Due to the experimental risk of damage by fluoroquinolones to the weight-bearing cartilage of immature animals and reversible joint injuries described in children receiving some fluoroquinolones, moxifloxacin must not be used in pregnant women.
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.
Fertility: Animal studies do not indicate impairment of fertility.
Floxsafe IV: The safety of moxifloxacin in pregnancy has not been established, therefore, this drug must not be used in pregnant women (Reversible joint injuries have been reported in children who take some quinolone. However, these have not been observed in fetus exposed to moxifloxacin. Animal studies have shown reproductive toxicity and the potential risk for humans is unknown).
The damage to weight-bearing cartilage of immature animals has been caused by moxifloxacin like other quinolones. Quinolones has known to be excreted in human milk. In pre-clinical studies, small amount of moxifloxacin has been excreted in human milk. Therefore, this drug is not administered to nursing mothers.

Floxsafe: Adverse reactions based on all clinical trials with moxifloxacin 400 mg (oral and sequential therapy) sorted by frequencies are listed as follows: Apart from nausea and diarrhoea all adverse reactions were observed at frequencies below 3%. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Frequencies are defined as: common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) (see Tables 4a and 4b).

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Click on icon to see table/diagram/image

There have been very rare cases of the following side effects reported following treatment with other fluoroquinolones, which might possibly also occur during treatment with moxifloxacin: hypernatraemia, hypercalcaemia, haemolytic anaemia, rhabdomyolysis, photosensitivity reactions.
Floxsafe IV: Adverse reactions observed in clinical trials (total patients=17,951, sequential/I.V treatment study=4,583) with moxifloxacin 400 mg daily administered by the intravenous or oral route (intravenous only, sequential [I.V/oral] and oral administration) sorted by frequencies (according to the CIOMS III classification) are listed as follows: Apart from nausea and diarrhea all adverse reactions were observed at frequencies below 3%. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Frequencies are defined as: Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very rare (<1/10,000) (see Tables 5a and 5b.)

Click on icon to see table/diagram/image


Click on icon to see table/diagram/image

The following adverse reactions have a higher frequency category in the sub group of I.V treated patients with or without subsequent oral therapy: Common: Increased gamma-glutamyl-transferase. Uncommon: ventricular arrhythmia, hypotension, edema, antibiotic-associated colitis (in very rare cases associated with life-threatening complications), seizures with various clinical symptoms (including grand mal convulsions), hallucination, renal impairment, renal failure (by the dehydration in elderly patients with renal disorders).
Following changes may frequently occur regardless of moxifloxacin treatment: Hematocrit increased or decreased, White blood cell count increased, Red blood cell count increased or decreased, Blood glucose decreased, Hemoglobin decreased, ALP·AST·ALT increased, Blood urea increased, Creatinine increased, BUN increased. (It is unclear whether these symptoms occur by moxifloxacin treatment or in the course of therapy.)
Domestic Post-marketing surveillance: In domestic post-marketing surveillance including 1,343 patients for 6 years, adverse events have been reported in 6.48% (n:87/1,343) regardless of causality and 2,38% (n:32/1,343) have been investigated to have a causality with this drug. Nausea 0.67% (n:9) was most common of the reported adverse reactions, followed by headache 0.45% (n:6), diarrhea and fever 0.37% (n:5) respectively, vomiting and urticaria 0.30% (n:4), and pruritus and leukopenia 0.15% (n:2) respectively. Pneumonia, dyspepsia, chest pain, increased sweating, flare and edema at injection site have been reported in ≤0.1%.
As serious adverse reactions, pneumonia and exacerbation of pneumonia 0.67% (n:9) respectively, exacerbation of lung cancer 0.37% (n:5), respiratory failure 0.30% (n:4), dyspnea, respiratory distress syndrome and sepsis 0.22% (n:3) respectively, and bronchiectasis, asthma and exacerbation of tuberculosis 0.15% (n:2) respectively. GI bleeding, death, moniliasis, exacerbation of colorectal cancer, shock, exacerbation of heart failure, exacerbation of congestive heart failure, myocardial infarction, acidosis and tachycardia have been reported in ≤0.1%. Pneumonia (n:1) has been reported as drug adverse reaction, unable to exclude the causal relationship with this drug.
55 cases of unexpected adverse reactions have been reported in 47 patients (3.50%), including pneumonia 0.74% (n:10), exacerbation of pneumonia 0.67% (n:9), fever 0.52% (n:7), exacerbation of lung cancer 0.37% (n:5), respiratory distress syndrome 0.30% (n:4), infection and sepsis 0.22% (n:3), and bronchiectasis and exacerbation of tuberculosis 0.15% (n:2) respectively. Atelectasis, GI bleeding, death, exacerbation of colorectal cancer, exacerbation of heart failure, endocarditis, acidosis, and nephropyelitis have been reported in ≤0.1%. Fever 0.37% (n:5) and pneumonia 0.07% (n:1) have been investigated to be adverse reactions, unable to exclude the causal relationship with this drug.
The incidence rate of adverse events in the patients group with comorbidity has been statistically significantly higher than in the patients group without comorbidity.
The incidence rate of adverse events in the patients group without consecutive therapy after oral administration of antibiotics has been significantly higher than in the patients group with consecutive therapy after oral administration of antibiotics.

Floxsafe: 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, coadministration of moxifloxacin with any of the following medicinal products is contraindicated: 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.
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 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).
After repeated dosing in healthy volunteers, moxifloxacin increased C_max of digoxin by approximately 30% without affecting AUC or trough levels. No precaution is required for use with digoxin.
In studies conducted in diabetic volunteers, concomitant administration of oral moxifloxacin with glibenclamide resulted in a decrease of approximately 21% in the peak plasma concentrations of glibenclamide. The combination of glibenclamide and moxifloxacin could theoretically result in a mild and transient hyperglycaemia. However, the observed pharmacokinetic changes for glibenclamide did not result in changes of the pharmacodynamic parameters (blood glucose, insulin). Therefore no clinically relevant interaction was observed between moxifloxacin and glibenclamide.
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.
In vitro studies with human cytochrome P450 enzymes supported these findings. Considering these results a metabolic interaction via cytochrome P450 enzymes is unlikely.
Interaction with food: Moxifloxacin has no clinically relevant interaction with food including dairy products.
Floxsafe IV: Warfarin/Changes in INR (International Normalized Ratio): Antibacterial agents, including moxifloxacin, have been reported to enhance the anticoagulant effects of warfarin or its derivatives in the patients population. Infectious disease (accompanying inflammatory process), age and general status of the patient are risk factors. Although an interaction between moxifloxacin and warfain has not been demonstrated in clinical trials, INR should be monitored and, if necessary, the oral anticoagulant dosage should be adjusted as appropriate.
No interaction has occurred following concomitant oral administration of moxifloxacin with digoxin, ranitidine, glibenclamide (antidiabetics), morphine, probenecid, or oral contraceptives.
Theophylline: In accordance with in vitro data, moxifloxacin did not affect the pharmacokinetics of theophylline pharmacokinetics (and vice versa) and moxifloxacin does not interfere with the CYP1A2 isoenzyme.
Itraconazole: When moxifloxacin were administered concomitantly with itraconazole, the AUC of itraconazole was changed a little. Pharmacokinetics of moxifloxacin was not significantly altered by the administration of itraconazole. Therefore, no dose adjustment is necessary for itraconazole when given with moxifloxacin and vice versa.
Atenolol: The pharmacokinetics of atenolol is not significantly altered by moxifloxacin. AUC of atenolol was increased by approximately 4% and Cmax of atenolol was decreased by 10% following co-administration with a single dose of moxifloxacin to healthy volunteers.
Thiazide-diuretics, loop-diuretics, corticosteroids, ACTH, glycyrrhizin: These have an effect of potassium excretion, therefore, these can cause a hypokalemia. Ventricular tachyarrhythmias (including torsades de pointes) or QT prolongation may occur when moxifloxacin is administered to the patients with hypokalemia.
Nonsteroidal anti-inflammatory drugs of phenylacetic acid or propionic acid derivatives (ex. roxoprofen, etc.): The concomitant administration of a nonsteroidal anti-inflammatory drug with moxifloxacin may cause convulsions as inhibiting GABA receptor of CNS.

Floxsafe: Incompatibilities: Not applicable.
Floxsafe IV: Precautions for Handling: This drug may be administrated singly or with the following solutions. It is stable over 24 hours when this medicinal product is mixed with following solutions.
Sterile Water for Injection, Sodium Chloride Injection, 1M Sodium Chloride Injection, 5% Dextrose Injection, 10% Dextrose for Injection, 40% Dextrose for Injection, 20% Xylitol for Injection, Ringer's for Injection, Lactated Ringer's for Injection.
This drug is not compatible with the following solutions, therefore it should be separately administrated.
10% Sodium Chloride Injection, 20% Sodium Chloride Injection, 4.2% Sodium Bicarbonate Injection, 8.4% Sodium Bicarbonate Injection.
Use clear solution only.

Floxsafe: Store at temperatures not exceeding 25°C. Protect from light and moisture.
Floxsafe IV: Store at temperatures not exceeding 30°C.
Precautions for storage: Don't freeze or refrigerate.
Don't change the original container.
Precipitate may be produced at cool temperature, but is dissolved at room temperature. Therefore, do not preserve in a refrigerator.

Quinolones

J01MA14 - moxifloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.

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