Xiflox

Film-coated tablet: Moxifloxacin (Xiflox) 400 mg film coated tablet is available as pink oblong shaped, film coated tablet, engraved "GETZ" on one side and break line on other side.
Each film-coated tablet contains: Moxifloxacin (as hydrochloride), Ph. Eur. 400 mg.
Solution for injection: Moxifloxacin (XIFLOX) IV is a synthetic broad-spectrum antibacterial agent. Chemically, moxifloxacin is a fluoroquinolone and is available as a monohydrochloride salt of 1-cyclopropyl-7-[(S,S)-2,8 diazabicyclo[4.3.0]non-8-yl]-6-flouro-8-methoxy-1,4-dihydro-4-oxo-3 quinoline carboxylic acid. The molecular formula is C₂₁H₂₄FN₃O₄*HCl.
Each mL contains: Moxifloxacin (as hydrochloride) 1.6 mg.

Pharmacology: Film-coated tablet: Pharmacodynamics: 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 contains the C8-methoxy moiety that augments its antibacterial activity and reduces the possibility of Gram-positive mutations. Because the 8-fluroquinolones use a different mechanism of action than do the aminoglycosides, beta-lactams, macrolides, or tetracyclines, there has been no cross resistance between the quinolones and these antimicrobial agents.
Solution for injection: Mechanism of Action: Moxifloxacin is bactericidal against a wide range of gram positive and gram negative organisms. Such activity arises through the inhibition of DNA gyrase (topoisomerase II) and topoisomerase IV, which bacteria require for DNA replication, transcription, repair, and recombination. Moxifloxacin contains the C8-methoxy moiety that augments its antibacterial activity and reduces the possibility of gram-positive mutations. Because the 8-fluroquinolones use a different mechanism of action than the aminoglycosides, beta-lactams, macrolides, or tetracyclines, there has been no cross resistance between the quinolones and these antimicrobial agents.
Pharmacokinetics: Film-coated tablet: 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 - 1200 mg single dose and up to 600 mg once daily dosing over 10 days.
Following a 400 mg oral dose peak concentrations of 3.1 mg/L are reached within 0.5 - 4 h post administration. Peak and trough plasma concentrations at steady-state (400 mg once daily) were 3.2 mg/L and 0.6 mg/L, respectively.
Distribution: Moxifloxacin is distributed very rapidly to extravascular spaces. Exposure to drug in terms of AUC (AUC_norm = 6 kg.h/L) is high with steady-state volume of distribution (V_ss) of approximately 2 L/kg. In saliva peak concentrations higher than those of plasma maybe reached. In vitro and ex vivo experiments over a range of 0.02 to 2 mg/L shows the determination of protein binding of approximately 45% (independent of the concentration of the drug). Moxifloxacin is mainly bound to serum albumin. Due to this low value it shows high free peak concentration > 10x MIC are observed. Moxifloxacin reaches high concentrations in tissues like lung (epithelial fluid, alveolar macrophages, biotic tissues), the sinuses (maxillary and ethmoid sinus, nasal polyps) and inflamed lesions (catharide blister fluid) where total concentrations exceeding those of the plasma concentrations are reached. High free drug concentrations are measured in interstitial body water (saliva, intramuscular, subcutaneous). In addition, high drug concentrations were detected in abdominal tissues and fluids and female genital tract.
The peak concentrations and site vs. plasma concentration ratios for various target tissues yielded comparable results for both modes of drug administration after a single dose of 400 mg moxifloxacin.
Metabolism: Moxifloxacin undergoes Phase II biotransformation and is excreted via renal and biliary/faecal pathways as unchanged drug as well as in the form of a sulpho-compound (M1) and a glucuronide (M2). M1 and M2 are the only metabolites relevant in humans, both are microbiologically inactive.
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.
Concomitant administration of moxifloxacin with ranitidine or probenecid did not alter renal clearance of the parent drug.
Mass balance of the mother compound and Phase II metabolites of moxifloxacin yielded an almost complete recovery of approximately 96% - 98% independent from the route of administration with no indication of oxidative metabolism.
Special Population: Geriatric patients: Pharmacokinetics of moxifloxacin are not affected by age.
Gender: Drug absorption of Moxifloxacin is not affected by gender.
Solution for injection: Absorption: After a single 400 mg intravenous 1 hour infusion peak concentrations of approximately 4.1 mg/L were reached in the plasma at the end of infusion which corresponds to a mean increase of approximately 26% relative to the oral application. Following multiple intravenous dosing (1 hour infusion), peak and trough plasma concentrations at steady state (400 mg once daily) were between 4.1 to 5.9 mg/L and 0.43 to 0.84 mg/L respectively.
Distribution: Moxifloxacin is approximately 30-50% bound to serum proteins, independent of drug concentration. The volume of distribution of moxifloxacin ranges from 1.7 to 2.7 L/kg. Moxifloxacin is widely distributed throughout the body, with tissue concentrations often exceeding plasma concentrations. Moxifloxacin has been detected in the saliva, nasal and bronchial secretions, mucosa of the sinuses, skin blister fluid, subcutaneous tissue, skeletal muscle, and abdominal tissues and fluids following intravenous administration of 400 mg.
Metabolism: Approximately 52% of an intravenous dose of moxifloxacin is metabolized via glucuronide and sulfate conjugation. The cytochrome P450 system is not involved in moxifloxacin metabolism and is not affected by moxifloxacin. The sulfate conjugate (M1) accounts for approximately 38% of the dose and is eliminated primarily in the feces. While glucuronide conjugate (M2) accounts for approximately 14% of the dose which is excreted exclusively in the urine. Peak plasma concentration of M2 are approximately 40% those of the parent drug, while plasma concentrations of M1 are generally less than 10% those of moxifloxacin.
Excretion: 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 medicine from the kidneys. Approximately 45% of intravenous dose of moxifloxacin is excreted as unchanged drug (20% is excreted in the urine and 25% in the feces).
Microbiology: Film-coated tablet: Aerobic Gram-positive micro-organisms: Susceptible: Gardnerella vaginalis, Staphylococcus aureus (methicillin-susceptible strains), Streptococcus agalactiae, Streptococcus milleri group (S. anginosus, S. constellatus and S. intermedius), Streptococcus pneumoniae, Streptococcus pyogenes (Group A), Streptococcus viridans group (S. viridans, S. mutans, S. mitis, S. sanguinis, S. salivarius, S. thermophilus, S. constellatus), Streptococcus dysgalactiae, Coagulase negative Staphylococci (S. cohnii, S. epidermidis, S. haemolyticus, S. hominis, S. saprophyticus, S. simulans) methicillin susceptible strains.
Intermediate: Enterococcus faecalis (Vancomycin, Gentamycin, susceptible strains only), Enterococcus avium, Enterococcus faecium.
Resistant: Staphylococcus aureus (methicillin/ofloxacin resistant strains), Coagulase negative Staphylococci (S. cohnii, S. epidermidis), S. haemolyticus, S. hominis, S. saprophyticus, S. simulans) methicillin resistant strains.
Aerobic Gram-negative micro-organisms: Susceptible: Haemophilus influenzae (including β lactamase negative and positive strains), Haemophilus parainfluenzae, Moraxella catarrhalis (including β lactamase negative and positive strains), Bordetella pertussis, Legionella pneumophila, Acinetobacter baumannii, Proteus vulgaris.
Intermediate: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Citrobacter freundii, Enterobacter species (E. aerogenes, E. intermedius, E. sakazakii), Enterobacter cloacae, Pantoea agglomerans, Pseudomonas fluorescens, Burkholderia cepacia, Stenotrophomonas maltophilia, Proteus mirabilis, Morganella morganii, Neisseria gonorrhea, Providence species (P. rettgeri, P. stuartii).
Resistant: Pseudomonas aeruginosa.
Anaerobic micro-organisms: Susceptible: Fusobacterium spp., Porphyromonas spp., Prevotella spp., Propionibacterium spp.
Intermediate: Bacteroides sp (B. fragilis, B. distasonis, B. thetaiotaomicron, B. ovatus, B. uniformis, B. vulgaris), Peptostreptococcus spp., Clostridium sp.
Atypicals: Susceptible: Chlamydia pneumoniae, Chlamydia trachomatis, Mycoplasma genitalium, Mycoplasma hominis, Mycoplasma pneumoniae, Coxiella burnetii.
Solution for injection: Spectrum of moxifloxacin is broad and it is active against most strains of the following micro-organisms in both in vitro and in vivo.
Aerobic Gram-positive micro-organisms: Staphylococcus aureus (including methicillin-susceptible strains), Streptococcus pneumoniae (penicillin-susceptible strains only), Streptococcus pyogenes, Streptococcus anginosus, Streptococcus constellatus, Gardnerella vaginalis, Streptococcus milleri, Streptococcus mitior, Streptococcus agalactiae, Streptococcus dysgalactiae, Staphylococcus cohnii, Staphylococcus epidermidis, Staphylococcus haemolyticus, Staphylococcus hominis, Staphylococcus saprophyticus, Staphylococcus simulans, Corynebacterium diphtheriae, Enterococcus faecalis* (Vancomycin, gentamicin susceptible strains only).
Aerobic Gram-negative micro-organisms: Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis (including β-lactamase negative and positive strains), Enterobacter cloacae, Escherichia coli, Proteus mirabilis, Klebsiella pneumoniae, Bordetella pertussis, Klebsiella oxytoca, Enterobacter aerogenes, Enterobacter agglomerans, Enterobacter intermedius, Enterobacter sakazakii, Proteus vulgaris, Morganella morganii, Providencia rettgeri, Providencia stuartii.
Atypicals: Chlamydia pneumoniae, Chlamydia trachomatis, Mycoplasma pneumoniae, Mycoplasma hominis, Mycoplasma genitalium, Legionella pneumophila, Coxiella burnetii.
Anaerobic micro-organisms: Bacteroides distasonis, Bacteroides eggerthii, Bacteroides fragilis, Bacteroides ovatus, Bacteroides thetaiotaomicron, Bacteroides uniformis, Fusobacterium spp., Peptostreptococcus spp., Porphyromonas spp., Porphyromonas anaerobius, Porphyromonas asaccharolyticus, Porphyromonas magnus, Prevotella spp., Propionibacterium spp., Clostridium perfringens, Clostridium ramosum.

Film-coated tablet: Moxifloxacin (Xiflox) tablets are indicated for the treatment of the following bacterial infections in patients of 18 years and older caused by bacteria susceptible to moxifloxacin.
Respiratory tract infections: Acute bacterial sinusitis; Acute exacerbations of chronic bronchitis; Community acquired pneumonia, including CAP caused by multi-drug resistant strains.
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 (including diabetic foot infections).
Complicated intraabdominal infections including polymicrobial infections such as abscesses.
Solution for injection: Moxifloxacin (XIFLOX) IV is indicated for the treatment of adults (>18 years of age) with mild, moderate and severe infections caused by susceptible strains of micro-organisms in the conditions as follows: Acute bacterial sinusitis, Acute bacterial exacerbation of chronic bronchitis, Community acquired pneumonia, Uncomplicated skin and skin structure infections, Complicated intra-abdominal infections (including polymicrobial infections such as abscesses), Complicated skin and skin structure infections (including diabetic foot infections).

Film-coated tablet: The usual adult dose of Moxifloxacin (Xiflox) is 400 mg once every 24 hours. The duration of therapy depends on the type and severity of infection as described in the table as follows.
The film-coated tablet should be swallowed whole with sufficient liquid and maybe taken independent of meals. (See Table 1.)

Click on icon to see table/diagram/image

The film-coated tablet should be swallowed whole with sufficient liquid and maybe taken independent of meals.
Missed dose: 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.
Special Populations: Geriatric patients: No adjustment of dosage is required in elderly.
Ethnic differences: No adjustment of dosage is required in ethnic groups.
Patients with hepatic impairment: No adjustment of dosage is required in patients with impaired liver function.
Patients with renal impairment: No adjustment of dosage is required in patients with impaired renal function.
Solution for injection: The dose of Moxifloxacin (XIFLOX) IV is 400 mg/250 mL as intravenous infusion once every 24 hours. The duration of treatment should be determined by the severity of the indication or clinical response. The recommended duration of treatment for the indication being treated should not be exceeded. (See Table 2.)

Click on icon to see table/diagram/image

Moxifloxacin (XIFLOX) IV can be administered intravenously for the entire treatment duration. Alternatively, therapy may be initial intravenous administration, followed by oral administration when clinically indicated.
Method of Administration: Moxifloxacin (XIFLOX) IV should be administered by intravenous infusion only over a period of 60 minutes. It is not intended for intra-arterial, intramuscular, intrathecal, intraperitoneal or subcutaneous administration.
Additives or other medications should not be added to Moxifloxacin (XIFLOX) IV or infused simultaneously through the same intravenous line.

Film-coated tablet: No specific counter measures 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.
Solution for injection: 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.

Film-coated tablet: Moxifloxacin is contraindicated in patients: With hypersensitivity to moxifloxacin or other quinolones and any components of this medication.
Less than 18 years of age.
Pregnancy and lactation.
With history of tendon disease/disorder related to quinolone treatment.
With impaired liver function and in patients with transaminases > 5 fold ULN.
With congenital or documented acquired QT prolongation.
With electrolyte disturbances, particularly in uncorrected hypokalaemia.
With clinically relevant bradycardia.
With clinically relevant heart failure with reduced left ventricular ejection fraction.
With previous history of symptomatic arrhythmias.
Solution for injection: Moxifloxacin is contraindicated in: Patients with a history of hypersensitivity to moxifloxacin or any member of the quinolones class of antimicrobial agents.
Pediatric patients, adolescents (less than 18 years of age).
Pregnant and lactating women.
Moxifloxacin should be avoided in patients with known prolongation of the QT interval, with uncorrected hypokalemia and patients receiving Class IA (quinidine, procainamide) and Class III (amiodarone, sotalol) antiarrhythmic agents.

Film-coated tablet: Fluoroquinolones, including moxifloxacin are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants.

Film-coated tablet: As with all quinolones, moxifloxacin should be used with caution in patients with known or suspected CNS disorders (e.g. lowered convulsion threshold, previous history of convulsion, reduced cerebral blood flow, altered brain structure or stroke).
Antibiotic associated colitis have 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 is association with the use of Moxifloxacin.
Moxifloxacin has been shown to prolong the QT interval of the electrocardiogram in some patients, 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 sensitive to drug associated effects on the QT interval.
Moxifloxacin should be used with caution in patients treated concomitantly with drugs that prolong QT interval such as cisapride, erythromycin, antipsychotics, and tricyclic antidepressants, in the patients with ongoing proarrythmic conditions, such as clinically significant bradycardia, acute myocardial ischemia, in the patients with liver cirrhosis as preexisting QT prolongation, in women and elderly patients who are susceptible to QTc prolonging drugs.
Tendon inflammation and/or rupture have been reported with quinolone antibiotics. Risk may be increased with concurrent corticosteroids, particularly in the elderly. Discontinue at first signs or symptoms of tendon pain.
For patients with pelvic inflammatory disease (e.g. associated with a tubo-ovarian or pelvic abscess), treatment with Moxifloxacin 400 mg film-coated tablets is not recommended.
Use with caution in diabetes as glucose regulation may be altered.
Moxifloxacin is not recommended for the treatment of MRSA infections. In case of a suspected or confirmed infection due MRSA, treatment with an appropriate antibacterial agent should be started.
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.
Severe hypersensitivity reactions, including anaphylaxis, have occurred with quinolone therapy. If an allergic reaction occurs discontinue drug immediately.
Quinolones should be used with caution as they may exacerbate myasthenia gravis.
Peripheral neuropathy may rarely occur.
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.
Liver function tests/investigations should be performed in cases where indications of liver dysfunction occur.
If vision becomes impaired or any effects on the eyes are experienced, an eye specialist should be consulted immediately.
Moxifloxacin may result in an impairment of the patients 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.
Solution for injection: Moxifloxacin should be used with caution in patients with ongoing proarrhythmic conditions, such as bradycardia or acute myocardial ischemia.
Anaphylactic reactions in very rare instances can progress to a life threatening shock, in some instances after the first administration. In these cases the treatment with moxifloxacin must be discontinued, medical treatment (e.g. treatment for shock) is required.
As with all quinolones, moxifloxacin should be used with caution in patients with known or suspected CNS disorders or in the presence of other risk factors that may predispose to seizures or lower the threshold.
Moxifloxacin should be used with caution in patients with myasthenia gravis because the symptoms can be exacerbated.
Patients should be advised to contact their doctor prior to continuing treatment if signs and symptoms of 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.
Antibiotic associated colitis has been reported with the use of broad-spectrum antibiotics including moxifloxacin and may range in severity from mild diarrhea to fatal colitis. Therefore it is important to consider this diagnosis in patients who develop serious diarrhea in association with the use of moxifloxacin. If antibiotic associated colitis is suspected or confirmed, ongoing treatment with antibacterial agents, including moxifloxacin, should be discontinued and adequate therapeutic measures should be initiated immediately. Drugs inhibiting peristalsis are contraindicated in this situation.
Quinolones may cause central nervous system (CNS) events, including nervousness, agitation, insomnia, anxiety, nightmares or paranoia. As the magnitude of QT prolongation may increase with increasing concentrations of the drug, the recommended dose and the infusion rate (400 mg within 60 minutes) should not be exceeded.
Moxifloxacin should be used with caution in patients with liver cirrhosis as pre-existing QT prolongation in these patients cannot be excluded.
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 limbs.
Quinolones have been shown to cause photosensitivity reactions in patients. Patients should be advised to avoid extensive exposure to either UV irradiation or sunlight.
Cases of bullous skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis can occur due to use of moxifloxacin. Patients should be advised to contact their doctor immediately prior to continuing treatment if skin and/or mucosal reactions occur.
In patients for whom sodium intake is of medical concern (patients with congestive heart failure, renal failure, nephrotic syndrome, etc.) the additional sodium load of the solution for infusion should be taken into account.

Film-coated tablet: Moxifloxacin is usually well tolerated. Most adverse reactions are mild to moderate. The most common adverse reactions are nausea and diarrhea.
Infection and infestations: Common: Myotic superinfections.
Blood and Lymphatic system disorders: Uncommon: Anemia, Leukopenia, Neutropenia, Thrombocytopenia, Thrombocytothemia, Prothrombin time prolonged/INR increased.
Rare: Thromboplastin level abnormal.
Very rare: Prothrombin level increased/INR decreased, Prothrombin level/INR abnormal.
Immune system disorders: Uncommon: Allergic reaction, Pruritus, Rash, Urticaria, Blood eosinophilia.
Rare: Anaphylactic/anaphylactoid reaction, Allergic edema/angioedema.
Very rare: Anaphylactic/anaphylactoid shock.
Metabolism and nutrition disorders: Uncommon: Hyperlipidemia.
Rare: Hyperglycemia, Hyperuricemia.
Very rare: Hypoglycemia.
Psychiatric disorders: Uncommon: Anxiety reactions, Psychomotor hyperactivity/agitation.
Rare: Emotional liability, Depression, Hallucinations.
Very rare: Depersonalization, Psychotic reactions.
Nervous system disorders: Common: Headache, Dizziness.
Uncommon: Paresthesia and dysesthesia taste disorders (including ageusia in very rare cases), Confusion and disorientation, Sleep disorders, Tremor, Vertigo, Somnolence.
Rare: Hypoesthesia, Smell disorders (including anosmia), Abnormal dreams, Disturbed coordination (including gait disturbances, especially due to dizziness or vertigo; in very rare cases leading to fall with injuries, especially in elderly), Seizures of various clinical manifestations (including grand malconvulsions), Disturbed attention, Speech disorders, Amnesia, Peripheral neuropathy and polyneuropathy.
Very rare: Hyperesthesia.
Eye disorders: Uncommon: Visual disturbances (especially in the course of CNS reactions).
Very rare: Transient loss of vision (especially in the course of CNS reactions).
Ear and Labyrinth disorders: Rare: Tinnitus, Hearing impairment including deafness (usually reversible).
Cardiovascular system disorders: Common: QT prolongation in patients with hypokalaemia.
Uncommon: QT prolongation, Palpitations, Tachycardia, Vasodilation.
Rare: Ventricular tachyarrythmias, Syncope, Hypertension, Hypotension.
Very rare: Unspecified arrhythmias, Torsades de Pointes, Cardiac arrest (especially in patients with severe underlying proarrythmic conditions such as clinically significant bradycardia, acute myocardial ischemia).
Respiratory, thoracic, and mediastinal disorders: Uncommon: Dyspnea (including asthmatic conditions).
Gastrointestinal disorders: Common: Nausea, Vomiting, Gastrointestinal and abdominal pains, Diarrhea.
Uncommon: Decreased appetite and food intake, Constipation, Dyspepsia, Flatulence, Gastroenteritis (excluding erosive gastroenteritis), Increased amylase.
Rare: Dysphagia, Stomatitis, Antibiotic associated colitis.
Hepato-biliary disorders: Common: Increase in transaminases.
Uncommon: Hepatic impairment (including LDH increase), Increased bilirubin, Increase gamma-glutamyl-transferase, Increase in blood alkaline phosphatase.
Rare: Jaundice, Hepatitis (predominantly cholestatic).
Very rare: Fulminant hepatitis.
Skin and subcutaneous tissue disorders: Very rare: Bullous skin reactions like Stevens Johnson Syndrome or Toxic Epidermal Necrolysis.
Musculoskeletal, connective tissue and bone disorders: Uncommon: Arthralgia, Myalgia.
Rare: Tendonitis, Increased muscle tone and cramping, Muscular weakness.
Very rare: Tendon rupture, Arthritis, Gait disturbances (caused by muscular, tendon, or joint symptoms), Exacerbation of symptoms of myasthenia gravis.
Renal and urinary disorders: Uncommon: Dehydration (caused by diarrhea or reduced fluid intake).
Rare: Renal impairment, Renal failure (due to dehydration especially in elderly with pre-existing renal disorders).
General disorders and administration site conditions: Uncommon: Feeling unwell, Unspecific pain and sweating.
Rare: Edema.
Solution for injection: Following are the adverse effects reported with moxifloxacin.
Common: Mycotic superinfections, headache, dizziness, QT prolongation in patients with hypokalemia, nausea, vomiting, gastrointestinal and abdominal pains, diarrhea, increase in transaminases, injection and infusion site reactions.
Uncommon: Anemia, leukopenia, neutropenia, thrombocytopenia, thrombocythemia, prothrombin time prolonged/INR increased, allergic reaction, pruritus, rash, urticaria, blood eosinophilia, hyperlipidemia, anxiety reactions, psychomotor hyperactivity/agitation, par- and dysesthesia, taste disorders (incl. ageusia in very rare cases), confusion and disorientation, sleep disorders, tremor, vertigo, somnolence, visual disturbances (esp in the course of CNS reactions), QT prolongation, palpitations tachycardia, vasodilatation, dyspnea (including asthmatic conditions), anorexia, constipation, dyspepsia, flatulence, gastroenteritis (excl. erosive gastroenteritis), increased amylase, hepatic impairment (incl. LDH increase), increased bilirubin, increased gamma-glutamyl-transferase, increase in blood alkaline phosphatase, arthralgia, myalgia, dehydration (caused by diarrhea or reduced fluid intake), feeling unwell, unspecific pain, sweating, infusion site (thrombo-) phlebitis.
Rare: Thromboplastin level abnormal, anaphylactic/anaphylactoid reaction, allergic edema/angioedema (incl. laryngeal edema, potentially life threatening), hyperglycemia, hyperuricemia, emotional lability, depression (in very rare cases potentially culminating in self-endangering behaviour), hallucinations, hypoesthesia, smell disorders (incl. anosmia), abnormal dreams, disturbed coordination (incl. gait disturbances, esp. due to dizziness or vertigo; in very rare cases leading to fall with injuries, esp. in elderly) seizures of various clinical manifestations (incl. grand mal convulsions), disturbed attention, speech disorders, amnesia, tinnitus, ventricular tachyarrhythmias, syncope, hypertension, hypotension, dysphagia, stomatitis, antibiotic associated colitis (in very rare cases associated with life threatening complications), jaundice, hepatitis (predominantly cholestatic), tendonitis, increased muscle tone and cramping, renal impairment, renal failure (due to dehydration esp. in elderly with pre-existing renal disorders), edema.
Very Rare: Prothrombin level increased/INR decreased, prothrombin level/INR abnormal, anaphylactic/anaphylactoid shock (potentially life threatening), psychiatric disorders, depersonalization, psychotic reactions (potentially culminating in self-endangering behaviour), hyperesthesia, unspecified arrhythmias, torsade de Pointes, cardiac arrest (especially in patients with severe underlying proarrhythmic conditions such as clinically significant bradycardia, acute myocardial ischemia), fulminant hepatitis potentially leading to life-threatening liver failure (including fatal cases), bullous skin reactions like Stevens-Johnson-Syndrome or toxic epidermal necrolysis (potentially life threatening), tendon rupture, arthritis gait disturbance (caused by muscular, tendon or joint symptoms) exacerbation of symptoms of myasthenia gravis.

Film-coated tablet: Antacids, Minerals, and multivitamins: Concomitant ingestion of Moxifloxacin together antacids, minerals and multivitamins 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.
Moxifloxacin increases Cmax of digoxin by approximately 30 % at steady state without affecting AUC or trough levels.
Concomitant administration of charcoal with an oral dose of 400 mg moxifloxacin leads 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).
The prothrombin time, International Normalized Ratio (INR), or other suitable anticoagulation tests should be closely monitored if a quinolone is administered concomitantly with warfarin or its derivatives.
Concomitant administration of NSAIDs with quinolones may increase the risks of CNS stimulation and convulsions.
Solution for injection: Anticoagulants: Concomitant administration of anticoagulants with moxifloxacin may cause an increase in the anticoagulant activity. Therefore, INR monitoring should be performed and if necessary, the oral anticoagulant dosage should be adjusted as appropriate.
Nonsteroidal anti-inflammatory drugs (NSAIDs): The concomitant administration of an NSAID with a quinolone may increase the risks of CNS stimulation and convulsions.
Cisapride, erythromycin, anti-psychotics and tricyclic antidepressants: An additive effect of moxifloxacin and drugs that prolong the QT interval such as cisapride, erythromycin, anti-psychotics and tricyclic antidepressants cannot be excluded; therefore moxifloxacin should be used with caution when given concurrently with these drugs.
Morphine: Parental administration of morphine with moxifloxacin did not reduce the oral bioavailability of moxifloxacin and only slightly decreased Cmax (17%).
Atenolol: The pharmacokinetics of atenolol are not significantly altered by moxifloxacin. Following single dose administration in healthy subjects AUC was marginally increased (by approximately 4%) and peak concentrations were decreased by 10%.
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.

Solution for injection: CAUTION: Rapid or bolus intravenous infusion must be avoided.

Store at temperatures not exceeding 30°C.
Film-coated tablet: Protect from sunlight and moisture.
Solution for injection: Do not refrigerate or freeze.
Protect from light.
Infusion vial should be removed from the box only immediately before use.

Quinolones

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

Rx