Svoz Infusion

Svoz Infusion

moxifloxacin

Manufacturer:

Siam Bheasach

Distributor:

Siam Pharmaceutical

Marketer:

Siam Pharmaceutical
Full Prescribing Info
Contents
Moxifloxacin hydrochloride.
Description
Each mL contains Moxifloxacin 1.6 mg.
1 bottle of 250 mL infusion solution in 0.8% sodium chloride containing 400 mg Moxifloxacin.
Each bottle of SVOZ INFUSION (400 MG/250 ML) contains approximately 34.2 mmol (787 mg) of sodium.
Action
Pharmacology: Pharmacodynamics: Moxifloxacin is a 8-methoxy-fluoroquinolone antibacterial agent that has broad spectrum activities. Moxifloxacin inhibits DNA synthesis via inhibition of topoisomerase II and IV. There are essential bacterial enzymes which control DNA topology and assist in DNA replication, repair and transcription. Moxifloxacin has greater activity in vitro against gram-positive bacteria (Streptococcus pneumoniae including penicillin-resistant strains) than many other fluoroquinolones (e.g. ciprofloxacin, levofloxacin, ofloxacin).
Moxifloxacin is active in vitro and in clinical infections against bacteria such as: Gram-positive bacteria: Staphylococcus aureus (methicillin-susceptible [oxacillin-susceptible] strains only), Streptococcus pneumoniae (multi-drug resistant Streptococcus pneumoniae strains; MDRSP), Streptococcus pyogenes (group A β-hemolytic streptococci), Streptococcus agalactiae (group B streptococci), Streptococcus anginosus, Streptococcus constellatus, Streptococcus viridans, Staphylococci epidermidis (methicillin-susceptible [oxacillin-susceptible] strains only) and Enterococcus faecalis.
Gram-negative bacteria: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Citrobacter freundii, Enterobacter cloacae, Proteus mirabilis, Shigella
sp., Yersinia pestis, Haemophilus parainfluenzae, Haemophilus influenzae, Moraxella catarrhalis and Neisseria meningitidis.
Anaerobic bacteria: Fusobacterium spp., Porphyromonas spp., Prevotella spp., Peptostreptococcus spp., B. fragilis, B. thetaiotaomicron, Clostridium perfringens, Actinomyces, Bilophila wadsworthia, Eubacterium, Lactobacillus and Prevotella species.
Atypical bacteria: Chlamydia pneumoniae, Mycoplasma pneumoniae, Mycoplasma genitalum, Mycobacterium tuberculosis, M. avium complex (MAC), M. kansasii, M. fortuitum and Legionella pneumophila.
Pharmacokinetics: Absorption:
Moxifloxacin plasma concentrations increase proportionally. Steady state is reached after 3 days or longer with a 400 mg once-daily regimen.
Distribution: Moxifloxacin is widely distributed throughout the body tissue and has the volume of distribution (Vd) ranges from 1.7 to 2.7 L/kg. It accumulates in tissue such as respiratory tissues, alveolar macrophages, abdominal tissues/fluids, uterine tissues (endometrium, myometrium) and sinus tissues as tissue concentrations often exceed plasma concentrations. Moxifloxacin is about 30 to 50% bound to plasma proteins.
Metabolism: Moxifloxacin is metabolized mainly via sulfate and glucuronide conjugation which sulfate conjugate accounts for approximately 38% and glucuronide conjugate accounts for approximately 14%, respectively.
Elimination: Moxifloxacin has an elimination half-life of about 12 hours, allowing once-daily dosing. Moxifloxacin is eliminated in the feces and the urine as unchanged drug and as metabolites, approximately 25% of unchanged drug and sulfate conjugates are excreted in the feces and approximately 20% unchanged and glucuronide conjugates are excreted in the urine. The mean apparent total body clearance and renal clearance are approximately 12 L/h and 2.6 L/h, respectively.
Indications/Uses
Moxifloxacin is indicated for the treatment of the following bacterial infections caused by susceptible strains in the following conditions: Community acquired pneumonia (CAP) including CAP caused by multidrug-resistant strains*.
Complicated skin and skin structure infections (including diabetic foot infections).
Complicated intra-abdominal infections including polymicrobial infections such as abscesses.
*Multidrug-resistant Streptococcus pneumoniae (MDRSP) includes isolates known as Penicillin-resistant Streptococcus pneumoniae (PRSP), and strains resistant to two or more of the following antibiotics: penicillin (MIC ≥2 μg/mL), 2nd generation cephalosporins (e.g., cefuroxime), macrolides, tetracyclines and trimethoprim/sulfamethoxazole.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Dosage/Direction for Use
Recommended Dose and Mode of Administration: Moxifloxacin solution for infusion should only be administered by the intravenous infusion over 60 minutes.
Do not infuse by rapid or bolus intravenous infusion.
Moxifloxacin solution for infusion should not be admixed with other drugs or infused simultaneously through the same tubing with other drugs. If the same IV line or a Y-type line is used for sequential infusion of other drugs or if the piggyback method of administration is used, the tubing should be flushed before and after infusion of Moxifloxacin using an IV solution compatible with both Moxifloxacin and the other drug(s).
Moxifloxacin solution for infusion should be inspected visually for particulate matter prior to administration; the premixed solution should appear yellow. Any unused portion of the solution should be discarded.
When administering via IV infusion, do not exceed the recommended dose or infusion rate to avoid risk of QT interval prolongation. Patients receiving intravenous Moxifloxacin should be well hydrated and instructed to drink fluids liberally.
Compatibility: SVOZ INFUSION (400 MG/250 ML) is compatible with sterile water for injection, sodium chloride 0.9%, 5% dextrose in water, 10% dextrose in water and Lactated Ringer's solution.
Stability after mixing the drug: The mixture of SVOZ INFUSION (400 MG/250 ML) with compatible co-infusions solvent at ratio 1 to 10 and 10 to 1 volume to volume to obtain Moxifloxacin at the concentration of 0.145 mg/mL are stable at room temperature (25-30°C) for 24 hours.
Use in adults (18 years and older): The recommended dose for Moxifloxacin is 400 mg once daily.
The duration of treatment should be determined by the severity of the indication or clinical response.
Therapy may be initial intravenous administration, followed by oral administration when clinically indicated.
Community-acquired pneumonia: The total treatment duration for sequential administration (intravenous followed by oral therapy) is 7-14 days.
Complicated skin and skin structure infections: The total treatment duration for sequential administration (intravenous followed by oral therapy) is 7-21 days.
Complicated intra-abdominal infections: The total treatment duration for sequential administration (intravenous followed by oral therapy) is 5-14 days.
The recommended duration of treatment for the indication being treated should not be exceeded.
Moxifloxacin 400 mg solution for infusion has been studied in clinical trials for up to 21 days (in complicated skin and skin structure infections).
Use in children and adolescents: Safety and efficacy of Moxifloxacin have not been established for any indication in children or adolescents younger than 18 years of age.
Use in patients with renal impairment: No dose adjustment is necessary for patients with renal impairment (including creatinine clearance ≤ 30 mL/min/1.73 m2) and in patients on chronic dialysis e.g. hemodialysis and continuous ambulatory peritoneal dialysis.
Use in hepatic impairment: No dose adjustment is necessary for patients with mild, moderate or severe hepatic insufficiency (Child Pugh Class A, B or C). However, Moxifloxacin should be used with caution in patients with hepatic impairment because the metabolic disturbances associated with hepatic insufficiency may lead to QT prolongation. ECGs should be monitored in patients with liver cirrhosis.
Use in the elderly: No adjustment of dosage is required in elderly.
Overdosage
There is no specific antidote for Moxifloxacin overdose. In the event of overdose, it is recommended that appropriate supportive care including ECG measurements should be instituted as dictated by the patient's clinical status.
Fluoroquinolones are not efficiently removed by hemodialysis or peritoneal dialysis.
Contraindications
Moxifloxacin is contraindicated in patients with a known history of hypersensitivity to Moxifloxacin or other quinolone antibiotics or any component of the formulation.
Warnings
Do not use the drug in patients with a history of hypersensitivity to the drug or any other quinolones.
If the symptoms of rash, malaise, myalgia and tendonitis had occurred after the administration of the drug, immediately stop the drug and consult physician.
The drug may cause hepatic and renal toxicities.
Do not use this drug or used with caution in patients with central nervous system (CNS) disorder that may predispose to seizure dosing dependent.
The drug may cause a QT prolongation. Use with caution in elderly patients, patients with heart disease especially patients with arrhythmia, hypertension and uncorrected hypokalemia.
Avoid concomitant use of Moxifloxacin with other drugs that prolong the QT interval including class IA (e.g., quinidine, procainamide) or class III (e.g., amiodarone) antiarrhythmic agents, cisapride, erythromycin, antipsychotics agents, tricyclic antidepressants.
The use of drug can caused phototoxicity reaction or severe skin hypersensitivities including Toxic Epidermal Necrolysis, Stevens-Johnson syndrome and Erythema Multiforme.
The fluctuation of blood glucose will be affected by the use of this drug; therefore, it should be used with caution in diabetes patients.
The activity of warfarin may be increased after the concomitant use with this drug.
Use in Pregnancy & Lactation: Pregnant women and breastfeeding women should avoid the use of this drug.
Special Precautions
Fluoroquinolones including Moxifloxacin are associated with disabling and potentially irreversible serious adverse reactions that may occur together, including tendinitis and tendon rupture, peripheral neuropathy, and CNS effects. Discontinue Moxifloxacin immediately and avoid use of fluoroquinolones in patients with these serious adverse reactions.
Reserve use of Moxifloxacin for patients with no alternative treatment options for acute bacterial sinusitis or acute bacterial exacerbation of chronic bronchitis because of the risk of disabling and potentially serious adverse reactions (e.g., tendinitis and tendon rupture, peripheral neuropathy, CNS effects).
To reduce development of drug-resistant bacteria and maintain effectiveness of Moxifloxacin and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.
Avoid using Moxifloxacin in patients with known history of myasthenia gravis because it may exacerbate muscle weakness.
Moxifloxacin may cause phototoxicity reaction. Immediately discontinue the drug and consult physician, if the symptoms of skin occur after an administration. Avoid exposure to sunlight during the drug therapy.
Use with caution in patients with known or suspected CNS disorder or patients with risk factors that may predispose to seizures or lower the seizure threshold.
Use with caution in patients with mild, moderate or severe hepatic impairment or liver cirrhosis as it may increase the risk of QT prolongation.
Fulminant hepatitis potentially leading to liver failure (including fatalities) has been reported with use of Moxifloxacin.
Prolonged use of Moxifloxacin may result in fungal or bacterial superinfection, including Clostridium difficile-associated diarrhea (CDAD) and pseudomembranous colitis.
Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile. C. difficile-associated diarrhea and colitis or pseudomembranous colitis have been reported in patients receiving antibacterial agents including Moxifloxacin which may range in severity from mild diarrhea to fatal colitis. Therefore it is important to consider this diagnosis in patients who develop diarrhea during or after administration of the drug. If CDAD is suspected or confirmed, antibiotic use not directed against C. difficile may need to be discontinued. Patients should be managed with appropriate supportive therapy e.g., fluid and electrolyte management, protein supplementation and antibiotic treatment of C. difficile.
Moxifloxacin is not recommended for the treatment of MRSA infections. Instead, treatment with an appropriate antibacterial agent should be started.
In vitro, Moxifloxacin may interfere the Mycobacterium spp. culture test by suppression of mycobacterial growth, causing false negative results in specimens from patients currently taking Moxifloxacin.
Sensory or sensorimotor axonal polyneuropathy resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving fluoroquinolones including Moxifloxacin. Moxifloxacin should be discontinued immediately if symptoms of peripheral neuropathy (e.g. pain, burning, tingling, numbness and/or weakness) occur or if there are other alterations in sensations (e.g. light touch, pain, temperature, position sense, vibratory sensation). Symptoms may occur soon after initiation of Moxifloxacin and in some patients, may be irreversible. Avoid use in patients who have previously experienced peripheral neuropathy.
Psychotic reactions progressing to suicidal ideations/thoughts, hallucinations, paranoia, depression, self-injurious behavior (such as attempted or completed suicide), anxiety, agitation, nervousness and delirium have been reported with fluoroquinolones including Moxifloxacin. Psychotic reactions may occur after first dose. In the event that the patient develops these reactions, Moxifloxacin should be discontinued and appropriate measures instituted. Use with caution in psychotic patients or in patients with a history of psychiatric disease.
Monotherapy with Moxifloxacin should be avoided in patients with pelvic inflammatory disease, unless fluoroquinolone-resistant Neisseria gonorrhoeae can be excluded, because of the widespread and rising prevalence of fluoroquinolone-resistant N. gonorrhoeae infections. If fluoroquinolone-resistant N. gonorrhoeae cannot be excluded, the addition of an appropriate antibiotic which is active against N. gonorrhoeae (e.g., a cephalosporin) to empirical Moxifloxacin therapy should be considered.
Fluoroquinolones including Moxifloxacin may prolong QT interval. Moxifloxacin should be avoided in patients with known prolongation of the QT interval, ventricular arrhythmias (including torsades de pointes), any ongoing proarrhythmic conditions (e.g. clinically important bradycardia and acute myocardial ischemia), uncorrected hypokalemia or hypomagnesemia. Moxifloxacin also should be avoided in patients receiving class IA (e.g. quinidine, procainamide) or class III (e.g. amiodarone, sotalol) antiarrhythmic agents, or other drugs that prolong the QT interval (e.g. cisapride, erythromycin, antipsychotics agents, tricyclic antidepressants).
Use Moxifloxacin with caution in diabetes. Alterations in blood glucose concentrations, including hyperglycemia and hypoglycemia, have been reported with fluoroquinolones, including Moxifloxacin. Blood glucose disturbances usually have occurred in elderly patients with diabetes mellitus receiving an oral antidiabetic agent (e.g., sulfonylurea agent) or insulin. Patients should be monitored closely for signs/symptoms of disordered glucose regulation. Blood glucose concentrations should be carefully monitored in diabetic patients receiving antidiabetic agents and Moxifloxacin concomitantly.
Severe hypersensitivity reactions including anaphylaxis have occurred in patients receiving therapy with fluoroquinolones, including Moxifloxacin. Prompt discontinuation of the drug should occur if skin rash or other sign of hypersensitivity arise.
Use in Elderly: Use with caution in elderly patients (usually older than 60 years), patients taking corticosteroid drugs, patients with kidney, heart or lung transplants, patients with rheumatoid arthritis or renal impairment as it may increase risks of tendonitis and tendon rupture.
Use In Pregnancy & Lactation
Pregnant women and breastfeeding women should avoid the use of this drug.
Pregnancy: Information specific to Moxifloxacin use in pregnant women is limited. Animal studies have shown reproductive toxicities. The drug should be used during pregnancy only if the potential benefits justify potential risk to the fetus.
Lactation: It is not known if Moxifloxacin is excreted in breast milk. However, Moxifloxacin is distributed into milk in rats and may be distributed into human milk. Because of the potential for serious adverse reactions in the infant, a decision should be made whether to discontinue nursing or the drug, taking into account the risk of infant exposure, the benefits of breastfeeding to the infant and benefits of treatment to the mother.
Adverse Reactions
Undesirable Effects may be founded during treatment with Moxifloxacin as shown in the following; Cardiovascular disorders: angina pectoris, atrial fibrillation, bradycardia, cardiac arrest, cardiac failure, chest discomfort, chest pain, edema, hypertension, hypotension, increase blood pressure, palpitation, peripheral edema, phlebitis, prolonged Q-T interval on ECG, syncope, tachycardia.
Central nervous system disorders: agitation, anxiety, chills, confusion, depression, disorientation, dizziness, drowsiness, facial pain, fatigue, hallucination, headache, hypoesthesia, insomnia, lethargy, malaise, nervousness, noncardiac chest pain, pain, paresthesia, restlessness, vertigo.
Dermatologic disorders: allergic dermatitis, erythema, hyperhidrosis, night sweats, pruritus, skin rash, urticaria.
Endocrine & metabolic system disorders: decreased serum glucose, dehydration, hyperchloremia, hyperglycemia, hyperlipidemia, hypokalemia, increased gamma-glutamyl transferase, increased lactate dehydrogenase, increased serum albumin, increased serum glucose, increased serum triglycerides, increased uric acid.
Gastrointestinal disorders: abdominal discomfort, abdominal distension, abdominal pain, anorexia, constipation, decreased amylase, decreased appetite, diarrhea, dysgeusia, flatulence, gastritis, gastroenteritis, gastroesophageal reflux disease, increased amylase, increased serum lipase, nausea, oral candidiasis, vomiting, xerostomia.
Genitourinary disorders: dysuria, fungal vaginosis, vaginal infection, vulvovaginal candidiasis, vulvovaginal pruritus.
Hematologic disorders: anemia, decreased basophils, decreased hematocrit, decreased hemoglobin, decreased neutrophils, decreased prothrombin time, decreased red blood cells, eosinopenia, eosinophilia, increased MCH, increased neutrophils, leukocytosis, leukopenia, prolonged partial thromboplastin time, prolonged prothrombin time, thrombocythemia, thrombocytopenia.
Hepatic disorders: abnormal hepatic function tests, decreased serum bilirubin, increased liver enzymes, increased serum ALT, increased serum AST, increased serum bilirubin, increased serum transaminases.
Hypersensitivity: hypersensitivity reaction.
Immunologic disorders: increased serum globulins.
Infection: candidiasis, fungal infection (including oral).
Local: extravasation.
Neuromuscular & skeletal disorders: arthralgia, back pain, limb pain, muscle spasms, musculoskeletal pain, myalgia, tremor, weakness.
Ophthalmic disorder: blurred vision.
Otic disorder: tinnitus.
Renal disorders: increased blood urea nitrogen, increased ionized serum calcium, increased serum creatinine, renal failure.
Respiratory disorders: asthma, bronchospasm, dyspnea, hypoxia, wheezing.
Miscellaneous: fever.
Rare but important or life-threatening: agranulocytosis, anaphylactic shock, anaphylactoid reaction, anaphylaxis, aplastic anemia, ataxia, auditory impairment, cholestatic jaundice, Clostridium difficile associated diarrhea, deafness (reversible), decreased INR, ECG abnormality, exacerbation of myasthenia gravis, hemolytic anemia, hepatic failure, hepatic necrosis, hepatitis (predominantly cholestatic), hepatotoxicity (idiosyncratic), hypoglycemia, increased intracranial pressure, interstitial nephritis, jaundice, pancytopenia, peripheral neuropathy (may be irreversible), phototoxicity, pneumonitis (allergic), polyneuropathy, pseudomembranous colitis, pseudotumor cerebri, psychotic reaction, renal insufficiency, rupture of tendon, seizure, skin photosensitivity, Stevens-Johnson syndrome, suicidal ideation, suicidal tendencies, tendonitis, thrombotic thrombocytopenic purpura, toxic epidermal necrolysis, ventricular tachyarrhythmias (including torsades de pointes and cardiac arrest [usually in patients with concurrent, severe proarrhythmic conditions]), vasculitis, vision loss (transient).
Drug Interactions
Clinically important pharmacokinetic interactions have not been reported when warfarin and Moxifloxacin were used concomitantly. However, concurrent use of fluoroquinolones including Moxifloxacin may enhance the anticoagulant effect of vitamin K antagonists (e.g. warfarin) which may result in increased risk of bleeding. The prothrombin time (PT), international normalized ratio (INR) and other suitable coagulation tests should be monitored in patients receiving Moxifloxacin concomitantly with warfarin.
Concomitant use of Moxifloxacin and class IA (e.g. quinidine, procainamide) or class III (e.g. amiodarone, sotalol) antiarrhythmic agents should be avoided. Moxifloxacin should be used with caution in patients receiving other drugs that prolong the QT interval (e.g. cisapride, erythromycin, antipsychotic agents, tricyclic antidepressant) because concurrent use of Moxifloxacin and these drugs may result in increased risk of QT interval prolongation.
Concomitant use of Moxifloxacin with corticosteroids increase the risk of severe tendon disorders (e.g. tendonitis, tendon rupture), especially in geriatric patients older than 60 years of age. Patients receiving Moxifloxacin concomitantly with corticosteroids should be monitored.
No clinically important pharmacokinetic interactions between digoxin and Moxifloxacin. Although a transient increase in digoxin concentration may occur, this is not considered clinically important. Dosage adjustments are not necessary for either drug.
Storage
Store below 30°C.
Do not store in freezer and refrigerator as precipitation may occur.
MIMS Class
ATC Classification
J01MA14 - moxifloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Presentation/Packing
Soln for infusion (vial) 400 mg/250 mL (clear, yellow) x 1's.
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