Moxiflox GPO

Moxiflox GPO

moxifloxacin

Manufacturer:

GPO

Distributor:

GPO
Full Prescribing Info
Contents
Moxifloxacin hydrochloride.
Description
Each tablet contains moxifloxacin hydrochloride equivalent to 400 mg moxifloxacin.
Action
Pharmacology: Pharmacodynamics: Moxifloxacin is synthetic, broad-spectrum fluoroquinolone antibacterial agent that inhibits DNA gyrase and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription, and repair of bacterial DNA. Topoiosmerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division.
Pharmacokinetics: Absorption: Moxifloxacin is well absorbed from the GI tract. Coadministration with a high-fat meal does not affect the absorption of moxifloxacin. Steady state is achieved after ≥3 days with a 400 mg once-daily regimen.
Distribution: The volume of distribution ranges from 1.7 to 2.7 L/kg. Moxifloxacin is widely distributed throughout the body, with tissue concentrations often exceeding plasma concentrations.
Metabolism/Excretion: Moxifloxacin is metabolized via glucuronide and sulfate conjugation. The sulfate conjugate (M1) accounts for ~38% of the dose and is eliminated primarily in the feces. Approximately 14% of an oral dose are converted to a glucuronide conjugate (M2), which is excreted exclusively in the urine. A total of 96% of an oral dose is excreted as either unchanged drug or known metabolites. The mean apparent total body clearance and renal clearance are ~ 12 L/hr and 2.6 L/hr, respectively. (See Table 1.)

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Microbiology: The following organisms are generally susceptible to moxifloxacin in vitro: Gram negative: Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumonia, Moraxella-catarrhalis.
Gram positive: Staphylococcus aureus (methicillin susceptible), Streptococcus anginosus, Streptococcus constellatus, Streptococcus pneumoniae, Enterococcus faecalis.
Atypical bacteria: Mycoplasma pneumonia, Chlamydia pneumoniae.
Moxifloxacin exhibits in vitro minimum inhibitory concentrations (MICs) ≤2 mcg/mL against most (≥90%) strains of the following microorganisms; however, the safety and effectiveness of moxifloxacin in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials.
Gram negative: Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Proteus mirabilis.
Gram positive: Staphylococcus epidermidis (methicillin susceptible), Streptococci pyogenes, Streptococcus viridans, Streptococcus agalactiae.
Atypical bacteria: Legionella pneumophilia.
Indications/Uses
This medicine is indicated for adults (18 years and older) with infections caused by susceptible strains of the designated microorganisms in the following conditions.
Acute bacterial exacerbation of chronic bronchitis: Caused Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, methicillin-susceptible Staphylococcus aureus, Moraxella catarrhalis, or Streptococcus pneumoniae.
Acute bacterial sinusitis: Caused by H. influenzae, H. parainfluenzae, or S. pneumoniae.
Community-acquired pneumonia: Caused by Chlamydia pneumoniae, H. influenzae, K. pneumoniae, M. catarrhalis, methicillin-susceptible S. aureus, or S. pneumoniae (including multidrug-resistant strains), or Mycoplasma pneumoniae. Multidrug-resistant S. pneumoniae (MDRSP) includes isolates previously known as penicillin-resistant S. pneumoniae (PRSP), and are strains resistant to 2 or more of the following antibiotics: penicillin (MIC 2 mcg/mL or more), second generation cephalosporins (e.g., cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole.
Complicated intra-abdominal infections: Including polymicrobial infections, such as abscess caused by Bacteroides fragilis, Bacteroides thetaiotaomicron, Clostridium perfringes, Enterococcus faecalis, Escherichia coli, Peptostreptococcus species, Proteus mirabilis, Streptococcus anginosus, or Streptococcus constellatus.
Complicated skin and skin structure infections: Caused by E. coli, Enterobacter cloacae, K. pneumoniae, or methicillin-susceptible S. aureus.
Uncomplicated skin and skin structure infections: Caused by methicillin-susceptible S. aureus or Streptococcus pyogenes.
Dosage/Direction for Use
Adults: Usual dosage: 400 mg once every 24 hours. The duration of therapy depends on the type of infection. (See Table 2.)

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Mode of administration: Moxifloxacin may be taken with or without food; drink fluids liberally. Administer oral doses of moxifloxacin at least 4 hours before or 8 hours after products, including antacids, containing magnesium or aluminum, iron or zinc, sucralfate, metal cations (e.g., iron), multivitamins, and didanosine chewable/buffered tablets or pediatric powder for oral solution.
Overdosage
Manifestation: Single oral overdoses up to 2.8 g were not associated with any serious adverse events. In case of overdosage, monitor the patient in a suitably equipped medical facility and advise to avoid sun exposure for 5 days. ECG monitoring is recommended because of the possible prolongation of the QTc interval.
Treatment: The stomach should be empty by inducing vomiting or by gastric lavage. ECG monitoring is recommended because of the possible prolongation of the QT interval. Carefully observe the patient and give supportive treatment. Adequate hydration must be maintained. It is not known whether moxifloxacin is dialyzable.
Contraindications
Hypersensitivity to fluoroquinolones or the quinolone group; tendinitis or tendon rupture associated with quinolone use; any of the product components.
Special Precautions
Warnings: Moxifloxacin is contraindicated in patients with a history of hypersensitivity to the drug or to other quinolones.
The use of moxifloxacin in pregnancy and lactating women is not recommended.
Discontinue therapy of any fluoroquinolone antibiotics at the first signs or symptoms of rash, pain, myalgia, or tenodynia.
Moxifloxacin may be harmful to the liver and kidney.
Moxifloxacin should not be used or, if necessary, be used with caution in patients with known or suspected CNS disorders that predisposed to seizure and related to the administered dose.
Moxifloxacin may cause QT prolongation, use with caution in patients with the causative risks of QT prolongation e.g., elderly, cardiovascular disease especially arrhythmia, hypertension, hypokalemia etc.
Avoid concomitant use with the drugs known to cause QT prolongation e.g., antiarrhythmic drugs class IA (e.g., quinidine, procainamide), class III (e.g., amiodarone), cisapride, erythromycin, antipsychotic drugs, tricyclic antidepressants etc.
Moxifloxacin may cause phototoxic reactions or severe hypersensitivity such as Toxic Epidermal Necrolysis, Stevens-Johnson syndrome, Erythema Multiforme.
Moxifloxacin may alter blood glucose. Use with caution in patients with diabetes mellitus.
Concomitant use with warfarin may result in increased warfarin effect.
Fluoroquinolones, including moxifloxacin, are associated with an increased risk of tendonitis and tendon rupture in all ages. This risk is further increased in older patients usually older than 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart, or lung transplants.
Fluoroquinolones, including moxifloxacin, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid moxifloxacin in patients with known history of myasthenia gravis.
Cardiac toxicity: Moxifloxacin has been shown to prolong the QT interval of the electrocardiogram in some patients. Avoid in patients with known prolongation of the QT interval, patients with uncorrected hypokalemia, and patients receiving class IA (e.g., quinidine, procainamide) or class III (e.g., amiodarone, sotalol) antiarrhythmic agents, due to the lack of clinical experience with these drugs in these patients populations. Use with caution in patients with ongoing proarrhythmic conditions, such as significant bradycardia or acute myocardial ischemia.
Convulsion: Increased intracranial pressure, convulsion, and toxic psychosis have occurred. CNS stimulation may also occur, which may lead to tremor, restlessness, lightheadedness, confusion, dizziness, depression, hallucinations, and rarely, suicidal thoughts. Use with caution in patients with known or suspected CNS disorders (e.g., severe cerebral arteriosclerosis, epilepsy) or other factors that predispose to seizures or lower the seizure threshold, or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold (e.g., certain drug therapy, renal dysfunction). If these reactions occur, stop the drug, and institute appropriate measures.
Peripheral neuropathy: Rare cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in dysesthesias, hypesthesias, paresthesias, and weakness have been reported in patients receiving quinolones.
Clostridium difficile-associated diarrhea (CDAD): This has been reported with nearly all antibacterial agents, including fluoroquinolones, and may range from mild diarrhea to fatal colitis. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents.
Blood glucose abnormalities: As with other quinolones, disturbances of blood glucose, including symptomatic hyper- and hypoglycemia, have been reported, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic (e.g., glyburide) or with insulin. In these patients, careful monitoring of blood glucose is recommended. If a hypoglycemic reaction occurs, initiate appropriate therapy immediately.
Hypersensitivity reactions: Serious and occasionally fatal reactions have occurred in patients receiving quinolone therapy, some following the first dose. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and itching. If an allergic reaction occurs, discontinue the drug.
Superinfection: Use of antibiotics (especially prolonged or repeated therapy) may result in bacterial or fungal overgrowth of nonsusceptible organisms. Such overgrowth may lead to a secondary infection. Take appropriate measures if superinfection occurs.
Renal function impairment: The pharmacokinetic parameters of moxifloxacin are not significantly altered by mild, moderate, or severe renal impairment. No dosage adjustment is necessary in patients with renal impairment.
Hepatic function impairment: Moxifloxacin should be used with caution in mild, moderate, or severe hepatic insufficiency (Child-Pugh class A, B, or C) because the metabolic disturbances associated with hepatic insufficiency may lead to QT prolongation.
Use in Children: Safety and efficacy of moxifloxacin in children younger than 18 years of age have not been established. Moxifloxacin caused arthropathy and osteochondrosis in immature animals. Administration of moxifloxacin caused lameness in immature dogs due to permanent cartilage lesions.
Use in Elderly: Elderly patients may be more susceptible to drug-associated effects of QT interval and 7 tendon disorders. Use with caution, especially in those on corticosteroids.
Use In Pregnancy & Lactation
Pregnancy: Pregnancy category: C.
There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: Moxifloxacin is excreted in the breast milk of rats and may also be excreted in human milk. Because of the potential for serious adverse reactions in nursing infants, decide whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Adverse Reactions
2 to 10%: Central nervous system: Headache, dizziness, insomnia.
Endocrine & metabolic: Chloride increased, glucose decreased, ionized calcium increased.
Gastrointestinal: Nausea, diarrhea, amylase decreased, constipation, vomiting, abdominal pain.
Hematologic: Decreased serum levels of basophils, eosinophils, hemoglobin, PT, RBC, and neutrophils, increased serum levels of MCH, neutrophils, PT, and WBC.
Hepatic: Bilirubin decreased/increased.
Renal: Albumin increased.
Respiratory: PO2 decreased.
0.1 to <2%: Cardiovascular: Angina, atrial fibrillation, bradycardia, cardiac arrest, edema, heart failure, hypertension, hypotension, palpitation, peripheral edema, QTc prolongation, syncope, tachycardia.
Central nervous system: Fever, agitation, anxiety, chills, confusion, depression, disorientation, fatigue, hallucinations, hypoesthesia, lethargy, malaise, nervousness, pain, restlessness, somnolence, vertigo.
Dermatologic: Allergic dermatitis, erythema, hyperhidrosis, pruritus, rash, urticarial.
Endocrine & metabolic: Hypokalemia, dehydration, hyperglycemia, hyperlipidemia, triglycerides increased, uric acid increased.
Gastrointestinal: Dyspepsia, abdominal discomfort, abdominal distension, amylase increased, anorexia, appetite decreased, flatulence, gastritis, gastroenteritis, gastroesophageal reflux disease, lactic dehydrogenase increased, lipase increased, taste perversion, xerostomia.
Genitourinary: Dysuria, vaginitis, vulvovaginal candidiasis, vulvovaginal mycotic infection, vulvovaginal pruritus.
Hematologic: Anemia, eosinophilia, hematocrit decreased, leukocytosis, leukopenia, aPTT increased, thrombocytothemia, thrombocytopenia.
Hepatic: ALT increased, AST increased, alkaline phosphatase increased, GGTP increased, liver function test abnormal.
Neuromuscular & skeletal: Arthralgia, back pain, chest pain (noncardiac), facial pain, limb pain, muscle spasms, musculoskeletal pain, myalgia, paresthesia, tremor, weakness.
Ocular: Blurred vision.
Otic: Tinnitus.
Renal: BUN increased, creatinine increased, renal failure.
Respiratory: Asthma, bronchospasm, dyspnea, wheezing.
Miscellaneous: Allergic reaction, candidiasis, fungal infection, night sweats, oral candidiasis.
<0.1%: Agranulocytosis, anaphylactic reaction, anaphylactic shock, angioedema, aplastic anemia, C. difficile-positive diarrhea, cholestasis, deafness (reversible), ECG abnormalities, hearing impairment, hemolytic anemia, hepatic failure, hepatic necrosis, hepatitis, hypersensitivity reactions, INR decreased, interstitial nephritis, intracranial pressure increased, jaundice (cholestatic), myasthenia gravis exacerbation, nightmares, pancytopenia, peripheral neuropathy, photosensitivity/toxicity, pneumonitis (allergic), polyneuropathy, pseudomembranous colitis, pseudotumor cerebri, psychotic reaction, renal dysfunction, seizure, Stevens-Johnson syndrome, suicidal behavior/ideation, tendonitis, tendon rupture, thrombotic thrombocytopenic purpura, toxic epidermal necrolysis, ventricular tachyarrhythmias (including torsade de pointes and cardiac arrest [usually in patients with concurrent, severe proarrhythmic conditions]), vasculitis, vision loss (transient).
Drug Interactions
(See Table 3.)

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Storage
Do not store above 30°C. Store in original container.
MIMS Class
ATC Classification
J01MA14 - moxifloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Presentation/Packing
FC tab 400 mg (pink, oblong, debossed with "MF 40" on one side and "GPO" on the other side) x 1 x 5's.
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