Each 1 mL contains Moxifloxacin 1.60 mg.
1 bag contains 250 mL solution for infusion containing Moxifloxacin 400 mg.
Pharmacotherapeutic Group: Quinolone antibacterials, fluoroquinolones. ATC Code: J01MA14.
Pharmacology: Pharmacodynamics: Mechanism of Action: Moxifloxacin is a fluoroquinolone antibiotic which contains an 8-methoxy group and has been termed an 8-methoxy fluoroquinolone. The 8-methoxy and 7-diazabicylo moieties on the quinolone nucleus of moxifloxacin appear to enhance activity against gram-positive bacteria and decrease selection of resistant mutants in gram-positive bacteria.
Moxifloxacin inhibits DNA synthesis in susceptible organisms via inhibition of the type II DNA topoisomerases (DNA gyrase, topoisomerase IV). Cross-resistance can occur between moxifloxacin and other fluoroquinolones, but some gram-positive bacteria resistant to other fluoroquinolones may be susceptible to moxifloxacin.
Pharmacokinetics: The drug has mean serum elimination half-life of 8.2-15.4 hours following IV administration.
Moxifloxacin is metabolized principally via sufate and glucuronide conjugation; the drug is not metabolized by and does not appear to affect the cytochrome P-450 (CYP) enzyme system.
Movelox Injection 400 mg are indicated for the treatment of the following bacterial infections: Community acquired pneumonia (CAP), including CAP caused by multi-drug resistant strains*; complicated skin and skin structure infections, including diabetic foot infections; complicated intraabdominal infections, including polymicrobial infections such as abscess.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
*Multi-drug resistant Streptococcus pneumonia (MDRSP) includes isolates known as PRSP (Penicillin-resistant S. pneumoniae), and strains resistant to two or more of the following antibiotic: penicillin (MIC 2mg/ml), 2nd generation cephalosporins (e.g., cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole.
Movelox Injection 400 mg should be infused IV over 60 minutes, rapid IV infusion of the drug should be avoided.
Commercial available injection for IV infusion containing 400 mg of moxifloxacin in 0.8% sodium chloride injection may be used without further dilution.
When IV moxifloxacin therapy is used initially, therapy may be changed to oral moxifloxacin (when appropriate) using the same dosage to complete therapy. (See Table 1.)
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Special populations: Dosage adjustment is not necessary in patients with mild to moderate hepatic insufficiency (Child Pugh class A and B). The pharmacokinetics of moxifloxacin have not been evaluated in patients with severe hepatic insufficiency (Child Pugh class C).
No adjustment of dosage is required in patients with renal impairment, including those haemodialysis or continuous ambulatory peritoneal dialysis (CAPD).
Dosage adjustments based solely on age are not necessary for geriatric patients 65 years of age and older.
Mode of Administration:
Moxifloxacin is administered by IV infusion. The drug should not be given IM or by intrathecal, intraperitoneal, or subcutaneous administration.
Patients receiving IV moxifloxacin should be well hydrated and should be instructed to drink fluids liberally.
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; 5% Dextrose Injection; Lactated Ringer's for Injection.
No specific countermeasures after accidental overdose are recommended. General symptomatic therapy should be initiated. Concomitant administration of charcoal with a dose of 400 mg oral or intravenous moxifloxacin will reduce systemic availability of the drug by more than 80% or 20% respectively.
Known hypersensitivity to moxifloxacin, other quinolones, or any ingredient in the formulation.
Pregnancy and Lactation.
Patients below 18 years of age.
Tendinopathy and Tendon Rupture: Fluoroquinolones, including moxifloxacin, are associated with increased risk of tendinitis and tendon rupture in all age groups. This risk is further increased in older adults (usually those older than 60 years of age), individuals receiving concomitant corticosteroids, and kidney, heart, or lung transplant recipients.
Tendon rupture can occur during or following fluoroquinolone therapy and has been reported up to several months after completion of therapy.
Advise patients to rest and refrain from exercise and contact a clinician at the first sign of tendinitis or tendon rupture (e.g., pain, swelling, or inflammation of a tendon or weakness or inability to use a joint). Discontinue moxifloxacin if pain, swelling, inflammation, or rupture of a tendon occurs.
Musculoskeletal Effects: Safety and efficacy not established in children younger than 18 years of age or in pregnant or lactating women.
Prolongation of QT Interval: Prolonged QT interval leading to ventricular arrhythmias, including torsades de pointes, reported with some fluroroquinolones, including moxifloxacin.
Use of moxifloxacin should be avoided in patients with known prolongation of the QT interval, in those with uncorrected hypokalemia, and in those patients receiving class IA (e.g. quinidine, procainamide) or III (e.g. amiodarone, sotalol) antiarrhythmic agents.
Concomitant therapy with moxifloxacin and other drugs that prolong the QT interval (e.g., cisapride, erythromycin, antipsychotic agents, tricyclic antidepressants) has not been studied. Caution is advised when any of these drugs is used concurrently with moxifloxacin.
Moxifloxacin should be used with caution in patients with any ongoing proarrhythmic conditions, including clinically important bradycardia and acute myocardia ischemia.
The recommended dosage and IV infusion rate should not be exceeded since this may increase the risk of QT interval prolongation.
CNS Effects: Use with caution in patients with known or suspected CNS disorders (e.g., severe cerebral arteriosclerosis, epilepsy) or other risk factors that predispose to seizures or lower seizure threshold. If CNS effects occur, moxifloxacin should be discontinued.
Peripheral Neuropathy: Sensory or sensorimotor axonal polyneuropathy resulting in paresthesias, hypoesthesias, dysethesias, and weakness have been reported with fluoroquinolones. If a patient develops symptoms of peripheral neuropathy, the fluoroquinolone should be stopped, and the patient should be switched to another, nonfluoroquinolone antibacterial drug, unless the benefit of continued treatment with the drug outweighs the risk.
Superinfection/Clostridium difficile-associated Diarrhea: Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile. C. difficile-associated diarrhea and colitis (CDAD) has been reported in patients receiving fluoroquinolones, including moxifloxacin, and may range in severity from mild diarrhea to fatal colitis.
Consider CDAD if diarrhea develops and manage accordingly. Careful medical history is necessary since CDAD has been reported to occur as late as 2 months or longer after anti-infective therapy is discontinued. If CDAD is suspected or confirmed, moxifloxacin may need to be discontinued.
Hypersensitivity Reactions: Discontinue moxifloxacin at first appearance of rash, jaundice, or any other sign of hypersensitivity.
Photosensitivity Reactions: Moxifloxacin should be discontinued if photosensitivity or phototoxicity (sunburn-like reaction, skin eruption) occurs.
Specific Populations: Hepatic Impairment: Dosage adjustment not necessary in patients with mild to moderate hepatic insufficiency.
Renal Impairment: Dosage adjustment not necessary in patients with renal impairment.
Use in Children: Safety and efficacy not established in children or adolescents younger than 18 years of age.
Use in the Elderly: No overall differences in safety or efficacy were observed between geriatric individuals and younger adults.
Risk of severe tendon disorders, including tendon rupture, is increased in older adults. This risk further increased in those receiving concomitant corticosteroids. Use caution in geriatric adults, especially those receiving concomitant corticosteroids.
Risk of QT interval prolongation may be increased in geriatric patients.
Pregnancy: The use of this product during pregnancy is contraindicated (Category C).
Lactation: Moxifloxacin is distributed into milk in rats and may be distributed into human milk. Discontinue nursing or the drug because of potential for serious adverse effects in infants.
Adverse reactions observed with moxifloxacin 400mg daily administered by the intravenous or oral route sorted by frequencies are listed below.
Adverse drug reactions listed under "common" were observed with a frequencies below 3% with the exception of nausea and diarrhea.
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 Table 2.)
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The following adverse reactions have a higher frequency category in the subgroup of I.V treated patients with or without subsequent oral therapy: Common:
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).
Drugs that prolong QT interval: Potential pharmacologic interaction (additive effects on QT interval prolongation). Avoid concomitant use with class IA (e.g., quinidine, procainamide) or class III (e.g., amiodarone, sotalol) antiarrhythmic agents. Use with caution in patients receiving other drug that prolong the QT interval (e.g., cisapride, erythromycin, antipsychotic agents, tricyclic antidepressants).
Corticosteroids: Concomitant use of corticosteroids increases the risk of severe tendon disorders (e.g., tendinitis, tendon rupture), especially in geriatric patients older than 60 years of age.
Digoxin: No clinically important effect on pharmacokinetics of either drug. Dosage adjustment of moxifloxacin or digoxin not necessary.
Warfarin: No evidence of pharmacokinetic interactions. Careful monitoring of PT, INR, or other suitable coagulation tests in patients receiving concomitant warfarin and moxifloxacin is recommended.
Store below 30°C. Preserve in a hermetic containers.
Shelf-Life: 2 years.
J01MA14 - moxifloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Infusion (transparent, yellow aqueous solution in a non-PVC bag) 400 mg/250 mL x 1's.