Mosi

Mosi

moxifloxacin

Manufacturer:

FDC

Distributor:

Unimed
Full Prescribing Info
Contents
Moxifloxacin hydrochloride.
Description
Moxifloxacin Hydrochloride equivalent to Moxifloxacin base 0.545% w/v = 0.5% w/v.
Action
Pharmacology: Pharmacodynamics: Moxifloxacin has in vitro activity against a wide range of Gram-positive and Gram-negative microorganisms. Moxifloxacin inhibits the topoisomerase II (DNA gyrase) and topoisomerase IV required for bacterial DNA replication, transcription, repair and recombination. The C8-methoxy moiety of moxifloxacin also lessens the selection of resistant mutants of Gram-positive bacteria compared to the C8-methoxy moiety found in the older fluoroquinolones. Moxifloxacin's bulky C7 substituent group interferes with the quinolone efflux pump mechanism of bacteria. Moxifloxacin is often bacteriacidal at concentrations equal to or slightly greater than the inhibitory concentrations. Fluoroquinolones, including moxifloxacin is differ in chemical structure and mode of action from β-lactam antibiotics, macrolides and aminoglycosides, and therefore may be active against bacteria resistant to β-lactam antibiotics, macrolides and aminoglycosides. Therefore, organism resistant to these drugs may be susceptible to moxifloxacin. In-vitro resistance to moxifloxacin develops slowly via multiple-step mutations and occurs at a general frequency between 10-9 to 10-11 for Gram-positive bacteria.
Moxifloxacin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections: Gram-positive bacteria: Corynebacterium sp., Microbacterium sp., Micrococcus luteus [including erythromycin, gentamicin, tetracycline, and/or trimethoprim resistant strains], Staphylococcus aureus [including methicillin, erythromycin, gentamicin, ofloxacin, tetracycline and/or trimethoprim resistant strains], Staphylococcus epidermidis [including methicillin, erythromycin, gentamicin, ofloxacin, tetracycline and/or trimethoprim resistant strains]. Staphylococcus haemolyticus [including methicillin, erythromycin, gentamicin, ofloxacin, tetracycline and/or trimethoprim resistant strains], Staphylococcus hominis [including methicillin, erythromycin, gentamicin, ofloxacin, tetracycline and/or trimethoprim resistant strains], Staphylococcus warneri [including erythromycin resistant strains], Streptococcus mitis [including penicillin, erythromycin, tetracycline and/or trimethoprim resistant strains], Streptococcus pneumoniae [including penicillin, erythromycin, gentamicin, tetracycline and/or trimethoprim resistant strains], Streptococcus viridans [including penicillin, erythromycin, tetracycline and/or trimethoprim resistant].
Gram-negative bacteria: Actinetobacter sp., Haemophilus "alconae" [including ampicillin resistant strains], Haemophilus influenzae [including ampicillin resistant strains], Klebsiella pneumoniae, Moraxella catarrhalis, Pseudomonas aeruginosa.
Other microorganisms: Chlamydia trachomatis.
Moxifloxacin has been shown to be active in vitro against most strains of the following organisms; however, the significance of these data is unknown. (See table.)

Click on icon to see table/diagram/image

Pharmacokinetics: Following topical ocular administration of MOSI, moxifloxacin was absorbed into the systemic circulation. Study on the plasma concentration of moxifloxacin had taken placed and the mean steady state Cmax and AUC were 2.7 ng/ml and 41.9 ng.hr/ml. The plasma half-life of moxifloxacin was estimated to be 13 hours.
Indications/Uses
MOSI is indicated for treatment of patients 1 year of age and older with bacterial conjunctivitis caused by susceptible strains of the following organisms: Gram-positive bacteria: Corynebacterium sp.,
Microbacterium sp.,
Micrococcus luteus [including erythromycin, gentamicin, tetracycline, and/or trimethoprim resistant strains],
Staphylococcus aureus [including methicillin, erythromycin, gentamicin, ofloxacin, tetracycline and/or trimethoprim resistant strains],
Staphlococcus epidermidis [including methicillin, erythromycin, gentamicin, ofloxacin, tetracycline and/or trimethoprim resistant strains],
Staphylococcus haemolyticus [including methicillin, erythromycin, gentamicin, ofloxacin, tetracycline and/or trimethoprim resistant strains],
Staphylococcus hominis [including methicillin, erythromycin, gentamicin, ofloxacin, tetracycline and/or trimethoprim resistant strains],
Staphylococcus warneri [including erythromycin resistant strains],
Streptococcus mitis [including penicillin, erythromycin, tetracycline and/or trimethoprim resistant strains],
Streptococcus pneumoniae [including penicillin, erythromycin, gentamicin, tetracycline and/or trimethoprim resistant strains],
Streptococcus viridans [including penicillin, erythromycin, tetracycline and/or trimethoprim resistant strains].
Gram-negative bacteria: Acinetobacter sp.,
Haemophilus "alconae" [including ampicillin resistant strains],
Haemophilus influenza [including ampicillin resistant strains],
Klebsiella pneumoniae,
Moraxella catarrhalis,
Pseudomonas aeruginosa.
Other microorganisms: Chlamydia trachomatis.
*Efficacy for this organism was studied in fewer than 10 infections.
Dosage/Direction for Use
Instill one drop in the affected eye 3 times a day for 7 days.
Overdosage
No information is available on overdosage in humans. If a topical overdose of moxifloxacin Ophthalmic Solution occurs, the eye(s) may be flushed with tap water.
Contraindications
MOSI is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the other components in this medications.
Warnings
For ocular use only. Not for injection. Moxifloxacin solution should be injected subconjunctivally or introduced directly into the anterior chamber of the eye.
In patients receiving systemically administered quinolones, serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported, some following the first dose. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticarial, and itching. If an allergic reaction to moxifloxacin occurs, discontinue use of the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management should be administered as clinically indicated.
Special Precautions
General: As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. If superinfection occurs, discontinue use and institute alternative therapy. Whenever clinical judgment dictates, the patient should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis.
Information for Patients: Avoid contaminating the applicator tip with material from the eye, fingers or other source. Systematically administered quinolones have been associated with hypersensitivity reactions, even following a single dose. Discontinue use immediately and contact your physician at the first sign of a rash or allergic reaction.
Carcinogenesis, Mutagenesis , Impairment of Fertility: Moxifloxacin was not mutagenic in four bacterial in four bacterial strains used in the Ames Salmonell reversion assay. As with other quinolones, the positive response observed with moxifloxacin in strain TA 102 using the same assay may be due to the inhibition of DNA gyrase. Moxifloxacin was not mutagenic in the CHO/HGPRT mammalian cell gene mutation assay. An equivocal result was obtained in the same assay when V79 cells were used. Moxifloxacin was clastogenic in the V79 chromosome aberration assay, but it did not induce unscheduled DNA synthesis in cultured rat hepatocytes. There was no evidence in vivo in a micronucleus test or a dominant lethal test in mice.
Exacerbation of myasthenia gravis: Fluoroquinolones have neuromuscular blocking activity and may exacerbate muscle weakness in person with myasthenia gravis. Post marketing serious adverse events, including deaths and requirement for ventilator support have been associated with flouroquinolones use in persons with myasthenia gravis. Avoid flouroquinolones in patients with known history of myasthenia gravis.
Use in Children: Safety and effectiveness in pediatric patients below the age of 1 year have not been established. There is no evidence that the ophthalmic administration of MOSI has any effect on weight bearing joints, even though oral administration of some quinolones has been shown to cause arthropathy in immature animals.
Use in Elderly: No overall differences in safety and effectiveness have been observed between elderly and other adult patients.
Use In Pregnancy & Lactation
Teratogenic Effects.
Pregnancy: Category C: Since there are no adequate and well-controlled studies in pregnant woman, MOSI should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Nursing Mothers: Moxifloxacin has not been measured in human milk, although it can be presumed to be excreted in human milk. Caution should be exercise when MOSI is administered to a nursing mother.
Adverse Reactions
Post Marketing Experience: Exacerbation of myasthenia gravis: No serious ophthalmic or systemic adverse reactions related to MOSI were reported.
Adverse reactions were generally mild and occurred at an incidence similar to placebo (vehicle). The most frequently reported event was transient ocular discomfort (burning/stinging). Other reported events included headache, keratitis, ocular pruritus, ocular hyperemia, pharyngitis and subconjunctival haemorrhage which were reported at an incidence.
Drug Interactions
No serious ophthalmic or systemic adverse relations to MOSI were reported.
Storage
Storage condition: Preserve in tight containers. Store below 30°C.
Storage condition after first opening. Preserve in tight containers. Store below 30°C.
Shelf-Life: 24 months.
Shelf-Life after first opening: 28 days.
ATC Classification
S01AE07 - moxifloxacin ; Belongs to the class of quinolone antiinfectives. Used in the treatment of eye infections.
Presentation/Packing
Ophth soln 0.5% w/v (clear, yellow coloured solution) x 5 mL.
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