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Moxicip (Moxifloxacin HCL)
P1391 Moxicip (Moxifloxacin HCL) Cipla 5 ml drops 0.50% $7.56
Price is per pack & not per tab.. eg: if pack size is 10 tabs & price is $2.75 then for 100 tabs the price would be $27.50

Moxifloxacin 0.5% Eye Drops MOXICIP Eye Drops

Each ml contains: Active: Moxifloxacin 0.5% (5 mg/mL); Inactives: Boric acid, sodium chloride, and purified water. May also contain hydrochloric acid/sodium hydroxide to adjust pH to approximately 6.8.

Ophthalmic Solution

Pharmacodynamics Moxifloxacin is an 8-methoxy fluoroquinolone with a diazabicyclononyl ring at C7 position. The antibacterial action of moxifloxacin results from inhibition of the topoisomerase II (DNA gyrase) and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription and repair of bacterial DNA. Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division. The mechanism of action for quinolones, including moxifloxacin, is different from that of macrolides, aminoglycosides, or tetracyclines.

Therefore, moxifloxacin may be active against pathogens that are resistant to these antibiotics and these antibiotics may be active against pathogens that are resistant to moxifloxacin. There is no cross-resistance between moxifloxacin and the aforementioned classes of antibiotics. Cross resistance has been observed between systemic moxifloxacin and some other quinolones. In vitro resistance to moxifloxacin develops via multiple-step mutations. Resistance to moxifloxacin occurs in vitro at a general frequency of between 1.8 × 10 -9 to < 1 × 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 as described in the INDICATIONS section: Aerobic Gram-positive microorganisms : Corynebacterium species * ,Micrococcusluteus * ,Staphylococcus aureus ,Staphylococcus epidermidis ,Staphylococcus haemolyticus ,Staphylococcus hominis ,Staphylococcus warneri * ,Streptococcus pneumoniae ,Streptococcus viridans group Aerobic Gram-negative microorganisms : Acinetobacter lwoffii * ,Haemophilus influenzae ,Haemophilus parainfluenzae * Other microorganisms : Chlamydia trachomatis The following in vitro data are also available, but their clinical significance in ophthalmic infections is unknown. The safety and effectiveness of moxifloxacin in treating ophthalmological infections due to these microorganisms have not been established in adequate and well-controlled trials.

The following organisms are considered susceptible when evaluated using systemic breakpoints. However, a correlation between the in vitro systemic breakpoint and ophthalmological efficacy has not been established. The list of organisms is provided as guidance only in assessing the potential treatment of conjunctival infections. Moxifloxacin exhibits in vitro minimal inhibitory concentrations (MICs) of 2 µg/ml or less (systemic susceptible breakpoint) against most (>/= 90%) of strains of the following ocular pathogens. Aerobic Gram-positive microorganisms: Listeria monocytogenes ,Staphylococcus saprophyticus ,Streptococcus agalactiae ,Streptococcus mitis ,Streptococcus pyogenes ,Streptococcus Group C, G and F Aerobic Gram-negative microorganisms: Acinetobacter baumannii ,Acinetobacter calcoaceticus ,Citrobacter freundii Citrobacter koseri ,Enterobacter aerogenes ,Enterobacter cloacae ,Escherichia coli ,Klebsiella oxytoca ,Klebsiella pneumoniae ,Moraxella catarrhalis ,Morganella morganii ,Neisseria gonorrhoeae ,Proteus mirabilis ,Proteus vulgaris ,Pseudomonas stutzeri Anaerobic microorganisms: Clostridium perfringens ,Fusobacterium species ,Prevotella species ,Propionibacterium acnes Other microorganisms: Chlamydia pneumoniae ,Legionella pneumophila ,Mycobacterium avium Mycobacterium marinum ,Mycoplasma pneumonia *Efficacy for this organism was studied in fewer than 10 infections. Pharmacokinetics Plasma concentrations of moxifloxacin were measured in healthy adult male and female subjects who received bilateral topical ocular doses of moxifloxacin ophthalmic solution 3 times a day. The mean steady-state C max (2.7 ng/mL) and estimated daily exposure AUC (45 ng·hr/mL) values were 1,600 and 1,000 times lower than the mean C max and AUC reported after therapeutic 400 mg oral doses of moxifloxacin. The plasma half-life of moxifloxacin was estimated to be 13 hours.

Moxifloxacin ophthalmic solution is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of the following organisms: Aerobic Gram-positive microorganisms : Corynebacterium species * ,Micrococcus luteus * ,Staphylococcus aureus ,Staphylococcus epidermidis ,Staphylococcus haemolyticus ,Staphylococcus hominis ,Staphylococcus warneri * ,Streptococcus pneumoniae ,Streptococcus viridans group Aerobic Gram-negative microorganisms : Acinetobacter lwoffii * ,Haemophilus influenzae ,Haemophilus parainfluenzae * Other microorganisms: Chlamydia trachomatis *Efficacy for this organism was studied in fewer than 10 infections.

Instill one drop in the affected eye 3 times a day for 7 days.

Moxifloxacin ophthalmic solution is contraindicated in patients with a history of hypersensitivity to moxifloxacin, to other quinolones, or to any of the components in this medication

Moxifloxacin ophthalmic solution should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye. Drug interactions Drug-drug interaction studies have not been conducted with moxifloxacin ophthalmic solution. In vitro studies indicate that moxifloxacin does not inhibit CYP3A4, CYP2D6, CYP2C9, CYP2C19, or CYP1A2 indicating that moxifloxacin is unlikely to alter the pharmacokinetics of drugs metabolized by these cytochrome P450 isozymes.

Since there are no adequate and well-controlled studies in pregnant women, moxifloxacin solution should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus. Lactation Moxifloxacin has not been measured in human milk, although it can be presumed to be excreted in human milk. Caution should be exercised when moxifloxacin solution is administered to a lactating female. Paediatric use The safety and effectiveness of moxifloxacin ophthalmic solution in infants below 1 year of age have not been established.

Geriatric Use
No overall differences in safety and effectiveness have been observed between elderly and younger patients. In patients receiving systemically administered quinolones, including moxifloxacin, 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, urticaria, 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. 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 examined with the aid of magnification, such as slit-lamp biomicroscopy, and, where appropriate, fluorescein staining. Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial conjunctivitis. Avoid contaminating the applicator tip with material from the eye, fingers or other source. Systemically administered quinolones including moxifloxacin 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.

The most frequently reported ocular undesirable effects were conjunctivitis, decreased visual acuity, dry eye, keratitis, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, sub-conjunctival hemorrhage, and tearing. These events occurred in approximately 1-6% of patients. Nonocular undesirable effects reported at a rate of 1-4% were fever, increased cough, infection, otitis media, pharyngitis, rash, and rhinitis.



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