Mograflox eye drops presentation


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Presentation for Mograflox (Moxifloxacin 0.5% eye drops) a Flouroquinolone used for the treatment of Keratitis, Conjunctivitis and corneal ulcers.

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Mograflox eye drops presentation

  1. 1.
  2. 2. Let us take a look again<br />on human eye structures <br />
  3. 3. Drug description<br />
  4. 4.
  5. 5. Mograflox®( Moxifloxacin Hcl ophthalmic solution)<br /> is a sterile ophthalmic solution. <br /><ul><li>It is an 8-methoxy fluoroquinolone anti-infective for topical ophthalmic use.</li></ul>Structure and Empirical Formula:<br />
  6. 6. Action & Clinical pharmacology<br />
  7. 7. Moxifloxacin is a synthetic fluoroquinolone antibacterial agent active against a broad spectrum of Gram-positive and Gram-negative ocular pathogens.<br />Mechanism of action<br />
  8. 8. <ul><li>DNA gyraseis an essential enzyme that is involved in the replication, transcription and repair of bacterial DNA.
  9. 9. Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division.</li></li></ul><li>Kinetics <br />
  10. 10. <ul><li>The mean steady-state Cmax and AUC were 2.7 ng/mL and 41.9 ngAhr/mL, respectively.
  11. 11. The plasma half-life of moxifloxacin was estimated to be 13 hours.</li></li></ul><li>Mograflox®ophthalmic solution is indicated for the treatment of patients 1 year of age and older with bacterial conjunctivitis & Keratitis caused by susceptible strains of the following organisms:<br />Aerobic, Gram-Positive<br />Staphylococcus aureus<br />Staphylococcus epidermidis<br />Staphylococcus haemolyticus<br />Staphylococcus hominis<br />Streptococcus pneumoniae<br />Streptococcus viridansgroup<br />Aerobic, Gram-Negative<br />Acinetobacterspecies<br />Haemophilusinfluenzae<br />
  12. 12. Mograflox®is also effective against:<br />MRSA and Pseudomonas aeruginosa<br />Moxifloxacin has a good activity against Pseudomonas aeruginosa. assisted by its excellent penetration power into the cornea which is much higher than Ciprofloxacin (used as a traditional therapy in Pseudomonas corneal ulcers before).<br />
  13. 13. Contra-Indications<br />
  14. 14. Mograflox®Ophthalmic solution is contraindicated in patients with a history of hypersensitivity to:<br />Moxifloxacin<br />Other quinolones<br />Any of the components in this medication<br />
  15. 15. Warnings<br />
  16. 16. <ul><li>Mograflox®ophthalmic solution is not for injection into the eye.
  17. 17. Mograflox®Solution should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye.</li></li></ul><li>Precautions<br />
  18. 18. <ul><li>General: As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms, including fungi. </li></ul>If super infection occurs, discontinue use and institute alternative therapy.<br /><ul><li>Patients should be advised not to wear contact lenses if they</li></ul>have signs and symptoms of bacterial conjunctivitis.<br />X<br />
  19. 19. <ul><li>Safety and effectiveness in infants below the age of one year have not been established.</li></li></ul><li>Drug interaction<br />
  20. 20. Drug-drug interaction studies have not been conducted with Mograflox®solution.<br />
  21. 21. Side effects<br />
  22. 22. <ul><li>The most frequently reported treatment-related adverse drug reactions were transient eye irritation</li></ul>(3.9%) (burning and/or stinging) and eye pruritus (1.1%).<br /><ul><li>Treatment-related adverse drug reactions that occurred at an incidence of 0.1% to less than 1.0% included the following:</li></ul>Eye disorders: ocular hyperaemia, keratoconjunctivitissicca, abnormal sensation in eye, ocular<br />discomfort, corneal epithelium defect,<br />conjunctivitis, conjunctival haemorrhage, visual<br />acuity reduced, eyelid oedema, eye pain.<br />
  23. 23. <ul><li>General disorders and administration site conditions: </li></ul>sensation of foreign body.<br /><ul><li>Investigations: corneal staining, alanine aminotransferase increased.</li></li></ul><li>Dosage & administration<br />
  24. 24. The recommended dosage regimen for patients<br />one year of age and older is one drop in the affected<br />eye(s) 3 times a day for 7 days.<br />
  25. 25. Pack & Price<br />
  26. 26. Mograflox® is supplied sterile in a white, low density polyethylene (LDPE) bottle with a controlled dropper tip and a tan, with the size 5 mL in an 10 mL bottle.<br />Price<br />30 L.E <br />
  27. 27. Competitors<br />
  28. 28. The 1st and the only available Moxifloxacin in the market (Till 6 /2010)is :<br />Vigamox<br />Price<br />45L.E <br />
  29. 29. So,, what is new in our hands??<br />
  30. 30. it valuable? <br />1- BAK is active against bacteria, some viruses, fungi and protozoa.<br />2- Enhances medication's absorption rate.<br />3- In some cases increases the speed of microbial killing.<br />4- Prevents contamination of the content of the bottle. <br />
  31. 31. Biocidal action of Benzalkoniumchloride<br />1- BAK causes dissociation of cellular membrane lipid bilayers, which compromises cellular permeability controls and induces leakage of cellular contents.<br />2- BAK Deactivates Enzymes, which finely control a wide range of respiratory and metabolic cellular activities.<br />
  32. 32. Benzalkonium chloride tolerability<br />In the patient with mild to moderate dry eye, BAK preserved solutions are usually well tolerated when used 4-6 times a day or less. <br />
  33. 33. Market Analysis<br />
  34. 34. VigamoxSales<br />In 2009<br />( Units )<br />
  35. 35. Total 2009 sales were: 151,837 unit<br />
  36. 36. VigamoxSales<br />2007 - 2009<br />( Units )<br />
  37. 37.
  38. 38. How to compete?!<br />
  39. 39. Mograflox®is the 1st Moxifloxacin 0.5% solution containing a preservative <br />(Benzalkonium Chloride 0.01%)<br />1<br />BAK<br />
  40. 40. Mograflox®is a high quality product with an affordable price, as patients can use the whole bottle with no fear of contamination with <br />only 30 L.E. / bottle<br />2<br />Price<br />
  41. 41. Mograflox® is a normal continuation for our successful R&D department sticking to the role of creating what the market really needs. <br />3<br />Beta pharma is serving for patients’ sake <br />
  42. 42. Now it’s your turn<br />Thanks ;)<br />