Moxezar P 5ml
Moxifloxacin 0.3% and
PrednisolO9eAcetale%
Moxezar- P Eye Drops
COMPOSITION
Moxifloxacin 0.5% w/n
Prednisolone acelate 1% w/n
Benzalkonium Chloride Solution IP (as preservative)0.02%w/n in Sterileaqueous vehicle q.s.
DOSAGE Form Opthalmic Suspension:
DESCRIPTION : Moxezar-P is a combination of Moxifloxacin a fluoroquinolone Antimicrobial and presnisolone, a potent corticosleroid. Occur inflammation and Infection often coexist. Combination of antiblotic-steriod exerts efficacy in resolving both infection and inflammation.
PHARMACOLOGY : Pharmacodynamics Moxifloxacin is an 8-methoxyfluoroquinolone with a 3- methypiperazinyl substitute at C7 . The antibacterial action of Moxifloxacin result from inhibition of DNAgyrase and topolsomerase IV.DNAgyrase is an essential enzyme that is involved in the replication, transcription and repair of bacterial DNA. Topolosomerase IV is an enzyme known to play a key role in the portioning of the chromosomal DNA during bacterial cell division.
PREDNISOLONE ACETATE
Prednisolone acetate is a glucocortiocoid that, on the basis of weight, has 3 to 5 times The anti-inflammatory potency of hydrocortisone. Glucocorticoids the hibit the edema Fibrin deposition. Capillary dilation, and phagocytic migration of the acute Inflammatory response . As well as capillary proliferation , deposition of collagen and Scar formation. Pharmacokinetics Moxifloxacin ophthalmic solution 0.3% or 0.5% was Administered to one eye of 6 healthy male subjects each in an escalated dosing Regimen starting with a single 2 drop dose, then 2 drops 4 times daily for 7 days and Finally 2 drops 8 times daily for 3 days. At all time points, serum Moxifloxacin levels Were below the lower limit of quantification(5 ng/ml)in all subjects.
INDICATIONS : Moxezar – P is indicated for steroid-responsive inflammatory ocular Conditions for which a corticosteroid is indicated and where bacterial infection or a Risk of bacteria ocular infection exists.Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjuctive , comea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjuctivies is accepted to obtain a diminution in edema and inflammation.They are also indicated in chronic anterior uvities and come all injury from chemical radiation , Or thermal burns, or penetration of foreign bodies.Me use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.The combination can also be - used for post – operative inflammation and any other ocular inflammation assoiciated with infection.
DOSAGE AND ADMINISTRATION :
One or two drops instilled into the conjuctival Sac(s) , every 4 to 6 hours. During the initial 24 to 48 hours.the dosage may be increased to 1 or 2 drops every two hours.Frequency must be decreased gradually or warranted by improvement in clinical signs. Care should be taken not to discontinue the therapy Prematurely – CONTRADICTIONS :Moxzar - P is contraindicated in epithell al Herpes simplex keratitis (Dendritic Keratits),Vaccinia Varicella, and in many other viral diseases of the cojuctive and comea,Individuals hypersensitive to any of the components of the medication.
WARNING AND PRECAUTIONS : Pharmacodynamics Moxifloxacin is an 8-methoxyfluoroquinolone with a 3- methypiperazinyl substitute at C7 . The antibacterial action of Moxifloxacin result from inhibition of DNAgyrase and topolsomerase IV.DNAgyrase is an essential enzyme that is involved in the replication, transcription and repair of bacterial DNA. Topolosomerase IV is an enzyme known to play a key role in the portioning of the chromosomal DNA during bacterial cell division.For Topical Opthalmic Use only in patients receiving systemic quinolones, including Moxifloxacine, serious and occasionally fatal hypersensitivity (anaphylatic) reactions, some following cardiovascular collapse loss of consciousness, angioadema, uticaria, and itching. If an allergic reaction to Moxifloxacin occurs, discontinue the drug.Undesirable EFFECTS Undesirable effects have occurred with steroid anti-Infective combination drugs,Which can be attributed to the steroid component The anti-infective component or the combination which are described below. Moxifloxacin,The most frequently reported adverse events in the overall study Population were conjunctive irritation , increased lacrimation,Keratitis,and papillary Conjunctivitis.In case of such events stop using the therapy & consult your physician. Storage and handling instruction store in a cool place, Protect from light Packaging information Moxezar-P-Eye Drops:Vial of 10ml