Flario T Eye Drops


Flario Eye Drops
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    FLUOROMETHOLONE ACTIONS :
    Corticosteroids, such as Fluorometholone, inhibit the inflammatory response to a variety of inciting agents.The inhibit edema fibrin deposition, capillary dilation & Perforation, leukocyte migration, phagocytic activity, deposition of collagen and scar formation associated with inflammation. Corticosteroids inhibit the synthesis of histamine within the mast cells.They also decrease prostaglandin synthesis and epithelial regeneration, Corticosteroids are capable of raising the intra ocular pressure.

DESCRIPTION:

Each mL contains:                            
Tobramycin Sulphate USP Equivalent to Tobramycin           3mg
Fluorometholone USP                                                         1mg
Benzalkonium Chloride IP/USNF                                      0.05mg
Purified Water IP                                                                   q.s


FLUOROMETHOLONE ACTIONS:
Corticosteroids, such as Fluorometholone, inhibit the inflammatory response to a variety of inciting agents.The inhibit edema fibrin deposition, capillary dilation & Perforation, leukocyte migration, phagocytic activity, deposition of collagen and scar formation associated with inflammation. Corticosteroids inhibit the synthesis of histamine within the mast cells.They also decrease prostaglandin synthesis and epithelial regeneration, Corticosteroids are capable of raising the intra ocular pressure.

INDICATIONS:
1.FLARIO – T is effective in treatement of infectious conjunctivitis due to organisms sensitive to Tobramycin. 2.FLARIO – T imay be used for the treatment of the anterior segment inflammatory discovers which may be threatened  with  or  complicated  by  bacteria  sensitive  to  Tobramycin.
3.FLARIO – T  is  effective following removal off oreign bodies as well as before and after surgery where the possibility of infection with susceptible organisms exists.

TOBRAMYCIN ACTIONS:
Tobramycin is an Aminoglycoside antibiotic obtained from the culture of Streptomyces tenebranius.Tobramycin is bactericide in actions and exerts its effects by inhibiting protein synthesis by binding irreversibly to 30 ribosomal subunits.Tobramycin has been shown to be active in-vitro against staphylococci including S. aureus and  S. epidermidis,including enicillin    resistant strains. Streptococci including S.pneumoniae,Pneumoniae, Pseudomonas aeruginose, Escherichia coli,  Klebsiella Pneumoniae,Enterobacter aerogences, Haemophilus influenza, Ancinetobacter calcoceticus & some Neisseria species.Bacterial susceptibility studies demonstrate that in some cases,microorganisms resistant to Gentamycin retain susceptibility  To Tobramycin. Bacterial resistance may develop upon prolonged  use.

CONTRADICTION :
Acute superficial herpers simplex (dendritic keratitis),vaccinia, Varicella and most viral diseases of the cornea and conjunctiva ,ocular tuberculosis,and fungal diseases of the eye,and sensitivity to the drug.It is contraindicated in patients with history of hypersensitivity to Tubramycinor to any of the components in this medication.

WARNINGS :
1.In those diseases causing thinning of the cornea,perforation has been reported with the use of topical steroids.

2.Acute purulent infections of the eye may be masked or enhanced by the use of topical steroid.
3.Use of steroids medication in presence of stormal herpes simplex requires caution and should be followed by frequent mandatory slit-lamp microscopy.
4.As fungal infections of the cornea have been reported coincidentally with long-term local steroid applications, tungal invasion may be suspected in persistent cornea ulceration where a steroid has been used,or is in use.
5.Use of topical corticosteroids may cause increased intraocular pressure in certain individuals.This may result in damage to the optic nerve with defects in teh visual field.It is advisable that the intraocular pressure be checked frequently.


USE IN PREGNANCY :
Safety of intensive or protracted use of topical steroids during pregrancy has not been substantiaited.Category B Reproduction studies in animal using systemic Tobramycin dosages upto 33 times the usual human systemic dosage using topical of systemic Tobramycin in Pregnant women and ophthalmic Tobramycin should be used during pregnancy only when clearly needed.

PRECAUTONS:
Posterior sub capsular cataract formation has been reported after heavy or protracted use of topical ophthalmic corticosteroids.Patients with histories of herpes simplex keratitis should be treated with caution.As with other anitoccurs discontinue use and institute alternative therapy.

ADVERSE REACTIONS:
Increased intraocular pressure,with optic nerve damage,defects in the visual fields.Also posterior sub capsular cataract  formatoion, secondary ocular infections from fungi or viruses liberated from ocular tissues,and perforation of the globe when used in conditions where there is thinning of the cornea orsclera.systemic side effects may occur wit extensive use of steroids.The most frequently reported    drug-related adverse reaction was transient ocular burning or discomfort. Other reported reactions include increase ophthalmric Tobramycin and usually disappear when the drug is discontinued.

DOSAGE AND ADMINISTRATION:
1 to 2 drops instilled into conjunctival sac two to three times daily.Suring the initial acute phase the dosage may safely be increased to 2 drops every hour.Care should be taken to discontinue therapy prematurely.

OVERDOSAGE:
Clinically apparent symptoms of overdosage may be seen as punclate keratitis.Erythema,lid edema,etc. The drug should with held and appropriate change in therapy instituted.

HOW SUPPLIED:
FLARIO-T (Tobramycin sulphate plus Fluorometholone ophthalmic suspension)is supplied in sterile 5 ml plastic dropper bottle.
Note:Store in a cool dry place.Shake well before use.

PREDNISOLONE ACETATE:
Prednisolone acetate is a glucocortiocoid that, on the basis of weight, has 3 to 5 timesThe 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.

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