FLOSOFT
Brand:
FLOSOFT
Manufacturer:
CIPLA
Manufacturer Details
CIPLA
Compositions:
Fluorometholone 0.1% w/v eye drops 5ml,
Strength
|
Rate
|
Packing Style
|
0.1% w/v
|
99.50
|
5ml eye drops
|
List of Related Indications:
- Allergic & Inflammatory conditions of the eye
List Of Drugs:
- Fluorometholone - @ Ophthalmic Corticosteroids- (FDC- List )( July 1996)
Indication Type Description:
Pharmacology/ Pharmacokinetics
Indication:
Coticosteroid sensitive inflammation
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Fluromethalone In non inflammatory 20-07-1996
with Neomycin ocular condition
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
1.Flurometholone 1mg+ 04-09-1996
Neomycin sulphate 3.5mg (as base) +
Benzalkonium chloride 0.04mg per ml
Ophthalmic suspension
In the treatment of infected Inflammatory ocular condition
2.Flurometholone USP 1mg+ 28-07-2000
Gentamicin 3mg (as sulphate) per ml drops
The infection of the anterior segment of the eye due to
bacteria susceptible to gentamicin
3.Flurometholone 10mg + 28-04-1997
Gentamicin sulphate 3mg per ml
Eye drops
The infection of the anterior segment of the eye due to
bacteria susceptible to Gentamicin
Adverse Reaction:
Glaucoma ( elevated IOP ) with optic nrve damage loss of visual acuity and field defects posterior subcapsular cataract formation secondary ocular infection exacerbation of viral or fungal infections transcient stinging , blurred vision dischage discomfort ocular pain foreign body sensation
Contra-Indications:
acute suprerficial herpes simplex. keratitis, fungal diseases of ocular structure Warnings moderate to severe inflammation - use highrer strengths for moderate to severe inflammation when deeper ocular structres are involved use systemic therapy Ocular damage- prolonged use may result in glaucoma, elvated IOP, optic nerve damage defects in visual acuity and field visions posterior subcapsular cataract formation of secondary ocular infections from pathogens liberated from ocular tissues
Dosages/ Overdosage Etc:
Corneal injury Inflammatory conditions of eye
Instil 1 or 2 drops into the conjuntival sac every hour during the day and every 2 hours during the night
Patient Information:
1. Medical supervison is recommended
2, To avoid contamination , do not tough applicator tip to any surface, replace cap after every use
3. If improvement in condition does not occur within several days or pain , itching or swelling of eye occurs, notify physician
4. Do not discontinue without consulting physician
5. Take care not to discontinue prematurely
Pharmacology/ Pharmacokinetics:
Pharmacology :
Topical corticosteroids exert an anti-inflammatory action Mechanism of anti-inflammatory action is thought to be potentiation of epinephrine vasoconstriction , stabilisation of lysosomal membranes, retardation of macrophage movement, prevention of kinase release, inhibition of lymphocyte and neutrophil function, inhibition of prostagladin synthesis and in prolonged use decrease in antibody production
Pregnancy and lactation:
Pregnancy :
Use only when clearly needed when potential benefits outweigh potential hazards
Lactation:
Excercise caution when administering to nursing mother
Children:
Safety and efficacy have not been established