DUREZOL *
Manufacturer Details
SIRION THERAPEUTICS INC.
Compositions:
0.05 ophthalmic emulsion,
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Strength
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Rate
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Packing Style
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0.05% emulsion
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0.00
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2.5ml/5ml bottles
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List of Related Indications:
- Ocular Inflammation and pain
List Of Drugs:
- Difluprednate - Ophthalmic Agents - Corticosteroids- ( FDC- List )
Indication Type Description:
Indication:
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1. Difluprednate 0.05% w/v + 22-09-2011
moxifloxacin 0.5% w/v eye drops
For steroid responsive inflammatory ocular conditions for which a coorticosteroid
is indicated and where bacterial infection or a risk of bacterial ocular infection exists
2. Difluprednate Ophthalmic Emulsion 30-03-2010
0.05% w/v
For the treatment of inflammation and pain associated with ocular surgery
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
Diefluprednate 0.05% w/v + 22-09-2011
Moxifloxacin 0.5% w/v eye Drops
For steroid responsive inflammatory ocular conditions for
which a corticosteroid is indicated and where bacterial
infection or a risk of bacterial ocular infection exists
Ocular inflammation and pain - treatment of inflammation and pain associated with ocular surgery
Dosages/ Overdosage Etc:
Indication-
Ocular inflammation and pain - treatment of inflammation and pain associated with ocular surgery
Dosage-
Instill 1 drop into the conjuntiva sac of the affected eye/s 4 times daily beginning 24 hours
after surgery and continuing through out the first 2 weeks of the post operative period followed
by 2 times daily for 1 week and then taper based on response
Store at 15 to 25C ( 59 to 77F ). do not freeze. Protect from light
