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HSA Approval

TRUSOPT OPHTHALMIC SOLUTION 2%

SIN08880P

TRUSOPT OPHTHALMIC SOLUTION 2%

TRUSOPT OPHTHALMIC SOLUTION 2%

August 28, 1996

SANTEN PHARMACEUTICAL ASIA PTE. LTD.

SANTEN PHARMACEUTICAL ASIA PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantSANTEN PHARMACEUTICAL ASIA PTE. LTD.
Licence HolderSANTEN PHARMACEUTICAL ASIA PTE. LTD.

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

SOLUTION

**DOSAGE AND ADMINISTRATION** When used as monotherapy, the dose is one drop of TRUSOPT Ophthalmic Solution in the affected eye(s) three times daily. When used as adjunctive therapy with an ophthalmic beta-blocker, the dose is one drop of TRUSOPT in the affected eye(s) two times daily. When substituting TRUSOPT for another ophthalmic antiglaucoma agent, discontinue the other agent after proper dosing on one day, and start TRUSOPT on the next day. If more than one topical ophthalmic drug is being used, the drugs should be administered at least ten minutes apart.

OPHTHALMIC

Medical Information

**INDICATIONS** TRUSOPT Ophthalmic Solution is indicated in the treatment of elevated intraocular pressure in patients with: - ocular hypertension - open-angle glaucoma - pseudoexfoliative glaucoma and other secondary open-angle glaucomas

**CONTRAINDICATIONS** TRUSOPT is contraindicated in patients who are hypersensitive to any component of this product.

S01EC03

dorzolamide

Manufacturer Information

SANTEN PHARMACEUTICAL ASIA PTE. LTD.

Santen Pharmaceutical Co., Ltd. Noto Plant

Active Ingredients

DORZOLAMIDE HCl EQV DORZOLAMIDE

2%

Dorzolamide

Documents

Package Inserts

Trusopt Opthalmic Solution 2% PI.pdf

Approved: October 25, 2021

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