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HSA Approval

ACULAR OPHTHALMIC SOLUTION 0.5%

SIN11189P

ACULAR OPHTHALMIC SOLUTION 0.5%

ACULAR OPHTHALMIC SOLUTION 0.5%

October 11, 1999

ABBVIE PTE. LTD.

ABBVIE PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantABBVIE PTE. LTD.
Licence HolderABBVIE PTE. LTD.

Product Classification

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

Formulation Information

SOLUTION

**DOSAGE AND ADMINISTRATION** The recommended dose of ACULAR® ophthalmic solution is one drop (0.25 mg) four times a day for relief of ocular itching due to seasonal allergic conjunctivitis. For the treatment of postoperative inflammation in patients who have undergone cataract extraction, one drop of ACULAR® ophthalmic solution should be applied to the affected eye(s) four times daily beginning 24 hours after cataract surgery and continuing through the first 2 weeks of the postoperative period.

OPHTHALMIC

Medical Information

**INDICATIONS AND USAGE** ACULAR® ophthalmic solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. ACULAR® is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.

**CONTRAINDICATIONS** ACULAR® ophthalmic solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation.

S01BC05

ketorolac

Manufacturer Information

ABBVIE PTE. LTD.

ALLERGAN PHARMACEUTICALS IRELAND

Active Ingredients

KETOROLAC TROMETHAMINE

0.5% w/v

Ketorolac

Documents

Package Inserts

Acular Ophthalmic Solution PI.pdf

Approved: April 26, 2018

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