Acular 5 mg/mL

Ketorolac Tromethamine · SOLUTION/ DROPS · Allergan, Inc.

No Recall HistoryCurrently in Shortage

Plain English

Acular is a solution/ drops containing ketorolac tromethamine at 5 mg/mL, taken ophthalmic. Manufactured by Allergan, Inc..

Key Facts

Brand Name: Acular
Generic Name: Ketorolac Tromethamine
NDC Code (Product): 0023-2181
Manufacturer: Allergan, Inc.
Strength: 5 mg/mL
Dosage Form: SOLUTION/ DROPS
Route: OPHTHALMIC
Marketing Status
Application #: NDA019700
Marketing Start: 12/01/1992

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective524 reports

drug hypersensitivity323 reports

nausea265 reports

pain257 reports

headache253 reports

fatigue241 reports

dyspnoea230 reports

treatment failure213 reports

off label use176 reports

eye pain174 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE ACULAR LS ophthalmic solution is indicated for the reduction of ocular pain and burning/stinging following corneal refractive surgery. ACULAR LS ophthalmic solution is a nonsteroidal, anti-inflammatory drug (NSAID) indicated for the reduction of ocular pain and burning/stinging following corneal refractive surgery. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION One drop of ACULAR LS should be applied in the operated eye 4 times per day as needed for pain and burning/stinging for up to 4 days following corneal refractive surgery. ( 2.1 ) 2.1 Recommended Dosing The recommended dose of ACULAR LS ophthalmic solution is one drop four times a day in the operated eye as needed for pain and burning/stinging for up to 4 days following corneal refractive surgery. 2.2 Use With Other Topical Ophthalmic Medications ACULAR LS has been safely administered in conjunction with other topical ophthalmic medications such as alpha-agonists, antibiotics, beta-blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics. Drops should be administered at least 5 minutes apart.

Contraindications

4 CONTRAINDICATIONS ACULAR LS ophthalmic solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation [see Adverse Reactions ( 6.1 )] . Hypersensitivity to any component of this product. ( 4 )

Adverse Reactions

6 A DVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Delayed Healing [ see Warnings and Precautions (5.1) ] Cross-Sensitivity or Hypersensitivity [ see Warnings and Precautions (5.2) ] Increased Bleeding Time [ see Warnings and Precautions (5.3) ] Corneal Effects [ see Warnings and Precautions (5.4) ] The most common adverse reactions occurring in 1 - 5% of patients included conjunctival hyperemia, corneal infiltrates, headache, ocular edema and ocular pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1-800-678-1605 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most frequently reported adverse reactions for ACULAR LS ophthalmic solution occurring in approximately 1 to 5% of the overall study population were conjunctival hyperemia, corneal infiltrates, headache, ocular edema, and ocular pain. The most frequent ad…

Frequently Asked Questions

What is Acular used for?

Acular contains Ketorolac Tromethamine. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.

Is Acular a controlled substance?

Acular is not classified as a controlled substance by the DEA.

What is the generic name for Acular?

The generic name for Acular is Ketorolac Tromethamine. There are 12 other brand versions of Ketorolac Tromethamine.

What is the NDC code for Acular 5 mg/mL?

The NDC (National Drug Code) for Acular 5 mg/mL is 0023-2181, listed by Allergan, Inc..

Product NDC

0023-2181

Package NDC

0023-2181-05

Other Ketorolac Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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