ACUVAIL 4.5 mg/mL

ketorolac tromethamine · SOLUTION/ DROPS · Allergan, Inc.

No Recall HistoryCurrently in Shortage

Plain English

ACUVAIL is a solution/ drops containing ketorolac tromethamine at 4.5 mg/mL, taken ophthalmic. Manufactured by Allergan, Inc..

Key Facts

Brand Name: ACUVAIL
Generic Name: ketorolac tromethamine
NDC Code (Product): 0023-3507
Manufacturer: Allergan, Inc.
Strength: 4.5 mg/mL
Dosage Form: SOLUTION/ DROPS
Route: OPHTHALMIC
Marketing Status
Application #: NDA022427
Marketing Start: 08/01/2009

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective475 reports

drug hypersensitivity298 reports

nausea238 reports

headache231 reports

pain224 reports

fatigue209 reports

treatment failure205 reports

dyspnoea204 reports

off label use165 reports

vomiting148 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE ACUVAIL ® is indicated for the treatment of pain and inflammation following cataract surgery. ACUVAIL is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of pain and inflammation following cataract surgery. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION One drop of ACUVAIL should be applied to the affected eye twice daily beginning 1 day prior to cataract surgery, and continued through the first 2 weeks of the postoperative period. ( 2.1 ) 2.1 Recommended Dos age Apply one drop of ACUVAIL to the affected eye twice daily beginning 1 day prior to cataract surgery, continued on the day of surgery, and through the first 2 weeks of the postoperative period. 2.2 Use W ith Other Topical Ophthalmic Medications ACUVAIL may be administered in conjunction with other topical ophthalmic medications such as alpha-agonists, beta-blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics. Drops should be administered at least 5 minutes apart.

Contraindications

4 CONTRAINDICATIONS ACUVAIL 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 ADVERSE 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 )] Most common adverse reactions occurring in 1% to 6% of patients were increased intraocular pressure, conjunctival hemorrhage, and vision blurred. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1-800-678-1605 or 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 the rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reactions were reported in 1% to 6% of patients and included increased intraocular pressure, conjunctival hyperemia and/or hemorrhage, corneal edema, ocular pain, headache, tearing and vision blurred. Some of these reactions may be the consequence of…

Frequently Asked Questions

What is ACUVAIL used for?

ACUVAIL contains ketorolac tromethamine. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.

Is ACUVAIL a controlled substance?

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

What is the generic name for ACUVAIL?

The generic name for ACUVAIL is ketorolac tromethamine. There are 12 other brand versions of ketorolac tromethamine.

What is the NDC code for ACUVAIL 4.5 mg/mL?

The NDC (National Drug Code) for ACUVAIL 4.5 mg/mL is 0023-3507, listed by Allergan, Inc..

Product NDC

0023-3507

Package NDC

0023-3507-05

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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