Acuvail

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• 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.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Use in children

The safety and effectiveness of ACUVAIL have not been established in pediatric patients younger than 2 years old.

Quoted from the official label, section “Pediatric Use”.

Use in older people

No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

Quoted from the official label, section “Geriatric Use”.

Side effects

• 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 the cataract surgical procedure.
• Other adverse reactions occurring during treatment with ketorolac tromethamine ophthalmic solutions included allergic reactions (including eye swelling, hyperemia, and pruritis).
• 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of ketorolac tromethamine ophthalmic solutions in clinical practice.
• Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to the drug.
• Eye Disorders:
• Corneal erosion, corneal perforation, corneal thinning and corneal melt, epithelial breakdown [see Warnings and Precautions ( 5.2 , 5.4 )] , and ulcerative keratitis.
• Respiratory, Thoracic and Mediastinal Disorders : Bronchospasm, exacerbation of asthma.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• Slow or Delayed Healing Advise patients of the possibility that slow or delayed healing may occur while using nonsteroidal anti-inflammatory drugs (NSAIDs).
• Avoiding Contamination of the Product Instruct patients that the solution from one individual single-dose vial is to be used immediately after opening for administration to the affected eye.
• The remaining vial contents should be discarded.
• Instruct patients to
• avoid allowing the tip of the single-dose vial to contact the eye or surrounding structures because this could cause the tip to become contaminated by common bacteria known to cause ocular infections or cause injury to the eye.
• Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.
• Store the vials in the pouch, protected from light.
• Fold pouch ends closed.
• Contact Lens Wear Advise patients that ACUVAIL should not be administered while wearing contact lenses.
• Intercurrent Ocular Conditions Advise patients that if they develop an intercurrent ocular condition (e.g., trauma or infection) or have ocular surgery, they should immediately seek their physician’s advice concerning the continued use of ACUVAIL.
• Concomitant Topical Ocular Therapy Advise patients that if more than one topical ophthalmic medication is being used, the medicines should be administered at least 5 minutes apart.
• Distributed by: AbbVie Inc.
• North Chicago, IL 60064 © 2024 AbbVie.
• All rights reserved.
• ACUVAIL and its design are trademarks of Allergan, Inc., an AbbVie company.
• V3.0USPI3507 Shape Description automatically generated

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS ACUVAIL (ketorolac tromethamine ophthalmic solution) is a sterile, clear, and colorless to pale yellow ophthalmic solution containing 0.45% (4.5 mg/mL) ketorolac tromethamine in a single-dose vial.
• ACUVAIL ophthalmic solution containing 0.45% (4.5 mg/mL) ketorolac tromethamine in a single-dose vial.
• ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• ACUVAIL (ketorolac tromethamine ophthalmic solution) 0.45% is supplied as a sterile, clear, and colorless to pale yellow ophthalmic solution in clear, low density polyethylene (LDPE), single-dose vials packaged in 3 foil pouches, 10 vials per pouch:
• 30 Single-Dose Vials 0.4 mL each (Carton containing 3 pouches):
• NDC 0023-3507-31 Storage :
• Store at 15 o C to 30ºC (59 o F to 86ºF).
• Store the vials in the pouch, protected from light.
• Fold pouch ends closed.
• The solution from one individual single-dose vial is to be used immediately after opening.
• The remaining vial contents should be discarded.

Quoted from the official label, section “How Supplied”.

What is in it

• ACUVAIL (ketorolac tromethamine ophthalmic solution) 0.45% is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for topical ophthalmic use.
• Its chemical name is (±)-5-Benzoyl-2,3-dihydro-1 H -pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and its molecular weight is 376.40.
• Its molecular formula is C 19 H 24 N 2 O 6 .
• Its chemical structure is:
• ACUVAIL solution is supplied as a sterile isotonic aqueous 0.45% solution, with a pH of approximately 6.8.
• ACUVAIL solution contains a racemic mixture of R-(+) and S-(-)- ketorolac tromethamine.
• Ketorolac tromethamine may exist in three crystal forms.
• All forms are equally soluble in water.
• The pKa of ketorolac is 3.5.
• This white to off-white crystalline substance discolors on prolonged exposure to light.
• The osmolality of ACUVAIL solution is approximately 285 mOsml/kg.
• Each mL of ACUVAIL ophthalmic solution contains: Active: ketorolac tromethamine 0.45%.
• Inactives:
• carboxymethylcellulose sodium; sodium chloride; sodium citrate dihydrate; and purified water with sodium hydroxide and/or hydrochloric acid to adjust pH.
• ACUVAIL does not contain an anti-microbial preservative.
• The chemical structure for ACUVAIL® (ketorolac tromethamine ophthalmic solution) 0.45% is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use.
• Its chemical name is (±)-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and its molecular weight is 376.40.
• Its molecular formula is C19H24N2O6.

Quoted from the official label, section “Description”.

Ingredients people check for

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Same active substance, strength and form in other countries

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Same active substance

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