Acuvail

What is Acuvail?

Acuvail (ketorolac tromethamine) ophthalmic solution is a nonsteroidal, anti-inflammatory used for the treatment of pain and inflammation following cataract surgery.

Ketorolac-tromethamine

What are the uses of this medicine?

• Acuvail (ketorolac tromethamine) is used for the treatment of pain and inflammation following cataract surgery.

How does this medicine work?

• The tromethamine salt of ketorolac, a synthetic pyrrolizine carboxylic acid derivative with anti-inflammatory, analgesic and antipyretic properties.
• Ketorolac tromethamine, a non-selective inhibitor of the cyclooxygenases (COX), inhibits both COX-1 and COX-2 enzymes.
• This agent exerts its anti-inflammatory effect by preventing conversion of arachidonic acid to prostaglandins at inflammation site mediated through inhibition of COX-2, which is undetectable in most tissues but is up-regulated at the inflammation sites.
• Since COX-1 is expressed virtually in all tissues, inhibition of COX-1 enzyme by this agent prevents normal state production of prostaglandins, which plays housekeeping roles in the protection of the gastrointestinal tract, regulating renal blood flow, and functioning in platelet aggregation.
• As a result, inhibition of COX-1 is usually associated with adverse effects such as gastrointestinal toxicity and nephrotoxicity.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• with previously demonstrated hypersensitivity to any of the ingredients in the formulation.

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted with Acuvail.

Is this medicine FDA approved?

• Initial U.S. Approval: 1991

How should this medicine be used?

Recommended dosage:

• One drop of ACUVAIL should be applied by the patient to the affected eye twice daily beginning 1 day prior to cataract surgery, and continued through the first 2 weeks of the postoperative period.

Administration:

• Patients should be instructed that the solution from one individual single-use vial is to be used immediately after opening for administration to the affected eye. The remaining vial contents should be discarded.
• The use of the same single-use vial of topical eye drops for both eyes following bilateral ocular surgery is not recommended. In these circumstances, advise patients to use one vial for each eye immediately after opening and discard the remaining contents after use.
• Patients should be instructed to avoid allowing the tip of the 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.
• Patients should be advised that ACUVAIL solution should not be administered while wearing contact lenses.
• ACUVAIL ophthalmic solution 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.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As ACUVAIL ophthalmic solution containing 4.5 mg/mL ketorolac tromethamine in a single-use vial.

This medicine is available in fallowing brand namesː

• ACUVAIL

What side effects can this medication cause?

The most common side effects of this medicine include:

• increased intraocular pressure
• conjunctival hemorrhage
• vision blurred

What special precautions should I follow?

• Topical nonsteroidal anti-inflammatory drugs (NSAIDs) may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems.
• There have been reports of bronchospasm or exacerbation of asthma associated with the use of ketorolac tromethamine ophthalmic solution in patients who either have a known hypersensitivity to aspirin/non-steroidal anti-inflammatory drugs, or a past medical history of asthma. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.
• It is recommended that ACUVAIL ophthalmic solution be used with caution in patients with known bleeding tendencies or who are receiving other medications, which may prolong bleeding time.
• Use of topical NSAIDs may result in keratitis. These events may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs and should be closely monitored for corneal health.
• ACUVAIL should not be administered while wearing contact lenses.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled studies in pregnant women.
• ACUVAIL solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• Pregnancy Category C.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• KETOROLAC TROMETHAMINE

Inactive ingredients:

• CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
• SODIUM CHLORIDE
• TRISODIUM CITRATE DIHYDRATE
• WATER
• SODIUM HYDROXIDE
• HYDROCHLORIC ACID

Who manufactures and distributes this medicine?

• Distributed by: Allergan USA, Inc.
• Madison, NJ

What should I know about storage and disposal of this medication?

• Store at 15o-30º C (59o-86º F).
• Store the vials in the pouch, protected from light.
• Fold pouch ends closed.

• Dailymed label info on Acuvail
• FDA Acuvail

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