Ketorolac

Acuvail

0.45% solution/dropsÉtats-UnisCommercialiséAutorisé le 22 juil. 2009

Contenu en anglais

Indications

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 )

Contre-indications

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 )

Mises en garde et précautions d’emploi

Delayed healing ( 5.1 ) Cross-sensitivity or hypersensitivity ( 5.2 ) Increased bleeding time due to interference with thrombocyte aggregation ( 5.3 ) Corneal effects including keratitis ( 5.4 )

5.1Delayed Healing

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. 5. 2 Cross-Sensitivity or Hypersensitivity There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs. 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. 5. 3 Increased Bleeding Time With some NSAIDs, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied nonsteroidal anti-inflammatory drugs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery.

Mises en garde et précautions d’emploi

Delayed healing ( 5.1 ) Cross-sensitivity or hypersensitivity ( 5.2 ) Increased bleeding time due to interference with thrombocyte aggregation ( 5.3 ) Corneal effects including keratitis ( 5.4 )

5.1Delayed Healing

Effets indésirables

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.

6.1Clinical 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).

6.2Postmarketing 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.

Acuvail

Indications

Contre-indications

Mises en garde et précautions d’emploi

5.1Delayed Healing

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Acuvail

Indications

Contre-indications

Mises en garde et précautions d’emploi

5.1Delayed Healing

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5.5Risk of Contamination

5.6Contact Lens Wear

Grossesse et allaitement

8.1Pregnancy Risk Summary

Effets indésirables

6.1Clinical Trials Experience

6.2Postmarketing Experience

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