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Side Effects > Acuvail

Acuvail Side Effects

Please note - some side effects for Acuvail may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).



Acuvail Side Effects - for the Professional

Acuvail

Most common adverse reactions occurring in 1-6% of patients were increased intraocular pressure, conjunctival hemorrhage, and vision blurred. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Allergan at 1-800-433-8871 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.



See 17 for PATIENT COUNSELING INFORMATION

Revised: 07/2009
FULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosing

2.2 Use with Other Topical Ophthalmic Medications

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Delayed Healing

5.2 Potential for Cross-Sensitivity

5.3 Increased Bleeding Time

5.4 Corneal Effects

5.5 Contact Lens Wear

6 ADVERSE REACTIONS

6.1 Clinical Studies

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

17.1 Slow or Delayed Healing

17.2 Avoiding Contamination of the Product

17.3 Contact Lens Wear

17.4 Intercurrent Ocular Conditions

17.5 Concomitant Topical Ocular Therapy


FULL PRESCRIBING INFORMATION Top

Side Effects by Body System

Ocular

Ocular side effects have included transient burning and stinging upon instillation in 20% to 40% of patients. Conjunctival hyperemia, corneal infiltrates, and ocular edema have been reported in 1% to 5% of patients. Corneal edema, iritis, ocular inflammation, ocular irritation, ocular pain, superficial keratitis, and superficial ocular infections have been reported in 1% to 10% of patients. Corneal erosion, corneal thinning, and epithelial breakdown have also been reported.

Hypersensitivity

A 44-year-old female with a history of severe asthma was given ophthalmic ketorolac for the treatment of conjunctivitis previously unresponsive to topical antihistamine treatment. Two hours after instillation, she developed coughing and tightness in her chest which worsened over night. The next morning the patient was hospitalized with complaints of coughing, dyspnea at rest and wheezing. Her condition improved after administration of intravenous steroids and albuterol nebulizations.

Hypersensitivity reactions have been reported in 1% to 10% of patients.

Top

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