ACUVAIL™ (Ketorolac tromethamine ophthalmic solution) 0.45%

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Ketorolac tromethamine

Available from:

ALLERGAN SINGAPORE PTE. LTD.

ATC code:

S01BC05

Dosage:

0.45% W/V

Pharmaceutical form:

SOLUTION, STERILE

Composition:

Ketorolac tromethamine 0.45% W/V

Administration route:

OPHTHALMIC

Prescription type:

Prescription Only

Manufactured by:

Allergan Sales, LLC

Authorization status:

ACTIVE

Authorization date:

2012-10-29

Patient Information leaflet

Page 1 of 2
Part #: 72220AS10DRAFT
Drawing #: 0274401
Artwork is actual size
Drop template and notes before processing
XXXX
ACUV
AIL™ 
(KE
TOR
OLA
C T
ROM
ETH
AM
INE
 OP
HTH
ALM
IC 
SO
LUT
ION
) 0
.45
%
72220AS10DrAFT
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE 
INFORMATION NEEDED TO USE ACUVAIL™ SAFELY AND 
EFFECTIVELY.  SEE FULL PRESCRIBING INFORMATION FOR 
ACUVAIL™.  
ACUVAIL™ (KETOROLAC TROMETHAMINE OPHTHALMIC 
SOLUTION) 0.45%
INDICATIONS AND USAGE
ACUVAIL™ ophthalmic solution is a nonsteroidal, 
anti-inflammatory indicated for the treatment of pain 
and inflammation following cataract surgery. (1)
DOSAGE AND ADMINISTRATION
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. (2.1)
DOSAGE FORMS AND STRENGTHS
•  4.5 mg/mL ketorolac tromethamine solution in  
a single-use vial. (3)
WARNINGS AND PRECAUTIONS
•  Delayed healing (5.1)
•  Potential for cross-sensitivity (5.2) 
•  Increased bleeding time due to interference  
with thrombocyte aggregation (5.3)
•  Corneal effects including keratitis (5.4)
ADVERSE REACTIONS
Most common adverse reactions occurring in 
1-6% of patients were increased intraocular 
pressure, conjunctival hemorrhage, and vision 
blurred. (6.1)
SEE 15 FOR PATIENT COUNSELING 
INFORMATION. 
REVISED: MAY-2010
FULL PRESCRIBING INFORMATION: CONTENTS*
1  INDICATION
S AND USAGE
2  DOSAGE AN
D ADMINISTRATION
2.1  Recommended Dosing
2.2  Use with Other Topical Ophthalmic Medications
3  DOSAGE FOR
MS 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
7  USE IN SPECIFIC POPULATIONS
7.1  Pregnancy
7.2  Nursing Mothers
7.3  Pediatric Use

Summary of Product characteristics

HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ACUVAIL
®
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR ACUVAIL
®
.
ACUVAIL
®
(KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION) 0.45%
INDICATIONS AND USAGE
ACUVAIL
®
ophthalmic solution is a nonsteroidal, anti-inflammatory indicated for
the treatment of pain and inflammation following cataract surgery. (1)
DOSAGE AND ADMINISTRATION
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. (2.1)
DOSAGE FORMS AND STRENGTHS
•
4.5 mg/mL ketorolac tromethamine solution in a single-use vial. (3)
•
Cross-sensitivity (5.1)
WARNINGS AND PRECAUTIONS
•
Increased bleeding time due to interference with thrombocyte
aggregation (5.2)
•
Delayed healing (5.3)
•
Corneal effects including keratitis (5.4)
•
Contact lens wear (5.5)
•
Eye injury and contamination (5.6)
ADVERSE REACTIONS
Most common adverse reactions occurring in 1-6% of patients were
increased intraocular pressure, conjunctival hemorrhage, and vision
blurred. (7.1)
SEE 16 FOR PATIENT COUNSELING INFORMATION.
REVISED: APR-2018
FULL PRESCRIBING INFORMATION: CONTENTS*
1.
INDICATIONS AND USAGE
2.
DOSAGE AND ADMINISTRATION
2.1
Recommended Dosing
3.
DOSAGE FORMS AND STRENGTHS
4.
CONTRAINDICATIONS
5.
WARNINGS AND PRECAUTIONS
5.1
Cross-Sensitivity
5.2
Bleeding
5.3
Delayed Healing
5.4
Corneal Effects
5.5
Contact Lens Wear
5.6
Eye Injury and Contamination
6.
DRUG INTERACTIONS
7.
ADVERSE REACTIONS
7.1
Clinical Studies Experience
7.2
Post-marketing Experience
8.
USE IN SPECIFIC POPULATIONS
8.1
Pregnancy
8.2
Nursing Mothers
8.3
Pediatric Use
8.4
Geriatric Use
9.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
10.
OVERDOSE
11.
DESCRIPTION
12.
CLINICAL PHARMACOLOGY
12.1
Mechanism of Action
12.2 Pharmacokinetics
13.
NONCLINICAL TOXICOLOGY
13.1
Carcinogenesis, Mutagenesis, Impairment of Fertility
14.
CLINICAL STUDIES
15