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Drug overview for ACUVAIL (PF) (ketorolac tromethamine/pf):
Generic name: ketorolac tromethamine/PF (KEE-toe-ROLE-ak)
Drug class: Ophthalmic NSAIDS
Therapeutic class: Ophthalmic Agents
Ketorolac, a pyrrolizine carboxylic acid derivative, is a prototypical nonsteroidal anti-inflammatory agent (NSAIA).
No enhanced Uses information available for this drug.
Generic name: ketorolac tromethamine/PF (KEE-toe-ROLE-ak)
Drug class: Ophthalmic NSAIDS
Therapeutic class: Ophthalmic Agents
Ketorolac, a pyrrolizine carboxylic acid derivative, is a prototypical nonsteroidal anti-inflammatory agent (NSAIA).
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for ACUVAIL (PF) (ketorolac tromethamine/pf) have been approved by the FDA:
Indications:
Post-op ocular inflammation
Post-op photophobia
Postoperative ocular pain
Professional Synonyms:
Post-op ocular pain
Postoperative eye pain
Postoperative ocular inflammation
Postoperative ophthalmic inflammation
Postoperative photophobia
Indications:
Post-op ocular inflammation
Post-op photophobia
Postoperative ocular pain
Professional Synonyms:
Post-op ocular pain
Postoperative eye pain
Postoperative ocular inflammation
Postoperative ophthalmic inflammation
Postoperative photophobia
The following dosing information is available for ACUVAIL (PF) (ketorolac tromethamine/pf):
No enhanced Dosing information available for this drug.
Ketorolac tromethamine is applied topically to the eye as an ophthalmic solution. To prevent contamination of the solution, patients should be instructed to avoid allowing the tip of the dispensing container to contact any surface, the eyelids, or surrounding structures. Contact lenses should be removed prior to administration of ketorolac tromethamine ophthalmic solution. The preservative-free solution is for single use only in one or both eyes; the preservative-free solution should be used immediately after opening and any unused portion should be discarded immediately after administration.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| ACUVAIL 0.45% OPHTH SOLUTION | Maintenance | Adults instill 1 drop into affected eye(s) by ophthalmic route 2 times per day starting 24 hours before cataract surgery and continuing for 2 weeks |
No generic dosing information available.
The following drug interaction information is available for ACUVAIL (PF) (ketorolac tromethamine/pf):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for ACUVAIL (PF) (ketorolac tromethamine/pf):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 0 contraindications.
There are 0 severe contraindications.
There are 7 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Corneal degeneration |
| Corneal erosion |
| Diabetes mellitus |
| Dry eye |
| Hemophilia |
| Increased risk of bleeding due to coagulation disorder |
| Rheumatoid arthritis |
The following adverse reaction information is available for ACUVAIL (PF) (ketorolac tromethamine/pf):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 8 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Keratitis |
| Rare/Very Rare |
|---|
|
Asthma exacerbation Bronchospastic pulmonary disease Corneal erosion Corneal ulcer Impaired wound healing Ocular hemorrhage Perforation of cornea |
There are 17 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Blurred vision Conjunctival hemorrhage Conjunctival hyperemia Headache disorder Infiltrate of cornea Ocular hypertension Ocular pain |
Contact dermatitis Ocular irritation Ocular itching Ocular redness Skin rash |
| Rare/Very Rare |
|---|
|
Corneal dystrophy Corneal edema Dry eye Eyelid edema Iritis |
The following precautions are available for ACUVAIL (PF) (ketorolac tromethamine/pf):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Reproduction studies in rabbits and rats receiving oral ketorolac tromethamine dosages up to 109 and 303 times the maximum recommended human topical ophthalmic dosage of ketorolac tromethamine 0.5% (on a mg/kg basis), respectively, have not revealed evidence of harm to the fetus. However, oral dosages exceeding 45 times the maximum recommended human topical ophthalmic dosage of ketorolac tromethamine 0.5%
(on a mg/kg basis) in rats produced dystocia and was associated with an increased neonatal death rate. There are no adequate and controlled studies to date using ophthalmic ketorolac tromethamine in pregnant women, and the drug should be used during pregnancy only when the potential benefits justify the possible risk to the fetus. Ketorolac tromethamine ophthalmic solution should not be used during late pregnancy, since inhibitors of prostaglandin synthesis may have adverse effects on the fetal cardiovascular system (e.g., premature closure of the ductus arteriosus).
(on a mg/kg basis) in rats produced dystocia and was associated with an increased neonatal death rate. There are no adequate and controlled studies to date using ophthalmic ketorolac tromethamine in pregnant women, and the drug should be used during pregnancy only when the potential benefits justify the possible risk to the fetus. Ketorolac tromethamine ophthalmic solution should not be used during late pregnancy, since inhibitors of prostaglandin synthesis may have adverse effects on the fetal cardiovascular system (e.g., premature closure of the ductus arteriosus).
Because ketorolac is distributed into milk following systemic administration (see Pharmacokinetics: Distribution, in Ketorolac 28:08.04.92), the ophthalmic solution should be used with caution in nursing women.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for ACUVAIL (PF) (ketorolac tromethamine/pf):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for ACUVAIL (PF) (ketorolac tromethamine/pf)'s list of indications:
| Post-op ocular inflammation | |
| H57.8 | Other specified disorders of eye and adnexa |
| Post-op photophobia | |
| H53.14 | Visual discomfort |
| H53.141 | Visual discomfort, right eye |
| H53.142 | Visual discomfort, left eye |
| H53.143 | Visual discomfort, bilateral |
| H53.149 | Visual discomfort, unspecified |
| Postoperative ocular pain | |
| H57.1 | Ocular pain |
| H57.10 | Ocular pain, unspecified eye |
| H57.11 | Ocular pain, right eye |
| H57.12 | Ocular pain, left eye |
| H57.13 | Ocular pain, bilateral |
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