Package Leaflet: Information for the User
Ketorolac tromethamine 0.45% ophthalmic solution*
Ketorolac tromethamine 10mg/ml – 30mg/ml solution for injection*
Ketorolac tromethamine 10 mg tablet*
What is in this leaflet
1. What Ketorolac tromethamine is and what it is used for
2. What you need to know before you take Ketorolac tromethamine 3. How to take Ketorolac tromethamine
4. Possible side effects
5. How to store Ketorolac tromethamine
1. What is Ketorolac tromethamine and what it is used for Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug.
The ophthalmic solution is indicated for the treatment of pain and inflammation following cataract surgery.
General information
What is cataract
Cataracts are when the lens, a small transparent disc inside your eye, develops cloudy patches. Over time these patches usually become bigger causing blurry, misty vision and eventually blindness.
2. What you need to know before you take Ketorolac tromethamine Do not take Ketorolac tromethamine if:
Beyond 24 weeks of amenorrhea (5 months of age pregnancy)
Hypersensitivity to Ketorolac tromethamine
History of asthma triggered by the use of Ketorolac tromethamine or substances of similar activity such as other NSAIDs, aspirin
Gastrointestinal haemorrhage, cerebrovascular haemorrhage or another evolving haemorrhage
An evolving gastric ulcer or intestinal
Severe hepatic impairment
Severe renal impairment
Severe uncontrolled heart failure.
Warnings and precautions
Delayed Healing: Topical nonsteroidal anti-inflammatory drugs (NSAIDs) may slow or delay healing.
Tell your doctor if you are taking topical corticosteroids
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.
Increased Bleeding Time: With some NSAIDs, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation.
It is recommended that ophthalmic solution be used with caution in patients with known bleeding tendencies or who are receiving other medications, which may prolong bleeding time.
If you have evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs and should be closely monitored for corneal health.
If you used more than 1 day prior to surgery or used beyond 14 days post-surgery may increase risk for the occurrence and severity of corneal adverse events.
It should not be administered while wearing contact lenses.
Other medicines and Ketorolac tromethamine
Tell your doctor or pharmacist about all medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
Tell your doctor if you are taking any of the following medicines:
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.
Several substances are involved in interactions, due to their antiplatelet medicinal products properties: aspirin and NSAIDs, ticlopidine and clopidogrel, tiroban, eptibatide and
abciximab, iloprost. The use of several antiplatelet agents increases the risk of bleeding.
Pregnancy and breastfeeding
Ophthalmic solution should be used during pregnancy and breastfeeding only if the potential benefit justifies the potential risk to the fetus.
Driving and using machines
In rare cases, taking this medicine may cause dizziness, drowsiness, convulsions or visual disturbances. It is recommended not to drive or operate machinery if any of these symptoms occurs.
3. How to take Ketorolac tromethamine Adults:
One drop should be applied to the affected eye twice daily beginning 1 day prior to cataract surgery, continued on the day of surgery, and through the first 2 weeks of the postoperative period.
If 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.
If you forget to take Ketorolac tromethamine Take the missed dose as soon as you remember.
If it is too close to the next dose, skip it.
Do not take two doses at the same time.
4. Possible side effects
Like all medicines, this can cause side effects, although not everybody gets them. The side effects below may happen with this medicine.
Stop taking Ketorolac tromethamine if:
Evidence of corneal epithelial breakdown (sudden onset of ocular pain, blurred vision, tearing, and photophobia, typically upon awakening.)
Common side effects These include
High pressure in the eye
Headache
Blurred vision
5. How to store Ketorolac tromethamine
Keep this medicine out of the sight and reach of children.
Store at 15°-30°C (59°-86°F).
Store the vials in the pouch, protected from light.
Fold pouch ends closed.
* Dosage form and route of administration Ketorolac tromethamine 10mg/ml – 30mg/ml solution for injection and Ketorolac tromethamine 10 mg tablet should be prescribed according to therapeutic indication and disease severity of each individual patient.
Contact with Saudi Food Drugs Authority
Call Center 19999
Phone 0118806000-0112038222 Free Phone 8002490000
Email: [email protected] Postal address
Saudi Food & Drugs Authority (3292) North Road – Al Nafal Unit (1)
Riyadh 13312-6288 Saudi Arabia
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