ofpain
Generic Name
Ketorolac Tromethamine
Manufacturer
Example Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| ofpain 05 eye drop | ৳ 80.24 | N/A |
Description
Overview of the medicine
Ketorolac tromethamine ophthalmic solution is a non-steroidal anti-inflammatory drug (NSAID) indicated for the treatment of pain and inflammation following cataract extraction. It works by reducing the production of certain natural substances in the body that cause inflammation and pain.
Uses & Indications
Dosage
Adults
For post-cataract pain and inflammation: one drop in the affected eye(s) four times a day, starting 24 hours after surgery and continuing for up to two weeks. For allergic conjunctivitis (off-label): one drop in the affected eye(s) four times a day.
Elderly
No specific dosage adjustment is required for elderly patients.
Renal_impairment
No ophthalmic dosage adjustment is needed in patients with renal impairment due to minimal systemic absorption.
How to Take
For ophthalmic use only. Tilt your head back, pull down the lower eyelid, and instill one drop into the conjunctival sac. Close your eye gently for a moment. Avoid touching the dropper tip to the eye or any other surface to prevent contamination. If using other eye drops, wait at least 5 minutes between applications.
Mechanism of Action
Ketorolac tromethamine inhibits prostaglandin synthesis by decreasing the activity of cyclooxygenase (COX-1 and COX-2) enzymes. Prostaglandins are mediators of inflammation and pain, thus reducing their production helps alleviate symptoms.
Pharmacokinetics
Onset
Pain relief typically occurs within 1 hour after topical ocular administration.
Excretion
Mainly renal excretion of metabolites and some unchanged drug. Approximately 90% of a systemically administered dose is excreted in the urine, with the remainder in feces.
Half life
The systemic elimination half-life is approximately 5-7 hours. Ocular half-life is not precisely defined but the therapeutic effects persist for several hours.
Absorption
Minimal systemic absorption occurs after ocular administration, with low plasma concentrations of ketorolac detected. Most of the drug remains localized in ocular tissues.
Metabolism
Primarily hepatic metabolism. Ketorolac is extensively metabolized in the liver, primarily via glucuronidation.
Side Effects
Contraindications
- Hypersensitivity to ketorolac tromethamine or any component of the formulation
- Patients with a history of aspirin-induced asthma, urticaria, or other allergic-type reactions to NSAIDs
- Patients with active corneal ulceration or infection
Drug Interactions
Anticoagulants (systemic)
Though systemic absorption is minimal, theoretical risk of increased bleeding if absorbed systemically in susceptible individuals. Use with caution.
Corticosteroids (topical ophthalmic)
Concurrent use may increase the potential for corneal healing problems, particularly in compromised corneas.
Other topical ophthalmic medications
If using more than one topical ophthalmic medication, they should be administered at least 5 minutes apart.
Storage
Store at controlled room temperature, 20°C to 25°C (68°F to 77°F). Protect from light. Do not freeze. Keep out of reach of children.
Overdose
Accidental overdose through ophthalmic administration is unlikely to cause systemic toxicity due to minimal absorption. If accidental ingestion occurs, symptoms like nausea, vomiting, abdominal pain, and drowsiness may occur. Seek immediate medical advice if a large amount is swallowed.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether ketorolac is excreted in human milk after ocular administration; exercise caution when administered to a nursing mother. Always consult a doctor.
Side Effects
Contraindications
- Hypersensitivity to ketorolac tromethamine or any component of the formulation
- Patients with a history of aspirin-induced asthma, urticaria, or other allergic-type reactions to NSAIDs
- Patients with active corneal ulceration or infection
Drug Interactions
Anticoagulants (systemic)
Though systemic absorption is minimal, theoretical risk of increased bleeding if absorbed systemically in susceptible individuals. Use with caution.
Corticosteroids (topical ophthalmic)
Concurrent use may increase the potential for corneal healing problems, particularly in compromised corneas.
Other topical ophthalmic medications
If using more than one topical ophthalmic medication, they should be administered at least 5 minutes apart.
Storage
Store at controlled room temperature, 20°C to 25°C (68°F to 77°F). Protect from light. Do not freeze. Keep out of reach of children.
Overdose
Accidental overdose through ophthalmic administration is unlikely to cause systemic toxicity due to minimal absorption. If accidental ingestion occurs, symptoms like nausea, vomiting, abdominal pain, and drowsiness may occur. Seek immediate medical advice if a large amount is swallowed.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether ketorolac is excreted in human milk after ocular administration; exercise caution when administered to a nursing mother. Always consult a doctor.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 months for an unopened bottle. Discard any remaining solution 28 days after first opening the bottle.
Availability
Pharmacies, hospitals
Approval Status
Approved by FDA and DGDA
Patent Status
Generic available
Clinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of Ketorolac Tromethamine ophthalmic solution for the treatment of pain and inflammation following cataract surgery. Studies typically show significant reduction in pain scores and inflammatory cell counts compared to placebo.
Lab Monitoring
- No specific lab monitoring required for ophthalmic use due to minimal systemic effects. Routine eye exams are recommended to monitor ocular health.
Doctor Notes
- Emphasize proper instillation technique to patients to minimize contamination and maximize therapeutic effect.
- Caution patients against prolonged use beyond the recommended duration, especially in those with risk factors for corneal complications.
- Advise patients to report any worsening eye pain, redness, or vision changes immediately.
Patient Guidelines
- Do not wear contact lenses during treatment unless directed by a doctor, especially after eye surgery.
- Wash hands thoroughly before and after using the eye drops.
- Do not allow the dropper tip to touch the eye or any other surface to avoid contamination.
- Store the bottle tightly closed when not in use.
Missed Dose Advice
If you miss a dose, administer it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to make up for a missed one.
Driving Precautions
ofpain-05-eye-drop may cause temporary blurred vision immediately after instillation. Avoid driving or operating machinery until your vision is clear and stable.
Lifestyle Advice
- Avoid rubbing eyes if irritation occurs, as this can worsen symptoms or cause further damage.
- Protect eyes from excessive light if photophobia (sensitivity to light) is experienced.
- Follow up with your eye doctor as scheduled for post-operative care or condition management.
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