Diclofenac Sod 0.1% Ophth Sol 2.5ml
It is used to treat swelling and pain after cataract surgery.It is used to treat pain and sun sensitivity in patients who have had cornea surgery.
Drug Class
Ophthalmic Nonsteroidal Anti-inflammatory Drug (NSAID)
Pharmacologic Class
Cyclooxygenase Inhibitor
Pregnancy Category
Category C (D in 3rd trimester)
FDA Approved
Aug 1991
DEA Schedule
Not Controlled
Overview
What is this medicine?
Diclofenac ophthalmic solution is an eye drop used to reduce pain, swelling, and inflammation in the eye, often after eye surgery or for certain eye conditions. It works by blocking substances in the body that cause inflammation.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. For optimal results, use this medication only in the eye.
Precautions and Administration
Avoid wearing contact lenses unless your doctor advises you to do so.
Wash your hands thoroughly before and after using the medication.
To prevent contamination and potential severe eye problems or vision loss, do not touch the container tip to your eye, eyelid, or surrounding skin.
Tilt your head back and gently drop the medication into your eye.
Special Considerations After Eye Surgery
If you are using this medication after surgery on both eyes, your doctor may prescribe two separate bottles of eye drops, one for each eye. Make sure to use the correct bottle for each eye and do not mix them up.
Storage and Disposal
Store the medication at room temperature, avoiding freezing temperatures.
Protect the medication from light exposure.
* Keep all medications in a safe and secure location, out of the reach of children and pets.
Missed Dose Instructions
If you miss a dose, use it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not use two doses at the same time or take extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. For optimal results, use this medication only in the eye.
Precautions and Administration
Avoid wearing contact lenses unless your doctor advises you to do so.
Wash your hands thoroughly before and after using the medication.
To prevent contamination and potential severe eye problems or vision loss, do not touch the container tip to your eye, eyelid, or surrounding skin.
Tilt your head back and gently drop the medication into your eye.
Special Considerations After Eye Surgery
If you are using this medication after surgery on both eyes, your doctor may prescribe two separate bottles of eye drops, one for each eye. Make sure to use the correct bottle for each eye and do not mix them up.
Storage and Disposal
Store the medication at room temperature, avoiding freezing temperatures.
Protect the medication from light exposure.
* Keep all medications in a safe and secure location, out of the reach of children and pets.
Missed Dose Instructions
If you miss a dose, use it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not use two doses at the same time or take extra doses.
Lifestyle & Tips
- Wash hands thoroughly before and after administering eye drops.
- Do not touch the dropper tip to any surface, including the eye, to avoid contamination.
- If using other eye drops, wait at least 5 minutes between applications.
- Remove contact lenses before instilling drops and wait at least 15 minutes before reinserting them.
- Store at room temperature, away from light and moisture.
Available Forms & Alternatives
Available Strengths:
- Diclofenac Potassium 50mg Tablets
- Diclofenac Sod 0.1% Ophth Soln 5ml
- Diclofenac Sodium 75mg DR Tablets
- Diclofenac Sod 0.1% Ophth Sol 2.5ml
- Diclofenac Sodium 25mg DR Tablets
- Diclofenac Sodium 75mg DR Tablets
- Diclofenac Sodium 50mg DR Tablets
- Diclofenac Sodium 50mg DR Tablets
- Diclofenac 1.5% Topical Sol 150ml
- Diclofenac 3% Gel 100gm
- Diclofenac Sodium 100mg ER Tablets
- Diclofenac 75mg DR Tablets
- Diclofenac 1% Gel 100gm (rx)
- Diclofenac Epolamine 1.3% Top Patch
- Diclofenac 1% Gel 100gm (rx)
- Diclofenac 1% Gel 100gm (otc)
- Diclofenac 1% Gel 50gm (otc)
- Diclofenac 25mg Capsules
- Diclofenac 2% Topical Soln 112gm
- Diclofenac Potassium 25mg Tablets
- Diclofenac 25mg Capsules
- Diclofenac 50mg Powder
- Diclofenac 2% Topical Soln 112gm
- Diclofenac Sodium 25mg DR Tablets
- Diclofenac 2% Topical Soln 112gm
- Diclofenac Potassium 25mg Tablets
- Diclofenac 50mg Powder
Dosing & Administration
Adult Dosing
Standard Dose:
1 drop into the affected eye(s) 4 times daily for up to 2 weeks (postoperative inflammation) or 1 drop to the affected eye 4 times daily for 3 days starting 24 hours after surgery (post-cataract surgery inflammation). For corneal refractive surgery, 1 drop to the affected eye 1 hour prior to surgery, then 1 drop immediately after surgery, and then 1 drop 4 times daily for up to 3 days.
Condition-Specific Dosing:
postoperative_inflammation:
1 drop 4 times daily for up to 2 weeks
post_cataract_surgery_inflammation:
1 drop 4 times daily for 3 days starting 24 hours after surgery
corneal_refractive_surgery:
1 drop 1 hour prior to surgery, then 1 drop immediately after surgery, then 1 drop 4 times daily for up to 3 days
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed due to minimal systemic absorption.
Moderate:
No specific adjustment needed due to minimal systemic absorption.
Severe:
No specific adjustment needed due to minimal systemic absorption.
Dialysis:
No specific considerations needed due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No specific adjustment needed due to minimal systemic absorption.
Moderate:
No specific adjustment needed due to minimal systemic absorption.
Severe:
No specific adjustment needed due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits prostaglandin synthesis by reversibly inhibiting cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2) enzymes. Prostaglandins are mediators of inflammation, pain, and fever. In the eye, this action reduces inflammation and pain associated with ocular surgery or conditions.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic bioavailability (less than 5% of topical dose reaches systemic circulation).
Tmax:
Not typically relevant for systemic Tmax due to minimal absorption; local ocular effect is rapid.
FoodEffect:
Not applicable for ophthalmic administration.
Distribution:
Vd:
Not clinically significant for ophthalmic use due to minimal systemic absorption.
ProteinBinding:
Highly protein bound (>99%) if absorbed systemically, but systemic levels are negligible.
CnssPenetration:
Limited (minimal systemic absorption).
Elimination:
HalfLife:
Systemic half-life is 1-2 hours, but not clinically relevant for ophthalmic use.
Clearance:
Not clinically significant for ophthalmic use due to minimal systemic absorption.
ExcretionRoute:
Primarily renal and biliary excretion if absorbed systemically.
Unchanged:
Minimal unchanged drug excreted systemically.
Pharmacodynamics
OnsetOfAction:
Within minutes to hours for anti-inflammatory and analgesic effects.
PeakEffect:
Within hours for anti-inflammatory effect.
DurationOfAction:
Several hours (requires multiple daily dosing).
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Changes in eyesight, eye pain, or severe eye irritation
Eye discharge
Bleeding in the eye
Eye or eyelid swelling
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you or do not go away:
Burning or stinging
* Change in tears
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Changes in eyesight, eye pain, or severe eye irritation
Eye discharge
Bleeding in the eye
Eye or eyelid swelling
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you or do not go away:
Burning or stinging
* Change in tears
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe or worsening eye pain
- Significant vision changes
- Signs of eye infection (e.g., pus, severe redness, fever)
- Persistent or worsening eye irritation, burning, or stinging
- Corneal problems (e.g., white spots on the eye, feeling like something is in the eye, severe sensitivity to light)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
If you have an allergy to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or naproxen.
If you are more than 24 weeks pregnant, as this medication may have specific implications for your condition.
To ensure safe treatment, it is crucial to disclose all of your medications, including:
Prescription and over-the-counter (OTC) drugs
Natural products
Vitamins
Additionally, inform your doctor about any existing health problems. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances or health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to confirm that it is safe to do so.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
If you have an allergy to aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or naproxen.
If you are more than 24 weeks pregnant, as this medication may have specific implications for your condition.
To ensure safe treatment, it is crucial to disclose all of your medications, including:
Prescription and over-the-counter (OTC) drugs
Natural products
Vitamins
Additionally, inform your doctor about any existing health problems. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances or health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to confirm that it is safe to do so.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. When taking this drug, exercise caution while driving or performing tasks that require clear vision to ensure your safety. Do not exceed the prescribed duration of use, and only take the medication for the length of time specified by your doctor. If you have an existing eye infection or have suffered an eye injury, be sure to notify your doctor. Additionally, if you are pregnant, planning to become pregnant, or are breastfeeding, consult with your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Unlikely with ophthalmic administration due to minimal systemic absorption. Local irritation may occur with excessive use.
What to Do:
If accidental ingestion occurs, or if severe local irritation develops, contact a poison control center or seek medical attention. For ocular irritation, rinse eye with water. Call 1-800-222-1222 for poison control.
Drug Interactions
Monitoring
Baseline Monitoring
Ocular examination (visual acuity, intraocular pressure, slit lamp exam)
Rationale: To establish baseline ocular health and assess the condition requiring treatment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Ocular pain and inflammation
Frequency: Daily, or as clinically indicated
Target: Reduction in symptoms
Action Threshold: Worsening symptoms or lack of improvement may require re-evaluation.
Corneal integrity (e.g., signs of epithelial breakdown)
Frequency: Periodically, especially with prolonged use or in patients with compromised corneas
Target: Intact corneal surface
Action Threshold: Signs of corneal erosion, thinning, or perforation require immediate discontinuation and ophthalmologic consultation.
Symptom Monitoring
- Ocular pain
- Redness
- Swelling
- Photophobia
- Blurred vision
- Discharge
- Signs of infection (e.g., purulent discharge, severe pain)
Special Patient Groups
Pregnancy
Use with caution. Diclofenac ophthalmic is Pregnancy Category C. While systemic absorption is minimal, NSAIDs are known to cause premature closure of the fetal ductus arteriosus in the third trimester. Therefore, use should be avoided in late pregnancy unless the benefit outweighs the risk.
Trimester-Specific Risks:
First Trimester:
Limited data, generally considered low risk due to minimal systemic absorption.
Second Trimester:
Limited data, generally considered low risk due to minimal systemic absorption.
Third Trimester:
Potential risk of premature closure of the fetal ductus arteriosus. Avoid use if possible.
Lactation
Considered low risk. Diclofenac is minimally excreted into breast milk, and systemic absorption from ophthalmic use is negligible. Risk to the infant is low.
Infant Risk:
Low
Pediatric Use
Safety and effectiveness have not been established in pediatric patients. Use in children should be based on a careful risk-benefit assessment by a specialist.
Geriatric Use
No specific dosage adjustment is required for elderly patients. The safety and efficacy profile is similar to that in younger adults, given the minimal systemic absorption.
Clinical Information
Clinical Pearls
- Diclofenac ophthalmic is primarily used for postoperative inflammation and pain following ocular surgery, such as cataract extraction or corneal refractive surgery.
- It is an NSAID and should be used with caution in patients with a history of corneal epithelial defects, diabetes, or rheumatoid arthritis, as NSAIDs can potentially delay corneal healing or lead to corneal complications.
- Patients should be instructed on proper eye drop administration technique to maximize efficacy and minimize contamination.
- This formulation is for ophthalmic use only and should not be injected or taken orally.
Alternative Therapies
- Other ophthalmic NSAIDs (e.g., ketorolac, bromfenac, nepafenac)
- Ophthalmic corticosteroids (e.g., prednisolone, dexamethasone) for inflammation, often used in combination or sequentially with NSAIDs depending on the clinical situation.
Cost & Coverage
Average Cost:
Varies widely by pharmacy and insurance plan per 2.5ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 (brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, consult with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.