Diclofenac Sod 0.1% Ophth Soln 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 anti-inflammatory agent
Pharmacologic Class
Nonsteroidal anti-inflammatory drug (NSAID); Cyclooxygenase inhibitor
Pregnancy Category
Category C (first and second trimesters); Category D (third trimester)
FDA Approved
Aug 1991
DEA Schedule
Not Controlled
Overview
What is this medicine?
Diclofenac eye drops are a type of medicine called a nonsteroidal anti-inflammatory drug (NSAID). They work by reducing swelling, pain, and discomfort in your eyes, often used after eye surgery.
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 your eyes.
Administration Instructions
1. Avoid wearing contact lenses unless your doctor advises you to do so.
2. Wash your hands thoroughly before and after using the medication to prevent contamination.
3. To prevent bacterial contamination, do not touch the container tip to your eye, eyelid, or surrounding skin, as this can lead to severe eye problems or vision loss.
4. 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, one for each eye. Make sure to use the correct bottle for each eye and do not mix them up.
Storage and Disposal
To maintain the medication's effectiveness and safety:
1. Store the medication at room temperature, avoiding freezing temperatures.
2. Protect the medication from light exposure.
3. Keep all medications in a secure location, out of the reach of children and pets.
Missed Dose Instructions
If you miss a dose, take 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 take two doses at the same time or use extra doses to make up for a missed dose.
To use this medication correctly, follow your doctor's instructions and read all the information provided. For optimal results, use this medication only in your eyes.
Administration Instructions
1. Avoid wearing contact lenses unless your doctor advises you to do so.
2. Wash your hands thoroughly before and after using the medication to prevent contamination.
3. To prevent bacterial contamination, do not touch the container tip to your eye, eyelid, or surrounding skin, as this can lead to severe eye problems or vision loss.
4. 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, one for each eye. Make sure to use the correct bottle for each eye and do not mix them up.
Storage and Disposal
To maintain the medication's effectiveness and safety:
1. Store the medication at room temperature, avoiding freezing temperatures.
2. Protect the medication from light exposure.
3. Keep all medications in a secure location, out of the reach of children and pets.
Missed Dose Instructions
If you miss a dose, take 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 take two doses at the same time or use extra doses to make up for a missed dose.
Lifestyle & Tips
- Remove contact lenses before applying the eye drops and wait at least 15 minutes before reinserting them.
- Do not touch the dropper tip to your eye or any other surface to avoid contamination.
- If using other eye drops, wait at least 5 minutes between applications.
- Store at room temperature, away from light and moisture.
- Do not wear contact lenses if your eye is red or irritated.
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
Dose Range:
1 - 1 mg
Condition-Specific Dosing:
Post-operative inflammation (e.g., following cataract extraction):
1 drop into the affected eye(s) 4 times daily, beginning 24 hours after surgery and continuing for up to 2 weeks.
Pain and photophobia following corneal refractive surgery:
1-2 drops into the affected eye(s) within 1 hour prior to surgery, then 1-2 drops within 15 minutes after surgery, and then 1 drop 4 times daily for up to 3 days.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established (Safety and efficacy not established in pediatric patients younger than 3 years of age). For children âĨ3 years, dosing may be similar to adults for specific indications, but use with caution and under specialist guidance.
Adolescent:
Dosing typically similar to adults for approved indications.
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 adjustment 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. In the eye, this reduces inflammation, pain, and miosis during ocular surgery.
Pharmacokinetics
Absorption:
Bioavailability:
Negligible systemic bioavailability after ophthalmic administration.
Tmax:
Not applicable for systemic Tmax due to minimal absorption. Ocular tissue concentrations peak within hours.
FoodEffect:
Not applicable for ophthalmic formulation.
Distribution:
Vd:
Not applicable for systemic Vd due to minimal absorption. Distributes into ocular tissues.
ProteinBinding:
Highly protein bound (>99%) in systemic circulation, but systemic levels are negligible.
CnssPenetration:
Limited/Negligible systemic CNS penetration after ophthalmic administration.
Elimination:
HalfLife:
Systemic half-life is approximately 1-2 hours, but not clinically relevant for ophthalmic use.
Clearance:
Not clinically relevant for ophthalmic use due to minimal systemic absorption.
ExcretionRoute:
Systemically absorbed drug is primarily excreted in urine (approx. 65%) and bile (approx. 35%) as metabolites.
Unchanged:
Less than 1% of systemically absorbed drug is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Within hours for anti-inflammatory and analgesic effects.
PeakEffect:
Within 1-2 days for maximal anti-inflammatory effect.
DurationOfAction:
Effects persist for several hours after a single dose; requires multiple daily dosing for sustained effect.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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. Although many people do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
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.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
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. Although many people do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor:
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:
- Worsening eye pain or redness
- Changes in vision
- Signs of infection (e.g., pus, discharge)
- Severe eye irritation or discomfort
- Any new or worsening symptoms in the eye
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 you experienced, including any symptoms that occurred.
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.
Additionally, this medication may interact with other medications or health conditions. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all the medications you are taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
Discuss your health problems with your doctor and pharmacist to determine if it is safe to take this medication.
Never start, stop, or change the dose of any medication without first consulting your doctor to avoid potential interactions or complications.
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 you experienced, including any symptoms that occurred.
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.
Additionally, this medication may interact with other medications or health conditions. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all the medications you are taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
Discuss your health problems with your doctor and pharmacist to determine if it is safe to take this medication.
Never start, stop, or change the dose of any medication without first consulting your doctor to avoid potential interactions or complications.
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 when 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, notify your doctor promptly. Additionally, if you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Unlikely to cause systemic overdose due to minimal absorption.
- Local symptoms might include increased eye irritation, redness, or discomfort.
What to Do:
If accidentally ingested, drink fluids to dilute. If local irritation occurs, rinse eye with lukewarm water. For significant concerns or accidental ingestion, contact a poison control center (e.g., 1-800-222-1222) or seek medical attention.
Drug Interactions
Moderate Interactions
- Other topical NSAIDs (increased risk of corneal adverse events)
- Topical corticosteroids (potential for delayed healing, masking of infection)
Monitoring
Baseline Monitoring
Ocular examination (visual acuity, slit lamp exam)
Rationale: To assess baseline ocular health and inflammation.
Timing: Prior to initiation of therapy.
Routine Monitoring
Improvement in ocular pain and inflammation
Frequency: Daily during treatment period
Target: Reduction in symptoms
Action Threshold: Lack of improvement or worsening symptoms may require re-evaluation.
Corneal integrity (e.g., signs of keratitis, thinning, erosion)
Frequency: Periodically, especially with prolonged use or in high-risk patients
Target: Normal corneal appearance
Action Threshold: Any signs of corneal damage (e.g., epithelial defects, infiltrates) require immediate discontinuation and ophthalmologic consultation.
Intraocular pressure (IOP)
Frequency: As clinically indicated, especially in patients with glaucoma or ocular hypertension
Target: Within normal limits or target range for patient
Action Threshold: Significant increase in IOP may require re-evaluation.
Symptom Monitoring
- Eye pain
- Redness
- Swelling
- Photophobia
- Blurred vision
- Foreign body sensation
- Signs of infection (e.g., discharge, worsening pain)
Special Patient Groups
Pregnancy
Use during pregnancy should be avoided unless the potential benefits outweigh the potential risks. Diclofenac is classified as Category C during the first and second trimesters and Category D during the third trimester due to the risk of premature closure of the fetal ductus arteriosus. While systemic absorption from ophthalmic use is minimal, caution is still advised, especially in late pregnancy.
Trimester-Specific Risks:
First Trimester:
Category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Second Trimester:
Category C: Similar to first trimester. Risk of premature ductus arteriosus closure is lower than in the third trimester but still a theoretical concern.
Third Trimester:
Category D: Positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. Specifically, NSAIDs can cause premature closure of the fetal ductus arteriosus and persistent pulmonary hypertension in the newborn.
Lactation
Diclofenac is excreted in breast milk in small amounts after systemic administration. Due to minimal systemic absorption from ophthalmic use, the amount transferred into breast milk is expected to be negligible. Considered L3 (Moderately Safe) by some sources, but generally considered low risk for the infant.
Infant Risk:
Low risk of adverse effects to the breastfed infant due to minimal systemic absorption and low levels in breast milk.
Pediatric Use
Safety and efficacy have not been established in pediatric patients younger than 3 years of age. Use in older children should be based on specific indications and under the guidance of an ophthalmologist, considering the potential for corneal adverse events.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. No specific dosage adjustment is required. However, elderly patients may be more susceptible to corneal adverse events, especially with pre-existing corneal conditions or prolonged use.
Clinical Information
Clinical Pearls
- Diclofenac ophthalmic solution is primarily used for post-operative inflammation and pain, and for pain/photophobia after corneal refractive surgery.
- Patients should be advised to remove contact lenses before instillation and wait at least 15 minutes before reinserting them.
- Prolonged use of topical NSAIDs, including diclofenac, particularly in patients with compromised corneas (e.g., diabetes, rheumatoid arthritis, previous ocular surgery), may lead to corneal adverse events such as keratitis, corneal thinning, erosion, ulceration, or perforation. Monitor these patients closely.
- This formulation is for ophthalmic use only and should not be injected or administered orally.
- Advise patients to avoid touching the dropper tip to the eye or any other surface to prevent contamination.
Alternative Therapies
- Other ophthalmic NSAIDs (e.g., Ketorolac ophthalmic, Bromfenac ophthalmic, Nepafenac ophthalmic)
- Topical corticosteroids (e.g., Prednisolone acetate ophthalmic, Dexamethasone ophthalmic) for inflammation, often used in conjunction or sequentially with NSAIDs depending on the clinical situation.
- Topical anesthetics (for acute pain relief, but not for long-term use due to corneal toxicity).
Cost & Coverage
Average Cost:
$30 - $100 per 5ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.