Dexamethasone 0.1% Ophthsoln 5ml
It is used to treat eye swelling.It is used to treat eye irritation.It is used to treat ear swelling.
Drug Class
Ophthalmic Corticosteroid
Pharmacologic Class
Glucocorticoid
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Dexamethasone ophthalmic solution is an eye drop that contains a type of steroid. It works by reducing swelling, redness, and irritation in the eye caused by certain eye conditions or after eye surgery. It helps to calm down the body's natural inflammatory response.
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. Continue using the medication as directed, even if your symptoms improve. Before and after handling the container, wash your hands thoroughly.
When administering the medication, avoid touching the container tip to your eye, lid, or surrounding skin, as this can introduce bacteria and potentially cause severe eye problems or vision loss. If you wear contact lenses, remove them before using the medication and wait at least 15 minutes before reinserting them. However, do not put your contacts back in if your eyes are irritated or infected.
To administer the medication to your eye, tilt your head back and gently drop the medication into your eye. Afterward, keep your eyes closed and apply gentle pressure to the inner corner of your eye for 1 to 2 minutes to help the medication stay in your eye.
If you are using this medication in your ear, follow your doctor's specific instructions.
Storage and Disposal
Store the medication at room temperature, keeping it in a safe location out of the reach of children and pets. Dispose of unused or expired medication according to the recommended guidelines. Do not flush the medication down the toilet or pour it down the drain unless instructed to do so. If you have questions about the proper disposal method, consult your pharmacist, who may be aware of drug take-back programs in your area.
Missed Dose
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. Continue using the medication as directed, even if your symptoms improve. Before and after handling the container, wash your hands thoroughly.
When administering the medication, avoid touching the container tip to your eye, lid, or surrounding skin, as this can introduce bacteria and potentially cause severe eye problems or vision loss. If you wear contact lenses, remove them before using the medication and wait at least 15 minutes before reinserting them. However, do not put your contacts back in if your eyes are irritated or infected.
To administer the medication to your eye, tilt your head back and gently drop the medication into your eye. Afterward, keep your eyes closed and apply gentle pressure to the inner corner of your eye for 1 to 2 minutes to help the medication stay in your eye.
If you are using this medication in your ear, follow your doctor's specific instructions.
Storage and Disposal
Store the medication at room temperature, keeping it in a safe location out of the reach of children and pets. Dispose of unused or expired medication according to the recommended guidelines. Do not flush the medication down the toilet or pour it down the drain unless instructed to do so. If you have questions about the proper disposal method, consult your pharmacist, who may be aware of drug take-back programs in your area.
Missed Dose
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
- Wash hands thoroughly before and after applying eye drops.
- Do not touch the dropper tip to any surface, including the eye, to avoid contamination.
- Tilt head back, pull down the lower eyelid to form a pocket, and instill the prescribed number of drops.
- Close eye gently for 1-2 minutes after instillation to allow absorption.
- If using other eye drops, wait at least 5-10 minutes between applications.
- Remove contact lenses before instilling drops and wait at least 15 minutes before reinserting them.
- Do not wear contact lenses if your eye is inflamed or infected.
- Do not discontinue use abruptly, especially after prolonged therapy; follow your doctor's tapering instructions.
- Store at room temperature, away from light and moisture.
Available Forms & Alternatives
Available Strengths:
- Dexamethasone 0.1% Ophthsoln 5ml
- Dexamethasone 2mg Tablets
- Dexamethasone 1.5mg Tablets
- Dexamethasone Intensol 1mg/ml Soln
- Dexamethasone 0.5mg Tablets
- Dexamethasone 0.75mg Tablets
- Dexamethasone 4mg Tablets
- Dexamethasone 1mg Tablets
- Dexamethasone Pho 4mg/ml Injection
- Dexamethasone Sod Phos 10mg/ml Inj
- Dexamethasone 6mg Tablets
- Dexamethasone 0.5mg/5ml Oral Soln
- Dexamethasone Pho 4mg/ml Inj, 1ml
- Dexamethasone Pho 4mg/ml Inj, 5ml
- Dexamethasone 0.5mg/5ml Elixir
- Dexamethasone Sod Phos Inj, 10ml
- Dexamethasone Phos 120mg/30ml Inj
- Dexamethasone 6-Day 1.5mg Dose Pack
- Dexamethasone 10-Day 1.5mg Dose Pak
- Dexamethason 13-Day Tab
- Dexamethasone 2mg Tablets
- Dexamethasone 1.5mg Tablets
- Dexamethasone 6mg Tablets
- Dexamethasone 4mg Tablets
- Dexamethasone 0.5mg Tablets
- Dexamethasone 0.75mg Tablets
- Dexamethasone 1mg Tablets
- Dexamethasone 1mg Tablets
Dosing & Administration
Adult Dosing
Standard Dose:
1-2 drops instilled into the conjunctival sac 4-6 times daily. May be tapered to 1 drop 3-4 times daily as improvement occurs. For severe conditions, drops may be used hourly, tapering to discontinuation.
Condition-Specific Dosing:
post-operative inflammation:
1 drop 4 times daily, starting 24 hours after surgery and continuing for up to 2 weeks.
severe inflammation:
1-2 drops every hour during the day and every two hours during the night, until improvement, then reduce frequency.
Pediatric Dosing
Neonatal:
Not established
Infant:
Dosing similar to adults, but use with caution and for shortest duration possible. Consult ophthalmologist.
Child:
Dosing similar to adults, but use with caution and for shortest duration possible. Consult ophthalmologist.
Adolescent:
Dosing similar to adults.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Dialysis:
No specific considerations (minimal systemic absorption)
Hepatic Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Pharmacology
Mechanism of Action
Dexamethasone is a potent synthetic adrenocortical steroid with anti-inflammatory and immunosuppressive properties. It inhibits the inflammatory response to a variety of agents and may delay or slow healing. It acts by inducing phospholipase A2 inhibitory proteins, collectively called lipocortins. These proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption from ophthalmic route. Primarily absorbed locally into ocular tissues.
Tmax:
Not applicable for systemic Tmax due to minimal absorption; local ocular peak effect varies.
FoodEffect:
Not applicable (ophthalmic route)
Distribution:
Vd:
Not applicable for systemic Vd due to minimal absorption; localized in ocular tissues.
ProteinBinding:
Approximately 77% (for systemic dexamethasone, but minimal for ophthalmic)
CnssPenetration:
Limited (minimal systemic absorption)
Elimination:
HalfLife:
Approximately 3-4.5 hours (for systemic dexamethasone, but minimal for ophthalmic)
Clearance:
Not precisely quantified for ophthalmic route due to minimal systemic absorption.
ExcretionRoute:
Primarily renal (for systemically absorbed drug, minimal for ophthalmic).
Unchanged:
Not precisely quantified for ophthalmic route.
Pharmacodynamics
OnsetOfAction:
Within hours for anti-inflammatory effect.
PeakEffect:
Within 1-2 days of regular use.
DurationOfAction:
Varies, typically requires multiple daily dosing.
Safety & Warnings
Side Effects
Important Side Effects to Report to Your Doctor Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. Seek medical attention right away if you experience any of the following symptoms, which may indicate a serious reaction:
For all uses of this medication:
+ 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
For use in the eye:
+ Change in eyesight
+ Eye pain
+ Severe eye irritation
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. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:
For all uses of this medication:
+ Irritation at the site of application
For use in the eye:
+ Blurred vision
+ Feeling of something in the eye
Note: This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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. Seek medical attention right away if you experience any of the following symptoms, which may indicate a serious reaction:
For all uses of this medication:
+ 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
For use in the eye:
+ Change in eyesight
+ Eye pain
+ Severe eye irritation
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. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:
For all uses of this medication:
+ Irritation at the site of application
For use in the eye:
+ Blurred vision
+ Feeling of something in the eye
Note: This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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, redness, or swelling
- New or worsening blurred vision
- Pus or discharge from the eye
- Sensitivity to light
- Signs of a new eye infection
- Any new or unusual eye symptoms
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
To ensure safe use of this medication, it is essential to inform your doctor about the following:
General Considerations:
- If you have a known allergy to dexamethasone or any component of this medication.
- If you are allergic to this medication, any of its ingredients, or other drugs, foods, or substances. Describe your allergic reactions and symptoms to your doctor.
Specific Considerations for Ophthalmic Use:
- If you have a fungal, tuberculosis (TB), or viral infection of the eye.
- If you are experiencing any type of eye infection.
- If you have been diagnosed with glaucoma.
Specific Considerations for Otic Use:
- If you have a fungal infection of the ear.
- If you have a perforated eardrum (a hole in the eardrum).
Interactions with Other Medications and Health Conditions:
This list does not encompass all possible drug interactions or health problems that may affect the use of this medication. Therefore, it is crucial to:
- Inform your doctor and pharmacist about all prescription and over-the-counter (OTC) medications, natural products, and vitamins you are taking.
- Discuss all your health problems with your doctor.
- Verify that it is safe to use this medication with your other medications and health conditions.
- Do not initiate, cease, or adjust the dosage of any medication without first consulting your doctor.
To ensure safe use of this medication, it is essential to inform your doctor about the following:
General Considerations:
- If you have a known allergy to dexamethasone or any component of this medication.
- If you are allergic to this medication, any of its ingredients, or other drugs, foods, or substances. Describe your allergic reactions and symptoms to your doctor.
Specific Considerations for Ophthalmic Use:
- If you have a fungal, tuberculosis (TB), or viral infection of the eye.
- If you are experiencing any type of eye infection.
- If you have been diagnosed with glaucoma.
Specific Considerations for Otic Use:
- If you have a fungal infection of the ear.
- If you have a perforated eardrum (a hole in the eardrum).
Interactions with Other Medications and Health Conditions:
This list does not encompass all possible drug interactions or health problems that may affect the use of this medication. Therefore, it is crucial to:
- Inform your doctor and pharmacist about all prescription and over-the-counter (OTC) medications, natural products, and vitamins you are taking.
- Discuss all your health problems with your doctor.
- Verify that it is safe to use this medication with your other medications and health conditions.
- Do not initiate, cease, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
Important Warnings and Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Adhere to the prescribed duration of treatment and do not use this drug for longer than recommended by your doctor.
If you have a sulfite allergy, consult your doctor before taking this medication, as some products may contain sulfites. Additionally, if you are pregnant, planning to become pregnant, or are breastfeeding, discuss the potential benefits and risks to you and your baby with your doctor.
Special Precautions for Eye Use
When using this medication in the eye, exercise caution when driving or performing tasks that require clear vision. Long-term use may increase the risk of developing cataracts or glaucoma; therefore, consult your doctor to discuss these potential risks. If you are using this medication for an extended period, have your eye pressure checked regularly and consult your doctor to monitor any potential changes.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Adhere to the prescribed duration of treatment and do not use this drug for longer than recommended by your doctor.
If you have a sulfite allergy, consult your doctor before taking this medication, as some products may contain sulfites. Additionally, if you are pregnant, planning to become pregnant, or are breastfeeding, discuss the potential benefits and risks to you and your baby with your doctor.
Special Precautions for Eye Use
When using this medication in the eye, exercise caution when driving or performing tasks that require clear vision. Long-term use may increase the risk of developing cataracts or glaucoma; therefore, consult your doctor to discuss these potential risks. If you are using this medication for an extended period, have your eye pressure checked regularly and consult your doctor to monitor any potential changes.
Overdose Information
Overdose Symptoms:
- Unlikely with ophthalmic use due to minimal systemic absorption. Local irritation may occur with excessive use.
What to Do:
If accidentally ingested, drink fluids. If local irritation occurs, rinse eye with water. For any concerns, contact a poison control center (1-800-222-1222) or seek medical attention.
Drug Interactions
Moderate Interactions
- Topical NSAIDs (may increase risk of corneal healing problems)
Monitoring
Baseline Monitoring
Intraocular Pressure (IOP)
Rationale: Corticosteroids can cause an increase in IOP, leading to glaucoma.
Timing: Before initiating therapy, especially for prolonged use (more than 10 days).
Ocular examination (slit lamp, fundoscopy)
Rationale: To assess baseline ocular health and identify pre-existing conditions (e.g., cataracts, infections) that may be exacerbated.
Timing: Before initiating therapy.
Routine Monitoring
Intraocular Pressure (IOP)
Frequency: Regularly, especially with prolonged use (e.g., weekly for first few weeks, then monthly or as clinically indicated).
Target: Normal range (typically 10-21 mmHg)
Action Threshold: Significant increase from baseline or above normal range; consider discontinuation or alternative therapy.
Signs of secondary infection (bacterial, fungal, viral)
Frequency: Daily by patient, periodically by clinician.
Target: Absence of new or worsening infection.
Action Threshold: Presence of new redness, pain, discharge, or worsening vision; requires immediate evaluation and appropriate treatment.
Corneal integrity/healing
Frequency: Periodically, especially in patients with corneal defects or after surgery.
Target: Normal healing progression.
Action Threshold: Delayed healing or corneal thinning/perforation; discontinue use.
Symptom Monitoring
- Blurred vision
- Eye pain
- Redness or irritation of the eye
- Discharge from the eye
- Sensitivity to light
- New or worsening visual disturbances (e.g., halos, glare)
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. While systemic absorption from ophthalmic use is minimal, corticosteroids have been associated with adverse effects in animal studies (e.g., teratogenicity).
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though low with ophthalmic use.
Second Trimester:
Generally considered lower risk than first trimester for systemic effects.
Third Trimester:
Potential for adrenal suppression in the neonate with prolonged high-dose systemic use; unlikely with ophthalmic.
Lactation
Caution should be exercised when administered to a nursing mother. While systemic absorption is minimal, corticosteroids are excreted in human milk following systemic administration. The risk to the infant is considered low with ophthalmic use.
Infant Risk:
Low (L3 - Moderate risk, but likely lower for ophthalmic due to minimal systemic absorption).
Pediatric Use
Safety and effectiveness in pediatric patients have not been fully established. Use with caution, especially in infants and young children, due to potential for increased systemic absorption and risk of IOP elevation. Prolonged use should be avoided.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. No specific dose adjustment is typically required.
Clinical Information
Clinical Pearls
- Prolonged use of ophthalmic corticosteroids can lead to increased intraocular pressure (IOP), glaucoma, optic nerve damage, posterior subcapsular cataracts, and secondary ocular infections (bacterial, fungal, viral).
- Patients should be monitored for IOP if therapy extends beyond 10 days.
- This medication is for ophthalmic use only; do not inject or ingest.
- Shake the bottle gently before use if it's a suspension.
- Advise patients not to wear contact lenses during treatment for ocular inflammation or infection.
Alternative Therapies
- Prednisolone acetate ophthalmic solution
- Loteprednol etabonate ophthalmic suspension (less IOP elevation risk)
- Fluorometholone ophthalmic suspension
- Topical NSAIDs (e.g., ketorolac, bromfenac) for inflammation without infection risk.
- Immunomodulators (e.g., cyclosporine ophthalmic) for chronic inflammatory conditions.
Cost & Coverage
Average Cost:
Varies widely, typically $20-$100+ per 5ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.