Sod Chloride 5% Ophth Soln 15ml

Manufacturer RUGBY LABORATORIES Active Ingredient Sodium Chloride Eye Drops (Hypertonic)(SOW dee um KLOR ide) Pronunciation SOW-dee-um KLOR-ide
It is used to lower swelling.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Ophthalmic agent, Osmotic agent
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Pharmacologic Class
Hypertonic saline solution
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Pregnancy Category
Category C
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Sodium Chloride 5% Ophthalmic Solution is an eye drop used to reduce swelling in the front part of your eye (cornea). It works by drawing out excess water from the swollen cornea, which can help improve your vision.
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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. This medication is for use in the eyes only.

Preparation and Administration

1. Wash your hands before and after using this medication.
2. Remove contact lenses before applying the medication. You can put them back in 15 minutes after use, but only if your eyes are not irritated or infected.
3. Avoid touching the container tip to your eye, lid, or skin, as this can contaminate the medication and lead to severe eye problems or vision loss.
4. Tilt your head back and gently drop the medication into your eye.
5. To help the medication stay in your eye, gently press the skin under your lower eyelid and pull the eyelid away from your eye, creating a small pouch.
6. After applying the medication, keep your eyes closed and apply pressure to the inside corner of your eye for 1 to 2 minutes.

Important Safety Precautions

Do not use the medication if the solution is cloudy, leaking, or contains particles.
Do not use the medication if the solution has changed color.

Storage and Disposal

Store this medication at room temperature in a dry place, away from heat and moisture. Keep it out of the reach of children and pets. Do not store it in a bathroom. When you no longer need the medication or it has expired, throw it away. Do not flush it down the toilet or pour it down the drain unless instructed to do so. Check with your pharmacist for guidance on proper disposal, and consider participating in a drug take-back program in your area.

Missed Dose Instructions

If you use this medication regularly and miss a dose, take it as soon as you remember. If it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or extra doses. If you use this medication as needed, do not use it more frequently than directed by your doctor.
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Lifestyle & Tips

  • Do not touch the dropper tip to any surface, including the eye, to avoid contamination.
  • Wash hands thoroughly before and after use.
  • Remove contact lenses before applying drops and wait at least 15 minutes before reinserting them.
  • If using other eye drops, wait at least 5 minutes between applications.
  • Store at room temperature, away from light and moisture. Do not freeze.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: 1-2 drops in the affected eye(s) every 3-4 hours, or as directed by a physician.
Dose Range: 1 - 2 mg

Condition-Specific Dosing:

Corneal Edema: 1-2 drops every 3-4 hours
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Pediatric Dosing

Neonatal: Not established, use with caution and medical supervision.
Infant: Not established, use with caution and medical supervision.
Child: Not established, use with caution and medical supervision. Dosing typically similar to adults if used.
Adolescent: Dosing typically similar to adults (1-2 drops every 3-4 hours).
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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

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Mechanism of Action

Sodium chloride 5% ophthalmic solution is a hypertonic solution that creates an osmotic gradient across the corneal epithelium. This gradient draws excess fluid from the edematous cornea into the tear film, thereby reducing corneal swelling and improving visual acuity.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption
Tmax: Not applicable (local action)
FoodEffect: Not applicable

Distribution:

Vd: Not applicable (local action)
ProteinBinding: Not applicable (local action)
CnssPenetration: No

Elimination:

HalfLife: Not applicable (local action)
Clearance: Not applicable (local action)
ExcretionRoute: Not applicable (primarily removed via tear drainage)
Unchanged: Not applicable
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Pharmacodynamics

OnsetOfAction: Within minutes (local effect)
PeakEffect: Within minutes to an hour
DurationOfAction: Approximately 3-4 hours (until fluid re-accumulates or next dose)

Safety & Warnings

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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

Other Possible Side Effects

Like all medications, this drug can cause side effects. Although 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 that bother you or persist, contact your doctor for guidance:

Burning
Eye irritation

Important Note

This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, don't hesitate to reach out to your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Increased eye pain or discomfort
  • Persistent or worsening redness
  • Vision changes (other than expected improvement)
  • Signs of infection (e.g., pus, severe swelling)
  • Severe or persistent stinging/burning that does not subside
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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, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
* Any health problems you have, as they may interact with this medication.

This medication can interact with other drugs and health conditions, so it is crucial to discuss your individual situation with your doctor. Do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety. Your doctor and pharmacist need to know about all your medications and health problems to determine if it is safe for you to take this medication.
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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 engaging in activities that require clear vision, such as driving. If you are pregnant, planning to become pregnant, or are breast-feeding, notify your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Excessive stinging or burning
  • Increased eye irritation
  • Temporary blurred vision

What to Do:

If an overdose is suspected (e.g., accidental ingestion or excessive topical application), rinse the eye with lukewarm water if irritation is severe. Systemic overdose is highly unlikely due to minimal absorption. For ingestion, contact a poison control center immediately (Call 1-800-222-1222 in the US).

Drug Interactions

Monitoring

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Baseline Monitoring

Visual acuity

Rationale: To assess baseline vision and monitor improvement.

Timing: Before initiation of therapy

Corneal edema assessment (e.g., slit lamp examination)

Rationale: To confirm diagnosis and monitor response to therapy.

Timing: Before initiation of therapy

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Routine Monitoring

Visual acuity

Frequency: As clinically indicated, e.g., weekly or monthly

Target: Improvement from baseline

Action Threshold: Lack of improvement or worsening of vision

Corneal edema

Frequency: As clinically indicated, e.g., weekly or monthly

Target: Reduction in corneal swelling

Action Threshold: Persistent or worsening edema

Ocular irritation/discomfort

Frequency: Daily, patient self-monitoring

Target: Minimal to no irritation

Action Threshold: Significant or persistent burning, stinging, or irritation

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Symptom Monitoring

  • Blurred vision
  • Eye pain or discomfort
  • Redness
  • Stinging or burning sensation upon instillation
  • Foreign body sensation

Special Patient Groups

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Pregnancy

Sodium chloride 5% ophthalmic solution is generally considered safe for use during pregnancy due to minimal systemic absorption. Animal reproduction studies have not been conducted. Use only if clearly needed.

Trimester-Specific Risks:

First Trimester: Low risk due to minimal systemic absorption.
Second Trimester: Low risk due to minimal systemic absorption.
Third Trimester: Low risk due to minimal systemic absorption.
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Lactation

Considered safe for use during lactation. Sodium chloride is a natural component of the body, and systemic absorption from ophthalmic use is negligible, making transfer into breast milk unlikely to cause harm to the infant.

Infant Risk: Very low risk (L1)
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Pediatric Use

Safety and efficacy in pediatric patients have not been fully established in controlled clinical trials. However, it is used off-label in pediatric populations for corneal edema, often with similar dosing to adults, under medical supervision. Caution is advised.

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Geriatric Use

No specific dosage adjustments are required for geriatric patients. The safety and efficacy profile is similar to that in younger adults, given the minimal systemic absorption.

Clinical Information

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Clinical Pearls

  • This solution is hypertonic and may cause transient stinging or burning upon instillation, which usually subsides quickly.
  • It is crucial for patients to understand that this is an osmotic agent, not a steroid or antibiotic, and its primary role is to reduce corneal swelling.
  • Advise patients to avoid wearing soft contact lenses during treatment, as the solution may interact with the lens material or cause discomfort.
  • For best results, consistent application as prescribed is important.
  • If the solution appears discolored or contains particles, it should not be used.
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Alternative Therapies

  • Topical corticosteroids (for inflammatory corneal edema)
  • Topical NSAIDs (for inflammatory corneal edema)
  • Glycerin ophthalmic solution (less common for chronic use)
  • Corneal transplantation (for severe, refractory corneal edema)
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Cost & Coverage

Average Cost: $10 - $30 per 15ml bottle
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.