Sodium Chloride 5% Ophth Oint 3.5gm

Manufacturer HUB PHARMACEUTICALS Active Ingredient Sodium Chloride Eye Ointment (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, Hypertonic
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Pharmacologic Class
Osmotic agent
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Pregnancy 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?

This eye ointment helps to reduce swelling in the front part of your eye (cornea) by drawing out excess water. This can make your vision clearer if it's blurry due to swelling.
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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 eye use only.

1. Preparation: Wash your hands before and after using this medication. Remove your contact lenses before applying the medication. You can put your lenses back in 15 minutes after using the medication, but do not do so if your eyes are irritated or infected.
2. Administration: Avoid touching the container tip to your eye, lid, or other skin, as this can contaminate the medication and lead to severe eye problems or vision loss. Gently pull down your lower eyelid and apply the prescribed amount of medication. Release your lower eyelid and keep your eyes closed for 1 to 2 minutes.

Storage and Disposal

To maintain the medication's effectiveness and safety:

Store it at room temperature in a dry place, away from bathrooms and heat sources.
Keep all medications in a secure location, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. Consult your pharmacist for guidance on disposal, and consider participating in local drug take-back programs.

Missed Dose Instructions

If you use this medication regularly:

Take a missed dose 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, follow your doctor's instructions and do not use it more frequently than prescribed.
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Lifestyle & Tips

  • Wash hands thoroughly before and after applying the ointment.
  • Do not touch the tip of the tube to your eye or any other surface to prevent contamination.
  • If you wear contact lenses, remove them before applying the ointment and wait at least 15 minutes before reinserting them, or as advised by your doctor.
  • Do not share your eye ointment with others.
  • Store at room temperature, away from moisture and heat.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a small amount (approximately 1/4 inch) into the conjunctival sac of the affected eye(s) 3 to 4 times daily or as directed by a physician.
Dose Range: 3 - 4 mg

Condition-Specific Dosing:

corneal edema: Apply 3-4 times daily.
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Pediatric Dosing

Neonatal: Not established (use with caution, consult ophthalmologist)
Infant: Not established (use with caution, consult ophthalmologist)
Child: Dosing similar to adults, generally considered safe under medical supervision.
Adolescent: Dosing similar to adults.
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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 adjustment needed (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 ointment 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 clarity.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption
Tmax: Not applicable (topical ophthalmic)
FoodEffect: Not applicable (topical ophthalmic)

Distribution:

Vd: Not applicable (minimal systemic absorption)
ProteinBinding: Not applicable (minimal systemic absorption)
CnssPenetration: No (minimal systemic absorption)

Elimination:

HalfLife: Not applicable (minimal systemic absorption)
Clearance: Not applicable (minimal systemic absorption)
ExcretionRoute: Not applicable (primarily local action, excess removed via tear film)
Unchanged: Not applicable
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Pharmacodynamics

OnsetOfAction: Within minutes to hours (reduction in corneal edema)
PeakEffect: Variable, depends on severity of edema and frequency of application
DurationOfAction: Several hours, requiring multiple daily applications
Confidence: Medium

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

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 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. 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 that bother you or do not go away, contact your doctor:

Burning
Eye irritation

Reporting Side Effects

This list is not exhaustive, and you may experience other 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.
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Seek Immediate Medical Attention If You Experience:

  • Increased eye pain or discomfort
  • Worsening redness or irritation
  • Persistent or worsening blurred vision
  • Any new or unusual eye symptoms
  • Signs of allergic reaction (e.g., rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing) - seek immediate medical attention.
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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 allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is not an exhaustive list, and it is crucial to disclose all your medications and health conditions to your doctor and pharmacist.
* Any health problems you have, as this information will help your doctor determine if it is safe for you to take this medication.

Remember, it is vital to verify that this medication is safe to take with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
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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 performing tasks that require clear vision, such as driving, exercise caution to ensure your safety. If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor promptly. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Excessive stinging or burning upon application (local irritation)
  • Increased eye redness

What to Do:

If excessive amount is applied, wipe away excess. If irritation persists, discontinue use and consult a healthcare professional. Systemic overdose is highly unlikely due to minimal absorption. For accidental ingestion, contact a poison control center (e.g., 1-800-222-1222) or seek medical attention.

Drug Interactions

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Minor Interactions

  • Other ophthalmic preparations (allow 5-10 minutes between applications)

Monitoring

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Baseline Monitoring

Visual acuity

Rationale: To assess baseline vision and track improvement.

Timing: Prior to initiation of therapy

Corneal clarity/edema

Rationale: To assess the extent of corneal swelling.

Timing: Prior to initiation of therapy (slit lamp examination if possible)

Ocular discomfort/irritation

Rationale: To assess baseline symptoms.

Timing: Prior to initiation of therapy

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Routine Monitoring

Patient-reported visual improvement

Frequency: Daily

Target: Improved clarity, reduced blurriness

Action Threshold: No improvement or worsening of vision after several days of use

Ocular comfort

Frequency: Daily

Target: Reduced irritation, foreign body sensation

Action Threshold: Increased irritation, burning, or pain

Corneal appearance (if monitored by clinician)

Frequency: As clinically indicated (e.g., weekly to monthly)

Target: Reduced haziness, clearer cornea

Action Threshold: Persistent or worsening edema

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Symptom Monitoring

  • Blurred vision
  • Halos around lights
  • Eye pain or discomfort
  • Foreign body sensation
  • Increased tearing
  • Redness or irritation

Special Patient Groups

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Pregnancy

Sodium chloride 5% ophthalmic ointment is generally considered safe for use during pregnancy due to minimal systemic absorption. Consult a healthcare provider before use.

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

Sodium chloride 5% ophthalmic ointment is considered safe for use during lactation. Systemic absorption is minimal, making transfer into breast milk unlikely to cause adverse effects in the infant.

Infant Risk: L1 (Safest - compatible with breastfeeding)
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Pediatric Use

Generally considered safe for use in children under medical supervision. Dosing is typically similar to adults. Consult an ophthalmologist for use in infants and neonates.

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Geriatric Use

No specific dosage adjustments are necessary for geriatric patients. The safety and efficacy profile is similar to that in younger adults.

Clinical Information

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Clinical Pearls

  • This ointment is primarily used for temporary relief of corneal edema, often associated with Fuchs' dystrophy or after certain eye surgeries.
  • Patients should be instructed on proper ophthalmic ointment application technique to maximize efficacy and minimize contamination.
  • Advise patients that transient blurring of vision may occur immediately after application due to the ointment base.
  • If using other ophthalmic medications, apply drops first, wait 5-10 minutes, then apply the ointment.
  • This product is for external ophthalmic use only; do not ingest.
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Alternative Therapies

  • Sodium Chloride 5% Ophthalmic Solution (drops)
  • Topical corticosteroids (for inflammatory corneal edema, different mechanism)
  • Topical NSAIDs (for inflammatory corneal edema, different mechanism)
  • Corneal transplantation (for severe, refractory corneal edema)
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Cost & Coverage

Average Cost: $10 - $30 per 3.5gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic)
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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's a good idea to check with your pharmacist for more information. 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.