Tobrex Ophthalmic Soln 5ml
It is used to treat eye infections.
Drug Class
Ophthalmic Anti-infective
Pharmacologic Class
Aminoglycoside Antibiotic
Pregnancy Category
Category B
FDA Approved
Jun 1979
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tobramycin eye drops are an antibiotic medication used to treat bacterial infections of the eye, such as pink eye (conjunctivitis) or corneal infections. It works by stopping the growth of bacteria.
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. Use the medication as directed, even if your symptoms improve.
Administration Instructions
1. Use this medication for the eye only.
2. Wash your hands before and after use to maintain cleanliness.
3. Remove contact lenses before applying the medication. Do not replace them if your eyes are irritated or infected.
4. Avoid touching the container tip to the eye, lid, or other skin to prevent bacterial contamination, which can lead to severe eye problems or vision loss.
5. Tilt your head back and gently drop the medication into the eye.
6. After application, keep your eyes closed and apply pressure to the inside corner of the eye for 1 to 2 minutes to help the medication stay in the eye.
Storage and Disposal
Store the medication in the refrigerator or at room temperature (up to 77°F or 25°C). Do not freeze the medication. Protect it from heat and keep the lid tightly closed.
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 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. Use the medication as directed, even if your symptoms improve.
Administration Instructions
1. Use this medication for the eye only.
2. Wash your hands before and after use to maintain cleanliness.
3. Remove contact lenses before applying the medication. Do not replace them if your eyes are irritated or infected.
4. Avoid touching the container tip to the eye, lid, or other skin to prevent bacterial contamination, which can lead to severe eye problems or vision loss.
5. Tilt your head back and gently drop the medication into the eye.
6. After application, keep your eyes closed and apply pressure to the inside corner of the eye for 1 to 2 minutes to help the medication stay in the eye.
Storage and Disposal
Store the medication in the refrigerator or at room temperature (up to 77°F or 25°C). Do not freeze the medication. Protect it from heat and keep the lid tightly closed.
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 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
- Do not wear contact lenses while using this medication, especially if you have an eye infection. If you must wear them, remove them before applying the drops and wait at least 15 minutes before reinserting them.
- Avoid touching the dropper tip to your eye or any other surface to prevent contamination.
- Wash your hands thoroughly before and after applying the eye drops.
- Complete the full course of treatment, even if your symptoms improve, to prevent the infection from returning and to reduce the risk of antibiotic resistance.
- If using other eye drops, wait at least 5-10 minutes between applications.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
1-2 drops into the affected eye(s) every 4 hours.
Dose Range:
1 - 2 mg
Condition-Specific Dosing:
severeInfection:
For severe infections, 2 drops into the affected eye(s) every hour until improvement, then reduce frequency.
Pediatric Dosing
Neonatal:
Not established (generally not recommended for neonates due to potential for systemic absorption and ototoxicity/nephrotoxicity, though ophthalmic absorption is minimal).
Infant:
For infants 2 months of age and older: 1-2 drops into the affected eye(s) every 4 hours. For severe infections, 2 drops every hour until improvement, then reduce frequency.
Child:
1-2 drops into the affected eye(s) every 4 hours. For severe infections, 2 drops every hour until improvement, then reduce frequency.
Adolescent:
1-2 drops into the affected eye(s) every 4 hours. For severe infections, 2 drops every hour until improvement, then reduce frequency.
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 for ophthalmic use due to 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
Tobramycin is an aminoglycoside antibiotic that inhibits bacterial protein synthesis by irreversibly binding to the 30S ribosomal subunit, leading to misreading of the mRNA and premature termination of protein synthesis. This results in a bactericidal effect.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (<1%) from ophthalmic administration.
Tmax:
Not applicable for systemic Tmax due to minimal absorption; local concentration peaks rapidly.
FoodEffect:
Not applicable for ophthalmic administration.
Distribution:
Vd:
Not applicable for systemic Vd due to minimal absorption; primarily distributed locally in ocular tissues.
ProteinBinding:
Not applicable for systemic protein binding due to minimal absorption.
CnssPenetration:
Limited (not relevant for ophthalmic use).
Elimination:
HalfLife:
Not applicable for systemic half-life due to minimal absorption; local elimination from ocular surface.
Clearance:
Not applicable for systemic clearance due to minimal absorption.
ExcretionRoute:
Primarily eliminated from the ocular surface via tear drainage. If systemically absorbed, excreted unchanged by the kidneys.
Unchanged:
Not applicable for systemic unchanged excretion percentage due to minimal absorption.
Pharmacodynamics
OnsetOfAction:
Rapid (within hours for symptomatic relief, full therapeutic effect within days).
PeakEffect:
Within 24-48 hours for clinical improvement.
DurationOfAction:
Dependent on dosing frequency (e.g., 4 hours for q4h 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
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 or seek medical help:
* Eye irritation
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. 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. 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
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 or seek medical help:
* Eye irritation
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. 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:
- Increased eye redness or irritation
- New or worsening eye pain
- Swelling of the eyelids
- Severe itching or rash around the eyes
- Any signs of a new infection
- Vision changes
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 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. This information will help your doctor and pharmacist identify potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting 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 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. This information will help your doctor and pharmacist identify potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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, as this may increase the risk of a secondary infection. 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:
- Excessive tearing
- Increased redness
- Swelling of the eyelids
What to Do:
Due to minimal systemic absorption, an ophthalmic overdose is unlikely to cause systemic toxicity. If accidentally ingested, drink fluids. If local irritation occurs, flush the eye with lukewarm water. If symptoms persist or worsen, contact a poison control center (1-800-222-1222) or seek medical attention.
Drug Interactions
Moderate Interactions
- Other ophthalmic preparations: Concurrent use of other ophthalmic solutions or ointments may alter the absorption or effectiveness of tobramycin. Administer other ophthalmic medications at least 5-10 minutes apart.
Monitoring
Baseline Monitoring
Ocular examination (redness, discharge, swelling)
Rationale: To assess the severity and nature of the infection.
Timing: Prior to initiating therapy.
Visual acuity
Rationale: To establish baseline visual function.
Timing: Prior to initiating therapy.
Routine Monitoring
Clinical signs and symptoms of infection (e.g., reduction in redness, discharge, pain)
Frequency: Daily
Target: Improvement or resolution of symptoms.
Action Threshold: Lack of improvement or worsening of symptoms after 2-3 days may indicate resistant organisms or incorrect diagnosis; consider re-evaluation and alternative therapy.
Signs of local irritation or hypersensitivity (e.g., itching, lid swelling, conjunctival erythema)
Frequency: Daily
Target: Absence of new or worsening irritation.
Action Threshold: Development of new or severe irritation/hypersensitivity; discontinue use and consult physician.
Symptom Monitoring
- Decreased eye redness
- Reduced eye discharge
- Decreased eye pain or discomfort
- Improved vision (if affected by infection)
- Absence of itching or swelling around the eyes
Special Patient Groups
Pregnancy
Tobramycin ophthalmic is classified as Pregnancy Category B. Animal studies have not shown harm to the fetus, and systemic absorption in humans is minimal. It is generally considered safe for use during pregnancy when indicated, but use only if clearly needed and the potential benefit outweighs the potential risk.
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.
Lactation
Tobramycin ophthalmic is considered L3 (Moderately Safe) for lactation. While aminoglycosides are excreted in breast milk, systemic absorption from ophthalmic use is minimal, making infant exposure very low. Risk to the infant is considered unlikely. Monitor the infant for diarrhea or thrush.
Infant Risk:
Low risk of adverse effects due to minimal systemic absorption and low transfer into breast milk.
Pediatric Use
Safe and effective for use in pediatric patients 2 months of age and older. Dosing is similar to adults. Safety and efficacy in infants younger than 2 months have not been established.
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
Clinical Pearls
- Tobramycin ophthalmic is effective against a broad spectrum of gram-negative bacteria, including Pseudomonas aeruginosa, which is a common cause of severe eye infections.
- Ensure proper instillation technique to maximize drug delivery and minimize systemic absorption.
- Advise patients to remove contact lenses before instillation and wait at least 15 minutes before reinserting them.
- If symptoms do not improve within 2-3 days, or worsen, re-evaluate the diagnosis and consider bacterial resistance or a different pathogen.
- This medication is for bacterial infections only; it will not work for viral or fungal eye infections.
Alternative Therapies
- Moxifloxacin ophthalmic (Vigamox)
- Gatifloxacin ophthalmic (Zymar)
- Ofloxacin ophthalmic (Ocuflox)
- Ciprofloxacin ophthalmic (Ciloxan)
- Erythromycin ophthalmic ointment
- Polymyxin B/Trimethoprim ophthalmic (Polytrim)
Cost & Coverage
Average Cost:
$20 - $50 per 5ml bottle (generic)
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'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.