Tobrex 0.3% Opth Oint 3.5gm
It is used to treat eye infections.
Drug Class
Ophthalmic anti-infective
Pharmacologic Class
Aminoglycoside antibiotic
Pregnancy Category
Category B
FDA Approved
Jun 1975
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tobramycin ophthalmic ointment is an antibiotic used to treat bacterial infections of the eye. 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. Continue using the medication as directed, even if your symptoms improve.
Administration Instructions
Use this medication only in the eye.
Wash your hands before and after use.
Remove contact lenses before using this medication and do not replace them if your eyes are irritated or infected.
To avoid contamination, do not touch the container tip to the eye, lid, or other skin, as this can lead to bacterial infection, severe eye problems, or vision loss.
Tilt your head back and gently pull down the lower eyelid.
Squeeze in the prescribed amount of medication.
Look down before closing your eye.
Release the lower eyelid and keep your eyes closed for 1 to 2 minutes.
Storage and Disposal
Store this medication in the refrigerator or at room temperature (up to 77°F or 25°C). Do not freeze. Protect the medication from heat and keep the lid tightly closed.
Missed Dose
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 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. Continue using the medication as directed, even if your symptoms improve.
Administration Instructions
Use this medication only in the eye.
Wash your hands before and after use.
Remove contact lenses before using this medication and do not replace them if your eyes are irritated or infected.
To avoid contamination, do not touch the container tip to the eye, lid, or other skin, as this can lead to bacterial infection, severe eye problems, or vision loss.
Tilt your head back and gently pull down the lower eyelid.
Squeeze in the prescribed amount of medication.
Look down before closing your eye.
Release the lower eyelid and keep your eyes closed for 1 to 2 minutes.
Storage and Disposal
Store this medication in the refrigerator or at room temperature (up to 77°F or 25°C). Do not freeze. Protect the medication from heat and keep the lid tightly closed.
Missed Dose
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 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 active eye infection. If you must wear them, remove them before applying the ointment and wait at least 15 minutes before reinserting.
- Avoid touching the tip of the ointment tube to your eye or any other surface to prevent contamination.
- Wash your hands thoroughly before and after applying the ointment.
- Do not share your eye medication with others.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Apply a small amount (approximately 1/2 inch ribbon) into the conjunctival sac of the affected eye(s) 2 or 3 times daily.
Condition-Specific Dosing:
severeInfection:
For severe infections, apply every 3 to 4 hours for the first 1 to 2 days, then reduce frequency as infection improves.
Pediatric Dosing
Neonatal:
Not established (use with caution, consult specialist)
Infant:
Apply a small amount (approximately 1/2 inch ribbon) into the conjunctival sac of the affected eye(s) 2 or 3 times daily.
Child:
Apply a small amount (approximately 1/2 inch ribbon) into the conjunctival sac of the affected eye(s) 2 or 3 times daily.
Adolescent:
Apply a small amount (approximately 1/2 inch ribbon) into the conjunctival sac of the affected eye(s) 2 or 3 times daily.
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
Mechanism of Action
Tobramycin is an aminoglycoside antibiotic. It exerts its bactericidal effect by inhibiting bacterial protein synthesis. It binds irreversibly to the 30S ribosomal subunit, leading to misreading of the mRNA and premature termination of protein synthesis, ultimately resulting in bacterial cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (less than 1%) following topical ophthalmic administration.
Tmax:
Not clinically relevant for topical ophthalmic use.
FoodEffect:
Not applicable for topical ophthalmic use.
Distribution:
Vd:
Not clinically relevant for topical ophthalmic use.
ProteinBinding:
Not clinically relevant for topical ophthalmic use.
CnssPenetration:
Limited (not clinically relevant for topical ophthalmic use).
Elimination:
HalfLife:
Not clinically relevant for topical ophthalmic use (systemic half-life is 2-3 hours, but systemic absorption is negligible).
Clearance:
Not clinically relevant for topical ophthalmic use.
ExcretionRoute:
Primarily renal if systemically absorbed, but negligible systemic absorption from ophthalmic use.
Unchanged:
Not clinically relevant for topical ophthalmic use.
Pharmacodynamics
OnsetOfAction:
Within hours of first application (clinical improvement typically seen within 1-2 days).
PeakEffect:
Not precisely quantifiable for topical ophthalmic effect.
DurationOfAction:
Duration of effect supports 2-3 times daily dosing.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Immediately
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 medical attention 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. 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 do not go away, contact your doctor for advice:
* 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.
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 medical attention 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. 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 do not go away, contact your doctor for advice:
* 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, pain, or swelling
- New or worsening discharge from the eye
- Severe itching or burning in the eye
- Rash or hives
- Difficulty breathing or swallowing (signs of severe allergic reaction - seek immediate medical attention)
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 assess 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 current 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 assess 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 current 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 engaging in activities that require clear vision, such as driving. 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:
- Unlikely with topical ophthalmic use due to minimal systemic absorption. Local irritation (e.g., punctate keratitis, erythema, increased tearing, edema of the eyelid) may occur with excessive use.
What to Do:
If local irritation occurs, discontinue use and consult a healthcare professional. For accidental ingestion, call a poison control center (1-800-222-1222) or seek medical attention, though systemic toxicity is highly unlikely.
Drug Interactions
Monitoring
Baseline Monitoring
Visual acuity
Rationale: To assess baseline vision and monitor for improvement or worsening.
Timing: Prior to initiation of therapy.
Signs and symptoms of ocular infection (e.g., redness, discharge, swelling, pain)
Rationale: To confirm diagnosis and establish baseline severity.
Timing: Prior to initiation of therapy.
Routine Monitoring
Resolution of infection symptoms (e.g., decreased redness, discharge, pain)
Frequency: Daily
Target: Progressive improvement
Action Threshold: Lack of improvement or worsening after 2-3 days, or signs of allergic reaction/irritation.
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 significant irritation or allergic reaction; discontinue use.
Symptom Monitoring
- Eye redness
- Eye discharge
- Eye pain or discomfort
- Itching of the eyes or eyelids
- Swelling of eyelids
- Blurred vision (if new or worsening)
Special Patient Groups
Pregnancy
Category B. Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. Due to minimal systemic absorption, risk to the fetus from ophthalmic use is considered low.
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
L3 (Moderately Safe). It is not known whether tobramycin is excreted in human milk following topical ophthalmic administration. However, due to minimal systemic absorption, the amount excreted into breast milk is expected to be negligible, posing a low risk to the nursing infant.
Infant Risk:
Low risk.
Pediatric Use
Safe and effective for use in pediatric patients 2 months of age and older. Dosing is similar to adults. Safety and effectiveness in neonates (less than 2 months of age) have not been established.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. No specific dose adjustments are necessary.
Clinical Information
Clinical Pearls
- Ensure proper administration technique: pull down the lower eyelid, apply a small ribbon of ointment into the conjunctival sac, and close the eye gently for 1-2 minutes to allow distribution.
- Ophthalmic ointments can cause temporary blurred vision; advise patients not to drive or operate machinery until vision clears.
- If using other ophthalmic medications, apply the ointment last to ensure it stays in the eye and does not interfere with absorption of drops.
- Complete the full course of therapy, even if symptoms improve, to prevent recurrence and development of resistance.
- If no improvement is seen after 2-3 days, or if symptoms worsen, re-evaluate the diagnosis and treatment plan.
Alternative Therapies
- Erythromycin ophthalmic ointment
- Bacitracin ophthalmic ointment
- Polymyxin B/Bacitracin ophthalmic ointment
- Ciprofloxacin ophthalmic solution/ointment
- Ofloxacin ophthalmic solution
- Moxifloxacin ophthalmic solution
- Gatifloxacin ophthalmic solution
Cost & Coverage
Average Cost:
Varies, typically $20-$50 per 3.5gm tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (preferred generic or 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 this 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, including the amount taken and the time it happened, to facilitate prompt and effective treatment.