Tobramycin 0.3% Oph Sol 5ml
It is used to treat eye infections.
Drug Class
Ophthalmic Anti-infective
Pharmacologic Class
Aminoglycoside Antibiotic
Pregnancy Category
Category B
FDA Approved
Jun 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tobramycin eye drops are an antibiotic medication 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. 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 retain the medication.
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 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 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 retain the medication.
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 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 schedule. Do not use two doses at the same time or take extra doses.
Lifestyle & Tips
- Wash hands thoroughly before and after applying eye drops.
- Do not touch the dropper tip to your eye or any other surface to prevent contamination.
- Remove contact lenses before applying the drops and wait at least 15 minutes before reinserting them.
- If you are using other eye drops, wait at least 5 minutes between applications.
- Complete the full course of treatment, even if your symptoms improve, to prevent recurrence and antibiotic resistance.
Available Forms & Alternatives
Available Strengths:
- Tobramycin 0.3% Oph Sol 5ml
- Tobramycin 40mg/ml Injection 25x2ml
- Tobramycin 80mg/2ml Inj Mdv
- Tobramycin Sulf 40mg/ml Inj, 30ml
- Tobramycin 10mg/ml Inj, 2ml
- Tobramycin 300mg/5ml Inh Sol 5ml
- Tobramycin 80mg/2ml Inj, 2ml
- Tobramycin 1.2/30ml Inj, 30ml
- Tobramycin 300mg/5ml Inh Sol 56x5ml
- Tobramycin 300mg/4ml Neb Sol 4ml
- Tobramycin 40mg/ml Inj, 50ml
- Tobramycin 40mg/ml Inj, 2ml
- Tobramycin 1.2gm Inj, 1 Vial
- Tobramycin 1.2gm Inj 1 Vial
Dosing & Administration
Adult Dosing
Standard Dose:
1 to 2 drops into the affected eye(s) every 4 hours.
Condition-Specific Dosing:
severeInfections:
2 drops into the affected eye(s) every hour until improvement, then reduce frequency.
Pediatric Dosing
Neonatal:
Not established (use with caution, consult specialist)
Infant:
Similar to adult dosing, 1 to 2 drops into the affected eye(s) every 4 hours.
Child:
Similar to adult dosing, 1 to 2 drops into the affected eye(s) every 4 hours.
Adolescent:
Similar to adult dosing, 1 to 2 drops into the affected eye(s) every 4 hours.
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 code and premature termination of protein synthesis, ultimately resulting in bacterial cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (<1%) after topical ocular administration.
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Not applicable (topical ocular administration)
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:
Primarily via ocular surface drainage. Any systemically absorbed drug would be renally excreted.
Unchanged:
Not applicable (minimal systemic absorption)
Pharmacodynamics
OnsetOfAction:
Within hours (clinical improvement typically seen within 1-2 days)
PeakEffect:
Not precisely quantifiable for topical ocular effect
DurationOfAction:
Approximately 4-6 hours (based on dosing frequency)
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention 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 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. 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 or seek medical help:
* 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, consult your doctor for medical advice. 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 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. 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 or seek medical help:
* 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, consult your doctor for medical advice. 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 redness, pain, or discharge
- New or increased itching, swelling, or rash around the eyes
- Blurred vision that does not clear
- Signs of a new infection (e.g., white patches in the eye, unusual discharge)
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. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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 of the eye
- Lid swelling
- Punctate keratitis (small lesions on the cornea)
What to Do:
If an overdose occurs, the eye(s) may be flushed with lukewarm water. Contact a poison control center or healthcare provider if symptoms are severe or persistent. Call 1-800-222-1222 for Poison Control.
Drug Interactions
Monitoring
Baseline Monitoring
Visual acuity
Rationale: To establish baseline ocular function.
Timing: Prior to initiation of therapy
Signs and symptoms of ocular infection (e.g., redness, discharge, swelling)
Rationale: To assess the severity and nature of the infection.
Timing: Prior to initiation of therapy
Routine Monitoring
Clinical response to therapy (resolution of infection signs/symptoms)
Frequency: Daily
Target: Improvement or resolution of infection
Action Threshold: Lack of improvement or worsening of symptoms after 2-3 days; consider alternative therapy or re-evaluation.
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
- Increased eye redness
- Eye pain or discomfort
- Increased eye discharge
- Swelling of eyelids
- Itching of eyes
- Blurred vision (if new or worsening)
- Signs of new infection (e.g., fungal superinfection)
Special Patient Groups
Pregnancy
Tobramycin ophthalmic solution is classified as Pregnancy Category B. Studies in animals have not shown evidence of fetal harm. Due to minimal systemic absorption after topical ocular administration, the risk to the fetus 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
Tobramycin ophthalmic solution is considered to have a low risk during lactation (L3). Due to minimal systemic absorption, it is unlikely to be excreted in breast milk in clinically significant amounts. Infant exposure is expected to be negligible.
Infant Risk:
Low risk
Pediatric Use
Tobramycin ophthalmic solution is generally safe and effective for use in pediatric patients, including neonates, infants, children, and adolescents, for the treatment of bacterial eye infections. Dosing is typically similar to adults.
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
Clinical Pearls
- Advise patients to avoid wearing contact lenses during treatment for bacterial conjunctivitis or keratitis.
- Instruct patients on proper eye drop instillation technique to maximize efficacy and minimize contamination.
- If symptoms do not improve within 2-3 days, or worsen, re-evaluate the diagnosis and treatment plan.
- Prolonged use of topical antibiotics may lead to overgrowth of non-susceptible organisms, including fungi.
Alternative Therapies
- Moxifloxacin ophthalmic solution (e.g., Vigamox)
- Gatifloxacin ophthalmic solution (e.g., Zymar)
- Ofloxacin ophthalmic solution (e.g., Ocuflox)
- Ciprofloxacin ophthalmic solution (e.g., Ciloxan)
- Erythromycin ophthalmic ointment
- Polymyxin B/Trimethoprim ophthalmic solution (e.g., Polytrim)
Cost & Coverage
Average Cost:
Varies, typically $15-$50 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'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 it's a good idea to check with your pharmacist. 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.