Cortisporin-Tc Otic Susp (ear) 10ml
It is used to treat ear infections.
Drug Class
Otic anti-infective and anti-inflammatory
Pharmacologic Class
Aminoglycoside antibiotic, Polypeptide antibiotic, Corticosteroid, Wetting agent
Pregnancy Category
Not assigned for otic formulation; components: Neomycin (C/D if systemic), Hydrocortisone (C if systemic). Minimal systemic absorption expected with otic use.
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Cortisporin-Tc Otic Suspension is an ear drop medication used to treat ear infections and inflammation. It contains two antibiotics (neomycin and colistin) to kill bacteria, a steroid (hydrocortisone) to reduce swelling and itching, and a wetting agent (thonzonium) to help the medicine spread in the ear.
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 ear.
Avoid getting the medication in your eyes.
Before using the suspension, shake the bottle well.
Wash your hands before and after using the medication.
To administer the drops:
1. Lie on your side with the affected ear facing upwards.
2. For children under 3 years old, gently pull the outer ear downward and outward. For individuals 3 years and older, pull the outer ear upward and outward.
3. Place the drops in the ear without touching the dropper to the ear.
4. Remain on your side for 5 minutes or insert a cotton plug into the ear.
Storage and Disposal
Store the medication at room temperature.
Keep all medications in a safe and 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 the best disposal method. You may also have access to drug take-back programs in your area.
Missed Dose Instructions
If you miss a dose, use it as soon as you remember.
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. Continue using the medication as directed, even if your symptoms improve.
Administration Instructions
Use this medication only in the ear.
Avoid getting the medication in your eyes.
Before using the suspension, shake the bottle well.
Wash your hands before and after using the medication.
To administer the drops:
1. Lie on your side with the affected ear facing upwards.
2. For children under 3 years old, gently pull the outer ear downward and outward. For individuals 3 years and older, pull the outer ear upward and outward.
3. Place the drops in the ear without touching the dropper to the ear.
4. Remain on your side for 5 minutes or insert a cotton plug into the ear.
Storage and Disposal
Store the medication at room temperature.
Keep all medications in a safe and 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 the best disposal method. You may also have access to drug take-back programs in your area.
Missed Dose Instructions
If you miss a dose, use it as soon as you remember.
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
- Keep the ear clean and dry. Avoid getting water in the ear during treatment.
- Do not insert cotton swabs or other objects into the ear canal.
- Complete the full course of treatment, even if symptoms improve, to prevent recurrence of infection.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
4 drops instilled into the affected ear 3 to 4 times daily
Condition-Specific Dosing:
otitisExterna:
4 drops into the affected ear 3 to 4 times daily
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (use with caution, consult physician)
Child:
4 drops instilled into the affected ear 3 to 4 times daily (safety and efficacy generally established for children 2 years and older)
Adolescent:
4 drops instilled into the affected ear 3 to 4 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 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
Mechanism of Action
Cortisporin-Tc Otic Suspension combines the antibacterial actions of neomycin and colistin with the anti-inflammatory and antipruritic effects of hydrocortisone, and the wetting/dispersing action of thonzonium bromide. Neomycin (an aminoglycoside) inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit. Colistin (a polymyxin) acts as a cationic detergent, disrupting the integrity of the bacterial cell membrane, leading to leakage of intracellular components. Hydrocortisone (a corticosteroid) reduces inflammation by inhibiting phospholipase A2, thereby decreasing the formation of prostaglandins and leukotrienes. Thonzonium bromide is a quaternary ammonium compound that acts as a wetting agent, helping to disperse the active ingredients and penetrate earwax and debris, facilitating drug contact with the affected tissues.
Pharmacokinetics
Absorption:
Bioavailability:
Minimal systemic absorption (otic route)
Tmax:
Not applicable (local action)
FoodEffect:
Not applicable
Distribution:
Vd:
Not applicable (local action)
ProteinBinding:
Not applicable (local action)
CnssPenetration:
No (local action)
Elimination:
HalfLife:
Not applicable (local action)
Clearance:
Not applicable (local action)
ExcretionRoute:
Not applicable (local action)
Unchanged:
Not applicable (local action)
Pharmacodynamics
OnsetOfAction:
Within hours to days for symptom relief
PeakEffect:
Within days of consistent use
DurationOfAction:
Dependent on frequency of application and resolution of infection/inflammation
Safety & Warnings
Side Effects
Urgent 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
Irritation at the site where the medication was applied
Difficulty urinating or changes in urine output
Hearing loss or changes in hearing, which may be permanent and more likely with long-term use
Do not use this medication for longer than prescribed by your doctor. If you notice any changes in your hearing or experience hearing loss, inform your doctor immediately.
Other Possible Side Effects
Like all medications, this drug can cause side effects, although not everyone will experience them. Many people have no side effects or only mild ones. If you have any side effects that bother you or do not go away, contact your doctor or seek medical help.
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
Irritation at the site where the medication was applied
Difficulty urinating or changes in urine output
Hearing loss or changes in hearing, which may be permanent and more likely with long-term use
Do not use this medication for longer than prescribed by your doctor. If you notice any changes in your hearing or experience hearing loss, inform your doctor immediately.
Other Possible Side Effects
Like all medications, this drug can cause side effects, although not everyone will experience them. Many people have no side effects or only mild ones. If you have any side effects that bother you or do not go away, contact your doctor or seek medical help.
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:
- Worsening ear pain or discharge
- New or increased itching or rash in or around the ear (signs of allergic reaction)
- Hearing loss or ringing in the ears (tinnitus)
- Dizziness
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.
If you have a viral ear infection.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication in conjunction with your other medications and health issues.
Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
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.
If you have a viral ear infection.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication in conjunction with your other medications and health issues.
Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. To minimize the risk of a second infection, do not use this drug for a longer period than prescribed by your healthcare provider. If you are pregnant, planning to become pregnant, or are currently breast-feeding, notify your doctor immediately. Your doctor will discuss the potential benefits and risks of using this medication during pregnancy or breast-feeding to help you make an informed decision.
Overdose Information
Overdose Symptoms:
- Unlikely with topical otic use due to minimal systemic absorption. If ingested, symptoms could include gastrointestinal upset. Systemic absorption through a perforated eardrum could theoretically lead to ototoxicity (hearing loss, dizziness) or nephrotoxicity (kidney damage) from neomycin, but this is rare with proper use.
What to Do:
Discontinue use. For accidental ingestion or significant systemic exposure, seek medical attention. Call 1-800-222-1222 for poison control.
Drug Interactions
Monitoring
Baseline Monitoring
Otoscopic examination
Rationale: To assess the extent of infection/inflammation, presence of tympanic membrane perforation, and rule out other conditions.
Timing: Prior to initiation of therapy
Routine Monitoring
Clinical response (symptom improvement)
Frequency: Daily
Target: Reduction in pain, itching, discharge, and inflammation
Action Threshold: Lack of improvement or worsening symptoms after 7-10 days warrants re-evaluation and consideration of alternative therapy.
Otoscopic examination
Frequency: As clinically indicated, or at follow-up visit
Target: Resolution of inflammation and infection
Action Threshold: Persistent inflammation, discharge, or signs of fungal infection.
Symptom Monitoring
- Ear pain
- Itching
- Discharge (color, consistency, odor)
- Redness or swelling of the ear canal
- Hearing changes
- Signs of allergic reaction (rash, hives, severe itching)
Special Patient Groups
Pregnancy
Use during pregnancy should be considered only if the potential benefit justifies the potential risk to the fetus. While systemic absorption is minimal, components like neomycin (aminoglycoside) are associated with fetal ototoxicity when administered systemically. Consult a healthcare provider.
Trimester-Specific Risks:
First Trimester:
Low risk due to minimal systemic absorption, but caution advised.
Second Trimester:
Low risk due to minimal systemic absorption, but caution advised.
Third Trimester:
Low risk due to minimal systemic absorption, but caution advised. Systemic aminoglycosides in the third trimester have been associated with fetal ototoxicity.
Lactation
It is not known whether components are excreted in human milk following otic administration. Due to minimal systemic absorption, risk to the nursing infant is considered low. Use with caution and consult a healthcare provider.
Infant Risk:
Low risk (L3 - Moderately Safe) due to minimal systemic absorption.
Pediatric Use
Generally safe for use in children 2 years and older. Safety and efficacy in infants and neonates have not been established. Use in children should be under medical supervision, especially if the tympanic membrane integrity is uncertain.
Geriatric Use
No specific dosage adjustments are required for geriatric patients. Use with caution if there is a history of perforated tympanic membrane or pre-existing hearing impairment.
Clinical Information
Clinical Pearls
- Shake the suspension well before each use to ensure uniform distribution of ingredients.
- Warm the bottle by holding it in your hand for a few minutes before instilling drops to avoid dizziness.
- Lie on your side with the affected ear facing up for 5 minutes after instilling drops to allow the medication to penetrate.
- Do not touch the dropper tip to the ear or any other surface to prevent contamination.
- This product is discontinued; alternative combination otic drops are available (e.g., Cortisporin Otic Solution/Suspension, Cipro HC Otic).
Alternative Therapies
- Ofloxacin otic solution (fluoroquinolone antibiotic)
- Ciprofloxacin otic solution (fluoroquinolone antibiotic)
- Acetic acid otic solution (for swimmer's ear)
- Topical corticosteroids alone (e.g., hydrocortisone otic solution) for inflammation without infection.
Cost & Coverage
Average Cost:
Not applicable - Discontinued Not applicable
Generic Available:
Yes
Insurance Coverage:
Not applicable - Discontinued
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.