Usage
- This combination medication is prescribed for the treatment of otitis externa (outer ear infections) and otitis media (middle ear infections) caused by bacteria and fungi susceptible to the included antimicrobial agents. It is particularly effective for infections involving both bacterial and fungal components, as well as those accompanied by inflammation and pain.
- Pharmacological Classifications: This is a combination product containing drugs from multiple classes:
- Beclometasone: Corticosteroid, anti-inflammatory
- Clotrimazole: Antifungal
- Lidocaine: Local anesthetic, analgesic
- Ofloxacin: Fluoroquinolone antibiotic
- Mechanism of Action:
- Beclometasone reduces inflammation by inhibiting the release of inflammatory mediators.
- Clotrimazole inhibits ergosterol synthesis, disrupting fungal cell membrane integrity and leading to fungal cell death.
- Lidocaine blocks nerve conduction, providing local pain relief.
- Ofloxacin inhibits bacterial DNA gyrase and topoisomerase IV, essential enzymes for bacterial DNA replication and cell division.
Alternate Names
- No internationally recognized non-proprietary name exists for this combination. It is commonly referred to by the names of its components.
- Brand Names: A number of brand names exist for this combination, including Audicare, Amcure-O, Candiflox, Candistin, Mix Biotic, Otobiotic-Plus, Otic-4, Otiflox, and Otoxin. Brand names may vary regionally.
How It Works
- Pharmacodynamics: The combination exerts a synergistic effect against otic infections through its anti-inflammatory, antifungal, anesthetic, and antibiotic components. Beclometasone reduces inflammation and edema in the ear canal, while clotrimazole targets fungal pathogens. Lidocaine provides rapid pain relief, and ofloxacin eliminates susceptible bacteria.
- Pharmacokinetics:
- Absorption: Topical administration results in limited systemic absorption.
- Metabolism: Primarily hepatic metabolism for clotrimazole, beclometasone, and lidocaine; minimal hepatic metabolism for ofloxacin.
- Elimination: Primarily renal excretion for ofloxacin; hepatic metabolism and subsequent biliary/fecal excretion for other components.
- Mode of Action:
- Beclometasone binds to glucocorticoid receptors, inhibiting inflammatory gene transcription.
- Clotrimazole inhibits the enzyme 14-alpha-demethylase, preventing ergosterol synthesis.
- Lidocaine blocks voltage-gated sodium channels, preventing nerve impulse transmission.
- Ofloxacin inhibits bacterial DNA gyrase and topoisomerase IV, disrupting DNA replication and transcription.
Dosage
Standard Dosage
Adults:
- 2-5 drops into the affected ear 3-4 times daily for 7-14 days.
Children:
- For otitis externa with intact tympanic membrane: 2-5 drops into the affected ear 3-4 times daily for 7-14 days in children aged 6 months and older.
- For chronic suppurative otitis media with perforated tympanic membrane: Use is generally limited to children 12 years and older, with the same dosage as adults. However, some sources suggest avoiding use in children entirely, especially under 12 years of age, particularly when the eardrum is ruptured.
Special Cases:
- Elderly Patients: Close monitoring is advised, although dosage adjustments are not typically necessary.
- Patients with Renal Impairment: Use cautiously, dose adjustments may be necessary. Monitor renal function.
- Patients with Hepatic Dysfunction: Use cautiously, dose adjustments may be necessary. Monitor liver function.
- Patients with Comorbid Conditions: Use with caution in patients with diabetes (beclometasone can affect blood sugar), glaucoma or cataracts (beclometasone can exacerbate these), or adrenal gland problems.
Clinical Use Cases
This medication is primarily indicated for otitis externa and otitis media. It is not typically used in the listed clinical scenarios (intubation, surgical procedures, mechanical ventilation, ICU use, emergency situations).
Dosage Adjustments
Dose adjustments may be necessary based on individual patient characteristics, including renal/hepatic function, comorbid conditions, and response to therapy.
Side Effects
Common Side Effects
- Ear discomfort
- Irritation at the application site
- Burning or stinging sensation
Rare but Serious Side Effects
- Allergic reactions (rash, itching, swelling, severe dizziness, difficulty breathing)
- Hearing changes (hearing loss, tinnitus)
- Vertigo
- Dizziness
Long-Term Effects
Prolonged use may result in fungal or bacterial resistance, or local skin atrophy with beclometasone.
Adverse Drug Reactions (ADR)
Severe allergic reactions require immediate medical attention.
Contraindications
- Hypersensitivity to any component of the medication
- Perforated tympanic membrane (for otitis media)
- Viral infections of the ear
Drug Interactions
- Oral hypoglycemics: Beclometasone may affect blood sugar levels.
- Other local anesthetics: Increased risk of systemic toxicity.
- Class I antiarrhythmics: Ofloxacin may interact with these medications.
- Drugs affecting bacterial DNA synthesis: Potential interactions with other drugs in this class.
- CYP450 interactions: Clotrimazole is a CYP450 inhibitor.
Pregnancy and Breastfeeding
Safety during pregnancy and lactation has not been fully established. Use with caution only if potential benefits outweigh the potential risk.
Drug Profile Summary
- Mechanism of Action: See “Mechanism of Action” in the Usage section.
- Side Effects: Ear discomfort, irritation, rarely allergic reactions, hearing loss, dizziness.
- Contraindications: Hypersensitivity, perforated tympanic membrane (otitis media), viral ear infections.
- Drug Interactions: See Drug Interactions section.
- Pregnancy & Breastfeeding: Use with caution; safety not fully established.
- Dosage: Adults and children: 2-5 drops in affected ear 3-4 times daily for 7-14 days. Pediatric use restricted for otitis media with perforated tympanic membrane.
- Monitoring Parameters: Monitor for improvement of infection, resolution of symptoms, and adverse reactions.
Popular Combinations
The combination of beclometasone, clotrimazole, lidocaine, and ofloxacin is itself a popular formulation for treating otic infections. Sometimes, acetic acid is added to this combination.
Precautions
- General Precautions: Pre-screening for allergies and hypersensitivity is crucial.
- Specific Populations: See “Dosage - Special Cases” and “Pregnancy and Breastfeeding.”
- Lifestyle Considerations: Patients should be advised to avoid driving or operating machinery if they experience dizziness or vertigo.
FAQs (Frequently Asked Questions)
A: The usual dosage is 2-5 drops in the affected ear 3-4 times daily for 7-14 days. The dosage may vary in children.
Q2: Can this medication be used in children?
A: Yes, but with restrictions. For otitis externa with an intact tympanic membrane, it can be used in children aged 6 months and older. For chronic suppurative otitis media with a perforated tympanic membrane, its use is generally restricted to those 12 years and older. Consult product information for specific age and condition restrictions.
Q3: What are the common side effects?
A: Common side effects include ear discomfort, irritation, burning, or stinging sensation at the application site.
Q4: Are there any serious side effects?
A: Rare but serious side effects can include allergic reactions, hearing changes (hearing loss, tinnitus), vertigo, and dizziness. Immediate medical attention is required if these occur.
Q5: What should I do if I miss a dose?
A: If a dose is missed, instill it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not double the dose.
Q6: Can I use this medication if I am pregnant or breastfeeding?
A: The safety of this medication during pregnancy and breastfeeding has not been fully established. Consult a physician before using it if you are pregnant, planning to become pregnant, or breastfeeding.
Q7: What are the contraindications for this medication?
A: This medication is contraindicated in individuals with hypersensitivity to any of the components, a perforated tympanic membrane (in cases of otitis media), or viral infections of the ear.
Q8: Can I drink alcohol while using these eardrops?
A: There is no established interaction with alcohol. However, it is generally advisable to avoid alcohol during infections.
Q9: How should I store these eardrops?
A: Store below 25°C (77°F) and protect from light. Keep out of reach of children.
Q10: What if my symptoms don’t improve after a week?
A: If a favorable response does not occur within one week, discontinue use and consult your physician for further evaluation and possible alternative treatment.
