Usage
Clotrimazole + Lidocaine + Ofloxacin is prescribed for the treatment of superficial bacterial and fungal infections of the external auditory canal (otitis externa) and middle ear (otitis media), particularly when inflammation and pain are present. It is effective against organisms susceptible to ofloxacin and clotrimazole.
Pharmacological Classification: This is a combination product with multiple classifications:
- Ofloxacin: Fluoroquinolone antibiotic
- Clotrimazole: Imidazole antifungal
- Lidocaine: Local anesthetic
- Beclometasone: Corticosteroid (anti-inflammatory)
Mechanism of Action:
- Ofloxacin: Inhibits bacterial DNA gyrase and topoisomerase IV, enzymes essential for bacterial DNA replication and repair, leading to bacterial cell death.
- Clotrimazole: Alters fungal cell membrane permeability, causing leakage of essential cellular contents and inhibiting fungal growth.
- Lidocaine: Blocks voltage-gated sodium channels, inhibiting nerve impulse transmission and producing local anesthesia.
- Beclometasone: Exerts anti-inflammatory, antipruritic, and vasoconstrictive effects. Binds to glucocorticoid receptors, modulating inflammatory responses.
Alternate Names
No widely recognized alternate names exist for this specific combination. It is often referred to by its component drugs. Several brand names are available, including Amcure-O, Audicare, Candiflox, Candistin, Oflo Plus, Otobiotic-Plus, Otic-4, and Otoxin.
How It Works
Pharmacodynamics:
The combined effects of the individual components provide synergistic action against ear infections. Ofloxacin targets bacterial infections, clotrimazole addresses fungal infections, lidocaine provides pain relief, and beclometasone reduces inflammation.
Pharmacokinetics:
Primarily administered as ear drops, systemic absorption is minimal. Each component has its own pharmacokinetic profile following systemic administration:
- Ofloxacin: Well-absorbed orally, hepatic metabolism, renal excretion.
- Clotrimazole: Minimally absorbed topically, hepatic metabolism.
- Lidocaine: Well-absorbed topically, hepatic metabolism, renal excretion.
- Beclometasone: Minimally absorbed through skin, hepatic metabolism, renal excretion.
Mode of Action:
The pharmacodynamics and mechanisms of action are described above.
Elimination pathways are mentioned in the pharmacokinetics section.
Dosage
Standard Dosage
Adults: 2-5 drops into the affected ear three to four times daily for 7-14 days.
Children: 2-5 drops into the affected ear three to four times daily for 7-14 days.
For otitis externa with an intact tympanic membrane: From 6 months and older.
For chronic suppurative otitis media with a perforated tympanic membrane: 12 years and older.
Always consult a pediatrician for appropriate dosing in children.
Special Cases:
Dosage adjustments should be made under the guidance of a physician for elderly patients and patients with renal or hepatic impairment.
Clinical Use Cases
The dosage for otitis externa and otitis media are provided above. This combination medication is generally not used for other clinical use cases mentioned like: intubation, surgical procedures, mechanical ventilation, ICU use or emergency situations.
Dosage Adjustments
Consult a physician to establish appropriate dosage modifications based on the specific case.
Side Effects
Common Side Effects
Ear discomfort, irritation at the application site, burning sensation, itching.
Rare but Serious Side Effects
Allergic reactions, hearing loss, vertigo, dizziness.
Long-Term Effects
With topical administration, long-term systemic effects are unlikely. However prolonged use of antibiotics can lead to resistance.
Adverse Drug Reactions (ADR)
Severe allergic reactions, worsening of infection, new or worsening ear pain, hearing changes, dizziness.
Contraindications
Hypersensitivity to any of the components, perforated eardrum (for otitis media), viral ear infections.
Drug Interactions
Ofloxacin may interact with antacids, warfarin, theophylline, and certain other medications. Consult a physician for specific drug interactions.
Pregnancy and Breastfeeding
Safety during pregnancy and lactation has not been fully established. Use with caution and only if potential benefits outweigh potential risks to the fetus or nursing infant. Consult a physician.
Drug Profile Summary
(See previous sections for details)
Popular Combinations
The combination of clotrimazole, lidocaine, ofloxacin, and beclometasone is itself a popular formulation.
Precautions
(See previous sections, especially Contraindications, Drug Interactions, Pregnancy and Breastfeeding)
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Clotrimazole + Lidocaine + Ofloxacin ear drops?
A: The standard dosage for adults and children is 2-5 drops in the affected ear three to four times daily for 7-14 days. Pediatric use has age restrictions. Consult a physician for precise recommendations.
Q2: Can this combination be used if the eardrum is perforated?
A: No, this combination is contraindicated if the eardrum is perforated, except in specific cases of chronic suppurative otitis media as directed by a physician.
Q3: What are the common side effects of this ear drop?
A: Common side effects include ear discomfort, local irritation, burning, and itching.
Q4: Are there any serious side effects?
A: While rare, serious side effects can include allergic reactions, hearing changes, and worsening of the infection. Seek immediate medical attention if these occur.
Q5: Can this medication be used during pregnancy or breastfeeding?
A: The safety during pregnancy and breastfeeding is not fully established. Consult a physician before using this medication in these situations.
Q6: Are there any drug interactions I should be aware of?
A: Yes, potential drug interactions exist, primarily with ofloxacin. Inform your physician about all medications you are currently taking.
Q7: How should this medication be stored?
A: Store below 25°C (77°F) and protect from light. Keep out of the reach of children.
Q8: What should I do if I miss a dose?
A: Administer the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not double the dose to catch up.
Q9: What if my symptoms do not improve after a week of use?
A: If your symptoms do not improve or worsen after using this medication for a week, consult your physician. It is essential to rule out other causes or the need for a different treatment approach.
