Acetic acid + Beclometasone + Clotrimazole + Lidocaine + Ofloxacin

Usage

This combination medication is prescribed for the treatment of otitis externa (outer ear infections) and otitis media (middle ear infections) where bacterial and fungal infections are present. It is particularly effective in cases where inflammation and pain are significant symptoms.

• Pharmacological Classification: This is a combination product containing medications from different classes:

  • Acetic acid: antiseptic
  • Beclometasone: corticosteroid, anti-inflammatory
  • Clotrimazole: antifungal
  • Lidocaine: local anesthetic
  • Ofloxacin: fluoroquinolone antibiotic

• Mechanism of Action: This combination targets various aspects of ear infections:

  • Ofloxacin: Inhibits bacterial DNA gyrase, preventing bacterial DNA replication and transcription.
  • Clotrimazole: Alters fungal cell membrane permeability, leading to fungal cell death.
  • Beclometasone: Reduces inflammation by inhibiting prostaglandin synthesis.
  • Lidocaine: Provides local pain relief by blocking nerve signal transmission.
  • Acetic Acid: Creates an acidic environment that is hostile to many pathogens.

Alternate Names

While there isn’t one official international non-proprietary name for this specific five-drug combination, each component has its own established name. Some regional variations may exist for Lidocaine (Lignocaine).

• Brand Names: Mixbiotic-AC, Amcure-O, and Oflokan are among the brand names used for this combination.

How It Works

• Pharmacodynamics:

  • Ofloxacin: Bactericidal action against a broad spectrum of gram-positive and gram-negative bacteria.
  • Clotrimazole: Fungicidal against various fungi, including Candida and Trichophyton.
  • Beclometasone: Suppresses inflammation, reduces itching and swelling.
  • Lidocaine: Decreases pain sensation.
  • Acetic Acid: Antiseptic, helps maintain an acidic environment.

• Pharmacokinetics: Primarily topical administration via ear drops. Systemic absorption is minimal. The combination is not intended for oral or intravenous use.

  • Ofloxacin: While minimally absorbed systemically after otic administration, when administered orally, it is well-absorbed and metabolized in the liver, excreted primarily through the kidneys.
  • Beclometasone: Minimally absorbed through skin/ear canal. After systemic administration, metabolized by the liver and excreted in urine and feces.
  • Clotrimazole: Negligible systemic absorption with topical otic use. Following oral administration, it is metabolized in the liver.
  • Lidocaine: After topical application, minimal systemic absorption. When administered systemically, it is metabolized in the liver.
  • Acetic Acid: Metabolized to carbon dioxide and water.

• Mode of Action: See “Mechanism of Action” in the Usage section above for details on each component’s cellular/molecular action.

Dosage

Standard Dosage

Adults: The typical dose is 2-5 drops instilled into the affected ear 3-4 times daily for 7-14 days. The exact dosage and duration will depend on the severity of the infection.

Children: This combination is generally not recommended for very young children, especially those under two years of age, because of the potential side effects associated with some components. For children older than two, the dose may be adjusted based on age and weight; consult specialized pediatric resources.

Special Cases: Use with caution in:

• Elderly Patients: Careful monitoring of renal and hepatic function is recommended.
• Patients with Renal Impairment: Dose adjustment may be needed.
• Patients with Hepatic Dysfunction: Caution is advised due to potential for altered drug metabolism.
• Patients with Comorbid Conditions: Consider potential interactions with other medications and medical conditions (e.g., diabetes, glaucoma).

Clinical Use Cases

The clinical use of this combination is specifically for otitis externa and otitis media. It is not typically used in the settings listed (intubation, surgical procedures, mechanical ventilation, ICU, emergency situations).

Dosage Adjustments

Dosage adjustments are typically based on patient response and tolerance, rather than specific clinical scenarios like those listed. Consult specialized resources for case-specific recommendations.

Side Effects

Common Side Effects:

• Ear discomfort, irritation, itching, burning sensation at the application site
• Temporary hearing loss
• Unpleasant taste (if the medication runs into the throat)
• Redness, dryness, or scaling of the ear canal skin

Rare but Serious Side Effects:

• Allergic reactions (rash, hives, swelling, difficulty breathing)
• Severe dizziness or vertigo
• Persistent hearing loss

Long-Term Effects: Prolonged use can lead to the development of resistant microorganisms.

Adverse Drug Reactions (ADR): See “Rare but Serious Side Effects.”

Contraindications

• Hypersensitivity to any of the components
• Perforated tympanic membrane (ruptured eardrum)
• Viral infections of the ear (e.g., herpes simplex, varicella zoster)

Drug Interactions

• Ofloxacin: May interact with certain medications (e.g., antacids, warfarin, theophylline).
• Beclometasone: Interactions with other corticosteroids should be considered.
• Clotrimazole: Interactions with other antifungals (especially azoles) are possible.
• Lidocaine: May interact with certain antiarrhythmic medications.
• It is important to inform the prescribing physician about all other medications, including OTC drugs and supplements.

Pregnancy and Breastfeeding

The safety of this combination during pregnancy and breastfeeding has not been fully established. Use only if the potential benefits outweigh the risks. Consult specialized resources for detailed recommendations.

Drug Profile Summary

Please refer to the individual sections for more comprehensive information.

Popular Combinations

This specific combination is itself considered a popular combination for ear infections, incorporating anti-infective, anti-inflammatory, and analgesic properties.

Precautions

• General Precautions: Always assess the patient for allergies and pre-existing conditions before prescribing.
• Specific Populations: Exercise caution in pregnant/breastfeeding women, children, and the elderly.
• Lifestyle Considerations: While specific lifestyle advice is not generally associated with otic use, always counsel patients about medication adherence and proper administration technique.

FAQs (Frequently Asked Questions)

Q1: What is the recommended dosage for Acetic acid + Beclometasone + Clotrimazole + Lidocaine + Ofloxacin?

A: The usual dose is 2-5 drops in the affected ear, 3-4 times daily for 7-14 days. Dosage may be adjusted based on the severity of the infection and the patient’s age and overall health condition.

Q2: What is the mechanism of action of each component?

A: Ofloxacin inhibits bacterial DNA gyrase. Clotrimazole disrupts fungal cell membranes. Beclometasone reduces inflammation. Lidocaine provides local anesthesia. Acetic acid acts as an antiseptic.

Q3: What are the common side effects?

A: Common side effects include ear discomfort, itching, burning, and temporary hearing loss.

Q4: Is it safe to use during pregnancy or breastfeeding?

A: Safety during pregnancy and breastfeeding has not been definitively established. Use only if the potential benefits outweigh the risks, under careful medical supervision.

Q5: What should I do if I suspect an overdose?

A: Rinse the ear with clean water and seek medical advice immediately.

Q6: Are there any drug interactions I should be aware of?

A: Yes, potential interactions exist with various medications. Always review the patient’s medication list before prescribing this combination.

Q7: Can this combination be used in children?

A: While it can be used in some children, it is generally avoided in very young children (especially those under 2) due to potential side effects. Consult specialized resources for pediatric dosing.

Q8: Can this be used with a ruptured eardrum?

A: No, a perforated eardrum is a contraindication for this combination.

Q9: What are the signs of an allergic reaction?

A: Signs of an allergic reaction may include rash, hives, swelling, and difficulty breathing. Seek immediate medical attention if these occur.

Q10: How should I store the ear drops?

A: Store as directed on the product packaging, typically in a cool, dry place away from direct sunlight.