Usage
Ciprofloxacin + Dexamethasone + Hydroxypropylmethylcellulose is prescribed for bacterial infections of the ears (otitis externa and otitis media in patients with tympanostomy tubes) and eyes where inflammation is a component. It combines a fluoroquinolone antibiotic, a corticosteroid, and a lubricant.
Pharmacological Classification:
- Ciprofloxacin: Fluoroquinolone antibiotic
- Dexamethasone: Corticosteroid, anti-inflammatory, immunosuppressant
- Hydroxypropylmethylcellulose: Lubricant, viscosity enhancer
Mechanism of Action:
- Ciprofloxacin: Inhibits bacterial DNA gyrase and topoisomerase IV, essential enzymes for bacterial DNA replication and repair. This leads to bacterial cell death.
- Dexamethasone: Suppresses inflammation by reducing vascular permeability, inhibiting inflammatory cell migration, and decreasing the production of inflammatory mediators.
- Hydroxypropylmethylcellulose: Increases the viscosity of the solution, prolonging contact time with the affected area and providing lubrication.
Alternate Names
This combination is not commonly referred to by a single international nonproprietary name. The individual components are recognized by their respective generic names.
Some examples of brand names including Ceflox-Dee Optic Eye/Ear Drops, and Beuflox-D
How It Works
Pharmacodynamics:
- Ciprofloxacin: Bactericidal action against a broad spectrum of gram-positive and gram-negative bacteria.
- Dexamethasone: Reduces inflammation, redness, swelling, pain, and itching.
- Hydroxypropylmethylcellulose: Lubricates and increases residence time of the medication at the administration site.
Pharmacokinetics:
- Ciprofloxacin: After otic administration, systemic absorption is minimal. When given systemically, it is metabolized in the liver and excreted primarily through the kidneys.
- Dexamethasone: Systemic absorption following topical otic administration is low. When administered systemically, metabolized by the liver, predominantly by CYP3A4, and excreted renally.
- Hydroxypropylmethylcellulose: Not absorbed systemically.
Mode of Action:
- Ciprofloxacin: Targets bacterial DNA gyrase and topoisomerase IV, disrupting DNA replication and repair.
- Dexamethasone: Binds to glucocorticoid receptors, modulating gene transcription to suppress inflammatory responses.
Elimination Pathways:
- Ciprofloxacin: Primarily renal excretion, some hepatic metabolism.
- Dexamethasone: Hepatic metabolism, renal excretion.
Dosage
Standard Dosage
Adults:
Four drops in the affected ear twice daily for 7 days.
Children:
- Otitis Media (with Tympanostomy Tubes): 6 months and older: Four drops in the affected ear twice daily for 7 days.
- Otitis Externa: 6 months and older: Four drops in the affected ear twice daily for 7 days.
Special Cases:
- Elderly Patients: No specific dosage adjustments are typically needed, but monitor for adverse effects.
- Patients with Renal Impairment: No specific dosage adjustments, as systemic absorption is low following otic administration. Systemic administration of ciprofloxacin requires dosage adjustment.
- Patients with Hepatic Dysfunction: No specific dosage adjustments for otic use. Monitor closely if ciprofloxacin or dexamethasone are administered systemically.
- Patients with Comorbid Conditions: Evaluate based on the specific comorbidity.
Clinical Use Cases
This medication is intended for topical use in the ears and eyes. It is not for use in situations requiring systemic effects. The conditions treated are ear infections (otitis media with tympanostomy tubes and otitis externa) and eye infections accompanied by inflammation.
Dosage Adjustments
No specific dosage adjustments are required for otic use based on renal or hepatic function, as systemic absorption is minimal.
Side Effects
Common Side Effects:
- Ear discomfort
- Itching
- Burning sensation
- Transient blurred vision (when used in eyes)
Rare but Serious Side Effects:
- Allergic reactions (rash, hives, swelling, difficulty breathing)
- Tendon rupture (more likely with systemic ciprofloxacin use, rare with topical)
Long-Term Effects:
Prolonged or frequent use may lead to overgrowth of resistant organisms. Long-term use of topical corticosteroids can lead to glaucoma, cataracts, or delayed wound healing when applied to the eye.
Adverse Drug Reactions (ADR):
Severe allergic reactions (anaphylaxis), tendon rupture (rare with otic application).
Contraindications
- Hypersensitivity to ciprofloxacin, dexamethasone, other quinolones, or any component of the formulation.
- Viral infections of the ear canal (including herpes simplex).
- Fungal infections of the ear.
Drug Interactions
- CYP450 Interactions: Ciprofloxacin can inhibit CYP1A2 and may increase the levels of drugs metabolized by this enzyme.
- Other Interactions: Concomitant use of systemic corticosteroids may increase the risk of tendon rupture (though this is rare with otic application). No significant interaction with over-the-counter medication is expected. No interactions with food or life style factors are known.
Pregnancy and Breastfeeding
- Pregnancy Safety Category: C (Use only if the potential benefit justifies the potential risk to the fetus.)
- Fetal Risks: Potential for teratogenicity with systemic corticosteroids; ciprofloxacin may cause arthropathy in immature animals.
- Breastfeeding: Ciprofloxacin and dexamethasone are excreted in breast milk following systemic administration. Amounts excreted following otic use are unknown. Caution is advised.
Drug Profile Summary
- Mechanism of Action: Ciprofloxacin: Inhibits bacterial DNA synthesis; Dexamethasone: Suppresses inflammation; Hydroxypropyl methylcellulose: Lubricates and enhances viscosity.
- Side Effects: Burning/stinging, itching, discomfort, temporary blurred vision, allergic reactions.
- Contraindications: Hypersensitivity, viral or fungal ear infections.
- Drug Interactions: Systemic corticosteroids, drugs metabolized by CYP1A2.
- Pregnancy & Breastfeeding: Use with caution; potential risks to fetus/infant.
- Dosage: 4 drops in affected ear twice daily for 7 days.
- Monitoring Parameters: Resolution of infection, signs of hypersensitivity or adverse effects.
Popular Combinations
This product already combines three active ingredients. It is not typically combined with other ear drops. Oral or intravenous antibiotics may be used for severe or complicated infections.
Precautions
- General Precautions: Monitor for hypersensitivity. Evaluate if no improvement is seen after one week. Prolonged use may lead to overgrowth of non-susceptible organisms or fungal infections, especially in the eye.
- Specific Populations: Use cautiously in pregnancy and breastfeeding. Monitor the elderly for adverse effects, particularly with concomitant systemic quinolone or corticosteroid use. Safety and effectiveness have not been established for otic use in children younger than 6 months.
- Lifestyle Considerations: Avoid swimming and getting water in the ears during treatment.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Ciprofloxacin + Dexamethasone + Hydroxypropylmethylcellulose otic suspension?
A: Four drops in the affected ear(s) twice daily for 7 days.
Q2: Can this be used in children?
A: Yes, it is indicated for otitis media with tympanostomy tubes and otitis externa in children 6 months and older.
Q3: Can this medication be used for eye infections?
A: Some formulations may be suitable for eye infections, but this should be confirmed with prescribing information for the specific product.
Q4: What are the most common side effects?
A: Discomfort, itching, burning sensation, and temporary blurred vision (with ophthalmic use).
Q5: What should I do if symptoms don’t improve after a week?
A: Consult a physician for further evaluation. The infection may be caused by a resistant organism, or there may be a different underlying condition.
Q6: Can I use this if I’m allergic to other antibiotics?
A: If you have a known allergy to quinolone antibiotics, this medication is contraindicated. Discuss alternative treatment options with your physician.
Q7: Is it safe to use this during pregnancy or breastfeeding?
A: It should be used with caution. Consult a doctor to weigh the potential benefits against the risks.
Q8: Are there any serious side effects I should be aware of?
A: Although rare with otic application, severe allergic reactions (anaphylaxis) and tendon rupture are possible. Report any signs of allergic reaction or unusual musculoskeletal pain immediately.
Q9: How should I administer the ear drops?
A: Warm the bottle in your hand for a few minutes. Shake the bottle well. Lie on your side with the affected ear up. Instill the drops and remain in that position for 30-60 seconds.
Q10: Can I stop the medication if my symptoms improve before finishing the course?
A: No, it is important to complete the full course of treatment even if symptoms improve, to ensure complete eradication of the infection and reduce the risk of resistance.
