CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE
Clinical safety rating: caution
Chelates with divalent cations (antacids Ca2+ Fe2+) reducing absorption May enhance effects of warfarin Associated with tendonitis and tendon rupture.
Ciprofloxacin is a fluoroquinolone antibiotic that inhibits bacterial DNA gyrase and topoisomerase IV, preventing DNA replication and transcription. Hydrocortisone is a corticosteroid that suppresses inflammation by inhibiting phospholipase A2, reducing prostaglandin and leukotriene synthesis.
| Metabolism | Ciprofloxacin undergoes hepatic metabolism via CYP1A2, producing four major metabolites; hydrocortisone is primarily metabolized by hepatic reduction and conjugation. |
| Excretion | Ciprofloxacin: ~50-70% excreted unchanged in urine via glomerular filtration and tubular secretion; ~15-20% as metabolites; ~20-30% in feces via biliary excretion and transintestinal secretion. Hydrocortisone: metabolized in liver, metabolites excreted renally. |
| Half-life | Ciprofloxacin: ~4-5 hours (normal renal function); prolonged to 8-10 hours in severe renal impairment (CrCl <30 mL/min). Hydrocortisone: ~1.5-2 hours. |
| Protein binding | Ciprofloxacin: 20-40% bound to serum proteins (mainly albumin). Hydrocortisone: 90-95% bound to corticosteroid-binding globulin and albumin. |
| Volume of Distribution | Ciprofloxacin: Vd ~2-3 L/kg, indicating extensive tissue penetration (e.g., skin, lung, bone). Hydrocortisone: Vd ~0.4 L/kg, consistent with high protein binding. |
| Bioavailability | Otic suspension: Ciprofloxacin absorption is negligible (<1%) due to local application; hydrocortisone absorption is also minimal (<1%) with intact tympanic membrane. Systemic bioavailability is not clinically relevant. |
| Onset of Action | Otic suspension: Clinical relief of inflammation and infection within 24-48 hours. |
| Duration of Action | Otic suspension: Anti-inflammatory effect persists 6-12 hours; antibacterial effect continues 4-6 hours after each dose. Use twice daily for 7-10 days. |
| Molecular Weight | 385.82 |
Otic suspension: 3 drops (0.25 mL) into affected ear(s) twice daily for 7 days. Each drop contains ciprofloxacin HCl (equivalent to 0.2 mg ciprofloxacin base) and hydrocortisone 1 mg.
| Dosage form | SUSPENSION/DROPS |
| Renal impairment | No dosage adjustment required for otic use as systemic absorption is negligible. |
| Liver impairment | No dosage adjustment required for otic use as systemic absorption is negligible. |
| Pediatric use | Children ≥1 year: same as adult dose (3 drops twice daily for 7 days). Safety and efficacy in infants <1 year not established. |
| Geriatric use | No specific dose adjustment; use same as adult dose. Caution if concomitant renal impairment, but systemic absorption minimal. |
| 1st trimester | Limited human data; animal studies show arthropathy in immature animals. Avoid unless benefit outweighs risk. |
| 2nd trimester | Limited human data; animal studies show arthropathy in immature animals. Avoid unless benefit outweighs risk. |
| 3rd trimester | Fluoroquinolones may cause arthropathy in immature animals; theoretical risk to fetal cartilage. Avoid unless benefit outweighs risk. |
Clinical note
Chelates with divalent cations (antacids Ca2+ Fe2+) reducing absorption May enhance effects of warfarin Associated with tendonitis and tendon rupture.
| FDA category | Animal |
| Placental transfer | Ciprofloxacin crosses the placenta; fetal concentrations may reach 30-50% of maternal serum levels. |
| Breastfeeding |
■ FDA Black Box Warning
No black box warning for this formulation (topical otic suspension).
| Common Effects | Nausea |
| Serious Effects |
Hypersensitivity to ciprofloxacin, hydrocortisone, or any quinoloneHistory of tendon disorders with fluoroquinolonesViral otic infections (including herpes simplex)
| Precautions | For otic use only; not for ophthalmic or injection, Discontinue if hypersensitivity or irritation occurs, Prolonged use may lead to fungal superinfection, Use with caution in patients with tympanic membrane perforation or chronic otitis media, Potential for ototoxicity with uncontrolled infection |
| Food/Dietary | No clinically relevant food interactions for the otic formulation. |
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| Topical otic use unlikely to result in significant systemic absorption; however, systemic ciprofloxacin is excreted into breast milk. Caution with prolonged or extensive use. Monitor infant for diarrhea, rash, or candidiasis. |
| Lactation Rating | L2 (Probably Compatible) for topical otic use; L3 (Moderately Safe) for systemic use. |
| Teratogenic Risk | Ciprofloxacin (fluoroquinolone) is not recommended during pregnancy due to animal studies showing arthropathy and cartilage damage in immature animals. Limited human data suggest no major teratogenic risk, but use only if benefit outweighs risk. Hydrocortisone (corticosteroid) shows increased risk of cleft palate in animal studies at high doses; epidemiology suggests minimal risk with short-term topical use. First trimester: avoid unless essential. Second/Third trimester: cautious use. Fetal monitoring for growth restriction with prolonged corticosteroid exposure. |
| Fetal Monitoring | Monitor for hypersensitivity reactions (rash, urticaria), tendon pain or rupture, peripheral neuropathy. Monitor serum electrolytes, renal function, hepatic enzymes during prolonged therapy. Fetal monitoring for growth and development if used long-term. Watch for signs of ototoxicity, CNS effects. In neonates: avoid due to risk of kernicterus if given with sulfonamides. |
| Fertility Effects | Ciprofloxacin may impair fertility via reversible spermatogenesis suppression in animal studies; human data lacking. Hydrocortisone may affect menstrual cycle and ovulation at high systemic doses. No specific fertility effects reported with combined otic preparation. |
| Clinical Pearls | Ciprofloxacin/hydrocortisone otic suspension is indicated for acute otitis externa (swimmer's ear) and acute otitis media with tympanostomy tubes. Shake well before use. Avoid contact with eyes. For otic use only; not for injection or inhalation. Use for the full prescribed duration to prevent resistance. In pediatric patients, ensure tube patency for middle ear infections. |
| Patient Advice | Shake the bottle well for 10 seconds before each use. · Warm the bottle by holding in hands for 1-2 minutes to avoid dizziness. · Lie on your side with the affected ear upward, instill prescribed number of drops, and remain lying for 5 minutes to allow penetration. · Do not touch the dropper tip to the ear, fingers, or any surface to prevent contamination. · Complete the full course of treatment even if symptoms improve. · Avoid swimming or getting water in the ear during treatment. · Contact your doctor if you experience hearing loss, dizziness, or rash. · Store at room temperature, away from light and moisture. |