Applies to ciprofloxacin/fluocinolone otic: otic solution.

Get emergency medical help if you have signs of an allergic reaction: hives, rash, itching; dizziness; fast or pounding heartbeat; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• the first sign of any skin rash, no matter how mild;

• new or worsening symptoms of infection; or

• ear drainage that continues for up to 6 months after you have finished all doses of this medicine.

Common side effects may include:

• ear pain, swelling, or itching;

• problems with balance; or

• scar tissue on part of the ear.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to ciprofloxacin/fluocinolone otic: otic solution.

General

The most commonly reported side effects are otorrhea and the development of excessive granulation tissue.^[Ref]

Other

Common (1% to 10%): Ear discomfort, ear pain, ear pruritus, otorrhea

Uncommon (0.1% to 1%): Auricular swelling, contralateral otitis media, crying, device occlusion (tympanostomy tube obstruction), ear congestion, ear infection/fungal ear infection, fatigue, hypoacusis, tinnitus, tympanic membrane disorder

Ciprofloxacin:

Common (1% to 10%): Otorrhea, ear infection

Uncommon (0.1% to 1%): Ear pruritus, auricular swelling

Fluocinolone:

Common (1% to 10%): Otorrhea

Uncommon (0.1% to 1%): Ear infection^[Ref]

Nervous system

Common (1% to 10%): Dysgeusia

Uncommon (0.1% to 1%): Balance disorder, paresthesia/tingling in ears, dizziness, headache

Ciprofloxacin:

Frequency not reported: Loss of consciousness^[Ref]

Dermatologic

Common (1% to 10%): Excessive granulation tissue

Uncommon (0.1% to 1%): Exanthematous rash, rash, skin exfoliation

Ciprofloxacin:

Frequency not reported: Facial edema, itching, urticaria

Fluocinolone:

Uncommon (0.1% to 1%): Excessive granulation tissue^[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Flushing

Ciprofloxacin:

Frequency not reported: Cardiovascular collapse^[Ref]

Local

Uncommon (0.1% to 1%): Medication residue^[Ref]

Gastrointestinal

Uncommon (0.1% to 1%): Vomiting^[Ref]

Psychiatric

Uncommon (0.1% to 1%): Irritability^[Ref]

Immunologic

Uncommon (0.1% to 1%): Candidiasis^[Ref]

Musculoskeletal

Ciprofloxacin:

Frequency not reported: Achilles, hand, other tendon, or shoulder rupture^[Ref]

Patients given systemic fluoroquinolones have reported tendon rupture requiring surgery and/or resulting in prolonged disability. Risk of tendon rupture may be higher in those receiving corticosteroids concomitantly, especially in older patients and in high-stress tendons. It is unknown whether otic formulations are associated with an increased risk of tendon rupture.^[Ref]

Hypersensitivity

Postmarketing reports: Allergic reaction

Ciprofloxacin:

Frequency not reported: Angioedema, fatal anaphylactic/hypersensitivity reactions^[Ref]

Ocular

Frequency not reported: Blurred vision^[Ref]

Respiratory

Ciprofloxacin:

Frequency not reported: Airway obstruction, dyspnea, laryngeal edema, pharyngeal edema^[Ref]