Established Safety Profile

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Safety matters—CIPRODEX® Otic has undergone rigorous clinical study1

In patients with acute otitis externa (AOE), the most commonly reported adverse reactions in ≥0.4% of patients in clinical trials were:

  • 1.5% ear pruritus

  • 0.6% ear debris

  • 0.6% superimposed ear infection

  • 0.4% ear congestion

  • 0.4% ear pain

  • 0.4% erythema

The following adverse reactions were each reported in a single patient: ear discomfort; decreased hearing; and ear disorder (tingling).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • CIRPRODEX® Otic is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components in this medication.

  • Use of this product is contraindicated in viral infections of the external canal including herpes simplex infections and fungal otic infections.

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions: CIPRODEX® Otic should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones.

Potential for Microbial Overgrowth with Prolonged Use: Prolonged use of CIPRODEX® Otic may result in overgrowth of non-susceptible bacteria and fungi. If the infection is not improved after one week of treatment, cultures should be obtained to guide further treatment. If such infections occur, discontinue use and institute alternative therapy.

Continued or Recurrent Otorrhea: If otorrhea persists after a full course of therapy, or if two or more episodes occur within six months, further evaluation is recommended to exclude an underlying condition such as cholesteatoma, foreign body, or a tumor.

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The average out-of-pocket cost for CIPRODEX® Otic is $34

Eligible, commercially insured patients may pay as little as $30* for their prescription with the CIPRODEX® Otic co-pay card.

Help your patients save

*Terms and Conditions: Valid only for those with commercial insurance. Offer not valid under Medicare, Medicaid, or any other federal or state program, for cash-paying patients, or where plan reimburses you for the entire cost of your prescription drug. Eligible, commercially insured patients may pay as little as $30 in out-of-pocket expenses for each 7.5mL bottle of CIPRODEX® (ciprofloxacin 0.3% and dexamethasone 0.1%) Sterile Otic Suspension with a maximum benefit per bottle of $170. Offer good for up to three (3) 7.5mL bottles of CIPRODEX® Otic for a single patient. If insured patient reaches maximum benefit per bottle, patient will be responsible for the difference. Offer is not valid where prohibited by law. Valid only in the US, USVI, Guam and Puerto Rico. This program is only valid for those patients 6 months and older. This program is not health insurance. Offer may not be combined with any other rebate, coupon, or offer. This card is the property of Novartis Pharmaceuticals Corporation and must be returned upon request. Novartis reserves the right to rescind, revoke, or amend the program without notice. Patient certifies responsibility for complying with applicable limitations, if any, of any commercial insurance and reporting receipt of program rewards, if necessary, to any commercial insurer.

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INDICATIONS AND IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions: CIPRODEX® Otic should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones.

Potential for Microbial Overgrowth with Prolonged Use: Prolonged use of CIPRODEX® Otic may result in overgrowth of non-susceptible bacteria and fungi. If the infection is not improved after one week of treatment, cultures should be obtained to guide further treatment. If such infections occur, discontinue use and institute alternative therapy.

Continued or Recurrent Otorrhea: If otorrhea persists after a full course of therapy, or if two or more episodes occur within six months, further evaluation is recommended to exclude an underlying condition such as cholesteatoma, foreign body, or a tumor.

ADVERSE REACTIONS

The most commonly reported adverse reactions in clinical trials were:

INDICATIONS and USAGE

CIPRODEX® Otic is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in:

DOSAGE

For additional information on CIPRODEX® Otic, please click here for the full Prescribing Information.

Reference: 1. CIPRODEX [package insert]. Fort Worth, TX: Alcon Laboratories, Inc; 2015.