Otiprio
- Generic Name: ciprofloxacin otic suspension
- Brand Name: Otiprio
Otiprio (Ciprofloxacin Otic Suspension) side effects drug center
Otiprio Side Effects Center
What Is Otiprio?
Otiprio (ciprofloxacin otic suspension) is a fluoroquinolone antibacterial indicated for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement.
What Are Side Effects of Otiprio?
Common side effects of Otiprio include:
- runny or stuffy nose,
- sore throat, or
- irritability
Dosage for Otiprio
Otiprio is given as a single intratympanic administration of one 0.1 mL (6 mg) dose into each affected ear, following suctioning of the middle ear effusion.
What Drugs, Substances, or Supplements Interact with Otiprio?
Otiprio may interact with other drugs. Tell your doctor all medications and supplements you use.
Otiprio During Pregnancy or Breastfeeding
Tell your doctor if you are pregnant before using Otiprio. It is not expected to be harmful to a fetus. Otiprio passes into breast milk but is not expected to harm a nursing baby. Consult your doctor before breastfeeding.
Additional Information
Our Otiprio (ciprofloxacin otic suspension) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Otiprio Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using the ear drops and call your doctor at once if you have:
- a skin rash (no matter how mild); or
- new ear drainage with severe itching (may be signs of a yeast infection).
Common side effects may include:
- itching or pain after using the ear drops;
- fussiness or irritability;
- headache; or
- stuffy nose and sore throat.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Otiprio (Ciprofloxacin Otic Suspension)
Otiprio Professional Information
SIDE EFFECTS
Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Otitis Media With Effusion
In two randomized, sham-controlled Phase 3 clinical trials, 530 pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement were treated with OTIPRIO or sham administered intratympanically as a single dose (0.1 mL to each ear). The median age of the pediatric patients enrolled in the clinical trials was 1.5 years; 62% of patients were 6 months through 2 years of age and 38% of patients were greater than 2 years of age.
Adverse reactions that occurred in at least 3% of OTIPRIO patients and at an incidence greater than sham are presented in Table 1.
Table 1: Adverse Reactions in Phase 3 Otitis Media with Effusion Trials
| Adverse Reactions | OTIPRIO (N=357) |
Sham (N=173) |
| Nasopharyngitis | 5% | 4% |
| Irritability | 5% | 3% |
| Rhinorrhea | 3% | 2% |
Acute Otitis Externa
In a single randomized, sham controlled Phase 3 clinical trial, 259 pediatric and adult patients with acute otitis externa were treated with OTIPRIO or sham administered by a healthcare professional to the external ear canal as a single dose (0.2 mL to each affected ear). The median age of the patients enrolled in the clinical trial was 34 years; 26% were pediatric patients (age 3 to 17 years), 65% were adults (age 18 to 64 years), and 8% were elderly patients (age 65 years and older).
Adverse reactions that occurred in at least 2% of OTIPRIO patients and at an incidence greater than sham are presented in Table 2.
Table 2: Adverse Reactions in Phase 3 Acute Otitis Externa Trial
| Adverse Reactions | OTIPRIO (N=127) |
Sham (N=132) |
| Ear Pruritus | 2% | 2% |
| Headache | 2% | 1% |
| Otitis Media | 2% | 1% |
| Ear Discomfort | 2% | 0% |
Read the entire FDA prescribing information for Otiprio (Ciprofloxacin Otic Suspension)
&Copy; Otiprio Patient Information is supplied by Cerner Multum, Inc. and Otiprio Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.