OTIPRIO

OTIPRIO- ciprofloxacin suspension
ALK-Abello, Inc.

1 INDICATIONS AND USAGE

OTIPRIO is indicated for

● The treatment of pediatric patients (6 months of age and older) with bilateral otitis media with effusion undergoing tympanostomy tube placement.

● The treatment of acute otitis externa in patients 6 months of age and older due to Pseudomonas aeruginosa and Staphylococcus aureus.

2 DOSAGE AND ADMINISTRATION

Figure 1

2.1 Dosage and Important Administration Instructions

● OTIPRIO is for intratympanic or otic administration by a healthcare professional only.

● OTIPRIO is intended for single-patient use, discard unused portion.

● For bilateral otitis media with effusion, administer OTIPRIO as a single intratympanic administration of one 0.1 mL (6 mg) dose into each affected ear of pediatric patients (6 months of age and older), following suctioning of middle ear effusion.

● For acute otitis externa, administer OTIPRIO as a single 0.2 mL (12 mg) administration to the external ear canal of each affected ear of patients aged 6 months and older.

2.2 Preparation of OTIPRIO

Directions for OTIPRIO dose preparation and handling are presented in Figure 1. The directions differ for each indication. Follow the correct directions.

Figure 1
(click image for full-size original)

3 DOSAGE FORMS AND STRENGTHS

Otic Suspension: Each 1 mL of OTIPRIO contains a white, preservative-free, sterile otic suspension consisting of 6% (60 mg/mL) ciprofloxacin in a single-patient use glass vial.

4 CONTRAINDICATIONS

OTIPRIO is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components of OTIPRIO.

5 WARNINGS AND PRECAUTIONS

5.1 Potential for Microbial Overgrowth

OTIPRIO may result in overgrowth of non-susceptible bacteria and fungi. If such infections occur, institute alternative therapy.

6 ADVERSE REACTIONS

6.1 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%

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Animal reproduction studies have not been conducted with OTIPRIO. No adequate and well-controlled studies have been performed in pregnant women. Because of the negligible systemic exposure associated with clinical administration of OTIPRIO, this product is expected to be of minimal risk for maternal and fetal toxicity when administered to pregnant women.

8.2 Lactation

Risk Summary

Ciprofloxacin is excreted in human milk with systemic administration. However, because of the negligible systemic exposure after otic application, nursing infants of mothers receiving OTIPRIO should not be affected.

8.4 Pediatric Use

The safety and effectiveness of OTIPRIO for the treatment of pediatric patients (6 months of age and older) with bilateral otitis media with effusion undergoing tympanostomy tube placement was established in 530 patients who participated in the Phase 3 trials. The median age of 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 [see Adverse Reactions ( 6.1) and Clinical Studies ( 14)].

The safety and effectiveness of OTIPRIO for the treatment of acute otitis externa was established in 67 pediatric patients (3 through 17 years of age) who participated in the Phase 3 trial; 57% of patients were 3 through 11 years of age and 43% of patients were 12 through 17 years of age. The safety and efficacy observed in the pediatric patients was no different from the older population. OTIPRIO is indicated for the treatment of acute otitis externa in pediatric patients 6 months of age and older. [see Indications and Usage ( 1), Dosage and Administration ( 2), Adverse Reactions ( 6.1) and Clinical Studies ( 14)].

The safety and effectiveness of OTIPRIO in infants below 6 months of age have not been established for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement and acute otitis externa.

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