Ciprofloxacin and Dexamethasone
Generic: CIPROFLOXACIN AND DEXAMETHASONE
Basic Information
Manufacturer
Amneal Pharmaceuticals of New York LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
AURICULAR (OTIC)
FDA Set ID
55426495-5fd1-44ca-afcc-ffbbb0a0a569
Indications & Usage
1 INDICATIONS AND USAGE Ciprofloxacin and dexamethasone otic suspension is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific condition listed below: Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa.
Ciprofloxacin and dexamethasone otic suspension is a combination of ciprofloxacin, a fluoroquinolone antibacterial and dexamethasone, a corticosteroid, indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific condition listed below: Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult, and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa .
( 1 )
Ciprofloxacin and dexamethasone otic suspension is a combination of ciprofloxacin, a fluoroquinolone antibacterial and dexamethasone, a corticosteroid, indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific condition listed below: Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult, and elderly patients due to Staphylococcus aureus and Pseudomonas aeruginosa .
( 1 )
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ].
Potential for Microbial Overgrowth with Prolonged Use [see Warnings and Precautions (5.2) ].
Most common adverse reactions were ear discomfort (3%), ear pain (2.3%), and ear pruritus (1.5%).
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In Phases II and III clinical trials, a total of 537 patients were treated with ciprofloxacin and dexamethasone otic suspension with AOE.
The reported adverse reactions are listed below: Acute Otitis Externa The following adverse reactions occurred in 0.4% or more of the patients with intact tympanic membranes.
Adverse Reactions Incidence (N = 537) Ear pruritus 1.5% Ear debris 0.6% Superimposed ear infection 0.6% Ear congestion 0.4% Ear pain 0.4% Erythema 0.4% The following adverse reactions were each reported in a single patient: ear discomfort; decreased hearing; and ear disorder (tingling).
6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of ciprofloxacin and dexamethasone otic suspension.
Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
These reactions include auricular swelling, headache, hypersensitivity, otorrhea, skin exfoliation, rash erythematous, and vomiting.
Potential for Microbial Overgrowth with Prolonged Use [see Warnings and Precautions (5.2) ].
Most common adverse reactions were ear discomfort (3%), ear pain (2.3%), and ear pruritus (1.5%).
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In Phases II and III clinical trials, a total of 537 patients were treated with ciprofloxacin and dexamethasone otic suspension with AOE.
The reported adverse reactions are listed below: Acute Otitis Externa The following adverse reactions occurred in 0.4% or more of the patients with intact tympanic membranes.
Adverse Reactions Incidence (N = 537) Ear pruritus 1.5% Ear debris 0.6% Superimposed ear infection 0.6% Ear congestion 0.4% Ear pain 0.4% Erythema 0.4% The following adverse reactions were each reported in a single patient: ear discomfort; decreased hearing; and ear disorder (tingling).
6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of ciprofloxacin and dexamethasone otic suspension.
Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
These reactions include auricular swelling, headache, hypersensitivity, otorrhea, skin exfoliation, rash erythematous, and vomiting.