CIPROFLOXACIN

Post-LOESM

ciprofloxacin

Hikma

ANDAINJECTIONINJECTABLE

Approved

Dec 2009

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

4/8 — Partial

CIPROFLOXACIN (ciprofloxacin) by Hikma is [see ] . Approved for infections caused by susceptible isolates of the designated microorganisms in the specific condition listed below: acute otitis media (aom) in pediatric patients (age 6 months, older) with tympanostomy tubes due to staphylococcus aureus, streptococcus pneumoniae and 3 more indications. First approved in 2009.

Drug data last refreshed 21h ago

Mechanism of Action

[see ] . Dexamethasone, a corticosteroid, has been shown to suppress inflammation by inhibiting multiple inflammatory cytokines resulting in decreased edema, fibrin deposition, capillary leakage and migration of inflammatory cells.

Indications (6)

infections caused by susceptible isolates of the designated microorganisms in the specific condition listed below: Acute Otitis Media (AOM) in pediatric patients (age 6 months older) with tympanostomy tubes due to Staphylococcus aureus

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.

Clinical Trials (20)

NCT06815536N/ARecruiting

Master Protocol for Evaluating Multiple Infection Diagnostics for Ciprofloxacin-Resistant Neisseria Gonorrhoeae

Started Apr 2025

3,291 enrolled

Neisseria Gonorrheae Infection

NCT05843708Phase 1Completed

A Phase 1, Open-Label Study to Evaluate the Effect of a Low-Fat Meal and Multiple Doses of Ciprofloxacin on the Pharmacokinetics of Vorasidenib in Healthy Subjects

Started Apr 2023

64 enrolled

Healthy Subjects

NCT04678869N/AActive Not Recruiting

CiproPAL (Ciprofloxacin Prophylaxis in Acute Leukaemia)

Started Jun 2022

313 enrolled

Acute Lymphoblastic Leukaemia - Category

NCT04636957Phase 3Unknown

A Phase III Study of Ciprofloxacin Plus Fluocinolone in Acute Otitis Externa (AOE)

Started Nov 2020

600 enrolled

Acute Otitis Externa

NCT04147260Phase 1Completed

Evaluation of Photosafety of BI 730357 Compared to Placebo and the Known Photosensitizing Agent Ciprofloxacin

Started Nov 2019

85 enrolled

Healthy