CIPROFLOXACIN HYDROCHLORIDE
Details
- Status
- Prescription
- First Approved
- 2004-03-16
- Routes
- ORAL, OPHTHALMIC, OTIC
- Dosage Forms
- TABLET, SOLUTION/DROPS
Companies
CIPROFLOXACIN HYDROCHLORIDE Approval History
What CIPROFLOXACIN HYDROCHLORIDE Treats
10 indicationsCIPROFLOXACIN HYDROCHLORIDE is approved for 10 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Skin and Skin Structure Infections
- Bone and Joint Infections
- Complicated Intra-Abdominal Infections
- Infectious Diarrhea
- Typhoid Fever
- Gonorrhea
- Inhalational Anthrax
- Plague
CIPROFLOXACIN HYDROCHLORIDE Boxed Warning
SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS Fluoroquinolones, including ciprofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together [see Warnings and Precautions (5.1) ] including: Tendinitis and tendon rupture [see Warnings and Precautions (5.2) ] Peripheral neuropathy [see Warnings and Precautions (5.3) ] Centr...
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS Fluoroquinolones, including ciprofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together [see Warnings and Precautions (5.1) ] including: Tendinitis and tendon rupture [see Warnings and Precautions (5.2) ] Peripheral neuropathy [see Warnings and Precautions (5.3) ] Central nervous system effects [see Warnings and Precautions (5.4) ] Discontinue ciprofloxacin immediately and avoid the use of fluoroquinolones, including ciprofloxacin in patients who experience any of these serious adverse reactions [see Warnings and Precautions (5.1) ]. Fluoroquinolones, including ciprofloxacin, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid ciprofloxacin in patients with known history of myasthenia gravis [see Warnings and Precautions (5.5) ]. Because fluoroquinolones, including ciprofloxacin, have been associated with serious adverse reactions [see Warnings and Precautions (5.1 - 5.16) ], reserve ciprofloxacin for use in patients who have no alternative treatment options for the following indications: Acute exacerbation of chronic bronchitis [see Indications and Usage (1.10) ] Acute uncomplicated cystitis [see Indications and Usage (1.11) ] Acute sinusitis [see Indications and Usage (1.12) ] WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS See full prescribing information for complete boxed warning. Fluoroquinolones, including ciprofloxacin, have been associated with disabling and potentially irreversible seriou adverse reactions that have occurred together ( 5.1 ), including: Tendinitis and tendon rupture ( 5.2 ) Peripheral neuropathy ( 5.3 ) Central nervous system effects ( 5.4 ) Discontinue ciprofloxacin im
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Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
CIPROFLOXACIN HYDROCHLORIDE FDA Label Details
ProIndications & Usage
Ciprofloxacin is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: Skin and Skin Structure Infections Bone and Joint Infections Complicated Intra-Abdominal Infections Infectious Diarrhea Typhoid Fever (Enteric Fever) Uncomplicated Cervical and Urethral Gonorrhea Inhalational Anthrax post-exposure in adult and pediatric patients Plague in adult and pediatric patients Chronic Bacterial Prostatitis Lower Respiratory Tract Infections Acute Exacerbation o...
WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS Fluoroquinolones, including ciprofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions t...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.