Ciprofloxacin Hydrochloride 3 mg/mL
Ciprofloxacin Hydrochloride · SOLUTION/ DROPS · NuCare Pharmaceuticals,Inc.
Ciprofloxacin Hydrochloride is a solution/ drops containing ciprofloxacin hydrochloride at 3 mg/mL, taken ophthalmic. Manufactured by NuCare Pharmaceuticals,Inc..
Key Facts
- Brand Name
- Ciprofloxacin Hydrochloride
- Generic Name
- Ciprofloxacin Hydrochloride
- NDC Code (Product)
68071-3351- Manufacturer
- NuCare Pharmaceuticals,Inc.
- Strength
- 3 mg/mL
- Dosage Form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- NDA019992
- Marketing Start
- 05/07/2004
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND 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 ( 1.1 ) Bone and Joint Infections ( 1.2 ) Complicated Intra-Abdominal Infections ( 1.3 ) Infectious Diarrhea ( 1.4 ) Typhoid Fever (Enteric Fever) ( 1.5 ) Uncomplicated Cervical and Urethral Gonorrhea ( 1.6 ) Inhalational Anthrax post-exposure in adult and pediatric patients ( 1.7 ) Plague in adult and pediatric patients ( 1.8 ) Chronic Bacterial Prostatitis ( 1.9 ) Lower Respiratory Tract Infections ( 1.10 ) Acute Exacerbation of Chronic Bronchitis Urinary Tract Infections ( 1.11 ) Urinary Tract Infections (UTI) Acute Uncomplicated Cystitis Complicated UTI and Pyelonephritis in Pediatric Patients Acute Sinusitis ( 1.12 ) Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of ciprofloxacin tablets and other antibacterial drugs, ciprofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.13 ) 1.1 Sk…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Ciprofloxacin Tablets should be administered orally as described in the appropriate Dosage Guidelines tables. Infection Dose Frequency Duration Skin and Skin Structure 500 mg to 750 mg every 12 hours 7 to 14 days Bone and Joint 500 mg to 750 mg every 12 hours 4 to 8 weeks Complicated Intra-Abdominal 500 mg every 12 hours 7 to 14 days Infectious Diarrhea 500 mg every 12 hours 5 to 7 days Typhoid Fever 500 mg every 12 hours 10 days Uncomplicated Gonorrhea 250 mg single dose single dose Inhalational anthrax (post-exposure) 500 mg every 12 hours 60 days Plague 500 mg to 750 mg every 12 hours 14 days Chronic Bacterial Prostatitis 500 mg every 12 hours 28 days Lower Respiratory Tract 500 mg to 750 mg every 12 hours 7 to 14 days Urinary Tract 250 mg to 500 mg every 12 hours 7 to 14 days Acute Uncomplicated Cystitis 250 mg every 12 hours 3 days Acute Sinusitis 500 mg every 12 hours 10 days Adults with creatinine clearance 30-50 mL/min 250-500 mg q 12 h ( 2.3 ) Adults with creatinine clearance 5–29 mL/min 250–500 mg q 18 h ( 2.3 ) Patients on hemodialysis or peritoneal dialysis 250–500 mg q 24 h (after dialysis) ( 2.3 ) Pediatric Oral Dosage Guidelines Infection …
Contraindications
4 CONTRAINDICATIONS Known hypersensitivity to ciprofloxacin or other quinolones ( 4.1 , 5.6 , 5.7 ) Concomitant administration with tizanidine ( 4.2 ) 4.1 Hypersensitivity Ciprofloxacin is contraindicated in persons with a history of hypersensitivity to ciprofloxacin, any member of the quinolone class of antibacterials, or any of the product components [see Warnings and Precautions (5.7) ]. 4.2 Tizanidine Concomitant administration with tizanidine is contraindicated [see Drug Interactions (7) ].
Drug Interactions
7 DRUG INTERACTIONS Ciprofloxacin is an inhibitor of human cytochrome P450 1A2 (CYP1A2) mediated metabolism. Co-administration of ciprofloxacin with other drugs primarily metabolized by CYP1A2 results in increased plasma concentrations of these drugs and could lead to clinically significant adverse events of the co-administered drug. Table 8: Drugs That are Affected by and Affecting Ciprofloxacin Drugs That are Affected by Ciprofloxacin Drug(s) Recommendation Comments Tizanidine Contraindicated Concomitant administration of tizanidine and ciprofloxacin is contraindicated due to the potentiation of hypotensive and sedative effects of tizanidine [see Contraindications (4.2) ] Theophylline Avoid Use (Plasma Exposure Likely to be Increased and Prolonged) Concurrent administration of ciprofloxacin with theophylline may result in increased risk of a patienyt developing central nervous system (CNS) or other adverse reactions. If concomitant use cannot be avoided, monitor serum levels of theophylline and adjust dosage as appropriate [see Warnings and Precautions (5.10) ]. Drugs Known to Prolong QT Interval Avoid Use Ciprofloxacin may further prolong the QT interval in patients receiving dr…
Adverse Reactions
6 ADVERSE REACTIONS The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling: Disabling and Potentially Irreversible Serious Adverse Reactions [see Warnings and Precautions (5.1) ] 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) ] Exacerbation of Myasthenia Gravis [see Warnings and Precautions (5.5) ] Other Serious and Sometimes Fatal Adverse Reactions [see Warnings and Precautions (5.6) ] Hypersensitivity Reactions [see Warnings and Precautions (5.7) ] Hepatotoxicity [see Warnings and Precautions (5.8) ] Risk of Aortic Aneurysm and Dissection [see Warnings and Precautions (5.9) ] Serious Adverse Reactions with Concomitant Theophylline [see Warnings and Precautions (5.10) ] Clostridioides difficile -Associated Diarrhea [see Warnings and Precautions (5.11) ] Prolongation of the QT Interval [see Warnings and Precautions (5.12) ] Musculoskeletal Disorders in Pediatric Patients [see Warnings and Precautions (5.13) ] Photosensitivity/Phototoxicity [see Warnings and Prec…
Frequently Asked Questions
What is Ciprofloxacin Hydrochloride used for?
Ciprofloxacin Hydrochloride contains Ciprofloxacin Hydrochloride. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.
Is Ciprofloxacin Hydrochloride a controlled substance?
Ciprofloxacin Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Ciprofloxacin Hydrochloride?
The generic name for Ciprofloxacin Hydrochloride is Ciprofloxacin Hydrochloride. There are 7 other brand versions of Ciprofloxacin Hydrochloride.
What is the NDC code for Ciprofloxacin Hydrochloride 3 mg/mL?
The NDC (National Drug Code) for Ciprofloxacin Hydrochloride 3 mg/mL is 68071-3351, listed by NuCare Pharmaceuticals,Inc..