Ciprofloxacin in Dextrose 400 mg/200mL

ciprofloxacin · INJECTION, SOLUTION · ProPharma Distribution

2 Recalls on Record

Plain English

Ciprofloxacin in Dextrose is a injection, solution containing ciprofloxacin at 400 mg/200mL, taken intravenous. Manufactured by ProPharma Distribution.

Key Facts

Brand Name: Ciprofloxacin in Dextrose
Generic Name: ciprofloxacin
NDC Code (Product): 84549-300
Manufacturer: ProPharma Distribution
Strength: 400 mg/200mL
Dosage Form: INJECTION, SOLUTION
Route: INTRAVENOUS
Marketing Status
Application #: ANDA078252
Drug Class: Fluoroquinolone Antibacterial [EPC]
Marketing Start: 12/01/2022

Recall History

2 Recalls on Record

Class III11/06/2017

Claris Lifesciences Inc

Superpotent

TerminatedVoluntary: Firm initiated

Class II03/10/2017

Claris Lifesciences Inc

Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fatigue4,275 reports

pain4,165 reports

acute kidney injury4,149 reports

diarrhoea4,094 reports

nausea4,076 reports

arthralgia4,008 reports

chronic kidney disease3,953 reports

drug ineffective3,884 reports

drug hypersensitivity3,438 reports

off label use3,369 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Ciprofloxacin Injection is a fluoroquinolone antibacterial indicated in adults (≥18 years of age) 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 ) Nosocomial Pneumonia ( 1.4 ) Empirical Therapy for Febrile Neutropenic Patients ( 1.5 ) Inhalational Anthrax Post-Exposure in Adult and Pediatric Patients ( 1.6 ) Plague in Adult and Pediatric Patients ( 1.7 ) Chronic Bacterial Prostatitis ( 1.8 ) Lower Respiratory Tract Infections ( 1.9 ) Acute Exacerbation of Chronic Bronchitis Urinary Tract Infections ( 1.10 ) Urinary Tract Infections (UTI) Complicated UTI and Pyelonephritis in Pediatric Patients Acute Sinusitis ( 1.11 ) Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ciprofloxacin Injection and other antibacterial drugs, Ciprofloxacin Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.12 ) 1.1 Skin and Skin Structure Infections Ciprofloxacin Injection …

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Ciprofloxacin injection should be administered intravenously at dosages described in the appropriate Dosage Guidelines tables. Adult Dosage Guidelines Infection Dose Frequency Duration Skin and Skin Structure 400 mg every 8 to 12 hours 7 to 14 days Bone and Joint 400 mg every 8 to 12 hours 4 to 8 weeks Complicated Intra-Abdominal 400 mg every 12 hours 7 to 14 days Nosocomial Pneumonia 400 mg every 8 hours 10 to 14 days Empirical Therapy In Febrile Neutropenic Patients 400 mg and Piperacillin 50 mg/kg every 8 hours every 4 hours 7 to 14 days Inhalational anthrax (post-exposure) 400 mg every 12 hours 60 days Plague 400 mg every 8 to 12 hours 14 days Chronic Bacterial prostatitis 400 mg every 12 hours 28 days Lower Respiratory Tract 400 mg every 8 to 12 hours 7 to 14 days Urinary Tract 200 to 400 mg every 8 to 12 hours 7 to 14 days Acute Sinusitis 400 mg every 12 hours 10 days Adults with creatinine clearance 5 to 29 mL/min 250 to 500 mg q 18 h ( 2.3 ) Pediatric Intravenous Dosing Guidelines Infection Dose Frequency Duration Complicated UTI and Pyelonephritis (patients from 1 to 17 years of age) 6 mg/kg to 10 mg/kg (maximum 400 mg per dose) Every 8 hours 10…

Contraindications

4 CONTRAINDICATIONS Known hypersensitivity to ciprofloxacin injection or other quinolones ( 4.1 , 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 patient 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 receivi…

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 Warn…

Frequently Asked Questions

What is Ciprofloxacin in Dextrose used for?

Ciprofloxacin in Dextrose contains ciprofloxacin. It is a injection, solution taken intravenous. Consult your doctor for specific uses.

Is Ciprofloxacin in Dextrose a controlled substance?

Ciprofloxacin in Dextrose is not classified as a controlled substance by the DEA.

What is the generic name for Ciprofloxacin in Dextrose?

The generic name for Ciprofloxacin in Dextrose is ciprofloxacin. There are 12 other brand versions of ciprofloxacin.

What is the NDC code for Ciprofloxacin in Dextrose 400 mg/200mL?

The NDC (National Drug Code) for Ciprofloxacin in Dextrose 400 mg/200mL is 84549-300, listed by ProPharma Distribution.

Product NDC

84549-300

Package NDC

84549-300-24

Other Ciprofloxacin Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)