Finished product reference

Ciprofloxacin

Injection, Solution · Intravenous · 10 mg/1mL · 20 mL

List code
2250
Salt form
Lactate
Boxed warning

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 including: Tendinitis and tendon rupture Peripheral neuropathy Central n…

What it is and how it works

Mechanism of Action Ciprofloxacin is a member of the fluoroquinolone class of antibacterial agents .

Indications

Ciprofloxacin tablet 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 of Chronic Bronchitis Urinary Tract Infections Urinary Tract Infections (UTI) Acute Uncomplicated Cystitis Complicated UTI and Pyelonephritis in Pediatric Patients Acute Sinusitis 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.

Dosage and administration (summary)

Ciprofloxacin tablets should be administered orally as described in the appropriate Dosage Guidelines tables. Adult Dosage Guidelines Infection Dose Frequency Duration Skin and Skin Structure 500 to 750 mg every 12 hours 7 to 14 days Bone and Joint 500 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 to 750 mg every 12 hours 14 days Chronic Bacterial Prostatitis 500 mg every 12 hours 28 days Lower Respiratory Tr…

Contraindications

Known hypersensitivity to ciprofloxacin tablets or other quinolones ( 4.1 , 5.6 , 5.7 ) Concomitant administration with tizanidine Hypersensitivity Ciprofloxacin tablets are contraindicated in persons with a history of hypersensitivity to ciprofloxacin, any member of the quinolone class of antibacterials, or any of the product components . Tizanidine Concomitant administration with tizanidine is contraindicated .

Warnings and precautions

Hypersensitivity and other serious reactions: Serious and sometimes fatal reactions (for example, anaphylactic reactions) may occur after the first or subsequent doses of ciprofloxacin. Discontinue ciprofloxacin at the first sign of skin rash, jaundice or any sign of hypersensitivity. ( 4.1 , 5.6 , 5.7 ) Hepatotoxicity: Discontinue immediately if signs and symptoms of hepatitis occur. Clostridioides difficile -associated diarrhea: Evaluate if colitis occurs. QT Prolongation: Prolongation of the QT interval and isolated cases of torsade de pointes have been reported.

Pregnancy

Pregnancy Risk Summary Prolonged experience with ciprofloxacin in pregnant women over several decades, based on available published information from case reports, case control studies and observational studies on ciprofloxacin administered during pregnancy, have not identified any drug-associated risk of major birth defects, miscarriage or adverse …

Storage and supply

Ciprofloxacin Tablets USP, 250 mg are available as white to off-white, round shaped film coated tablets debossed with ‘C’ on one side and ‘95’ on the other side. Bottles of 6 NDC 85534-0069-0 (repackaged from NDC 65862-076-XX) Bottles of 10 NDC 85534-0069-1 (repackaged from NDC 65862-076-XX) Bottles of 14 NDC 85534-0069-2 (repackaged from NDC 65862…

Source: Ciprofloxacin Hydrochloride (Ciprofloxacin) — US FDA prescribing information, 2026-07-13, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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