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ciprofloxacin 250 mg Tablet, 14-count — NDC 68071-4260-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

ciprofloxacin 250 mg Tablet, 14-count — NDC 68071-4260-4 (Billing 68071-4260-04)

by NuCare Pharmaceuticals,Inc. · 14 TABLET in 1 BOTTLE

This is a package of 14 tablets of ciprofloxacin 250 mg Tablet from NuCare Pharmaceuticals,Inc., marketed since Sep 2004 and currently FDA-listed.

NDC 68071-4260-04
🏷️ FDA NDC (as labeled) 68071-4260-4 billing pads the package segment with a zero
This package
Contains14-count Pack sizes8 compare ↓
Also priced by: Part D plans $0.2764/unit — full pricing hub ↓
Product page 68071-4260-02 Also comes in: 6 tablets 68071-4260-6 10 tablets 68071-4260-7 20 tablets 68071-4260-5 21 tablets 68071-4260-2 28 tablets 68071-4260-8 30 tablets 68071-4260-3 90 tablets 68071-4260-9
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 68071-4260-4 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
68071 labeler · 4260 product · 4 package
Package marketed since
Jan 31, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0368071426069
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Ciprofloxacin (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 11, 2025 — Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle (FDC Limited) · FDA recall D-0282-2025
Class II · Dec 16, 2024 — Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle (FDC Limited) · FDA recall D-0182-2025
Class II · Jul 23, 2024 — Defective container: unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle. (FDC Limited) · FDA recall D-0623-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68071-4260-4
Product NDC 68071-4260
11-digit billing NDC 68071426004
RxCUI 197511
UNII 4BA73M5E37
UPC 0368071426069
Application # ANDA076639
SPL Set ID 641729a3-6dd3-3a2f-e053-2991aa0a015e
Established class (EPC) Fluoroquinolone Antibacterial
Mechanism of action Cytochrome P450 1A2 Inhibitors
Chemical class Fluoroquinolones
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2004-09-10
Route ORAL
Dosage form TABLET
Substance CIPROFLOXACIN HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS
Quick answers
  • RxCUI (RxNorm): 197511
Why two NDCs? The FDA registers this code as 68071-4260-4 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 68071-4260-04. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Fluoroquinolone Antibacterial class.

Pharmacologic class Fluoroquinolone Antibacterial
Drug family (ATC) Fluoroquinolones, Fluoroquinolones, Antiinfectives
How it works Cytochrome P450 1A2 Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

📖 What it is MedlinePlus · NLM

Ciprofloxacin is used to treat or prevent certain infections caused by bacteria. Ciprofloxacin is also used to treat or prevent plague (a serious infection that may be spread on purpose as part of a bioterror attack) and inhalation anthrax (a serious infection that may be spread by anthrax germs in the air on purpose as part of a bioterror attack). Ciprofloxacin is in a class of antibiotics called fluoroquinolones. It works by killing bacteria that cause infections. Antibiotics such as ciprofloxacin will not work for colds, flu, or other viral infections. Using antibiotics when they are not n...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats bacterial infections such as urinary tract, respiratory, skin, bone and abdominal infections, depending on the form. Eye and ear versions treat eye and ear infections. It...
  • Swallow them as prescribed, usually every 12 hours, and finish the full course unless your doctor says otherwise. Keep them 2 hours before or 6 hours after antacids, multivitamins,...
  • How should I take my ciprofloxacin tablets?
  • The most common ones are nausea, diarrhea, vomiting, rash and abnormal liver tests. Most are mild, but tell your doctor if they bother you.
📖 Read our full Ciprofloxacin guide →
11
Nutrient depletion considerations

Ciprofloxacin may be associated with lower levels of 11 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Ciprofloxacin nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.2764 $3.87 / 14 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
68071-4260-02 68071-4260-2 Main listing 21 TABLET in 1 BOTTLE 2018-01-31 — Active
68071-4260-03 68071-4260-3 30 TABLET in 1 BOTTLE 2018-01-31 — Active
68071-4260-04 You're viewing this 14 TABLET in 1 BOTTLE 2018-01-31 — Active
68071-4260-05 68071-4260-5 20 TABLET in 1 BOTTLE 2018-01-31 — Active
68071-4260-06 68071-4260-6 6 TABLET in 1 BOTTLE 2018-01-31 — Active
68071-4260-07 68071-4260-7 10 TABLET in 1 BOTTLE 2018-01-31 — Active
68071-4260-08 68071-4260-8 28 TABLET in 1 BOTTLE 2018-01-31 — Active
68071-4260-09 68071-4260-9 90 TABLET in 1 BOTTLE 2018-01-31 — Active

You're viewing one of 8 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 14-count package — 14 tablet in 1 bottle.
How does this package differ from NDC 68071-4260-06?
Both are ciprofloxacin 250 mg Tablet — the drug itself is identical. This page's package is the 14-count one, while NDC 68071-4260-06 is the 6 tablets package.
What NDC number is used to bill for this package of ciprofloxacin 250 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ciprofloxacin 250 mg 43547-0688-10 Solco 100 tablets $0.075 AB Availability likely —
Ciprofloxacin 250 mg 59651-0866-01 Aurobindo 100 tablets $0.075 AB Availability likely —
Ciprofloxacin Hydrochloride 250 mg 59651-0976-01 Aurobindo 100 tablets $0.075 — Availability likely —
Ciprofloxacin 250 mg 61442-0222-01 Carlsbad 100 tablets $0.075 AB Availability likely —
Ciprofloxacin 250 mg 62135-0308-01 Chartwell 100 tablets $0.075 AB Availability likely —
Ciprofloxacin 250 mg 65862-0076-01 Aurobindo 100 tablets $0.075 AB Availability likely —
Ciprofloxacin Hydrochloride 250 mg 69367-0385-01 Westminster 100 tablets $0.075 AB Availability likely —
Ciprofloxacin 250 mg 00143-9927-01 Hikma 100 tablets $0.088 — Availability likely —
Ciprofloxacin 250 mg 58657-0675-01 Method 100 tablets $0.104 AB FDA listed —
ciprofloxacin 250 mg 16571-0411-05 Rising 50 tablets — AB FDA listed —
ciprofloxacin 250 mg 43063-0410-06 PD-Rx 6 tablets — AB FDA listed —
Ciprofloxacin 250 mg 50090-4600-00 A-S 6 tablets — AB FDA listed —
Ciprofloxacin 250 mg 50090-7297-00 A-S 6 tablets — AB FDA listed —
Ciprofloxacin 250 mg 50090-7581-00 A-S 20 tablets — AB FDA listed —
Cipro 250 mg 50419-0758-01 Bayer 100 tablets — AB FDA listed —
Ciprofloxacin 250 mg 51407-0775-01 Golden 100 tablets — AB FDA listed —
Ciprofloxacin 250 mg 51655-0086-20 Northwind 20 tablets — — FDA listed —
ciprofloxacin 250 mg 54348-0662-06 PharmPak, 6 tablets — AB FDA listed —
Ciprofloxacin 250 mg 60760-0690-10 St. 10 tablets — AB FDA listed —
ciprofloxacin 250 mg 63187-0142-06 Proficient 6 tablets — AB FDA listed —
Ciprofloxacin 250 mg 67046-1460-03 Coupler 30 tablets — AB FDA listed —
Ciprofloxacin 250 mg 67296-2169-01 Redpharm 10 tablets — AB FDA listed —
Ciprofloxacin 250 mg 68071-2383-01 NuCare 10 tablets — AB FDA listed —
Ciprofloxacin 250 mg 68071-3693-06 NuCare 6 tablets — AB FDA listed —
Ciprofloxacin 250 mg 68071-3699-01 NuCare 10 tablets — AB FDA listed —
Ciprofloxacin 250 mg 68071-3901-01 NuCare 100 tablets — AB FDA listed —
ciprofloxacin 250 mgthis 68071-4260-04 NuCare 14 tablets — AB FDA listed —
Ciprofloxacin 250 mg 68788-8200-01 Preferred 10 tablets — AB FDA listed —
Ciprofloxacin 250 mg 68788-8875-00 Preferred 6 tablets — AB FDA listed —
Ciprofloxacin 250 mg 69117-0008-01 Yiling 100 tablets — AB FDA listed —
Ciprofloxacin 250 mg 69238-2432-01 Amneal 100 tablets — — FDA listed —
Ciprofloxacin 250 mg 70518-2837-02 REMEDYREPACK 30 tablets — — Discontinued —
Ciprofloxacin 250 mg 70518-4133-00 REMEDYREPACK 30 tablets — AB FDA listed —
Ciprofloxacin 250 mg 71205-0636-06 Proficient 6 tablets — AB FDA listed —
Ciprofloxacin 250 mg 71205-0749-05 Proficient 5 tablets — AB FDA listed —
ciprofloxacin 250 mg 71335-0408-00 Bryant 7 tablets — AB FDA listed —
Ciprofloxacin 250 mg 71335-1152-00 Bryant 7 tablets — AB FDA listed —
Ciprofloxacin 250 mg 71335-1867-00 Bryant 7 tablets — — FDA listed —
Ciprofloxacin 250 mg 71335-2097-00 Bryant 7 tablets — AB FDA listed —
Ciprofloxacin 250 mg 71335-2502-00 Bryant 7 tablets — AB FDA listed —
Ciprofloxacin 250 mg 72162-1740-01 Bryant 100 tablets — AB FDA listed —
Ciprofloxacin 250 mg 72189-0304-06 DirectRx 6 tablets — — FDA listed —
Ciprofloxacin 250 mg 72189-0323-06 Direct 6 tablets — AB FDA listed —
Ciprofloxacin 250 mg 72189-0616-06 Direct_Rx 6 tablets — AB FDA listed —
Ciprofloxacin 250 mg 72789-0124-01 PD-Rx 100 tablets — — FDA listed —
Ciprofloxacin 250 mg 72789-0193-06 PD-Rx 6 tablets — — FDA listed —
Ciprofloxacin 250 mg 72789-0519-06 PD-Rx 6 tablets — AB FDA listed —
Ciprofloxacin 250 mg 76420-0214-06 Asclemed 6 tablets — — FDA listed —
Ciprofloxacin 250 mg 76420-0928-01 Asclemed 100 tablets — AB FDA listed —
Ciprofloxacin 250 mg 82804-0256-06 Proficient 6 tablets — AB FDA listed —
Ciprofloxacin 250 mg 82868-0070-14 Northwind 14 tablets — AB FDA listed —
ciprofloxacin 250 mg 82868-0102-14 Northwind 14 tablets — AB FDA listed —
ciprofloxacin 250 mg 85293-0002-01 Umasuto, 100 tablets — AB FDA listed —
Ciprofloxacin 250 mg 85766-0099-01 Sportpharm 100 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2004
On the market since
Sep 2004
📍
2026
Currently FDA-listed
22 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color white
ShapeRound
ImprintP;250
Size11 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 68401960MK
    Crospovidone is a synthetic polymer made from polyvinylpyrrolidone. It acts as a disintegrant, helping tablets break apart quickly in the stomach so the medicine dissolves and absorbs into the body.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

9 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerNuCare Pharmaceuticals,Inc.
Application holderUNIQUE PHARMACEUTICAL LABORATORIES A DIV OF JB CHEMICALS AND PHARMACEUTICALS LTD
FDA applicationANDA076639 (ANDA)
Labeler code68071
First marketedSep 2004
Product typeHuman Prescription Drug
Portfolio1,015 products on file

More NDCs from NuCare Pharmaceuticals,Inc. labeler code 68071

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🍼 Nursing Mothers 🧬 Pharmacokinetics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 178 words ▾

WARNING: TENDON EFFECTS and MYASTHENIA GRAVIS Fluoroquinolones, including ciprofloxacin, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart, or lung transplants [see Warnings and Precautions (5.1) ]. Fluoroquinolones, including ciprofloxacin, may exacerbate muscle weakness in persons with myasthenia gravis.

Avoid ciprofloxacin in patients with known history of myasthenia gravis [see Warnings and Precautions (5.2) ]. WARNING: TENDON EFFECTS and MYASTHENIA GRAVIS See full prescribing information for complete boxed warning. Fluoroquinolones, including ciprofloxacin, are associated with an increased risk of tendinitis and tendon rupture in all ages.

This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants [see Warnings and Precautions (5.1) ]. Fluoroquinolones, including ciprofloxacin, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid ciprofloxacin in patients with known history of myasthenia gravis [see Warnings and Precautions (5.2) ].

🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS AND USAGE Ciprofloxacin is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the conditions and patient populations listed below. Ciprofloxacin is a fluoroquinolone antibacterial indicated in adults (≥18 years of age) with infections caused by designated, susceptible bacteria and in pediatric patients where indicated. Urinary tract infections ( 1.1 ) and Acute uncomplicated cystitis ( 1.2 ) Chronic bacterial prostatitis ( 1.3 ) Lower respiratory tract infections ( 1.4 ) Acute sinusitis ( 1.5 ) Skin and skin structure infections ( 1.6 ) Bone and joint infections ( 1.7 ) Complicated intra-abdominal infections ( 1.8 ) Infectious diarrhea ( 1.9 ) Typhoid fever (enteric fever) ( 1.10 ) Uncomplicated cervical and urethral gonorrhea ( 1.11 ) Complicated urinary tract infections and pyelonephritis in pediatric patients ( 1.12 ) Inhalational anthrax post-exposure in adult and pediatric patients ( 1.13 ) Plague in adult and pediatric patients ( 1.14 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of ciprofloxacin and other antibacterial drugs, ciprofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

( 1.16 )

1.1Urinary Tract Infections Ciprofloxacin is indicated in adult patients for treatment of urinary tract infections caused by Escherichia coli , Klebsiella pneumoniae , Enterobacter cloacae , Serratia marcescens , Proteus mirabilis , Providencia rettgeri , Morganella morganii , Citrobacter koseri , Citrobacter freundii , Pseudomonas aeruginosa , methicillin-susceptible Staphylococcus epidermidis , Staphylococcus saprophyticus , or Enterococcus faecalis .

1.2Acute Uncomplicated Cystitis Ciprofloxacin is indicated in adult female patients for treatment of acute uncomplicated cystitis caused by Escherichia coli or Staphylococcus saprophyticus.

1.3Chronic Bacterial Prostatitis Ciprofloxacin is indicated in adult patients for treatment of chronic bacterial prostatitis caused by Escherichia coli or Proteus mirabilis.

1.4Lower Respiratory Tract Infections Ciprofloxacin is indicated in adult patients for treatment of lower respiratory tract infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, or Streptococcus pneumoniae. Also, ciprofloxacin is indicated for the treatment of acute exacerbations of chronic bronchitis caused by Moraxella catarrhalis [see Indications and Usage (1.15) ].

1.5Acute Sinusitis Ciprofloxacin is indicated in adult patients for treatment of acute sinusitis caused by Haemophilus influenzae, Streptococcus pneumoniae, or Moraxella catarrhalis.

1.6Skin and Skin Structure Infections Ciprofloxacin is indicated in adult patients for treatment of skin and skin structure infections caused by Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Proteus vulgaris, Providencia stuartii, Morganella morganii, Citrobacter freundii, Pseudomonas aeruginosa, methicillin-susceptible Staphylococcus aureus, methicillin-susceptible Staphylococcus epidermidis, or Streptococcus pyogenes.

1.7Bone and Joint Infections Ciprofloxacin is indicated in adult patients for treatment of bone and joint infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa.

1.8Complicated Intra-Abdominal Infections Ciprofloxacin is indicated in adult patients for treatment of complicated intra-abdominal infections (used in combination with metronidazole) caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsiella pneumoniae, or Bacteroides fragilis.

1.9Infectious Diarrhea Ciprofloxacin is indicated in adult patients for treatment of infectious diarrhea caused by Escherichia coli (enterotoxigenic isolates), Campylobacter jejuni, Shigella boydii † , Shigella dysenteriae, Shigel… [Excerpted — this section continues on DailyMed.]

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Ciprofloxacin should be administered orally as described in the appropriate Dosage Guidelines tables. Adult Dosage Guidelines Infection Dose Frequency Duration Urinary Tract 250 mg - 500 mg every 12 hours 7 to 14 days Acute Cystitis 250 mg every 12 hours 3 days Chronic Bacterial Prostatitis 500 mg every 12 hours 28 days Lower Respiratory Tract 500 mg - 750 mg every 12 hours 7 to 14 days Acute Sinusitis 500 mg every 12 hours 10 days Skin and Skin Structure 500 mg - 750 mg every 12 hours 7 to 14 days Bone and Joint 500 mg - 750 mg every 12 hours 4 to 8 weeks 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 (postexposure) 500 mg every 12 hours 60 days Plague 500 mg - 750 mg every 12 hours 14 days Adults with creatinine clearance 30 - 50 mL/min 250 mg - 500 mg q 12 h Adults with creatinine clearance 5 - 29 mL/min 250 mg - 500 mg q 18 h Patients on hemodialysis or peritoneal dialysis 250 mg - 500 mg q 24 h (after dialysis) Pediatric Oral Dosage Guidelines Infection Dose Frequency Duration Complicated Urinary Tract Pyelonephritis (1 to 17 years of age) 10 - 20 mg/kg (maximum 750 mg per dose) Every 12 hours 10 - 21 days Inhalational Anthrax (Post-Exposure) 15 mg/kg (maximum 500 mg per dose) Every 12 hours 60 days Plague 15 mg/kg (maximum 500 mg per dose) Every 12 to 8 hours 10 - 21 days

2.1Dosage in Adults The determination of dosage and duration for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative microorganism, the integrity of the patient’s host-defense mechanisms, and the status of renal and hepatic function. Table 1: Adult Dosage Guidelines Infection Dose Frequency Usual Durations Generally ciprofloxacin should be continued for at least 2 days after the signs and symptoms of infection have disappeared, except for inhalational anthrax (post-exposure).

Urinary Tract 250 mg- 500 mg every 12 hours 7 to 14 days Acute Uncomplicated Cystitis 250 mg every 12 hours 3 days Chronic Bacterial Prostatitis 500 mg every 12 hours 28 days Lower Respiratory Tract 500 mg -750 mg every 12 hours 7 to 14 days Acute Sinusitis 500 mg every 12 hours 10 days Skin and Skin Structure 500 mg -750 mg every 12 hours 7 to 14 days Bone and Joint 500 mg -750 mg every 12 hours 4 to 8 weeks Complicated Intra–Abdominal Used in conjunction with metronidazole. 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 Urethral and Cervical Gonococcal Infections 250 mg single dose single dose Inhalational Anthrax (Post-Exposure) Begin drug administration as soon as possible after suspected or confirmed exposure.

500 mg every 12 hours 60 days Plague 500 mg - 750 mg every 12 hours 14 days Conversion of IV to Oral Dosing in Adults Patients whose therapy is started with ciprofloxacin IV may be switched to ciprofloxacin tablets or Oral Suspension when clinically indicated at the discretion of the physician (Table 2) [see Clinical Pharmacology (12.3) ]. Table 2: Equivalent AUC Dosing Regimens Ciprofloxacin Oral Dosage Equivalent Ciprofloxacin IV Dosage 250 mg Tablet every 12 hours 200 mg intravenous every 12 hours 500 mg Tablet every 12 hours 400 mg intravenous every 12 hours 750 mg Tablet every 12 hours 400 mg intravenous every 8 hours

2.2Dosage in Pediatric Patients Dosing and initial route of therapy (that is, IV or oral) for cUTI or pyelonephritis should be determined by the severity of the infection. Ciprofloxacin should be administered as described in Table 3. Table 3: Pediatric Dosage Guidelines Infection Dose Frequency Total Duration Complicated Urinary Tract or Pyelonephritis (patients from 1 to 17 years of age) 10 mg/kg to 20 mg/kg (maximum 750 mg per dose; not to be exceeded even in patients wei… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 82 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets: 250 mg, 500 mg, 750 mg ( 3 )

3.1Tablets 250 mg white to slightly yellowish, film-coated, round, biconvex, embossed with word “P” on one side and 250 on reverse side 500 mg white to slightly yellowish, film-coated, capsule shaped, embossed with the word “P” on one side and “500” on reverse side 750 mg white to slightly yellowish, film-coated, capsule shaped, embossed with the word “P” on one side and “750” on reverse side

⛔ Contraindications 68 words ▾

4 CONTRAINDICATIONS Known sensitivity to ciprofloxacin or other quinolones ( 4.1 , 5.3 ) Concomitant administration with tizanidine ( 4.2 )

4.1Hypersensitivity 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 (5.3) ].

4.2Tizanidine Concomitant administration with tizanidine is contraindicated [see Drug Interactions (7) ].

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Hypersensitivity and other serious reactions: Serious and sometimes fatal reactions may occur after first or subsequent doses. Discontinue at first sign of skin rash, jaundice or any sign of hypersensitivity. ( 4.1 , 5.3 , 5.4 ) Hepatotoxicity: Discontinue immediately if signs and symptoms of hepatitis occur.

( 5.5 ) Central nervous system effects, including convulsions, increased intracranial pressure (pseudotumor cerebri) and toxic psychosis have been reported. Caution should be taken in patients predisposed to seizures. ( 5.7 ) Clostridium difficile -associated diarrhea: Evaluate if colitis occurs.

( 5.8 ) Peripheral neuropathy: Discontinue if symptoms occur in order to prevent irreversibility. ( 5.9 ) QT Prolongation: Prolongation of the QT interval and isolated cases of torsade de pointes have been reported. Avoid use in patients with known prolongation, those with hypokalemia, and with other drugs that prolong the QT interval.

( 5.10 , 7 , 8.5 )

5.1Tendinopathy and Tendon Rupture Fluoroquinolones, including ciprofloxacin, are associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achilles tendon, and rupture of the Achilles tendon may require surgical repair. Tendinitis and tendon rupture in the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendon sites have also been reported.

The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Factors, in addition to age and corticosteroid use, that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have also occurred in patients taking fluoroquinolones who do not have the above risk factors.

Inflammation and tendon rupture can occur, sometimes bilaterally, even within the first 48 hours, during or after completion of therapy; cases occurring up to several months after completion of therapy have been reported. Ciprofloxacin should be used with caution in patients with a history of tendon disorders, ciprofloxacin should be discontinued if the patient experiences pain, swelling, inflammation or rupture of a tendon [see Adverse Reactions (6.2)

5.2Exacerbation of Myasthenia Gravis Fluoroquinolones, including ciprofloxacin, have neuromuscular blocking activity and may exacerbate muscle weakness in persons with myasthenia gravis. Postmarketing serious adverse events, including deaths and requirement for ventilatory support, have been associated with fluoroquinolone use in persons with myasthenia gravis. Avoid ciprofloxacin in patients with known history of myasthenia gravis. [see Adverse Reactions (6.2) .]

5.3Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving quinolone therapy, including ciprofloxacin. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and itching. Only a few patients had a history of hypersensitivity reactions.

Serious anaphylactic reactions require immediate emergency treatment with epinephrine and other resuscitation measures, including oxygen, intravenous fluids, intravenous antihistamines, corticosteroids, pressor amines, and airway management, including intubation, as indicated. [see Adverse Reactions (6.1) .]

5.4Other Serious and Sometimes Fatal Reactions Other serious and sometimes fatal events, some due to hypersensitivity, and some due to uncertain etiology, have been reported in patients receiving therapy with quinolones, including ciprofloxacin. These events may be severe and generally occur… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling: Tendon Effects [see Warnings and Precautions (5.1) ] Exacerbation of Myasthenia Gravis [see Warnings and Precautions (5.2) ] Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Other Serious and Sometimes Fatal Reactions [see Warnings and Precautions (5.4) ] Hepatotoxicity [see Warnings and Precautions (5.5) ] Serious Adverse Reactions with Concomitant Theophylline [see Warnings and Precautions (5.6) ] Central Nervous System Effects [see Warnings and Precautions (5.7) ] Clostridium difficile -Associated Diarrhea [see Warnings and Precautions (5.8) ] Peripheral Neuropathy [see Warnings and Precautions (5.9) ] Prolongation of the QT Interval [see Warnings and Precautions (5.10) ] Musculoskeletal Disorders in Pediatric Patients [see Warnings and Precautions (5.11) ] Photosensitivity/Phototoxicity [see Warnings and Precautions (5.13) ] Development of Drug Resistant Bacteria [see Warnings and Precautions (5.14) ] The most common adverse reactions ≥ 1% were nausea, diarrhea, liver function tests abnormal, vomiting, and rash.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharmaceuticals, Inc. at 1-866-562-4597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adult Patients During clinical investigations with oral and parenteral ciprofloxacin, 49,038 patients received courses of the drug. The most frequently reported adverse reactions, from clinical trials of all formulations, all dosages, all drug-therapy durations, and for all indications of ciprofloxacin therapy were nausea (2.5%), diarrhea (1.6%), liver function tests abnormal (1.3%), vomiting (1%), and rash (1%).

Table 6: Medically Important Adverse Reactions That Occurred In less than 1% of Ciprofloxacin Patients System Organ Class Adverse Reactions Body as a Whole Headache Abdominal Pain/Discomfort Pain Cardiovascular Syncope Angina Pectoris Myocardial Infarction Cardiopulmonary Arrest Tachycardia Hypotension Central Nervous System Restlessness Dizziness Insomnia Nightmares Hallucinations Paranoia Psychosis (toxic) Manic Reaction Irritability Tremor Ataxia Seizures (including Status Epilepticus) Malaise Anorexia Phobia Depersonalization Depression (potentially culminating in self-injurious behavior (such as suicidal ideations/thoughts and attempted or completed suicide) Paresthesia Abnormal Gait Migraine Gastrointestinal Intestinal Perforation Gastrointestinal Bleeding Cholestatic Jaundice Hepatitis Pancreatitis Hemic/Lymphatic Petechia Metabolic/Nutritional Hyperglycemia Hypoglycemia Musculoskeletal Arthralgia Joint Stiffness Muscle Weakness Renal/Urogenital Interstitial Nephritis Renal Failure Respiratory Dyspnea Laryngeal Edema Hemoptysis Bronchospasm Skin/Hypersensitivity Anaphylactic Reactions including life-threatening anaphylactic shock Erythema Multiforme/Stevens-Johnson Syndrome Exfoliative Dermatitis Toxic Epidermal Necrolysis Pruritus Urticaria Photosensitivity/Phototoxicity reaction Flushing Fever Angioedema Erythema Nodosum Sweating Special Senses Blurred Vision Disturbed Vision (chromatopsia and photopsia) Decreased Visual Acuity Diplopia Tinnitus Hearing Loss Bad Taste In randomized, double-blind controlled clinical trials comparing ciprofloxacin tablets [500 mg two times daily (BID)] to cefuroxime axetil (250 mg - 500 mg BID) and to clarithromycin (500 mg BID) in patients with respiratory tract infections, ciprofloxacin demonstrated a CNS adverse reaction profile comparable to the control drugs.

Pediatric Patients Short (6 weeks) and long term (1 year) musculoskeletal and neurological safety of o… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

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 9: 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 (5.6) .] Drugs Known to Prolong QT Interval Avoid Use Ciprofloxacin may further prolong the QT interval in patients receiving drugs known to prolong the QT interval (for example, class IA or III antiarrhythmics, tricyclic antidepressants, macrolides, antipsychotics) [see Warnings and Precautions (5.10) and Use in Specific Populations (8.5) ].

Oral antidiabetic drugs Use with caution Glucose-lowering effect potentiated Hypoglycemia sometimes severe has been reported when ciprofloxacin and oral antidiabetic agents, mainly sulfonylureas (for example, glyburide, glimepiride), were co-administered, presumably by intensifying the action of the oral antidiabetic agent. Fatalities have been reported . Monitor blood glucose when ciprofloxacin is co-administered with oral antidiabetic drugs. [see Adverse Reactions (6.1) .] Phenytoin Use with caution Altered serum levels of phenytoin (increased and decreased) To avoid the loss of seizure control associated with decreased phenytoin levels and to prevent phenytoin overdose-related adverse reactions upon ciprofloxacin discontinuation in patients receiving both agents, monitor phenytoin therapy, including phenytoin serum concentration during and shortly after coadministration of ciprofloxacin with phenytoin.

Cyclosporine Use with caution (transient elevations in serum creatinine) Monitor renal function (in particular serum creatinine) when ciprofloxacin is co-administered with cyclosporine. Anti-coagulant drugs Use with caution (Increase in anticoagulant effect) The risk may vary with the underlying infection, age and general status of the patient so that the contribution of ciprofloxacin to the increase in INR (international normalized ratio) is difficult to assess. Monitor prothrombin time and INR frequently during and shortly after co-administration of ciprofloxacin with an oral anti-coagulant (for example, warfarin).

Methotrexate Use with caution Inhibition of methotrexate renal tubular transport potentially leading to increased methotrexate plasma levels Potential increase in the risk of methotrexate associated toxic reactions. Therefore, carefully monitor patients under methotrexate therapy when concomitant ciprofloxacin therapy is indicated. Ropinirole Use with caution Monitoring for ropinirole-related adverse reactions and appropriate dose adjustment of ropinirole is recommended during and shortly after coadministration with ciprofloxacin [see Warnings and Precautions (5.15) ].

Clozapine Use with caution Careful monitoring of clozapine associated adverse reactions and appropriate adjustment of clozapine dosage during and shortly after co-administration with ciprofloxacin are advised. NSAIDs Use with caution Non-steroidal anti-inflammatory drugs (but not acetyl salicylic acid) in combination of very high doses of quinolones have been shown to provoke convulsions in pre-clinical studies and in postmarketing. Sildenafil Use with caution… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS See full prescribing information for use in pediatric and geriatric patients ( 8.4 , 8.5 )

8.1Pregnancy Teratogenic Effects. Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Ciprofloxacin should not be used during pregnancy unless the potential benefit justifies the potential risk to both fetus and mother.

An expert review of published data on experiences with ciprofloxacin use during pregnancy by TERIS–the Teratogen Information System–concluded that therapeutic doses during pregnancy are unlikely to pose a substantial teratogenic risk (quantity and quality of data = fair), but the data are insufficient to state that there is no risk. 2 A controlled prospective observational study followed 200 women exposed to fluoroquinolones (52.5% exposed to ciprofloxacin and 68% first trimester exposures) during gestation. 3 In utero exposure to fluoroquinolones during embryogenesis was not associated with increased risk of major malformations.

The reported rates of major congenital malformations were 2.2% for the fluoroquinolone group and 2.6% for the control group (background incidence of major malformations is 1% - 5%). Rates of spontaneous abortions, prematurity and low birth weight did not differ between the groups and there were no clinically significant musculoskeletal dysfunctions up to one year of age in the ciprofloxacin exposed children. Another prospective follow-up study reported on 549 pregnancies with fluoroquinolone exposure (93% first trimester exposures).

4 There were 70 ciprofloxacin exposures, all within the first trimester. The malformation rates among live-born babies exposed to ciprofloxacin and to fluoroquinolones overall were both within background incidence ranges. No specific patterns of congenital abnormalities were found.

The study did not reveal any clear adverse reactions due to in utero exposure to ciprofloxacin. No differences in the rates of prematurity, spontaneous abortions, or birth weight were seen in women exposed to ciprofloxacin during pregnancy. 2,3 However, these small postmarketing epidemiology studies, of which most experience is from short term, first trimester exposure, are insufficient to evaluate the risk for less common defects or to permit reliable and definitive conclusions regarding the safety of ciprofloxacin in pregnant women and their developing fetuses.

Reproduction studies have been performed in rats and mice using oral doses up to 100 mg/kg (0.6 and 0.3 times the maximum daily human dose based upon body surface area, respectively) and have revealed no evidence of harm to the fetus due to ciprofloxacin. In rabbits, oral ciprofloxacin dose levels of 30 and 100 mg/kg (approximately 0.4-and 1.3-times the highest recommended therapeutic dose based upon body surface area) produced gastrointestinal toxicity resulting in maternal weight loss and an increased incidence of abortion, but no teratogenicity was observed at either dose level.

After intravenous administration of doses up to 20 mg/kg (approximately 0.3-times the highest recommended therapeutic dose based upon body surface area), no maternal toxicity was produced and no embryotoxicity or teratogenicity was observed.

8.3Nursing Mothers Ciprofloxacin is excreted in human milk. The amount of ciprofloxacin absorbed by the nursing infant is unknown. Because of the potential risk of serious adverse reactions (including articular damage) in infants nursing from mothers taking ciprofloxacin, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

8.4Pediatric Use Although effective in clinical trials, ciprofloxacin is not a drug of first choice in the pediatric population due to an increased incidence of adverse reactions compared to controls. Quinolones, including ciprofloxacin, cause arthropathy in juvenile animals [see Warnings and Precautions (5.11) and Nonclinical Toxicolo… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Teratogenic Effects. Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Ciprofloxacin should not be used during pregnancy unless the potential benefit justifies the potential risk to both fetus and mother.

An expert review of published data on experiences with ciprofloxacin use during pregnancy by TERIS–the Teratogen Information System–concluded that therapeutic doses during pregnancy are unlikely to pose a substantial teratogenic risk (quantity and quality of data = fair), but the data are insufficient to state that there is no risk. 2 A controlled prospective observational study followed 200 women exposed to fluoroquinolones (52.5% exposed to ciprofloxacin and 68% first trimester exposures) during gestation. 3 In utero exposure to fluoroquinolones during embryogenesis was not associated with increased risk of major malformations.

The reported rates of major congenital malformations were 2.2% for the fluoroquinolone group and 2.6% for the control group (background incidence of major malformations is 1% - 5%). Rates of spontaneous abortions, prematurity and low birth weight did not differ between the groups and there were no clinically significant musculoskeletal dysfunctions up to one year of age in the ciprofloxacin exposed children. Another prospective follow-up study reported on 549 pregnancies with fluoroquinolone exposure (93% first trimester exposures).

4 There were 70 ciprofloxacin exposures, all within the first trimester. The malformation rates among live-born babies exposed to ciprofloxacin and to fluoroquinolones overall were both within background incidence ranges. No specific patterns of congenital abnormalities were found.

The study did not reveal any clear adverse reactions due to in utero exposure to ciprofloxacin. No differences in the rates of prematurity, spontaneous abortions, or birth weight were seen in women exposed to ciprofloxacin during pregnancy. 2,3 However, these small postmarketing epidemiology studies, of which most experience is from short term, first trimester exposure, are insufficient to evaluate the risk for less common defects or to permit reliable and definitive conclusions regarding the safety of ciprofloxacin in pregnant women and their developing fetuses.

Reproduction studies have been performed in rats and mice using oral doses up to 100 mg/kg (0.6 and 0.3 times the maximum daily human dose based upon body surface area, respectively) and have revealed no evidence of harm to the fetus due to ciprofloxacin. In rabbits, oral ciprofloxacin dose levels of 30 and 100 mg/kg (approximately 0.4-and 1.3-times the highest recommended therapeutic dose based upon body surface area) produced gastrointestinal toxicity resulting in maternal weight loss and an increased incidence of abortion, but no teratogenicity was observed at either dose level.

After intravenous administration of doses up to 20 mg/kg (approximately 0.3-times the highest recommended therapeutic dose based upon body surface area), no maternal toxicity was produced and no embryotoxicity or teratogenicity was observed.

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use Although effective in clinical trials, ciprofloxacin is not a drug of first choice in the pediatric population due to an increased incidence of adverse reactions compared to controls. Quinolones, including ciprofloxacin, cause arthropathy in juvenile animals [see Warnings and Precautions (5.11) and Nonclinical Toxicology (13.2) ] . Complicated Urinary Tract Infection and Pyelonephritis Ciprofloxacin is indicated for the treatment of cUTI and pyelonephritis due to Escherichia coli in pediatric patients 1 to 17 years of age .

Although effective in clinical trials, ciprofloxacin is not a drug of first choice in the pediatric population due to an increased incidence of adverse reactions compared to the controls, including events related to joints and/or surrounding tissues. [See Adverse Reactions (6.1) and Clinical Studies (14.1) .] Inhalational Anthrax (Post-Exposure) Ciprofloxacin is indicated in pediatric patients from birth to 17 years of age, for inhalational anthrax (postexposure). The risk-benefit assessment indicates that administration of ciprofloxacin to pediatric patients is appropriate [see Dosage and Administration (2.2) and Clinical Studies (14.2) ].

Plague Ciprofloxacin is indicated in pediatric patients from birth to 17 years of age, for treatment of plague, including pneumonic and septicemic plague due to Yersinia pestis (Y. pestis) and prophylaxis for plague. Efficacy studies of ciprofloxacin could not be conducted in humans with pneumonic plague for feasibility reasons. Therefore, approval of this indication was based on an efficacy study conducted in animals.

The risk-benefit assessment indicates that administration of ciprofloxacin to pediatric patients is appropriate [See Indications and Usage (1.14) , Dosage and Administration (2.2) and Clinical Studies (14.3) .]

🧓 Geriatric Use ~2 min read ▾

8.5Geriatric Use Geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as ciprofloxacin. This risk is further increased in patients receiving concomitant corticosteroid therapy. Tendinitis or tendon rupture can involve the Achilles, hand, shoulder, or other tendon sites and can occur during or after completion of therapy; cases occurring up to several months after fluoroquinolone treatment have been reported.

Caution should be used when prescribing ciprofloxacin to elderly patients especially those on corticosteroids. Patients should be informed of this potential adverse reaction and advised to discontinue ciprofloxacin and contact their healthcare provider if any symptoms of tendinitis or tendon rupture occur. [see Boxed Warning , Warnings and Precautions (5.1) , and Adverse Reactions (6.2) .] In a retrospective analysis of 23 multiple-dose controlled clinical trials of ciprofloxacin encompassing over 3500 ciprofloxacin-treated patients, 25% of patients were greater than or equal to 65 years of age and 10% were greater than or equal to 75 years of age.

No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals on any drug therapy cannot be ruled out. Ciprofloxacin is known to be substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. No alteration of dosage is necessary for patients greater than 65 years of age with normal renal function.

However, since some older individuals experience reduced renal function by virtue of their advanced age, care should be taken in dose selection for elderly patients, and renal function monitoring may be useful in these patients . [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3) .] In general, elderly patients may be more susceptible to drug-associated effects on the QT interval. Therefore, precaution should be taken when using ciprofloxacin with concomitant drugs that can result in prolongation of the QT interval (for example, class IA or class III antiarrhythmics) or in patients with risk factors for torsade de pointes (for example, known QT prolongation, uncorrected hypokalemia) . [see Warnings and Precautions (5.10) .]

🆘 Overdosage 89 words ▾

10 OVERDOSAGE In the event of acute overdosage, reversible renal toxicity has been reported in some cases. Empty the stomach by inducing vomiting or by gastric lavage. Observe the patient carefully and give supportive treatment, including monitoring of renal function, urinary pH and acidify, if required, to prevent crystalluria and administration of magnesium, aluminum, or calcium containing antacids which can reduce the absorption of ciprofloxacin.

Adequate hydration must be maintained. Only a small amount of ciprofloxacin (less than 10%) is removed from the body after hemodialysis or peritoneal dialysis.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Ciprofloxacin is a member of the fluoroquinolone class of antibacterial agents [see Microbiology (12.4) ] .

12.3Pharmacokinetics Absorption The absolute bioavailability of ciprofloxacin when given as an oral tablet is approximately 70% with no substantial loss by first pass metabolism. Ciprofloxacin maximum serum concentrations and area under the curve are shown in the chart for the 250 mg to 1000 mg dose range (Table 10). Table 10: Maximum Serum Concentrations and Areas Under the Curve Dose (mg) Maximum Serum Concentration (mcg/mL) Area Under Curve (AUC) (mcg•hr/mL) 250 1.2 4.8 500 2.4 11.6 750 4.3 20.2 1000 5.4

30.8Maximum serum concentrations are attained 1 to 2 hours after oral dosing. Mean concentrations 12 hours after dosing with 250, 500, or 750 mg are 0.1, 0.2, and 0.4 mcg/mL, respectively. The serum elimination half-life in subjects with normal renal function is approximately 4 hours.

Serum concentrations increase proportionately with doses up to 1000 mg. A 500 mg oral dose given every 12 hours has been shown to produce an area under the serum concentration time curve (AUC) equivalent to that produced by an intravenous infusion of 400 mg ciprofloxacin given over 60 minutes every 12 hours. A 750 mg oral dose given every 12 hours has been shown to produce an AUC at steady-state equivalent to that produced by an intravenous infusion of 400 mg given over 60 minutes every 8 hours.

A 750 mg oral dose results in a C max similar to that observed with a 400 mg intravenous dose. A 250 mg oral dose given every 12 hours produces an AUC equivalent to that produced by an infusion of 200 mg ciprofloxacin given every 12 hours (Table 11). Table 11: Steady-state Pharmacokinetic Parameters Following Multiple Oral and IV Doses Parameters 500 mg 400 mg 750 mg 400 mg Every 12 hours, orally Every 12 hours, intravenous Every 12 hours, orally Every 8 hours, IV AUC (mcg•hr/mL)

13.7AUC 0 to 12h 12.7

31.6 AUC 24h = AUC 0 to 12h x 2

32.9AUC 24h = AUC 0 to 8h x 3 C max (mcg/mL) 2.97 4.56 3.59

4.07Food When ciprofloxacin tablet is given concomitantly with food, there is a delay in the absorption of the drug, resulting in peak concentrations that occur closer to 2 hours after dosing rather than 1 hour. The overall absorption of ciprofloxacin tablets, however, is not substantially affected. Avoid concomitant administration of ciprofloxacin with dairy products (like milk or yogurt) or calcium-fortified juices alone since decreased absorption is possible; however, ciprofloxacin may be taken with a meal that contains these products With oral administration, a 500 mg dose, given as 10 mL of the 5% ciprofloxacin suspension (containing 250 mg ciprofloxacin/5mL) is bioequivalent to the 500 mg tablet.

Distribution The binding of ciprofloxacin to serum proteins is 20% to 40% which is not likely to be high enough to cause significant protein binding interactions with other drugs. After oral administration, ciprofloxacin is widely distributed throughout the body. Tissue concentrations often exceed serum concentrations in both men and women, particularly in genital tissue including the prostate.

Ciprofloxacin is present in active form in the saliva, nasal and bronchial secretions, mucosa of the sinuses, sputum, skin blister fluid, lymph, peritoneal fluid, bile, and prostatic secretions. Ciprofloxacin has also been detected in lung, skin, fat, muscle, cartilage, and bone. The drug diffuses into the cerebrospinal fluid (CSF); however, CSF concentrations are generally less than 10% of peak serum concentrations.

Low levels of the drug have been detected in the aqueous and vitreous humors of the eye. Metabolism Four metabolites have been identified in human urine which together account for approximately 15% of an oral dose. The metabolites have antimicrobial activity, but are less active than unchanged ciprofloxacin.

Ciprofloxacin is an inhibitor of human cytochrome P450 1A2 (CYP1A2) mediated metabolism. Co-admin… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 56 words ▾

12.1Mechanism of Action Ciprofloxacin is a member of the fluoroquinolone class of antibacterial agents [see Microbiology (12.4) ] .

Mechanism of Action The bactericidal action of ciprofloxacin results from inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV (both Type II topoisomerases), which are required for bacterial DNA replication, transcription, repair, and recombination.

📦 How Supplied / Storage and Handling 104 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Ciprofloxacin (ciprofloxacin hydrochloride) Tablets USP are available as round, biconvex white to slightly yellowish film coated tablets containing 250 mg of ciprofloxacin. The 250 mg tablet is embossed with the word “P” on one side and 250 on reverse side. NDC 68071-4260-6 BOTTLES OF 6 NDC 60871-4260-7 BOTTLES OF 7 NDC 68071-4260-4 BOTTLES OF 14 NDC 68071-4260-5 BOTTLES OF 20 NDC 68071-4260-2 BOTTLES OF 21 NDC 68071-4260-8 BOTTLES OF 28 NDC 68071-4260-9 BOTTLES OF 90 Store at 20° to 25°C (68° to 77° F); excursions permitted to 15° to 30°C (59° to 86° F) [see USP Controlled Room Temperature].

📋 Description 117 words ▾

11 DESCRIPTION Ciprofloxacin (ciprofloxacin hydrochloride) Tablets USP are synthetic antimicrobial agents for oral administration. Ciprofloxacin hydrochloride, USP, a fluoroquinolone, is the monohydrochloride monohydrate salt of 1-cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-7-(1-piperazinyl)-3quinolinecarboxylic acid. It is a faintly yellowish to light yellow crystalline substance with a molecular weight of 385.8.

Its empirical formula is C 17 H 18 FN 3 O 3 •HCl •H 2 O and its chemical structure is as follows: Ciprofloxacin film-coated Tablets are available in 250 mg, 500 mg and 750 mg (ciprofloxacin equivalent) strengths. Ciprofloxacin tablets USP are white to slightly yellowish. The inactive ingredients are pregelatinized starch, microcrystalline cellulose, colloidal silicon dioxide, crospovidone, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol, and purified water.

Ciprofloxacin Hydrochloride Structural Formula

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA -approved patient labeling ( Medication Guide ) Antibacterial Resistance Inform patients that antibacterial drugs including ciprofloxacin should only be used to treat bacterial infections. They do not treat viral infections (for example, the common cold). When ciprofloxacin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed.

Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by ciprofloxacin, or other antibacterial drugs in the future. Administration with Food, Fluids, and Concomitant Medications Inform patients that ciprofloxacin may be taken with or without food. Inform patients to drink fluids liberally while taking ciprofloxacin to avoid formation of highly concentrated urine and crystal formation in the urine.

Inform patients that antacids containing magnesium, or aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc or didanosine should be taken at least two hours before or six hours after ciprofloxacin administration. Ciprofloxacin should not be taken with dairy products (like milk or yogurt) or calcium-fortified juices alone since absorption of ciprofloxacin may be significantly reduced; however, ciprofloxacin may be taken with a meal that contains these products. Serious and Potentially Serious Adverse Reactions Inform patients of the following serious adverse reactions that have been associated with ciprofloxacin or other fluoroquinolone use: Tendon Disorders: Instruct patients to contact their healthcare provider if they experience pain, swelling, or inflammation of a tendon, or weakness or inability to use one of their joints; rest and refrain from exercise; and discontinue ciprofloxacin treatment.

The risk of severe tendon disorder with fluoroquinolones is higher in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Exacerbation of Myasthenia Gravis: Instruct patients to inform their physician of any history of myasthenia gravis. Instruct patients to notify their physician if they experience any symptoms of muscle weakness, including respiratory difficulties.

Hypersensitivity Reactions: Inform patients that ciprofloxacin can cause hypersensitivity reactions, even following a single dose, and to discontinue the drug at the first sign of a skin rash, hives or other skin reactions, a rapid heartbeat, difficulty in swallowing or breathing, any swelling suggesting angioedema (for example, swelling of the lips, tongue, face, tightness of the throat, hoarseness), or other symptoms of an allergic reaction. Hepatotoxicity: Inform patients that severe hepatotoxicity (including acute hepatitis and fatal events) has been reported in patients taking ciprofloxacin.

Instruct patients to inform their physician if they experience any signs or symptoms of liver injury including: loss of appetite, nausea, vomiting, fever, weakness, tiredness, right upper quadrant tenderness, itching, yellowing of the skin and eyes, light colored bowel movements or dark colored urine. Convulsions: Inform patients that convulsions have been reported in patients receiving fluoroquinolones, including ciprofloxacin. Instruct patients to notify their physician before taking this drug if they have a history of convulsions.

Neurologic Adverse Effects (for example, dizziness, lightheadedness, increased intracranial pressure) : Inform patients that they should know how they react to ciprofloxacin before they operate an automobile or machinery or engage in other activities requiring mental alertness and coordination. Instruct patients to notify their p… [Excerpted — this section continues on DailyMed.]

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Medication Guide for Ciprofloxacin Tablets USP, 250 mg, 500 mg and 750 mg Read this Medication Guide before you start taking ciprofloxacin and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about ciprofloxacin? Ciprofloxacin a fluoroquinolone antibacterial medicine, can cause serious side effects. Some of these serious side effects could result in death.

If you get any of the following serious side effects while you take ciprofloxacin, get medical help right away. Talk with your healthcare provider about whether you should continue to take ciprofloxacin. Tendon rupture or swelling of the tendon (tendinitis).

Tendon problems can happen in people of all ages who take ciprofloxacin. Tendons are tough cords of tissue that connect muscles to bones. Symptoms of tendon problems may include: pain swelling tears and inflammation of tendons including the back of the ankle (Achilles), shoulder, hand, or other tendon sites.

The risk of getting tendon problems while you take ciprofloxacin is higher if you: are over 60 years of age are taking steroids (corticosteroids) have had a kidney, heart or lung transplant Tendon problems can happen in people who do not have the above risk factors when they take ciprofloxacin. Other reasons that can increase your risk of tendon problems can include: physical activity or exercise kidney failure tendon problems in the past, such as in people with rheumatoid arthritis (RA) Call your healthcare provider right away at the first sign of tendon pain, swelling or inflammation.

Stop taking ciprofloxacin until tendinitis or tendon rupture has been ruled out by your healthcare provider. Avoid exercise and using the affected area. The most common area of pain and swelling is the Achilles tendon at the back of your ankle.

This can also happen with other tendons. Talk to your healthcare provider about the risk of tendon rupture with continued use of ciprofloxacin. You may need a different antibiotic that is not a fluoroquinolone to treat your infection.

Tendon rupture can happen while you are taking or after you have finished taking ciprofloxacin. Tendon ruptures have happened up to several months after people have finished taking their fluoroquinolone. Get medical help right away if you get any of the following signs or symptoms of a tendon rupture: hear or feel a snap or pop in a tendon area bruising right after an injury in a tendon area unable to move the affected area or bear weight Worsening of myasthenia gravis (a problem that causes muscle weakness).

Fluoroquinolones like ciprofloxacin may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Call your healthcare provider right away if you have any worsening muscle weakness or breathing problems. See “What are the possible side effects of ciprofloxacin?” What is ciprofloxacin?

Ciprofloxacin is a fluoroquinolone antibacterial medicine used in adults age 18 years and older to treat certain infections caused by certain germs called bacteria. These bacterial infection include: urinary tract infection chronic prostate infection lower respiratory tract infection sinus infection skin infection bone and joint infection nosocomial pneumonia intra-abdominal infection, complicated infectious diarrhea typhoid (enteric) fever cervical and urethral gonorrhea, uncomplicated people with a low white blood cell count and a fever inhalational anthrax plague Studies of ciprofloxacin for use in the treatment of plague and anthrax were done in animals only, because plague and anthrax could not be studied in people.

Ciprofloxacin is also used in children younger than 18 years of age to treat complicated urinary tract and kidney infectionsand who may have breathed in anthrax germs, have plague or have been exposed to plague germs. Ch… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 64 words ▾

8.3Nursing Mothers Ciprofloxacin is excreted in human milk. The amount of ciprofloxacin absorbed by the nursing infant is unknown. Because of the potential risk of serious adverse reactions (including articular damage) in infants nursing from mothers taking ciprofloxacin, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Absorption The absolute bioavailability of ciprofloxacin when given as an oral tablet is approximately 70% with no substantial loss by first pass metabolism. Ciprofloxacin maximum serum concentrations and area under the curve are shown in the chart for the 250 mg to 1000 mg dose range (Table 10). Table 10: Maximum Serum Concentrations and Areas Under the Curve Dose (mg) Maximum Serum Concentration (mcg/mL) Area Under Curve (AUC) (mcg•hr/mL) 250 1.2 4.8 500 2.4 11.6 750 4.3 20.2 1000 5.4

30.8Maximum serum concentrations are attained 1 to 2 hours after oral dosing. Mean concentrations 12 hours after dosing with 250, 500, or 750 mg are 0.1, 0.2, and 0.4 mcg/mL, respectively. The serum elimination half-life in subjects with normal renal function is approximately 4 hours.

Serum concentrations increase proportionately with doses up to 1000 mg. A 500 mg oral dose given every 12 hours has been shown to produce an area under the serum concentration time curve (AUC) equivalent to that produced by an intravenous infusion of 400 mg ciprofloxacin given over 60 minutes every 12 hours. A 750 mg oral dose given every 12 hours has been shown to produce an AUC at steady-state equivalent to that produced by an intravenous infusion of 400 mg given over 60 minutes every 8 hours.

A 750 mg oral dose results in a C max similar to that observed with a 400 mg intravenous dose. A 250 mg oral dose given every 12 hours produces an AUC equivalent to that produced by an infusion of 200 mg ciprofloxacin given every 12 hours (Table 11). Table 11: Steady-state Pharmacokinetic Parameters Following Multiple Oral and IV Doses Parameters 500 mg 400 mg 750 mg 400 mg Every 12 hours, orally Every 12 hours, intravenous Every 12 hours, orally Every 8 hours, IV AUC (mcg•hr/mL)

13.7AUC 0 to 12h 12.7

31.6 AUC 24h = AUC 0 to 12h x 2

32.9AUC 24h = AUC 0 to 8h x 3 C max (mcg/mL) 2.97 4.56 3.59

4.07Food When ciprofloxacin tablet is given concomitantly with food, there is a delay in the absorption of the drug, resulting in peak concentrations that occur closer to 2 hours after dosing rather than 1 hour. The overall absorption of ciprofloxacin tablets, however, is not substantially affected. Avoid concomitant administration of ciprofloxacin with dairy products (like milk or yogurt) or calcium-fortified juices alone since decreased absorption is possible; however, ciprofloxacin may be taken with a meal that contains these products With oral administration, a 500 mg dose, given as 10 mL of the 5% ciprofloxacin suspension (containing 250 mg ciprofloxacin/5mL) is bioequivalent to the 500 mg tablet.

Distribution The binding of ciprofloxacin to serum proteins is 20% to 40% which is not likely to be high enough to cause significant protein binding interactions with other drugs. After oral administration, ciprofloxacin is widely distributed throughout the body. Tissue concentrations often exceed serum concentrations in both men and women, particularly in genital tissue including the prostate.

Ciprofloxacin is present in active form in the saliva, nasal and bronchial secretions, mucosa of the sinuses, sputum, skin blister fluid, lymph, peritoneal fluid, bile, and prostatic secretions. Ciprofloxacin has also been detected in lung, skin, fat, muscle, cartilage, and bone. The drug diffuses into the cerebrospinal fluid (CSF); however, CSF concentrations are generally less than 10% of peak serum concentrations.

Low levels of the drug have been detected in the aqueous and vitreous humors of the eye. Metabolism Four metabolites have been identified in human urine which together account for approximately 15% of an oral dose. The metabolites have antimicrobial activity, but are less active than unchanged ciprofloxacin.

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 clinic… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Complicated Urinary Tract Infection and Pyelonephritis–Efficacy in Pediatric Patients Ciprofloxacin administered intravenously and/or orally was compared to a cephalosporin for treatment of cUTI and pyelonephritis in pediatric patients 1 to 17 years of age (mean age of 6 ± 4 years). The trial was conducted in the US, Canada, Argentina, Peru, Costa Rica, Mexico, South Africa, and Germany. The duration of therapy was 10 to 21 days (mean duration of treatment was 11 days with a range of 1 to 88 days).

The primary objective of the study was to assess musculoskeletal and neurological safety. Patients were evaluated for clinical success and bacteriological eradication of the baseline organism(s) with no new infection or superinfection at 5 to 9 days post-therapy (Test of Cure or TOC). The Per Protocol population had a causative organism(s) with protocol specified colony count(s) at baseline, no protocol violation, and no premature discontinuation or loss to follow-up (among other criteria).

The clinical success and bacteriologic eradication rates in the Per Protocol population were similar between ciprofloxacin and the comparator group as shown below. Table 14: Clinical Success and Bacteriologic Eradication at Test of Cure (5 to 9 Days Post-Therapy) Ciprofloxacin Comparator Randomized Patients 337 352 Per Protocol Patients 211 231 Clinical Response at 5 to 9 Days Post-Treatment 95.7% (202/211) 92.6% (214/231) 95% CI [-1.3%, 7.3%] Bacteriologic Eradication by Patient at 5 to 9 Days Post-Treatment Patients with baseline pathogen(s) eradicated and no new infections or superinfections/total number of patients.

There were 5.5% (6/211) ciprofloxacin and 9.5% (22/231) comparator patients with superinfections or new infections. 84.4% (178/211) 78.3% (181/231) 95% CI [-1.3%, 13.1%] Bacteriologic Eradication of the Baseline Pathogen at 5 to 9 Days Post-Treatment Escherichia coli 156/178 (88%) 161/179 (90%)

14.2Inhalational Anthrax in Adults and Pediatrics The mean serum concentrations of ciprofloxacin associated with a statistically significant improvement in survival in the rhesus monkey model of inhalational anthrax are reached or exceeded in adult and pediatric patients receiving oral and intravenous regimens. Ciprofloxacin pharmacokinetics have been evaluated in various human populations. The mean peak serum concentration achieved at steady-state in human adults receiving 500 mg orally every 12 hours is 2.97 mcg/mL, and 4.56 mcg/mL following 400 mg intravenously every 12 hours.

The mean trough serum concentration at steady-state for both of these regimens is 0.2 mcg/mL. In a study of 10 pediatric patients between 6 and 16 years of age, the mean peak plasma concentration achieved is 8.3 mcg/mL and trough concentrations range from 0.09 mcg/mL to 0.26 mcg/mL, following two 30-minute intravenous infusions of 10 mg/kg administered 12 hours apart. After the second intravenous infusion patients switched to 15 mg/kg orally every 12 hours achieve a mean peak concentration of 3.6 mcg/mL after the initial oral dose.

Long-term safety data, including effects on cartilage, following the administration of ciprofloxacin to pediatric patients are limited. Ciprofloxacin serum concentrations achieved in humans serve as a surrogate endpoint reasonably likely to predict clinical benefit and provide the basis for this indication. 1 A placebo-controlled animal study in rhesus monkeys exposed to an inhaled mean dose of 11 LD 50 (~5.5 x 105 spores (range 5 -30 LD 50 ) of B. anthracis was conducted.

The minimal inhibitory concentration (MIC) of ciprofloxacin for the anthrax strain used in this study was 0.08 mcg/mL. In the animals studied, mean serum concentrations of ciprofloxacin achieved at expected T max (1 hour post-dose) following oral dosing to steady-state ranged from 0.98 mcg/mL to 1.69 mcg/mL. Mean steady-state trough concentrations at 12 hours post-dose ranged from 0.12 mcg/mL to 0.19 mcg/mL.

10 Mortality due to anthrax for ani… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~3 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Eight in vitro mutagenicity tests have been conducted with ciprofloxacin, and the test results are listed below: Salmonella/Microsome Test (Negative) E. coli DNA Repair Assay (Negative) Mouse Lymphoma Cell Forward Mutation Assay (Positive) Chinese Hamster V 79 Cell HGPRT Test (Negative) Syrian Hamster Embryo Cell Transformation Assay (Negative) Saccharomyces cerevisiae Point Mutation Assay (Negative) Saccharomyces cerevisiae Mitotic Crossover and Gene Conversion Assay (Negative) Rat Hepatocyte DNA Repair Assay (Positive) Thus, 2 of the 8 tests were positive, but results of the following 3 in vivo test systems gave negative results: Rat Hepatocyte DNA Repair Assay Micronucleus Test (Mice) Dominant Lethal Test (Mice) Long-term carcinogenicity studies in rats and mice resulted in no carcinogenic or tumorigenic effects due to ciprofloxacin at daily oral dose levels up to 250 mg/kg and 750 mg/kg to rats and mice, respectively (approximately 1.7-and 2.5-times the highest recommended therapeutic dose based upon body surface area, respectively).

Results from photo co-carcinogenicity testing indicate that ciprofloxacin does not reduce the time to appearance of UV-induced skin tumors as compared to vehicle control. Hairless (Skh-1) mice were exposed to UVA light for 3.5 hours five times every two weeks for up to 78 weeks while concurrently being administered ciprofloxacin tablets. The time to development of the first skin tumors was 50 weeks in mice treated concomitantly with UVA and ciprofloxacin tablets (mouse dose approximately equal to the maximum recommended human dose based upon body surface area), as opposed to 34 weeks when animals were treated with both UVA and vehicle.

The times to development of skin tumors ranged from 16 weeks to 32 weeks in mice treated concomitantly with UVA and other quinolones. 9 In this model, mice treated with ciprofloxacin alone did not develop skin or systemic tumors. There are no data from similar models using pigmented mice and/or fully haired mice.

The clinical significance of these findings to humans is unknown. Fertility studies performed in rats at oral doses of ciprofloxacin up to 100 mg/kg (approximately 0.7-times the highest recommended therapeutic dose based upon body surface area) revealed no evidence of impairment.

13.2Animal Toxicology and/or Pharmacology Ciprofloxacin and other quinolones have been shown to cause arthropathy in immature animals of most species tested [see Warnings and Precautions (5.11) ] . Damage of weight bearing joints was observed in juvenile dogs and rats. In young beagles, 100 mg/kg ciprofloxacin, given daily for 4 weeks, caused degenerative articular changes of the knee joint.

At 30 mg/kg, the effect on the joint was minimal. In a subsequent study in young beagle dogs, oral ciprofloxacin doses of 30 mg/kg and 90 mg/kg ciprofloxacin (approximately 1.3-times and 3.5-times the pediatric dose based upon comparative plasma AUCs) given daily for 2 weeks caused articular changes which were still observed by histopathology after a treatment-free period of 5 months. At 10 mg/kg (approximately 0.6-times the pediatric dose based upon comparative plasma AUCs), no effects on joints were observed.

This dose was also not associated with arthrotoxicity after an additional treatment-free period of 5 months. In another study, removal of weight bearing from the joint reduced the lesions but did not totally prevent them. Crystalluria, sometimes associated with secondary nephropathy, occurs in laboratory animals dosed with ciprofloxacin.

This is primarily related to the reduced solubility of ciprofloxacin under alkaline conditions, which predominate in the urine of test animals; in man, crystalluria is rare since human urine is typically acidic. In rhesus monkeys, crystalluria without nephropathy was noted after single oral doses as low as 5 mg/kg. (approximately 0.07-times the highest recommended th… [Excerpted — this section continues on DailyMed.]

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~2 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Eight in vitro mutagenicity tests have been conducted with ciprofloxacin, and the test results are listed below: Salmonella/Microsome Test (Negative) E. coli DNA Repair Assay (Negative) Mouse Lymphoma Cell Forward Mutation Assay (Positive) Chinese Hamster V 79 Cell HGPRT Test (Negative) Syrian Hamster Embryo Cell Transformation Assay (Negative) Saccharomyces cerevisiae Point Mutation Assay (Negative) Saccharomyces cerevisiae Mitotic Crossover and Gene Conversion Assay (Negative) Rat Hepatocyte DNA Repair Assay (Positive) Thus, 2 of the 8 tests were positive, but results of the following 3 in vivo test systems gave negative results: Rat Hepatocyte DNA Repair Assay Micronucleus Test (Mice) Dominant Lethal Test (Mice) Long-term carcinogenicity studies in rats and mice resulted in no carcinogenic or tumorigenic effects due to ciprofloxacin at daily oral dose levels up to 250 mg/kg and 750 mg/kg to rats and mice, respectively (approximately 1.7-and 2.5-times the highest recommended therapeutic dose based upon body surface area, respectively).

Results from photo co-carcinogenicity testing indicate that ciprofloxacin does not reduce the time to appearance of UV-induced skin tumors as compared to vehicle control. Hairless (Skh-1) mice were exposed to UVA light for 3.5 hours five times every two weeks for up to 78 weeks while concurrently being administered ciprofloxacin tablets. The time to development of the first skin tumors was 50 weeks in mice treated concomitantly with UVA and ciprofloxacin tablets (mouse dose approximately equal to the maximum recommended human dose based upon body surface area), as opposed to 34 weeks when animals were treated with both UVA and vehicle.

The times to development of skin tumors ranged from 16 weeks to 32 weeks in mice treated concomitantly with UVA and other quinolones. 9 In this model, mice treated with ciprofloxacin alone did not develop skin or systemic tumors. There are no data from similar models using pigmented mice and/or fully haired mice.

The clinical significance of these findings to humans is unknown. Fertility studies performed in rats at oral doses of ciprofloxacin up to 100 mg/kg (approximately 0.7-times the highest recommended therapeutic dose based upon body surface area) revealed no evidence of impairment.

📚 References ~2 min read ▾

15 REFERENCES 21 CFR 314.510 (Subpart H–Accelerated Approval of New Drugs for Life-Threatening Illnesses). Friedman J, Polifka J. Teratogenic effects of drugs: a resource for clinicians (TERIS).

Baltimore, Maryland: Johns Hopkins University Press, 2000:149-195. Loebstein R, Addis A, Ho E, et al. Pregnancy outcome following gestational exposure to fluoroquinolones: a multicenter prospective controlled study.

Antimicrob Agents Chemother. 1998; 42(6):1336-1339. Schaefer C, Amoura-Elefant E, Vial T, et al.

Pregnancy outcome after prenatal quinolone exposure. Evaluation of a case registry of the European network of teratology information services (ENTIS). Eur J Obstet Gynecol Reprod Biol.

1996; 69:83-89. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically ; Approved Standard–9 th Edition .

CLSI Document M7-A9 [2012]. Clinical and Laboratory Standards Institute, 950 West Valley Rd., Suite 2500, Wayne, PA. 19087-1898.

Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; 24 th Informational Supplement . CLSI Document M100 S24 [2014].

Clinical and Laboratory Standards Institute, 950 West Valley Rd., Suite 2500, Wayne, PA. 19087-1898. Clinical and Laboratory Standards Institute (CLSI).

Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved Guideline–2 nd Edition . CLSI Document M45-A2 [2010]. Clinical and Laboratory Standards Institute, 950 West Valley Rd., Suite 2500, Wayne, PA.

19087-1898. Clinical and Laboratory Standards Institute (CLSI), Performance Standards for Antimicrobial Disk Susceptibility Tests; Approved Standard–11th Edition . CLSI Document M2-A11 [2012].

Clinical and Laboratory Standards Institute, 950 West Valley Rd., Suite 2500, Wayne, PA. 19087-1898. Report presented at the FDA’s Anti-Infective Drug and Dermatological Drug Product’s Advisory Committee meeting, March 31, 1993, Silver Spring, MD.

Report available from FDA, CDER, Advisors and Consultants Staff, HFD-21, 1901 Chapman Avenue, Room 200, Rockville, MD 20852, USA. Kelly DJ, et al. Serum concentrations of penicillin, doxycycline, and ciprofloxacin during prolonged therapy in rhesus monkeys.

J Infect Dis 1992; 166:1184-7. Friedlander AM, et al. Post-exposure prophylaxis against experimental inhalational anthrax.

J Infect Dis 1993; 167:1239-42. Anti-infective Drugs Advisory Committee Meeting, April 3, 2012 -The efficacy of Ciprofloxacin for treatment of Pneumonic Plague.

📄 Recent Major Changes 20 words ▾

Indications and Usage, Plague ( 1.14 ) 03/2015 Dosage and Administration, Adults ( 2.1 ), Pediatrics ( 2.2 ) 03/2015

📄 Package Label / Principal Display Panel 5 words ▾

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL pdp

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Cipro (matched by generic name) — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Cipro. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$92.9K
Claims incl. refills
550
Beneficiaries
474
Spend / beneficiary
$196.00
Spend / claim
$168.91
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
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Labeler ✓ Available
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Active ingredient / dosage form / route ✓ Available
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NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
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Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by NuCare Pharmaceuticals,Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 7 other package presentations of this same product, including 6 tablets (68071-4260-06), 10 tablets (68071-4260-07), 20 tablets (68071-4260-05). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
NuCare Pharmaceuticals,Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 68071-4257-01 · NuCare 68071-4272-03 · NuCare →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.