Home › NDC Lookup › Ingredients › Ciprofloxacin Hydrochloride › 71335-1347-02
Ciprofloxacin 500 mg Tablet, Film Coated, 30-count — NDC 71335-1347-02 package photo

Ciprofloxacin 500 mg Tablet, Film Coated, 30-count

by Bryant Ranch Prepack · 30 TABLET, FILM COATED in 1 BOTTLE (71335-1347-2)
NDC 71335-1347-02
🏷️ FDA NDC (as labeled) 71335-1347-2 billing pads the package segment with a zero
This package
Contains30-count Pack sizes10 compare ↓
Also priced by: Part D plans $0.2764/unit — full pricing hub ↓
Also comes in: 6 tablets 71335-1347-05 7 tablets 71335-1347-00 10 tablets 71335-1347-06 14 tablets 71335-1347-01 20 tablets 71335-1347-03 28 tablets 71335-1347-07 40 tablets 71335-1347-09 60 tablets 71335-1347-04 100 tablets 71335-1347-08
Rx only Generic On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 71335-1347-2
Product NDC 71335-1347
11-digit billing NDC 71335134702
RxCUI 197511, 309309
UNII 4BA73M5E37
Application # ANDA076126
SPL Set ID b283d662-9be1-49c7-be03-cb21055314c1
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 2009-10-10
Route ORAL
Dosage form TABLET, FILM COATED
Substance CIPROFLOXACIN HYDROCHLORIDE
GPI-14 05000020100315
GPI class Ciprofloxacin HCl
GCN Seq No 009510
GCN 47051
HICL code 004124
Ingredient (HICL) Ciprofloxacin Hcl
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W1
Therapeutic class — intermediate (HIC2) Antibiotics
HIC3 code W1Q
Therapeutic class — specific (HIC3) Quinolone Antibiotics
AHFS code 08:12.18.00
AHFS class Quinolone Antibiotics
FDB label name CIPROFLOXACIN HCL 500 MG TAB
FDB brand name Ciprofloxacin Hcl
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 71335-1347-2 — 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 → 71335-1347-02. 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.

🏭 Manufacturer & labeler

LabelerBryant Ranch Prepack
Application holderCARLSBAD TECHNOLOGY INC
FDA applicationANDA076126 (ANDA)
Labeler code71335
First marketedOct 2009
Product typeHuman Prescription Drug
Portfolio4,433 products on file
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.

🩺 Clinical

Label name CIPROFLOXACIN HCL 500 MG TAB Ingredient Ciprofloxacin Hcl
📗 Our plain-language guide HelloPharmacist
  • Ciprofloxacin treats a wide range of bacterial infections — things like urinary tract infections, skin infections, bone and joint infections, infectious diarrhea, typhoid fever, an...
  • What kinds of infections does ciprofloxacin actually treat?
  • You can take ciprofloxacin with or without food — that part's flexible. But avoid taking it at the same time as milk, yogurt, or calcium-fortified juices, because dairy and calcium...
  • The most common side effects are nausea, diarrhea, and vomiting — uncomfortable, but usually manageable. The ones that mean stop-and-call-your-doctor-now are tendon pain (especiall...
📖 Read our full Ciprofloxacin guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.

💊 What it looks like

Color white
ShapeOval
ImprintCTI;223
Size18 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 EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • 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 461P5CJN6T
    Modified corn starch derived from cornstarch and treated with octenyl succinic anhydride. It acts as a thickener, stabilizer, and emulsifier to improve texture and prevent separation in the medicine.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.

4 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.

💲 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 $8.29 / 30 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ciprofloxacin 500 mg 00143-9928-01 Hikma 100 tablets $0.124 — Availability likely —
ciprofloxacin 500 mg 00904-7243-61 Major 100 tablets $0.124 AB Availability likely —
Ciprofloxacin 500 mg 16252-0515-01 Teva 100 tablets $0.124 AB Availability likely —
Ciprofloxacin 500 mg 43547-0689-10 Solco 100 tablets $0.124 AB Availability likely —
Ciprofloxacin 500 mg 59651-0867-01 Aurobindo 100 tablets $0.124 AB Availability likely —
Ciprofloxacin 500 mg 60687-0860-01 American 1 tablet $0.124 AB Availability likely —
Ciprofloxacin 500 mg 60687-0947-01 American 1 tablet $0.124 AB Availability likely —
Ciprofloxacin 500 mg 61442-0223-01 Carlsbad 100 tablets $0.124 AB Availability likely —
Ciprofloxacin 500 mg 62135-0309-01 Chartwell 100 tablets $0.124 AB Availability likely —
Ciprofloxacin 500 mg 65862-0077-01 Aurobindo 100 tablets $0.124 AB Availability likely —
Ciprofloxacin Hydrochloride 500 mg 69367-0386-01 Westminster 100 tablets $0.124 AB Availability likely —
Ciprofloxacin 500 mg 58657-0676-01 Method 100 tablets $0.159 AB FDA listed —
Ciprofloxacin 500 mg 00615-8546-10 NCS 10 tablets — AB Discontinued —
Ciprofloxacin 500 mg 00615-8630-10 NCS 10 tablets — AB FDA listed —
ciprofloxacin 500 mg 16571-0412-05 Rising 50 tablets — AB FDA listed —
Ciprofloxacin 500 mg 42708-0088-14 QPharma 14 tablets — AB FDA listed —
ciprofloxacin 500 mg 42708-0192-14 QPharma, 14 tablets — AB FDA listed —
Ciprofloxacin 500 mg 43063-0547-01 PD-Rx 100 tablets — AB FDA listed —
ciprofloxacin 500 mg 43063-0869-06 PD-Rx 6 tablets — AB FDA listed —
Ciprofloxacin 500 mg 43063-0923-02 PD-Rx 2 tablets — AB FDA listed —
ciprofloxacin 500 mg 50090-1648-00 A-S 20 tablets — AB FDA listed —
ciprofloxacin 500 mg 50090-1649-00 A-S 20 tablets — AB FDA listed —
Ciprofloxacin Hydrochloride 500 mg 50090-7843-00 A-S 20 tablets — AB FDA listed —
Ciprofloxacin Hydrochloride 500 mg 50090-7848-01 A-S 14 tablets — AB FDA listed —
Cipro 500 mg 50419-0754-01 Bayer 100 tablets — AB FDA listed —
Ciprofloxacin 500 mg 51407-0165-01 Golden 100 tablets — AB FDA listed —
Ciprofloxacin 500 mg 51655-0216-20 Northwind 20 tablets — AB FDA listed —
Ciprofloxacin 500 mg 51655-0490-20 Northwind 20 tablets — AB FDA listed —
ciprofloxacin 500 mg 54348-0663-01 PharmPak, 1 tablet — AB FDA listed —
ciprofloxacin 500 mg 55154-0193-00 Cardinal 1 tablet — AB FDA listed —
Ciprofloxacin 500 mg 59651-0977-15 Aurobindo 1500 tablets — AB FDA listed —
Ciprofloxacin 500 mg 60429-0042-20 Golden 20 tablets — — FDA listed —
Ciprofloxacin 500 mg 60760-0676-10 St. 10 tablets — AB FDA listed —
Ciprofloxacin 500 mg 60760-0689-10 ST. 10 tablets — AB FDA listed —
ciprofloxacin 500 mg 63187-0017-06 Proficient 6 tablets — AB FDA listed —
Ciprofloxacin 500 mg 63629-1010-01 Bryant 100 tablets — AB FDA listed —
ciprofloxacin 500 mg 66267-0716-02 NuCare 2 tablets — AB FDA listed —
ciprofloxacin 500 mg 66267-0919-06 NuCare 6 tablets — AB FDA listed —
Ciprofloxacin 500 mg 67046-1537-03 Coupler 30 tablets — AB FDA listed —
Ciprofloxacin 500 mg 67296-1848-02 Redpharm 20 tablets — AB Discontinued —
Ciprofloxacin 500 mg 67296-2135-01 Redpharm 14 tablets — AB FDA listed —
Ciprofloxacin Hydrochloride 500 mg 67296-2208-01 Redpharm 10 tablets — AB FDA listed —
Ciprofloxacin 500 mg 68071-2267-01 NuCare 10 tablets — AB FDA listed —
Ciprofloxacin 500 mg 68071-2269-04 NuCare 4 tablets — AB FDA listed —
Ciprofloxacin 500 mg 68071-2384-01 NuCare 10 tablets — AB FDA listed —
Ciprofloxacin 500 mg 68071-2404-02 NuCare 2 tablets — AB FDA listed —
Ciprofloxacin 500 mg 68071-3610-01 NuCare 10 tablets — AB FDA listed —
Ciprofloxacin 500 mg 68071-3737-02 NuCare 2 tablets — AB FDA listed —
ciprofloxacin 500 mg 68071-4122-01 NuCare 10 tablets — AB FDA listed —
Ciprofloxacin 500 mg 68788-8136-00 Preferred 6 tablets — AB FDA listed —
Ciprofloxacin 500 mg 68788-8692-00 Preferred 6 tablets — AB FDA listed —
Ciprofloxacin 500 mg 69117-0009-01 Yiling 500 tablets — AB FDA listed —
Ciprofloxacin 500 mg 69238-2433-01 Amneal 100 tablets — — FDA listed —
Ciprofloxacin 500 mg 70518-3063-00 REMEDYREPACK 30 tablets — — Discontinued —
Ciprofloxacin 500 mg 70518-4214-00 REMEDYREPACK 30 tablets — AB FDA listed —
Ciprofloxacin 500 mg 70518-4229-00 REMEDYREPACK 14 tablets — AB FDA listed —
Ciprofloxacin 500 mg 70934-0965-06 Denton 6 tablets — AB Discontinued —
Ciprofloxacin 500 mg 71205-0649-06 Proficient 6 tablets — AB FDA listed —
Ciprofloxacin 500 mg 71205-0997-00 Proficient 100 tablets — AB FDA listed —
ciprofloxacin 500 mg 71335-0070-00 Bryant 7 tablets — AB FDA listed —
Ciprofloxacin 500 mg 71335-1229-00 Bryant 7 tablets — AB Discontinued —
Ciprofloxacin 500 mgthis 71335-1347-02 Bryant 30 tablets — AB FDA listed —
Ciprofloxacin 500 mg 71335-2046-00 Bryant 7 tablets — AB FDA listed —
Ciprofloxacin 500 mg 71335-2054-00 Bryant 7 tablets — AB FDA listed —
Ciprofloxacin 500 mg 71335-2450-00 Bryant 7 tablets — AB FDA listed —
Ciprofloxacin 500 mg 71610-0081-83 Aphena 3600 tablets — AB FDA listed —
Ciprofloxacin 500 mg 71610-0109-30 Aphena 30 tablets — AB FDA listed —
Ciprofloxacin 500 mg 71610-0159-83 Aphena 3600 tablets — AB FDA listed —
Ciprofloxacin 500 mg 72162-1741-02 Bryant 14 tablets — AB FDA listed —
Ciprofloxacin 500 mg 72162-2425-01 Bryant 100 tablets — AB FDA listed —
Ciprofloxacin 500 mg 72189-0111-14 DIRECT 14 tablets — AB FDA listed —
Ciprofloxacin 500 mg 72189-0300-06 DirectRx 6 tablets — — FDA listed —
Ciprofloxacin 500 mg 72189-0623-10 Direct_Rx 10 tablets — AB FDA listed —
Ciprofloxacin 500 mg 72189-0627-10 Direct_Rx 10 tablets — AB FDA listed —
Ciprofloxacin 500 mg 72789-0065-20 PD-Rx 20 tablets — AB FDA listed —
Ciprofloxacin 500 mg 72789-0108-02 PD-Rx 2 tablets — — FDA listed —
Ciprofloxacin 500 mg 72789-0118-01 PD-Rx 100 tablets — — FDA listed —
Ciprofloxacin 500 mg 72789-0330-06 PD-Rx 6 tablets — AB FDA listed —
Ciprofloxacin 500 mg 72789-0511-10 PD-Rx 10 tablets — AB FDA listed —
Ciprofloxacin 500 mg 72789-0520-06 PD-Rx 6 tablets — AB FDA listed —
Ciprofloxacin 500 mg 76420-0045-06 Asclemed 6 tablets — AB FDA listed —
Ciprofloxacin 500 mg 76420-0929-01 Asclemed 100 tablets — AB FDA listed —
Ciprofloxacin HCL 500 mg 80425-0192-01 Advanced 20 tablets — AB FDA listed —
Ciprofloxacin 500 mg 80425-0492-01 Advanced 20 tablets — AB FDA listed —
Ciprofloxacin Hydrochloride 500 mg 80425-0493-01 Advanced 20 tablets — AB FDA listed —
Ciprofloxacin 500 mg 82804-0130-06 Proficient 6 tablets — AB FDA listed —
Ciprofloxacin Hydrochloride 500 mg 82804-0260-06 Proficient 6 tablets — AB FDA listed —
Ciprofloxacin 500 mg 82982-0050-14 Pharmasource 14 tablets — AB Discontinued —
Ciprofloxacin 500 mg 83008-0078-20 Quality 20 tablets — AB Discontinued —
Ciprofloxacin Hydrochloride 500 mg 83939-0002-01 VERITYRX, 1 tablet — AB FDA listed —
ciprofloxacin 500 mg 85293-0003-01 Umasuto, 100 tablets — AB FDA listed —
Ciprofloxacin 500 mg 85766-0100-01 Sportpharm 100 tablets — AB FDA listed —
Ciprofloxacin 500 mg 50090-3791-00 A-S 20 tablets — AB Discontinued —
Ciprofloxacin 500 mg 50090-3852-00 A-S 20 tablets — AB Discontinued —
Ciprofloxacin 500 mg 50090-5373-00 A-S 20 tablets — AB Discontinued —
Ciprofloxacin Hydrochloride 500 mg 72789-0577-14 PD-Rx 14 tablets — AB FDA listed —
Ciprofloxacin 500 mg 85534-0047-00 HAWAII 6 tablets — AB FDA listed —
Ciprofloxacin Hydrochloride 500 mg 68788-4177-00 Preferred 6 tablets — AB FDA listed —
Ciprofloxacin Hydrochloride 500 mg 67046-1692-03 Coupler 30 tablets — AB FDA listed —
Ciprofloxacin 500 mg 67296-2291-04 Redpharm 14 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

🏛️
2009
On the market since
Oct 2009
📍
2026
Currently FDA-listed
17 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Ciprofloxacin (this brand).

Top reported reactions

Fatigue4,781
Pain4,648
Nausea4,607
Diarrhoea4,587
Acute Kidney Injury4,360
Arthralgia4,330
Chronic Kidney Disease4,106

Age at onset

Neonate88
Infant94
Child288
Adolescent239
Adult6,774
Elderly4,290

Reporter sex

76,395 reports
Male · 44%
Female · 56%
Unknown · 0%

Serious outcomes

Hospitalization31,671
Death8,309
Disabling5,604
Life-threatening5,260
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 8,225 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
71335-1347-00 7 TABLET, FILM COATED in 1 BOTTLE (71335-1347-0) 2009-10-10 Active
71335-1347-01 14 TABLET, FILM COATED in 1 BOTTLE (71335-1347-1) 2009-10-10 Active
71335-1347-02 You're viewing this 30 TABLET, FILM COATED in 1 BOTTLE (71335-1347-2) 2009-10-10 Active
71335-1347-03 20 TABLET, FILM COATED in 1 BOTTLE (71335-1347-3) 2009-10-10 Active
71335-1347-04 60 TABLET, FILM COATED in 1 BOTTLE (71335-1347-4) 2009-10-10 Active
71335-1347-05 6 TABLET, FILM COATED in 1 BOTTLE (71335-1347-5) 2009-10-10 Active
71335-1347-06 10 TABLET, FILM COATED in 1 BOTTLE (71335-1347-6) 2009-10-10 Active
71335-1347-07 28 TABLET, FILM COATED in 1 BOTTLE (71335-1347-7) 2009-10-10 Active
71335-1347-08 100 TABLET, FILM COATED in 1 BOTTLE (71335-1347-8) 2009-10-10 Active
71335-1347-09 40 TABLET, FILM COATED in 1 BOTTLE (71335-1347-9) 2009-10-10 Active

You're viewing one of 10 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 71335-1347-02?
NDC 71335-1347-02 is a 30-count package — 30 tablet, film coated in 1 bottle.
What is the difference between NDC 71335-1347-02 and NDC 71335-1347-05?
Both are Ciprofloxacin 500 mg Tablet, Film Coated — the drug itself is identical. NDC 71335-1347-02 is the 30-count package, while NDC 71335-1347-05 is the 6 tablets package.
What NDC number is used to bill for this package of Ciprofloxacin 500 mg Tablet, Film Coated?
Bill NDC 71335-1347-02 — the 11-digit billing format is 71335134702. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

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 FDA registers it as 71335-1347-2, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 71335-1347-02, written without dashes as 71335134702. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 71335-1347-02, the first segment (71335) is the labeler code FDA assigned to Bryant Ranch Prepack; the middle segment (1347) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
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 Bryant Ranch Prepack. 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 9 other package presentations of this same product, including 6 tablets (71335-1347-05), 7 tablets (71335-1347-00), 10 tablets (71335-1347-06). 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?
Bryant Ranch Prepack 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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. 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
🚨 Boxed Warning ~2 min read ▾

WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS Fluoroquinolones, including Ciprofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together [see Warnings and Precautions ( 5.1 )] including : Tendinitis and tendon rupture [see Warnings and Precautions ( 5.2 )] Peripheral neuropathy [see Warnings and Precautions ( 5.3 )] Central nervous system effects [see Warnings and Precautions ( 5.4 )] Discontinue Ciprofloxacin immediately and avoid the use of fluoroquinolones, including Ciprofloxacin, in patients who experience any of these serious adverse reactions [see Warnings and Precautions ( 5.1 )] .Fluoroquinolones, including Ciprofloxacin, may exacerbate muscle weakness in patients with myasthenia gravis.

Avoid Ciprofloxacin in patients with known history of myasthenia gravis [see Warnings and Precautions ( 5.5 )]. Because fluoroquinolones, including Ciprofloxacin, have been associated with serious adverse reactions [see Warnings and Precautions ( 5.1 – 5.15 )] , reserve Ciprofloxacin for use in patients who have no alternative treatment options for the following indications: Acute exacerbation of chronic bronchitis [see Indications and Usage ( 1.10 )] Acute uncomplicated cystitis [see Indications and Usage ( 1.11 )] Acute sinusitis [see Indications and Usage ( 1.12 )] WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS See full prescribing information for complete boxed warning.

Fluoroquinolones, including Ciprofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together ( 5.1 ), including: Tendinitis and tendon rupture( 5.2 ) Peripheral neuropathy ( 5.3 ) Central nervous system effects( 5.4 ) Discontinue Ciprofloxacin immediately and avoid the use of fluoroquinolones, including Ciprofloxacin, in patients who experience any of these serious adverse reactions ( 5.1 ) Fluoroquinolones, including Ciprofloxacin, may exacerbate muscle weakness in patients with myasthenia gravis.

Avoid Ciprofloxacin in patients with known history of myasthenia gravis. ( 5.5 ) Because fluoroquinolones, including Ciprofloxacin, have been associated with serious adverse reactions ( 5.1 - 5.15 ), reserve Ciprofloxacin for use in patients who have no alternative treatment options for the following indications: Acute exacerbation of chronic bronchitis ( 1.10 ) Acute uncomplicated cystitis ( 1.11 ) Acute sinusitis ( 1.12 )

🎯 Indications and Usage ~3 min read ▾

1 INDICATIONS AND USAGE Ciprofloxacin Tablets 250 mg, 500 mg, and 750 mg are a fluoroquinolone antibacterial indicated in adults (≥18 years of age) with the following infections caused by designated, susceptible bacteria and in pediatric patients where indicated: Skin and Skin Structure Infections ( 1.1 ) Bone and Joint Infections ( 1.2 ) Complicated Intra-Abdominal Infections ( 1.3 ) Infectious Diarrhea ( 1.4 ) Typhoid Fever (Enteric Fever) ( 1.5 ) Uncomplicated Cervical and Urethral Gonorrhea ( 1.6 ) Inhalational Anthrax post-exposure in adult and pediatric patients ( 1.7 ) Plague in adult and pediatric patients ( 1.8 ) Chronic Bacterial Prostatitis ( 1.9 ) Lower Respiratory Tract Infections ( 1.10 ) Acute Exacerbation of Chronic Bronchitis Urinary Tract Infections ( 1.11 ) Urinary Tract Infections (UTI) Acute Uncomplicated Cystitis Complicated UTI and Pyelonephritis in Pediatric Patients Acute Sinusitis ( 1.12 ) Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ciprofloxacin 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.

( 1.13 )

1.1Skin 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.

1.2Bone 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.

1.3Complicated 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.

1.4Infectious Diarrhea Ciprofloxacin is indicated in adult patients for treatment of infectious diarrhea caused by Escherichia coli (enterotoxigenic isolates), Campylobacter jejuni, Shigella boydii † , Shigella dysenteriae, Shigella flexneri or Shigella sonnei † when antibacterial therapy is indicated. † Although treatment of infections due to this organism in this organ system demonstrated a clinically significant outcome, efficacy was studied in fewer than 10 patients.

1.5Typhoid Fever (Enteric Fever) Ciprofloxacin is indicated in adult patients for treatment of typhoid fever (enteric fever ) caused by Salmonella typhi. The efficacy of ciprofloxacin in the eradication of the chronic typhoid carrier state has not been demonstrated.

1.6Uncomplicated Cervical and Urethral Gonorrhea Ciprofloxacin is indicated in adult patients for treatment of uncomplicated cervical and urethral gonorrhea due to Neisseria gonorrhoeae [see Warnings and Precautions ( 5.16 )].

1.7Inhalational Anthrax (Post-Exposure) Ciprofloxacin is indicated in adults and pediatric patients from birth to 17 years of age for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. Ciprofloxacin serum concentrations achieved in humans served as a surrogate endpoint reasonably likely to predict clinical benefit and provided the initial basis for approval of this indication. 1 Supportive clinical information for ciprofloxacin for anthrax post-exposure prophylaxis was obtained during the anthrax bioterror attacks of October 2001 [see Clinical Studies ( 14.2 )].

1.8Plague Ciprofloxacin is indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis (Y. pestis) and prophylaxis for plague in adults and pediatric patient…

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION 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 -750 mg every 12 hours 7 to 14 days Bone and Joint 500-750 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 500–750 mg every 12 hours 14 days Chronic Bacterial Prostatitis 500 mg every 12 hours 28 days Lower Respiratory Tract 500 -750 mg every 12 hours 7 to 14 days Urinary Tract 250-500 mg every 12 hours 7 to 14 days Acute Uncomplicated Cystitis 250 mg every 12 hours 3 days Acute Sinusitis 500 mg every 12 hours 10 days Adults with creatinine clearance 30–50 mL/min 250–500 mg q 12 h ( 2.3 ) Adults with creatinine clearance 5–29 mL/min 250–500 mg q 18 h ( 2.3 ) Patients on hemodialysis or peritoneal dialysis 250–500 mg q 24 h (after dialysis) ( 2.3 ) Pediatric Oral Dosage Guidelines Infection Dose Frequency Duration Complicated UTI and 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 15mg/kg (maximum 500 mg per dose) Every 8 to 12 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. 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 1. 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). 1.

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). 2. Used in conjunction with metronidazole.

2. Used in conjunction with metronidazole. 3.

Begin drug administration as soon as possible after suspected or confirmed exposure. 3. Begin drug administration as soon as possible after suspected or confirmed exposure.

Infection Dose Frequency Usual Durations 1 Skin and Skin Structure 500–750 mg every 12 hours 7 to 14 days Bone and Joint 500–750 mg every 12 hours 4 to 8 weeks Complicated Intra–Abdominal 2 500 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) 3 500 mg every 12 hours 60 days Plague 3 500–750 mg every 12 hours 14 days Chronic Bacterial Prostatitis 500 mg every 12 hours 28 days Lower Respiratory Tract Infections 500–750 mg every 12 hours 7 to 14 days Urinary Tract Infections 250–500 mg every 12 hours 7 to 14 days Acute Uncomplicated Cystitis 250 mg every 12 hours 3 days Acute Sinusitis 500 mg every 12 hours 10 days 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 intrave…

💊 Dosage Forms and Strengths 71 words ▾

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

3.1Tablets Ciprofloxacin Tablets USP (white to off-white round tablets) containing 250 mg of ciprofloxacin and engraved with "CTI 222" Ciprofloxacin Tablets USP (white to off-white capsule-shaped tablets) containing 500 mg of ciprofloxacin and engraved with "CTI 223" Ciprofloxacin Tablets USP (white to off-white capsule-shaped tablets) containing 750 mg of ciprofloxacin and engraved with "CTI 224"

⛔ Contraindications 72 words ▾

4 CONTRAINDICATIONS Known hypersensitivity to Ciprofloxacin or other quinolones ( 4.1 , 5.6 , 5.7 ) 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 ( 5.7 )].

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 (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.

( 5.8 ) Clostridium difficile -associated diarrhea: Evaluate if colitis occurs. ( 5.10 ) 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.

( 5.11 , 7 , 8.5 )

5.1Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects Fluoroquinolones, including Ciprofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient. Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion).

These reactions can occur within hours to weeks after starting Ciprofloxacin. Patients of any age or without pre-existing risk factors have experienced these adverse reactions [see Warnings and Precautions ( 5.2 , 5.3 , 5.4 )] . Discontinue Ciprofloxacin immediately at the first signs or symptoms of any serious adverse reaction.

In addition, avoid the use of fluoroquinolones, including Ciprofloxacin, in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones.

5.2Tendinitis and Tendon Rupture Fluoroquinolones, including Ciprofloxacin, have been associated with an increased risk of tendinitis and tendon rupture in all ages [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.2 )] . This adverse reaction most frequently involves the Achilles tendon, and has also been reported with the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendons. Tendinitis or tendon rupture can occur, within hours or days of starting Ciprofloxacin, or as long as several months after completion of fluoroquinolone therapy.

Tendinitis and tendon rupture can occur bilaterally. The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is increased in patients over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Other factors 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. Discontinue Ciprofloxacin immediately if the patient experiences pain, swelling, inflammation or rupture of a tendon. Avoid fluoroquinolones, including Ciprofloxacin, in patients who have a history of tendon disorders or have experienced tendinitis or tendon rupture [see Adverse Reactions ( 6.2 )].

5.3Peripheral Neuropathy Fluoroquinolones, including Ciprofloxacin, have been associated with an increased risk of peripheral neuropathy. Cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving fluoroquinolones, including Ciprofloxacin. Symptoms may occur soon after initiation of Ciprofloxacin and may be irreversible in some patients [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 , 6.2 )] .

Discontinue Ciprofloxacin immediately if the patient experiences symptoms of peripheral neuropathy incl…

🤒 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: Disabling and Potentially Irreversible Serious Adverse Reactions [see Warnings and Precautions ( 5.1 )] Tendinitis and Tendon Rupture [see Warnings and Precautions ( 5.2 )] Peripheral Neuropathy [see Warnings and Precautions ( 5.3 )] Central Nervous System Effects [see Warnings and Precautions ( 5.4 )] Exacerbation of Myasthenia Gravis [see Warnings and Precautions ( 5.5 )] Other Serious and Sometimes Fatal Adverse Reactions [see Warnings and Precautions ( 5.6 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.7 )] Hepatotoxicity [see Warnings and Precautions ( 5.8 )] Serious Adverse Reactions with Concomitant Theophylline [see Warnings and Precautions ( 5.9 )] Clostridium difficile-Associated Diarrhea [see Warnings and Precautions ( 5.10 )] Prolongation of the QT Interval [see Warnings and Precautions ( 5.11 )] Musculoskeletal Disorders in Pediatric Patients [see Warnings and Precautions ( 5.12 )] 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 test abnormal, vomiting, and rash.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Carlsbad Technology, Inc. at 1-855-397-9777 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 System Organ Class Adverse Reactions 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 demonstra…

🔄 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 ( 5.9 )]. 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 ( 5.11 ) 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 co-administration 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 co-administration with Ciprofloxacin [see Warnings and Precautions ( 5.16 )].

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…

👥 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 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 embryo toxicity 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 ( 5.12 ) and Nonclinical Toxicology ( 13.2 )] . Compli…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy 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 embryo toxicity 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 ( 5.12 ) 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 (post exposure). 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 ( 1.8 ), 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 ( 5.2 ), 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 ( 5.11 )].

🆘 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 1.

AUC 0–12h 2. AUC 24h = AUC 0–12h x 2 3. AUC 24h = AUC 0–8h x 3 Parameters 500 mg 400 mg 750 mg 400 mg every 12 hours, orally every 12 hours, intravenous every 12 hours, orally. every 8 hours, intravenous AUC (mcg•hr/mL) 13.7 1 12.7 1 31.6 2 32.9 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 Tablet, however, is not substantially affected. The pharmacokinetics of ciprofloxacin given as the suspension are also not affected by food.

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. 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…

🧬 Mechanism of Action 20 words ▾

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

📦 How Supplied / Storage and Handling 212 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Ciprofloxacin Tablets USP (white to off-white round tablets) containing 250 mg of Ciprofloxacin and engraved with “CTI 222”. NDC: 71335-0836-0: 7 TABLET in a BOTTLE NDC: 71335-0836-1: 20 TABLET in a BOTTLE NDC: 71335-0836-2: 10 TABLET in a BOTTLE NDC: 71335-0836-3: 14 TABLET in a BOTTLE NDC: 71335-0836-4: 6 TABLET in a BOTTLE NDC: 71335-0836-5: 30 TABLET in a BOTTLE NDC: 71335-0836-6: 60 TABLET in a BOTTLE NDC: 71335-0836-7: 12 TABLET in a BOTTLE NDC: 71335-0836-8: 40 TABLET in a BOTTLE NDC: 71335-0836-9: 90 TABLET in a BOTTLE Ciprofloxacin Tablets USP (white to off-white capsule-shaped tablets) containing 500 mg of ciprofloxacin and engraved with “CTI 223”.

NDC: 71335-1347-0: 7 TABLET in a BOTTLE NDC: 71335-1347-1: 14 TABLET in a BOTTLE NDC: 71335-1347-2: 30 TABLET in a BOTTLE NDC: 71335-1347-3: 20 TABLET in a BOTTLE NDC: 71335-1347-4: 60 TABLET in a BOTTLE NDC: 71335-1347-5: 6 TABLET in a BOTTLE NDC: 71335-1347-6: 10 TABLET in a BOTTLE NDC: 71335-1347-7: 28 TABLET in a BOTTLE NDC: 71335-1347-8: 100 TABLET in a BOTTLE NDC: 71335-1347-9: 40 TABLET in a BOTTLE 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].

Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

📋 Description 144 words ▾

11 DESCRIPTION Ciprofloxacin (Ciprofloxacin hydrochloride) Tablets 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)-3-quinolinecarboxylic 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 is 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its empirical formula is C 17 H 18 FN 3 O 3 and its molecular weight is 331.4. It is a faintly yellowish to light yellow crystalline substance 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 are white to slightly yellowish. The inactive ingredients are Lactose Monohydrate, Magnesium Stearate, Sodium Starch Gylcolate, and Starch 1500 (Modified Corn Starch).

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA- approved patient labeling (Medication Guide) Serious Adverse Reactions Advise patients to stop taking Ciprofloxacin if they experience an adverse reaction and to call their healthcare provider for advice on completing the full course of treatment with another antibacterial drug. Inform patients of the following serious adverse reactions that have been associated with Ciprofloxacin or other fluoroquinolone use: Disabling and potentially irreversible serious adverse reactions that may occur together: Inform patients that disabling and potentially irreversible serious adverse reactions, including tendinitis and tendon rupture, peripheral neuropathies, and central nervous system effects, have been associated with use of Ciprofloxacin and may occur together in the same patient.

Inform patients to stop taking Ciprofloxacin immediately if they experience an adverse reaction and to call their healthcare provider. Tendinitis and tendon rupture: 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. Symptoms may be irreversible.

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. Peripheral Neuropathies: Inform patients that peripheral neuropathies have been associated with ciprofloxacin use, symptoms may occur soon after initiation of therapy and may be irreversible. If symptoms of peripheral neuropathy including pain, burning, tingling, numbness and/or weakness develop, immediately discontinue Ciprofloxacin and tell them to contact their physician.

Central nervous system effects (for example, convulsions, dizziness, lightheadedness, increased intracranial pressure): 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. 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 physician if persistent headache with or without blurred vision occurs. 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. Diarrhea: Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the l…

💬 Medication Guide ~3 min read ▾

Medication Guide CIPROFLOXACIN TABLETS (Sip roe flox a sin) for oral use 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, you should stop taking Ciprofloxacin immediately and get medical help right away. 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) Stop taking Ciprofloxacin immediately and get medical help right away at the first sign of tendon pain, swelling, or inflammation. 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.

Tendon rupture can happen while you are taking or after you have finished taking Ciprofloxacin. Tendon ruptures can happen within hours or days of taking Ciprofloxacin and have happened up to several months after people have finished taking their fluoroquinolone. Stop taking Ciprofloxacin immediately and 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 Changes in sensation and possible nerve damage (Peripheral Neuropathy) .Damage to the nerves in arms, hands, legs, or feet can happen in people who take fluoroquinolones, including Ciprofloxacin.

Talk with your healthcare provider right away if you get any of the following symptoms of peripheral neuropathy in your arms, hands, legs, or feet: pain burning tingling numbmbness weakness Ciprofloxacin may need to be stopped to prevent permanent nerve damage. 3. Central Nervous System (CNS) effects.

Seizures have been reported in people who take fluoroquinolone antibacterial medicines, including Ciprofloxacin. Tell your healthcare provider if you have a history of seizures. Ask your healthcare provider whether taking Ciprofloxacin will change your risk of having a seizure.CNS side effects may happen as soon as after taking the first dose of Ciprofloxacin.

Talk to your healthcare provider right away if you get any of these side effects, or other changes in mood or behavior: seizures hear voices, see things, or sense things that are not there (hallucinations) feel restless tremors feel anxious or nervous confusion depression trouble sleeping nightmares feel lightheaded or dizzy feel more suspicious (paranoia) suicidal thoughts or acts headaches that will not go away, with or without blurred vision 4. 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. Tell your healthcare provider if you have any history of myasthenia gravis before you start tak…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 71335-1343-01 · Bryant 71335-1348-00 · Bryant →
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.