CIPROFLOXACIN tablet, film coated

United States - English - NLM (National Library of Medicine)

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Active ingredient:
CIPROFLOXACIN HYDROCHLORIDE (UNII: 4BA73M5E37) (CIPROFLOXACIN - UNII:5E8K9I0O4U)
Available from:
Cardinal Health
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Ciprofloxacin tablets are indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the conditions and patient populations listed below. Ciprofloxacin tablets are 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. Ciprofloxacin tablets are indicated in adult patients for treatment of bone and joint infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa. Ciprofloxacin tablets are indicated in adult patients for treatment of complicated intra-abdominal infections (used in combination with metronidazole) caused by Escherichia coli, Pseudomonas aeruginosa, Proteus mirabilis, Klebsi
Product summary:
Ciprofloxacin Tablets USP, 500 mg are white, oval shaped, beveled edge film-coated tablets debossed with “R” on one side and “127” on other side and are supplied in bottles of 50, 100, 500 and unit dose packages of 10 x 10. Overbagged with 10 tablets per bag, NDC 55154-7283-0 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Authorization status:
Abbreviated New Drug Application
Authorization number:
55154-7283-0

CIPROFLOXACIN- ciprofloxacin tablet, film coated

Cardinal Health

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Medication Guide

Ciprofloxacin Tablets, USP for oral use

(sip'' roe flox' a sin)

Read this Medication Guide before you start taking ciprofloxacin tablets 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 tablets?

Ciprofloxacin tablet, a fluoroquinolone antibacterial medicine, can cause serious side effects. Some of these

serious side effects can happen at the same time and could result in death.

If you get any of the following serious side effects while you take ciprofloxacin tablets, you should stop

taking ciprofloxacin tablets immediately and get medical help right away.

1. Tendon rupture or swelling of the tendon (tendinitis).

Tendon problems can happen in people of all ages who take ciprofloxacin tablets. Tendons are tough cords

of tissue that connect muscles to bones. Symptoms of tendon problems may include:

Pain, swelling, tears and swelling of the tendons including the back of the ankle (Achilles), shoulder,

hand, or other tendon sites.

The risk of getting tendon problems while you take ciprofloxacin tablets 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 tablets.

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 tablets 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 tablets.

Tendon ruptures can happen within hours or days of taking ciprofloxacin tablets have happened up to

several months after people have finished taking their fluoroquinolone.

Stop taking ciprofloxacin tablets 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

2. 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 tablets. Stop

taking ciprofloxacin tablets immediately and talk to 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

numbness

weakness

Ciprofloxacin tablets 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 tablets. Tell your healthcare provider if you have a history of

seizures before you start taking ciprofloxacin tablets. CNS side effects may happen as soon as after taking the

first dose of ciprofloxacin tablets. Stop taking ciprofloxacin tablets immediately and 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 tablets may cause worsening of myasthenia gravis symptoms, including muscle weakness and

breathing problems. Tell your healthcare provider if you have a history of myasthenia gravis before you start

taking ciprofloxacin tablets. Call your healthcare provider right away if you have any worsening muscle

weakness or breathing problems.

What are ciprofloxacin tablets?

Ciprofloxacin tablets are a fluoroquinolone antibacterial medicine used in adults age 18 years and older to

treat certain infections caused by certain germs called bacteria. These bacterial infections 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 tablets 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 tablets should not be used in patients with acute exacerbation of chronic bronchitis, acute

uncomplicated cystitis, and sinus infections, if there are other treatment options available.

Ciprofloxacin tablets should not be used as the first choice of antibacterial medicine to treat lower

respiratory tract infections cause by a certain type of bacterial called Streptococcus pneumoniae.

Ciprofloxacin tablets are also used in children younger than 18 years of age to treat complicated urinary

tract and kidney infections or who may have breathed in anthrax germs, have plague or have been

exposed to plague germs.

Children younger than 18 years of age have a higher chance of getting bone, joint, or tendon

(musculoskeletal) problems such as pain or swelling while taking ciprofloxacin tablets. Ciprofloxacin

tablets should not be used as the first choice of antibacterial medicine in children under 18 years of age.

Who should not take ciprofloxacin tablets?

Do not take ciprofloxacin tablets if you:

Have ever had a severe allergic reaction to an antibacterial medicine known as a fluoroquinolone, or

are allergic to ciprofloxacin hydrochloride or any of the ingredients in ciprofloxacin tablets. See the end

of this Medication Guide for a complete list of ingredients in ciprofloxacin tablets.

Also take a medicine called tizanidine (Zanaflex®).

Ask your healthcare provider if you are not sure.

What should I tell my healthcare provider before taking ciprofloxacin tablets?

Before you take ciprofloxacin tablets, tell your healthcare provider if you:

have tendon problems; ciprofloxacin tablets should not be used in patients who have a history of tendon

problems

have a disease that causes muscle weakness (myasthenia gravis); ciprofloxacin tablets should not be

used in patients who have a known history of myasthenia gravis

have liver problems

have central nervous system problems (such as epilepsy)

have nerve problems; ciprofloxacin tablets should not be used in patients who have a history of a nerve

problem called peripheral neuropathy

have or anyone in your family has an irregular heartbeat, especially a condition called “QT

prolongation”

have or have had seizures

have kidney problems. You may need a lower dose of ciprofloxacin tablets if your kidneys do not work

well.

have joint problems including rheumatoid arthritis (RA)

have trouble swallowing pills

have any other medical conditions

are pregnant or plan to become pregnant. It is not known if ciprofloxacin tablets will harm your unborn

baby.

are breastfeeding or plan to breastfeed. Ciprofloxacin passes into breast milk. You and your healthcare

provider should decide whether you will take ciprofloxacin tablets or breastfeed. You should not do

both.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter

medicines, vitamins, and herbal supplements.

Ciprofloxacin tablets and other medicines can affect each other causing side effects.

Especially tell your healthcare provider if you take:

a steroid medicine

an anti-psychotic medicine

a tricyclic antidepressant

a water pill (diuretic)

theophylline (such as Theo-24®, Elixophyllin®, Theochron®, Uniphyl®, Theolair®)

a medicine to control your heart rate or rhythm (antiarrhythmics)

an oral anti-diabetes medicine

phenytoin (Fosphenytoin Sodium®, Cerebyx®, Dilantin-125®, Dilantin®, Extended Phenytoin

Sodium®, Prompt Phenytoin Sodium®, Phenytek®)

cyclosporine (Gengraf®, Neoral®, Sandimmune®, Sangcya®).

a blood thinner (such as warfarin, Coumadin®, Jantoven®)

methotrexate (Trexall®)

ropinirole (Requip®)

clozapine (Clozaril®, Fazaclo® ODT®)

a Non-Steroidal Anti-Inflammatory Drug (NSAID). Many common medicines for pain relief are

NSAIDs. Taking an NSAID while you take ciprofloxacin tablets or other fluoroquinolones may

increase your risk of central nervous system effects and seizures.

sildenafil (Viagra®, Revatio®)

duloxetine

products that contain caffeine

probenecid (Probalan®, Col-probenecid®)

Certain medicines may keep ciprofloxacin tablets from working correctly. Take ciprofloxacin tablets either

2 hours before or 6 hours after taking these medicines, vitamins, or supplements:

an antacid, multivitamin, or other medicine or supplements that has magnesium, calcium, aluminum,

iron, or zinc

sucralfate (Carafate®)

didanosine (Videx®, Videx EC®)

Ask your healthcare provider for a list of these medicines if you are not sure.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when

you get a new medicine.

How should I take ciprofloxacin tablets?

Take ciprofloxacin tablets exactly as your healthcare provider tells you to take them.

Your healthcare provider will tell you how much ciprofloxacin tablets to take and when to take it.

Take ciprofloxacin tablets in the morning and evening at about the same time each day. Swallow the

tablet whole. Do not split, crush or chew the tablet. Tell your healthcare provider if you cannot swallow

the tablet whole.

Ciprofloxacin tablets can be taken with or without food.

Ciprofloxacin tablets should not be taken with dairy products (like milk or yogurt) or calcium-fortified

juices alone, but may be taken with a meal that contains these products.

Drink plenty of fluids while taking ciprofloxacin tablets.

Do not skip any doses of ciprofloxacin tablets, or stop taking them, even if you begin to feel better,

until you finish your prescribed treatment unless:

you have tendon problems. See “What is the most important information I should know about

ciprofloxacin tablets?”

you have nerve problems. See “What is the most important information I should know about

ciprofloxacin tablets?”

you have central nervous system problems. See “What is the most important information I should know

about ciprofloxacin tablets?”

you have a serious allergic reaction. See “What are the possible side effects of ciprofloxacin tablets?”

your healthcare provider tells you to stop taking ciprofloxacin tablets

Taking all of your ciprofloxacin tablet doses will help make sure that all of the bacteria are killed. Taking all

of your ciprofloxacin tablet doses will help lower the chance that the bacteria will become resistant to

ciprofloxacin tablets. If you become resistant to ciprofloxacin tablets, ciprofloxacin tablets and other

antibacterial medicines may not work for you in the future.

If you take too much ciprofloxacin tablets, call your healthcare provider or get medical help right away.

What should I avoid while taking ciprofloxacin tablets?

Ciprofloxacin tablets can make you feel dizzy and lightheaded. Do not drive, operate machinery, or do

other activities that require mental alertness or coordination until you know how ciprofloxacin tablets

affects you.

Avoid sunlamps, tanning beds, and try to limit your time in the sun. Ciprofloxacin tablets can make

your skin sensitive to the sun (photosensitivity) and the light from sunlamps and tanning beds. You

could get a severe sunburn, blisters or swelling of your skin. If you get any of these symptoms while

you take ciprofloxacin tablets, call your healthcare provider right away. You should use a sunscreen

and wear a hat and clothes that cover your skin if you have to be in sunlight.

What are the possible side effects of ciprofloxacin tablets?

Ciprofloxacin tablets may cause serious side effects, including:

See “What is the most important information I should know about ciprofloxacin tablets?”

Serious allergic reactions. Serious allergic reactions, including death, can happen in people taking

fluoroquinolones, including ciprofloxacin tablets, even after only 1 dose. Stop taking ciprofloxacin

tablets and get emergency medical help right away if you get any of the following symptoms of a

severe allergic reaction:

hives

trouble breathing or swallowing

swelling of the lips, tongue, face

throat tightness, hoarseness

rapid heartbeat

faint

skin rash

Skin rash may happen in people taking ciprofloxacin tablets even after only 1 dose. Stop taking ciprofloxacin

tablets at the first sign of a skin rash and call your healthcare provider. Skin rash may be a sign of a more

serious reaction to ciprofloxacin tablets.

Liver damage (hepatotoxicity). Hepatotoxicity can happen in people who take ciprofloxacin tablets.

Call your healthcare provider right away if you have unexplained symptoms such as:

nausea or vomiting

stomach pain

fever

weakness

abdominal pain or tenderness

itching

unusual tiredness

loss of appetite

light colored bowel movements

dark colored urine

yellowing of your skin or the whites of your eyes

Stop taking ciprofloxacin tablets and tell your healthcare provider right away if you have yellowing of your

skin or white part of your eyes, or if you have dark urine. These can be signs of a serious reaction to

ciprofloxacin tablets (a liver problem).

Aortic aneurysm and dissection. Tell your healthcare provider if you have ever been told that you have

an aortic aneurysm, a swelling of the large artery that carries blood from the heart to the body. Get

emergency medical help right away if you have sudden chest, stomach, or back pain.

Intestine infection (Pseudomembranous colitis). Pseudomembranous colitis can happen with many

antibacterial medicines, including ciprofloxacin tablets. Call your healthcare provider right away if you

get watery diarrhea, diarrhea that does not go away, or bloody stools. You may have stomach cramps

and a fever. Pseudomembranous colitis can happen 2 or more months after you have finished your

antibacterial medicine.

Serious heart rhythm changes (QT prolongation and torsade de pointes). Tell your healthcare provider

right away if you have a change in your heart beat (a fast or irregular heartbeat), or if you faint.

Ciprofloxacin tablets may cause a rare heart problem known as prolongation of the QT interval. This

condition can cause an abnormal heartbeat and can be very dangerous. The chances of this event are

higher in people:

who are elderly

with a family history of prolonged QT interval

with low blood potassium (hypokalemia)

who take certain medicines to control heart rhythm (antiarrhythmics)

Joint Problems. Increased chance of problems with joints and tissues around joints in children under 18

years old can happen. Tell your child’s healthcare provider if your child has any joint problems during

or after treatment with ciprofloxacin tablets.

Sensitivity to sunlight (photosensitivity). See “What should I avoid while taking ciprofloxacin tablets?”

Changes in blood sugar

People who take ciprofloxacin and other fluoroquinolone medicines with oral anti-diabetes medicines or

with insulin can get low blood sugar (hypoglycemia) and high blood sugar (hyperglycemia). Follow your

healthcare provider's instructions for how often to check your blood sugar. If you have diabetes and you get

low blood sugar while taking ciprofloxacin tablets, stop taking ciprofloxacin tablets and call your healthcare

provider right away. Your antibiotic medicine may need to be changed.

The most common side effects of ciprofloxacin tablets include:

nausea

diarrhea

changes in liver function tests

vomiting

rash

Tell your healthcare provider about any side effect that bothers you, or that does not go away.

These are not all the possible side effects of ciprofloxacin tablets. For more information, ask your healthcare

provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-

1088.

How should I store ciprofloxacin tablets?

Ciprofloxacin Tablets

Store at 20° to 25°C (68° to 77°F).

Keep ciprofloxacin tablets and all medicines out of the reach of children.

General Information about the safe and effective use of ciprofloxacin tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use

ciprofloxacin tablets for a condition for which it is not prescribed. Do not give ciprofloxacin tablets to other

people, even if they have the same symptoms that you have. They may harm them.

This Medication Guide summarizes the most important information about ciprofloxacin tablets. If you would

like more information about ciprofloxacin tablets, talk with your healthcare provider. You can ask your

healthcare provider or pharmacist for information about ciprofloxacin tablets that is written for healthcare

professionals.

For more information call 1-888-375-3784.

What are the ingredients in ciprofloxacin tablets?

Ciprofloxacin Tablets:

Active ingredient: ciprofloxacin hydrochloride

Inactive ingredients: colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose,

polyethylene glycol 400, sodium starch glycolate, corn starch and titanium dioxide.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

The brands listed are the trademarks of their respective owners and are not trademarks of Dr.Reddy’s

Laboratories Limited.

Rx Only

Manufactured by:

Dr. Reddy’s Laboratories Limited

Bachupally – 500 090 INDIA

Distributed by:

Cardinal Health

Dublin, OH 43017

L54926320219

Revised: 0519

Dispense the Medication Guide available at:

www.drreddys.com/medguide/ciprofloxacintabs.pdf

Revised: 5/2020

Document Id: 56b9ff3d-10c4-4356-8a37-004789aa4b12

34391-3

Set id: 5793e376-7978-4473-81a6-e1a5f9a674b0

Version: 2

Effective Time: 20200520

CIPROFLOXACIN- ciprofloxacin tablet, film coated

Cardinal Health

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use CIPROFLOXACIN TABLETS safely and

effectively. See full prescribing information for CIPROFLOXACIN TABLETS.

CIPROFLOXACIN tablets, for oral use

Initial U.S. Approval: 1987

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:

o Tendinitis and tendon rupture (5.2)

o Peripheral neuropathy (5.3)

o 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(5.1)

Because fluoroquinolones, including ciprofloxacin, have been associated with serious adverse reactions

(5.1-5.16), reserve ciprofloxacin for use in patients who have no alternative treatment options for the

following indications:

o Acute exacerbation of chronic bronchitis (1.10)

o Acute uncomplicated cystitis (1.11)

o Acute sinusitis (1.12)

RECENT MAJOR CHANGES

Warnings and Precautions, Central Nervous System Effects (5.4) 10/2018

Warnings and Precautions, Risk of Aortic Aneurysm and Dissection (5.9) 5/2019

Warnings and Precautions, Blood Glucose Disturbances (5.19) 10/2018

INDICATIONS AND USAGE

Ciprofloxacin tablets are fluoroquinolone antibacterial indicated in adults (18 years of age and older) with the following

infections caused by designated, susceptible bacteria and in pediatric patients where indicated:

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of ciprofloxacin tablets and other

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)

antibacterial drugs, ciprofloxacin tablets should be used only to treat or prevent infections that are proven or strongly

suspected to be caused by bacteria. (1.13)

DOSAGE AND ADMINISTRATION

Adult Dosage Guidelines

Infe c tio n

Do se

Frequency

Duratio n

Skin and Skin Structure

500 to 750 mg

every 12 hours

7 to 14 days

Bone and Joint

500 to 750 mg

every 12 hours

4 to 8 weeks

Complicated Intra-

Abdominal

500 mg

every 12 hours

7 to 14 days

Infectious Diarrhea

500 mg

every 12 hours

5 to 7 days

Typhoid Fever

500 mg

every 12 hours

10 days

Uncomplicated Gonorrhea

250 mg

single dose

single dose

Inhalational anthrax (post-

e xposure )

500 mg

every 12 hours

60 days

Plague

500 to 750 mg

every 12 hours

14 days

Chronic Bacterial Prostatitis 500 mg

every 12 hours

28 days

Lower Respiratory Tract

500 to 750 mg

every 12 hours

7 to 14 days

Urinary Tract

250 to 500 mg

every 12 hours

7 to 14 days

Acute Uncomplicated

Cystitis

250 mg

every 12 hours

3 days

Acute Sinusitis

500 mg

every 12 hours

10 days

Adults with creatinine clearance 30 to 50 mL/min 250 to 500 mg q 12 h (2.3)

Adults with creatinine clearance 5 to 29 mL/min 250 to 500 mg q 18 h (2.3)

Patients on hemodialysis or peritoneal dialysis 250 to 500 mg q 24 h (after dialysis) (2.3)

Pediatric Oral Dosage

Guide line s

Infe c tio n

Do se

Frequency

Duratio n

Complicated UTI and

Pyelonephritis (1 to 17

years of age)

10 to 20 mg/kg

(maximum 750 mg per

dose )

Every 12 hours

10 to 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 8 to 12 hours

10 to 21 days

DOSAGE FORMS AND STRENGTHS

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

The most common adverse reactions ≥1% were nausea, diarrhea, liver function tests abnormal, vomiting, and rash. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy's Laboratories Inc., at 1-888-375-3784 or

FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Tablets: 100 mg, 250 mg, 500 mg and 750 mg (3)

Known hypersensitivity to ciprofloxacin or other quinolones (4.1, 5.6, 5.7)

Concomitant administration with tizanidine (4.2)

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. (5.11)

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.

(5.12, 7, 8.5)

DRUG INTERACTIONS

Interacting Drug

Interaction

The ophylline

Serious and fatal reactions. Avoid concomitant use. Monitor

serum level (7)

Warfarin

Anticoagulant effect enhanced. Monitor prothrombin time,

INR, and bleeding (7)

Antidiabetic agents

Hypoglycemia including fatal outcomes have been reported.

Monitor blood glucose (7)

Phe nytoin

Monitor phenytoin level (7)

Me thotre xate

Monitor for methotrexate toxicity (7)

Cyclosporine

May increase serum creatinine. Monitor serum creatinine (7)

Multivalent cation-containing products including antacids,

metal cations or didanosine

Decreased ciprofloxacin absorption. Take 2 hours before or 6

hours after ciprofloxacin (7)

USE IN SPECIFIC POPULATIONS

See full prescribing information for use in pediatric and geriatric patients (8.4, 8.5)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 5/2020

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON

RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS

AND EXACERBATION OF MYASTHENIA GRAVIS

1 INDICATIONS AND USAGE

1.1 Skin and Skin Structure Infections

1.2 Bone and Joint Infections

1.3 Complicated Intra-Abdominal Infections

1.4 Infectious Diarrhea

1.5 Typhoid Fever (Enteric Fever)

1.6 Uncomplicated Cervical and Urethral Gonorrhea

1.7 Inhalational Anthrax (Post-Exposure)

1.8 Plague

1.9 Chronic Bacterial Prostatitis

1.10 Lower Respiratory Tract Infections

1.11 Urinary Tract Infections

1.12 Acute Sinusitis

1.13 Usage

2 DOSAGE AND ADMINISTRATION

2.1 Dosage in Adults

2.2 Dosage in Pediatric Patients

2.3 Dosage Modifications in Patients with Renal Impairment

2.4 Important Administration Instructions

3 DOSAGE FORMS AND STRENGTHS

3.1 Tablets

4 CONTRAINDICATIONS

4.1 Hypersensitivity

4.2 Tizanidine

5 WARNINGS AND PRECAUTIONS

5.1 Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and

Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects

5.2 Tendinitis and Tendon Rupture

5.3 Peripheral Neuropathy

5.4 Central Nervous System Effects

5.5 Exacerbation of Myasthenia Gravis

5.6 Other Serious and Sometimes Fatal Reactions

5.7 Hypersensitivity Reactions

5.8 Hepatotoxicity

5.9 Risk of Aortic Aneurysm and Dissection

5.10 Serious Adverse Reactions with Concomitant Theophylline

5.11 Clostridium difficile-Associated Diarrhea

5.12 Prolongation of the QT Interval

5.13 Musculoskeletal Disorders in Pediatric Patients and Arthropathic Effects in Animals

5.14 Photosensitivity/Phototoxicity

5.15 Development of Drug Resistant Bacteria

5.16 Potential Risks With Concomitant Use of Drugs Metabolized by Cytochrome P450 1A2

Enzymes

5.17 Interference with Timely Diagnosis of Syphilis

5.18 Crystalluria

5.19 Blood Glucose Disturbances

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

6.3 Adverse Laboratory Changes

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Renal Impairment

8.7 Hepatic Impairment

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.3 Pharmacokinetics

12.4 Microbiology

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

13.2 Animal Toxicology and/or Pharmacology

14 CLINICAL STUDIES

14.1 Complicated Urinary Tract Infection and Pyelonephritis-Efficacy in Pediatric Patients

14.2 Inhalational Anthrax in Adults and Pediatrics

14.3 Plague

15 REFERENCES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

FULL PRESCRIBING INFORMATION

Sections or subsections omitted from the full prescribing information are not listed.

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:

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 (5.15.16)], reserve ciprofloxacin for use in

patients who have no alternative treatment options for the following indications:

1 INDICATIONS AND USAGE

Ciprofloxacin tablets are indicated for the treatment of infections caused by susceptible isolates of the

designated microorganisms in the conditions and patient populations listed below.

1.1 Skin and Skin Structure Infections

Ciprofloxacin tablets are 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.

1.2 Bone and Joint Infections

Ciprofloxacin tablets are indicated in adult patients for treatment of bone and joint infections caused by

Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa.

1.3 Complicated Intra-Abdominal Infections

Ciprofloxacin tablets are 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.

1.4 Infectious Diarrhea

Ciprofloxacin tablets are indicated in adult patients for treatment of infectious diarrhea caused by

Escherichia coli (enterotoxigenic isolates), Campylobacter jejuni, Shigella boydii

, Shigella dysenteriae,

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)]

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)]

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.

1.5 Typhoid Fever (Enteric Fever)

Ciprofloxacin tablets are 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.

1.6 Uncomplicated Cervical and Urethral Gonorrhea

Ciprofloxacin tablets are indicated in adult patients for treatment of uncomplicated cervical and urethral

gonorrhea due to Neisseria gonorrhoeae[see Warnings and Precautions (5.17)].

1.7 Inhalational Anthrax (Post-Exposure)

Ciprofloxacin tablets are 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.

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)].

1.8 Plague

Ciprofloxacin tablets are indicated for treatment of plague, including pneumonic and septicemic plague,

due to Yersinia pestis (Y. pestis) and prophylaxis for plague in adults and pediatric patients from birth to

17 years of age. Efficacy studies of ciprofloxacin could not be conducted in humans with plague for

feasibility reasons. Therefore this indication is based on an efficacy study conducted in animals only

[see Clinical Studies (14.3)].

1.9 Chronic Bacterial Prostatitis

Ciprofloxacin tablets are indicated in adult patients for treatment of chronic bacterial prostatitis caused

by Escherichia coli or Proteus mirabilis.

1.10 Lower Respiratory Tract Infections

Ciprofloxacin tablets are 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.

Ciprofloxacin tablets are not a drug of first choice in the treatment of presumed or confirmed

pneumonia secondary to Streptococcus pneumoniae.

Ciprofloxacin tablets are indicated for the treatment of acute exacerbations of chronic bronchitis

(AECB) caused by Moraxella catarrhalis.

Because fluoroquinolones, including ciprofloxacin tablets are, have been associated with serious

adverse reactions [see Warnings and Precautions (5.1 – 5.16)] and for some patients AECB is self-

limiting, reserve ciprofloxacin tablets are for treatment of AECB in patients who have no alternative

treatment options.

1.11 Urinary Tract Infections

Urinary Tract Infections in Adults

Ciprofloxacin tablets are 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.

Acute Uncomplicated Cystitis

Ciprofloxacin tablets are indicated in adult female patients for treatment of acute uncomplicated cystitis

caused by Escherichia coli or Staphylococcus saprophyticus. Because fluoroquinolones, including

ciprofloxacin tablets, have been associated with serious adverse reactions [seeWarnings and

Precautions (5.1- 5.16)] and for some patients acute uncomplicated cystitis is self-limiting, reserve

ciprofloxacin tablets for treatment of acute uncomplicated cystitis in patients who have no alternative

treatment options.

Complicated Urinary Tract Infection and Pyelonephritis in Pediatric Patients

Ciprofloxacin tablets are indicated in pediatric patients aged one to 17 years of age for treatment of

complicated urinary tract infections (cUTI) and pyelonephritis due to Escherichia coli[see Use in Specific

Populations(8.4)].

Although effective in clinical trials, ciprofloxacin tablets are not a drug of first choice in the pediatric

population due to an increased incidence of adverse reactions compared to controls, including reactions

related to joints and/or surrounding tissues. Ciprofloxacin, like other fluoroquinolones, is associated

with arthropathy and histopathological changes in weight-bearing joints of juvenile animals [see

Warnings and Precautions (5.13), Adverse Reactions(6.1), Use in Specific Populations(8.4) and Nonclinical

Toxicology(13.2)].

1.12 Acute Sinusitis

Ciprofloxacin tablets are indicated in adult patients for treatment of acute sinusitis caused by

Haemophilus influenzae, Streptococcus pneumoniae, or Moraxella catarrhalis.

Because fluoroquinolones, including ciprofloxacin tablets, have been associated with serious adverse

reactions [see Warnings and Precautions (5.1 -5.16)] and for some patients acute sinusitis is self-

limiting, reserve ciprofloxacin tablets are for treatment of acute sinusitis in patients who have no

alternative treatment options.

1.13 Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of ciprofloxacin

tablets are and other antibacterial drugs, ciprofloxacin tablets are should be used only to treat or prevent

infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and

susceptibility information are available, they should be considered in selecting or modifying

antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may

contribute to the empiric selection of therapy.

If anaerobic organisms are suspected of contributing to the infection, appropriate therapy should be

administered. Appropriate culture and susceptibility tests should be performed before treatment in order

to isolate and identify organisms causing infection and to determine their susceptibility to ciprofloxacin.

Therapy with ciprofloxacin tablets may be initiated before results of these tests are known; once results

become available appropriate therapy should be continued.

As with other drugs, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly

during treatment with ciprofloxacin. Culture and susceptibility testing performed periodically during

therapy will provide information not only on the therapeutic effect of the antimicrobial agent but also on

the possible emergence of bacterial resistance.

2 DOSAGE AND ADMINISTRATION

Ciprofloxacin tablets should be administered orally as described in the appropriate Dosage Guidelines

tables.

2.1 Dosage 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. Ciprofloxacin tablets

may be administered to adult patients when clinically indicated at the discretion of the physician.

Table 1: Adult Dosage Guidelines

InfectionTable 1:

Adult Dosage

Guidelines

Dos e

Frequency

Usual Durations

Skin and Skin

Structure

500 to 750 mg

every 12 hours

7 to 14 days

Bone and Joint

500 to 750 mg

every 12 hours

4 to 8 weeks

Complicated Intra–

Abdominal

500 mg

every 12 hours

7 to 14 days

Infectious Diarrhea

500 mg

every 12 hours

5 to 7 days

Typhoid Fever

500 mg

every 12 hours

10 days

Uncomplicated

Urethral and Cervical

Gonococcal

Infections

250 mg

single dose

single dose

Inhalational anthrax

(post-exposure)

500 mg

every 12 hours

60 days

Plague

500 to 750 mg

every 12 hours

14 days

Chronic Bacterial

Prostatitis

500 mg

every 12 hours

28 days

Lower Respiratory

Tract Infections

500 to 750 mg

every 12 hours

7 to 14 days

Urinary Tract

Infections

250 to 500 mg

every 12 hours

7 to 14 days

Acute Uncomplicated

Cystitis

250 mg

every 12 hours

3 days

Acute Sinusitis

500 mg

every 12 hours

10 days

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.

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

Conversion of IV to Oral Dosing in Adults

Patients whose therapy is started with ciprofloxacin IV may be switched to ciprofloxacin tablets 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

1

500 mg Tablet every 12 hours

400 mg intravenous every 12 hours

750 mg Tablet every 12 hours

400 mg intravenous every 8 hours

2.2 Dosage 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 tablets should be administered as described in Table 3.

Table 3: Pediatric Dosage Guidelines

The total duration of therapy for cUTI and pyelonephritis in the clinical trial was determined by the

physician. The mean duration of treatment was 11 days (range 10 to 21 days).

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

Begin drug administration as soon as possible after suspected or confirmed exposure to Y. pestis.

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 weighing

more than 51 kg)

Every 12 hours

10 to 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 8 to 12 hours

10 to 21 days

2.3 Dosage Modifications in Patients with Renal Impairment

Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and

partially cleared through the biliary system of the liver and through the intestine. These alternative

pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal

impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with

severe renal dysfunction. Dosage guidelines for use in patients with renal impairment are shown in

Table 4.

Table 4: Recommended Starting and Maintenance Doses for Adult Patients with Impaired Renal

Function

Creatinine Clearance (mL/min)

Dose

> 50

See Usual Dosage.

30 to 50

250 to 500 mg every12 hours

5 to 29

250 to 500 mg every 18 hours

Patients on hemodialysis or Peritoneal dialysis

250 to 500 mg every 24 hours (after dialysis)

When only the serum creatinine concentration is known, the following formulas may be used to estimate

creatinine clearance:

Men - Creatinine clearance (mL/min) = Weight (kg) x (140–age)

72 x serum creatinine (mg/dL)

Women - 0.85 x the value calculated for men.

The serum creatinine should represent a steady state of renal function.

In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be

administered at the intervals noted above. Patients should be carefully monitored.

1

Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of

cUTI and pyelonephritis. No information is available on dosing adjustments necessary for pediatric

patients with moderate to severe renal insufficiency (that is, creatinine clearance of < 50 mL/min/1.73

m ).

2.4 Important Administration Instructions

With Multivalent Cations

Administer ciprofloxacin tablets at least 2 hours before or 6 hours after magnesium/aluminum antacids;

polymeric phosphate binders (for example, sevelamer, lanthanum carbonate) or sucralfate; Videx

(didanosine) chewable/buffered tablets or pediatric powder for oral solution; other highly buffered

drugs; or other products containing calcium, iron or zinc.

With Dairy Products

Concomitant administration of ciprofloxacin tablets with dairy products (like milk or yogurt) or calcium-

fortified juices alone should be avoided since decreased absorption is possible; however,

ciprofloxacin tablets may be taken with a meal that contains these products.

Hydration of Patients Receiving Ciprofloxacin Tablets

Assure adequate hydration of patients receiving ciprofloxacin tablets to prevent the formation of highly

concentrated urine. Crystalluria has been reported with quinolones.

Instruct the patient of the appropriate ciprofloxacin tablets administration [see Patient Counseling

Information (17)].

3 DOSAGE FORMS AND STRENGTHS

3.1 Tablets

4 CONTRAINDICATIONS

4.1 Hypersensitivity

Ciprofloxacin is contraindicated in persons with a history of hypersensitivity to ciprofloxacin, any

member of the quinolone class of antibacterials, or any of the product components [see Warnings and

Precautions(5.7)]

4.2 Tizanidine

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

5 WARNINGS AND PRECAUTIONS

5.1 Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and

Ciprofloxacin Tablets USP, 100 mg are white, oval shaped film-coated tablets debossed with “R”

on one side and “125” on other side.

Ciprofloxacin Tablets USP, 250 mg are white, oval shaped film-coated tablets debossed with “R”

on one side and “126” on other side.

Ciprofloxacin Tablets USP, 500 mg are white, oval shaped, beveled edge film-coated tablets

debossed with “R” on one side and “127” on other side.

Ciprofloxacin Tablets USP, 750 mg are white, modified capsule shaped film-coated tablets

debossed with “R” on one side and “128” on other side.

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