CIPROFLOXACIN- ciprofloxacin hydrochloride 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:
PD-Rx Pharmaceuticals, Inc.
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
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. Ciprofloxacin is indicated in adult patients for treatment of bone and joint infections caused by Enterobacter cloacae, Serratia marcescens, or Pseudomonas aeruginosa. 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
Product summary:
Ciprofloxacin Tablets USP (white to off-white round tablets) containing 250 mg of Ciprofloxacin and engraved with Bottle of 6..........(NDC 72789-006-06) 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].
Authorization status:
Abbreviated New Drug Application
Authorization number:
72789-006-06

CIPROFLOXACIN- ciprofloxacin hydrochloride tablet, film coated

PD-Rx Pharmaceuticals, Inc.

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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 taking Ciprofloxacin. Call your healthcare provider right away if you have any worsening

muscle weakness or breathing problems.

What is Ciprofloxacin?

Ciprofloxacin is a fluoroquinolone antibacterial medicine used in adults age 18 years and older to treat

certain infections caused by certain germs called bacteria. These bacterial 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 while blood cell count and a fever

inhalational anthrax

plague

Studies of Ciprofloxacin for use in the treatment of plague and anthrax were done in animals only,

because plague and anthrax could not be studied in people.

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

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

Ciprofloxacin is 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. Ciprofloxacin should

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

Who should not take Ciprofloxacin?

Do not take Ciprofloxacin 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. See the end of

this Medication Guide for a complete list of ingredients in Ciprofloxacin.

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?

Before you take Ciprofloxacin, tell your healthcare provider if you:

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

problems

have a disease that causes muscle weakness (myasthenia gravis); Ciprofloxacin should not be used in

patients who have a history of myasthenia gravis

have liver problems

have central nervous system problems (such as epilepsy)

have nerve problems; Ciprofloxacin 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 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 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 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 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 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?

Take Ciprofloxacin exactly as your healthcare provider tells you to take it.

Your healthcare provider will tell you how much Ciprofloxacin 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 can be taken with or without food.

Ciprofloxacin 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.

Do not skip any doses of Ciprofloxacin, or stop taking it, 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?”

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

Ciprofloxacin?”

you have central nervous system problems. See "What is the most important information I

should know about Ciprofloxacin?"

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

Ciprofloxacin?”

your healthcare provider tells you to stop taking Ciprofloxacin

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

your Ciprofloxacin doses will help lower the chance that the bacteria will become resistant to Ciprofloxacin.

If you become resistant to Ciprofloxacin, Ciprofloxacin and other antibacterial medicines may not work for

you in the future.

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

What should I avoid while taking Ciprofloxacin?

Ciprofloxacin 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 affects you.

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

Ciprofloxacin may cause serious side effects, including:

See, “What is the most important information I should know about Ciprofloxacin?”

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

fluoroquinolones, including Ciprofloxacin even after only 1 dose. Stop taking Ciprofloxacin 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

rabid heartbeat

faint

skin rash

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

Liver damage (hepatotoxicity).Hepatotoxicity can happen in people who take Ciprofloxacin. 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 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 (a

liver problem).

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

antibacterial medicines, including Ciprofloxacin. 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 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.

Sensitivity to sunlight (photosensitivity). See “What should I avoid while taking

Ciprofloxacin?”

The most common side effects of Ciprofloxacin 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. 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?

Ciprofloxacin Tablets

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).

Keep Ciprofloxacin and all medicines out of the reach of children.

General Information about the safe and effective use of Ciprofloxacin.

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

Ciprofloxacin for a condition for which it is not prescribed. Do not give Ciprofloxacin to other people, even

if they have the same symptoms that you have. It may harm them.

This medication Guide summarizes the most important information about Ciprofloxacin. If you would like

more information about Ciprofloxacin, talk with your healthcare provider. You can ask your healthcare

provider or pharmacist for information about Ciprofloxacin that is written for healthcare professionals.

For more information call 1-855-397-9777.

What are the ingredients in Ciprofloxacin?

Ciprofloxacin Tablets:

Active ingredient: Ciprofloxacin Hydrochloride

Inactive ingredients: Lactose Monohydrate, Magnesium Stearate, Starch 1500 (Modified Corn

Starch), and Sodium Starch Glycolate.

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

Trademarks are the property of their respective owners.

Rx Only

Manufactured and Distributed by:

Carlsbad Tech

5928 Farnsworth Court

Carlsbad, CA 92008

CTI-6 MG Rev G 07/16

Revised: 9/2020

Document Id: ae6c8fa2-cb3d-76cc-e053-2995a90ac968

34391-3

Set id: 5cd6c4bc-a5dd-4fe6-891d-ec2989b39d8a

Version: 12

Effective Time: 20200903

PD-Rx Pharmaceuticals, Inc.

CIPROFLOXACIN- ciprofloxacin hydrochloride tablet, film coated

PD-Rx Pharmaceuticals, Inc.

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use CIPROFLOXACIN Tablets, USP safely and

effectively. See full prescribing information for CIPROFLOXACIN Tablets, USP.

CIPROFLOXACIN Tablets, USP (ciprofloxacin hydrochloride) tablet 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:

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)

RECENT MAJOR CHANGES

Boxed Warning

07/2016

Indications and Usage ( 1.10, 1.11, 1.12)

07/2016

Dosage and Administration, Dosage in Adults ( 2.1)

07/2016

Warnings and Precautions ( 5.1)

07/2016

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)

DOSAGE AND ADMINISTRATION

Adult Dosage Guidelines

Infe c tio n

Do se

Frequency

Duratio n

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

Infe c tio n

Do se

Frequency

Duratio n

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

DOSAGE FORMS AND STRENGTHS

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

CONTRAINDICATIONS

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

Concomitant administration with tizanidine ( 4.2)

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)

ADVERSE REACTIONS

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.

DRUG INTERACTIONS

Interacting Drug

Inte rac tio n

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: 9/2017

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 Adverse Reactions

5.7 Hypersensitivity Reactions

5.8 Hepatotoxicity

5.9 Serious Adverse Reactions with Concomitant Theophylline

5.10 Clostridium difficile-Associated Diarrhea

5.11 Prolongation of the QT Interval

5.12 Musculoskeletal Disorders in Pediatric Patients and Arthropathic Effects in Animals

5.13 Photosensitivity/Phototoxicity

5.14 Development of Drug Resistant Bacteria

5.15 Potential Risks with Concomitant Use of Drugs Metabolized by Cytochrome P450 1A2

Enzymes

5.16 Interference with Timely Diagnosis of Syphilis

5.17 Crystalluria

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

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)]

1 INDICATIONS AND USAGE

1.1 Skin 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.

1.2 Bone 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.

1.3 Complicated 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.

1.4 Infectious Diarrhea

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

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.

1.5 Typhoid 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.

1.6 Uncomplicated 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)].

1.7 Inhalational 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.

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 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 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 is indicated in adult patients for treatment of chronic bacterial prostatitis caused by

Escherichia coli or Proteus mirabilis.

1.10 Lower Respiratory Tract Infections

Ciprofloxacin is indicated in adult patients for treatment of lower respiratory tract infections caused by

Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Proteus mirabilis, Pseudomonas

aeruginosa, Haemophilus influenzae, Haemophilus parainfluenzae, or Streptococcus pneumoniae.

Ciprofloxacin is not a drug of first choice in the treatment of presumed or confirmed pneumonia

secondary to Streptococcus pneumoniae.

Ciprofloxacin is indicated for the treatment of acute exacerbations of chronic bronchitis (AECB)

caused by Moraxella catarrhalis.

Because fluoroquinolones, including Ciprofloxacin, have been associated with serious adverse

reactions [see Warnings and Precautions (5.1– 5.15)] and for some patients AECB is self-limiting,

reserve Ciprofloxacin for treatment of AECB in patients who have no alternative treatment options.

1.11 Urinary Tract Infections

Urinary Tract Infections in Adults

Ciprofloxacin is indicated in adult patients for treatment of urinary tract infections caused by Escherichia

coli, Klebsiella pneumoniae, Enterobacter cloacae, Serratia marcescens, Proteus mirabilis, Providencia

rettgeri, Morganella morganii, Citrobacter koseri, Citrobacter freundii, Pseudomonas aeruginosa,

methicillin-susceptible Staphylococcus epidermidis, Staphylococcus saprophyticus, or Enterococcus

faecalis.

Acute Uncomplicated Cystitis

Ciprofloxacin is indicated in adult female patients for treatment of acute uncomplicated cystitis caused

by Escherichia coli or Staphylococcus saprophyticus.

Because fluoroquinolones, including Ciprofloxacin, have been associated with serious adverse

reactions [see Warnings and Precautions (5.1- 5.15)] and for some patients acute uncomplicated cystitis

is self-limiting, reserve Ciprofloxacin for treatment of acute uncomplicated cystitis in patients who

have no alternative treatment options.

Complicated Urinary Tract Infection and Pyelonephritis in Pediatric Patients

Ciprofloxacin is 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 is 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 (5.12), Adverse Reactions (6.1), Use in Specific Populations (8.4) and Nonclinical

Toxicology (13.2)].

1.12 Acute Sinusitis

Ciprofloxacin is indicated in adult patients for treatment of acute sinusitis caused by or Ciprofloxacin is

indicated in adult patients for treatment of acute sinusitis caused by Haemophilus influenzae,

Streptococcus pneumoniae, or Moraxella catarrhalis.

Because fluoroquinolones, including Ciprofloxacin, have been associated with serious adverse

reactions and for some patients acute sinusitis is self-limiting, reserve Ciprofloxacin for treatment of

acute sinusitis in patients who have no alternative treatment options. Because fluoroquinolones,

including Ciprofloxacin, have been associated with serious adverse reactions [see Warnings and

Precautions (5.1- 5.15)] and for some patients acute sinusitis is self-limiting, reserve Ciprofloxacin 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

and other antibacterial drugs, Ciprofloxacin 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 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. 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

Dos e

Frequency

Usual Durations

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 Urethral and

Cervical Gonococcal Infections

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 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

1

2

3

3

Ciprofloxacin Oral Dosage

Equivalent Ciprofloxacin IV Dosage

250 mg Tablet every 12 hours

200 mg intravenous every 12 hours

500 mg Tablet every 12 hours

400 mg intravenous every 12 hours

750 mg Tablet every 12 hours

400 mg intravenous every 8 hours

2.2 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 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

Dos e

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

10–21 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

10–21 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)

Dos e

> 50

See Usual Dosage.

30–50

250–500 mg every12 hours

5–29

250–500 mg every 18 hours

Patients on hemodialysis or Peritoneal dialysis

250–500 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

1

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

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/1.73m

2.4 Important Administration Instructions

With Multivalent Cations

Administer Ciprofloxacin 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 with dairy products (like milk or yogurt) or calcium-

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

Ciprofloxacin may be taken with a meal that contains these products.

Hydration of Patients Receiving Ciprofloxacin

Assure adequate hydration of patients receiving Ciprofloxacin to prevent the formation of highly

concentrated urine. Crystalluria has been reported with quinolones.

Instruct the patient of the appropriate Ciprofloxacin administration [see Patient Counseling Information (

17)].

3 DOSAGE FORMS AND STRENGTHS

3.1 Tablets

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"

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

Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects

Fluoroquinolones, including Ciprofloxacin, have been associated with disabling and potentially

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