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Gatifloxacin

Class: Quinolones
VA Class: AM900
Chemical Name: (±-1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(3-methyl-1-piperazinyl)-4-oxo-3-quinoline- carboxylic acid sesquihydrate
Molecular Formula: C19H22FN3O4
CAS Number: 112811-59-3
Brands: Tequin

Introduction

Antibacterial; 8-methoxy fluoroquinolone.1 2

Uses for Gatifloxacin

Respiratory Tract Infections

Acute bacterial sinusitis caused by Streptococcus pneumoniae or Haemophilus influenzae.1 8 12

Acute bacterial exacerbations of chronic bronchitis caused by susceptible S. pneumoniae, H. influenzae, H. parainfluenzae, Moraxella catarrhalis, or Staphylococcus aureus (oxacillin-susceptible [methicillin-susceptible] strains).1 8 11 b

Community-acquired pneumonia (CAP) caused by susceptible S. pneumoniae (including multidrug-resistant strains), H. influenzae, H. parainfluenzae, M. catarrhalis, S. aureus, Mycoplasma pneumoniae, Chlamydophila pneumoniae (formerly Chlamydia pneumoniae), or Legionella pneumophila.1 8 13 14 15 b

Slideshow: 10 Things to Know About Antibiotic Resistance

Skin and Skin Structure Infections

Uncomplicated skin and skin structure infections (i.e., simple abscesses, furuncles, folliculitis, wound infections, cellulitis) caused by susceptible S. aureus (oxacillin-susceptible [methicillin-susceptible] strains) or S. pyogenes (group A β-hemolytic streptococci).1 b

Urinary Tract Infections (UTIs)

Uncomplicated UTIs caused by susceptible Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis.1

Complicated UTIs caused by susceptible E. coli, K. pneumoniae, or P. mirabilis.1

Pyelonephritis caused by susceptible E. coli.1 8

Endocarditis

Alternative for treatment of native or prosthetic valve endocarditis caused by fastidious gram-negative bacilli known as the HACEK group (Actinobacillus actinomycetemcomitans, Cardiobacterium hominis, Eikenella corrodens, Haemophilus aphrophilus, H. influenzae, H. parainfluenzae, H. paraphrophilus, Kingella denitrificans, K. kingae).c AHA and IDSA recommend ceftriaxone or ampicillin-sulbactam as drugs of choice,c but a fluoroquinolone (ciprofloxacin, gatifloxacin, levofloxacin, moxifloxacin) may be considered when β-lactam anti-infectives cannot be used.c Consultation with an infectious disease specialist is recommended.c

Gonorrhea

Uncomplicated urethritis and cervicitis caused by susceptible Neisseria gonorrhoeae.1

Acute, uncomplicated rectal infections caused by susceptible N. gonorrhoeae in women.1

Should not be used for treatment of gonococcal infections acquired in Asia or Pacific islands (including Hawaii); use may be inadvisable in other areas where N. gonorrhoeae with quinolone resistance has been reported (including California).18 20

Anthrax

Alternative for postexposure prophylaxis following suspected or confirmed exposure to aerosolized anthrax spores (inhalational anthrax) when oral ciprofloxacin and oral doxycycline are unavailable.21

Alternative for treatment of inhalational anthrax when a parenteral regimen is unavailable (e.g., supply or logistic problems because large numbers of individuals require treatment in a mass casualty setting).21

Mycobacterial Infections

Alternative for use in multiple-drug regimens for treatment of active tuberculosis in patients with relapse, treatment failure, or Mycobacterium tuberculosis resistant to isoniazid and/or rifampin or when first-line drugs cannot be tolerated.28

Gatifloxacin Dosage and Administration

Administration

Administer orally or by slow IV infusion; not for IM, rapid IV, intrathecal, intraperitoneal, or sub-Q use.1

No dosage adjustment needed when switching from IV to oral administration, or vice versa.1

Administer once daily every 24 hours.1

Oral Administration

Administer tablets without regard to meals, including milk or dietary supplements containing calcium.1 (See Interactions: Specific Drugs.)

IV Administration

Gatifloxacin injection concentrate must be diluted prior to administration.1 (See Solution Compatibility under Stability.)

No further dilution necessary for gatifloxacin premixed injection.1

Manufacturer states that additives or other drugs should not be added to gatifloxacin solutions or infused simultaneously through the same IV line1 .

Dilution

Dilute gatifloxacin injection concentrate to concentration of 2 mg/mL with a compatible IV solution before administration (see Solution Compatibility under Stability).1 Do not use water for injection as a diluent;1 a hypotonic solution results.1

Use strict aseptic technique since drug product contains no preservative.1

Rate of Administration

Administer by IV infusion over 1 hour.1

Dosage

Adults

Respiratory Tract Infections
Oral or IV

400 mg once daily.1 Usual duration is 5 days for acute bacterial exacerbation of chronic bronchitis, 10 days for acute sinusitis, and 7–14 days for CAP.1

Skin and Skin Structure Infections
Oral or IV

400 mg once daily for 7–10 days.1

UTIs
Oral or IV

400 mg as a single dose or 200 mg once daily for 3 days in patients with uncomplicated UTIs; 400 mg once daily for 7–10 days in those with complicated UTIs or pyelonephritis.1

Gonorrhea
Oral or IV

400 mg as a single dose in men with uncomplicated urethral gonorrhea or in women with endocervical or rectal gonorrhea.1

Anthrax
Oral

400 mg once daily for ≥60 days for postexposure prophylaxis or treatment of inhalational anthrax.21 22 23

Mycobacterial Infections
Active Tuberculosis
Oral

400 mg once daily.28 Must be used in conjunction with other antituberculosis agents.28

Multiple-drug regimen usually given for 12–18 months when rifampin-resistant M. tuberculosis are involved; for 18–24 months when isoniazid- and rifampin-resistant strains are involved; or for 24 months when the strain is resistant to isoniazid, rifampin, ethambutol, and/or pyrazinamide.28

Special Populations

Hepatic Impairment

Dosage adjustment not necessary in patients with moderate (Child-Pugh class B) cirrhosis.1

Not studied to date in patients with severe (Child-Pugh class C) impairment;1 manufacturer makes no recommendations regarding dosage in such patients.16

Renal Impairment

Adjust dosage in patients with Clcr <40 mL/minute, including those who require hemodialysis or CAPD: initial dose of 400 mg, followed by 200 mg daily beginning on day 2 of therapy.1 Administer dose in hemodialysis patients after dialysis session.1

Dosage adjustment not required for single-dose regimen (for uncomplicated UTIs or gonorrhea) or 3-day regimen (for uncomplicated UTIs).1

Renal impairment increases risk of dysglycemia.b (See Hypoglycemia and Hyperglycemia under Cautions.)

Geriatric Patients

Select dosage with caution and closely monitor renal function because of age-related decreases in renal function.b (See Renal Impairment under Dosage and Administration.)

Cautions for Gatifloxacin

Contraindications

  • Known hypersensitivity to gatifloxacin, other quinolones, or any ingredient in the formulation.1

  • Diabetes mellitus.b

Warnings/Precautions

Warnings

Hypoglycemia and Hyperglycemia

Symptomatic hypoglycemia or hyperglycemia reported.1 Usually have occurred in patients with diabetes, but blood glucose disturbances (especially hyperglycemia) have occurred in patients without a history of diabetes.1

Serious (sometimes fatal) disturbances of glucose homeostasis (e.g., hyperosmolar nonketotic hyperglycemic coma, diabetic ketoacidosis, hypoglycemic coma, seizures, loss of consciousness) reported rarely during postmarketing surveillance.b

In addition to diabetes, risk factors for dysglycemia during gatifloxacin therapy include advanced age, renal insufficiency, and concurrent use of glucose-altering medication (especially oral hypoglycemic agents).b

Closely monitor blood glucose concentrations in patients with risk factors for developing dysglycemia.1 If signs and symptoms of hypoglycemia or hyperglycemia occur, discontinue gatifloxacin and immediately initiate appropriate therapy.1

Musculoskeletal Effects

Arthropathy and chondrodysplasia in weight-bearing joints of in immature animals reported with fluoroquinolones, including gatifloxacin.1 b Permanent lesions in cartilage reported in immature dogs; clinical relevance to humans unknown.1 Safety and efficacy not established in children and adolescents <18 years of age or in pregnant or lactating women.1

Rupture of the shoulder, hand, Achilles, or other tendons that required surgical repair or resulted in prolonged disability reported in patients receiving fluoroquinolones, including gatifloxacin.b Tendon rupture can occur during or after treatment; tendinitis or tendon rupture may occur more frequently in those receiving corticosteroids, especially geriatric patients.b

Discontinue gatifloxacin if pain, inflammation, or tendon rupture occurs.b Patient should rest and refrain from exercise until the diagnosis of tendinitis or tendon rupture excluded.b

Prolongation of QT Interval

Prolonged QT interval leading to ventricular arrhythmias, including torsades de pointes, reported with some fluoroquinolones, including gatifloxacin.1

QT interval prolongation is dose related; do not exceed recommended dosage or infusion rate.b

Increased torsades de pointes risk with advanced age (>60 years of age), female gender, underlying cardiac disease, and/or concurrent use of multiple medications.b

Avoid use in patients with prolonged QTc interval or uncorrected hypokalemia. Also avoid use in those receiving class IA (e.g., quinidine, procainamide) or class III (e.g., amiodarone, sotalol) antiarrhythmic agents.b Use with caution in patients receiving drugs that prolong QT interval (e.g., cisapride,17 erythromycin, antipsychotic agents, tricyclic antidepressants) and in patients with ongoing proarrhythmic conditions, such as clinically important bradycardia or acute myocardial ischemia.1

CNS Effects

Seizures, increased intracranial pressure, and psychoses reported with fluoroquinolones, including gatifloxacin.1 CNS stimulation leading to tremors, restlessness, lightheadedness, confusion, hallucinations, paranoia, depression, nightmares, insomnia, nervousness, agitation, or anxiety also reported.1

Use with caution in patients with known or suspected CNS disorders (e.g., severe cerebral arteriosclerosis, epilepsy) or other risk factors predisposing to seizures.1

If CNS effects occur, discontinue gatifloxacin and institute appropriate measures.1

Peripheral Neuropathy

Sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias, and weakness reported with fluoroquinolones.b

Discontinue gatifloxacin if symptoms of neuropathy (e.g., pain, burning, tingling, numbness, and/or weakness) occur.b

Superinfection/Clostridium difficile-associated Colitis

Possible emergence and overgrowth of nonsusceptible bacteria or fungi.1

Consider Clostridium difficile-associated diarrhea and colitis (antibiotic-associated pseudomembranous colitis) if diarrhea develops and manage accordingly.1

Sensitivity Reactions

Hypersensitivity Reactions

Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions reported in patients receiving fluoroquinolones.1 These reactions may occur with first dose.1

Some hypersensitivity reactions have been accompanied by cardiovascular collapse, hypotension or shock, seizures, loss of consciousness, tingling, angioedema (e.g., edema or swelling of the tongue, larynx, throat, or face), airway obstruction (e.g., bronchospasm, shortness of breath, acute respiratory distress), urticaria, pruritus, and other severe skin reactions.1

In addition, other possible severe and potentially fatal reactions (may be hypersensitivity reactions or of unknown etiology) have been reported most frequently after multiple doses.1 These include fever, rash or other severe dermatologic reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome), vasculitis, arthralgia, myalgia, serum sickness, allergic pneumonitis, interstitial nephritis, acute renal insufficiency or failure, hepatitis, jaundice, acute hepatic necrosis or failure, anemia (including hemolytic and aplastic), thrombocytopenia (including thrombotic thrombocytopenic purpura), leukopenia, agranulocytosis, pancytopenia, and/or other hematologic effects.1

Discontinue gatifloxacin at first appearance of rash or any other sign of hypersensitivity.1 Institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, and maintenance of an adequate airway and oxygen).1

Photosensitivity Reactions

Phototoxicity reported with some other quinolones.1 Potential for photosensitivity reaction may be lower with gatifloxacin than with some other fluoroquinolones (e.g., ciprofloxacin, levofloxacin).1

Avoid excessive sunlight or artificial UV light (e.g., tanning beds).1

General Precautions

Selection and Use of Anti-infectives

To reduce development of drug-resistant bacteria and maintain effectiveness of gatifloxacin and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.b

When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.b In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.b

Specific Populations

Pregnancy

Category C.1

Lactation

Distributed into milk in rats.1 Use with caution.1 16

Pediatric Use

Safety and efficacy not established in children <18 years of age.1

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.1

Patients ≥65 years of age with unrecognized diabetes, age-related decreases in renal function, underlying medical problems, or receiving concomitant therapy associated with alterations of blood glucose concentration may be at particular risk for serious dysglycemia.a (See Hypoglycemia and Hyperglycemia under Cautions.)

Age-related decline in renal function may increase risk of adverse reactions.1

Hepatic Impairment

Effects of severe hepatic impairment on gatifloxacin pharmacokinetics not determined.1 Use with caution.1

Renal Impairment

Decreased clearance.1 Dosage adjustment recommended.1 (See Renal Impairment under Dosage and Administration.)

Renal impairment increases risk of dysglycemia.b (See Hypoglycemia and Hyperglycemia under Cautions.)

Common Adverse Effects

Nausea, vaginitis, redness at injection site, diarrhea, headache, dizziness.1

Interactions for Gatifloxacin

Does not inhibit CYP isoenzymes 3A4, 2D6, 2C9, 2C19, or 1A2 in vitro and is not an enzyme inducer.1 Pharmacokinetic interactions with drugs metabolized by CYP isoenzymes unlikely.1

Drugs Affecting Glucose Metabolism

Potential pharmacologic interaction (possible additive hypoglycemic or hyperglycemic effect); monitor blood glucose.a (See Hypoglycemia and Hyperglycemia under Cautions.)

Drugs That Prolong QT Interval

Potential pharmacologic interaction (additive effect on QT interval prolongation).1 (See Prolongation of QT Interval under Cautions.)

Specific Drugs

Drug

Interaction

Comments

Antacids (aluminum- or magnesium-containing)

Decreased absorption of gatifloxacin1

Administer gatifloxacin at least 4 hours before such antacids1

Antacids (calcium-containing); calcium supplements, milk

No clinically important pharmacokinetic interactions 1

Antidiabetic agents (e.g., glyburide)

Hypoglycemia and hyperglycemia reportedb

Glyburide: Pharmacokinetic interaction unlikely1

Closely monitor blood glucose; discontinue gatifloxacin and initiate appropriate therapy if hypoglycemia or hyperglycemia occurs1

Didanosine

Decreased absorption of gatifloxacin with buffered didanosine preparations1 16

Administer gatifloxacin at least 4 hours before buffered didanosine preparations1 16

Digoxin

Potential increase in serum digoxin concentration and toxicity1

Monitor for digoxin toxicity; determine serum digoxin concentrations and adjust digoxin dosage as appropriate1

Iron preparations

Decreased absorption of gatifloxacin1

Administer gatifloxacin at least 4 hours before ferrous sulfate and dietary supplements containing iron1

Multivitamins and mineral supplements

Decreased absorption of gatifloxacin1

Administer gatifloxacin at least 4 hours before supplements containing zinc, magnesium, or iron1

NSAIAs

Possible increased risk of CNS stimulation, seizures1

Omeprazole

Pharmacokinetic interaction unlikelyb

Probenecid

Increased systemic exposure to gatifloxacin1

Sucralfate

Potential pharmacokinetic interaction16

Warfarin

Potential for enhanced warfarin effect1 16

Careful monitoring recommended1

Gatifloxacin Pharmacokinetics

Absorption

Bioavailability

Well absorbed from the GI tract following oral administration.1 40 Absolute bioavailability is 96%.1 37 41 When administered orally in fasting individuals, peak plasma concentrations usually occur 1–2 hours following a dose.1 b

Pharmacokinetics are similar after oral or IV (1-hour infusion) administration.1 41

Food

Administration with food does not affect peak plasma concentration or extent or rate of absorption.39

Distribution

Extent

Rapidly and widely distributed into most body tissues and fluids.1 37 38 41

Distributed into milk in rats; not known whether distributed into milk in humans.1

Plasma Protein Binding

Approximately 20%.1 41

Elimination

Metabolism

Undergoes limited biotransformation.1

Elimination Route

Excreted principally in urine as unchanged drug;1 37 38 41 <1% of a dose is excreted in urine as metabolites,1 and 5% is recovered in feces as unchanged drug.1 40

Half-life

7–14 hours.1 37 40

Special Populations

In patients with moderate to severe renal insufficiency, clearance is decreased and systemic exposure is increased.1

Stability

Storage

Oral

Tablets

Tightly sealed containers at 25°C (may be exposed to 15–30°C).1

Parenteral

Injection Concentrate for IV infusion

25°C (may be exposed to 15–30°C).1

Following dilution to concentration of 2 mg/mL with compatible IV fluid, solution is stable for 14 days at room temperature (20–25°C) or under refrigeration (2–8°C).1

Following dilution to concentration of 2 mg/mL with compatible IV fluid (except 5% sodium bicarbonate injection), solution may be stored for up to 6 months at -25 to -10°C.1 Thaw at controlled room temperature;1 stable for 14 days at room temperature or under refrigeration after thawing.1 Do not refreeze.1

Premixed Injection for IV infusion

25°C (may be exposed to 15–30°C);1 do not freeze.1

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility

For dilution of gatifloxacin injection concentrate:

Compatible1 g

Dextrose 5% in Ringer’s injection, lactated

Dextrose 5% in sodium chloride 0.45% with potassium chloride 20 mEq/L

Dextrose 5% in sodium chloride 0.9%

Dextrose 5% in water

Plasma-Lyte 56 and dextrose 5%

Sodium bicarbonate 5%

Lactated Ringer’s and dextrose 5%

Sodium bicarbonate 5%

Sodium chloride 0.9%

Sodium lactate (1/6)M

Drug Compatibility
Y-Site Compatibilityg

Compatible

Acyclovir sodium

Alfentanil HCl

Amikacin sulfate

Aminophylline

Ampicillin sodium

Ampicillin sodium-sulbactam sodium

Aztreonam

Bretylium tosylate

Buprenorphine HCl

Butorphanol tartrate

Calcium chloride

Calcium gluconate

Carboplatin

Cefazolin sodium

Cefotetan disodium

Ceftazidime

Ceftizoxime sodium

Ceftriaxone sodium

Chlorpromazine HCl

Cimetidine HCl

Cisplatin

Clindamycin phosphate

Co-trimoxazole

Cyclophosphamide

Cyclosporine

Cytarabine

Dexamethasone sodium phosphate

Dexmedetomidine HCl

Digoxin

Diphenhydramine HCl

Dobutamine HCl

Dopamine HCl

Doxorubicin HCl

Droperidol

Enalaprilat

Esmolol HCl

Etoposide phosphate

Famotidine

Fenoldopam mesylate

Fentanyl citrate

Fluconazole

Fluorouracil

Ganciclovir sodium

Gemcitabine HCl

Gentamicin sulfate

Granisetron HCl

Haloperidol lactate

Hydrocortisone sodium succinate

Hydromorphone HCl

Hydroxyzine HCl

Ifosfamide

Imipenem-cilastatin sodium

Labetalol HCl

Leucovorin calcium

Lidocaine HCl

Lorazepam

Magnesium sulfate

Mannitol

Meperidine HCl

Mesna

Methotrexate sodium

Methylprednisolone sodium succinate

Metoclopramide HCl

Metronidazole

Midazolam HCl

Mitoxantrone HCl

Morphine sulfate

Nalbuphine HCl

Naloxone HCl

Nicardipine HCl

Nitroglycerin

Ondansetron HCl

Paclitaxel

Pentamidine isethionate

Pentobarbital sodium

Phenobarbital sodium

Potassium chloride

Prochlorperazine edisylate

Promethazine HCl

Propranolol HCl

Ranitidine HCl

Remifentanil HCl

Sodium bicarbonate

Sodium phosphates

Sufentanil citrate

Theophylline

Ticarcillin disodium

Ticarcillin disodium-clavulanate potassium

Tobramycin sulfate

Trimethoprim-sulfamethoxazole

Vecuronium bromide

Verapamil HCl

Vinblastine sulfate

Vincristine sulfate

Vinorelbine tartrate

Zidovudine

Incompatible

Amphotericin B

Amphotericin B cholesteryl sulfate complex

Cefoperazone sodium

Cefoxitin sodium

Diazepam

Furosemide

Heparin sodium

Phenytoin sodium

Piperacillin sodium-tazobactam sodium

Potassium phosphates

Vancomycin HCl

Actions

  • Like other fluoroquinolone antibacterials, gatifloxacin inhibits bacterial DNA gyrase and topoisomerase IV.1 2 29

  • Spectrum of activity includes gram-positive aerobic bacteria, some gram-negative bacteria, a few anaerobic bacteria, and some other organisms (e.g., Mycobacterium, Chlamydia, Mycoplasma).1

  • More active in vitro than ciprofloxacin or levofloxacin against Streptococcus pneumoniae (including penicillin-resistant strains) and anaerobic bacteria (i.e., Clostridium and Bacteroides),3 6 7 while retaining in vitro activity of ciprofloxacin and levofloxacin against gram-negative organisms3 6 and etiologic agents of atypical pneumonia (e.g., C. pneumoniae, M. pneumoniae, Legionella).3

  • Gram-positive aerobes: Active in vitro and in clinical infections against S. aureus (oxacillin-susceptible [methicillin-susceptible] strains only),1 b S. pneumoniae (including multidrug-resistant strains),1 b and S. pyogenes (group A β-hemolytic streptococci).1 Also active in vitro against some other staphylococci (e.g., S. epidermidis, S. saprophyticus) and some other streptococci (e.g., S. agalactiae [group B streptococci], S. pneumoniae [penicillin-resistant strains], viridans streptococci).1

  • Gram-negative aerobes: Active in vitro and in clinical infections against E. coli,1 H. influenzae,1 H. parainfluenzae,1 K. pneumoniae,1 M. catarrhalis,1 N. gonorrhoeae,1 and P. mirabilis.1 Also active in vitro against some strains of Acinetobacter, Citrobacter, Enterobacter, K. oxytoca, Morganella, and P. vulgaris.1

  • Other organisms: Active in vitro and in clinical infections against Chlamydophila pneumonia (formerly Chlamydia pneumoniae),1 L. pneumophila,1 M. pneumoniae,1 and M. tuberculosis.30 32

Advice to Patients

  • Advise patients that antibacterials (including gatifloxacin) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).b

  • Importance of completing full course of therapy, even if feeling better after a few days.b

  • Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with gatifloxacin or other antibacterials in the future.b

  • Importance of taking gatifloxacin at least 4 hours before multivitamins containing iron, magnesium, or zinc; aluminum- or magnesium-containing antacids; or didanosine chewable/dispersible buffered tablets, buffered powder for oral solution, or pediatric powder for oral solution prepared as an admixture with antacid.1 16

  • Importance of notifying clinician of persistent or worsening symptoms of infection.1

  • Potential for gatifloxacin to impair mental alertness or physical coordination; need for caution when operating machinery or driving a motor vehicle until effects of drug on individual are known.1 16

  • Potential for gatifloxacin to cause other CNS effects, including confusion, tremor, hallucinations, and depression.b

  • Importance of informing clinician if medical history includes palpitations, convulsions, or fainting spells or if any of these events occur during therapy.1

  • Importance of discontinuing therapy and of informing clinician if an allergic or hypersensitivity reaction occurs.1

  • Potential for hypoglycemia or hyperglycemia, usually in patients with diabetes or in patients at risk for dysglycemia, but also in those without diabetes.b Importance of monitoring blood sugar concentrations.b Importance of initiating appropriate therapy immediately, discontinuing gatifloxacin, and contacting clinician if symptoms of high or low blood sugar occur.b (See Hypoglyecemia and Hyperglycemia under Cautions.)

  • Importance of informing clinician of personal or family history of QT interval prolongation or proarrhythmic conditions (e.g., hypokalemia, bradycardia, recent myocardial ischemia).1 b

  • Importance of discontinuing therapy and consulting clinician if symptoms of peripheral neuropathy (e.g., pain, burning, tingling, numbness, and/or weakness) develop.b

  • Advise patients of risk of adverse musculoskeletal effects and importance of discontinuing gatifloxacin, resting, refraining from exercise, and consulting clinician if pain, inflammation, or rupture of a tendon occurs.1

  • Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs, especially drugs that may affect the QT interval (e.g., cisapride, erythromycin, antipsychotic agents, tricyclic antidepressants), antiarrhythmic agents (e.g., amiodarone, quinidine, procainamide, sotalol), diuretics (e.g., furosemide, hydrochlorothiazide), or drugs that may affect blood sugar concentrations.1 b

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of advising patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Gatifloxacin

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, film-coated

200 mg

Tequin

Bristol-Myers Squibb

400 mg

Tequin

Bristol-Myers Squibb

Parenteral

For injection concentrate, for IV infusion

10 mg/mL (400 mg)

Tequin Injection

Bristol-Myers Squibb

Injection, for IV infusion

2 mg/mL (200 and 400 mg) in 5% dextrose

Tequin Injection Premixed (in flexible containers)

Bristol-Myers Squibb

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2010, Selected Revisions June 2006. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Bristol-Myers Squibb Company. Tequin (gatifloxacin) tablets and injection prescribing information. Princeton, NJ; 2002 Dec.

2. Zhanel GC, Ennis K, Vercaigne L et al. A critical review of the fluoroquinolones: focus on respiratory tract infections. Drugs. 2002; 62:13-59. [PubMed 11790155]

3. Blondeau JM. Expanded activity and utility of the new fluoroquinolones: a review. Clin Ther. 1999; 21:3-40. [IDIS 424194] [PubMed 10090423]

4. Nakashima M, Uematsu T, Kosuge K et al. Single- and multiple-dose pharmacokinetics of AM-1155, a new 6-fluoro-8-methoxy quinolone, in humans. Antimicrob Agents Chemother. 1995; 39:2635-40. [IDIS 358702] [PubMed 8592993]

5. Lober S, Ziege S, Rau M et al. Pharmacokinetics of gatifloxacin and interaction with an antacid containing aluminum and magnesium. Antimicrob Agents Chemother. 1999; 43:1067-71. [IDIS 426804] [PubMed 10223915]

6. Bauernfeind A. Comparison of the antibacterial activities of the quinolones Bay 12-8039, gatifloxacin (AM-1155), trovafloxacin, clinafloxacin, levofloxacin and ciprofloxacin. J Antimicrob Chemother. 1997; 40:639-51. [IDIS 398240] [PubMed 9421311]

7. Blondeau JM. A review of the comparative in-vitro activities of 12 antimicrobial agents, with a focus on five new ’respiratory quinolones’. J Antimicrob Chemother. 1999; 43(Suppl):1B-11B.

8. Perry CM, Barman Balfour JA, Lamb HM. Gatifloxacin. Drugs. 1999; 58:683-96. [PubMed 10551438]

9. Bayer Corporation. Avelox (moxifloxacin) tablets and I.V. prescribing information. West Haven, CT; 2003 Mar.

10. Andriole VT. The future of the quinolones. Drugs. 1999; 58(Suppl 2): 1-5. [PubMed 10553697]

11. DeAbate CA, McIvor RA, Di Bartolo C et al. Gatifloxacin vs. cefuroxime axetil in patients with acute exacerbations of chronic bronchitis. J Respir Dis. 1999; 20(Suppl 11A):23-9.

12. Fogarty C, McAdoo M, Paster RZ et al. Gatifloxacin vs. clarithromycin in the management of acute sinusitis. J Respir Dis. 1999; 20(Suppl 11A):17-22.

13. Fogarty C, Powell ME, Ellison T et al. Treating community-acquired pneumonia in hospitalized patients: gatifloxacin vs. ceftriaxone/clarithromycin. J Respir Dis. 1999; 20(Suppl 11A):60-9.

14. Ramirez J, Nguyen TH, Tellier G et al. Treating community-acquired pneumonia with once-daily gatifloxacin vs. twice-daily clarithromycin. J Respir Dis. 1999; 20(Suppl 11A):40-8.

15. Sullivan JG, McElroy AD, Hunsinger RW et al. Treating community-acquired pneumonia with once-daily gatifloxacin vs. once-daily levofloxacin. J Respir Dis. 1999; 20(Suppl 11A):49-59.

16. Manufacturer’s comments (personal observations).

17. US Food and Drug Administration. Janssen Pharmaceutica stops marketing cisapride in the U.S. FDA Talk Paper. Rockville, MD; 2000 March 23.

18. Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines 2002. MMWR Morb Mortal Wkly Rep. 2002; 51(No. RR-6):1-78.

19. Centers for Disease Control and Prevention. Decreased susceptibility of Neisseria gonorrhoeae to fluoroquinolones—Ohio and Hawaii, 1992–1994. MMWR Morb Mortal Wkly Rep. 1994; 43:325-7. [IDIS 329259] [PubMed 8164636]

20. Centers for Disease Control and Prevention. Fluoroquinolone-resistance in Neisseria gonorrhoeae, Hawaii, 1999, and decreased susceptibility to azithromycin in N. gonorrhoeae, Missouri, 1999. MMWR Morb Mortal Wkly Rep. 2000; 49:833-7. [IDIS 453336] [PubMed 11012233]

21. Inglesby TV, O’Toole T, Henderson DA et al for the Working Group on Civilian Biodefense. Anthrax as a biological weapon, 2002: updated recommendations for management. JAMA. 2002; 287:2236-52. [IDIS 480001] [PubMed 11980524]

22. Centers for Disease Control and Prevention. Update: investigation of anthrax associated with intentional exposure and interim public health guidelines, October 2001. MMWR Morb Mortal Wkly Rep. 2001; 50:889-93. [IDIS 471389] [PubMed 11686472]

23. Centers for Disease Control and Prevention. Update: investigation of bioterrorism-related anthrax and interim guidelines for exposure management and antimicrobial therapy, October 2001. MMWR Morb Mortal Wkly Rep. 2001; 50:909-19. [IDIS 471910] [PubMed 11699843]

24. Bartlett JG, Dowell SF, Mandell LA et al. Practice guidelines for the management of community-acquired pneumonia in adult. Clin Infect Dis. 2000; 31:347-82. [IDIS 454042] [PubMed 10987697]

25. Heffelfinger JD, Dowell SF, Jorgensen JH et al. Management of community-acquired pneumonia in the era of pneumococcal resistance: a report from the drug-resistance streptococcus pneumoniae therapeutic working group. Arch Intern Med. 2000; 160:1399-1408. [IDIS 448719] [PubMed 10826451]

26. American Thoracic Society. Guidelines for the management of adults with community-acquired pneumonia. Diagnosis, assessment of severity, antimicrobial therapy, and prevention. Am J Resp Crit Care Med. 2001; 163:1730-54. [IDIS 466552] [PubMed 11401897]

27. Bishai W. Current issues on resistance, treatment guidelines, and the appropriate use of fluoroquinolones for respiratory tract infections. Clin Ther. 2002; 24:838-50. [IDIS 483635] [PubMed 12117077]

28. Centers for Disease Control and Prevention. Treatment of tuberculosis, American Thoracic Society, CDC, and Infectious Diseases Society of America. MMWR Morb Mortal Wkly Rep. 2003; 52(No. RR-11):1-88.

29. Bearden DT, Danziger LH. Mechanism of action of and resistance to quinolones. Pharmacotherapy. 2001; 21:224S-32S. [IDIS 472236] [PubMed 11642689]

30. Alvirez-Freites EJ, Carter JL, Cynamon MH. In vitro and in vivo activities of gatifloxacin against Mycobacterium tuberculosis. 2002; 46:1022-5.

31. Yang SC, Hsueh PR, Lai HC et al. High prevalence of antimicrobial resistance in rapidly growing mycobacteria in Taiwan. Antimicrob Agents Chemother. 2003; 47:1958-62. [PubMed 12760874]

32. Tomioka H, Sato K, Akaki T et al. Comparative in vitro antimicrobial activities of the newly synthesized quinolone HSR-903, sitafloxacin (DU-6859s), gatifloxacin (AM-1155), and levofloxacin against Mycobacterium tuberculosis and Mycobacterium avium complex. Antimicrob Agents Chemother. 1999; 43:3001-4. [PubMed 10582897]

33. Zhanel GG, Palatnick L, Nichol KA et al. Antimicrobial resistance in respiratory tract Streptococcus pneumoniae isolates: results of the Canadian respiratory organism susceptibility study, 1997 to 2002. Antimicrob Agents Chemother. 2003; 47:1867-74. [PubMed 12760860]

34. Ortho-McNeil Pharmaceutical. Floxin (ofloxacin) tablets prescribing information. Raritan, NJ; 2000 Feb.

35. Merck & Co. Inc. Noroxin (norfloxacin) prescribing information. West Point, PA; 1999 Sept.

36. Bertek Rorer Pharmaceuticals, Inc. Zagam (sparfloxacin) tablets prescribing information. Sugar Land, TX; 1999 Nov.

37. Fish DN, North DS. Gatifloxacin, an advanced 8-methoxy fluoroquinolone. Pharmacotherapy. 2001; 21:35-59. [IDIS 457662] [PubMed 11191737]

38. Rodvold KA, Neuhauser M. Pharmacokinetics and pharmacodynamics of fluoroquinolones. Pharmacotherapy. 2001; 21:233S-252S. [IDIS 472237] [PubMed 11642690]

39. Mignot A, Guillaume M, Gohler K et al. Oral bioavailability of gatifloxacin in healthy volunteers under fasting and fed conditions. Chemotherapy. 2002; 48:111-5. [IDIS 484951] [PubMed 12138325]

40. Mignot A, Guillaume M, Brault M et al. Multiple-dose pharmacokinetics and excretion balance of gatifloxacin, a new fluoroquinolone antibiotic, following oral administration to healthy Caucasian volunteers. Chemotherapy. 2002; 48:116-21. [IDIS 484952] [PubMed 12138326]

41. Grasela DM. Clinical pharmacology of gatifloxacin, a new fluoroquinolone. Clin Infect Dis. 2000; 31(Suppl 2):S51-8. [IDIS 454411] [PubMed 10984329]

g. Trissel LA. Handbook of injectable drugs. 13th ed. Bethesda, MD: American Society of Health-System Pharmacists, Inc; 2005:706-714.

a. Lewis-Hall F. Dear health care provider letter regarding Tequincontraindication in patients with diabetes and important safety information on the use of Tequin in patients with risk factors for dysglycemia. Princeton, NJ: Bristol-Myers Squibb; 2006 Feb 15. From FDA website ().

b. Bristol-Myers Squibb Company. Tequin (gatifloxacin) tablets and injection prescribing information. Princeton, NJ; 2006 Jan.

c. Baddour LM, Wilson WR, Bayer AS et al. Infective endocarditis: diagnosis, antimicrobial therapy, and management of complications: a statement for healthcare professionals from the Committee on Rheumatic Fever, Endocarditis, and Kawasaki Disease, Council on Cardiovascular Disease of the Young, and the Councils on Clinical Cardiology, Stroke, and Cardiovascular Surgery and Anesthesia, American Heart Association: endorsed by the Infectious Diseases Society of America. Circulation. 2005; 111:e394-433. [PubMed 15956145]

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