ti FLOKS a
Treatment of the following infections when caused by susceptible bacteria:
Acute bacterial exacerbation of chronic bronchitis due to S. pneumoniae,
H. influenzae, H. parainfluenzae, M. catarrhalis, or
S. aureus; acute sinusitis due to S. pneumoniae, H.
influenzae; community acquired pneumonia due to S. pneumoniae,
H. influenzae, H. parainfluenzae, M. catarrhalis, S.
aureus, M. pneumoniae, C. pneumoniae, or L.
pneumophilia; uncomplicated urinary tract infections (cystitis) due to
E. coli, K. pneumoniae, or P. mirabilis; complicated urinary
tract infections due to E. coli, K. pneumoniae, or P.
mirabilis; pyelonephritis due to E. coli; uncomplicated urethral and
cervical gonorrhea; acute, uncomplicated rectal infections in women due to
No adequate or well-controlled studies in pregnant women. Should be used
during pregnancy only when the potential benefit justifies the potential risk to
Hypersensitivity to gatifloxacin, other quinolone antibiotics, or any
Use with caution in patients with significant bradycardia or acute myocardial
ischemia. May have potential to prolong Q-T interval; should avoid in patients
with uncorrected hypokalemia, or concurrent administration of other medications
known to prolong the Q-T interval (including class Ia and class III
antiarrhythmics, cisapride, erythromycin, antipsychotics, and tricyclic
antidepressants). Safety and effectiveness in pediatric patients (<18 years
of age) have not been established. Experience in immature animals has resulted
in permanent arthropathy. Use with caution in individuals at risk of seizures
(CNS disorders or concurrent therapy with medications which may lower seizure
threshold). Discontinue in patients who experience significant CNS adverse
effects (dizziness, hallucinations, suicidal ideation or actions). Use caution
in renal dysfunction (dosage adjustment required) and in severe hepatic
insufficiency (no data available). Use caution in patients with diabetes -
glucose regulation may be altered.
3% to 10%:
Central nervous system: Headache (3%), dizziness (3%)
Gastrointestinal: Nausea (8%), diarrhea (4%)
Genitourinary: Vaginitis (6%)
Local: Injection site reactions (5%)
0.1% to 3%: Allergic reaction, chills, fever, back pain, chest pain,
palpitation, abdominal pain, constipation, dyspepsia, glossitis, oral
candidiasis, stomatitis, mouth ulceration, vomiting, peripheral edema, abnormal
dreams, insomnia, paresthesia, tremor, vasodilation, vertigo, dyspnea,
pharyngitis, rash, sweating, abnormal vision, taste perversion, tinnitus,
dysuria, hematuria, elevated serum transaminases, elevated alkaline phosphatase,
increased serum bilirubin, increased serum amylase
<0.1% (Limited to important or life-threatening symptoms): Abnormal
thinking, agitation, alcohol intolerance, anorexia, anxiety, arthralgia,
arthritis, asthenia, ataxia, bone pain, bradycardia, breast pain, bronchospasm,
cheilitis, colitis, confusion, cyanosis, depersonalization, depression, diabetes
mellitus, dry skin, dysphagia, ear pain, ecchymosis, edema, epistaxis, euphoria,
eye pain, facial edema, flatulence, gastritis, gastrointestinal hemorrhage,
gingivitis, halitosis, hallucination, hematemesis, hostility, hyperesthesia,
hyperglycemia, hypertension, hypertonia, hyperventilation, hypoglycemia, leg
cramps, lymphadenopathy, maculopapular rash, metrorrhagia, migraine, myalgia,
myasthenia, neck pain, nervousness, panic attacks, paranoia, parosmia, pruritus,
pseudomembranous colitis, psychosis, ptosis, rectal hemorrhage, seizures,
somnolence, stress, tachycardia, taste disturbance, thirst, tongue edema,
Potential symptoms of overdose may include CNS excitation, seizures, QT
prolongation, and arrhythmias (including torsade de pointes). Patients should be
monitored by continuous EKG in the event of an overdose. Management is
supportive and symptomatic. Not removed by dialysis.
Gatifloxacin may prolong Q-T interval; avoid use with drugs which prolong Q-T
interval (including class Ia and class III antiarrhythmics, erythromycin,
cisapride, antipsychotics, and cyclic antidepressants).
Metal cations (magnesium, aluminum, iron, and zinc) bind quinolones in the
gastrointestinal tract and inhibit absorption (by up to 98%). Antacids,
electrolyte supplements, sucralfate, quinapril, and some didanosine formulations
should be avoided. Gatifloxacin should be administered 4 hours before or 8 hours
after these agents.
Antineoplastic agents may decrease the absorption of quinolones
Calcium carbonate was not found to alter the absorption of gatifloxacin.
Cimetidine, and other H2 antagonists may inhibit renal elimination
Digoxin levels may be increased in some patients by gatifloxacin; monitor for
Foscarnet has been associated with an increased risk of seizures with some
H2 antagonists and proton pump inhibitors may decrease absorption
of some quinolones
Loop diuretics: Serum levels of some quinolones are increased by loop
diuretic administration. May diminish renal excretion.
NSAIDs: The CNS stimulating effect of some quinolones may be enhanced,
resulting in neuroexcitation and/or seizures. This effect has not been observed
Probenecid: Blocks renal secretion of gatifloxacin, increasing AUC and
Warfarin: The hypoprothrombinemic effect of warfarin is enhanced by some
quinolone antibiotics. No significant effect has been demonstrated for
gatifloxacin, however, monitoring of the INR during concurrent therapy is
recommended by the manufacturer.
Store at 25°C (77°F). Do not
freeze injection. Injection must be diluted to a concentration of 2 mg/mL prior
to administration. Compatible with 5% dextrose in water, 0.9% sodium chloride,
lactated Ringer's and 5% dextrose injection, 5% sodium bicarbonate injection,
water for injection, PlasmaLyte® 56/5% dextrose injection.
Compatible with 5% dextrose or 0.45% sodium chloride containing up to 20 mEq/L
Gatifloxacin is a DNA gyrase inhibitor, and also inhibits topoisomerase IV.
DNA gyrase (topoisomerase II) is an essential bacterial enzyme that maintains
the superhelical structure of DNA. DNA gyrase is required for DNA replication
and transcription, DNA repair, recombination, and transposition; inhibition is
Absorption: Well absorbed after oral administration
Distribution: Vd: 1.5-2.0 L/kg; concentrates in alveolar
macrophages and lung parenchyma
Protein binding: 20%
Metabolism: Only 1% metabolized. No interaction with hepatic microsomal
Half-life: 7.1-13.9 hours (up to 30-40 hours in ESRD or CAPD)
Time to peak: Oral: 1 hour
Elimination: In urine, as unchanged drug (5% in feces)
Adult: Oral, I.V.:
Acute sinusitis: 400 mg every 24 hours for 10 days
Community acquired pneumonia: 400 mg every 24 hours for 7-14 days
Uncomplicated urinary tract infections (cystitis): 200-400 mg every 24 hours
for 3 days
Complicated urinary tract infections: 400 mg every 24 hours for 7-10 days
Acute pyelonephritis: 400 mg every 24 hours for 7-10 days
Uncomplicated urethral gonorrhea in men, cervical or rectal gonorrhea in
women: 400 mg single dose
Dosage adjustment in renal impairment: Creatinine clearance <40
mL/minute (or patients on hemodialysis/CAPD) should receive an initial dose of
400 mg, followed by a subsequent dose of 200 mg every 24 hours. Patients
receiving single-dose or 3-day therapy for appropriate indications do not
require dosage adjustment.
Dosage adjustment in hepatic impairment: No dosage adjustment is
required in mild-moderate hepatic disease. No data are available in severe
hepatic impairment (Child-Pugh Class C).
Elderly: No dosage adjustment is required based on age, however, assessment
of renal function is particularly important in this population.
Concentrated injection (10 mg/mL) must be diluted to 2 mg/mL prior to
administration. No further dilution is required for premixed 100 mL and 200 mL
WBC, signs of infection
|Dental Health: Local
No information available to require special precautions
Effects on Dental Treatment|
No effects or complications reported
May be taken with or without food. Drink plenty of fluids. Avoid exposure to
direct sunlight during therapy and for several days following. Do not take
antacids within 4 hours before or 2 hours after dosing. Contact your physician
immediately if signs of allergy occur or if signs of tendon inflammation or pain
occur. Do not discontinue therapy until your course has been completed. Take a
missed dose as soon as possible, unless it is almost time for your next
Infusion: 2 mg/mL (100 mL, 200 mL)
Injection: 10 mg/mL (20 mL, 40 mL)
Tablet: 200 mg, 400 mg
"Expanded Activity and Utility of the New Fluoroquinolones: A Review,"
Clinical Therapeutics, 1999, 21(1):3-40.
"Gatifloxacin and Moxifloxacin: Two New Fluoroquinolones," The Medical
Letter, 2000, Vol 42, 1072:15.
Perry CM, Barman Balfour JA, Lamb HM, "Gatifloxacin," Drugs, 1999,
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