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Gemifloxacin (United States: Not available): Drug information

Gemifloxacin (United States: Not available): Drug information
(For additional information see "Gemifloxacin (United States: Not available): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed Warning
Serious adverse reactions:

Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together, including tendinopathy and tendon rupture, peripheral neuropathy, and CNS effects. Discontinue gemifloxacin immediately and avoid use of fluoroquinolones in patients who experience any of these serious adverse reactions. Because fluoroquinolones have been associated with serious adverse reactions, reserve gemifloxacin for use in patients who have no alternative treatment options for acute bacterial exacerbation of chronic bronchitis.

Exacerbation of myasthenia gravis:

Fluoroquinolones may exacerbate muscle weakness in individuals with myasthenia gravis. Avoid gemifloxacin in patients with known history of myasthenia gravis.

Pharmacologic Category
  • Antibiotic, Fluoroquinolone;
  • Antibiotic, Respiratory Fluoroquinolone
Dosing: Adult

Note: Factive is no longer available in the United States.

Susceptible infections

Susceptible infections: Oral: 320 mg once daily.

Chronic bronchitis, acute exacerbation

Chronic bronchitis, acute exacerbation: Oral: 320 mg once daily for 5 days.

Gonococcal infection, uncomplicated

Gonococcal infection, uncomplicated (alternative agent) (off-label use):

Note: Not recommended by the CDC; other regimens are preferred due to availability, cost, and antimicrobial stewardship concerns (CDC [Workowski 2021]). Some experts reserve for patients with cephalosporin allergy when other options are not available (Seña 2022).

Oral: 320 mg as a single dose in combination with oral azithromycin 2 g (Kirkcaldy 2014; Seña 2022). When treatment failure is suspected (eg, detection of Neisseria gonorrhoeae after treatment without additional sexual exposure), consult an infectious diseases specialist. Report failures to the CDC through state and local health departments (CDC [Workowski 2021]).

Plague

Plague (Yersinia pestis) (alternative agent) (off-label use):

Note: Consult public health officials for event-specific recommendations.

Postexposure prophylaxis: Oral: 320 mg once daily for 7 days (CDC [Nelson 2021]).

Treatment, excluding meningitis : Oral: 320 mg once daily for 7 to 14 days and for at least a few days after clinical resolution (CDC [Nelson 2021]; Stout 2022).

Pneumonia, community-acquired, outpatients with comorbidities or inpatients

Pneumonia, community-acquired, outpatients with comorbidities or inpatients (alternative agent):

Note: Some experts reserve fluoroquinolones for patients who cannot take other preferred regimens (File 2021). Avoid use in patients with risk factors for Pseudomonas aeruginosa (ATS/IDSA [Metlay 2019]; File 2021).

Oral: 320 mg once daily. Duration is a minimum of 5 days; patients should be clinically stable with normal vital signs before therapy is discontinued (ATS/IDSA [Metlay 2019]).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

Note: Renal function may be estimated using the Cockcroft-Gault formula for dosage adjustment purposes.

CrCl >40 mL/minute: No dosage adjustment necessary.

CrCl ≤40 mL/minute: 160 mg once daily

Hemodialysis: Dialyzable (20% to 30%): 160 mg once daily (administer dose following hemodialysis on dialysis days).

CAPD: 160 mg once daily

Dosing: Hepatic Impairment: Adult

No dosage adjustment necessary.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

1% to 10%:

Dermatologic: Skin rash (≤4%)

Gastrointestinal: Abdominal pain (≤2%), diarrhea (5%), nausea (4%), vomiting (≤2%)

Hematologic & oncologic: Thrombocythemia (1%)

Hepatic: Increased serum alanine aminotransferase (≤4%), increased serum aspartate aminotransferase (≤1%)

Nervous system: Dizziness (≤2%), headache (4%)

Frequency not defined: Nervous system: Agitation, anxiety, confusion, delirium, depression, disorientation, disturbance in attention, hallucination, idiopathic intracranial hypertension, memory impairment, paranoid ideation, restlessness, seizure, suicidal ideation, suicidal tendencies, toxic psychosis

<1%, postmarketing, and/or case reports: Acute renal failure, agranulocytosis, anaphylaxis, anemia, angioedema, anorexia, antibiotic-associated colitis, aplastic anemia, arthralgia, asthenia, axonal peripheral polyneuropathy, back pain, candidiasis, Clostridioides difficile associated diarrhea, Clostridioides difficile colitis, constipation, decreased hematocrit, decreased hemoglobin, decreased neutrophils, decreased serum albumin, decreased serum calcium, decreased serum potassium, decreased serum sodium, decreased serum total protein, dermatitis, drowsiness, dysesthesia, dysgeusia, dyspepsia, dyspnea, eczema, eosinophilia, eosinophilic pneumonitis, erythema multiforme, exacerbation of myasthenia gravis, exfoliation of skin, facial edema, fatigue, fever, flatulence, flushing, fungal infection, gastritis, gastroenteritis, genital candidiasis, genital pruritus, granulocytopenia, hemolytic anemia, hemorrhage, hepatic necrosis, hepatitis, hepatotoxicity (Chalasani 2021), hot flash, hyperbilirubinemia, hyperglycemia, hypersensitivity reaction, hypoesthesia, increased blood urea nitrogen, increased creatine phosphokinase in blood specimen, increased gamma-glutamyl transferase, increased hematocrit, increased hemoglobin, increased INR, increased intracranial pressure, increased lactate dehydrogenase, increased neutrophils, increased nonprotein nitrogen, increased serum alkaline phosphatase, increased serum bilirubin, increased serum calcium, increased serum creatinine, increased serum potassium, increased serum sodium, insomnia, interstitial nephritis, jaundice, leukopenia, lower limb cramp, myalgia, nervousness, pain, pancytopenia, paresthesia, peripheral edema, peripheral neuropathy, pharyngitis, pneumonia, prolonged QT interval on ECG, pruritus, renal failure syndrome, retinal hemorrhage, rupture of tendon, serum sickness, severe dermatological reaction, skin photosensitivity, Stevens-Johnson syndrome, supraventricular tachycardia, syncope, tendinopathy, thrombocythemia, thrombocytopenia, thrombotic thrombocytopenic purpura, toxic epidermal necrolysis, transient ischemic attacks, tremor, urine abnormality, urticaria, vaginitis, vertigo, visual disturbance, xerostomia

Contraindications

Hypersensitivity to gemifloxacin, other fluoroquinolones, or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Altered cardiac conduction: Fluoroquinolones may prolong QTc interval; avoid use in patients with a history of QTc prolongation, uncorrected electrolyte disorders (hypokalemia or hypomagnesemia) or concurrent administration of other medications known to prolong the QT interval (including Class Ia and Class III antiarrhythmics, cisapride, erythromycin, antipsychotics, and tricyclic antidepressants).

• Aortic aneurysm and dissection: Fluoroquinolones have been associated with aortic aneurysm ruptures or dissection within 2 months following use, particularly in elderly patients. Fluoroquinolones should not be used in patients with a known history of aortic aneurysm or those at increased risk, including patients with peripheral atherosclerotic vascular diseases, hypertension, genetic disorders involving blood vessel changes (eg, Marfan syndrome, Ehlers-Danlos syndrome), and elderly patients, unless no other treatment options are available. Longer treatment duration (eg, >14 days) may increase risk (Lee 2018).

• Glucose regulation: Fluoroquinolones have been associated with disturbances in glucose regulation, including hyperglycemia and hypoglycemia. These events have occurred most often in patients receiving concomitant oral hypoglycemic agents or insulin. Severe cases of hypoglycemia, including coma and death, have been reported. Diabetic patients should be monitored closely for signs/symptoms of disordered glucose regulation. Discontinue if a hypoglycemic reaction occurs and immediately initiate appropriate therapy.

• Hypersensitivity reactions: Severe hypersensitivity reactions, including anaphylaxis, have occurred with fluoroquinolone therapy. The spectrum of these reactions can vary widely; reactions may present as typical allergic symptoms (eg, itching, urticaria, rash, edema) after a single dose, or may manifest as severe idiosyncratic dermatologic (eg, Stevens-Johnson, toxic epidermal necrolysis), vascular (eg, vasculitis), pulmonary (eg, pneumonitis), renal (eg, nephritis), hepatic (eg, hepatic failure or necrosis), and/or hematologic (eg, anemia, cytopenias) events, usually after multiple doses. Some reactions have been accompanied by cardiovascular collapse, hypotension/shock, seizure, loss of consciousness, tingling, angioedema, and/or airway obstruction. May cause maculopapular rash, usually 8 to 10 days after treatment initiation; risk factors may include age <40 years, female gender (including postmenopausal women on HRT), and treatment duration >7 days. Prompt discontinuation of drug should occur if skin rash or other symptoms arise.

• Phototoxicity: Avoid excessive sunlight and take precautions to limit exposure (eg, loose fitting clothing, sunscreen); may cause moderate-to-severe phototoxicity reactions. Discontinue use if photosensitivity occurs.

• Serious adverse reactions: [US Boxed Warning]: Fluoroquinolones are associated with disabling and potentially irreversible serious adverse reactions that may occur together, including tendinopathy and tendon rupture, peripheral neuropathy, and CNS effects. Discontinue gemifloxacin immediately and avoid use of fluoroquinolones in patients who experience any of these serious adverse reactions. Patients of any age or without preexisting risk factors have experienced these reactions; may occur within hours to weeks after initiation.

- CNS effects: Fluoroquinolones have been associated with an increased risk of CNS effects including seizures, increased intracranial pressure (including pseudotumor cerebri), lightheadedness, and tremors. Use with caution in patients with known or suspected CNS disorder, or risk factors that may predispose to seizures or lower the seizure threshold. Discontinue immediately if reaction occurs and institute appropriate therapy.

- Peripheral neuropathy: Fluoroquinolones have been associated with an increased risk of peripheral neuropathy; may occur soon after initiation of therapy and may be irreversible; discontinue if symptoms of sensory or sensorimotor neuropathy occur. Avoid use in patients who have previously experienced peripheral neuropathy.

- Psychiatric reactions: Fluoroquinolones have been associated with an increased risk of psychiatric reactions, including toxic psychosis, hallucinations, or paranoia; may also cause agitation or restlessness, delirium, attention disturbances, insomnia, anxiety, memory impairment, confusion, depression, and suicidal thoughts or actions. Use with caution in patients with a history of or risk factor for depression; discontinue if reaction occurs and institute appropriate therapy.

- Tendinopathy/tendon rupture: Fluoroquinolones have been associated with an increased risk of tendinopathy and tendon rupture in all ages; risk may be increased with concurrent corticosteroids, solid organ transplant recipients, and in patients >60 years of age, but has also occurred in patients without these risk factors. Rupture of the Achilles tendon has been reported most frequently; but other tendon sites (eg, rotator cuff, biceps, hand) have also been reported. Inflammation and rupture may occur bilaterally. Cases have been reported within hours or days of initiation, and up to several months after discontinuation of therapy. Strenuous physical activity, renal failure, and previous tendon disorders may be independent risk factor for tendon rupture. Discontinue at first sign of tendon pain, swelling, inflammation or rupture. Avoid use in patients with a history of tendon disorders or who have experienced tendinopathy or tendon rupture.

• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including Clostridioides difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with significant bradycardia or acute myocardial ischemia.

• Myasthenia gravis: [US Boxed Warning]: May exacerbate muscle weakness related to myasthenia gravis; avoid use in patients with known history of myasthenia gravis. Cases of severe exacerbations, including the need for ventilatory support and deaths, have been reported.

• Renal impairment: Use with caution in renal impairment; dosage adjustment required for CrCl ≤40 mL/minute. May increase risk of tendon rupture.

• Rheumatoid arthritis: Use with caution in patients with rheumatoid arthritis; may increase risk of tendon rupture.

Special populations:

• Older adult: Adverse effects (eg, tendon rupture, QT changes) may be increased in elderly patients.

• G6PD deficiency: Hemolytic reactions may (rarely) occur with fluoroquinolone use in patients with G6PD deficiency (Luzzatto 2020).

Other warnings/precautions:

• Appropriate use: [US Boxed Warning]: Reserve use of gemifloxacin for treatment of acute bacterial exacerbation of chronic bronchitis for patients who have no alternative treatment options because of the risk of disabling and potentially serious adverse reactions (eg, tendinopathy and tendon rupture, peripheral neuropathy, CNS effects).

Product Availability

Factive is no longer available in the United States.

Generic Equivalent Available: US

Yes

Pricing: US

Tablets (Factive Oral)

320 mg (5): $239.20

Disclaimer: The pricing data provide a representative AWP and/or AAWP price from a single manufacturer of the brand and/or generic product, respectively. The pricing data should be used for benchmarking purposes only, and as such should not be used to set or adjudicate any prices for reimbursement or purchasing functions. Pricing data is updated monthly.

Administration: Adult

Oral: May be administered with or without food. Do not administer with dairy products (eg, milk, yogurt) or calcium-fortified juices alone; however, may be administered with a meal that contains these products. Do not administer products (including multivitamins) containing iron, zinc, or magnesium within 3 hours before or 2 hours after gemifloxacin.

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and at http://www.fda.gov/downloads/Drugs/DrugSafety/UCM152723.pdf, must be dispensed with this medication.

Use: Labeled Indications

Treatment of acute exacerbation of chronic bronchitis; treatment of community-acquired pneumonia (CAP), including pneumonia caused by multidrug-resistant strains of S. pneumoniae (MDRSP)

Limitations of use: Because fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions (eg, tendinopathy and tendon rupture, peripheral neuropathy, CNS effects), reserve gemifloxacin for use in patients who have no alternative treatment options for acute bacterial exacerbation of chronic bronchitis.

Use: Off-Label: Adult

Gonococcal infection, uncomplicated; Plague (Yersinia pestis)

Metabolism/Transport Effects

Substrate of OAT1/3

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Agents with Blood Glucose Lowering Effects: Quinolones may enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Quinolones may diminish the therapeutic effect of Agents with Blood Glucose Lowering Effects. Specifically, if an agent is being used to treat diabetes, loss of blood sugar control may occur with quinolone use. Risk C: Monitor therapy

Aminolevulinic Acid (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Risk X: Avoid combination

Aminolevulinic Acid (Topical): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Topical). Risk C: Monitor therapy

Amiodarone: Gemifloxacin may enhance the QTc-prolonging effect of Amiodarone. Risk X: Avoid combination

Amisulpride (Oral): May enhance the QTc-prolonging effect of QT-prolonging Agents (Moderate Risk). Risk C: Monitor therapy

Amphetamines: May enhance the cardiotoxic effect of Quinolones. Risk C: Monitor therapy

Antacids: May decrease the absorption of Quinolones. Of concern only with oral administration of quinolones. Management: Avoid concurrent administration of quinolones and antacids to minimize the impact of this interaction. Recommendations for optimal dose separation vary by specific quinolone; see full monograph for details. Risk D: Consider therapy modification

Bacillus clausii: Antibiotics may diminish the therapeutic effect of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider therapy modification

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Risk C: Monitor therapy

Calcium Salts: May decrease the absorption of Quinolones. Of concern only with oral administration of both agents. Management: Consider administering an oral quinolone at least 2 hours before or 6 hours after the dose of oral calcium to minimize this interaction. Monitor for decreased therapeutic effects of quinolones during coadministration. Risk D: Consider therapy modification

Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid combination

Corticosteroids (Systemic): May enhance the adverse/toxic effect of Quinolones. Specifically, the risk of tendonitis and tendon rupture may be increased. Risk C: Monitor therapy

Dabrafenib: QT-prolonging Quinolone Antibiotics (Moderate Risk) may enhance the QTc-prolonging effect of Dabrafenib. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Delamanid: May enhance the QTc-prolonging effect of QT-prolonging Quinolone Antibiotics (Moderate Risk). QT-prolonging Quinolone Antibiotics (Moderate Risk) may enhance the QTc-prolonging effect of Delamanid. Management: Avoid concomitant use of delamanid and quinolone antibiotics if possible. If coadministration is considered to be unavoidable, frequent monitoring of electrocardiograms throughout the full delamanid treatment period should occur. Risk D: Consider therapy modification

Didanosine: Quinolones may decrease the serum concentration of Didanosine. Didanosine may decrease the serum concentration of Quinolones. Management: Administer oral quinolones at least 2 hours before or 6 hours after didanosine. Monitor for decreased therapeutic effects of quinolones, particularly if doses cannot be separated as recommended. This does not apply to unbuffered enteric coated didanosine. Risk D: Consider therapy modification

Domperidone: QT-prolonging Agents (Moderate Risk) may enhance the QTc-prolonging effect of Domperidone. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider therapy modification

Fecal Microbiota (Live) (Oral): May diminish the therapeutic effect of Antibiotics. Risk X: Avoid combination

Fecal Microbiota (Live) (Rectal): Antibiotics may diminish the therapeutic effect of Fecal Microbiota (Live) (Rectal). Risk X: Avoid combination

Fexinidazole: May increase the serum concentration of OAT1/3 Substrates (Clinically Relevant). Management: Avoid use of fexinidazole with OAT1/3 substrates when possible. If combined, monitor for increased OAT1/3 substrate toxicities. Risk D: Consider therapy modification

Fluorouracil Products: QT-prolonging Quinolone Antibiotics (Moderate Risk) may enhance the QTc-prolonging effect of Fluorouracil Products. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Haloperidol: May enhance the QTc-prolonging effect of QT-prolonging Quinolone Antibiotics (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Hydroxychloroquine: May enhance the hyperglycemic effect of Gemifloxacin. Hydroxychloroquine may enhance the hypoglycemic effect of Gemifloxacin. Hydroxychloroquine may enhance the QTc-prolonging effect of Gemifloxacin. Risk C: Monitor therapy

Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may diminish the therapeutic effect of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor therapy

Iron Preparations: May decrease the serum concentration of Quinolones. Management: Give oral quinolones at least several hours before (4 h for moxi- and sparfloxacin, 2 h for others) or after (8 h for moxi-, 6 h for cipro/dela-, 4 h for lome-, 3 h for gemi-, and 2 h for enox-, levo-, nor-, oflox-, peflox, or nalidixic acid) oral iron. Risk D: Consider therapy modification

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Risk C: Monitor therapy

Leflunomide: May increase the serum concentration of OAT1/3 Substrates (Clinically Relevant). Risk C: Monitor therapy

Levoketoconazole: QT-prolonging Agents (Moderate Risk) may enhance the QTc-prolonging effect of Levoketoconazole. Risk X: Avoid combination

Magnesium Salts: May decrease the serum concentration of Quinolones. Management: Administer oral quinolones several hours before (4 h for moxi/pe/spar/enox-, 2 h for others) or after (8 h for moxi-, 6 h for cipro/dela-, 4 h for lome/pe/enox-, 3 h for gemi-, and 2 h for levo-, nor-, or ofloxacin or nalidixic acid) oral magnesium salts. Risk D: Consider therapy modification

Methadone: Gemifloxacin may enhance the QTc-prolonging effect of Methadone. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk Risk D: Consider therapy modification

Methoxsalen (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Methoxsalen (Systemic). Risk C: Monitor therapy

Methylphenidate: May enhance the cardiotoxic effect of Quinolones. Risk C: Monitor therapy

Multivitamins/Minerals (with ADEK, Folate, Iron): May decrease the serum concentration of Quinolones. Specifically, polyvalent cations in multivitamin products may decrease the absorption of orally administered quinolone antibiotics. Management: Administer oral quinolones at least 2 hours before, or 6 hours after, the dose of a multivitamin that contains polyvalent cations (ie, calcium, iron, magnesium, selenium, zinc). Monitor for decreased quinolone efficacy. Risk D: Consider therapy modification

Multivitamins/Minerals (with AE, No Iron): May decrease the serum concentration of Quinolones. Specifically, minerals in the multivitamin/mineral product may impair absorption of quinolone antibiotics. Management: Administer oral quinolones at least 2 hours before, or 6 hours after, the dose of a multivitamin that contains polyvalent cations (ie, calcium, iron, magnesium, selenium, zinc). Monitor for decreased therapeutic effects of quinolones. Risk D: Consider therapy modification

Mycophenolate: Quinolones may decrease the serum concentration of Mycophenolate. Specifically, quinolones may decrease concentrations of the active metabolite of mycophenolate. Risk C: Monitor therapy

Nadifloxacin: May enhance the adverse/toxic effect of Quinolones. Risk X: Avoid combination

Nitisinone: May increase the serum concentration of OAT1/3 Substrates (Clinically Relevant). Risk C: Monitor therapy

Nonsteroidal Anti-Inflammatory Agents: May enhance the neuroexcitatory and/or seizure-potentiating effect of Quinolones. Nonsteroidal Anti-Inflammatory Agents may increase the serum concentration of Quinolones. Risk C: Monitor therapy

Ondansetron: May enhance the QTc-prolonging effect of QT-prolonging Quinolone Antibiotics (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Pentamidine (Systemic): May enhance the QTc-prolonging effect of QT-prolonging Quinolone Antibiotics (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Pimozide: May enhance the QTc-prolonging effect of QT-prolonging Agents (Moderate Risk). Risk X: Avoid combination

Polyethylene Glycol-Electrolyte Solution: May decrease the absorption of Quinolones. Management: Give oral quinolones at least 2 hours before or at least 6 hours after polyethylene glycol-electrolyte solutions that contain magnesium sulfate (Suflave brand). Other products without magnesium do not require dose separation. Risk D: Consider therapy modification

Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Risk C: Monitor therapy

Pretomanid: May increase the serum concentration of OAT1/3 Substrates (Clinically Relevant). Risk C: Monitor therapy

Probenecid: May increase the serum concentration of Gemifloxacin. Risk C: Monitor therapy

QT-prolonging Antidepressants (Moderate Risk): QT-prolonging Quinolone Antibiotics (Moderate Risk) may enhance the QTc-prolonging effect of QT-prolonging Antidepressants (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

QT-prolonging Antipsychotics (Moderate Risk): QT-prolonging Quinolone Antibiotics (Moderate Risk) may enhance the QTc-prolonging effect of QT-prolonging Antipsychotics (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

QT-prolonging Class IA Antiarrhythmics (Highest Risk): Gemifloxacin may enhance the QTc-prolonging effect of QT-prolonging Class IA Antiarrhythmics (Highest Risk). Risk X: Avoid combination

QT-prolonging Class IC Antiarrhythmics (Moderate Risk): QT-prolonging Quinolone Antibiotics (Moderate Risk) may enhance the QTc-prolonging effect of QT-prolonging Class IC Antiarrhythmics (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

QT-prolonging Class III Antiarrhythmics (Highest Risk): Gemifloxacin may enhance the QTc-prolonging effect of QT-prolonging Class III Antiarrhythmics (Highest Risk). Risk X: Avoid combination

QT-Prolonging Inhalational Anesthetics (Moderate Risk): May enhance the QTc-prolonging effect of QT-prolonging Quinolone Antibiotics (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

QT-prolonging Kinase Inhibitors (Highest Risk): May enhance the QTc-prolonging effect of Gemifloxacin. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider therapy modification

QT-prolonging Kinase Inhibitors (Moderate Risk): QT-prolonging Quinolone Antibiotics (Moderate Risk) may enhance the QTc-prolonging effect of QT-prolonging Kinase Inhibitors (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

QT-prolonging Miscellaneous Agents (Highest Risk): Gemifloxacin may enhance the QTc-prolonging effect of QT-prolonging Miscellaneous Agents (Highest Risk). Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider therapy modification

QT-prolonging Miscellaneous Agents (Moderate Risk): May enhance the QTc-prolonging effect of QT-prolonging Quinolone Antibiotics (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

QT-prolonging Moderate CYP3A4 Inhibitors (Moderate Risk): QT-prolonging Quinolone Antibiotics (Moderate Risk) may enhance the QTc-prolonging effect of QT-prolonging Moderate CYP3A4 Inhibitors (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

QT-prolonging Quinolone Antibiotics (Moderate Risk): May enhance the QTc-prolonging effect of other QT-prolonging Quinolone Antibiotics (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

QT-prolonging Strong CYP3A4 Inhibitors (Highest Risk): QT-prolonging Quinolone Antibiotics (Moderate Risk) may enhance the QTc-prolonging effect of QT-prolonging Strong CYP3A4 Inhibitors (Highest Risk). Management: Consider alternatives to this combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider therapy modification

QT-prolonging Strong CYP3A4 Inhibitors (Moderate Risk): QT-prolonging Quinolone Antibiotics (Moderate Risk) may enhance the QTc-prolonging effect of QT-prolonging Strong CYP3A4 Inhibitors (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Sertindole: May enhance the QTc-prolonging effect of QT-prolonging Agents (Moderate Risk). Risk X: Avoid combination

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Risk D: Consider therapy modification

Strontium Ranelate: May decrease the serum concentration of Quinolones. Management: In order to minimize any potential impact of strontium ranelate on quinolone antibiotic concentrations, it is recommended that strontium ranelate treatment be interrupted during quinolone therapy. Risk X: Avoid combination

Sucralfate: May decrease the serum concentration of Quinolones. Management: Avoid concurrent administration of quinolones and sucralfate to minimize the impact of this interaction. Recommendations for optimal dose separation vary by specific quinolone. Risk D: Consider therapy modification

Taurursodiol: May increase the serum concentration of OAT1/3 Substrates (Clinically Relevant). Risk X: Avoid combination

Teriflunomide: May increase the serum concentration of OAT1/3 Substrates (Clinically Relevant). Risk C: Monitor therapy

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Risk D: Consider therapy modification

Vaborbactam: May increase the serum concentration of OAT1/3 Substrates (Clinically Relevant). Risk C: Monitor therapy

Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Risk C: Monitor therapy

Vitamin K Antagonists (eg, warfarin): Quinolones may enhance the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy

Zinc Salts: May decrease the serum concentration of Quinolones. Management: Give oral quinolones at several hours before (4 h for moxi- and sparfloxacin, 2 h for others) or after (8 h for moxi-, 6 h for cipro/dela-, 4 h for lome-, 3 h for gemi-, and 2 h for enox-, levo-, nor-, pe- or ofloxacin or nalidixic acid) oral zinc salts. Risk D: Consider therapy modification

Pregnancy Considerations

Adverse events have been observed in some animal reproduction studies.

Gemifloxacin is used in the management of plague (Yersinia pestis). Untreated infections in pregnant patients may result in hemorrhage (including postpartum hemorrhage), maternal and fetal death, preterm birth, and stillbirth. Limited data suggest maternal-fetal transmission of Y. pestis can occur if not treated. Pregnant patients should be treated for Y. pestis; parenteral antibiotics are preferred for initial treatment when otherwise appropriate. Gemifloxacin is an alternative fluoroquinolone recommended for use (in combination with an aminoglycoside) for treating pregnant patients with bubonic, pharyngeal, pneumonic, or septicemic plague (CDC [Nelson 2021]).

Breastfeeding Considerations

Gemifloxacin is present in breast milk (Sagirli 2015).

In general, antibiotics that are present in breast milk may cause nondose-related modification of bowel flora. Monitor infants for GI disturbances (WHO 2002).

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. Other sources recommend avoiding quinolone antibiotics if alternative agents are available (WHO 2002).

Dietary Considerations

Do not take with dairy products (eg, milk, yogurt) or calcium-fortified juices alone; however, may be taken with a meal that contains these products.

Monitoring Parameters

WBC, signs/symptoms of infection, renal function; signs and symptoms of disordered glucose regulation

Mechanism of Action

Gemifloxacin is a DNA gyrase inhibitor and also inhibits topoisomerase IV. DNA gyrase (topoisomerase IV) 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; bactericidal

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Well absorbed from the GI tract

Distribution: Vdss: 4.2 L/kg

Protein binding: ~60% to 70%

Metabolism: Hepatic (minor); forms metabolites (CYP isoenzymes are not involved)

Bioavailability: ~71%

Half-life elimination: 7 hours (range 4-12 hours)

Time to peak, plasma: 0.5-2 hours

Excretion: Feces (61%); urine (36%)

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Altered kidney function: Average increase in AUC of approximately 70% in patients with renal insufficiency.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Factive;
  • (BD) Bangladesh: Facticin | Factiq | Flogem | Gefcin | Gelcin | Geloxin | Gemelon | Gemicin | Gemif | Gemiflox | Geminox | Gemiquin | Gemitab | Geoflox | Kmi | Rtnor | Toplon;
  • (BR) Brazil: Factive;
  • (CL) Chile: Factive;
  • (CN) China: Factive;
  • (EC) Ecuador: Factive;
  • (EG) Egypt: Anthzon | Factive | Floxguard | Gemifloxacin | Gemiloxes | Gemionce | Gemique | Gemoxacin | Genkystar | Quinabiotic | Weptonal;
  • (ET) Ethiopia: Factive;
  • (IN) India: Eg1 | Floxigem | G Floren | Gembax | Gembio | Gemexin | Gemez | Gemicare | Gemif | Geminex | Gemiquin | Gemistar | Gemitab | Gemone | Gemsharp | Gini | Gq | Quinhext | Topgem | Zemi;
  • (JO) Jordan: Factive;
  • (KE) Kenya: Actigem | Gemflox | Gemiflox;
  • (KR) Korea, Republic of: Factive;
  • (KW) Kuwait: Factive;
  • (MA) Morocco: Factive;
  • (MX) Mexico: Factive 5;
  • (MY) Malaysia: Factive;
  • (NG) Nigeria: Gemxit | Safgem;
  • (PH) Philippines: Spektrel;
  • (PK) Pakistan: Actigem | Adegem | Crohist | Factacin | Factim | Floragem | Floxigem | G cure | Gamibiotic | Gatiking | Gefloak | Geflox | Gemacin | Gemap | Gembro | Gemgex | Gemglow | Gemi | Gemicin | Gemicon | Gemista | Gemisynth | Gemixa | Gemizak | Gemlox | Gemo | Gemxin | Getec | Gezlin | Gim | Grat | Inoflox | Jamicid | Lagem | Lingem | Meglocin | Qflox | Qupric | Renova | Saigem | Siflogem | Wemiflox | Wimcin | Zemi;
  • (PR) Puerto Rico: Factive;
  • (QA) Qatar: Factive;
  • (RU) Russian Federation: Factiv;
  • (SA) Saudi Arabia: Factive;
  • (TH) Thailand: Factive;
  • (TN) Tunisia: Factive;
  • (TR) Turkey: Factive | Gemiloks;
  • (TW) Taiwan: Factive;
  • (UA) Ukraine: Factive;
  • (ZA) South Africa: Factive
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Topic 8760 Version 270.0

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