Gemifloxacin (Monograph)

Brand name: Factive
Drug class: Quinolones
VA class: AM900
Chemical name: (Z-7-[3-(Aminomethyl)-4-(methoxyimino)-1-pyrrolidinyl]-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-1,8-naphthyridine-3-carboxylic acid monomethanesulfonate
Molecular formula: C₁₈H₂₀FN₅O₄•CH₄O₃S
CAS number: 204519-65-3

Medically reviewed by Drugs.com on Aug 23, 2023. Written by ASHP.

Introduction

Antibacterial; naphthyridine derivative; fluoroquinolone.

Uses for Gemifloxacin

Respiratory Tract Infections

Treatment of acute bacterial exacerbations of chronic bronchitis caused by susceptible Streptococcus pneumoniae, Haemophilus influenzae, H. parainfluenzae, or Moraxella catarrhalis.

Treatment of mild to moderate community-acquired pneumonia (CAP) caused by susceptible S. pneumoniae (including multidrug-resistant strains; MDRSP), H. influenzae, M. catarrhalis, Mycoplasma pneumoniae, Chlamydophila pneumoniae (formerly Chlamydia pneumoniae), or Klebsiella pneumoniae.

Use for treatment of acute bacterial exacerbations of chronic bronchitis only when no other treatment options available. Because systemic fluoroquinolones, including gemifloxacin, have been associated with disabling and potentially irreversible serious adverse reactions (e.g., tendinitis and tendon rupture, peripheral neuropathy, CNS effects) that can occur together in the same patient(see Cautions) and because acute bacterial exacerbations of chronic bronchitis may be self-limiting in some patients, risks of serious adverse reactions outweigh benefits of fluoroquinolones for patients with these infections.

Consult current IDSA clinical practice guidelines available at [Web] for additional information on management of respiratory tract infections.

Related/similar drugs

amoxicillin, doxycycline, azithromycin, ciprofloxacin, metronidazole, clindamycin, ceftriaxone

Gemifloxacin Dosage and Administration

Administration

Oral Administration

Administer orally once daily without regard to meals.

Take with liberal amounts of fluids.

Swallow tablets intact; do not chew or crush.

Administer aluminum- or magnesium-containing antacids, dietary supplements containing zinc or iron (e.g., multivitamins, ferrous sulfate), or buffered didanosine preparations at least 3 hours before or 2 hours after gemifloxacin; administer gemifloxacin at least 2 hours before sucralfate. (See Specific Drugs under Interactions.)

Dosage

Available as gemifloxacin mesylate; dosage expressed in terms of gemifloxacin.

Adults

Respiratory Tract Infections

Acute Exacerbations of Chronic Bronchitis

Oral

320 mg once daily for 5 days. (See Respiratory Tract Infections under Uses.)

Mild to Moderate Community-acquired Pneumonia (CAP)

Oral

Known or suspected to be caused by S. pneumoniae, H. influenzae, M. pneumoniae, or C. pneumoniae: 320 mg once daily for 5 days.

Known or suspected to be caused by multidrug-resistant S. pneumoniae, K. pneumoniae, or M. catarrhalis: 320 mg once daily for 7 days.

Manufacturer recommends using results of initial sputum cultures to guide clinical decisions regarding use of a 5- or 7-day regimen.

Prescribing Limits

Adults

Do not exceed recommended dosage or duration of therapy.

Special Populations

Hepatic Impairment

Mild, moderate, or severe hepatic impairment (Child Pugh class A, B, or C): Dosage adjustments not needed.

Renal Impairment

Cl_cr >40 mL/minute: Dosage adjustments not needed.

Cl_cr ≤40 mL/minute: Reduce dosage to 160 mg once daily.

Hemodialysis or CAPD patients: Reduce dosage to 160 mg once daily. Because gemifloxacin partially removed by hemodialysis, administer dose after hemodialysis.

Geriatric Patients

Dosage adjustments based solely on age not needed. Caution advised since geriatric patients may be at increased risk for certain adverse effects. (See Geriatric Use under Cautions.)

Cautions for Gemifloxacin

Contraindications

• Known hypersensitivity to gemifloxacin, other fluoroquinolones, or any ingredient in the formulation.

Warnings/Precautions

Warnings

Disabling and Potentially Irreversible Serious Adverse Reactions

Systemic fluoroquinolones, including gemifloxacin, associated with disabling and potentially irreversible serious adverse reactions (e.g., tendinitis and tendon rupture, peripheral neuropathy, CNS effects) that can occur together in the same patient. May occur within hours to weeks after a systemic fluoroquinolone is initiated; have occurred in all age groups and in patients without preexisting risk factors for such adverse reactions.

Immediately discontinue gemifloxacin at first signs or symptoms of any serious adverse reactions.

Avoid systemic fluoroquinolones, including gemifloxacin, in patients who have experienced any of the serious adverse reactions associated with fluoroquinolones.

Tendinitis and Tendon Rupture

Systemic fluoroquinolones, including gemifloxacin, are associated with an increased risk of tendinitis and tendon rupture in all age groups.

Risk of developing fluoroquinolone-associated tendinitis and tendon rupture is increased in older adults (usually those >60 years of age), individuals receiving concomitant corticosteroids, and kidney, heart, or lung transplant recipients. (See Geriatric Use under Cautions.)

Other factors that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have been reported in patients receiving fluoroquinolones who did not have any risk factors for such adverse reactions.

Fluoroquinolone-associated tendinitis and tendon rupture most frequently involve the Achilles tendon; also reported in rotator cuff (shoulder), hand, biceps, thumb, and other tendon sites.

Tendinitis or tendon rupture can occur within hours or days after gemifloxacin is initiated or as long as several months after completion of therapy and can occur bilaterally.

Immediately discontinue gemifloxacin if pain, swelling, inflammation, or rupture of a tendon occurs. (See Advice to Patients.)

Avoid systemic fluoroquinolones, including gemifloxacin, in patients who have a history of tendon disorders or have experienced tendinitis or tendon rupture.

Peripheral Neuropathy

Systemic fluoroquinolones, including gemifloxacin, are associated with an increased risk of peripheral neuropathy.

Sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias, and weakness reported with systemic fluoroquinolones, including gemifloxacin. Symptoms may occur soon after initiation of the drug and, in some patients, may be irreversible.

Immediately discontinue gemifloxacin if symptoms of peripheral neuropathy (e.g., pain, burning, tingling, numbness, and/or weakness) occur or if there are other alterations in sensations (e.g., light touch, pain, temperature, position sense, vibratory sensation). (See Advice to Patients.)

Avoid systemic fluoroquinolones, including gemifloxacin, in patients who have experienced peripheral neuropathy.

CNS Effects

Systemic fluoroquinolones, including gemifloxacin, are associated with an increased risk of adverse psychiatric effects, including toxic psychosis, hallucinations, paranoia, depression, suicidal thoughts or acts, anxiety, agitation, nervousness, restlessness, confusion, delirium, disorientation, disturbances in attention, insomnia, and memory impairment. These adverse effects may occur after first dose.

Systemic fluoroquinolones, including gemifloxacin, are associated with increased risk of seizures (convulsions), increased intracranial pressure (pseudotumor cerebri), lightheadedness, and tremors. Use with caution in patients with CNS disorders (e.g., epilepsy) or other risk factors that predispose to convulsions.

If psychiatric or other CNS effects occur, immediately discontinue gemifloxacin and institute appropriate measures. (See Advice to Patients.)

Exacerbation of Myasthenia Gravis

Fluoroquinolones, including gemifloxacin, have neuromuscular blocking activity and may exacerbate muscle weakness in myasthenia gravis patients; death or need for ventilatory support reported.

Avoid use in patients with known history of myasthenia gravis. (See Advice to Patients.)

Sensitivity Reactions

Hypersensitivity Reactions

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

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

Other serious and sometimes fatal adverse reactions reported with fluoroquinolones, including gemifloxacin, that may or may not be related to hypersensitivity reactions include one or more of the following: 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.

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

Photosensitivity Reactions

Moderate to severe photosensitivity/phototoxicity reactions reported rarely with fluoroquinolones, including gemifloxacin.

Phototoxicity may manifest as exaggerated sunburn reactions (e.g., burning, erythema, exudation, vesicles, blistering, edema) on areas exposed to sun or artificial ultraviolet (UV) light (usually face, neck, extensor surfaces of forearms, dorsa of hands).

Relative potential of the various fluoroquinolones to cause photosensitivity/phototoxicity unclear. Factors that contribute to susceptibility to this adverse effect during fluoroquinolone therapy include patient’s skin pigmentation, frequency and duration of exposure to sun and UV light, use of protective clothing and sunscreen, concomitant use of other drugs, and dosage and duration of fluoroquinolone therapy.

Avoid unnecessary or excessive exposure to sunlight or artificial UV light (tanning beds, UVA/UVB treatment) while receiving gemifloxacin. If patient needs to be outdoors, they should wear loose-fitting clothing that protects skin from sun exposure and use other sun protection measures (sunscreen).

Discontinue gemifloxacin if photosensitivity or phototoxicity (sunburn-like reaction, skin eruption) occurs.

Other Warnings and Precautions

Risk of Aortic Aneurysm and Dissection

Rupture or dissection of aortic aneurysms reported in patients receiving systemic fluoroquinolones. Epidemiologic studies indicate an increased risk of aortic aneurysm and dissection within 2 months following use of systemic fluoroquinolones, particularly in elderly patients. Cause for this increased risk not identified.

Unless there are no other treatment options, do not use systemic fluoroquinolones, including gemifloxacin, in patients who have an aortic aneurysm or are at increased risk for an aortic aneurysm. This includes elderly patients and patients with peripheral atherosclerotic vascular disease, hypertension, or certain genetic conditions (e.g., Marfan syndrome, Ehlers-Danlos syndrome).

If patient reports adverse effects suggestive of aortic aneurysm or dissection, immediately discontinue the fluoroquinolone. (See Advice to Patients.)

Prolongation of QT Interval

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

Do not exceed recommended gemifloxacin dosage since this may increase risk of prolonged QT interval, especially in those with renal or hepatic impairment.

Avoid use in patients with history of prolonged QT interval, in those with uncorrected electrolyte disorders (e.g., hypokalemia, hypomagnesemia), and in those receiving class IA (e.g., quinidine, procainamide) or class III (e.g., amiodarone, sotalol) antiarrhythmic agents.

Use with caution in patients receiving other drugs that prolong QT interval (e.g., cisapride [available in US only under limited-access protocol], erythromycin, antipsychotic agents, tricyclic antidepressants) and in those with ongoing proarrhythmic conditions, such as clinically important bradycardia or acute myocardial ischemia.

Risk of QT interval prolongation may be increased in geriatric patients. (See Geriatric Use under Cautions.)

Hypoglycemia or Hyperglycemia

Systemic fluoroquinolones are associated with alterations in blood glucose concentrations, including symptomatic hypoglycemia and hyperglycemia. Blood glucose disturbances during fluoroquinolone therapy usually have occurred in patients with diabetes mellitus receiving an oral antidiabetic agent (e.g., glyburide) or insulin.

Severe cases of hypoglycemia resulting in coma or death reported with some systemic fluoroquinolones. Although most reported cases of hypoglycemic coma involved patients with risk factors for hypoglycemia (e.g., older age, diabetes mellitus, renal insufficiency, concomitant use of antidiabetic agents [especially sulfonylureas]), some involved patients receiving a fluoroquinolone who were not diabetic and not receiving an oral antidiabetic agent or insulin.

Carefully monitor blood glucose concentrations when systemic fluoroquinolones, including gemifloxacin, used in patients with diabetes mellitus receiving antidiabetic agents.

If hypoglycemic reaction occurs, discontinue the fluoroquinolone and immediately initiate appropriate therapy. (See Advice to Patients.)

Dermatologic Reactions

Rash (maculopapular, urticarial) reported; approximately 7–10% of rash cases were described as severe.

Rash reported most frequently in patients <40 years of age (especially women), in women receiving hormone replacement therapy, and in patients who received gemifloxacin for >7 days (although this was not evident in men ≥40 years of age).

If rash or urticaria develops, discontinue gemifloxacin. (See Hypersensitivity Reactions under Cautions.)

Musculoskeletal Effects

Fluoroquinolones, including gemifloxacin, cause arthropathy and osteochondrosis in immature animals of various species. Degeneration of articular cartilage reported in juvenile dogs, but not in mature dogs. (See Pediatric Use under Cautions.)

C. difficile-associated Diarrhea and Colitis

Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridioides difficile (formerly known as Clostridium difficile). C. difficile infection (CDI) and C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) reported with nearly all anti-infectives, including gemifloxacin, and may range in severity from mild diarrhea to fatal colitis. C. difficile produces toxins A and B which contribute to development of CDAD; Hypertoxin-producing strains of C. difficile are associated with increased morbidity and mortality since they may be refractory to anti-infectives and colectomy may be required.

Consider CDAD if diarrhea develops during or after therapy and manage accordingly. Careful medical history necessary since CDAD may occur as late as 2 months or longer after anti-infective therapy is discontinued.

If CDAD suspected or confirmed, discontinue anti-infectives not directed against C. difficile as soon as possible. Manage using appropriate anti-infective therapy directed against C. difficile (e.g., vancomycin, fidaxomicin, metronidazole), supportive therapy (e.g., fluid and electrolyte management, protein supplementation), and surgical evaluation as clinically indicated.

Selection and Use of Anti-infectives

Use for treatment of acute bacterial exacerbations of chronic bronchitis only when no other treatment options available. Because gemifloxacin, like other systemic fluoroquinolones, has been associated with disabling and potentially irreversible serious adverse reactions (e.g., tendinitis and tendon rupture, peripheral neuropathy, CNS effects) that can occur together in the same patient, risks of serious adverse reactions outweigh benefits for patients with these infections.

When prescribing a fluoroquinolone, consider potential benefits and risks for the individual patient. Most patients tolerate the drugs, but serious adverse reactions (e.g., CNS effects, QT prolongation, C. difficile-associated diarrhea and colitis, damage to liver, kidneys, or bone marrow, alterations in glucose homeostasis) may occur rarely.

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

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

Information on test methods and quality control standards for in vitro susceptibility testing of antibacterial agents and specific interpretive criteria for such testing recognized by FDA is available at [Web].

Specific Populations

Pregnancy

Available data regarding use in pregnant women insufficient to inform any drug-associated risk for miscarriages, major birth defects, and/or adverse maternal or fetal outcomes.

Based on animal studies, gemifloxacin may cause fetal harm. Administration of gemifloxacin to pregnant mice or rabbits produced embryofetal toxicity at exposures 2 or 3 times, respectively, the human exposure reported with maximum recommended dosage.

Advise pregnant women of potential risk to fetus.

Lactation

Not known whether gemifloxacin distributes into human milk, affects milk production, or affects the breast-fed infant. Distributed into milk in rats.

Consider developmental and health benefits of breast-feeding along with the mother's clinical need for gemifloxacin; also consider potential adverse effects on breast-fed infant from the drug or underlying maternal condition.

Pediatric Use

Safety and efficacy of gemifloxacin not established in children or adolescents <18 years of age.

Like other fluoroquinolones, gemifloxacin causes arthropathy and osteochondrosis in juvenile animals. (See Musculoskeletal Effects under Cautions.)

AAP states use of a systemic fluoroquinolone may be justified in children <18 years of age in certain specific circumstances when there are no safe and effective alternatives and the drug is known to be effective.

Geriatric Use

No overall differences in safety or efficacy relative to younger adults.

Risk of severe tendon disorders, including tendon rupture, is increased in older adults (usually those >60 years of age). This risk is further increased in those receiving concomitant corticosteroids. (See Tendinitis and Tendon Rupture under Cautions.) Use caution in geriatric adults, especially those receiving concomitant corticosteroids.

Risk of aortic aneurysm and dissection may be increased in geriatric patients. (See Risk of Aortic Aneurysm and Dissection under Cautions.)

Risk of QT interval prolongation may be increased in geriatric patients. (See Prolongation of QT Interval under Cautions.)

Hepatic Impairment

Serum concentrations and AUC may be increased; dosage adjustments not needed.

Renal Impairment

Decreased renal clearance and prolonged half-life; reduce dosage in adults with Cl_cr ≤40 mL/minute. (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

GI effects (diarrhea, nausea, abdominal pain, vomiting), rash, headache, dizziness.

Drug Interactions

Does not inhibit and is not metabolized by CYP isoenzymes. Pharmacokinetic interactions with drugs metabolized by CYP isoenzymes unlikely.

Drugs that Prolong QT Interval

Potential pharmacologic interaction (additive effect on QT interval prolongation). Avoid use in patients receiving class IA (e.g., quinidine, procainamide) or class III (e.g., amiodarone, sotalol) antiarrhythmic agents. Use with caution in patients receiving other drugs that prolong QT interval (e.g., cisapride [available in US only under limited-access protocol], erythromycin, antipsychotic agents, tricyclic antidepressants). (See Prolongation of QT Interval under Cautions.)

Specific Drugs

Gemifloxacin Pharmacokinetics

Absorption

Bioavailability

Approximately 71%.

Rapidly absorbed from GI tract; peak plasma concentrations attained within 0.5 –2 hours.

Steady state achieved by third day of once-daily dosing.

Food

Administration of 320-mg dose with a standard high-fat breakfast (2 eggs cooked in butter, 2 strips of bacon, hash brown potatoes, 2 slices of toast with butter, 300 mL whole milk) reduces peak plasma concentration and AUC by 12 and 3%, respectively; this reduction in systemic exposure not considered clinically important.

Distribution

Extent

Widely distributed into body tissues and fluids, including lung tissue and fluids, following oral administration.

Distributed into milk in rats; not known whether distributed into human milk.

Plasma Protein Binding

60–70%.

Elimination

Metabolism

Metabolized to a limited extent in liver. Not metabolized by CYP isoenzymes.

Elimination Route

Eliminated by renal and nonrenal mechanisms.

Following an oral dose, 36% of dose eliminated in urine and 61% excreted in feces as unchanged drug and metabolites.

Half-life

7 hours (range 4–12 hours).

Special Populations

Hepatic impairment: Peak plasma concentrations increased 25% in adults with mild to moderate hepatic impairment (Child-Pugh class A or B) and increased 41% in those with severe hepatic impairment (Child-Pugh class C); no substantial change in plasma half-life. Increased serum concentrations not considered clinically important.

Renal impairment: Decreased clearance and prolonged half-life.

Geriatric patients: Pharmacokinetics in adults not affected by age.

Stability

Storage

Oral

Tablets

25°C (may be exposed to 15–30°C). Protect from light.

Actions and Spectrum

• Usually bactericidal.

• Like other fluoroquinolones, gemifloxacin inhibits bacterial DNA gyrase and topoisomerase IV.

• Spectrum of activity includes gram-positive aerobic bacteria, some gram-negative aerobic bacteria, and some other organisms (e.g., Chlamydophila, Mycoplasma).

• More active in vitro than some other fluoroquinolones against S. pneumoniae, but less active than ciprofloxacin in vitro against many Enterobacteriaceae and Pseudomonas aeruginosa.

• Gram-positive aerobes: Active in vitro and in clinical infections against S. pneumoniae (including penicillin-resistant and multidrug-resistant strains). Also active in vitro against Staphylococcus aureus (oxacillin-susceptible [methicillin-susceptible] strains only) and S. pyogenes (group A β-hemolytic streptococci).

• Gram-negative aerobes: Active in vitro and in clinical infections against H. influenzae, H. parainfluenzae, K. pneumoniae, and M. catarrhalis. Also active in vitro against some strains of Acinetobacter, K. oxytoca, Legionella pneumophila, and Proteus vulgaris.

• Other organisms: Active in vitro and in clinical infections against C. pneumoniae and M. pneumoniae. Has some activity against Mycobacterium tuberculosis in vitro, but is considerably less active against mycobacteria than some other fluoroquinolones (e.g., ciprofloxacin, ofloxacin, levofloxacin).

• Resistance to fluoroquinolones can occur because of mutations in DNA gyrase and/or topoisomerase IV. Like other fluoroquinolones, resistance to gemifloxacin develops slowly via multiple-step mutations and efflux.

• S. pneumoniae with mutations in both DNA gyrase and topoisomerase IV (double mutants) are resistant to most fluoroquinolones. Although clinical importance unknown, some S. pneumoniae with double mutants may be susceptible to gemifloxacin in vitro.

• Some cross-resistance occurs between gemifloxacin and other fluoroquinolones.

Advice to Patients

• Advise patients to read the manufacturer’s patient information (medication guide) prior to initiating gemifloxacin therapy and each time prescription refilled.

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

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

• 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 gemifloxacin or other antibacterials in the future.

• May be taken without regard to meals, but should be taken with liberal amounts of fluids.

• Importance of taking gemifloxacin at least 2 hours before or 3 hours after multivitamins containing iron, magnesium, or zinc; aluminum- or magnesium-containing antacids; or buffered didanosine (pediatric oral solution admixed with antacid). Importance of taking gemifloxacin at least 2 hours before sucralfate.

• Inform patients that systemic fluoroquinolones, including gemifloxacin, have been associated with disabling and potentially irreversible serious adverse reactions (e.g., tendinitis and tendon rupture, peripheral neuropathy, CNS effects) that may occur together in same patient. Advise patients to immediately discontinue gemifloxacin and contact a clinician if they experience any signs or symptoms of serious adverse effects (e.g., unusual joint or tendon pain, muscle weakness, a “pins and needles” tingling or pricking sensation, numbness of the arms or legs, confusion, hallucinations) while taking the drug. Advise patients to talk with a clinician if they have any questions or concerns.

• Inform patients that systemic fluoroquinolones, including gemifloxacin, are associated with an increased risk of tendinitis and tendon rupture in all age groups and this risk is increased in adults >60 years of age, individuals receiving corticosteroids, and kidney, heart, or lung transplant recipients. Importance of resting and refraining from exercise at first sign of tendinitis or tendon rupture (e.g., pain, swelling, or inflammation of a tendon or weakness or inability to use a joint) and importance of immediately discontinuing the drug and contacting a clinician. (See Tendinitis and Tendon Rupture under Cautions.)

• Inform patients that peripheral neuropathies have been reported with systemic fluoroquinolones, including gemifloxacin, and that symptoms may occur soon after initiation of the drug and may be irreversible. Importance of immediately discontinuing gemifloxacin and contacting a clinician if symptoms of peripheral neuropathy (e.g., pain, burning, tingling, numbness, and/or weakness) occur.

• Inform patients that systemic fluoroquinolones, including gemifloxacin, have been associated with CNS effects (e.g., convulsions, dizziness, lightheadedness, increased intracranial pressure, tremors, restlessness, lightheadedness, confusion, hallucinations) that can occur following first dose. Importance of informing clinician of any history of convulsions, seizures, or epilepsy before initiating therapy with the drug.

• Advise patients that gemifloxacin may cause dizziness and lightheadedness; caution patients not to engage in activities requiring mental alertness and motor coordination (e.g., driving a vehicle, operating machinery) until effects of the drug on the individual are known.

• Advise patients that systemic fluoroquinolones, including gemifloxacin, may worsen myasthenia gravis symptoms; importance of informing clinician of any history of myasthenia gravis. Importance of immediately contacting a clinician if any symptoms of muscle weakness, including respiratory difficulties, occur.

• Inform patients that gemifloxacin may be associated with hypersensitivity reactions (including anaphylactic reactions), even after first dose. Importance of immediately discontinuing gemifloxacin and contacting a clinician at first sign of rash, jaundice, or any other sign of hypersensitivity.

• Advise patient that gemifloxacin has been associated with rash or hives and that rash occurs most frequently in patients <40 years of age (especially women), in women receiving hormone replacement therapy, and in patients who receive gemifloxacin for >5 days (especially when given for >7 days). Importance of discontinuing gemifloxacin and informing a clinician if rash occurs.

• Inform patients that photosensitivity/phototoxicity reactions reported following exposure to sun or UV light in patients receiving fluoroquinolones. Importance of avoiding or minimizing exposure to sunlight or artificial UV light (e.g., tanning beds, UVA/UVB treatment) and using protective measures (e.g., wearing loose-fitting clothes, sunscreen) if outdoors during gemifloxacin therapy. Importance of discontinuing gemifloxacin and contacting a clinician if a sunburn-like reaction or skin eruption occurs.

• Inform patients that systemic fluoroquinolones may increase risk of aortic aneurysm and dissection; importance of informing clinician of any history of aneurysms, blockages or hardening of the arteries, high blood pressure, or genetic conditions such as Marfan syndrome or Ehlers-Danlos syndrome. Advise patients to seek immediate medical treatment if they experience sudden, severe, and constant pain in the stomach, chest, or back.

• Advise patient that gemifloxacin may prolong QT interval and should be avoided in those receiving class IA (e.g., quinidine, procainamide) or class III (e.g., amiodarone, sotalol) antiarrhythmic agents and should be used with caution in those receiving other drugs that prolong QT interval (e.g., cisapride [available in US only under limited-access protocol], erythromycin, antipsychotic agents, tricyclic antidepressants).

• Importance of informing clinician of personal or family history of QT interval prolongation or proarrhythmic conditions (e.g., hypokalemia, bradycardia, recent myocardial ischemia). Importance of informing a clinician if palpitations or fainting spells occur.

• Inform patients that hypoglycemia reported when systemic fluoroquinolones used in some patients receiving antidiabetic agents. Advise patients with diabetes mellitus receiving oral antidiabetic agents or insulin to discontinue gemifloxacin and contact a clinician if they experience hypoglycemia or symptoms of hypoglycemia.

• Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued. Importance of contacting a clinician if watery and bloody stools (with or without stomach cramps and fever) occur during or as late as 2 months or longer after the last dose.

• Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs (e.g., drugs that may affect QT interval, warfarin), as well as any concomitant illnesses.

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

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

Preparations

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

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

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