Applies to gemifloxacin: oral tablets.
Warning
-
Serious Adverse Reactions
- 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 have occurred together.1 Discontinue immediately and avoid use of fluoroquinolones, including gemifloxacin, in patients who have experienced any of these serious adverse reactions.1 (See Warnings under Cautions.)
- Fluoroquinolones, including gemifloxacin, may exacerbate muscle weakness in patients with myasthenia gravis.1 Avoid in patients with known history of myasthenia gravis.1
- Because of risk of serious adverse reactions, use gemifloxacin for treatment of acute bacterial exacerbations of chronic bronchitis only when no other treatment options available.1
Side effects include:
GI effects (diarrhea, nausea, abdominal pain, vomiting), rash, headache, dizziness.
For Healthcare Professionals
Applies to gemifloxacin: oral tablet.
Dermatologic
Most side effects reported during postmarketing experience were cutaneous (some were considered serious) and the majority of these were rash. Most rashes occurred in patients younger than 40 years, in women (especially those on hormone replacement therapy), and in patients taking this drug for longer treatment durations (over 7 days).
The phototoxic potential of this drug may be dose-dependent.[Ref]
Common (1% to 10%): Rash
Uncommon (0.1% to 1%): Dermatitis, pruritus, urticaria
Rare (less than 0.1%): Eczema, photosensitivity/phototoxicity reactions
Postmarketing reports: Erythema multiforme, skin exfoliation[Ref]
Gastrointestinal
Common (1% to 10%): Diarrhea, nausea, abdominal pain, vomiting
Uncommon (0.1% to 1%): Constipation, dry mouth, dyspepsia, flatulence, gastritis
Rare (less than 0.1%):Gastroenteritis, nonspecified gastrointestinal disorder
Frequency not reported: Clostridium difficile-associated diarrhea
Postmarketing reports: Antibiotic-associated colitis[Ref]
Nervous system
Cases of sensory or sensorimotor axonal polyneuropathy (affecting small and/or large axons) resulting in paresthesias, hypoesthesias, dysesthesias, and weakness have been reported.[Ref]
Common (1% to 10%): Headache, dizziness
Uncommon (0.1% to 1%): Somnolence, taste perversion
Rare (less than 0.1%): Tremor, vertigo, central nervous system effects
Frequency not reported: Seizures, sensory axonal polyneuropathy, sensorimotor axonal polyneuropathy, paresthesias, hypoesthesias, dysesthesias, neurotoxicity (presenting as encephalopathy)
Postmarketing reports: Exacerbation of myasthenia gravis, peripheral neuropathy (may be irreversible), syncope[Ref]
Hepatic
Common (1% to 10%): Increased ALT, increased AST
Uncommon (0.1% to 1%): Increased GGT, increased total bilirubin
Rare (less than 0.1%): Bilirubinemia[Ref]
Other
Uncommon (0.1% to 1%): Fatigue, fungal infection, increased alkaline phosphatase, increased potassium, decreased albumin, decreased sodium, decreased calcium, decreased total protein, decreased potassium, increased sodium
Rare (less than 0.1%): Asthenia, facial edema, flushing, hot flashes, pain, moniliasis, increased LDH, increased calcium
Frequency not reported: Weakness
Postmarketing reports: Facial swelling, peripheral edema[Ref]
Metabolic
Uncommon (0.1% to 1%): Anorexia, hyperglycemia[Ref]
Musculoskeletal
Uncommon (0.1% to 1%): Increased creatine phosphokinase
Rare (less than 0.1%): Arthralgia, back pain, leg cramps, myalgia
Frequency not reported: Tendinitis
Postmarketing reports: Tendon rupture[Ref]
Hematologic
Uncommon (0.1% to 1%): Increased platelets, decreased neutrophils, increased neutrophils, decreased hematocrit, decreased hemoglobin, decreased platelets, decreased RBCs, increased hematocrit, increased hemoglobin, increased RBCs, leukopenia, thrombocythemia
Rare (less than 0.1%): Anemia, eosinophilia, granulocytopenia, thrombocytopenia
Postmarketing reports: Hemorrhage, increased INR[Ref]
Psychiatric
Uncommon (0.1% to 1%): Insomnia
Rare (less than 0.1%): Nervousness
Renal
Uncommon (0.1% to 1%): Increased BUN, increased serum creatinine
Rare (less than 0.1%): Increased non-protein nitrogen
Frequency not reported: Acute renal failure
Postmarketing reports: Renal failure[Ref]
Genitourinary
Uncommon (0.1% to 1%): Genital moniliasis, genital pruritus, vaginitis
Rare (less than 0.1%): Abnormal urine[Ref]
Ocular
Rare (less than 0.1%): Abnormal vision
Postmarketing reports: Retinal hemorrhage[Ref]
Respiratory
Rare (less than 0.1%): Dyspnea, pharyngitis, pneumonia
Frequency not reported: Bronchitis[Ref]
Cardiovascular
QTc interval prolongation has been reported; no cardiovascular morbidity or mortality due to QTc prolongation occurred during studies. Maximum QTc changes occurred 5 to 10 hours after oral administration of this drug. This effect may be dose-related.[Ref]
Frequency not reported: Ventricular extrasystoles
Postmarketing reports: Prolonged QT, supraventricular tachycardia, transient ischemic attack[Ref]
Hypersensitivity
Frequency not reported: Hypersensitivity reactions
Postmarketing reports: Anaphylactic reactions[Ref]
