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Pharmacologic class: Quinolone
Therapeutic class: Broad-spectrum anti-infective
Pregnancy risk category C
Inhibits DNA synthesis by inhibiting DNA gyrase and topoisomerase IV, enzymes needed for bacterial growth
Tablets: 320 mg
Indications and dosages
➣ Acute exacerbation of chronic bronchitis caused by susceptible organisms
Adults: 320 mg P.O. daily for 5 days
➣ Mild to moderate communityacquired pneumonia caused by susceptible organisms
Adults: 320 mg P.O. daily for 5 days
• Renal impairment
• Hypersensitivity to drug
• History of prolonged QTc interval
Use cautiously in:
• epilepsy or history of seizures
• pregnant or breastfeeding patients
• children younger than age 18 (safety not established).
• Give at same time every day with plenty of fluids, with or without food.
• Make sure patient swallows tablet whole without chewing.
• Don't give iron, multivitamins, didanosine, sucralfate, or antacids containing magnesium or aluminum within 3 hours of gemifloxacin.
CNS: fatigue, headache, insomnia, drowsiness, nervousness, dizziness, tremor, vertigo, seizures, loss of consciousness
CV: hypotension, prolonged QTc interval, cardiovascular collapse, shock
EENT: vision abnormality, pharyngitis
GI: nausea, vomiting, diarrhea, constipation, abdominal pain, dyspepsia, gastritis, gastroenteritis, flatulence, anorexia, dry mouth, pseudomembranous colitis
GU: genital candidiasis, vaginitis, acute renal insufficiency or failure, interstitial nephritis
Hematologic: eosinophilia, anemia, leukopenia, granulocytopenia, thrombocytopenia
Hepatic: jaundice, hepatitis, acute hepatic necrosis, hepatic failure
Musculoskeletal: joint, back, or muscle pain; leg cramps; tendinitis; rupture of shoulder, hand, or Achilles tendon
Respiratory: dyspnea, pneumonia
Skin: rash, urticaria, pruritus, eczema, flushing, photosensitivity, angioedema
Other: altered taste, hot flashes, fungal infection, hypersensitivity reaction
Drug-drug. Antacids containing aluminum or magnesium, didanosine, iron, multivitamins, sucralfate: reduced gemifloxacin absorption
Antiarrhythmics (class IA, such as quinidine and procainamide, and class III, such as amiodarone and sotalol), antipsychotics, erythromycin, tricyclic antidepressants: increased risk of prolonged QTc interval
Sucralfate: decreased gemifloxacin bioavailability
Drug-diagnostic tests. Alanine aminotransferase, aspartate aminotransferase, bilirubin: increased levels
Drug-behaviors. Sun exposure: increased risk of photosensitivity
• Stay alert for signs and symptoms of hypersensitivity reaction and other serious adverse reactions.
• Monitor ECG in patients at risk for prolonged QTc interval.
☞ Watch for signs and symptoms of tendinitis or tendon rupture.
• Instruct patient to take drug at same time each day, with or without food.
• Teach patient how to recognize and report signs and symptoms of allergic response.
• Advise patient to take iron, vitamins, antacids, didanosine, or sucralfate 3 hours before or 2 hours after gemifloxacin.
☞ Instruct patient to stop taking drug and immediately report signs or symptoms of hypersensitivity reaction, severe diarrhea, change in urination pattern, easy bruising or bleeding, unusual tiredness, or yellowing of eyes or skin.
☞ Advise patient to stop taking drug and immediately report sudden severe pain in shoulder, hand, or Achilles tendon.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration and alertness.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, and behaviors mentioned above.