GEMIFLOXACIN (gem-i-flox'a-cin)
Factive Classifications: antibiotic; quinolone; Therapeutic: antibiotic Prototype: Ciprofloxacin HCl Pregnancy Category: C
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Availability
320 mg tablet
Action
Gemifloxacin inhibits bacterial DNA gyrases (topoisomerase II), enzymes essential in replication, transcription, and repair
of bacterial DNA.
Therapeutic Effect
Gemifloxacin is active against a wide range of gram-positive and gram-negative bacteria. Gemifloxacin has greater activity
against gram-positive cocci and against penicillin- and ciprofloxacin-resistant Streptococcus pneumoniae than other fluoroquinolones.
Uses
Treatment of acute exacerbations of chronic bronchitis, mild to moderate community-acquired pneumonia.
Unlabeled Uses
Acute sinusitis, UTI, acute pyelonephritis.
Contraindications
Hypersensitivity to gemifloxacin or other fluoroquinolone antibiotics; known QT prolongation; tendon pain; viral disease;
pregnancy (category C), lactation. Safety and effectiveness in children <18 y have not been established.
Cautious Use
Hypokalemia, hypomagnesemia, or concurrent use of Class IA or III antiarrhythmic agents; bradycardia, acute myocardial ischemia;
concurrent use of other medications that may prolong the QT interval; renal disease or impairment; hepatic disease; central
nervous system disorders such as epilepsy; glucose 6-phosphate dehydrogenase deficiency; tendonitis, elderly, concurrent use
of corticosteroids.
Route & Dosage
Acute Exacerbation of Chronic Bronchitis Adult: PO 320 mg q.d. x 5 d
Community-Acquired Pneumonia Adult: PO 320 mg q.d. x 7 d
Sinusitis Adult: PO 320 mg q.d. x 10 d
UTI Adult: PO 320 mg q.d. x 3 d
Renal Impairment Clcr ≤40 mL/min: 160 mg q.d.
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Administration
Oral
- Give 2 h before/3 h after drugs containing aluminum, magnesium, iron, zinc, or buffered tablets of any type.
- Give at least 2 h before sucralfate.
- Store at 15°30° C (59°86° F) and protect from light.
Adverse Effects (≥1%)
CNS: Headache.
GI: Nausea, vomiting, diarrhea, elevated liver enzymes.
Skin: Rash.
Interactions
Drug: antacids,
didanosine (tablets and powder), iron, sevelamer, sulcralfate decrease absorption; may prolong the QT interval with
amiodarone, bretylium, disopyramide, dofetilide, ibutilide, quinidine, procainamide, sotalol leading to arrhythmias; may augment phototoxicity of
retinoids.
Pharmacokinetics
Absorption: 71% absorbed.
Peak: 0.52 h.
Metabolism: Minimally in liver.
Elimination: Primarily renal.
Half-Life: 7 h.
Nursing Implications
Assessment & Drug Effects
- Monitor cardiac status, especially with concurrent use of drugs that may prolong the QT interval. Report immediately bradycardia
or S&S of heart failure.
- Withhold drug and report to physician any of the following: tremors, restlessness, lightheadedness, confusion, hallucinations,
paranoia, depression, nightmares, and insomnia.
- Lab tests: C&S prior to initiation of therapy; baseline and periodic serum electrolytes; frequent blood glucose levels in
diabetics; CBC with differential and platelet count with prolonged treatment.
Patient & Family Education
- Use sunscreen and protective clothing outdoors. Avoid sun lamps.
- Stop gemifloxacin and notify physician for pain or swelling of a tendon or around a joint.
- Drink fluid liberally (unless contraindicated) while taking this drug.
- Do not drive or engage in other hazardous activities until reaction to drug is known.