GEMIFLOXACIN

GEMIFLOXACIN (gem-i-flox'a-cin) Factive Classifications: antibiotic; quinolone; Therapeutic: antibiotic Prototype: Ciprofloxacin HCl Pregnancy Category: C

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.

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: 0.5–2 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.

---

Common adverse effects in italic, life-threatening effects underlined; generic names in bold; classifications in SMALL CAPS; Canadian drug name; Prototype drug