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All about: Gemifloxacin Mesylate

Big Image Pronouncation: (jeh-mih-FLOKS-ah-sin MEH-sih-LATE)
Class: Fluoroquinolone

Trade Names:
Factive
- Tablets 320 mg

Mechanism of Action

Pharmacology

Interferes with microbial DNA synthesis.

Pharmacokinetics

Absorption

Rapidly absorbed from the GI tract. Bioavailability is approximately 71%. C max is about 1.61 mcg/mL, and the AUC is about 9.93 mcg•h/mL.

Distribution

Protein binding ranges from 55% to 73%. Mean Vd ss is 4.18 L/kg.

Metabolism

Metabolized to a limited extent by the liver.

Elimination

61% in the feces and 36% in the urine as unchanged drug and metabolites. The t ½ is approximately 7 h. The mean renal Cl following multiple doses was approximately 11.6 L/h.

Special Populations

Renal Function Impairment

Average increase in AUC of approximately 70% in patients with renal function impairment.

Indications and Usage

Treatment of acute bacterial exacerbation of chronic bronchitis and community-acquired pneumonia (mild to moderate) caused by susceptible strains of designated microorganisms.

Contraindications

Standard considerations.

Dosage and Administration

Acute Bacterial Exacerbation of Chronic Bronchitis
Adults

PO 320 mg/day for 5 days.

Community-Acquired Pneumonia (Mild to Moderate Severity)
Adults

PO 320 mg/day for 7 days.

Renal function impairment
Adults (CrCl 40 mL/min or less)

PO 160 mg every 24 h. Patients requiring routine hemodialysis or continuous ambulatory peritoneal dialysis should receive 160 mg every 24 h.

General Advice

  • Administer gemifloxacin either 2 h before or 3 h after sucralfate, antacids containing magnesium or aluminum, didanosine buffered tablets or pediatric powder, or other products containing iron or zinc.
  • Administer prescribed dose with a full glass of water.
  • Administer without regard to meals, but administer with food if GI upset occurs.

Storage/Stability

Store tablets at room temperature (59° to 86°F). Protect from light.

Drug Interactions

Antacids containing aluminum, magnesium, and calcium; drug formulations containing divalent and trivalent cations (eg, didanosine); metal cations (eg, iron); multivitamins containing iron or zinc

May decrease the bioavailability of gemifloxacin.

Probenecid

The renal clearance of gemifloxacin may be decreased, increasing the bioavailability and AUC.

Sucralfate

May decrease the bioavailability of gemifloxacin. Take at least 2 h before sucralfate.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Headache, dizziness (1%).

Dermatologic

Rash (3%).

GI

Diarrhea (4%); nausea (3%); vomiting, abdominal pain (1%).

Hepatic

Increased ALT (2%) and AST (1%).

Precautions

Monitor

Response to therapy

Monitor patient's response to therapy. Notify health care provider if infection does not appear to improve or worsens.


Pregnancy

Category C .

Lactation

Undetermined; however, other fluoroquinolones have been shown to be excreted in breast milk.

Children

Safety and efficacy not established.

Hypersensitivity

Mild to life-threatening. Discontinue drug at first sign of hypersensitivity reaction.

Renal Function

Reduced clearance may occur; decrease the dose in patients with CrCl of 40 mL/min or less.

Superinfection

Use of antibiotics may result in bacterial or fungal overgrowth.

Photosensitivity

Photosensitivity reaction may occur.

CNS effects

Use with caution in patients with CNS disease (eg, epilepsy) or patients predisposed to convulsions.

Pseudomembranous colitis

Consider possibility in patients with diarrhea.

QT effects

Gemifloxacin may prolong the QT interval in some patients; avoid in patients with a history of prolongation of the QTc interval, patients with uncorrected electrolyte disorder (eg, hypokalemia or hypomagnesemia), and patients receiving class IA (eg, quinidine, procainamide) or class III (eg, amiodarone, sotalol) antiarrhythmic agents. Use gemifloxacin with caution in patients receiving drugs that prolong the QTc interval (eg, erythromycin, tricyclic antidepressants, antipsychotics) and in patients with ongoing proarrhythmic conditions (eg, clinically important bradycardia, acute MI).

Tendon and cartilage effects

Tendonitis and rupture of the shoulder, hand, and Achilles tendons, requiring surgical repair and resulting in prolonged disability, have been reported in patients receiving fluoroquinolones. The risk may be increased in patients receiving corticosteroids, especially in the elderly.

Overdosage

Symptoms

Possible QTc prolongation, tremor, convulsions.

Patient Information

  • Advise patient to read patient information leaflet before starting therapy and with each refill.
  • Review dosing schedule and prescribed length of therapy with patient.
  • Instruct patient to take each dose with a full glass of water.
  • Advise patient that medication can be taken without regard to meals, but to take with food if GI upset occurs.
  • Advise patient that if a dose is missed to take as soon as remembered. However, if it is nearing the time for the next dose, to skip the dose and take the next dose at the regularly scheduled time. Caution patient not to take more than 1 dose of medication in a day.
  • Remind patient to complete entire course of therapy, even if symptoms of infection have disappeared.
  • Advise patient to inform health care provider if infection does not improve or worsens.
  • Advise patient to drink fluids liberally (eg, eight 8 oz glasses of water daily) while taking this medication.
  • Advise patient to discontinue therapy and contact health care provider immediately if skin rash, hives, itching, shortness of breath, palpitations, fainting, pain, tenderness, or rupture of tendon occur.
  • Warn patient that diarrhea containing blood or pus may be a sign of a serious disorder and to seek medical care if noted and not to treat at home.
  • Caution patient that drug may cause dizziness and to use caution while driving or performing other tasks requiring mental alertness until tolerance is determined.
  • Advise patient to avoid unnecessary exposure to direct and indirect sunlight or tanning lamps, and to use sunscreen and wear protective clothing to avoid photosensitivity reactions during therapy and for several days after stopping medication. Advise patient to discontinue therapy and notify health care provider if any of the following occur following exposure to sunlight or artificial UV light (eg, sunlamp): sensation of skin burning, redness, swelling, blistering, rash or itching.
  • Inform patient not to take antacids containing magnesium and/or aluminum or products containing ferrous sulfate (iron), multivitamins containing zinc or other metal cations, or chewable buffered tablets (didanosine) within 3 h before or 2 h after taking gemifloxacin.
  • Inform patient that gemifloxacin may produce prolongation of the QTc interval on an ECG.
  • Instruct patient to inform health care provider of any personal or family history of QTc prolongation or proarrhythmic conditions such as recent hypokalemia, significant bradycardia, acute MI, or history of convulsions.

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