Home Drug Guide Gemifloxacin Mesylate

Drug Guide

Generic Name

Gemifloxacin Mesylate

Brand Names Factive

Classification

Therapeutic: Antibiotic, Fluoroquinolone

Pharmacological: DNA gyrase and topoisomerase IV inhibitor

FDA Approved Indications

Treatment of adult community-acquired pneumonia caused by susceptible bacteria

Mechanism of Action

Inhibits bacterial DNA gyrase and topoisomerase IV enzymes, disrupting bacterial DNA replication, transcription, repair, and recombination, leading to bacterial cell death.

Dosage and Administration

Adult: 320 mg once daily, taken orally with or without food

Pediatric: Not approved for pediatric use

Geriatric: No specific dosage adjustment needed, but caution in elderly due to potential for increased adverse reactions

Renal Impairment: Adjust dose in severe impairment; see prescribing information

Hepatic Impairment: No specific adjustment recommended

Pharmacokinetics

Absorption: Well absorbed orally, peak plasma levels in 1-2 hours

Distribution: Widely distributed in body tissues and fluids, protein binding approximately 45%

Metabolism: Primarily excreted unchanged in urine; minimal hepatic metabolism

Excretion: Renal and fecal routes

Half Life: About 11 hours

Contraindications

Hypersensitivity to gemifloxacin or other quinolones

Precautions

Not recommended for use in children and adolescents due to risk of musculoskeletal adverse effects
History of tendon disorders related to quinolone use
Use with caution in patients with central nervous system disorders,QT prolongation, or electrolyte abnormalities

Adverse Reactions - Common

Nausea (Common)
Diarrhea (Common)
Headache (Common)
Dizziness (Common)

Adverse Reactions - Serious

Tendon rupture (Rare)
QT prolongation leading to arrhythmias (Rare)
Hypersensitivity reactions including anaphylaxis (Rare)
Serious skin reactions like Stevens-Johnson syndrome (Rare)

Drug-Drug Interactions

Theophylline (monitor levels)
Warfarin (increased anticoagulant effect)
Agents that prolong QT interval

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Assessment: Monitor for signs of tendon pain or swelling, CNS effects, and signs of hypersensitivity. Assess for history of QT prolongation.

Diagnoses:

Risk for tendon rupture
Risk for hypoglycemia if used with hypoglycemic agents
Risk for QT prolongation

Implementation: Administer with food to reduce gastrointestinal upset. Educate patient on signs of adverse effects.

Evaluation: Monitor for resolution of infection, adverse effect symptoms, and any signs of tendon injury or cardiac arrhythmias.

Patient/Family Teaching

Take exactly as prescribed, complete the entire course.
Report any pain, swelling, or rupture of tendons.
Avoid excessive sun exposure; skin reactions may occur.
Report any signs of allergic reactions, severe diarrhea, or neurological symptoms.
Inform about potential interactions with other medications.

Special Considerations

Black Box Warnings:

Tendon rupture and tendinitis, especially in patients >60 years, concurrent corticosteroid use, or transplant recipients.
Myasthenia gravis exacerbation.

Genetic Factors: QT prolongation risk may be increased in patients with certain genetic variants affecting cardiac repolarization.

Lab Test Interference: May cause false-positive urinary tests for sugar.

Overdose Management

Signs/Symptoms: Nausea, vomiting, dizziness, hallucinations, seizures, QT prolongation,

Treatment: Supportive care, activated charcoal if ingestion recent, monitor cardiac function, electrolyte correction.

Storage and Handling

Storage: Store at room temperature, away from light and moisture.

Stability: Stable for the duration of labeled expiration date.