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Gemifloxacin information from DrugsUpdate  

See Available Brands of Gemifloxacin in India

P - Caution when used during pregnancy
L - Caution when used during lactation

Gemifloxacin mesylate (trade name Factive, Oscient Pharmaceuticals) is an oral broad-spectrum quinolone antibacterial agent used in the treatment of acute bacterial exacerbation of chronic bronchitis and mild-to-moderate pneumonia. Oscient Pharmaceuticals has licensed the active ingredient from LG Life Sciences of Korea.

Pharmacodynamics

Pharmacokinetics

Gemifloxacin inhibits DNA gyrase and DNA topoisomerase IV. DNA gyrase is needed for DNA replication and transcription, DNA repair, recombination and transposition. Topoisomerase IV facilitates separation of intertwined, replicated DNA before cell division occurs. Gemifloxacin forms a ternary complex with gyrase and topoisomerase IV, which blocks DNA replication, thus resulting in DNA release, chromosomal disruption and cell death.


Absorption Rapidly absorbed from the GI tract; absolute bioavailability: About 71%.


Distribution Widely distributed into body tissues including bronchial mucosa and lungs. 55-73% bound to plasma proteins.


Metabolism Limited hepatic metabolism.


Excretion Elimination half-life: 7 hr. As unchanged drug and metabolites in the faeces and urine.

Gemifloxacin Indications / Gemifloxacin Uses

Information Not Available

Gemifloxacin Adverse Reactions / Gemifloxacin Side Effects

Diarrhoea, nausea, vomiting; headache, dizziness; rash, urticaria. May cause elevation of liver enzymes

Precautions

Warnings Tendonitis Gemifloxacin has been associated with an increased risk of tendonitis and tendon rupture in patients of all ages. The risk is increased in patients older than 60 yr of age, in patients taking corticosteroids, and in patients with kidney, heart, or lung transplants. Monitor Response to therapy Monitor patient's response to therapy.

Special Precautions

History of prolongation of QT interval, uncorrected electrolyte disorders, CNS diseases such as epilepsy. Maintain adequate hydration. Increased risk of rash when treatment duration is prolonged. Children <18 yr. Pregnancy, lactation.

Other Drug Interactions

Lower bioavailability if coadministered with multivalent cation preparations e.g. aluminum, magnesium, or iron salts. May potentiate QT prolongation when used with drugs that affect the QT interval e.g. cisapride, erythromycin, antipsychotics and TCAs. May increase prothrombin time when used with warfarin or its derivatives. Increased plasma levels when used with probenecid.

Other Interactions

Information Not Available

Dosage

Oral Acute bacterial exacerbation of chronic bronchitis Adult: 320 mg once daily for 5 days. CrCl (ml/min):≤40 Dosage Recommendation: 160 mg every 24 hr. Oral Community-acquired pneumonia Adult: 320 mg once daily for 7 days. CrCl (ml/min): ≤40 Dosage Recommendation: 160 mg every 24 hr.

Food(before/after)

May be taken with or without food

List of Contraindications

Gemifloxacin and Pregnancy

Caution when used during pregnancy Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Gemifloxacin and Lactation

Caution when used during lactation

Gemifloxacin and Children

Safety and efficacy not established

Gemifloxacin and Geriatic

Information Not Available

Gemifloxacin and Other Contraindications

Hypersensitivity. Patients receiving class IA or III antiarrhythmics.

Storage

Oral: Store between 15-30 ℃.

Lab interference

Oral: Store between 15-30 ℃.

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