Gemifloxacin- @-(FDC- List )-(Jun 1995)
Drug Name:Gemifloxacin- @-(FDC- List )-(Jun 1995)
List Of Brands:
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Drug Interaction:
Avoid drugs that prolong QTc intervals eg.
class 1A or class III antarrhythmics , erythromycin, antipsychotics , tricyclics
Separate dosing of magnesium or aluminium containing antacids and didanosine , sucrafate, iron, zinc or other metals cations (do not take within 3 hours before or 2 hours after gemifloxacin Potentiated by probenecid Increased risk of tendinitis and tendon rupture with corticosteroids Monitor warfarin
Indication:
Adverse Reaction:
Photoxic potentials of fluroquinolones are infuenced by the sybstituent at position 8.
Gemifloxacins potential to cause photoxicity ie less compared to other quinolones Reported to demonstrate small nonsignificant QTc interval prolongation by gemifloxacin is not significant as compared to other quinolones Gemifloxacin has less propensity to cause hyperglkycemia and hypoglycemia of all pts who received a hypoglycemic agent combined with gemifloxcin or a compartor antibitic.
Contra-Indications:
Contraindicated pts with a history of hypersensitivity to gemifloxacin antibiotic agents or any of product components
Dosages/ Overdosage Etc:
Gemifloxacin is indicated for -
infections by suseptible strains
Acute bacterial exacerbation of chronic bronchitis, Community aquired pneumonia
Dosage-
320mg once daily Swallow whole Take with a full glass of water Bronchitis - treat for 5 days
Patient Information:
Information for Patients
Patients should be counseled:
• that antibacterial drugs including FACTIVE should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold).
When FACTIVE is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed.
Skipping doses or not completing the full course of therapy may (1) decrease effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by 580 FACTIVE or other antibacterial drugs in the future;
•. that FACTIVE has been associated with rash and hives. Rash occurs more commonly in those under 40, especially women and in women on hormone replacement therapy. The incidence of rash increases with duration more than 5 days and particularly longer than 7 days.
Patients should discontinue FACTIVE and call their healthcare provider if they develop a rash;
• that FACTIVE may be associated with hypersensitivity reactions, including anaphylactic reactions, even following a single dose; patients should immediately discontinue the drug at the sign of a rash or other allergic reaction and seek medical care;
• that diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible;
• that FACTIVE may cause changes in the electrocardiogram (QTc interval prolongation);
• that FACTIVE should be avoided in patients receiving Class IA (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic agents;
• that FACTIVE should be used with caution in patients receiving drugs that affect the QTc interval such as cisapride, erythromycin, antipsychotics, and tricyclic antidepressants;
• to inform their physician of any personal or family history of QTc prolongation or proarrhythmic conditions such as hypokalemia, bradycardia, or recent myocardial ischemia;
• to contact their physician if they experience palpitations or fainting spells while 6taking FACTIVE;
• that FACTIVE may cause dizziness; if this occurs, patients should not operate an automobile or machinery or engage in activities requiring mental alertness or coordination;
• that they should discontinue FACTIVE therapy and inform their physician if they feel pain, tenderness or rupture of a tendon. Patients should rest and avoid exercise until the diagnosis of tendonitis or tendon rupture has been excluded. The risk of serious tendon disorders is higher in those over 65 years of age, especially those on steroids;
• that convulsions have been reported in patients receiving quinolones. Patients should notify their physician before taking FACTIVE if they have a history of convulsions, seizures, or epilepsy;
• that other central nervous system problems such as tremors, restlessness, lightheadedness, confusion and hallucinations may occur rarely;
• that phototoxicity has been reported with certain quinolones. The potential for FACTIVE to cause phototoxicity was low. In keeping with good clinical practice, avoid excessive sunlight or artificial ultraviolet light (e.g., tanning beds). If a sunburn-like reaction or skin eruption occurs, contact your physician;
August 2011
Pharmacology/ Pharmacokinetics:
Pharmacology-
Gemifloxacin is a dual acting quinolone which inhibits two specific enzymes.DNA gyrase and DNA topoisonmerase IV which aid in bacterial DNA replicatin. Other hand older quinolones inhibit either DNA gyrase or topoisonmerase IV
The efficacy of gemifloxacin has been studied in the treatment of respiratory tract infections like community acquited pneumonia and acute exacerbation of chronic bronchitis.
Phamacokinetics-
Rapidly absorbed after poral administration .Peak conc occurs in 30-120 minutes. Bioavailability is 71%.Approx 20-30% of administred dosage is excreted unchanged in urine.Plasma half-lfe is approx 6-8 hrs . Fecal exctretion is through biliary and gastrointestinal pathways.