FACTIVE Tablets / Film-coated
Gemifloxacin
320mg
Tabuk Pharmaceutical Manufacturing Co.
| Pack size | 7's Blister |
|---|---|
| Dispensing mode | POM |
| Source | SAUDI ARABIA |
| Agent | ALPHAMED CO. (AUH) LTD. |
| Retail Price | 108.50 AED |
Available as:
Indications
FACTIVE Tablets / Film-coated is used for:
Chronic bronchitis, Community-acquired pneumonia
Adult Dose
Oral
Acute bacterial exacerbation of chronic bronchitis
Adult: 320 mg once daily for 5 days.
Community-acquired pneumonia
Adult: Mild to moderate: 320 mg once daily for 7 days.
Child Dose
Safety and efficacy not established
Renal Dose
Renal impairment:
CrCl (ml/min)
<40 (or patient on haemodialysis/CAPD) 160 mg once daily.
Administration
May be taken with or without food.
Contra Indications
Hypersensitivity. Patients receiving class IA or III antiarrhythmics.
Precautions
Patient w/ known or suspected CNS disorders (e.g. seizure disorders) or other risk factors predisposing to seizures, myasthenia gravis, previous tendon disorders (e.g. rheumatoid arthritis), history of QT interval prolongation, significant bradycardia or acute myocardial ischaemia, uncorrected electrolyte disorders. Kidney, heart or lung transplant recipients. Renal impairment. Pregnancy and lactation. Patient Counselling May impair ability to perform activities that require mental alertness or coordination (e.g. driving, operating machinery).
Rest and refrain from doing strenuous physical activity as it may increase risk of tendon rupture. Avoid excessive exposure to sunlight or artificial UV light (e.g. tanning beds) and use protective measures (e.g. sunscreen, wear loose-fitting clothes) if staying outdoors is necessary during therapy. Monitoring Parameters Monitor WBC, signs and symptoms of infection and renal function.
Lactation: excretion in milk unknown; do not use unless benefit to mother outweighs risk
Pregnancy-Lactation
Pregnancy
Limited available human data with use in pregnant women are insufficient to inform an associated risk of miscarriages, major birth defects, and/or adverse maternal or fetal outcomes; based on animal studies with gemifloxacin, therapy, may cause fetal harm; in animal reproduction studies, administration of drug to pregnant mice and rabbits during the period of organogenesis produced embryofetal toxicity at exposures up to 2 and 3 times, respectively, the maximum recommended human dose; advise pregnant women of potential risk to fetus
Lactation
There is no data on presence of gemifloxacin in human milk, effects on milk production, on breastfed infant; drug is excreted in breast milk of rats; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from treatment or from underlying maternal condition
Interactions
Additive effect on QT interval prolongation w/ class IA (e.g. quinidine) or class III (e.g. amiodarone) antiarrhythmics and other drugs that prolong QT interval (e.g. erythromycin, TCAs, antipsychotic agents). Renal clearance reduced w/ probenecid. Decreased absorption w/ Al or Mg-containing antacids, buffered didanosine, sucralfate or dietary supplements containing metal cations (e.g. Zn, Mg, Fe).
Increased risk of severe tendon disorders esp in elderly (>60 yr) w/ corticosteroids. May increase prothrombin time, INR and/or bleeding w/ warfarin.
Adverse Effects
Side effects of Gemifloxacin :
1-10%
Diarrhea (5%), Headache (4%), Nausea (4%), Rash (4%), Transaminases increased (1-4%), Abdominal pain (2%), Dizziness (2%), Vomiting (2%), Neutropenia (1%), Platelets increased (1%), Thrombocythemia (1%), GGT increased (1%)
<1%
Peripheral neuropathy, Photosensitivity, Tendon rupture
Mechanism of Action
The bactericidal action of gemifloxacin results from inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV, which are required for bacterial DNA replication, transcription, repair, and recombination.
Note
FACTIVE 320mg Tablets / Film-coated manufactured by Tabuk Pharmaceutical Manufacturing Co.. Its generic name is Gemifloxacin. FACTIVE is availble in United Arab Emirates.
Farmaco UAE drug index information on FACTIVE Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.