Xemi

Xemi320mg

Type:Tablet

Generic Name:Gemifloxacin

Manufacturer:Orion Pharma Ltd.

Price:50.15

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Indication

Chronic bronchitis, Community-acquired pneumonia

Administration

May be taken with or without food.

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.

Contraindication

Hypersensitivity. Patients receiving class IA or III antiarrhythmics.

Mode 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.

Precaution

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

Side Effect

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

Interaction

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.

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