Factive

Factive

gemifloxacin

Manufacturer:

LG Chem

Distributor:

Pahang Pharmacy
Concise Prescribing Info
Contents
Gemifloxacin mesylate
Indications/Uses
Mild to moderate community-acquired pneumonia.
Dosage/Direction for Use
Pneumonia due to S pneumoniae, H influenzae, M pneumoniae or C pneumoniae infection 1 tab once daily for 5 days. Pneumonia due to MDRSP, K pneumoniae or M catarrhalis infection 1 tab once daily for 7 days. Severe renal impairment, haemodialysis & continuous ambulatory peritoneal dialysis (CAPD) patient 160 mg once daily.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity to gemifloxacin or other quinolones. History of gemifloxacin or other quinolone-associated tendonitis & tendon rupture. Pregnancy & lactation. Childn or adolescents <18 yr.
Special Precautions
Discontinue use if hypersensitivity, tendon pain, swelling, inflammation or rupture occurs. Previous tendon disorder eg, RA. Increased risk of peripheral neuropathy. Clostridium difficile-associated diarrhea. Epilepsy, patients predisposed to convulsions. Known history of myasthenia gravis & QTc interval prolongation. Uncorrected electrolyte disorders (hypokalemia or hypomagnesemia). Patients w/ ongoing proarrhythmic conditions eg, significant bradycardia or acute myocardial ischemia; kidney, heart or lung transplants. Avoid strenuous physical activity & excessive sun or UV light exposure. Concomitant use w/ class IA or III antiarrhythmic agents & corticosteroid drugs. May affect ability to drive & use machines. Renal & hepatic impairment. Not to be used during pregnancy & lactation. Childn & adolescents <18 yr. Elderly >60 yr.
Adverse Reactions
Shock; increased ICP & CNS stimulation; abdominal pain, vomiting, constipation, dry mouth, dyspepsia, flatulence, gastritis, hyperglycemia; transient elevation of liver enzymes; rash, hives, itching; dermatitis, fungal infection, genital pruritus, vaginitis; arthralgia, tendonitis, increased creatine phosphokinase; decreased & increased platelets, decreased leucopenia, fatigue, taste perversion. SJS & Lyell's syndrome. Exacerbation of myasthenia gravis.
Drug Interactions
Reduced absorption w/ Al- &/or Mg-containing antacids, ferrous sulphate, Ca prep, Zn- or Fe-containing multivit prep. Increased INR or prothrombin time &/or clinical bleeding episodes w/ warfarin & its derivatives. Didanosine, sucralfate, Ca carbonate.
MIMS Class
Quinolones
ATC Classification
J01MA15 - gemifloxacin ; Belongs to the class of fluoroquinolones. Used in the systemic treatment of infections.
Presentation/Packing
Form
Factive FC tab 320 mg
Packing/Price
1 × 5's;1 × 7's
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