Gemifloxacin

These indications are based on manufacturer information for both originator and generic products. For product specific registered indications, please refer to product specific manufacturer information

Registered South African indications:

• Community acquired pneumonia caused by S. pneumoniae, C. pneumoniae, M. pneumoniae, H. influenzae, M. catarrhalis
• Acute exacerbations of chronic bronchitis caused by H. influenzae, M. catarrhalis, S. pneumoniae
• Acute bacterial sinusitis caused by S. pneumoniae, H. influenzae, M. catarrhalis

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Pre-existing aortic aneurysm and/or dissection
• Pre-existing tendinitis and tendon rupture
• Pre-existing severe valvular heart disease

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Elderly
• History of QT prolongation
• Uncorrected hypokalemia
• Hypomagnesemia
• Diabetes mellitus
• Excessive exposure to sunlight
• Known or suspected central nervous system disorder
• Risk factors that may predispose to seizures or lower the seizure threshold
• History of peripheral neuropathy
• Prolonged use
• Significant bradycardia
• Acute myocardial ischaemia
• Mitral valve and/or aortic valve regurgitation
• Patients with solid organ transplants
• Risk of fluoroquinolone-induced tendinitis and tendon rupture
• Risk of aortic aneurysm and dissection (particularly in the elderly)
• Marfan syndrome
• Vascular Ehlers-Danlos syndrome
• Takayasu arteritis
• Giant cell arteritis
• Behçet's disease
• Uncontrolled hypertension
• Atherosclerosis
• Myasthenia gravis
• Rheumatoid arthritis
• Glucose-6-phosphate dehydrogenase deficiency

Forms avail. in SA and covered in this monograph: tab

Infections caused by Gram positive, aerobic cocci (including, S. pneumonia); Gram negative, aerobic organisms (including, M. catarrhalis and H. influenzae); Others, including Chlamydia pneumonia and Mycoplasma pneumonia

Specific doses based on individual indications

Please note that the dosages below should be used in combination with regional guidelines, taking into account local antibiotic sensitivities

Acute bacterial exacerbation of chronic bronchitis
Acute sinusitis

• Oral (tab): 320mg, dly; Treatment duration: 5 days

Community acquired pneumonia 
- Mild to moderate

• Oral (tab): 320mg, dly; Treatment duration: 5-7 days

Not established for use in children below 18 years

Pregnancy

• FDA Pregnancy Category C

Breastfeeding

• Caution

Renal Impairment

• Mild: Caution; no dose adjustment recommended 
• Moderate to severe: Caution; dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly            

• Caution; no dose adjustment recommended

Central Nervous System Disorders

• Dizziness 
• Insomnia
• Headache

Cardiovascular Disorders

• Mitral valve and/or aortic valve regurgitation

Gastrointestinal Disorders

• Abdominal pain
• Diarrhoea
• Nausea and vomiting

Hepatobiliary Disorders

• Increased hepatic enzymes
• Increased bilirubin

Musculoskeletal Disorders

• Tendinitis
• Increased creatine phosphokinase

Skin and Subcutaneous Tissue Disorders

• Rash
• Urticaria
• Pruritis 
• Maculopapular erythmatous rash
• Photosensitivity reactions 

Immune, Blood and Lymphatic System Disorders

• Fungal overgrowth
• Thrombocytopenia
• Thrombocythemia 
• Thrombophilia
• Neutropenia
• Neutrophilia

• Corticosteroids
• QT prolonging agents
• Aminolevulinic acid
• Antacids
• Bacillus Calmette–Guérin
• Calcium salts
• Cholera vaccine
• Delamanid
• Didanosine
• Hydroxychloroquine
• Iron salts
• Magnesium salts
• Mifepristone
• Multivitamins and minerals
• Nadifloxacin
• Probucol
• Promazine
• Quinapril
• Sevelamer
• Sodium picosulfate
• Strontium ranelate
• Sucralfate
• Typhoid vaccine
• Vinflunine
• Zinc salts

• White blood cell count
• Renal function

Risk of mitral and aortic regurgitation

• There is a possible increased risk for patients to develop mitral valve and/or aortic valve regurgitation (left sided heart valves) while on treatment with oral and injectable fluoroquinolones. The increased risk continues until about 60 days after completion of treatment
• A thorough cardiovascular examination, including an echocardiogram (ECG), should be performed, before oral or injectable fluoroquinolones are prescribed
• Fluoroquinolones should not be prescribed to patients with mitral valve and/or aortic valve regurgitation, unless no safer alternative antibiotic is available, has failed or is not well tolerated

Gemifloxacin is a fluoroquinolone antibiotic, with bactericidal activity. Gemifloxacin acts by inhibiting DNA synthesis through inhibition of the bacterial type II topoisomerases, DNA gyrase, and/or topoisomerase IV which are both essential for bacterial growth.

Spectrum of activity: Gram positive, aerobic cocci (including, S. pneumonia); Gram negative, aerobic organisms (including, M. catarrhalis and H. influenzae); Others, including Chlamydia pneumonia and Mycoplasma pneumonia 

Tablet 320mg

• Factive (Pharmacare) originator