Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET, FILM COATED
**\[DOSAGE AND ADMINISTRATION\]** FUGACIN is generally given to adults orally in a daily dose of 1.5–3 tablets (300–600mg) divided into 2 to 3 times. Dosage may be adjusted according to causative organisms and severity of symptoms. **Overdose: In the event of overdose, symptomatic treatment should be implemented. ECG monitoring should be undertaken, because of the possibility of QT interval prolongation.**
ORAL
Medical Information
**\[INDICATIONS\]** The following infections caused by ofloxacin-susceptible Staphylococcus sp., Streptococcus pyogenes, hemolytic streptococci, enterococci, Streptococcus pneumoniae, peptostreptococcus sp., Escherichia coli, Citrobacter sp., Shigella sp., Klebsiella pneumoniae, Enterobacter sp., Serratia sp., Proteus sp., Pseudomonas aeruginosa, Haemophilus influenzae, Acinetobacter sp., and Campylobacter sp. - Folliculitis, furuncle, furunculosis, carbuncle, erysipelas, phlegmon, lymphangitis (lymphadenitis) - Felon, subcutaneous abscess, spiradenitis, acne conglobata, infectious atheroma, perianal abscess - Mastadenitis, superficial secondary infections after traumas, burns, surgery traumas - Pharyngolaryngitis, acute bronchitis, tonsillitis, chronic bronchitis, diffuse panbronchiolitis, bronchiectasis with infection, secondary infections of chronic respiratory diseases, pneumonia - Pyelonephritis, cystitis, prostatitis, epididymitis, gonococcal urethritis, non-gonococcal urethritis - Cholecystitis, cholangitis, bacillary dysentery, enteritis - Intrauterine infection, adnexitis, bartholinitis - Blepharitis, hordeolum, dacryocystitis, tarsadentitis, keratohelcosis - Otitis media, sinusitis
1. Contraindication Patients with a history of hypersensitivity to ofloxacin. 2. Careful administration 1. Patients with severe renal disorders 2. Patients with or with a history of convulsive diseases such as epilepsy. 3. Patients with a history of hypersensitivity to quinolones. 4. The elderly patients
J01MA01
ofloxacin
Manufacturer Information
ZYFAS PHARMA PTE. LTD.
SHIN POONG PHARMACEUTICAL CO LTD
Active Ingredients
Documents
Package Inserts
Fugacin PI.pdf
Approved: May 7, 2021