Each tablet contains
Active ingredient: Ofloxacin 200 mg
Inactive ingredients: Lactose, Microcrystalline cellulose, Silicone dioxide, hydroxypropyl cellulose, low-substitued hydroxypropyl cellulose, polyethylene glycol, titanium dioxide…
Description: White to slight yellowish, film-coated tablet.
Indications: The following infections caused by ofloxacin-susceptible
Staphylococcus sp., Streptococcus pyogens, Hemolyticstreptococci, Enteroccocci, Streptococcus pneumoniae, Peptostreptococcus sp., Neisseria gonorrhoeae, Escherichia Coli, Citrobacter sp., Shigella sp., Klebsiella pneumoniae, Enterobacter sp., Serratia sp., Proteus sp., Pseudomonas aeruginosa, Haemophius 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.
• Pharyngolarygitis, acute bronchitis, tonsillitis, chronic bronchitis, bronchiectasis with infection, diffuse panbronchiolitis, 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, dacryocrystitis, tarsadenitis, keratohelcosis.
• Otitis media, sinusitis.
Dosage and administration
Ofloxacin tablet is generally given to adults orally in a daily dose of 1.5 to3 tablets (300-600 mg) divided into 2 to 3 times. Dosage should be adjusted according to causative organisims and severity of symptoms.
1. Contraindication: Patients with a history of hypersensitivity to quinolones, tendinitis,and tendon rupture.
2. Careful administration
Patients with severe renal disorders.
Patients with or with a history of convulsive diseases such as epilepsy.
3. Adverse reactions:
1) Shock: Since shock-like symptoms rarely occur, observe the patients carefully. If such symptoms as felling unwell, sweating, dyspnea, or hypotension are observed, discontinue the medication and take appropriate treatments.
2) Hypersensitivity: Edema, urticaria, or heat, anaphylactic symptoms, such as erythema, chill, or dyspnea may rarely occur, and rash or pruritus may infrequently occur, discontinue the medication if such symptoms are oserved.
3) Renal: Acute renal failure may rarely occur, and increasing in BUN and serum creatinine may appear infrequently.
4) Hepatic: Jaundice may rarely occur, and elevation of GOT, GPT, alkaline phosphate, r-GTP, total bilirubin may appear infrequently.
5) Digestive: Colitis with hematochazia such as pseudomembranous colitis may rarely occur. If such as abdominal pain or frequent diarrhea are observed, discontinue the medication and take appropriate treatments. Nausea/vomiting, discomfort in stomach abdomen, diarrhea/loose stool, anoxeria, stomachache/abdominal pain, or heartburn may occur, and thirst or stomatitis may appear rarely.
6) Hematologic: Anemia, decrease in leukocytes, hemoglobin, hematocrit, or platelets and increase in eosinophiles may infrequently occur, observe carefully, discontinue the medication if any abnormality is observed.
7) Psychoneurologic: Insomnia, dizziness or headache may infrequently occur, and convulsion, tremor, numbness, vision abnormal, sonitus, fallacia, or drowsiness may appear rarely.
8) Skin: Toxic epidermal necrosis may occur, observe the patients carefully, discontinue the medication if any abnormality is observed.
9) Muscular: myalgia, elastic syndrome, elevation of CPK, and abrupt renal failure, which is charateristic elevation of myoglobin in blood and urine, with striate muscular synchysis may occur.
10) Respiratory: flush, tussis, dyspnea, abnormality of X-ray for chest and pneumonitis with eosinophilia may occur. Discontinue the medication if such symptoms are observed and take appropriate treatments. (adrenocortical hormone, etc,.)
* As it has been reported that hypoglycemia occurred in other new quinolones, elderly patients and patient with kidney failure, administrate carefully.
* Malaise, flush, or palpitation may appear rarely.
12) Stroke, sleeping disorder may appear.
Inform your doctor in case of any adverse reactions related to drug use.
4. Drug interactions
* It has been reported that convulsion may rarely occurred by the concomitant use of other quinolones (enoxacin, etc.) with nonsteroidal antiinflamatory phenylacetic/propionic acid derivatives, such as fenbufen, etc.
* As antacids containing aluminum or magnesium may interfere with the absorption of ofloxacin, resulting in attenuation of the efficacy of ofloxacin, it is recommended to refrain from the concomitant use.
5. Use during Pregnancy orLactation
* Safety during pregnancy has not been established, therefore this drug not should be administered to patients who are or may become pregnant.
* Since Ofloxacin transfers to human milk, it is recommended to refrain from lactation during the administration of this drug.
6. Pediatric use
Since the safety in children has not been established, this drug should not be administered to children.
7. Geriatric use
Oflaxacin is excreted into urine, as renal function of elderly patients is usually become worse, high blood concentration may continue. Therefore careful dosage management is recommended.
* In foreign country, tendon impairment such as Archilles’tendinitis and tendon rupture, etc. may occur. Discontinue the medication and take appropriate treatment if such symptoms are observed.
* Animal studies have shown that ofloxacin can produce arthropathy in immature dogs and rats.
* Patient with predisposition should be warned to occur such as seizure or other CNS adverse.
* Discontinue treatment if pain, inflammation, tendon rupture appear. And notify physician. Patient should take a rest and refrain from exercising until it is diagnosed not to be tendinitis or tendon rupture.
Storage: well-closed container, at room temperature.
Use term: 3 years since the manufacturing date.
Do not use of the drugs out of date
Package: 10 tablets/blister, 100 tablets/box.
Specifications: Home standard.