部份中文巴洛沙星处方资料（仅供参考）
英文名：Balofloxacin
商品名：Q-roxin
中文名：巴洛沙星片
生产商：Choongwae Pharmaceutical
持证商：EPHARMALINK. KR LTD
上市国：Korea
药品类型：喹诺酮类
适应症
用于治疗由葡萄球菌、链球菌、肠球菌、摩根菌、大肠杆菌、普罗菲登菌、柠檬菌、肺炎克雷白杆菌、肠杆菌、沙雷氏菌、变形杆菌、假单胞菌、消化链球菌等敏感菌引起的非复杂性尿道感染，如膀胱炎、尿道炎等。
用法用量
口服。成人一次0.1g(一片)，一日2次
不良反应
Drug Information: CYROK Shin Jung 100mg (Q-roxin Tab. 100mg)
Product Name: CYROK Shin Jung 100mg (Q-roxin Tab. 100mg)
Manufacturing and Importer: Choongwae Pharmaceutical
Sales Company: Choongwae Pharmaceutical
Welfare Division Classification: 629-Other Chemical Legislation
Balofloxacin 100 mg
Ingredient name: valofroxacin 100 mg
Production: Production
US FDA Maternal Stability: Classification
Appearance: Circular white film coating
Formulation: Film-coated tablet
Display (front): Q
Display (back): CWP
Mark (front):
Mark (back):
Color front: white
Color back:
Before the splitting line:
After split:
Long axis (mm): 7.5
Shortening (mm): 7.5
Thickness (mm): 3.6
Identification display registration day: 2004-12-22
Efficacy/Effectiveness:
1) Effective species: Staphylococcus, Streptococcus, Enterococcus, Morganella, Providencia, Escherichia coli, Citrobacter, Klebsiella, Enterobacter, Serratia, Proteus, Pseudomonas, Peptostreptococcus CNS coagulase- , Acinetobacter spp., Chlamydia
2) Target disease: Simple urinary tract infections (cystitis, urethritis, etc.), pelvic infections, cervicitis
Usage/Capacity:
1. Simple urinary tract infection (cystitis, urethritis, etc.)
1) Adults: Take 100mg twice a day
2) Patients with renal impairment (patients with severe renal impairment with a creatinine clearance of less than 40ml/min)
- Take 100mg once a day twice a day
2. Pelvic infections, cervicitis
1) Adults: Take 200mg twice a day for 7 days
(Pelvic infections can be taken up to 14 days depending on the degree of symptom improvement.)
2) Patients with renal impairment (patients with severe renal impairment with a creatinine clearance of less than 40ml/min)
- Take 200mg once a day twice a day
* If only serum creatinine concentration is known, creatinine clearance can be calculated using the following formula.
 Man: creatinine clearance(ml/min) = body weight (Kg)×(140-age)/72×plasma creatinine concentration(mg/ml)
 Female: 0.85 ×value obtained for male
Precautions for use:
1. Do not administer to the following patients
1) Persons with hypersensitivity to this drug or other quinolones
2) Pregnant and lactating women
3) Children and infants whose growth has not ended
4) Patients with a history of hypersensitivity, tendinitis, and rupture associated with quinolone antibiotics
2. The following patients should be treated with caution
1) Patients with severe renal impairment
In phase 1c clinical trials of renal patients, the serum creatinine level was increased by more than 20% in 7 of 15 patients with a creatinine clearance of less than 20 ml / min during one week of repeated administration of crooxin 100 mg tablets. Continuous monitoring of renal function-related test scores is required, or if there are clinically significant changes, discontinue use.
2) Patients with seizure disorders such as epilepsy or a history of the disease (other quinolone antibiotics may cause seizures).
3) Patients with hypersensitivity to new quinolone antibiotics
4) Elderly people
3. Adverse reactions
1) Shock: In rare cases, shock may occur. If symptoms are observed, stop the administration and take appropriate measures.
2) Hypersensitivity: Occasionally, urticaria, rashes, rashes, redness, facial edema, and necrosis may occur. If these symptoms occur, discontinue administration.
3) Kidney: Sometimes BUN, creatinine rise, etc. may appear. In addition, there is a rare report of acute renal failure in other new quinolone antibiotics.
4) Hepatic: Sometimes GOT, GPT, LDH, AL-P elevation and total bilirubin elevation may occur. If the abnormality is observed enough, stop the administration and take appropriate measures.
5) Blood: Sometimes anemia, leukocytosis, thrombocytopenia, and eosinophilia may occur, so be sure to observe and stop the administration if the abnormality is confirmed.
6) Digestive system: Occasionally anorexia, abdominal pain, diarrhea, nausea, Yanbian, constipation, abdominal discomfort, stomach discomfort, abdominal bloating, indigestion, vomiting, Other new quinolone antimicrobial agents have been reported to cause colitis, which rarely involves stool, such as pseudomembranous colitis. If abdominal pain and frequent diarrhea occur, take appropriate measures such as stopping the administration immediately.
7) Mental nervous system: Sometimes dizziness, rarely headache, insomnia may appear.
8) Others: Sometimes there is a feeling of warmth and palpitation. It has been reported that rarely hypoglycemia occurs in other quinolone antimicrobial agents (elderly patients, particularly those in elderly patients).
9) Randomization of 283 patients with urinary tract infection. The following table lists the adverse events associated with the test drug in the double-blind Phase III clinical trial.
[& C1]
10) Random assignment to 288 patients with obstetrics and gynecological infections, and drug reactions that are presumed to be related to the test drug in the double-blind Phase III clinical trial are shown in the following table.
[& C2]
Post-market research results
In Korea, 3174 patients were randomly assigned to one of three follow-up examinations. The incidence of adverse events was reported as 1.2% (38/3174, 53 cases) regardless of causality, Of the adverse reactions that occurred, 1.0% (31/3174, total 42) were found to be causally related to the drug. The reported adverse events were 0.2% (6/3174), diarrhea, headache, dyspepsia 0.2% (5/3174), facial edema 0.1% (4/(3174 persons), vomiting, abdominal pain 0.1% (3 persons/3174 persons), vaginal discharge, fever, anorexia, anorexia, anorexia, heartburn 0.1% Stiffness, coughing, dizziness, drowsiness, insomnia, abdominal discomfort, abdominal bloating and constipation were reported in 0.1% (1/3174). Among these, unexpected adverse events are drowsiness, vaginal discharge, cough, dyspnea, edema, fatigue, and fever. Among these, severe adverse events include dyspnea, systemic edema, and anemia.
4. General caution
1) Remind patients that they may have seizures or other central nervous system side effects.
2) Tinnitus and tendon rupture have been reported elsewhere in the elderly and those who are taking corticosteroids due to quinolone therapy. If symptoms such as pain, tenderness, or rupture occur, discontinue treatment and inform your doctor. Take a break and refrain from exercising until you are sure that it is not a tendonitis or tear. No rupture was reported with the use of this drug.
3) QTc interval prolongation is reported in other quinolone antimicrobials, so QTc interval prolongation during the administration of antiarrhythmics (Ia or III group antiarrhythmics), patients with heart disease (arrhythmia, ischemic heart disease, etc.), hypokalemia, hypomagnesemia, Care should be taken when administering to patients who may be at risk. No QTc interval extension was reported with the use of this drug.
5. Interaction
1) Combination with antacids containing aluminum or magnesium may reduce the absorption of the drug and may reduce the effect, so it is preferable to avoid the combination.
2) In similar compounds (such as enoxasin), absorption is decreased by combination with phenylacetic acid or propionic acid-based nonsteroidal anti-inflammatory analgesics such as penbufen, and cramps are rarely reported.
3) It is reported that other quinolone antibiotics increase the concentration of theophylline in combination with theophylline, so if you use it together, theophylline should be carefully administered.
6. Administration to pregnant and lactating women
1) Pregnant women, women who are pregnant or those who are breastfeeding are not given safety because they are not established.
2) The reproductive toxicity test using animals showed significant ossification delay of the high dose (300mg/kg) group fetus in the fertility test and teratogenicity test of rats. In the teratogenicity test of rabbit, the medium dose (10mg / kg) (30mg / kg) group and high dose (300mg/kg) group were significantly decreased in the rats' teratogenicity test, and significant weight loss of the fetus in the high dose group, In the lactic acid test of the rats, it was observed that the delivery time tended to be somewhat delayed in the high dose (300 mg/kg) group.
7. Administration to children
No safety is established for pediatric patients.
8. Administration to elderly people
This drug is mainly excreted in the kidneys. Since elderly people often have low renal function, high blood levels may persist. Therefore, they should be administered with caution in consideration of dose and interval of administration.
9. Other
1) Anorexia is recognized in animal experiments (young dogs, young rats) of other new quinolone antibiotics.
2) Due to administration of other quinolone antibiotics in foreign countries, it is rarely reported that dryness such as achilles tendonitis, dry heat, etc. is observed. If observation is enough and abnormalities are recognized, discontinue administration and take appropriate measures.
Storage: Airtight container, room temperature(1 ~ 30 ℃) 36 months from date of manufacture
Packing unit: 100 tablets