Approved date: January 29, 2007
Date of revision: October 1, 2010
         November 30, 2015
Fluoxacin tablets instructions
Please read the instructions carefully and use them under the guidance of a physician.
For food and feed processing
【Drug Name】
    Generic name: fleroxacin tablets
    English name: Fleroxacin Tablets
    Pinyin: Fuluoshaxing Pian
[Ingredients] The main ingredient of this product is: fleroxacin. Its chemical name is: 6,8-difluoro-1-(2-fluoroethyl)-1,4-dihydro-7-(4-methyl-1-piperazinyl)-4-oxo-3 - Quinolinecarboxylic acid.
    Molecular formula: C17H18F3N3O3
    Molecular weight: 369.34
【Properties】 This product is white to slightly yellow.
[Indications] It can be used for acute bronchitis caused by sensitive bacteria, acute bronchitis and respiratory infections such as pneumonia; cystitis, pyelonephritis, prostatitis, epididymitis, Neisseria gonorrhoeae and other urinary tract infections Reproductive system infections; Salmonella typhimurium infection, bacterial dysentery and other digestive system infections; skin and soft tissue infections, bone infections, abdominal infections and pelvic infections.
【Specification】 0.1g
【Usage and Dosage】 Oral. The usual amount of adult: 0.2 ~ 0.4g (2 ~ 4 tablets) a day, divided into 1 ~ 2 times service, the general course of treatment 7 ~ 14 days.
【Adverse reactions】
    1. Gastrointestinal reactions are more common, which can be manifested as abdominal discomfort or pain, diarrhea, nausea and vomiting, loss of appetite.
    2. Central nervous system reactions can have dizziness, headache, excitement, lethargy or insomnia.
    3. Allergic reactions include rash, itchy skin, and occasional exudative erythema multiforme and angioedema. A small number of patients have photosensitivity reactions.
    4. A small number of patients may have blood aminotransferase, blood urea nitrogen increased, peripheral blood leukocytes decreased, mostly mild, and transient.
5. Occasionally:
(1) seizures, mental disorders, irritability, confusion, hallucinations, tremors;
(2) interstitial nephritis manifestations such as hematuria, fever, rash;
(3) Crystalline urine, more common in high-dose applications;
(4) joint pain.
    1. It is forbidden to be allergic to this product or quinolones.
    2. Pregnant women, lactating women and patients under 18 years of age are banned.
1. Renal dysfunction should be used with caution. If used, the dose should be adjusted according to the degree of decline.
2. Patients with liver dysfunction should be used with caution. If used, attention should be paid to monitoring liver function.
3. Patients with original central nervous system diseases, including those with cerebral arteriosclerosis or epilepsy, should avoid application and have advantages and disadvantages when referring to them.
4. There is a cross-allergic reaction between quinolones. It is not suitable for anyone who is allergic to quinolones.
5. When the patient's urine pH value is above 7, the crystal urine is prone to occur, so the daily water consumption must be sufficient to keep the daily urine volume above 1200-1500ml.
6. This product can cause photosensitivity reaction, at least 12 hours after exposure to light, and should be avoided for long periods of exposure to bright light during treatment and within a few days after treatment.
7. Stop treatment if there is an indication of photosensitivity such as skin burning, redness, swelling, blisters, rash, itching, or dermatitis.
8. It is strictly forbidden to be used in food and feed processing.
[Pregnant women and lactating women] Fluoroquinolone can penetrate the blood placenta barrier and can be secreted into the milk. Its concentration is close to the blood concentration, so pregnant women and lactating women are prohibited.
[Children's medication] Fluoroquinolone can cause permanent damage to the dog's weight-bearing articular cartilage, causing joint disease in other minor animals, so patients under 18 years old are banned. In the case of infection caused by multi-drug resistant bacteria, bacteria are only sensitive to fluoroquinolones, and the product can be applied only after weighing the pros and cons.
[Geriatric Use] In elderly patients, renal function has decreased, and the amount of medication should be reduced.
【medicine interactions】
    1. The aluminum and magnesium contained in the didanosine (DDI) preparation can be chelated with the fluoroquinolone and should not be used in combination.
    2. Urine alkalizing agent can reduce the solubility of this product in urine, leading to crystallized urine and nephrotoxicity.
    3. Probenecid can delay the excretion of this product, so that the blood concentration of this product is increased and the toxicity is produced.
4. The antacid containing aluminum or magnesium can reduce the oral absorption of this product. It is recommended to avoid taking the same service. It should not be taken 2 hours before taking this product or 6 hours after taking it.
[Drug overdose] is not clear.
【Pharmacology and Toxicology】 This product is a third-generation fluoroquinolone antibacterial with a wide spectrum of antibacterial activity against Gram-negative bacteria, including Escherichia coli, Klebsiella, Proteus, Salmonella typhi, Salmonella paratyphi, and Hemococcus, Enterobacter cloacae, Enterobacter aerogenes, Citrobacter, Serratia marcescens, Pseudomonas aeruginosa, Neisseria meningitidis, Haemophilus influenzae, Moraxella, pulmonary Legionella, Neisseria gonorrhoeae, etc. have strong antibacterial effects. It also has moderate antibacterial activity against Gram-positive cocci, such as Staphylococcus and Streptococcus hemolyticus.
 The mechanism of action of this product is to inhibit the bacteria by inhibiting the DNA gyrase.
[Pharmacokinetics] This product is rapidly and completely absorbed after oral administration, and its bioavailability is above 90%. After a single oral dose of 0.1, 0.2, and 0.4 g, healthy volunteers reached a peak of about 1 to 2 hours. The peak plasma concentration (Cmax) reached 1.6, 2.9, and 5.1 μg/ml, respectively. The blood elimination half-life (t1/2b) was 9.9. The plasma protein binding rate was 23% at ~11.6 hours. This product can be widely distributed in various tissues. The concentration in most tissues is close to or higher than the contemporaneous blood concentration, but the concentration in the central nervous system is very low. This product is mainly in the form of a drug in the plasma, with a small amount of metabolites. This product is mainly excreted with the urine, and the urine is discharged 86% within 72 hours after oral administration, of which 75% is the original drug, a small part is excreted by the bile, and only 3% is discharged with the feces.
[Storage] Shading, sealing, and storing in a dry place (10 ~ 30 ° C).
[Packing] Aluminum-plastic packaging, 6 pieces per box; 8 pieces per box; 12 pieces per box.
[Validity Period] 24 months
[Executive Standards] "Chinese Pharmacopoeia" 2015 Edition 2
[Approval No.] Guoyao Zhunzi H20054401
    Company Name: Guangdong Pi Di Pharmaceutical Co., Ltd.
    Production address: No. 66, Pidi Avenue, Yueshan Town, Kaiping City, Guangdong Province
    Postal code: 529331
    Phone number: 0750-2789285 2789348 400-8899-328 (National Service Phone)
Fax number: 0750-2789285 2789348


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