Levofloxacin Hydrochloride Tablets

This product is the levorotatory form of ofloxacin, and its antibacterial activity is about twice that of ofloxacin. Its main mechanism of action is to inhibit the activity of bacterial DNA gyrase (bacterial topoisomerase II) and hinder the replication of bacteria to achieve antibacterial effect. This product has the characteristics of a broad antibacterial spectrum and strong antibacterial effect. It has strong antibacterial activity against most Enterobacteriaceae, such as Escherichia coli, Klebsiella, Serratia, Proteus, Shigella, Salmonella, Citrobacter, Acinetobacter, and Gram-negative bacteria such as Pseudomonas aeruginosa, Haemophilus influenzae, and gonorrhea. It also has good antibacterial effects on some methicillin-sensitive Staphylococci, Streptococcus pneumoniae, Streptococcus pyogenes, hemolytic Streptococci, and Legionella, Mycoplasma, Chlamydia, etc. However, it has poor effects on anaerobic bacteria and enterococci.

The main ingredient of this product is levofloxacin hydrochloride.

This product is a film-coated tablet, which is off-white or light yellow after the film coating is removed. [Specification] 0.1g*6s*2 tablets [Usage and Dosage] Oral, 1-2 tablets (0.1-0.2g) each time for adults, twice a day. For patients with more serious conditions, it can be increased to three times a day. In addition, it can be appropriately increased or decreased according to the type of infection and symptoms. [Adverse reactions] Adverse reactions may occur during the use of levofloxacin hydrochloride: Digestive system: sometimes nausea, vomiting, abdominal discomfort, diarrhea, loss of appetite, abdominal pain, indigestion, etc.; Allergies: Occasionally there are symptoms such as edema, urticaria, fever, photosensitivity, and sometimes rash, itching, erythema, etc.; Nervous system: Occasionally there are tremors, numbness, visual abnormalities, tinnitus, hallucinations, drowsiness, and sometimes there are symptoms such as insomnia, dizziness, and headache; Kidneys: Occasionally there is an increase in blood urea nitrogen; Liver: Transient liver function abnormalities may occur, such as increased blood transaminase and increased serum total bilirubin; Blood: Sometimes there is anemia, leukopenia, thrombocytopenia, and increased eosinophils; The incidence of the above adverse reactions is between 0.1 and 5%, which are generally tolerated and disappear quickly after the end of the course of treatment. If abnormalities are found, they should be observed carefully, and if necessary, the medication can be stopped and properly handled. [Contraindications] It is contraindicated for patients who are allergic to quinolones, pregnant and lactating women, and patients under 18 years old. 【Precautions】1. Patients with renal insufficiency should reduce the dosage or extend the dosing interval. Patients with severe renal insufficiency should use with caution. 2. Patients with central nervous system diseases and a history of epilepsy should use with caution. Quinolones can also cause rare phototoxic reactions (incidence rate, please read the instructions carefully and use according to the doctor's advice. [Use in children] It is contraindicated for patients under 18 years old. [Use in elderly patients] This product is mainly excreted in the urine in its original form. Elderly patients often have impaired renal function and need to be used in reduced doses as appropriate. The recommended dose for elderly patients is one tablet at a time, once every 12 hours. [Use in pregnant and lactating women] It is contraindicated for pregnant and lactating women. [Drug interactions] 1. Benjia cannot be used in the same infusion tube with polyvalent metal ion solutions such as magnesium and calcium. 2. Avoid using it at the same time with theophylline. If it is necessary to use it at the same time, the blood concentration of theophylline should be monitored and the dose should be adjusted accordingly. 3. When used simultaneously with warfarin or its derivatives, the prothrombin time or other coagulation tests should be monitored. 4. When used simultaneously with non-steroidal anti-inflammatory drugs, there is a possibility of convulsions. 5. Simultaneous use with oral hypoglycemic drugs may cause hypoglycemia, Therefore, during medication, blood sugar concentration should be monitored carefully. Once hypoglycemia occurs, this product should be discontinued immediately and appropriate treatment should be given. [Drug Overdose] When quinolones are overdosed, the following symptoms may occur: nausea, vomiting, stomach pain, heartburn, diarrhea, thirst, stomatitis, staggering, dizziness, headache, general fatigue, numbness, chills, fever, extrapyramidal symptoms, excitement, hallucinations, convulsions, delirium, cerebellar ataxia, increased intracranial pressure (headache, vomiting, papilledema), metabolic acidosis, increased blood sugar, increased GOT/GPT/AL-P, leukopenia, increased eosinophils, thrombocytopenia, hemolytic anemia, hematuria, cartilage joint disorders, cataracts, visual impairment, color vision abnormalities and diplopia. First aid measures and antidotes 1. Gastric lavage; 2. Adsorbent: activated carbon (40g-60g, add 200ml of water orally); 3. Laxative: magnesium sulfate (30g, add 200ml of water). ml), or other laxatives; 4. Infusion (with liver-protecting drugs): give sodium bicarbonate injection for metabolic acidosis, and give sodium bicarbonate injection for urine alkalinization to increase the excretion of this product by the kidneys; 5. Forced diuresis: give furanine injection; 6. Symptomatic treatment: diazepam intravenous injection should be repeatedly administered during convulsions; 7. Severe cases: hemodialysis may be considered. [Pharmacology and Toxicology] This product is the levorotatory form of ofloxacin, and its antibacterial activity is about twice that of ofloxacin. Its main mechanism of action is to inhibit the activity of bacterial DNA gyrase (bacterial topoisomerase II) and hinder the replication of bacterial DNA to achieve antibacterial effects. This product has the characteristics of a broad antibacterial spectrum and strong antibacterial effect. It is effective against most Enterobacteriaceae, such as Escherichia coli, Klebsiella, Serratia, Proteus, Shigella, Salmonella, Citrobacter, Acinetobacter, as well as Pseudomonas aeruginosa and Haemophilus influenzae It has strong antibacterial activity against gram-negative bacteria such as septic shock, gonorrhea, etc. It also has good antibacterial effects on some methicillin-sensitive staphylococci, pneumococcus, pyogenic streptococci, hemolytic streptococci, and gram-positive bacteria such as Legionella, mycoplasma, and chlamydia. However, it has poor effects on anaerobic bacteria and enterococci. Repeated dose toxicity: Rats were orally administered this product at doses of 50, 200, and 800 mg/kg for 4 consecutive weeks. Only the 800 mg/kg group showed a decrease in neutrophils and an increase in bone marrow M/E; pathological histology showed mild degeneration on the surface of limb joints. Macaques were orally administered for 4 weeks, and animals in the 100 mg/kg group also showed salivation, diarrhea, slight weight loss, and increased urine pH. Rats were orally administered for 26 weeks, and animals in the 80 and 320 mg/kg groups also showed salivation and increased urine pH. The fecal volume of animals in the 320 mg/kg group increased, and the goblet cells of the cecal mucosa Swelling occurred. When the macaques were given the drug orally for 26 weeks, no obvious toxic reactions were observed at doses of 10, 25, and 62.5 mg/kg. Effects on articular cartilage: When young and 3-4 week old rats and 4 month old beagle dogs were given the drug orally for 7 days, articular cartilage lesions occurred in rats at doses above 300 mg/kg and in beagle dogs at doses above 10 mg/kg, and joint toxicity was easily found in young and young beagle dogs. In 13 month old dogs, mild joint toxicity was observed at a dose of 40 mg/kg after oral administration for 7 days. However, no joint toxicity was observed in 18 month old dogs at a dose of 30 mg/kg after 14 days of intravenous injection. Reproductive toxicity: When rats were given the drug orally before and in the early stages of pregnancy at a dose of 360 mg/kg, no effects were observed on the reproductive capacity and fetus of both male and female animals. When rats were given the drug during the period of organogenesis, at a dose of 90 mg/kg, there was no obvious effect on the fetus and newborn. Oral administration in rabbits At 50mg/kg, there was no embryonic or fetal lethality, fetal growth retardation, or teratogenic effect. When rats were given oral administration of about 360mg/kg during the perinatal and lactation period, there was no significant effect on the animals' delivery, lactation, and newborns. Phototoxicity: Long-wavelength ultraviolet rays (320-400nm) were used to irradiate, and the change in the thickness of the mouse ear corridor was used as an indicator for phototoxicity studies. The results showed that no significant abnormal changes were observed when the oral dose reached 200mg/kg. [Pharmacokinetics] After a single oral administration of 0.2g (C18H24FN3O4) of levofloxacin in healthy adults, the peak blood concentration can be reached in 0.67±0.15 hours. Cmax is 2.92±0.54μg/ml, and the elimination half-life is 6 hours. The pharmacokinetic parameters of a single intravenous injection of 0.3g levofloxacin are similar to those of the same oral dose (see table). Levofloxacin 0.3g intravenous injection (n= 8) and the average value of pharmacokinetic parameters after oral administration (n=12) Levofloxacin is widely distributed in tissues in the body. It is mainly excreted in the urine in its original form. Within 48 hours after oral administration, the amount of original form excreted in the urine accounts for 87% of the dose; the amount of drug excreted in the feces within 72 hours is less than 4% of the dose; about 5% of the drug is excreted in the urine in the form of inactive metabolites. The clearance rate of levofloxacin is decreased and the elimination half-life is prolonged in patients with impaired renal function. In order to avoid drug accumulation, the dose should be adjusted. Hemodialysis and continuous peritoneal dialysis (CAPD) do not affect the elimination of levofloxacin from the body. [Storage] Keep it away from light and store it in a sealed container. [Packaging] Aluminum-plastic packaging, 2 plates per box, 6 tablets per plate. [Validity period] 24 months [Approval number] National Medicine Standard H20103757 [Manufacturer] Shanxi Qianhui Pharmaceutical Co., Ltd. [Indications] This product is suitable for the following mild and moderate infections caused by sensitive bacteria: 1. Respiratory system infections: acute bronchitis, acute exacerbation of chronic bronchitis, diffuse bronchiolitis, bronchiectasis with infection, pneumonia, tonsillitis (peritonsillar abscess); 2. Urinary system infections: pyelonephritis, complicated urinary tract infection, etc.; 3. Reproductive system infections: acute prostatitis, acute epididymitis, organ cavity infection, adnexitis, pelvic inflammatory disease (metronidazole can be used in combination when anaerobic infection is suspected); 4. Skin and soft tissue infections: infectious impetigo, cellulitis, lymphangiitis (adenitis), subcutaneous abscess, perianal abscess, etc.; 5. Intestinal infections: bacillary dysentery, infectious enteritis, salmonella enteritis, typhoid and paratyphoid; sepsis, neutropenia and various infections in immunocompromised patients; 6. Other infections: mastitis, trauma, burns and postoperative wound infection, abdominal infection (metronidazole can be used in combination when necessary), cholecystitis, cholangitis, bone and joint infection, and ENT infection, etc.

1. This product is suitable for the following mild and moderate infections caused by sensitive bacteria; respiratory system infections: acute bronchitis, acute exacerbation of chronic bronchitis, diffuse bronchiolitis, bronchiectasis complicated with infection, pneumonia, tonsillitis (peritonsillar abscess); 2. Urinary system infections: pyelonephritis, complicated urinary tract infection, etc.; reproductive system infections: acute prostatitis, acute epididymitis, uterine cavity infection, uterine adnexitis, pelvic inflammatory disease (metronidazole can be used in combination when anaerobic bacteria infection is suspected); Skin and soft tissue infections: infectious impetigo, cellulitis, lymphangitis (adenitis), subcutaneous abscess, perianal abscess, etc.; intestinal infections: bacterial dysentery, infectious enteritis, Salmonella enteritis, typhoid and paratyphoid; 3. Various infections in patients with sepsis, neutropenia and immunodeficiency; other infections: mastitis, trauma, burns and postoperative wound infection, abdominal infection (combined with metronidazole when necessary), cholecystitis, cholangitis, bone and joint infection and ENT infection, etc.

Oral administration: 0.1-0.2g per time for adults, twice a day. For patients with severe conditions, it can be increased to three times a day.

During medication, symptoms such as nausea, vomiting, abdominal discomfort, diarrhea, loss of appetite, abdominal pain, abdominal distension, insomnia, dizziness, headache and other neurological symptoms, as well as rash, itching and other symptoms may occur. Transient liver function abnormalities may also occur, such as increased serum transaminase and increased serum total bilirubin. The incidence of the above adverse reactions is between 0.1% and 5%. Occasionally, blood urea nitrogen rises, fatigue, fever, palpitations, abnormal taste, etc., which are generally tolerated and disappear quickly after the end of the treatment.

1. It is contraindicated for pregnant and lactating women and patients under 18 years old; 2. It is contraindicated for those who are allergic to quinolones.

Precautions for children: Patients under 18 years old are prohibited. Precautions for pregnancy and lactation: Precautions for pregnant and lactating women and patients under 18 years old are prohibited. Precautions for the elderly: This product is mainly excreted in the urine in its original form. Elderly patients often have impaired renal function and should be used in reduced doses as appropriate. The recommended dose for elderly patients is one tablet at a time, once every 12 hours.

1. This product cannot be used in the same infusion tube with polyvalent metal ion solutions such as magnesium and calcium. 2. Avoid using it simultaneously with theophylline. If it is necessary to use it simultaneously, the blood concentration of theophylline should be monitored and the dosage should be adjusted accordingly. 3. When used simultaneously with warfarin or its derivatives, the prothrombin time or other coagulation tests should be monitored. 4. When used simultaneously with non-steroidal anti-inflammatory drugs, convulsions may be induced. 5. When used simultaneously with oral hypoglycemic drugs, hypoglycemia may be caused. Therefore, blood glucose concentration should be monitored during medication. Once hypoglycemia occurs, this product should be discontinued immediately and appropriate treatment should be given.

Keep away from light and store in a sealed container.

0.1g (based on C18H2OFN3O4)

24 months

Shanxi Qianhui Pharmaceutical Co., Ltd.

• Founded in:

  1996-03-19

• Address:

  Biomedical Park, Taiyuan Economic and Technological Development Zone, Shanxi Province (No. 42, Tangming Road)

• Tax NO.:

  91140100110095100W

• Registered Funds:

  50 million yuan

• Website:

  Log in to view

• Email:

  Log in to view