Levofloxacin Instructions

Instructions for Levofloxacin Tablets: Drug Name Generic Name: Levofloxacin Tablets English Name: Levofloxacin Tablets Chinese Pinyin: Zuoyangfushaxing Pian [编辑本段]主要成分 The main ingredient is Levofloxacin. Its chemical name: (S)-(-)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-[1,4]benzo? Zin-6-carboxylic acid hemihydrate.　Molecular Formula: C18H20FN3O4-1/2H2O Molecular Weight: 370.38 [edit this paragraph] Properties White film-coated tablets, white to light yellow when the film coat is removed. [edit this paragraph] Drug Pharmacology Pharmacology and Toxicology This product is the levofloxacin, and its in vitro antibacterial activity is about twice as much as that of of ofloxacin. Its mechanism of action is to cause bacterial death by inhibiting the activity of bacterial DNA rotamase and preventing bacterial DNA synthesis and replication. Drug interactions 1. Urine alkalinizing agents may reduce the solubility of the product in urine, leading to crystalluria and nephrotoxicity.　2. Quinolone antimicrobials and theophyllines may be used in combination due to the competitive inhibition with the cytochrome P450 binding site, resulting in a significant reduction in the hepatic elimination of theophyllines, prolongation of the blood elimination half-life (t1/2), increased blood concentration, the symptoms of theophylline toxicity, such as nausea, vomiting, tremor, restlessness, agitation, convulsions, palpitations and so on. This product on the theophylline metabolism, although the impact is small, but when combined with theophylline blood concentration should be measured and adjust the dose.　3. This product and cyclosporine combination, can make the blood concentration of cyclosporine increased, must monitor the blood concentration of cyclosporine, and adjust the dose.　4. This product and anticoagulant warfarin combination of the latter's anticoagulant effect of the enhancement of small, but the combination should also be closely monitored the patient's prothrombin time.　5. Probenecid can reduce the secretion of the product from the renal tubules by about 50%, and the combination can be toxic due to the increase in blood concentration of the product.　6. This product can interfere with the metabolism of caffeine, resulting in reduced caffeine elimination, blood elimination half-life (t1/2β) prolongation, and may produce central nervous system toxicity.　7. Aluminum, magnesium-containing acid-forming drugs, iron can reduce the oral absorption of the product, and should not be combined.　8, this product and non-steroidal anti-inflammatory drugs fenbufen, the combination of occasional convulsions, so should not be used in combination with fenbufen.　9, this product and shaandan injection mixing, can appear precipitation and turbidity, can not be mixed in the same container, need to be used in conjunction with other liquids must be spaced out, or with saline flushing tube.　10. The combination of this product with oral hypoglycemic drugs may cause blood glucose imbalance, therefore, attention should be paid to monitoring the blood glucose concentration in the course of administration, once hypoglycemia occurs, the product should be discontinued immediately and appropriate treatment should be given.　Levofloxacin and Shuanghuanglian injections have serious adverse reactions The National Center for Adverse Drug Reaction Monitoring released the latest issue of Adverse Drug Reaction Information Circular, reminding medical institutions and health care workers and drug manufacturers and operators to be alert to the serious adverse reactions of levofloxacin injections and Shuanghuanglian injections. According to the introduction, levofloxacin injection serious adverse reactions/events to systemic damage, central and peripheral nervous system damage, skin and its accessories damage, respiratory system damage, gastrointestinal system damage, in which the problem of allergic reaction is more typical, the main clinical manifestations of anaphylactic shock, anaphylactic-like reaction, respiratory distress, polymorphic erythema-type drug rashes, laryngeal edema, and so on. In the database of National Adverse Drug Reaction Monitoring Center, the analysis of serious case reports of levofloxacin injection shows that there is clinical irrationality in the use of this product, and part of the irrational use of medication has become the main factor causing serious adverse events. For example, the instruction manual of levofloxacin injection clearly suggests that it should be used by patients under 18 years of age There are many case reports of patients under 18 years of age applying this drug and causing serious adverse events in the database.　The National Center for Monitoring of Adverse Drug Reactions suggests that clinicians should use levofloxacin injection in strict accordance with the "Guiding Principles for the Clinical Application of Antimicrobial Drugs" and the instructions of the drug. Avoid contraindications in compounding, and choose reasonably when it is necessary to use other antibacterial drugs. Renal insufficiency, elderly patients, patients with neurological diseases should be used with caution or under strict supervision. Medical personnel should carefully observe the patient's symptoms and signs during the use of medication, once abnormalities are found, the drug should be stopped immediately, and as soon as possible to clarify the diagnosis, and give symptomatic treatment in a timely manner. Shuanghuanglian injection, which was notified at the same time, is a Chinese medicinal preparation prepared by extracts of honeysuckle, scutellaria baicalensis and forsythia, with the effects of clearing heat and detoxifying toxins, dispersing wind and relieving epidemiology, and is often used for treating fever, cough and sore throat caused by exogenous wind-heat.In November 2001, the National Center for Adverse Drug Reaction (NCADR) notified the first time of the anaphylactic reaction caused by Shuanghuanglian injection. After the release of the notification, serious adverse reaction/event reports on Shuanghuanglian injection were still received one after another. It is reported that the serious adverse reactions/events of Shuanghuanglian injection are mainly systemic damage and respiratory system damage. The product has been used clinically irrationally, and some of the irrational use of drugs has caused serious adverse events. Unreasonable use of medication phenomenon is mainly manifested as: contraindication to the use of medication, will be mixed with a variety of drugs or the existence of contraindications to the use of drugs successively using the same infusion device drip, no other liquid interval; children overdose medication; allergic to patients with the use of medication and so on. The National Center for Adverse Drug Reaction Monitoring suggests that healthcare professionals should fully understand the functions and treatments of Shuanghuanglian injection, strictly grasp its indications, weigh the advantages and disadvantages of the treatment of patients, and use the drug with caution. In addition to the clinical necessity of using intravenous infusion, try to choose relatively safe oral biflavan preparations, or use intramuscular injection method of drug delivery. For medical institutions without well-established emergency drugs and equipment, use Biflavin injection with caution. Pharmacokinetics Absorption is complete after oral administration, with relative bioavailability approaching 100%. After a single oral dose of 0.1 g and 0.2 g on an empty stomach, the peak blood concentration (Cmax) reaches 1.36 mg/L and 3.06 mg/L, respectively, and the time to peak (Tmax) is about 1 hour. The blood elimination half-life (t1/2β) is about 5.1～7.1 hours. The protein binding rate is about 30% to 40%. The product is widely distributed to tissues and body fluids after absorption, and the ratio of concentration to blood concentration in tissues and body fluids such as tonsils, prostate tissues, sputum, tear fluid, women's reproductive tract tissues, skin and saliva is approximately between 1.1 and 2.1. The product is excreted from the kidneys mainly in its original form and is minimally metabolized in the body. Urinary excretion within 48 hours of oral administration is approximately 80% to 90% of the administered dose. A small amount of the product is excreted in the feces in its original form, and the cumulative amount excreted within 72 hours of administration is less than 4% of the administered dose. [edit]Indications Indicated for sensitive bacteria caused by: 1. Genitourinary infections, including simple, complex urinary tract infections, bacterial prostatitis, Neisseria gonorrhoeae urethritis or cervicitis (including those caused by enzyme-producing strains).　2. Respiratory tract infections, including acute episodes of bronchial infections and pulmonary infections caused by sensitive gram-negative bacilli.　3. Gastrointestinal infections, caused by Shigella spp, Salmonella spp, enterotoxin-producing Escherichia coli, Aeromonas hydrophila, Vibrio parahaemolyticus, and others.　4. Typhoid fever.　5. Bone and joint infections.　6. Skin and soft tissue infections.　7. Systemic infections such as sepsis. [edit]Usage and dosage Oral. Adult usual amount: 1. Bronchial infection, lung infection: 0.2g once, twice a day, or 0.1g once, three times a day, the course of treatment 7 ~ 14 days.　2. Acute simple lower urinary tract infection: 0.1g once, 2 times a day, 5-7 days; complex urinary tract infection: 0.2g once, 2 times a day, or 0.1g once, 3 times a day, 10-14 days.　3. Bacterial prostatitis: 0.2g once, twice a day, for 6 weeks.　Adults commonly used for a day 0.3 ~ 0.4g, divided into 2 ~ 3 times, such as more serious infections or infectious agents with poor sensitivity, such as Pseudomonas aeruginosa and other Pseudomonas spp. bacterial infections of the therapeutic dose can also be increased to a day of 0.6g, divided into 3 times to take.　Use in pregnant and lactating women: Animal experiments have not confirmed that quinolones have a teratogenic effect, but studies conducted on the use of drugs in pregnant women have not yet reached a clear conclusion. In view of the fact that the drug can cause arthropathy in immature animals, it is prohibited for pregnant women, and lactating women should suspend breastfeeding when applying this product.　Pediatric Use: The safety of this product in infants and adolescents under 18 years of age has not been established. However, this product can cause arthropathy when used in several species of young animals. Therefore, it should not be used in children and adolescents under 18 years of age.　Elderly patients: Elderly patients often have reduced renal function, and because the product is partially excreted through the kidneys, a reduced dosage of the product is required. [edit]Adverse reactions 1.Gastrointestinal reactions: abdominal discomfort or pain, diarrhea, nausea or vomiting.　2. Central nervous system reactions may include dizziness, headache, drowsiness or insomnia.　3. Allergic reactions: rash, itching, occasionally exudative polymorphic erythema and angioneurotic edema. Photosensitivity reactions are rare.　4. Occasionally: (1) seizures, mental abnormality, agitation, confusion, hallucinations, tremor.　(2) Interstitial nephritis manifestations such as hematuria, fever, and rash.　(3)Phlebitis.　(4)Crystalluria, mostly seen in high dose application.　(5) Joint pain.　(5) A small number of patients may occur serum aminotransferase elevation, blood urea nitrogen increase and peripheral blood leukocyte decrease, mostly mild, and transient. [edit this paragraph] Contraindications It is contraindicated in patients who are allergic to this product and fluoroquinolones. [Editorial paragraph] Precautions 1. Because Escherichia coli is resistant to fluoroquinolones, urine culture specimens should be taken before the administration of the drug, with reference to the results of bacterial drug sensitivity to adjust the drug.　2. Crystalluria may occur when the product is applied in large doses or when the urine pH is above 7. In order to avoid the occurrence of crystalluria, it is advisable to drink more water and keep the 24-hour urine output above 1200ml.　3. For those with reduced renal function, the dose should be adjusted according to renal function.　4. Avoid excessive exposure to sunlight when applying this product, and discontinue the drug if photosensitization or other allergic symptoms occur.　5. Hepatic decompensation, such as severe (cirrhosis ascites) can reduce drug clearance, blood concentration increases, hepatic and renal function are decompensation, especially obvious, need to weigh the pros and cons of the application, and adjust the dose.　6. Patients with pre-existing central nervous system disorders, such as epilepsy and a history of epilepsy should be avoided, and when indicated, should be carefully weighed against the pros and cons of the application.　7. Occasionally, there are reports of heel-over-heels inflammation or heel-over-heels rupture after the use of the drug, if the above symptoms occur, the drug should be immediately discontinued until the symptoms disappear.