Levofloxacin hydrochloride pills | Yansuan Zuoyangfushaxing Pian

  • 【Drug Name】Use name: Levofloxacin Hydrochloride Pills
    Pinyin: Yansuan Zuoyangfushaxing Pian
  • 【Ingredients】The main ingredient of this product is levofloxacin hydrochloride
  • 【Properties】This product is a film-coated tablet. After removing the coating, it appears white to pale yellow
  • 【Indications】This product is suitable for the following mild to moderate infections caused by sensitive bacteria: Respiratory infections: acute bronchitis, chronic bronchitis, acute episodes of chronic bronchitis, diffuse bronchiolitis, bronchiectasis with infection, pneumonia, pharyngitis, tonsils Inflammation (peritonsillar abscess); Urinary system infections: pyelonephritis, complicated urinary tract infections, etc.; Reproductive system infections: prostatitis, epididymitis, uterine cavity infection, uterine accessory inflammation, pelvic inflammatory disease (can be suspected when anaerobic infections are suspected) Combined with metronidazole); skin and soft tissue infections: infectious pustulosis, cellulitis, lymphatic (knot) inflammation…
  • 【Specifications】Calculate 0.1g according to C18H20FN3O4
  • 【Dosage】Adults: 200 mg to 300 mg daily, orally taken in 2 to 3 times, 1 tablet each time. In severe cases, the maximum daily dose can be increased to 600 mg and taken orally three times. In addition, it can be appropriately increased or decreased according to the type of infection and symptoms
  • 【Storage】Shading, sealed (10~30℃)
  • 【Package】Aluminum-plastic packaging. 12 pieces per box
Description

Description

Levofloxacin hydrochloride pills

【Drug Name】

Common name: Levofloxacin hydrochloride pills

English name: Levofloxacin Hydrochloride Pills

Chinese Pinyin: Yansuan Zuoyangfushaxing Pian

To [ parts] the main ingredients of levofloxacin.

Chemical name: (—) – ( S ) -3 -methyl -9- fluoro -2,3 -dihydro- 10- ( 4- methyl- 1 -piperazinyl) -7- oxo- 7 H- Pyrido [1,2,3-de]-[1,4] benzo

Chemical Structure:

Molecular formula: C 18 H 20 FN 3 O 4 · HCl · H 2 O

Molecular weight: 415.85

[Of ] product is film-coated tablets, remove the coating substantially white to pale yellow.

[Indications] This product is suitable for the following mild to moderate infections caused by sensitive bacteria:

Respiratory infections: acute bronchitis, chronic bronchitis, acute onset of chronic bronchitis, diffuse bronchiolitis, bronchiectasis with infection, pneumonia, pharyngitis, tonsillitis (peritonsillar abscess);

Urinary system infections: pyelonephritis, complicated urinary tract infections, etc.;

Reproductive system infections: prostatitis, epididymitis, uterine cavity infection, uterine appendicitis, pelvic inflammatory disease (metronidazole can be combined when suspected of anaerobic infection);

Skin and soft tissue infections: infectious pustulosis, cellulitis, lymphatic (node) inflammation, subcutaneous abscess, perianal abscess, etc.;

Intestinal infections: bacterial dysentery, infectious enteritis, Salmonella enteritis, typhoid fever and paratyphoid fever;

Other infections: trauma, burns, postoperative wound infections, abdominal infections (metronidazole combined if necessary), mastitis, cholecystitis, cholangitis, bone and joint infections, and facial infections.

[Regulation grid Press] C 18 is H 20 is FN . 3 O . 4 calculates 0.1g

[Usage and Dosage] Adults 200mg ~ 300mg daily , divided into 2 to 3 times orally, 1 tablet each time . In severe cases, the maximum daily dose can be increased to 600 mg and taken orally in 3 doses. In addition, it can be increased or decreased according to the type of infection and symptoms.

[Adverse Reactions] The possible adverse reactions during medication are as follows:

Digestive system: Sometimes nausea, vomiting, abdominal discomfort, diarrhea, loss of appetite, abdominal pain, indigestion, etc.;

Allergies: Occasionally edema, urticaria, fever, light allergies and sometimes rashes, itching, erythema and other symptoms;

Nervous system: Occasionally tremor, numbness, visual abnormality, tinnitus, hallucinations, drowsiness, sometimes insomnia, dizziness, headache and other symptoms;

Kidney: Occasional increase in blood urea nitrogen;

Liver: transient liver dysfunction may occur, such as increased blood transaminase, increased total serum bilirubin, etc.;

Blood: Sometimes anemia, leukopenia, thrombocytopenia and eosinophilia increase;

The incidence of the above-mentioned adverse reactions is between 0.1 and 5% , which are generally tolerable and disappear quickly after the course of treatment. If abnormality is found, attention should be paid to observation, and if necessary, medication can be stopped and appropriate treatment can be taken.

[Ban Taboo of quinolones allergies, pregnant women and lactating women, 18 years of age disabled patients.

【Precautions】

  1. Renal insufficiency should be reduced or extended the administration period, severe renal insufficiency should be used with caution.The recommended dosage adjustment scheme is as follows:

Muscle liver clearance:

70 ~> 40ml / min. 1 times 100 mg , . 1 Day 2 times;

40 ~ ≥ 20ml / min 1 times 100 mg , 1 Day 1 times;

< 20ml / min first 100 mg , then every 48 hours 100 mg ;

  1. Patients with central nervous system diseases and a history of epilepsy should be used with caution.
  2. Quinolones can still cause rare phototoxic reactions (incidence rate<0.1% ). Avoid excessive sun exposure and artificial ultraviolet light when receiving this product. This product should be discontinued if photosensitivity or skin damage occurs.
  3. If allergies occur, the drug should be stopped immediately, and the following drugs or methods should be used according to the specific clinical situation: epinephrine and other rescue measures, including oxygen inhalation, intravenous infusion, antihistamines, corticosteroids, etc.
  4. Quinolones can still cause rare shocks, allergic reactions, toxic epidermal necrosis, acute renal insufficiency, jaundice, agranulocytosis, leukopenia, hemolytic anemia, interstitial pneumonia, pseudomembranous colitis, etc. Severe colitis with bloody stools.
  5. In addition, there are occasional reports of rhabdomyolysis, hypoglycemia, heel inflammation or heel fracture, mental disorders, and allergic vasculitis after taking the medicine, so if the above symptoms occur, you must stop the medicine immediately and take appropriate measures. Until symptoms disappear.
  6. This product has found joint disease in the experiment of young animals.
  7. Levofloxacin cannot be effectively excluded by hemodialysis or peritoneal dialysis.

【Medication for pregnant women and lactating women】Pregnant women and lactating women are prohibited.

Pediatric Use 18 -year-old disabled patients.

【Elderly Medicine】Elderly patients should be used with caution. Generally use 1 times 100 mg , 1 Day 2 administration, and note the dosing interval.

【medicine interactions】

When this product is used together with antacids containing magnesium or aluminum, aluminum sulfate, metal cations (such as iron), multi-vitamin preparations containing zinc, etc., it will interfere with the absorption of this product by the gastrointestinal tract, so that the drug The concentration in the system is significantly reduced. Therefore, the time to take the above drugs should be at least 2 hours before or after using this product .

Avoid simultaneous use with theophylline. For simultaneous application, the plasma concentration of theophylline should be monitored and the dosage adjusted accordingly.

When used with warfarin or its derivatives, prothrombin time or other coagulation tests should be monitored.

When used in conjunction with non-steroidal anti-inflammatory drugs, it may cause convulsions.

When used together with oral hypoglycemic drugs, it may cause blood sugar disorders, including hyperglycemia and hypoglycemia. Therefore, attention should be paid to monitoring blood glucose concentration during medication. Once hypoglycemia occurs, this product should be stopped immediately and appropriate treatment should be given.

【Overdose】

When this product is used excessively, the following symptoms may appear: 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, bloody nipple symptoms), metabolic acidosis, increased blood glucose, increased GOT/GPT/AI-P , leukopenia, Increased eosinophils, thrombocytopenia, hemolytic anemia, hematuria, cartilage / joint disorders, cataracts, visual impairment, abnormal color vision, and diplopia.

First aid measures and antidote ( 1 ) Gastric lavage; ( 2 ) Adsorbent: activated carbon ( 40 ~ 60g plus water 200ml oral); ( 3 ) laxative: magnesium sulfate ( 30g plus water 200ml ), or other laxatives; ( 4 ) infusion (Adding liver-protecting drugs): Metabolic acidosis is given sodium bicarbonate injection, and urine alkalization is given sodium bicarbonate injection, to increase the excretion of the product by the kidneys; ( 5 ) Compulsory diuresis: furan aniline Injection; ( 6 ) symptomatic therapy: stable intravenous injection should be administered repeatedly during convulsions. ( 7 ) Severe: Hemodialysis may be considered.

【Pharmacology and Toxicology】

Pharmacological effects

This product levo ofloxacin, twice its main mechanism of ofloxacin about its antibacterial activity by inhibiting bacterial DNA gyrase (bacterial topoisomerase Ⅱ) activity hinder bacterial DNA To achieve antibacterial effect.

This product has the characteristics of broad antibacterial spectrum and strong antibacterial effect. It is effective against most Enterobacteriaceae bacteria, such as Escherichia coli, Klebsiella, Serratia, Proteus, Shigella, Salmonella. , Citrobacter, Acinetobacter, Pseudomonas aeruginosa, Haemophilus influenzae, Neisseria gonorrhoeae and other Gram-negative bacteria have strong antibacterial activity. It also has good antibacterial effect on some gram-positive bacteria such as methicillin-sensitive staphylococcus, streptococcus pneumoniae, streptococcus pyogenes, and hemolytic streptococcus, legionella, mycoplasma, and chlamydia, but it has effects on anaerobic bacteria and enterococci Poor.

【Pharmacokinetics】

There is still lack of detailed pharmacokinetic research data of levofloxacin hydrochloride tablets in China.

The research data of levofloxacin tablets abroad shows that the blood concentration of healthy adults after oral administration of this product is proportional to the dosage. The peak time, peak blood concentration and elimination half-life are shown in the table below.

Pharmacokinetic parameters of single dose oral levofloxacin

Levofloxacin is widely distributed in tissues in the body. Prototype drugs are mainly excreted in the urine. Within 48 hours after oral administration of 100 mg and 200 mg , the excretion of prototype drugs in urine accounts for about 85% and 87% of the dose; excreted drugs in feces within 72 hours after oral administration of 200 mg The amount is less than 4% of the dose ; within 24 hours after a single dose of 100 mg orally , about 3.5% of the drug is excreted in the urine as an inactive metabolite.

The clearance rate of levofloxacin decreases in patients with renal impairment, and the elimination half-life is prolonged. In order to avoid drug accumulation, dose adjustment should be performed.

[Storage ] shading, sealing (10 ~ 30 deg.] C ) storage.

[Package installed] plastic packaging. 12 pieces per box .

[Validity Period] 24 months.

[Executive Standards] “Chinese Pharmacopoeia” 2010 edition two.

[Approval number] National Pharmaceutical Standard H20067602