Levofloxacin Hydrochloride Capsules
Function and Efficacy
Repeated dose toxicity: Rats were orally administered this product at doses of 50, 200, and 800 mg/kg for 4 consecutive weeks. Only animals in 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. Rhesus monkeys were orally administered for 4 weeks, and animals in the 100 mg/kg group showed salivation, diarrhea, mild weight loss, and increased urine pH. Rats were orally administered for 26 weeks, and animals in the 80 and 320 mg/kg dose groups also showed salivation and increased urine pH. The fecal volume of animals in the 320 mg/kg group increased, and goblet cells in the cecal mucosa became swollen. When rhesus monkeys were orally administered 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 orally administered 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, extremely mild articular toxicity occurred at a dose of 40 mg/kg after oral administration for 7 days. However, no articular toxicity was observed in 18 month old dogs at a dose of 30 mg/kg after intravenous injection for 14 days. Reproductive toxicity: When rats were orally administered a dose of 360 mg/kg before and during early pregnancy, no effect was observed on the reproductive capacity and fetus of female and male animals. When rats were administered during the organogenesis period, the dose reached 90 mg/kg, and there was no significant effect on the fetus and newborn. When rabbits were orally administered 50 mg/kg, no embryonic or fetal lethality, fetal growth retardation, or teratogenic effects were observed. When the oral administration of 360 mg/kg was given to rats during the perinatal and lactation period, no significant effects were observed on the animals' delivery, lactation, and newborns. Phototoxicity: The phototoxicity study was conducted using long-wavelength ultraviolet rays (20-400nm) and the change in the thickness of the mouse ear as an indicator. The results showed that no significant abnormal changes were observed when the oral administration dose reached 200 mg/kg.
Ingredients
Levofloxacin hydrochloride.
| Name | Description | Content | CAS NO. | Manufacturer |
|---|---|---|---|---|
| Levofloxacin hydrochlorideIngredients |
Repeated dose toxicity: Rats were orally administered with doses of 50, 200, and 800 mg/kg for 4 consecutive weeks. Only animals in 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. Rhesus monkeys were orally administered for 4 weeks, and animals in the 100 mg/kg group showed salivation, diarrhea, mild weight loss, and increased urine pH. Rats were orally administered for 26 weeks, and animals in the 80 and 320 mg/kg dose groups also showed salivation and increased urine pH. The fecal volume of animals in the 320 mg/kg group increased, and goblet cells in the cecal mucosa became swollen. When rhesus monkeys were orally administered 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 orally administered 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, extremely mild articular toxicity occurred at a dose of 40 mg/kg after oral administration for 7 days. However, no articular toxicity was observed in 18 month old dogs at a dose of 30 mg/kg after intravenous injection for 14 days. Reproductive toxicity: When rats were orally administered a dose of 360 mg/kg before and during early pregnancy, no effect was observed on the reproductive capacity and fetus of female and male animals. When rats were administered during the organogenesis period, the dose reached 90 mg/kg, and there was no significant effect on the fetus and newborn. When rabbits were orally administered 50 mg/kg, no embryonic or fetal lethality, fetal growth retardation, or teratogenic effects were observed. When the oral administration of 360 mg/kg was given to rats during the perinatal and lactation period, no significant effects were observed on the animals' delivery, lactation, and newborns. Phototoxicity: The phototoxicity study was conducted using long-wavelength ultraviolet rays (20-400nm) and the change in the thickness of the mouse ear as an indicator. The results showed that no significant abnormal changes were observed when the oral administration dose reached 200 mg/kg. More |
177325-13-2 | 18 |
Appearance
This product is a hard capsule, and the contents are off-white or light yellow powder or granules.
Indication
Applicable to infections caused by sensitive bacteria: 1. Urinary and reproductive system infections, including simple and complicated urinary tract infections, bacterial prostatitis, urethritis or cervicitis caused by Neisseria gonorrhoeae (including those caused by enzyme-producing strains). 2. Respiratory tract infections, including acute bronchial infections and lung infections caused by sensitive Gram-negative bacilli. 3. Gastrointestinal infections caused by Shigella, Salmonella, enterotoxigenic Escherichia coli, Aeromonas hydrophila, Vibrio parahaemolyticus, etc. 4. Typhoid fever. 5. Bone and joint infections. 6. Skin and soft tissue infections. 7. Systemic infections such as sepsis.
Usage and Dosage
Oral administration: Adults take 1-2 capsules (0.1-0.2g) twice a day. For patients with severe conditions, the dosage can be increased to three times a day. In addition, the dosage can be increased or decreased according to the type of infection and symptoms.
Adverse Reactions
Adverse reactions may occur during the use of levofloxacin hydrochloride: 1. Digestive system: sometimes nausea, vomiting, abdominal discomfort, diarrhea, loss of appetite, abdominal pain, indigestion, etc.; 2. Allergies: Occasionally there are edema, urticaria, fever, photosensitivity, and sometimes there are rash, itching, erythema and other symptoms; 3. Nervous system: Occasionally there are tremors, numbness, visual abnormalities, tinnitus, hallucinations, drowsiness, and sometimes there are insomnia, dizziness, headache and other symptoms; 4. Kidney: 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; 5. 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 appropriate treatment can be carried out.
Precautions
It is contraindicated for patients who are allergic to quinolones, pregnant and lactating women, and patients under 18 years of age.
Special Population Medication
Precautions for children: The safety of this product in infants and adolescents under 18 years of age has not been determined. However, this product can cause joint lesions when used in several young animals. Therefore, it should not be used in children and adolescents under 18 years of age. Precautions for pregnancy and lactation: Animal experiments have not confirmed that quinolones are teratogenic, but studies on the use of drugs in pregnant women have not yet reached a clear conclusion. Since this drug can cause joint lesions in underage animals, it is contraindicated for pregnant women, and lactating women should suspend breastfeeding when using this product. Precautions for the elderly: Elderly patients often have impaired renal function, and since this product is partially excreted through the kidneys, it needs to be used in reduced doses.
Drug Interactions
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.
Storage
seal.
Packaging Specification
0.1g (based on C18H20FN3O4)
Validity Period
Tentative 2 years
Manufacturer
Zhejiang Huayuan Pharmaceutical Co., Ltd.
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Founded in:
2001-08-03 -
Address:
Huayuan Industrial Zone, Nanma Town, Dongyang City, Zhejiang Province -
Tax NO.:
91330783730924109A -
Registered Funds:
150 million yuan -
Website:
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Email: