| Application: | Internal Medicine |
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| Usage Mode: | For external use |
| Suitable for: | Elderly, Children, Adult |
| State: | Liquid |
| Shape: | Injection |
| Type: | Organic Chemicals |
| Samples: |
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| Customization: |
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Generic name: Ofloxacin injection
English name: Ofloxacin Injection
The main component of this product is ofloxacin, and its chemical name is (±)-9-fluoro-2, 3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7 -Oxo-7H-pyrido[1,2,3-de] -[1,4]benzoxazine-6-carboxylic acid.
Molecular formula: C18H20FN3O4
Molecular weight: 361.38
Properties
This product is a light yellow-green clear liquid.
Pharmacology and Toxicology
This product has a broad-spectrum antibacterial effect, especially high antibacterial activity against aerobic gram-negative bacilli, and has a good antibacterial effect in vitro against the following bacteria: Most bacteria of the Enterobacteriaceae family, including Citrobacter, cloacae, Enterobacter species such as Enterobacter, Escherichia coli, Klebsiella, Proteus, Salmonella, Shigella, Vibrio, Yersinia, etc. It also has antibacterial activity against multi-drug resistant bacteria. Neisseria gonorrhoeae, enzyme-producing Haemophilus influenzae, and Moraxella, which are resistant to penicillin, all have high antibacterial activity. It has antibacterial effect on most strains of Pseudomonas such as Pseudomonas aeruginosa. This product has antibacterial activity against methicillin-sensitive Staphylococcus, and only moderate antibacterial activity against Streptococcus pneumoniae, Streptococcus hemolyticus and Enterococcus faecalis. It has a good antimicrobial effect on Chlamydia trachomatis, Mycoplasma, Legionella, and has antibacterial activity on Mycobacterium tuberculosis and atypical mycobacteria. Poor antibacterial activity against anaerobic bacteria. Ofloxacin is a bactericide, which inhibits DNA synthesis and replication by acting on the A subunit of bacterial DNA helicase, leading to bacterial death.
Pharmacokinetics
This product is widely distributed to various tissues and body fluids after administration, and the concentration in the tissue often exceeds the blood concentration to reach an effective level. This product can still pass the placental barrier. The protein binding rate is 20% to 25%. This product is mainly excreted from the kidney in its original form, and a small amount (3%) is metabolized in the liver. Very few metabolites in urine. A small amount of this product is excreted from the feces in its original form, and the cumulative excretion within 24 hours and 48 hours after administration is 1.6% and 3.9% of the administration amount, respectively. This product can also be secreted through milk.
Indications
Suitable for sensitive bacteria:
1. Urogenital infections, including simple, complicated urinary tract infections, bacterial prostatitis, Neisseria gonorrhoeae urethritis or cervicitis (including those caused by enzyme-producing strains).
2. Respiratory tract infections, including acute attacks of chronic bronchial infections and lung infections caused by sensitive gram-negative bacilli.
3. Gastrointestinal infections are caused by Shigella, Salmonella, enterotoxigenic Escherichia coli, Aeromonas hydrophila, and Vibrio parahaemolyticus.
4. Typhoid fever.
5. Bone and joint infections.
6. Skin and soft tissue infections.
7. septicemia.
Dosage
Intravenous drip. Common dosage for adults:
1. Bronchial infection and lung infection: 0.3g once, (calculated as ofloxacin, the same below), twice a day, the course of treatment is 7 to 14 days.
2. Acute simple lower urinary tract infection: 0.2g once, twice a day, the course of treatment is 5-7 days; for complicated urinary tract infections: 0.2g once, twice a day, the course of treatment is 10-14 days.
3. Prostatitis: 0.3g once, twice a day, the course of treatment is 6 weeks; chlamydia cervicitis or urethritis, 0.3g once, twice a day, the course of treatment is 7 to 14 days.
4. Simple gonorrhea: 0.4g once, single dose.
5. Typhoid fever: 0.3g once, 2 times a day, the course of treatment is 10-14 days.
The dose of Pseudomonas aeruginosa infection or severe infection can be increased to 0.4g once, twice a day.
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: skin rash, itchy skin, occasionally exudative erythema multiforme and angioneurotic
Edema. Photosensitive reactions are rare.
4. Occasionally:
(1) Seizures, mental disorders, restlessness, confusion, hallucinations, tremors.
(2) Interstitial nephritis such as hematuria, fever, and rash.
(3) Phlebitis.
(4) Crystal urine is more common in high-dose applications.
(5) Joint pain.
5. A small number of patients may have increased serum aminotransferase, increased blood urea nitrogen, and decreased peripheral blood white blood cells, and symptoms of irritation at the injection site, mostly mild and transient.
Taboo
Patients who are allergic to this product and quinolones are contraindicated
Precautions
1. The intravenous drip time of this product should not be less than 30 minutes per 100ml.
2. Since Escherichia coli is more resistant to fluoroquinolone drugs, urine culture specimens should be collected before administration, and medication should be adjusted according to the results of bacterial drug sensitivity.
3. Crystaluria may occur when the product is used in large doses or when the urine pH is above 7. In order to avoid the occurrence of crystaluria, it is advisable to drink more water and maintain a 24-hour urine output above 1200ml.
4. For patients with impaired renal function, the dosage should be adjusted according to renal function.
5. Avoid excessive exposure to sunlight when applying this product. Stop the drug if photosensitivity occurs.
6. When liver function declines, it can reduce drug clearance and increase blood drug concentration. This is especially obvious when liver and kidney function declines. It is necessary to weigh the pros and cons before applying and adjust the dosage.
7. Patients with existing central nervous system diseases, such as those with a history of epilepsy and epilepsy, should avoid the application, and use it after carefully weighing the pros and cons when indicated.
[Medicine for pregnant and lactating women]
Animal experiments have not confirmed that quinolones have teratogenic effects, but there is no clear conclusion in the study of pregnant women. In view of the fact that this medicine can cause joint disease in juvenile animals, pregnant women are prohibited from taking it, and breastfeeding women should stop breastfeeding.
Children's Medication
The safety of this product in children and adolescents under the age of 18 has not been determined. However, this product can cause joint disease when used in several young animals. Therefore, it is not suitable for children and adolescents under 18 years of age.
Medication for elderly patients
Elderly patients often have decreased renal function, because part of this product is excreted through the kidneys, so it needs to be used in a reduced amount.
medicine interactions
1. Urine alkalizers can reduce the solubility of this product in urine, leading to crystaluria and nephrotoxicity.
2. The combination of quinolone antibacterial drugs and theophylline may be due to competition with cytochrome P450 binding sites.
Competitive inhibition leads to a significant reduction in liver elimination of theophylline, prolonged blood elimination half-life (T1/2β), increased blood concentration, and symptoms of theophylline poisoning, such as nausea, vomiting, tremor, restlessness, agitation, convulsions, and palpitations Wait. Although this product has little effect on the metabolism of theophylline, the blood concentration of theophylline should be measured and the dosage adjusted when used in combination.
3. When this product is used in combination with cyclosporine, the blood concentration of cyclosporine can be increased. The blood concentration of cyclosporine must be monitored and the dose adjusted.
4. When this product is combined with the anticoagulant warfarin, although the anticoagulant effect of the latter is small, the patient's prothrombin time should be closely monitored when combined.
5. Probenecid can reduce the secretion of this product from the renal tubules by about 50%. When used in combination, it can cause toxicity due to the increase in blood concentration of this product.
6. This product can interfere with the metabolism of caffeine, resulting in reduced caffeine elimination, prolonged blood elimination half-life (T1/2β), and may cause central nervous system toxicity.
| Comercial Packing | 10x10's/Box or Customized |
| Production Time | About 30-60days after artwork confirmed |
Since 2015, NINGBO VOICE BIOCHEMIC CO. LTD. is a professional company to offer one-package service for FPP (Finished Pharmaceutical Products ); APIs (Active Pharmaceutical Ingredients); Chemicals (Pharmaceutical Intermediates ); Veterinary Pharmaceuticals.that meet requirements of Standard GMP and current BP,USP version.
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