| 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: Ciprofloxacin Lactate and Sodium Chloride Injection
English name: Ciprofloxacin Lactate Injection
Chinese Pinyin: Rusuan Huanbingshaxing Zhusheye
The main component of this product is: ciprofloxacin lactate, its chemical name is: 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3 -Quinoline carboxylic acid lactate.
Molecular formula: C17 H18FN3O3·C3H6O3
Molecular weight: 421.43
[Properties] This product is a colorless or almost colorless clear liquid.
Pharmacology and Toxicology
Pharmacological action: This product has a broad-spectrum antibacterial effect, especially high antibacterial activity against aerobic gram-negative bacilli. It has a good antibacterial effect in vitro against the following bacteria: most bacteria of the Enterobacteriaceae, including Citrobacter spp. , Enterobacter aerogenes, Escherichia coli, Klebsiella, Proteus, Salmonella, Shigella, Vibrio, Yersinia, etc. It also has antibacterial activity against multi-drug resistant bacteria. The penicillin-resistant Neisseria gonorrhoeae, the enzyme-producing influenza Bacillus and Moraxella 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.
Ciprofloxacin is a bactericide, which inhibits DNA synthesis and replication by acting on the A subunit of bacterial DNA helicase, leading to bacterial death.
Toxicological research:
Carcinogenicity and mutagenicity: 8 in vitro mutagenicity tests were performed on ciprofloxacin, and 2 of them were positive (rat hepatocyte DNA repair test and mouse lymphoma cell reversion test). However, in vivo tests of rat hepatocyte DNA repair test, micronucleus test (mice), and dominant test (mice) were all negative. Long-term carcinogenicity in vivo tests on rats and mice have been completed. After daily oral medication for 2 years, these animals did not show any carcinogenic or tumorigenic effects of ciprofloxacin.
Reproductive toxicity: Rats and mice were used to take 6 times the usual daily dose of humans for reproductive research. Ciprofloxacin has not been found to be harmful to the fetus or cause fertility damage. When ciprofloxacin is used in rabbits (30 and 100 mg/kg orally), gastrointestinal disturbances occur, leading to weight loss and increased miscarriage in female rabbits. However, no teratogenic effects were observed at the two doses. After intravenous administration of up to 20mg/kg, there was no maternal toxicity, embryo toxicity or teratogenicity. However, there are not enough, well-controlled studies on pregnant women. For pregnant women, ciprofloxacin can only be used when its potential benefits outweigh the potential risks to the fetus.
[Pharmacokinetics] After intravenous infusion of 200mg and 400mg of this product within 60 minutes, the blood drug depth peak is about 1 hour, respectively 2.1mg/L and 4.6mg/L. It can be widely distributed in various body fluids (including cerebrospinal fluid) and tissues, and the concentration in the tissues often exceeds the blood concentration. The protein binding rate is about 20%-40%. After intravenous administration, 50-70% of the drug is excreted in the urine in its original form, and about 14% is excreted in bile and feces. More than 90% of the dose is discharged within 24 hours. The elimination half-life is 5-6 hours, which can be prolonged by decreased renal function.
[Indications] Used for sensitive bacteria:
1. Urogenital system infections, including simple, complicated urinary tract infections, bacterial prostatitis, Neisseria gonorrhoeae urethritis or uterine
Cervical inflammation (including those caused by enzyme-producing strains).
2. Respiratory tract infections, including acute onset of bronchial infections and lung infections caused by sensitive gram-negative bacilli.
3. Gastrointestinal infections are caused by Shigella, Salmonella, Enterotoxigenic Escherichia coli, Hydrophilic Aeromonas, and Vibrio parahaemolyticus.
4. Typhoid fever.
5. Bone and joint infections.
6. Skin and soft tissue infections.
7. Systemic infections such as sepsis.
[Usage and Dosage] This product is for intravenous drip administration. For any patient, the dosage should be determined according to the degree and nature of the infection, the sensitivity of pathogenic bacteria, the patient's body resistance and liver and kidney function.
The general dosage for adults is 0.1-0.2g once, intravenously instilled once every 12 hours, and the infusion time of every 0.2g should be at least 30 minutes. For severe infection or Pseudomonas aeruginosa infection, the dose can be increased to 0.4g once a day 2-3 times.
The course of treatment depends on the degree of infection. Usually simple lower urinary tract infections are 5-7 days; complicated urinary tract infections are 7-14 days; pneumonia and skin and soft tissue infections: 7-14 days; intestinal infections: 5-7 days; bone and joint infections: 4-6 Weeks or longer; typhoid fever: 10-14 days.
Adverse reactions
1. Gastrointestinal reactions are more common and can be manifested as abdominal discomfort or pain, diarrhea, nausea or vomiting, indigestion, and anorexia. If you find severe long-term diarrhea during treatment, you must consult a doctor, because this may be a serious gastrointestinal disease, pseudomembranous enteritis. Once this happens, the drug should be stopped immediately. Give appropriate treatment (such as giving vancomycin). Drugs that inhibit gastrointestinal motility are prohibited.
2. Central nervous system reactions may include dizziness, headache, drowsiness or insomnia. A few cases may have abnormal peripheral pain, increased intracranial pressure, ataxia, convulsions, anxiety, confusion, depression, hallucinations, seizures, etc. Individual patients even have mental reaction and self-risk behavior. Some patients may have these reactions at the first time, so they should stop the medication immediately and notify the doctor.
3. Allergic reactions: skin rash, skin itching, drug fever, urticaria, and occasionally exudative erythema multiforme and angioedema may occur. In some cases, laryngeal edema, dyspnea, and anaphylactic shock may occur at the first medication, and anti-shock treatment should be given immediately. A few patients have photosensitivity.
4. Occasionally:
(1) Abnormal vision, impaired taste, tinnitus, and hearing loss.
(2) Hematuria, interstitial nephritis, hepatitis, and liver necrosis failure.
(3) Phlebitis or thrombophlebitis.
(4) Crystal urine is more common in high-dose applications.
(5) Joint pain, muscle pain, tenosynovitis, Achilles tendinitis;
(6) Tachycardia, facial flushing, migraine, syncope;
(7) Blood system effects: anemia, thrombocytopenia, leukopenia, eosinophilia, hemolytic anemia, coagulation changes. (8) Skin spotting (petechia) blisters, accompanied by bleeding (blood blisters) and crusted nodules (papules), stevens-Johnson and Yell syndrome.
(9) Long-term and repeated application of this product can cause infection by resistant bacteria or yeast-like bacteria.
5. Abnormal laboratory data: a small number of patients may have elevated serum aminotransferase, alkaline phosphatase, cholestatic jaundice, especially in patients with liver damage, blood urea nitrogen, creatinine or bilirubin increased, and individual patients have hyperglycemia and crystals Urine, hematuria.
6. Ciprofloxacin can affect the patient's ability to drive or operate machinery, especially in patients who drink at the same time.
[Contraindications] Patients who have a history of allergies to this product and any fluoroquinolones are contraindicated.
[Precautions] 1. Since Escherichia coli is more resistant to fluoroquinolones, urine culture specimens should be collected before administration, and the medication should be adjusted according to the results of bacterial susceptibility.
2. 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.
3. For patients with impaired renal function, the dosage should be adjusted according to renal function.
4. The application of fluoroquinolones can cause moderate to severe photosensitivity. Avoid excessive exposure to sunlight when applying this product. Stop the drug if photosensitivity occurs.
5. 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.
6. Patients with original central nervous system diseases, such as epilepsy and those with a history of epilepsy, should avoid the application, and should be used after careful weighing of the pros and cons when indicated.
[Medication for pregnant women and lactating women] Animal experiments have not confirmed that quinolones have teratogenic effects, but there is no clear conclusion on the study of pregnant women. In view of the fact that this drug can cause joint disease in juvenile animals, it can pass through the placental barrier, so pregnant women are not allowed to use it; this product can also be secreted into milk, and breastfeeding women should suspend breastfeeding when using this product.
[Children's medication] The safety of this product in infants and young people under 18 has not been established. However, this product can cause joint disease when used in several young animals. Therefore, it is prohibited 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, it needs to be used in a reduced dose.
[Drug interaction] 1. Urine alkalizers can reduce the solubility of this product in urine, leading to crystaluria and nephrotoxicity.
2. When this product is used in combination with theophylline, due to the competitive inhibition of the binding site of cytochrome P450, the liver clearance of theophylline is significantly reduced, the blood elimination half-life (t1/2β) is prolonged, the blood concentration increases, and theophylline appears Symptoms of poisoning, such as nausea, vomiting, tremor, restlessness, agitation, convulsions, heart palpitations, etc. Therefore, the blood concentration of theophylline should be measured and the dose adjusted when combined.
3. The combination of cyclosporine and this product can increase the blood concentration of the former. The blood concentration of cyclosporine must be monitored and the dose adjusted.
4. When this product is used in combination with the anticoagulant warfarin, the anticoagulant effect of the latter can be enhanced, and the patient's prothrombin time should be closely monitored when used in combination.
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 interferes with the metabolism of caffeine, resulting in reduced caffeine clearance, prolonged blood elimination half-life (t1/2β), and may cause central nervous system toxicity.
7. Metoclopramide can accelerate the absorption of this product, but has no effect on the bioavailability.
8. Animal experiments show that high-dose quinolone combined with certain non-steroidal anti-inflammatory drugs can cause convulsions, and rapid intravenous injection can cause hypotension.
[Drug overdose] In the case of acute drug overdose, the changes in the condition should be carefully observed, and symptomatic treatment and supportive therapy should be given. And keep adequate moisture. Hemodialysis or peritoneal dialysis can only excrete a small amount of drugs (< 10%).
| 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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