| 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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General name: Metronidazole and Sodium Chloride Injection
The main ingredients of this product and its chemical name are: Metronidazole (2-methyl-5-nitroimidazole-1-ethanol)
Molecular formula: C6H9N3O3
Molecular weight: 171.16
[Properties] This product is a colorless or almost colorless clear liquid.
[Pharmacology and Toxicology]
Metronidazole has a strong antibacterial effect on most anaerobic bacteria, but has no effect on aerobes and facultative anaerobes. The antibacterial spectrum includes Bacteroides fragilis and other Bacteroides, Clostridium, Clostridium aerogenes, Eubacterium, Veillonella, Peptococcus and Peptostreptococcus. Actinomyces, Lactobacillus, Propionibacterium are resistant to this product. The bactericidal concentration is slightly higher than the inhibitory concentration. This product can still inhibit the redox reaction of amoeba protozoa, causing the protozoan nitrogen chain to break. In vitro experiments have proved that when the drug concentration is 1~2mg/L, histolytic amoeba can change its form within 6~20 hours, and it will be completely killed within 24 hours. When the concentration is 0.2mg/L, it can be changed within 72 hours. Kill histolytic amoeba. This product has a powerful effect of killing trichomoniasis. The mechanism is unclear. Animal tests or in vitro tests have found that this product has carcinogenic and mutagenic effects, but the human body has not yet confirmed it.
[Pharmacokinetics]
The peak plasma concentration after a single intravenous administration of 500 mg is 20 mg/L. The drugs in the serum are mainly in their original form, with a small amount of 2-hydroxymethyl metabolites, both of which have antibacterial effects. The serum protein binding rate is less than 20%, and the apparent volume of distribution is 0.6 to 0.8 L/kg. The drug concentration in cerebrospinal fluid, placenta, saliva, milk, and bile was similar to the blood drug concentration in the same period. Effective bactericidal concentration can be reached in liver abscess, pus, lung, bone, semen, and vaginal secretions. Serum T1/2 is 7-8 hours, serum T1/2 of patients with alcoholic cirrhosis is 18 hours (10-29 hours), 60%-80% of this product and its metabolites are excreted in urine, of which about 20% are in their original form Excretion; 6%~15% is excreted with feces. The renal clearance rate is 10ml/min. This product and its metabolites can be quickly cleared by hemodialysis. The serum T1/2 of hemodialysis patients is 2-6 hours. Abdominal dialysis cannot clear the product. The pharmacokinetics of patients with impaired renal function remains unchanged after a single administration, but Serum clearance slows in patients with impaired liver function. For newborns born at 28-30 weeks, 32-35 weeks, and 36-40 weeks of gestation, serum T1/2 are 75 hours, 35 hours and 25 hours.
[Indications]
This product is mainly used for the treatment of anaerobic infections.
[Dosage]
Intravenous drip.
1. Commonly used dose of adult anaerobic infection: intravenous administration of 15mg/kg for the first dose, followed by 7.5mg/kg for maintenance, each time the maximum dose does not exceed 1g, once every 8-12 hours, intravenous infusion time is more than 1 hour . The course of treatment is 7 days or longer.
2. Common dosage for children The injection dosage for anaerobic infection is the same as that for adults.
[Adverse reactions]
The most serious adverse reaction of this product is that it can cause seizures and peripheral neuropathy at high doses. The latter mainly manifests as numbness and paresthesias. In some cases, persistent peripheral neuropathy can occur during long-term medication.
(1) Gastrointestinal reactions, such as nausea, loss of appetite, vomiting, diarrhea, abdominal discomfort, taste changes, dry mouth, metallic taste in the mouth;
(2) In a few cases, urticaria, flushing, itching, cystitis, dysuria, leukopenia, etc., are all reversible and will recover automatically after stopping the drug.
(3) Central nervous system symptoms, such as headache, dizziness, syncope, ataxia, and confusion.
(4) Local reactions such as thrombophlebitis.
(5) Other fever, vaginal candida infection, dark urine may be caused by the metabolite of this product, which seems to have no clinical significance.
[Taboo]
People with active central nervous system diseases and blood diseases are prohibited.
[Precautions]
(1) The dose for patients with original liver disease should be reduced. The drug should be discontinued when dyskinesia or other central nervous system symptoms occur. Before repeating a course of treatment, a white blood cell count should be done. For patients with anaerobic infection and renal failure, the interval of administration should be extended from 8 hours to 12 hours.
(2) This product can interfere with the test results of alanine aminotransferase, lactate dehydrogenase, triglyceride, hexokinase, etc., to reduce the measured value to zero.
(3) This product can inhibit alcohol metabolism. During medication, you should stop drinking. Symptoms such as abdominal pain, vomiting, and headache may occur after drinking.
[Medication for pregnant women and lactating women]
(1) This product can quickly enter the fetal circulation through the placenta. The effect of this product on the fetus has not been sufficiently and closely observed. Therefore, pregnant women should only use this product when there are clear indications, but it should not be used within the first 3 months of pregnancy.
(2) The concentration of this product in milk is similar to that in blood. Animal experiments show that this product has carcinogenic effects on young rats, so it is not recommended for lactating women. If medication is necessary, breastfeeding should be interrupted. Breastfeeding can only be repeated 24 to 48 hours after the treatment.
[Medication for elderly patients]
The pharmacokinetics of this product in the elderly due to decreased liver function has changed, and blood drug concentration needs to be monitored. If adverse reactions to the central nervous system occur during the course of treatment, the drug should be stopped in time.
[medicine interactions]
(1) This product can inhibit the metabolism of warfarin and other oral anticoagulants, strengthen their effects, and cause prothrombin time to prolong.
(2) Simultaneous application of phenytoin, phenytoin and other drugs that induce liver microsomal enzymes can enhance the metabolism of this product and decrease the blood concentration, while the excretion of phenytoin sodium is slowed.
(3) Simultaneous application of cimetidine and other drugs that inhibit liver microsomal enzyme activity can slow down the metabolism and excretion of this product in the liver and prolong the serum half-life of this product. The dosage should be adjusted according to the results of blood concentration determination.
(4) This product interferes with the metabolism of disulfiram. If the two are used in combination, patients may have mental symptoms after drinking alcohol. Therefore, it is not suitable for those who use disulfiram within 2 weeks.
(5) This product can interfere with the determination results of aminotransferase and LDH, and can reduce cholesterol and triglyceride levels.
[Drug overdose] Large doses can cause convulsions.
| 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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