Ornidazole for injection

Pharmacological action: This product is a third-generation nitroimidazole derivative. Its mechanism of antimicrobial action may be: through the nitro group in its molecule, it is reduced to amino group in an anaerobic environment or through the formation of free radicals, which interacts with cell components, thereby causing the death of microorganisms. Toxicological study: Repeated dose toxicity: Rats were given this product at a dose of 400 mg/kg/day for 2 consecutive years, and no effect on the life span of the animals was observed, nor did it cause serious functional or morphological changes. Dogs were given this product for 1 year at a dose of 250 mg/kg/day, and central nervous system symptoms appeared. These symptoms can be seen in rat tests of nitroimidazole derivatives. Genotoxicity: Similar to other nitroimidazole drugs, this product has a mutagenic effect on a variety of bacteria, but human lymphocyte and mouse dominant lethal tests show that this product has no effect on mammalian cell chromosomes. Reproductive toxicity: In the high-dose studies conducted on rats, mice and rabbits, there was no obvious effect on the fetus and perinatal period. No teratogenic effect was observed when the dose of rats and mice reached 400 mg/kg/day and the dose of rabbits reached 100 mg/kg/day. Oral administration can inhibit the reproductive ability of male rats, but unlike other 5-nitroimidazole compounds, this product does not inhibit sperm production. However, there is currently no sufficient and strictly controlled clinical research data on pregnant women. Since animal reproduction studies cannot fully predict the effects of drugs on humans, this product can only be taken during pregnancy when it is really necessary. Carcinogenicity: When rats were given a dose of 400 mg/kg/day for 2 consecutive years, no tumorigenicity was observed in this product.

The main ingredient of this product is ornidazole, and the auxiliary materials are mannitol, hydrochloric acid, and sodium hydroxide. Its chemical name is: α-(chloromethyl)-2-methyl-5-nitroimidazole-1-ethanol, and its structural formula is as follows: Molecular formula: C7H10ClN3O3 Molecular weight: 219.63

This product is off-white to slightly yellow freeze-dried mass or powder.

1. Used to treat various infectious diseases caused by sensitive anaerobic bacteria such as Bacteroides fragilis, Bacteroides dissimilar, Bacteroides ovale, Bacteroides thetaiotaomicron, Bacteroides vulgaris, Clostridium, Eubacterium, Peptococcus and Peptostreptococcus, Helicobacter pylori, Bacteroides melaninus, Fusobacterium, CO2-phagocytosis, Bacteroides gingivalis, etc., including: 1) Abdominal infection: peritonitis, intra-abdominal abscess, liver abscess, etc.; 2) Pelvic infection: endometritis, myometritis, fallopian tube or ovarian abscess, pelvic soft tissue infection, Haemophilus vaginitis, etc.; 3) Oral infection: periodontitis, apical periodontitis, pericoronitis, acute ulcerative gingivitis, etc.; 4) Surgical infection: wound infection, epidermal abscess, bedsore ulcer infection, cellulitis, gas gangrene, etc.; 5) Brain infection: meningitis, brain abscess; 6) Severe anaerobic infection such as sepsis and bacteremia, etc. 2. Used to prevent infection before surgery and treat anaerobic infection after surgery. 3. Treat severe amoebiasis of the digestive system, such as amoebic dysentery, amoebic liver abscess, etc.

Dissolve the drug in an appropriate amount of 5% glucose injection, 10% glucose injection or 0.9% sodium chloride injection, then add it to the liquid and slowly drip it intravenously. The drip concentration is 5 mg/ml, and the drip time for every 100 ml is not less than 30 minutes. The dosage is as follows: 1. Preoperative and postoperative preventive medication: For adults, intravenous drip of 1g of ornidazole 1-2 hours before surgery, intravenous drip of 500 mg 12 hours after surgery, and intravenous drip of 500 mg 24 hours after surgery. 2. Treatment of infections caused by anaerobic bacteria: The starting dose for adults is 0.5-1g, then intravenous drip of 0.5g every 12 hours for 3-6 days. If the patient's symptoms improve, it is recommended to switch to oral preparations. 3. Treatment of severe amebiasis: The starting dose for adults is 0.5-1g, then 0.5g every 12 hours for 3-6 days. 4. The dosage for children is 20-30 mg/kg body weight per day, intravenous drip once every 12 hours, and the drip time is 30 minutes.

This product is usually well tolerated, and the following reactions may occur during medication: 1. Digestive system: including mild stomach discomfort (such as nausea, vomiting), stomach pain, bad breath, etc.; 2. Nervous system: including headache and drowsiness, dizziness, tremor, movement disorders, peripheral neuropathy, epileptic seizures, temporary loss of consciousness, numbness of the limbs, cramps and mental confusion, etc.; 3. Allergic reactions: such as rash, itching, etc.; 4. Local reactions: including tingling, pain, etc.; 5. Others: leukopenia, etc.

Precautions for children: Use with caution in children. It is not recommended for children under 3 years old. Precautions for pregnancy and lactation: Use with caution in early pregnancy (first three months of pregnancy) and lactating women. Precautions for the elderly: Use the same medication as adults.

1. Compared with other nitroimidazole drugs, this product has no inhibitory effect on acetaldehyde dehydrogenase. 2. Ornidazole can inhibit the metabolism of the anticoagulant warfarin, prolong its half-life, and enhance the efficacy of the anticoagulant. When used with warfarin, attention should be paid to observing the prothrombin time and adjusting the dosage. 3. Barbiturates, ranitidine, cimetidine and other drugs can accelerate the elimination of ornidazole and reduce its efficacy and affect coagulation, so their combined use should be contraindicated. 4. The simultaneous use of drugs that induce liver microsomal enzymes such as phenytoin sodium and phenobarbital can enhance the metabolism of this product, reduce blood drug concentrations, and slow down the excretion of phenytoin sodium. 5. This product can delay the effect of the muscle relaxant vecuronium bromide.

Keep in a light-proof and airtight container.

0.25g

24 months

Hubei Changlian Dule Pharmaceutical Co., Ltd.

• Founded in:

  2000-04-24

• Address:

  No. 180, Yixing Avenue, Yiling District, Yichang City, Hubei Province

• Tax NO.:

  914205066764994030

• Registered Funds:

  73.460277 yuan

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