Product Overview
[Drug name]
Generic name: Ornidazole vaginal suppository
Trade name: Yajie
English name: Ornidazole Suppositories
Chinese pinyin: Aoxiaozuo Shuan
[Ingredients]
The main ingredient of this product is ornidazole, and its chemical name is: α-chloromethyl-2-methyl-5-nitroimidazole-1-ethanol. Its structural formula: Molecular formula: C7H10CIN3O3 Molecular weight: 219.63
[Properties]
This product is a torpedo-shaped suppository with off-white or slightly yellow color.
[Indications]
Used for trichomonas vaginitis and anaerobic bacterial infection vaginitis.
[Usage and dosage]
Vaginal administration. Wash the vulva, put on a finger cot and insert the suppository deep into the vagina, once a night, one piece at a time, for 10 consecutive days.
[Adverse reactions]
Occasionally, itching of the vulvar skin, papules or local redness, and increased leucorrhea are seen. Adverse reactions of oral ornidazole capsules include: 1. Mild side effects such as drowsiness, headache, gastrointestinal discomfort (including nausea and vomiting) may be seen. 2. Some patients may experience central nervous system disorders: such as headache, tremor, rigidity, epileptic seizure, ataxia, fatigue, dizziness, temporary loss of consciousness or peripheral neuropathy. 3. Taste disorders, abnormal liver function and skin reactions.
[Contraindications]
It is contraindicated for those who are allergic to this product and nitroimidazole drugs.
[Precautions]
1. Avoid sexual intercourse during treatment; 2. Do not use the drug during menstruation; 3. If stored improperly, this product will soften or melt. It can be placed in a refrigerator or cold water to cool and form before use, which will not affect the efficacy; 4. Please keep this product out of reach of children.
[Medication for special populations]
Children's precautions: There is a lack of experience in children's medication.
Precautions during pregnancy and lactation: Women in early pregnancy or lactation should try to avoid using it. If you need to use it, it is recommended to consult a doctor.
Precautions for the elderly: Use the same medication as adults.
[Drug Interactions]
1. Ornidazole can inhibit the metabolism of the anticoagulant warfarin and prolong its half-life. When used with warfarin, the prothrombin time should be observed and the dosage should be adjusted. 2. Cimetidine can accelerate the elimination of ornidazole. Therefore, cimetidine should be avoided when using ornidazole. 3. Compared with other nitroimidazole drugs, ornidazole has no inhibitory effect on acetyl dehydrogenase. 4. Ornidazole can prolong the muscle relaxant effect of vecuronium bromide.
[Pharmacological Action]
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, interacting with cell components, thereby causing the death of microorganisms. Toxicological Studies: Repeated Dosing Toxicity: Rats were given this product at a dose of 400 mg per kilogram per 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 the drug for one year at a dose of 250 mg/kg per 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 mutagenic effects on a variety of strains, 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. When rats and mice were given a dose of 400 mg/kg per day, and rabbits were given a dose of 100 mg/kg per day, no teratogenic effect was observed. Oral administration can inhibit the reproductive capacity 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 used during pregnancy when it is really necessary. Carcinogenicity: When rats were given 400 mg/kg per day for two consecutive years, no carcinogenicity was found.
[Storage] Keep in a dark and sealed place below 30°C.
[Specification] 0.5g
[Packaging specification] 0.5g
[Validity period] tentatively 24 months
[Approval number] National Medicine Standard H20041018
[Manufacturer] Company name: Harbin Gloria Pharmaceutical Co., Ltd.
