Product Overview
【Drug name】
Generic name: Shuangzuotai suppository
Trade name: OuTi Pharmaceutical Shuangzuotai suppository 7 pieces
Pinyin full code: OuTi ShuangZuoTaiShuan 7Mei
【Main ingredients】
This product is a compound preparation, each containing the main ingredients of metronidazole, clotrimazole, and chlorhexidine acetate.
【Properties】
This product is a milky yellow duckbill or bullet-shaped suppository.
【Indications/Main functions】
It is used for bacterial vaginitis, candidal vaginitis, trichomonas vaginitis, and mixed infectious vaginitis.
【Specifications】
7 pieces (OuTi Pharmaceutical)
【Usage and dosage】
For vaginal administration, wash your hands before going to bed, take the suppository, remove the outer packaging, put on the finger cot, and send this product deep into the vagina (posterior fornix), 1 piece each time, and use it for 7 consecutive days as a course of treatment. Repeat one course of treatment after the first menstruation after stopping the drug.
[Adverse Reactions]
Occasionally, skin rash, vaginal burning sensation, itching or other mucosal irritation symptoms may occur. Because this product can be absorbed from the mucosa, long-term and large-scale use may also produce the same adverse reactions as systemic medication: 1. It can cause epileptic seizures and peripheral neuropathy, the latter of which is mainly manifested as numbness and paresthesia of the extremities. In some cases, long-term use of the drug may cause persistent peripheral neuropathy. 2. Other common adverse reactions include: (1) Gastrointestinal reactions, such as nausea, loss of appetite, vomiting, diarrhea, abdominal discomfort, taste changes, dry mouth, metallic taste in the mouth, etc. (2) Reversible neutropenia. (3) Allergic reactions, such as skin rash, urticaria, itching, etc. (4) Central nervous system symptoms, such as headache, dizziness, syncope, paresthesia, limb numbness, ataxia and mental confusion. (5) Other symptoms include elevated serum aminotransferase, fever, cystitis, dysuria, dark urine color, etc., which are all reversible and will recover on their own after stopping the drug.
【Contraindications】
1. Patients who are allergic to this product or pyrrole (imidazole) drugs and patients with active central nervous system diseases and blood diseases are prohibited from using it.
2. Pregnant women are prohibited from using it.
【Precautions】
1. Bisoxazolidinone suppositories are only for vaginal administration and should not be taken orally.
2. Avoid using Bisoxazolidinone suppositories during menstruation.
3. Women with no sexual history should use it under the guidance of a physician.
4. If there is a burning sensation, redness or swelling at the medication site, stop taking the medication and wash the local medication off. Consult a physician if necessary.
5. Wash your hands or wear cots or gloves when administering the medication.
6. Pay attention to personal hygiene during medication, prevent repeated infection, use condoms or avoid sexual intercourse.
7. Lactating women should stop breastfeeding when using Bisoxazolidinone suppositories.
8. Elderly people should use it with caution.
9. If allergic symptoms or adverse reactions of the central nervous system occur during use, stop taking the medication immediately.
10. Use with caution in patients with impaired liver and kidney function.
11. When treating vaginal trichomoniasis, the sexual partner should be treated at the same time.
12. Do not drink alcohol or alcoholic beverages during the use of chlorhexidine suppositories.
13. Patients who are allergic to chlorhexidine suppositories are prohibited from using chlorhexidine suppositories, and those with allergic constitutions should use it with caution.
14. Patients who are allergic to chlorhexidine suppositories are prohibited from using chlorhexidine suppositories when their properties change.
15. Please keep chlorhexidine suppositories out of reach of children.
16. If you are using other medicines, please consult a doctor or pharmacist before using chlorhexidine suppositories.
[Drug Interactions]
1. Chlorhexidine is incompatible with soap, potassium iodide, etc. It is also incompatible with borax, bicarbonate, carbonate, oxide, citrate, phosphate and sulfate. 2. When this product is used in combination with oxytetracycline, the latter may interfere with the effect of metronidazole in eliminating vaginal trichomoniasis. 3. Long-term and large-scale use, after absorption through the mucosa, can also produce drug interactions similar to systemic medication, such as inhibiting the metabolism of warfarin and other oral anticoagulants, interfering with disulfiram metabolism and serum aminotransferase and lactate dehydrogenase assay results, and combining with liver microsomal enzyme inducers or inhibitors to accelerate or slow down the metabolism of this product in the liver, etc.
[Drug use in children]
Children should use with caution.
[Drug use in elderly patients]
Due to decreased liver function, the pharmacokinetics of this product are changed when the elderly use it, so it should be used with caution.
[Drug use in pregnant women and lactating women]
Animal experiments have found that metronidazole and clotrimazole are toxic to the fetus after intraperitoneal or oral administration. However, there is currently a lack of sufficient and rigorous controlled studies on pregnant and lactating women. Therefore, pregnant women are prohibited from using this product, and lactating women should stop breastfeeding when using this product.
[Drug overdose]
It is not clear yet.
【Pharmacology and Toxicology】
1. Metronidazole: Metronidazole has a strong antibacterial effect on most anaerobic bacteria, but has no effect on aerobic bacteria and facultative anaerobes. The antibacterial spectrum includes Bacteroides fragilis and other Bacteroides, Fusobacterium, Clostridium perfringens, Eubacterium, Veillonella, Peptococcus and Peptostreptococcus. Its bactericidal concentration is slightly higher than the inhibitory concentration. In addition, it also has a strong killing effect on amoeba and Trichomonas. The bactericidal mechanism of metronidazole has not been fully elucidated. The nitroreductase of anaerobic bacteria plays an important role in the energy metabolism of sensitive strains. The nitro group of this product is reduced to a cytotoxin, which acts on the DNA metabolism process of bacteria and promotes cell death. The mechanism of anti-amoeba protozoa is to inhibit its redox reaction and break the nitrogen chain of the protozoa. 2. Clotrimazole: It has an antibacterial effect and can also have a bactericidal effect at high concentrations. It can inhibit the biosynthesis of fungal ergosterol and other sterols; damage the fungal cell membrane nucleus to change its permeability, causing the leakage of important substances in the cell; it can also inhibit the biosynthesis of fungal triglycerides and phospholipids; it can also inhibit the activity of oxidation and peroxidase, causing excessive accumulation of peroxides in the cell, leading to degeneration and necrosis of fungal subcellular structures. 3. Chlorhexidine acetate: This product is an antibacterial and anti-inflammatory drug. Some Staphylococci, Streptococcus mutans, Streptococcus salivarius, Candida albicans, Escherichia coli and anaerobic propionic acid bacteria are highly sensitive to this product; Haemophilus Streptococcus is moderately sensitive, while Proteus, Pseudomonas, Klebsiella and Gram-negative cocci are less sensitive. Chlorhexidine can be adsorbed on the mucosal surface due to its positive charge, gradually diffuse and release from the adsorption site, and produce a continuous antibacterial effect. It can be adsorbed on the permeability barrier of the bacterial cytoplasmic membrane, causing the cell contents to leak out, inhibiting bacteria at low concentrations and killing bacteria at high concentrations.
【Pharmacokinetics】
This product is for topical use and is partially absorbed through the mucosa. The absorption of metronidazole and clotrimazole is approximately 20% to 25% and 3% to 10% of the administered dose, respectively, and the absorption of chlorhexidine acetate is very low. After absorption, metronidazole is widely distributed in various tissues and body fluids, and can pass the blood-cerebrospinal fluid barrier. 60% to 80% is excreted through the kidneys, of which 20% is the original form and the rest is metabolites. A small part is excreted with feces or from the skin. After absorption, clotrimazole is metabolized into inactive metabolites in the liver and excreted with feces and urine.
【Storage】
Shade, seal.
【Packaging】
Solid medicinal composite hard tablet packaging, 7 tablets per box.
【Validity period】
24 months
【Approval number】
National medicine standard H10983208
【Manufacturer】
Harbin Tianmei Pharmaceutical Co., Ltd.
