Product Overview
【Drug name】
Generic name: Metronidazole, Clotrimazole and Chlorhexidine Acetate Cream
English name: Metronidazole, Clotrimazole and Chlorhexidine Acetate Cream
Chinese Pinyin: Shuang Zuo Tai Ru Gao
【Ingredients】
This product is a compound preparation, and its components are: each tablet contains 0.2g of metronidazole, 0.16g of clotrimazole, and 8mg of chlorhexidine acetate.
【Properties】
This product is a milky white or light yellow ointment.
【Indications】
It is used for bacterial vaginitis, fungal vaginitis, trichomoniasis vaginitis, and mixed bacterial, fungal, and trichomoniasis vaginitis.
【Usage and Dosage】
Vaginal administration. Wash the vagina before medication, lie on your back with your knees bent, gently insert the ointment injector deep into the vagina to the vault, push the plug to inject all the medicine, 1 tablet at a time, once a night, and use it for 4 consecutive days as a course of treatment.
【Adverse Reactions】
Occasionally, 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 can 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 by numbness and paresthesia of the extremities. In some cases, long-term use of the drug can 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 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 recover on their own after stopping the drug.
[Contraindications]
This product is contraindicated for patients who are allergic to this product or azole drugs and patients with active central nervous system diseases and blood diseases.
【Precautions】
1. Do not use during menstruation. 2. If allergic symptoms or adverse reactions of the central nervous system occur during use, the drug should be discontinued immediately. 3. Patients with impaired liver and kidney function should use with caution. 4. When treating vaginal trichomoniasis, their sexual partners need to be treated at the same time. 5. Do not drink alcoholic beverages during medication. 6. Avoid contact with eyes.
【Special population medication】
Precautions for children: Children should use with caution.
Precautions for pregnancy and lactation: 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.
Precautions for the elderly: Due to impaired liver function, the pharmacokinetics of this product are changed when the elderly use it, so it should be used with caution.
【Drug interactions】
1. Chlorhexidine is incompatible with soap, potassium iodide, etc. It is also contraindicated 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 clearing vaginal Trichomonas. 3. After long-term and large-scale use through mucosal absorption, it may 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.
【Pharmacological Action】
1. Metronidazole: Metronidazole has a strong antibacterial effect on most anaerobic bacteria, but has no effect on aerobic bacteria and facultative anaerobic bacteria. The antibacterial spectrum includes Bacteroides fragilis and other Bacteroides, Fusobacterium, Clostridium perfringens, Eubacterium, Veillonella, Peptococcus and Peptostreptococcus, etc. 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 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 propionibacterium are highly sensitive to this product; Haemophilus Streptococcus is moderately sensitive, while Proteus, Pseudomonas, Klebsiella and Gram-negative cocci are slightly sensitive. Chlorhexidine has a positive charge and can be adsorbed on the mucosal surface, gradually diffuse and release from the adsorption site, and produce a sustained 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.
【Storage】 Store in a light-proof and sealed place.
【Specification】 4g (containing 200mg of mefenamic acid, 160mg of clotrimazole, 8mg of chlorhexidine acetate)
【Packaging specification】 4g*4 sticks/box
【Validity period】 24 months
【Approval number】 National Medicine Standard H20090204
【Manufacturer】 Company name: Jiangsu Yabang Johnson Pharmaceutical Co., Ltd.
