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Metronidazole tablets

Product description
Approved date: January 29, 2007
 
Date of revision: October 1, 2010
 
         November 30, 2015
 
Metronidazole sheet instructions
 
Please read the instructions carefully and use them under the guidance of a physician.
 
For food and feed processing
 
【Drug Name】
 
Common name: metronidazole tablets
 
English name: Metronidazole Tablets
 
Chinese Pinyin: Jiaxiaozuo Pian
 
[Ingredients] The main ingredients of this product are: metronidazole. Its chemical name is: 2-methyl-5-nitroimidazole-1-ethanol.
 
 
 
Molecular formula: C6H9N3O3
 
Molecular weight: 171.16
 
【Properties】 This product is white or off-white.
 
[Indications] for the treatment of intestinal and parenteral amebiasis (such as amoebic liver abscess, pleural amebiasis, etc.). It can also be used for the treatment of vaginal trichomoniasis, pouch worm disease and cutaneous leishmaniasis, guinea worm infection. It is also widely used in the treatment of anaerobic infections.
 
[Specification] 0.2g
 
[Usage and dosage] Oral
 
1, the amount of adult use
 
1 intestinal amebiasis, once 0.4 ~ 0.6g (2 ~ 3), 3 times a day, 7 days of treatment; intestinal amebic disease, once 0.6 ~ 0.8g (3 ~ 4), one day 3 times, the treatment is 20 days.
 
2 Giardiasis, once 0.4g (2 tablets), 3 times a day, 5 to 10 days of treatment.
 
3 Dracunculiasis, 0.2g (1 tablet), 3 times a day, 7 days of treatment.
 
4 small bagworm disease, once 0.2g (1 tablet), 2 times a day, 5 days of treatment.
 
5 cutaneous leishmaniasis, once 0.2g (1 tablet), 4 times a day, 10 days of treatment. Repeat a course of treatment after 10 days.
 
6 trichomoniasis, once 0.2g (1 tablet), 4 times a day, 7 days of treatment; can be used at the same time with a suppository, 0.5g per night into the vagina, used for 7 to 10 days.
 
7 Anaerobic infection, oral daily 0.6~1.2g (3~6 tablets), divided into 3 times, 7~10 days for a course of treatment.
 
2, the amount of children commonly used
 
1 amebiasis, daily weight 35~50mg/kg, 3 times orally, 10 days for a course of treatment.
 
2 Giardia disease, daily weight 15 ~ 25mg / kg, 3 times orally, even for 10 days; treatment of guinea worm disease, small bagworm disease, trichomoniasis dose and Giardia disease.
 
3 Anaerobic infection, oral daily weight of 20 ~ 50mg / kg.
 
[Adverse reactions] 15~30% of cases have adverse reactions, the most common digestive tract reactions, including nausea, vomiting, loss of appetite, abdominal cramps, generally do not affect treatment; nervous system symptoms have headache, dizziness, occasional paresthesia, Limb numbness, ataxia, polyneuritis, etc., large doses can cause convulsions. In a few cases, urticaria, flushing, itching, cystitis, difficulty in urinating, metallic taste in the mouth, and leukopenia are all reversible, and they recover spontaneously after stopping the drug.
 
[Contraindications] Active central nervous system disorders and blood diseases are banned.
 
【Precautions】
 
(1) Interference with diagnosis: The metabolite of this product can make the urine dark red.
 
(2) The dose of the original liver disease patients should be reduced. The drug should be discontinued in the event of a motor disorder or other central nervous system symptoms. White blood cell counts should be done before repeating a course of treatment. In patients with anaerobic infection and renal failure, the interval between doses should be extended from 8 hours to 12 hours.
 
(3) This product can inhibit alcohol metabolism, alcohol should be abstained during medication, and abdominal pain, vomiting, headache and other symptoms may occur after drinking.
 
[Pregnant women and lactating women] Pregnant women and lactating women are prohibited.
 
[Child medication] See [Usage and Dosage].
 
[Geriatric medication] is not clear.
 
[Drug interaction] This product can enhance the anticoagulant drugs such as warfarin. In combination with oxytetracycline, it can interfere with the effect of metronidazole on the clearance of vaginal trichomoniasis.
 
[Drug overdose] Large doses can cause convulsions.
 
[Pharmacology and Toxicology] This product is a nitroimidazole derivative, which can inhibit the redox reaction of the amoeba, and break the nitrogen chain of the protozoa. In vitro tests have shown that when the drug concentration is 1~2mg/L, the immersion tissue amoeba can be morphologically changed within 6~20 hours, and all of them will be killed within 24 hours. When the concentration is 0.2mg/L, it can be within 72 hours. Kill the tissue amoeba.
 
This product has a strong role in killing trichomoniasis, the mechanism is unknown.
 
Metronidazole has a killing effect on anaerobic microorganisms. The metabolites produced by reduction in the human body also have an anti-anaerobic effect, inhibiting the synthesis of bacterial DNA, thereby interfering with the growth and reproduction of bacteria, and eventually causing bacterial death. It is carcinogenic to certain animals.
 
[Pharmacokinetics] Rapid and complete absorption after oral or rectal administration, protein binding rate <5%, widely distributed in various tissues and body fluids after absorption, and can pass the blood-brain barrier, the effective concentration of drugs can appear in saliva , placenta, bile, milk, amniotic fluid, semen, urine, pus and cerebrospinal fluid. It has been reported that the concentration of the drug in the placenta, milk, and bile is similar to the blood concentration. The blood concentration in the cerebrospinal fluid of healthy people is 43% of the blood concentration in the same period. A small number of patients with brain abscess, after taking 1.2 ~ 1.8g daily, the concentration of pus (34 ~ 45mg / L) is higher than the blood concentration (11 ~ 35mg / L). The concentration of the drug in the pus after infection in the ear is above 8.5 mg/L. The blood concentration reached a peak 1 to 2 hours after oral administration, and the effective concentration was maintained for 12 hours. The plasma concentrations of 0.25g, 0.4g, 0.5g, and 2g after oral administration were 6 mg/L, 9 mg/L, 12 mg/L, and 40 mg/L, respectively. This product is excreted by the kidneys 60~80%, about 20% of the original drug is excreted from the urine, and the rest is excreted in the form of metabolites (25% glucuronic acid conjugate, 14% other metabolic conjugates), 10% Excreted with feces, 14% excreted from the skin.
 
[Storage] shading, sealed (10 ~ 30 ° C) preservation.
 
[Package] medicinal plastic bottles, 100 tablets per bottle.
 
[Validity Period] 24 months
 
[Executive Standards] "Chinese Pharmacopoeia" 2015 Edition 2
 
[Approval No.] National Drug Standard H44021423
 
【manufacturer】
 
  Company Name: Guangdong Pi Di Pharmaceutical Co., Ltd.
 
  Production address: No. 66, Pidi Avenue, Yueshan Town, Kaiping City, Guangdong Province
 
  Postal code: 529331
 
  Phone number: (0750) 2789348
 
400-8899-328 (National Service Phone)
 
  Fax number: (0750) 2789348
 
  Website: http://www.pdpharm.com
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