Rifampicin Capsules

Rifampicin is a semi-synthetic broad-spectrum antibacterial drug of the rifamycin class, which has antibacterial activity against a variety of pathogenic microorganisms. The drug has a significant bactericidal effect on Mycobacterium tuberculosis and some non-tuberculous mycobacteria (including Mycobacterium leprae, etc.) both inside and outside the host cells. Rifampicin has a good antibacterial effect on aerobic Gram-positive bacteria, including enzyme-producing strains of Staphylococcus and methicillin-resistant strains, Streptococcus pneumoniae, other Streptococcus, Enterococcus, Listeria, Bacillus anthracis, Clostridium perfringens, Corynebacterium diphtheriae, anaerobic cocci, etc. It also has a high degree of antibacterial activity against aerobic Gram-negative bacteria such as Neisseria meningitidis, Haemophilus influenzae, and Neisseria gonorrhoeae. Rifampicin also has a good effect on Legionella, and has an inhibitory effect on pathogens such as Chlamydia trachomatis, lymphogranuloma venereum, and psittacosis. Bacteria have cross-resistance to rifamycin antibiotics. Rifampicin binds firmly to the β-subunit of DNA-dependent RNA polymerase, inhibiting the synthesis of bacterial RNA and preventing the enzyme from connecting to DNA, thereby blocking the RNA transcription process and stopping the synthesis of DNA and protein.

The main ingredient of this product is rifampicin, and its chemical name is 3-[[(4-methyl-1-piperazinyl)imino]methyl]-rifamycin.

This product is a capsule containing bright red or dark red crystalline powder.

1 This product is used in combination with other anti-tuberculosis drugs for the initial and retreatment of various tuberculosis diseases, including the treatment of tuberculous meningitis. 2 This product is used in combination with other drugs to treat leprosy and non-tuberculous mycobacterial infections. 3 This product can be used in combination with vancomycin (intravenous) for severe infections caused by methicillin-resistant Staphylococci. The combination of rifampicin and erythromycin is used for severe Legionella infections. 4 It is used for asymptomatic carriers of Neisseria meningitidis to eliminate Neisseria meningitidis in the nasopharynx; but it is not suitable for the treatment of Neisseria meningitidis infections.

1. For anti-tuberculosis treatment of adults: Oral, 0.45g-0.60g per day, taken on an empty stomach, not more than 1.2g per day; for children over 1 month old, 10-20mg/kg per day, taken on an empty stomach, not more than 0.6g per day. 2. For carriers of Neisseria meningitidis: 5mg/kg per day, once every 12 hours for 2 consecutive days; for children over 1 month old, 10mg/kg per day, once every 12 hours for 4 consecutive days. 3. For elderly patients, oral, 10mg/kg per day, taken on an empty stomach.

1. Digestive tract reactions are the most common. After oral administration of this product, gastrointestinal reactions such as anorexia, nausea, vomiting, upper abdominal discomfort, diarrhea, etc. may occur, with an incidence of 1.7% to 4.0%, but they are all tolerable. 2. Hepatotoxicity is the main adverse reaction of this product, with an incidence of about 1%. In the first few weeks of treatment, a small number of patients may experience elevated serum aminotransferase, hepatomegaly and jaundice. Most of them are asymptomatic transient elevations of serum aminotransferase, which can recover on their own during the course of treatment. The elderly, alcoholics, malnourished, and those with pre-existing liver disease or other factors that cause abnormal liver function are more likely to occur. 3. Allergic reactions After high-dose intermittent therapy, flu-like syndrome may occasionally occur, manifested as chills, chills, fever, discomfort, dyspnea, dizziness, drowsiness and muscle pain, etc. The frequency of occurrence is significantly related to the dose and intermittent time. Acute hemolysis or renal failure may occasionally occur, and its mechanism is currently believed to be an allergic reaction. 4. After other patients take this product, urine, feces, saliva, sputum, tears, etc. may be orange-red. Occasionally, leukopenia, shortened prothrombin time, headache, dizziness, and visual impairment may occur.

1. Patients who are allergic to this product or rifamycin antibiotics are contraindicated. 2. Patients with severe liver dysfunction, biliary obstruction and pregnant women within 3 months are contraindicated.

Precautions for children: The safety of this product for children under 5 years old has not been established. Precautions for pregnancy and lactation: 1. Rifampicin can cross the placenta and has caused teratogenesis in animal experiments. Although there are no reports of teratogenesis in humans, there is currently insufficient information to indicate that it can be safely used during pregnancy. 2. Rifampicin can be excreted in breast milk. Lactating women should fully weigh the pros and cons before deciding whether to use the drug. Precautions for the elderly: Elderly patients have decreased liver function and the dosage should be reduced as appropriate.

1. Drinking alcohol can increase the incidence of rifampicin hepatotoxicity and increase the metabolism of rifampicin. The rifampicin dose needs to be adjusted, and the patient should be closely observed for hepatotoxicity. 2. Para-aminosalicylate can affect the absorption of this product, resulting in a decrease in its blood concentration; if it must be used in combination, the interval between taking the two should be at least 6 hours. 3. The risk of hepatotoxicity increases when this product is used in combination with isoniazid, especially in patients with pre-existing liver damage and patients with rapid acetylation of isoniazid. 4. The combination of rifampicin and ethionamide can aggravate its adverse reactions. 5. Chlorophenazine can reduce the absorption of rifampicin, delay the peak time and prolong the half-life. 6. The combination of rifampicin with miconazole or ketoconazole can reduce the blood concentration of the latter two, so this product should not be used in combination with imidazoles. 7. When adrenocortical hormones (glucocorticoids, mineralocorticoids), anticoagulants, aminophylline, theophylline, chloramphenicol, clofibrate, cyclosporine, verapamil (Isopamine), tocainide, propafenone, trimethoprim, coumarin or indandione derivatives, oral hypoglycemic drugs, corticotropin, dapsone, digitalis glycosides, disopyramide, quinidine, etc. are used in combination with rifampicin, because the latter induces the activity of liver microsomal enzymes, the efficacy of the above drugs can be weakened. Therefore, except for digoxin and dapsone, the above drugs need to be adjusted in dose before and during the course of treatment. When this product is used in combination with coumarin or indandione, the prothrombin time should be measured daily or regularly to adjust the dose accordingly. 8. This product can promote the metabolism of estrogen or reduce its enterohepatic circulation, reduce the effect of oral contraceptives, and lead to irregular menstruation, intermenstrual bleeding and unplanned pregnancy. Therefore, when patients take rifampicin, they should use other contraceptive methods instead. 9. This product can induce liver microsomal enzymes, increase the metabolism of anti-tumor drugs dacarbazine and cyclophosphamide, form alkylated metabolites, and promote the decrease of white blood cells, so the dosage needs to be adjusted. 10. This product combined with diazepam (valium) can increase the elimination of the latter and reduce its blood concentration, so the dosage needs to be adjusted. 11. This product can increase the metabolism of phenytoin in the liver, so when the two are used together, the blood concentration of phenytoin should be measured and the dosage should be adjusted. 12. This product can increase the degradation of levothyroxine in the liver, so the dose of levothyroxine should be increased when the two are used together. 13. This product can also increase the metabolism of methadone and mexiletine in the liver, causing methadone withdrawal symptoms and a decrease in mexiletine blood concentration, so the latter two need to adjust the dose when used together. 14. Probenecid can compete with this product for being taken up by liver cells, increasing the blood concentration of this product and producing toxic reactions. However, this effect is unstable, so it is usually not advisable to add probenecid to increase the blood concentration of this product.

Sealed, store in a dark and dry place.

0.15g

24 months.

Hangzhou Minsheng Pharmaceutical Co., Ltd.

• Founded in:

  1963-11-29

• Address:

  No. 36, Linping Avenue, Donghu Street, Linping District, Hangzhou City, Zhejiang Province

• Tax NO.:

  913301101430685558

• Registered Funds:

  88.97 million yuan

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