Rifampicin Injection

Pharmacology Rifampicin inhibits the activity of DNA-dependent RNA polymerase in sensitive cells, especially bacterial RNA polymerase, but does not inhibit mammalian enzymes. It has been shown that rifampicin has bactericidal activity against both intracellular and extracellular Mycobacterium tuberculosis at therapeutic concentrations. Microorganisms resistant to rifampicin may also be resistant to other rifamycins. Rifampicin has bactericidal activity against slowly and intermittently growing Mycobacterium tuberculosis and has significant activity against Neisseria meningitidis. In the treatment of pulmonary tuberculosis, the presence of a small number of resistant cells among a large number of sensitive cells can quickly become the majority in number. In addition, when a single-step mutation occurs in the DNA-dependent RNA polymerase, resistance to rifampicin will certainly occur, because resistance can develop rapidly.

Rifampin

This product is red or dark red clear liquid.

1. This product is used for emergency patients who cannot tolerate oral administration, such as patients after surgery, in coma, and with impaired gastrointestinal absorption. 2. Tuberculosis: This product is used in combination with other anti-tuberculosis drugs to treat various types of tuberculosis, including initial treatment, progressive, chronic and drug-resistant cases. This product is also effective against most atypical mycobacterial strains. 3. Other infections: This product can treat refractory Legionella and severe methicillin-resistant Staphylococcus infections. In order to prevent the development of drug resistance in the infected body, this product should be used in combination with other antibiotics suitable for the corresponding infection.

Dilute this product with 500ml of 5% glucose injection or 0.9% sodium chloride injection using aseptic technique and then drip intravenously. The recommended infusion time is more than 2-3 hours, but it should be completed within 4 hours. The prepared solution must be used within 4 hours. This product cannot be mixed with other drugs to avoid precipitation. When combined with other intravenous drugs for treatment, it needs to be injected through different parts. Dosage and administration: This product should be used in combination with other appropriate antibiotics to prevent the pathogenic bacteria from becoming drug-resistant strains. Tuberculosis: Adults: Single daily intravenous drip of 600mg over 2-3 hours. The blood drug concentration achieved by administration in this way is similar to the blood drug concentration after oral administration of 600mg.

Intestinal Heartburn, epigastric discomfort, anorexia, nausea, vomiting, jaundice, flatulence, cramping, and diarrhea have been reported in some patients. Although C. difficile is susceptible to rifampicin in vitro, pseudomembranous colitis has been reported with the use of rifampicin (and some other broad-spectrum antibiotics). Therefore, it is important to consider this diagnosis in patients who develop diarrhea while taking antibiotics concomitantly. Hepatitis or a shock-like syndrome with liver involvement and abnormal liver function tests are rare. Hematological thrombocytopenia is mainly seen with high-dose intermittent therapy and also when intermittent therapy is restarted. It is rare with good monitoring during daily treatment. If treatment is discontinued once purpura occurs, the reaction is reversible. Continuing the drug or restarting rifampicin after purpura has appeared has been reported to cause cerebral

1 This product is contraindicated for patients who are allergic to rifampicin. 2 Pregnant women should avoid using this product as much as possible. Especially in the first 3 months of pregnancy, the drug may endanger the safety of the fetus, so the pros and cons of the treatment of the mother and the safety of the fetus must be carefully weighed. 3 The use of this product in the last few weeks of pregnancy can cause postpartum bleeding in the mother and newborn, and vitamin K1 should be added for treatment. This product can enter breast milk, so mothers using this product cannot breastfeed their babies. 4 Although this product is not recommended for patients with jaundice, the benefits of using this product for treatment should be weighed against the possible risks.

Precautions for children: For the use of children, please refer to [Pharmacokinetics] and [Usage and Dosage]. Precautions for pregnancy and lactation: 1. Pregnant women: When using rifampicin in pregnant women in the last few weeks of pregnancy, it can cause postpartum hemorrhage in mothers and postnatal hemorrhage in infants. Vitamin K can be given for treatment. 2. Lactation: Since animal studies have shown that rifampicin has potential tumorigenicity, whether to discontinue breastfeeding or medication should be decided based on the current importance of the drug. Precautions for the elderly: The renal excretion of rifampicin in elderly patients decreases proportionally with the weakening of physiological renal function, resulting in a compensatory increase in liver metabolism, making the final serum half-life similar to that of young patients. However, in a trial using rifampicin in the elderly, its blood concentration was found to be increased. Therefore, caution should be exercised when using rifampicin in such patients, especially in the case of liver damage. When patients can use oral medications, they should be given oral rifampicin. Clinical studies of rifampicin did not include a sufficient number of subjects aged ≥65 years to determine whether they are different from young subjects. Clinical medication experience has not shown that elderly patients differ from young patients in terms of treatment response. Therefore, elderly patients should be observed with caution when using rifampin.

Tests have shown that rifampicin has an inducing effect on liver enzymes in animals and humans, and can reduce the activity of drugs such as anticoagulants, corticosteroids, cardiac glycosides, oral contraceptives, and oral hypoglycemic drugs. If this product is used at the same time, it is necessary to adjust the dosage of these drugs, especially when it is just started or stopped. After a long interval, renal function and blood cell counts should be closely monitored when this product is used again.

Keep away from light and store in a cool dark place. The validity period is tentatively set at 18 months.

5ml:0.3g (in terms of rifampicin)

Tentative 12 months

M&C International Trading Limited

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