Rifaximin soft capsules

1. Pharmacological action Rifaximin is a broad-spectrum intestinal antibiotic. It is a semi-synthetic derivative of rifamycin SV. Like other rifamycin antibiotics, rifaximin inhibits bacterial RNA synthesis by irreversibly binding to the β-subunit of bacterial DNA-dependent RNA polymerase, and ultimately inhibits bacterial protein synthesis. Since its binding to the enzyme is irreversible, its activity is bactericidal against sensitive bacteria. Studies on the antibacterial activity of rifaximin have shown that this product has the same broad antibacterial spectrum as rifamycin, and has a bactericidal effect on most Gram-positive and Gram-negative bacteria, including aerobic and anaerobic infections. Since rifaximin is not absorbed by the gastrointestinal tract when taken orally, it exerts its antibacterial effect locally by killing intestinal pathogens. 2. Toxicological studies (1) Repeated dose toxicity: Rats were orally administered 25 mg/kg, 50 mg/kg and 100 mg/kg of this product daily for 180 consecutive days. The tolerance was good. Except for a dose-related increase in serum total cholesterol in female rats (which may be the result of an effect on intestinal flora), no other abnormal changes were observed. (2) Genotoxicity: In vivo and in vitro studies have not shown that this product has a mutagenic effect. (3) Reproductive toxicity: Rats and rabbits were given 50 mg/kg and 100 mg/kg of this product. No teratogenic effect or other reproductive toxicity was observed.

The main ingredient of this product is rifaximin, and its chemical name is 4-deoxy-4'-methylpyrido[1',2'-1,2]imidazo[5,4-C]rifamycin SV. Its structural formula is: Molecular formula: C43H51N3O11 Molecular weight: 785.89

This product is a soft capsule containing a red oily suspension.

Intestinal infections caused by pathogens sensitive to rifaximin, including acute and chronic intestinal infections, diarrheal syndrome, summer diarrhea, traveler's diarrhea and enterocolitis.

1. Adults: Oral. 0.2g (2 tablets) each time, 3 to 4 times a day. 2. Children aged 6 to 12 years: Oral. 0.1 to 0.2g (1 to 2 tablets) each time, 4 times a day. 3. Children over 12 years old: The dosage is the same as that of adults.

Some patients may experience nausea after taking the drug (usually after the first dose), but the symptoms will subside quickly. With long-term use of large doses, a very small number of patients may experience urticaria-like skin reactions. 1. Central nervous system: There have been reports of headaches. 2. Metabolic/endocrine system: Patients with hepatic encephalopathy may experience weight loss and a slight increase in serum potassium and serum sodium concentrations after taking this drug. 3. Gastrointestinal system: Common symptoms are abdominal distension, abdominal pain, nausea and vomiting. The incidence of the above symptoms is less than 1%. 4. Skin: With long-term use of large doses, a very small number of patients may experience urticaria-like skin reactions. 5. Others: There are reports that the drug may cause foot edema.

The following patients are contraindicated to use this drug: 1. Those who are allergic to this drug or rifamycins; 2. Those with intestinal obstruction; 3. Those with severe intestinal ulcerative lesions.

Precautions for children: It is recommended that children under 6 years old should not take this drug. For the method of taking this drug for children 6 years old and above, please refer to [Usage and Dosage]. Precautions for pregnancy and lactation: 1. Effects of the drug on pregnancy: This drug has no teratogenic effect in animal experiments. However, the safety and effectiveness of the drug for pregnant women are still unclear. Therefore, pregnant women need to weigh the pros and cons before taking the drug. 2. Effects of the drug on lactation: Only a very small amount of this drug is absorbed after oral administration, and the concentration in breast milk is also very low. Lactating women can take this drug under appropriate medical supervision. Precautions for the elderly: This experiment has not been conducted and there are no reliable references.

Less than 1% of an oral dose of rifaximin is absorbed from the gastrointestinal tract, so rifaximin is unlikely to cause systemic problems due to drug interactions.

Sealed, store in a cool, dry place.

0.1g

Tentative 24 months