Dirithromycin Enteric-coated Capsules

Dirithromycin is a macrolide antibiotic and a prodrug of erythromycinamine. Its mechanism of action is to inhibit bacterial protein synthesis by binding to the 50S ribosomal subunit of sensitive microorganisms. Animal in vitro tests and clinical infection treatment have confirmed that this product is active against the following microorganisms: aerobic Gram-positive microorganisms: Staphylococcus aureus (only for methicillin-sensitive bacteria), Streptococcus pneumoniae, and Streptococcus pyogenes. Aerobic Gram-negative microorganisms: Haemophilus influenzae, Legionella pneumophila, and Moraxella catarrhalis. Other microorganisms: Mycoplasma pneumoniae. In vitro studies have shown that this product is active against Listeria monocytogenes, Staphylococci (Groups C, F, and G), Bordetella pertussis, and Propionibacterium acnes. Bacteria resistant to other macrolide antibiotics are also resistant to this product.

The main component of this product is dirithromycin, and its chemical name is 9(S)-9-deoxy-11-deoxy-9,11-[imino(1R)-2-(2-methoxyethoxy)-ethylidene]oxy]erythromycin. Its molecular formula is C42H78N2O4, and its molecular weight is 835.09.

This product is an enteric-coated capsule, and the contents are white or off-white powder.

This product is a broad-spectrum macrolide antibiotic, suitable for patients over 12 years old, used to treat mild and moderate infections caused by the following sensitive bacteria: 1. Acute exacerbation of chronic bronchitis: caused by Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pneumoniae. 2. Acute bronchitis: caused by Moraxella catarrhalis and Streptococcus pneumoniae. 3. Community-acquired pneumonia: caused by Legionella pneumophila, Mycoplasma pneumoniae, and Streptococcus pneumoniae. 4. Nasopharyngitis and tonsillitis: caused by Streptococcus pyogenes. 5. Simple skin and soft tissue infections: caused by Staphylococcus aureus (methicillin-sensitive strains) and Streptococcus pyogenes.

This product can be taken with food or within one hour after a meal. Do not split, crush or chew. Usual dose: once a day, two tablets at a time.

3299 patients took this product orally (500 mg/day) for 7-14 days, and no death or disability related to toxicity was found. 2.6% of patients discontinued the medication due to adverse reactions, of which 1% were due to nausea and abdominal pain. The results of another clinical trial (oral administration of this product 500 mg/day, 5 days of treatment) showed that 3.8% of patients discontinued the medication due to adverse reactions, of which 1.6% were due to nausea and abdominal pain. The adverse reactions related to the treatment of this product are as follows: headache (7.7%), abdominal pain (7.1%), diarrhea (6.7%), nausea (5.9%), indigestion (2.6%), dizziness/dizziness (2.1%), rash (1.4%), vomiting (1.1%), etc.

It is contraindicated in patients with severe allergies to dirithromycin, erythromycin, and other macrolide antibiotics. It should not be used in patients with suspected or potential bacteremia (because it cannot provide effective drug concentrations to the treatment site).

Precautions for children: The safety and effectiveness of this product for children under 12 years of age have not yet been determined. Precautions for pregnancy and lactation: Pregnant women: Reproduction studies were conducted on rats at doses up to 21 times the human dose (calculated based on mg/m2), and the study dose on rabbits was 4 times the human dose. The results showed that this product had no damage to fertility and the fetus. Reproduction studies were conducted on mice at doses up to 8 times the human dose. The results showed that this product could significantly reduce fetal weight. However, there are no appropriate, well-controlled clinical studies on pregnant women. Therefore, the use of this product by pregnant women should weigh the pros and cons. Delivery: The effect on delivery is unclear. Lactation: It is unclear whether this product is contained in breast milk of lactating women, but other macrolide antibiotics have been found in breast milk, and this product is also contained in breast milk of rodents. Therefore, lactating women should use it with caution. Precautions for the elderly: The average Cmax and AUC tend to increase with age, but there is no statistically or clinically significant difference. Therefore, it is not necessary to adjust the dose when used by elderly patients.

Terfenadine: This product does not affect the metabolism of terfenadine. In vitro tests have shown that the two drugs do not interact with each other, but there is an interaction with erythromycin. Theophylline: In general, patients who are taking theophylline do not need to adjust theophylline dosage or monitor blood drug concentration when receiving this product. When it is necessary to maintain a higher blood concentration of theophylline, the blood concentration should be tested and the dosage should be adjusted appropriately. Antacids or H2 receptor antagonists: Taking this product immediately after taking antacids or H2 receptor antagonists can increase the absorption of erythromycin. The interaction between erythromycin and the following drugs has been clarified, but the interaction with erythromycin is not clear. Therefore, caution should be exercised when using the drugs in combination. Triazolam: It can reduce the clearance rate of triazolam and increase its pharmacological effect. Digoxin: It can increase the blood concentration of digoxin. Anticoagulants: It can increase the effect of anticoagulants, especially in the elderly. Ergotamine: It produces symptoms of poisoning, such as peripheral vasospasm and dysesthesia. Other drugs: Drug interactions have been reported with erythromycin: cyclosporine, cyclohexylbarbital, carbamazepine, alfentanil, probarbital, phenytoin, bromocriptine, valproate, astemizole, and lovastatin.

Sealed, store in a cool, dry place.

250mg

24 months