Dirithromycin Enteric-coated Tablets

Dirithromycin is a macrolide antibiotic and a prodrug of erythromycinamine. Its mechanism of action is to inhibit 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 tests show (its clinical significance is not yet fully understood): This product is active against Listeria monocytogenes, Staphylococcus (C.F.G group), Bordetella pertussis, and Propionibacterium acnes. Bacteria resistant to other macrolide antibiotics are also resistant to this product.

The main ingredients of this product and their chemical names: The main ingredient of this product is dirithromycin

This product is enteric-coated tablets or enteric-coated film-coated tablets, which appear white or off-white after removing the coating.

It is 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. Pharyngitis and tonsillitis: caused by Streptococcus pyogenes. 5. Simple skin and soft tissue infections: caused by Staphylococcus aureus (methicillin-sensitive strains) and Streptococcus pyogenes. Note: Penicillin is a commonly used drug for the treatment and prevention of streptococcal infections (including the prevention of rheumatic fever). Generally speaking, erythromycin is effective in the treatment of nasopharyngitis caused by Streptococcus pyogenes and can eradicate it; its efficacy in preventing rheumatic fever is still unknown.

This product should be taken with food or within 1 hour after a meal. It should not be split, crushed or chewed. Dirithromycin Usage and Dosage Infection (mild and moderate) Dosage Number of medications Course of treatment (days) Acute exacerbation of chronic bronchitis 0.5g once a day 5-7 Acute bronchitis 0.5g once a day 7 Community-acquired pneumonia 0.5g once a day 14 Pharyngitis and tonsillitis 0.5g once a day 10 Simple skin and soft tissue infections 0.5g once a day 5-7.

3299 patients took this drug orally (0.5g/day) for 7-14 days, and no death or disability related to toxicity was found. 87 patients (2.6%) discontinued the drug due to adverse reactions, of which 35 (40%) discontinued the drug due to nausea and abdominal pain. The results of another clinical trial (oral administration of this drug 0.5g/day, 5-day course of treatment) showed that 35 patients (3.8%) discontinued the drug due to adverse reactions, of which 15 (43%) discontinued the drug due to nausea and abdominal pain. The adverse reactions related to the treatment of this drug 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. Platelet count increased (3.8%), potassium ion increased (2.6%), bicarbonate decreased (1.4%), CPK increased (1.2%), eosinophils increased (1.2%), neutrophils increased (1.2%), white blood cells increased (0.8%), etc.

It is contraindicated in patients who are allergic to dirithromycin, erythromycin and other macrolide drugs. It should not be used in patients with suspected or potential bacteremia (because it cannot provide effective drug concentration to the treatment site).

Precautions for children: The safety and effectiveness of this product for children under 12 years old have not been established. Precautions for pregnancy and lactation: 1. Pregnant women: Reproduction studies were conducted on rats with doses as high as 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 with doses as high as 8 times the human dose. The results showed that this product could significantly reduce fetal weight. However, there are no appropriate and well-controlled clinical studies on pregnant women. Therefore, pregnant women should weigh the pros and cons when using this product. 2. Delivery: The effect on delivery is not clear. 3. Lactation: It is not clear 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 using it in 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 theophylline blood drug concentration, the blood drug concentration should be tested and the dosage should be adjusted accordingly. 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, such as cyclosporine, cyclohexylbarbital, carbamazepine, alfentanil, probarbital, phenytoin, bromocriptine, valproate, astemizole, and lovastatin.

Sealed, store in a cool, dry place.

0.25g

24 months

GuangzhouDaguang Pharmaceutical Co., Ltd.

• Founded in:

  2009-07-09

• Address:

  Building 1, 2, 3 and 5, No. 7, Ruitai Road, Huangpu District, Guangzhou

• Tax NO.:

  91440101689315087G

• Registered Funds:

  286.028114 million yuan

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