Dirithromycin Enteric-coated Tablets
Function and Efficacy
Oral administration of 60 and 180 mg/kg of this product to mice had no significant effect on the central nervous system, and no synergistic effect was observed when used in combination with anesthetics; oral administration of 120 mg/kg and 240 mg/kg of this product to dogs had no significant effect on heart rate, electrocardiogram and respiration compared with before administration. The results of toxicological studies showed that: (1) Acute toxicity: The LD50 of this product for mice taken orally once was 1972.7 mg/kg for males and 1882.4 mg/kg for females; the LD50 of this product for rats taken orally was greater than 4000 mg/kg; the LD50 of this product for dogs taken orally was greater than 4500 mg/kg. (2) Reproductive toxicity: When mice were gavaged with 200-600 mg/kg of this product, no significant toxicity or teratogenicity was observed on pregnant mice and embryos. (3) Mutagenicity: No mutagenicity was observed in microbial reverse mutation test, Chinese hamster lung cell chromosome aberration test and mouse bone marrow micronucleus test. (4) Long-term toxicity: Rats were orally administered with 40, 500 and 1000 mg/kg.d for two consecutive months. Except for a temporary increase in transaminase at the dose of 1000 mg/kg.d, no other functional and pathological changes were observed. 40 and 500 mg/kg.d are safe doses. Dogs were orally administered with 35, 88 and 220 mg/kg.d for two consecutive months. Except for vomiting and increased transaminase at the medium and high doses, no other biochemical functions and pathological sections showed obvious pathological changes.
Ingredients
Dirithromycin. Chemical name: 9(S)-9-deoxy-11-deoxy-9,11-[imino(1R)-2-(2-methoxyethoxy)-ethylidene]oxy]erythromycin. Molecular weight: C42H78N2O14
| Name | Description | Content | CAS NO. | Manufacturer |
|---|---|---|---|---|
| DirithromycinIngredients |
Oral administration of 60 and 180 mg/kg of this product to mice had no significant effect on the central nervous system, and no synergistic effect was observed when used in combination with anesthetics; oral administration of 120 mg/kg and 240 mg/kg of this product to dogs had no significant effect on heart rate, electrocardiogram and respiration compared with before administration. The results of toxicological studies showed that: (1) Acute toxicity: The LD50 of this product for mice taken orally once was 1972.7 mg/kg for males and 1882.4 mg/kg for females; the LD50 of this product for rats taken orally was greater than 4000 mg/kg; the LD50 of this product for dogs taken orally was greater than 4500 mg/kg. (2) Reproductive toxicity: When mice were gavaged with 200-600 mg/kg of this product, no significant toxicity or teratogenicity was observed on pregnant mice and embryos. (3) Mutagenicity: No mutagenicity was observed in microbial reverse mutation test, Chinese hamster lung cell chromosome aberration test and mouse bone marrow micronucleus test. (4) Long-term toxicity: Rats were orally administered with 40, 500 and 1000 mg/kg.d for two consecutive months. Except for a temporary increase in transaminase at the dose of 1000 mg/kg.d, no other functional and pathological changes were observed. 40 and 500 mg/kg.d are safe doses. Dogs were orally administered with 35, 88 and 220 mg/kg.d for two consecutive months. Except for vomiting and increased transaminase at the medium and high doses, no other biochemical functions and pathological sections showed obvious pathological changes. More |
62013-04-1 | 7 |
Appearance
This product is an enteric film-coated tablet, which appears white or off-white after removing the coating.
Indication
It is suitable for patients over 12 years old, for the treatment of mild and moderate infections caused by the following sensitive bacteria: Acute exacerbation of chronic bronchitis: caused by Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pneumoniae. Acute bronchitis: caused by Moraxella catarrhalis and Streptococcus pneumoniae. Community-acquired pneumonia: caused by Legionella pneumophila, Mycoplasma pneumoniae, and Streptococcus pneumoniae. Pharyngitis and tonsillitis: caused by Streptococcus pyogenes. Simple skin and soft tissue infections: caused by Staphylococcus aureus (methicillin-sensitive strains) and Streptococcus pyogenes.
Usage and Dosage
It should be taken with food or within one hour after a meal and should not be split, crushed or chewed. Dosage and Administration of Dirithromycin: Infection (mild and moderate) Dosage: See the instructions inside the package for details.
Adverse Reactions
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. The 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.
Precautions
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).
Special Population Medication
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: This product has 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 can significantly reduce the weight of the fetus. 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. Delivery: The effect on delivery is not clear. Lactation: It is not clear whether this product is contained in the breast milk of lactating women, but other leuprolide antibiotics have been found in breast milk, and this product is also contained in the breast milk of rodents, so 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.
Drug Interactions
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 interact 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 appropriately. Antacids or H2 receptor antagonists: Taking this product orally immediately after taking antacids or H2 receptor antagonists can increase the absorption of erythromycin. The interaction of erythromycin is still unclear, so caution should be exercised when using the drug in combination.
Storage
seal.
Packaging Specification
0.5g
Validity Period
24 months
Manufacturer
Hunan Jiudian Pharmaceutical Co., Ltd.
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Founded in:
2001-01-19 -
Address:
No. 1 Jiankang Avenue, Liuyang Economic and Technological Development Zone, Changsha -
Tax NO.:
91430100722520761D -
Registered Funds:
345.145427 yuan -
Website:
-
Email: