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 teratogenic effect 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 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 medium and high doses, no obvious pathological changes were observed in other biochemical functions and pathological sections.
Ingredients
The main ingredient of this product is erythromycin.
| 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 teratogenic effect 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 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 medium and high doses, no obvious pathological changes were observed in other biochemical functions and pathological sections. More |
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Appearance
This product is enteric-coated tablets or enteric-coated film-coated tablets, which appear white or off-white after removing the coating.
Indication
It is suitable for patients over 12 years old, and is used to treat mild and moderate infections caused by the following sensitivities: 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 bacteria) and Streptococcus pyogenes.
Usage and Dosage
This product should be taken with food or within one hour after a meal. It should not be split, crushed or chewed. Dosage and Administration of Dirithromycin: Infection (mild and moderate) Dosage: Number of doses: Course of treatment: Acute exacerbation of chronic bronchitis: 0.5g (two tablets) once a day 5-7 Acute bronchitis: 0.5g (two tablets) once a day 7 Community-acquired pneumonia: 0.5g (two tablets) once a day 14 Pharyngitis and tonsillitis: 0.5g (two tablets) once a day 10 Simple skin and soft tissue infections: 0.5g (two tablets) once a day 5-7.
Adverse Reactions
This product has fewer adverse reactions, mainly abdominal pain, headache, nausea, diarrhea, vomiting, indigestion, 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 determined. Precautions for pregnancy and lactation: Pregnant women: Reproduction studies were conducted on rats with 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 with 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, pregnant women should weigh the pros and cons when using this product. 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 are no statistically or clinically significant differences.
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
Sealed, store in a cool, dry place.
Packaging Specification
0.125g
Validity Period
24 months
Manufacturer
Hubei Shubang Pharmaceutical Co., Ltd.
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Founded in:
2012-04-17 -
Address:
No. 1 Sibao Road, Xiantao City -
Tax NO.:
914290045942134679 -
Registered Funds:
48 million yuan -
Email: