Clarithromycin Tablets

1. Pharmacology This product is a macrolide antibiotic, which has an inhibitory effect on Gram-positive bacteria such as Staphylococcus aureus, Streptococcus, and Pneumococcus, as well as some Gram-negative bacteria such as Haemophilus influenzae, Bordetella pertussis, Neisseria gonorrhoeae, Legionella pneumophila, and some anaerobic bacteria such as Bacteroides fragilis, Streptococcus peptostreptococcus, and Propionibacterium acnes. In addition, it also has an inhibitory effect on mycoplasma. The characteristics of this product are that its antibacterial activity in vitro is similar to that of erythromycin, but its antibacterial activity in vivo against some bacteria such as Staphylococcus aureus, Streptococcus, and Haemophilus influenzae is stronger than that of erythromycin. There is cross-resistance between this product and erythromycin. The mechanism of action of this product is to inhibit the association of the 50S subunit of the nuclear protein and inhibit protein synthesis to produce an antibacterial effect. 2. Toxicology: Except for the in vitro chromosome aberration test, which was weakly positive once and negative once, other in vitro mutagenicity tests such as the Salmonella/mammalian cell microsome test, bacterial mutagenicity frequency test, rat hepatocyte DNA synthesis assay, mouse lymphoma assay, mouse dominant lethality test and mouse micronucleus test were all negative. Fertility and reproduction studies have shown that the administration of clarithromycin to female and male rats at 160 mg/kg/day (1.3 times the maximum recommended dose for humans based on body surface area) had no effect on the estrus, fertility, delivery, number and survival rate of offspring. Monkeys were given clarithromycin orally at 150 mg/kg/day (2.4 times the maximum recommended dose for humans based on body surface area), and embryo loss occurred. Long-term animal toxicity studies have not confirmed that clarithromycin is carcinogenic.

The main ingredient of this product is clarithromycin.

This product is a film-coated tablet, which appears white or off-white after removing the coating.

It is suitable for infections caused by microorganisms that are sensitive to clarithromycin: 1. Lower respiratory tract infections: such as bronchitis, pneumonia, etc.; 2. Upper respiratory tract infections: such as pharyngitis, sinusitis, etc.; 3. Mild to moderate infections of the skin and soft tissues: such as folliculitis, cellulitis, erysipelas, etc.

1. Adults: Oral, the usual dose is 0.25g once, once every 12 hours; for patients with severe infection, 0.5g once, once every 12 hours. It should be taken continuously for 6 to 14 days according to the severity of the infection. 2. Children: Oral, children over 6 months old should take 7.5mg/kg once according to body weight, once every 12 hours. Or administer according to the following method: 8 to 11kg, 62.5mg once, once every 12 hours; 12 to 19kg, 0.125g once, once every 12 hours; 20 to 29kg, 0.1875g once, once every 12 hours; 30 to 40kg, 0.250g once, once every 12 hours; it should be taken continuously for 5 to 10 days according to the severity of the infection.

1. Mainly bad breath (3%), abdominal pain, diarrhea, nausea, vomiting and other gastrointestinal reactions (2% to 3%), headache (2%), transient increase in serum aminotransferase. 2. Allergic reactions may occur, ranging from drug rash and urticaria in mild cases to allergies and Stevens-Johnson syndrome in severe cases. 3. Occasionally, hepatotoxicity and pseudomembranous colitis caused by Clostridium difficile are seen. 4. There have been reports of transient adverse reactions of the central nervous system, including anxiety, dizziness, insomnia, hallucinations, nightmares or confusion, but the cause and the relationship between the drug are still unclear.

1. It is contraindicated for those who are allergic to this product or macrolide drugs. 2. It is contraindicated for pregnant women and lactating women. 3. It is contraindicated for those with severe liver damage, water and electrolyte disorders, and those taking terfenadine. 4. It is contraindicated for patients with certain heart diseases (including arrhythmia, bradycardia, prolonged Q-T interval, ischemic heart disease, congestive heart failure, etc.).

Precautions for children: The efficacy and safety of children under 6 months old have not been determined. Precautions for pregnancy and lactation: In animal experiments, this product has toxic effects on embryos and fetuses. At the same time, this product and its metabolites can enter breast milk, so pregnant and lactating women are prohibited from using it. Precautions for the elderly: The tolerance of the elderly is similar to that of young people.

1. This product can slightly increase the blood concentration of carbamazepine. When the two are used together, the latter's blood concentration needs to be monitored. 2. This product has a slight effect on the metabolism of aminophylline and theophylline in the body. Generally, there is no need to adjust the dosage of the latter, but the blood concentration needs to be monitored when the dosage of aminophylline and theophylline is too high. 3. Similar to other macrolide antibiotics, this product will increase the serum concentration of drugs that need to be metabolized by the cytochrome P450 system (such as astemizole, warfarin, ergot alkaloids, triazolam, midazolam, cyclosporine, omeprazole, ranitidine, phenytoin, bromocriptine, alfentanil, hexobical, disopyramide, lovastatin, tacrolimus, etc.). 4. When used in combination with HMGCoA reductase inhibitors (such as lovastatin and simvastatin), there are very few reports of rhabdomyolysis. 5. When used in combination with cisapride and pimozide, the latter's blood concentration will increase, leading to QT interval prolongation and arrhythmias such as ventricular tachycardia, ventricular fibrillation and congestive heart failure. When used in combination with astemizole, the QT interval will be prolonged, but there will be no clinical symptoms. 6. Macrolide antibiotics can change the metabolism of terfenadine and increase its blood concentration, leading to arrhythmias such as ventricular tachycardia, ventricular fibrillation and congestive heart failure. 7. When used in combination with digoxin, the blood concentration of digoxin will increase, and blood drug concentration monitoring should be performed. 8. When HIV-infected adults take this product and zidovudine orally at the same time, this product will interfere with the absorption of the latter, causing its steady-state blood concentration to decrease, and the time of taking should be staggered. 9. When used in combination with ritonavir, the metabolism of this product will be significantly inhibited, so this product should not be used in combination with ritonavir when the daily dose is greater than 1g. 10. When used in combination with fluconazole, the blood concentration of this product will increase.

Protect from light, seal tightly, and store in a cool and dry place.

0.25g

24 months

Yueyang Tonglian Pharmaceutical Co., Ltd.

• Founded in:

  1999-05-18

• Address:

  Muligang Road, Kangwang Industrial Park, Yueyang Economic and Technological Development Zone

• Tax NO.:

  914306001861229377

• Registered Funds:

  50 million yuan

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