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, and also has an inhibitory effect on 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, and 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 binding of the 50S subunit of the nuclear protein and inhibit protein synthesis to produce an antibacterial effect. 2 Toxicology Except for one weakly positive result and another negative result in the in vitro chromosome aberration test, 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 daily administration of clarithromycin to female and male rats (1.3 times the maximum recommended dose for humans based on body surface area) has no effect on the estrus, fertility, delivery, number and survival rate of offspring in rats. Monkeys were given clarithromycin 150 mg/kg orally daily (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. Its chemical name is 6-O-methylerythromycin. Molecular formula: C38H69NO13 Molecular weight: 747.96

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

It is suitable for the following infections caused by clarithromycin-sensitive bacteria. 1. Nasopharyngeal infections: tonsillitis, pharyngitis, sinusitis. 2. Lower respiratory tract infections: acute bronchitis, acute exacerbation of chronic bronchitis and pneumonia. 3. Skin and soft tissue infections: impetigo, erysipelas, folliculitis, furunculosis and wound infections. 4. Acute otitis media, pneumonia caused by Mycoplasma pneumonia, urethritis and cervicitis caused by Chlamydia trachomatis, etc. 5. It is also used for Legionella infection, or combined with other drugs for the treatment of Mycobacterium avium infection and Helicobacter pylori infection.

Oral administration for adults, the usual dose is 0.25g once, once every 12 hours; for severe infections, 0.5g once, once every 12 hours. It should be taken continuously for 6 to 14 days depending on the severity of the infection. Oral administration for children, children over 6 months old should take 7.5mg/kg once according to body weight, once every 12 hours. Or it can be administered as follows: 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 depending on the severity of the infection.

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

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

Precautions for children: The efficacy and safety of children under 6 months old have not been determined. Precautions for pregnancy and lactation: Pregnant and lactating women are prohibited. 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 dose of the latter, but the blood concentration needs to be monitored when the dose 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 HMG-CoA reductase inhibitors (such as lovastatin and simvastatin), there are very few reports of rhabdomyolysis. 5. Combination with cisapride and pimozide will increase the blood concentration of the latter, leading to Q-T interval prolongation and arrhythmias such as ventricular tachycardia, ventricular fibrillation and congestive heart failure. Combination with astemizole will lead to Q-T interval prolongation, but without any 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. Combination with digoxin will cause an increase in digoxin blood concentration, 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 and cause its steady-state blood concentration to decrease, so the time of administration should be staggered. 9. When used in combination with ritonavir, the metabolism of this product will be significantly inhibited. Therefore, when the daily dose of this product is greater than 1g, it should not be used in combination with ritonavir. 10. Combination with fluconazole will increase the blood concentration of this product.

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

0.25g

24 months

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

• Founded in:

  1997-04-28

• Address:

  No. 38 Huanghe Road, Lianyungang Economic and Technological Development Zone

• Tax NO.:

  9132070070404786XB

• Registered Funds:

  6,379,002,274 yuan

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