Clarithromycin Capsules

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 at an oral dose of 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.

Clarithromycin.

The content of this product is white or off-white granules or crystalline powder.

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.

For oral administration in adults, the usual dose is 250 mg once every 12 hours; for patients with severe infection, 500 mg once every 12 hours. It should be taken continuously for 6 to 14 days depending on the severity of the infection. For oral administration in children, children over 6 months old should take 7.5 mg/kg of body weight once every 12 hours. Or it can be administered as follows: for patients with body weight of 8 to 11 kg, 62.5 mg once every 12 hours; for patients with body weight of 12 to 19 kg, 125 mg once every 12 hours; for patients with body weight of 20 to 29 kg, 187.5 mg once every 12 hours; for patients with body weight of 30 to 40 kg, 250 mg once every 12 hours; it should be taken continuously for 5 to 10 days depending on the severity of the infection.

1. The main symptoms are bad breath (3%), gastrointestinal reactions such as abdominal pain, diarrhea, nausea, vomiting (2% to 3%), headache (2%), and 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 central nervous system side effects, including anxiety, dizziness, insomnia, hallucinations, nightmares, or confusion, but the cause and relationship with the drug remain 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. This product is used in combination with HMGCoA reductase inhibitors (such as lovastatin and simvastatin). There are very few reports of rhabdomyolysis. 5. The combination of this product with cisapride and pimozide will increase the blood concentration of the latter, leading to QT interval prolongation and arrhythmias such as ventricular tachycardia, ventricular fibrillation and congestive heart failure. The combination with astemizole will lead to QT 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. The combination of this product 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 taking should be staggered. 9. The metabolism of this product will be significantly inhibited when used in combination with ritonavir, so this product should not be used in combination with ritonavir when the daily dose is greater than 1g. 10. The blood concentration of this product will increase when used in combination with fluconazole.

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

0.125g

24 months.

Hainan Poly Pharm. Co., Ltd.

• Founded in:

  1992-07-14

• Address:

  Guilinyang Economic Development Zone, Meilan District, Haikou City

• Tax NO.:

  91460000620000247L

• Registered Funds:

  448.350021 million yuan

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