Clarithromycin Dispersible Tablets

This product is a macrolide antibiotic, which has inhibitory effects 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 inhibitory effects 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.

The main ingredient of this product is clarithromycin, and its chemical name is 6-O-methylerythromycin. Molecular formula: C38H69NO13 Molecular weight: 747.96

This product is white or off-white tablets.

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, furuncle and wound infection. (4) Acute otitis media, 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.

1 Oral administration for 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 according to the severity of the infection. 2 Oral administration for children, children over 6 months old, 7.5 mg/kg once every 12 hours according to body weight. Or administration according to the following method: ① 8 to 11 kg body weight, 62.5 mg once every 12 hours; ② 12 to 19 kg body weight, 125 mg once every 12 hours; ③ 20 to 29 kg body weight, 187.5 mg once every 12 hours; ④ 30 to 40 kg body weight, 250 mg once every 12 hours; ⑤ 5 to 10 days according to 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 central nervous system side effects, 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 the drug for children under 6 months of age have not been determined. Precautions for pregnancy and lactation: Pregnant and lactating women are prohibited from using the drug. 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 This product is used in combination with HMG-CoA reductase inhibitors (such as lovastatin and simvastatin), and 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 Q-T interval prolongation and arrhythmias such as ventricular tachycardia, ventricular fibrillation and congestive heart failure. The 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. 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. Therefore, when the daily dose of this product is greater than 1g, it should not be used in combination with ritonavir. 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.

0.25 g

24 months

Jiangsu Haian Pharmaceutical Co., Ltd.

• Founded in:

  2012-05-14

• Address:

  No. 2688, Luxu National Road, Lili Town, Wujiang District

• Tax NO.:

  9132050959561916X4

• Registered Funds:

  150 million yuan

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