Clarithromycin Dispersible Tablets

Cominoxa is a second-generation derivative of the macrolide antibiotic erythromycin and one of the alternatives to erythromycin. It has a strong antibacterial effect on Gram-positive bacteria. Cominoxa is highly stable to acid and is not easily destroyed by gastric acid. It has the advantages of high blood concentration, wide distribution in the body, long half-life, good oral absorption, high bioavailability, long duration of action, low toxicity and side effects, and is not easy to develop drug resistance.

6-O-methylerythromycin

This product is white or off-white tablets.

It is suitable for the following infections caused by clarithromycin-sensitive bacteria.

(1) For oral administration in adults, the usual dose is 250 mg (2 tablets) once every 12 hours; for patients with severe infection, 500 mg (4 tablets) once every 12 hours. It should be taken continuously for 6 to 14 days depending on the severity of the infection. (2) For oral administration in children, for children over 6 months old, 7.5 mg/kg per day based on body weight, once every 12 hours. Or the following methods can be used for administration: ① For patients with body weight of 8 to 11 kg, 62.5 mg (half tablet) once every 12 hours; ② For patients with body weight of 12 to 19 kg, 125 mg (1 tablet) once every 12 hours; ③ For patients with body weight of 20 to 29 kg, 187.5 mg (1 and a half tablets) once every 12 hours; ④ For patients with body weight of 30 to 40 kg, 250 mg (2 tablets) once every 12 hours; ⑤ For patients with body weight of 5 to 10 days, it should be taken continuously depending on the severity of the infection.

(1) The main side effects include bad breath (3%), gastrointestinal reactions such as abdominal pain, diarrhea, nausea, vomiting (2%-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 have been reported. (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 to the drug remain unclear.

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

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 blood concentration of the latter 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, hexobacterial, disopyramide, lovastatin, tacrolimus, etc.). (4) There are very few reports of rhabdomyolysis when this product is used in combination with HMG-CoA reductase inhibitors (such as lovastatin and simvastatin). (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 administration should be staggered. (9) The metabolism of this product will be significantly inhibited when combined 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 combined with fluconazole.

Keep away from light, seal tightly, and store in a cool (not exceeding 20℃) and dry place.

0.125 g (125,000 units)

24 months

Kangmei Pharmaceutical Co., Ltd.

• Founded in:

  1997-06-18

• Address:

  East side of Jieshen Road, Liusha, Puning City, Guangdong Province

• Tax NO.:

  91445200231131526C

• Registered Funds:

  13,863,866,690 yuan

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