Azithromycin Granules

The mechanism of action is the same as that of erythromycin, mainly binding to the 50S subunit of bacterial ribosomes, inhibiting RNA-dependent protein synthesis. It is rapidly absorbed after oral administration, with a bioavailability of 37%. After a single oral dose of 0.5g, the peak time is 2.5 to 2.6 hours, and the peak blood concentration (Cmax) is 0.4 to 0.45 mg/L. This product is widely distributed in the body, and the concentration in various tissues can reach 10 to 100 times the blood concentration in the same period. The concentration in macrophages and fibroblasts is high, and the former can transport azithromycin to the site of inflammation. The blood elimination half-life (t1/2β) of this product after a single dose is 35 to 48 hours, and more than 50% of the dose is excreted in the bile duct in its original form, and about 4.5% is excreted in the urine in its original form within 72 hours after administration. The serum protein binding rate of this product decreases with the increase of blood drug concentration. When the blood drug concentration is 0.02μg/ml, the serum protein binding rate is 15%; when the blood drug concentration is 2μg/ml, the serum protein binding rate is 7%.

The main ingredients of this product are: Azithromycin

This product is white tablets or off-white granules.

1. Acute pharyngitis and acute tonsillitis caused by Streptococcus pyogenes. 2. Sinusitis, otitis media, acute bronchitis, and acute exacerbation of chronic bronchitis caused by sensitive bacteria. 3. Pneumonia caused by Streptococcus pneumoniae, Haemophilus influenzae, and Mycoplasma pneumoniae. 4. Urethritis and cervicitis caused by Chlamydia trachomatis and non-multi-drug resistant Neisseria gonorrhoeae. 5. Skin and soft tissue infections caused by sensitive bacteria.

Pour this product into a cup, add appropriate amount of cold boiled water, dissolve and shake well, then take orally, 1 hour before or 2 hours after meals. Adult dosage: 1. For sexually transmitted diseases caused by Chlamydia trachomatis or sensitive Neisseria gonorrhoeae, only 1.0g of this product is needed for a single oral administration. 2. For the treatment of other infections: On the first day, take 0.5g at a time, on the 2nd to 5th day, take 0.25g at a time; or take 0.5g at a time for 3 consecutive days. Pediatric dosage: 1. For the treatment of otitis media and pneumonia, on the first day, take 10mg/kg of body weight at a time (the maximum daily amount shall not exceed 0.5g), on the 2nd to 5th day, take 5mg/kg of body weight at a time (the maximum daily amount shall not exceed 0.25)

Gastrointestinal reactions such as abdominal pain, diarrhea (loose stools), upper abdominal discomfort (pain or cramps), nausea, and vomiting may occur after taking the drug, and their incidence is significantly lower than that of erythromycin. Mild to moderate abdominal distension, dizziness, headache, fever, rash, joint pain and other allergic reactions may occur occasionally, while anaphylactic shock, angioedema, and cholestatic jaundice are extremely rare. A small number of patients may experience transient neutropenia and elevated serum aminotransferase.

It is contraindicated in patients who are allergic to azithromycin, erythromycin, or any other macrolide drugs.

Precautions for children: The efficacy and safety of treating otitis media, community-acquired pneumonia in children under 6 months old and pharyngitis or tonsillitis in children under 2 years old have not been determined. Precautions for pregnancy and lactation: Animal experiments show that this product has no effect on the fetus, but there is still a lack of experience in its use in pregnant women, so the pros and cons must be fully weighed before using it in pregnant women. There is no data to show whether this product can be secreted into breast milk, so the use of it in lactating women must be considered with caution. Precautions for the elderly: It is not yet clear.

1. It is not suitable to be taken at the same time with antacids containing aluminum or magnesium, as the latter can reduce the peak blood concentration of this product; if it must be used together, this product should be given 1 hour before or 2 hours after taking the above drugs. 2. When used in combination with theophylline, the concentration of the latter in plasma can be increased, and attention should be paid to detecting the plasma theophylline level. 3. When used in combination with warfarin, attention should be paid to checking the prothrombin time. 4. When used simultaneously with the following drugs, it is recommended to closely observe the patient: Digoxin - increases digoxin levels. Ergotamine or dihydroergotamine - acute ergot toxicity, symptoms are severe peripheral vasospasm and dysesthesia (pain when touching objects). Triazolam - by reducing the degradation of triazolam, the pharmacological effect of triazolam is enhanced. Cytochrome P450 system metabolizers - increase the levels of carbamazepine, terfenadine, cyclosporine, cyclohexylbarbital, and phenytoin in serum. 5. When used in combination with rifabutin, the latter's toxicity will be increased.

Sealed, store in a dry place.

0.1 g

24 months

Simcere Pharmaceutical Co., Ltd.

• Founded in:

  1998-09-10

• Address:

  No. 99, Huakang Road, Jiangbei New District, Nanjing, Jiangsu Province

• Tax NO.:

  91320100135665907G

• Registered Funds:

  1.60281382 million yuan

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