Approval Date: March 29, 2007
First Amendment Date: November 13, 2007
Second Amendment Date: October 31, 2014

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Azithromycin Sulfate Instructions
Please read the instructions carefully and use them under the guidance of doctors.

[Drug Name]
Common Name: Azithromycin Sulfate for Injection
Trade Name: Verude
English Name: Azithromycin Sulfate for Injection
Chinese Pinyin: ZhusheyongLiusuan Aqimeisu
[Ingredients] The main ingredient of this product is azithromycin sulfate, and its chemical name is: 9-deoxy -9 α-aza -9 α-methyl -9 α-erythromycin A sulfate.
Chemical Structural Formula:

Molecular Formula: C38H72N2012 H2S04
Molecular Weight: 847.00
[Character] This product is white or almost white loose block or powder.
[indications] 1, for acute pharyngitis caused by Streptococcus pyogenes, acute tonsillitis.
2. For pneumonia caused by Streptococcus pneumoniae, influenza bacillus and Mycoplasma pneumoniae.
3, for chlamydia caused by urethritis and cervicitis.
4. It is used for acute bronchitis and acute attack of chronic bronchitis caused by sensitive bacteria.
5. For skin and soft tissue infections caused by sensitive bacteria.
[Specifications] 0.25g (250000 units) and 0.5g (500000 units) (calculated by C38H72N2012)

[Usage and Dosage] Fully dissolve the product with appropriate amount of water for injection to prepare a solution containing 0.1g per 1ml, then add it to 250ml or 500ml of 0.9 sodium chloride injection or 5% glucose injection, and the final azithromycin concentration is 1.0-2.0 mg/ml for intravenous drip, instillation time: 1 mg/ml, instillation for 3 hours; 2 mg/ml, instillation for 1 hour. For the treatment of community-acquired pneumonia, the adult dosage is 0.5g each time, once a day, for at least 2 consecutive days. Next, azithromycin oral preparation 0.5g/day, 7-10 days of treatment for a course of treatment. The timing of conversion to oral therapy should be determined by the physician based on clinical response. For the treatment of pelvic inflammatory disease, the adult dosage is 0.5g each time, once a day. After 1 day or 2 days of medication, azithromycin oral preparation O.25g is used instead, with 7 days as a course of treatment. The timing of conversion to oral therapy should be determined by the physician based on clinical response. If an anaerobic infection is suspected, an anti-anaerobic drug should be used.
[adverse reactions] occasionally can appear dizziness, headache and fever, rash, joint pain and other allergic reactions, rare anaphylactic shock and angioedema. A few patients may have transient neutropenia and elevated serum aminotransferase.
[taboo] to erythromycin or other macrolide drug allergy is prohibited.
[Precautions] Patients with liver damage should use this product with caution.
[medication for pregnant and lactating women] animal experiments have shown that azithromycin has no effect on the fetus, but it is still lack of experience in the application of human pregnant women, so it is necessary to fully weigh the pros and cons in the application of pregnant women.
There is no information on whether azithromycin can be secreted into breast milk, and the use of azithromycin in lactating women should be considered with caution.
[Children's medication] The dosage and administration method for children under 6 months of age have not been established. Efficacy and safety for the treatment of otitis media in infants less than 6 months of age, community-acquired pneumonia, and pharyngitis or tonsillitis in children less than 2 years of age have not been established.
[Geriatric use] This experiment has not been performed and there are no reliable references.
[Drug Interactions] l. When combined with aminophylline, attention should be paid to monitoring the blood concentration of the latter.
2, and warfarin should pay attention to check the prothrombin time.
3, combined with carbamazepine and digoxin, can increase the blood concentration of carbamazepine and digoxin.
[Overdose] This experiment was not performed and there are no reliable references.
[Pharmacology and Toxicology] Azithromycin is a 15-member ring macrolide, the first variety of nitrogen lactones. Its mechanism of action is the same as that of erythromycin, which mainly binds to the 50s subunit of bacterial ribosome and inhibits RNA-dependent protein synthesis. This product has good antibacterial effect on Streptococcus pyogenes, Streptococcus pneumoniae and influenza bacillus, and also has antibacterial activity on Staphylococcus. This product on Staphylococcus, Streptococcus and other Gram-positive cocci antibacterial effect is slightly worse than erythromycin on influenza bacilli and Moraxella catarrh antibacterial effect than erythromycin 4~8 times and 2~4 times, on a small number of Escherichia coli, Salmonella, Shigella can also have antibacterial effect. This product has good antimicrobial effect on anaerobic bacteria such as digestive streptococcus, mycoplasma pneumoniae and chlamydia trachomatis.
[Pharmacokinetics] This product is widely distributed in the body, and its concentration in various tissues can reach l0 ~ 100 times of the blood drug concentration in the same period. This product has high concentration in macrophages and fibroblasts, the former can transport azithromycin to the site of inflammation. The half-life (tl/2) of azithromycin after a single dose is 35-48 hours, more than 50% of the dose is excreted through the biliary tract in the original form, and about 4.5 within 72 hours after administration is excreted in the original form with urine.
[Storage] Closed and stored in a cool place (not more than 20 ℃).
[Packaging] Glass bottles, 0.25g × 2 bottles/box, 0.25g × 1 bottle/box, 0.25g × 10 bottles/box, 0.5g × 1 bottle/box, 0.5g × 10 bottles/box.
[validity] tentatively 24 months.
[Implementation Standard] WS-359(X-305)-2002(1)(0.25g);WS-359(X-305)-2002(2)(0.5g)
[Approval Document No.] H20000728(0.25g), H20000729(0.5g).
[Production Enterprise]
Enterprise Name: Zhejiang Jianfeng Pharmaceutical Co., Ltd.
Address: No. 58, Gaofan Section, Baitang Downline, Wucheng District, Jinhua City, Zhejiang Province
Tel: 0579-82661998 (Consultation) 0579-82131973 (Sales)
Fax Number: 0579-82661998 Postal Code: 321075
Website: www.zjjfyy.com.cn