Acetylspiramycin Tablets

[Pharmacology and Toxicology] Acetylspiramycin is an acetylated derivative of spiramycin and belongs to the 16-membered macrolide class. This product has good antibacterial effects on Gram-positive cocci such as Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, and Enterococcus faecalis. It also has inhibitory effects on Listeria, Moraxella catarrhalis, Neisseria gonorrhoeae, Campylobacter fetus, Haemophilus influenzae, Legionella pneumophila, Bordetella pertussis, Bacteroides, Clostridium perfringens, Propionibacterium acnes, Peptococcus and Streptococcus, as well as Chlamydia, Mycoplasma, Toxoplasma, Cryptosporidium, etc. Intestinal Gram-negative bacilli are usually resistant. The mechanism of action is that acetylspiramycin binds to the 50S subunit of the ribosome of sensitive microorganisms, inhibits RNA-dependent protein synthesis, and exerts an antibacterial effect. [Pharmacokinetics] This product is acid-resistant and well absorbed orally. After absorption through the gastrointestinal tract, it is deacetylated and converted into spiramycin to exert an antibacterial effect. After a single oral dose of 0.2g, the peak blood concentration (Cmax) reaches 1mg/L 2 hours later. This product is widely distributed in the body. The concentration in bile, urine, pus, bronchial secretions, lung tissue and prostate is generally higher than the blood concentration. This product cannot pass through the blood-cerebrospinal fluid barrier. The average blood elimination half-life (t1/2beta;) is about 4 to 8 hours. There is an accumulation effect in the body after multiple administrations. This product is mainly excreted through feces, and the amount excreted through urine in 12 hours is about 5% to 15% of the dose, most of which are metabolites. The concentration in bile can reach 15 to 40 times the blood concentration.

This product is a mixture of four main components: monoacetylspiramycin II, monoacetylspiramycin III, diacetylspiramycin II and diacetylspiramycin III.

This product is a sugar-coated tablet or a film-coated tablet. After removing the coating, it appears off-white or slightly yellow.

It is suitable for mild and moderate infections caused by sensitive Staphylococci, Streptococci and Streptococcus pneumoniae, such as pharyngitis, tonsillitis, sinusitis, otitis media, periodontitis, acute bronchitis, acute exacerbation of chronic bronchitis, pneumonia, non-gonococcal urethritis, skin and soft tissue infections. It can also be used for cryptosporidiosis or as an optional drug for the treatment of toxoplasmosis in pregnant women.

Adult dose: 0.2-0.3g at a time, 4 times a day, double the dosage for the first time. Pediatric dose: 20-30mg/kg per day, divided into 4 doses.

Patients tolerated the drug well. Adverse reactions mainly included gastrointestinal reactions such as abdominal pain, nausea, and vomiting, which often occurred when taking large doses. Most of them were mild and disappeared on their own after stopping the drug. Allergic reactions were rare, mainly drug eruptions. No liver or kidney damage or abnormal blood or urine routine tests were found.

Patients who are allergic to this product, erythromycin, or other macrolides are contraindicated.

Precautions for children: The efficacy and safety of pediatric patients under 6 months old have not been determined. Precautions for pregnancy and lactation: This product can penetrate the placenta, so the use of it in pregnant women needs to be determined after fully weighing the pros and cons. There is no data showing whether acetylspiramycin is excreted through breast milk, but since many macrolide drugs can be excreted through breast milk, lactating women should use this product with caution. If it must be used, breastfeeding should be suspended. Precautions for the elderly: Elderly patients with normal liver and kidney function do not need to reduce the dosage.

1. This product does not affect the metabolism of aminophylline and other drugs in the body. 2. In patients receiving ergot derivatives, ergot poisoning has occurred when certain macrolides are used at the same time. There are currently no reports of ergot and acetylspiramycin interacting, but this possibility still exists in theory. Therefore, acetylspiramycin and ergot should not be taken at the same time.

Sealed, store in a cool, dark and dry place.

0.1g (100,000 units)

24 months

Sichuan YIKE Pharmaceutical Co., Ltd.

• Founded in:

  1999-02-03

• Address:

  No. 2, Section 4, Zhongshan Avenue South, Guanghan City, Sichuan Province

• Tax NO.:

  915106817118139642

• Registered Funds:

  93.41 million yuan

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