Expiration date: 09/2025

Composition and form of issue:

Tablets, film-coated. 1 tablet contains:

spiramycin 3 million IU

other ingredients: microcrystalline polyplasdone X l 10 (crospovidone) sodium carboximetilkrahmal (primogel) PVP (povidone) Aerosil (silica colloidal anhydrous) magnesium stearate Opadry II 

in a contour acheikova package 5 PCs. in cardboard pack 2 packages or contour acheikova packing 10 PCs in the paper cartons 1 package or in the banks dark glasses to 10 PCs in the paper cartons 1 Bank.

Description of dosage form:

Tablets, film-coated cream colour, oblong in shape (oblong).

Pharmacokinetics:

Absorption spiramycin is fast, but not full, with a large variability (from 10 to 60%).

After oral administration of 6 million ME spiramizina Cmax in plasma is about 3, 3 µg/ml.

Spiramycin not penetrate into the cerebrospinal fluid, however, diffuses into breast milk. It penetrates through the placental barrier (the concentration in the blood of the fetus is about 50% of the concentration in the serum of the mother). Concentrations in placental tissue are 5 times higher than the corresponding serum concentrations.

The volume of distribution-about 383 liters.

The drug penetrates well into saliva and tissue (concentration in the lungs — from 20 to 60 µg/g, tonsils — from 20 to 80 µg/g, infected sinuses — from 75 to 110 µg/g, bones — from 5 to 100 µg/g). 10 days after the end of treatment, the concentration of the drug in the spleen, liver and kidneys is from 5 to 7 µg/g.

Plasma protein binding is low (approximately 10%).

Spiramycin metabolized in the liver to form active metabolites with unknown chemical structure.

Is deduced, mainly, with bile (concentration in 15-40 times higher, than in serum). The news is about 10% of the administered dose.

T1/2 after administration of 3 million ME spiramizina approximately 8 h. It can be extended in elderly patients. In patients with impaired renal function do not require dose adjustments spiramizina.

Description of the pharmacological action:

Antibiotic from the macrolide group acts bacteriostatically (when used in high doses can act bactericidal against more sensitive strains): suppresses protein synthesis in the microbial cell by reversible binding to 50S ribosomal subunit, which leads to a blockade of transpeptidation and translocation reactions. Unlike 14-member macrolides, it is able to connect not with one, but with three (I–III) domains of the subunit, which may provide a more stable binding to the ribosome and, therefore, a longer antibacterial effect. Can accumulate in high concentrations in the bacterial cell.

The following microorganisms are usually sensitive to the preparation: Staphylococcus spp. (including strains of Staphylococcus aureus sensitive to methicillin), Streptococcus spp., Neisseria meningitidis, Neisseria gonorrhoeae, Bordetella pertussis, Corynebacterium diphtheriae, Listeria monocytogenes, Clostridium spp., Mycoplasma pneumoniae, Chlamydia spp., Legionella pneumophila, Treponema spp., Leptospira spp., Campylobacter spp., Toxoplasma gondii. Moderately sensitive: Haemophilus influenzae. Resistant to spiral: Enterobacteriaceae spp., Pseudomonas spp..

There is cross-resistance between erythromycin and spiramycin.

Indications:

• bacterial infections caused by sensitive microorganisms: acute community-acquired pneumonia (including atypical, caused by Mycoplasma, Chlamydia, Legionella), exacerbation of chronic bronchitis sinusitis, tonsillitis, otitis osteomyelitis, arthritis, extragenital chlamydia, prostatitis, urethritis of various etiologies of sexually transmitted diseases
  
• skin infections: erysipelas, infected dermatoses, abscess, phlegmon (including dentistry)
  
• toxoplasmosis, including during pregnancy
  
• prevention of meningococcal meningitis among persons in contact with patients no more than 10 days before its hospitalization
  
• prevention of acute articular rheumatism
  
• treatment of bacteria causative agents of whooping cough and diphtheria.
  

Contraindications:

• hypersensitivity to spiramycin and other components of the drug
  
• breastfeeding period
  
• children's age (tablets of 3 million ME in children are not used)
  
• do not use spiramycin in patients with deficiency of the enzyme glucose-6-phosphate dehydrogenase, due to the possible occurrence of acute hemolysis.
  

Be wary, with obstruction of the bile ducts or liver failure.

Application for pregnancy and breastfeeding:

May be prescribed, if necessary, during pregnancy (no teratogenic effect).

Spiramycin can stand out with breast milk, therefore, if necessary, the appointment of the drug during lactation should stop breastfeeding.

Side effect:

From the digestive tract: nausea, vomiting, diarrhea and very rare cases of pseudomembranous colitis (less than 0, 01%). Isolated cases of ulcerative esophagitis and acute colitis are described. It was also noted the possibility of development of acute damage of the intestinal mucosa in patients with AIDS in the application of high doses spiramizina about cryptosporidiosis.

From the peripheral system and the Central nervous system: transient paresthesia.

From the liver: in very rare cases (less than 0, 01%) — changes in liver function tests and the development of cholestatic hepatitis.

From the hematopoietic organs: very rare cases (less than 0, 01%) of acute hemolysis (see "Contraindications" section "caution") and thrombocytopenia.

Of the cardiovascular system: possible prolongation of the QT interval on the electrocardiogram.

Hypersensitivity reactions: skin rash, urticaria, skin itching. Very rarely (less than 0, 01%) — angioedema, anaphylactic shock.

Drug interaction:

With caution is prescribed with drugs containing dehydrogenated ergot alkaloids.

The combination of levodopa and carbidopa-an increase in the half-life of levodopa, which may be due to the suppression of absorption of carbidopa spirumitsin due to changes in the peristalsis of the gastrointestinal tract.

Unlike erythromycin (a related macrolide), liver isoenzymes of the R450 system do not participate in the metabolism of spiramycin, it does not interact with cyclosporine or theophylline.

Method of application and doses:

Inside. Adults-2-3 table. 3 million ME (i.e. 6-9 million ME) per day for 2 or 3 receptions. The maximum daily dose is 9 million me.

Prevention of meningococcal meningitis — a 3 million international units over 12 h for 5 days.

Overdose:

Treatment: specific antidote does not exist. Symptomatic therapy is recommended in case of suspected overdose of spiramycin.

Special instruction:

In patients with liver disease, it is necessary to periodically monitor its function during treatment with the drug.

Patients with impaired renal function, due to low renal excretion, do not need to change the dose.