Spiramycin-vero 3 million 10 pcs film-coated tablets

Nosological classification (ICD-10)

• A36.9 Diphtheria, unspecified
• A37 Whooping cough
• A39.0 Meningococcal meningitis
• A64 Sexually transmitted diseases, unspecified
• A74.9 Chlamydial infection, unspecified
• B58 Toxoplasmosis
• H66 Suppurative and unspecified otitis media
• J01 Acute sinusitis
• J03.9 Acute tonsillitis, unspecified (angina agranulocytic)
• J15.6 Pneumonia caused by other aerobic gram-negative bacteria
• J15.7 Pneumonia caused by Mycoplasma pneumoniae
• J16.0 Pneumonia caused by chlamydia
• J32 Chronic sinusitis
• J35.0 Chronic tonsillitis
• J42 Chronic bronchitis, unspecified
• K12.2 Cellulitis and abscess of the oral cavity
• L02 Skin abscess, boil and carbuncle
• L08.9 Local infection of skin and subcutaneous tissue, unspecified
• M13.9 Arthritis, unspecified
• M79.0 Rheumatism, unspecified
• M86 Osteomyelitis
• N34 Urethritis and urethral syndrome
• N39.0 Urinary tract infection without established location
• N41.0 Acute prostatitis
• N41.1 Chronic prostatitis

Composition and release form

in a blister pack 5 pcs.; in a cardboard pack 2 packs or in a blister pack 10 pcs.; in a cardboard pack 1 package or in dark glass jars of 10 pcs.; in a cardboard pack 1 jar.

Instructions for use Spiramycin-Vero (Method and dosage)

Taken orally. Adults—2-3 tablets. 3 million IU per day, divided into 2-3 doses. The maximum daily dose is 9 million ME.

To prevent meningitis caused by meningococcus, take 1 tablet (3 million ME) per day for 5 days.

IV drip only for adults: the contents of the bottle are dissolved in 4 ml of water for injection + 100 ml of 5% dextrose solution .

For pneumonia , 1.5 million IU is prescribed every 8 hours.

Instructions for use of Spiramycin-Vero contain information that if renal function is impaired, dose adjustment is not carried out.

Pharmacodynamics

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

The following microorganisms are usually sensitive to the drug: 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 spiramycin: Enterobacteriaceae spp., Pseudomonas spp..

There is cross-resistance between spiramycin and erythromycin.

Use during pregnancy

Spiramycin-Vero is used during pregnancy according to indications. No teratogenic effect of the drug has been detected. Its use is contraindicated during lactation, since it can be excreted in milk. During this period, breastfeeding stops.

For hospital-acquired pneumonia in pregnant women, the drugs of choice are the latest generation cephalosporins clavulanate , and reserve antibiotics: Spiramycin , Clindamycin , Vancomycin .

The prescription regimens for Spiramycin for this disease are different. It is used in the form of tablets of 3 million ME 3 times a day, in the form of infusions of 3 million ME 3 times a day intravenously. It may be prescribed in the first 2-4 days in the form of infusions, and then orally for 7-10 days. Moreover, parenteral (IV) antibiotics for the treatment of pneumonia have no advantages over oral ones.

For pyelonephritis in pregnant women, the drug is prescribed at a dose of 1.5-3 million IU 3 times a day. For ureaplasma infection in pregnant women, this drug is also prescribed, however, information has appeared on the identification of mycoplasmas and ureplasmas resistant to spiramycin.

Treatment of pregnant women with chlamydia - 3 million IU orally 3 times a day for 10 days. In the treatment of this infection, spiramycin has greater therapeutic efficacy than erythromycin .

Pharmacokinetics

Absorption of spiramycin occurs quickly, but not completely, with great variability (from 10 to 60%).

After oral administration of 6 million IU of spiramycin, Cmax in plasma is about 3.3 mcg/ml.

Spiramycin does not penetrate into the cerebrospinal fluid, but diffuses into breast milk. Penetrates the placental barrier (the concentration in the fetal blood is approximately 50% of the concentration in the maternal blood serum). Concentrations in placental tissue are 5 times higher than corresponding concentrations in serum.

Distribution volume: approximately 383 liters.

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

Plasma protein binding is low (approximately 10%).

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

It is excreted mainly in bile (concentrations are 15–40 times higher than in serum). About 10% of the administered dose is excreted by the kidneys.

T1/2 after taking 3 million IU of spiramycin is approximately 8 hours. It may be prolonged in elderly patients. In patients with impaired renal function, no dose adjustment of spiramycin is required.

Spiramycin-Vero 3 million IU tablet p/o No. 10

Dosage

3 million IU

Active substance

Spiramycin

Manufacturer

Veropharm JSC (Russia)

Shelf life

4 years

Storage conditions

At a temperature not exceeding 30 °C

Registration certificate number

LS-001504 dated 09.17.2015

Description of the dosage form

Tablets, coated with a cream-colored coating, oblong in shape (oblong).

Pharmacokinetics

Absorption of spiramycin occurs quickly, but not completely, with great variability (from 10 to 60%).

After oral administration of 6 million IU of spiramycin, Cmax in plasma is about 3.3 mcg/ml.

Spiramycin does not penetrate into the cerebrospinal fluid, but diffuses into breast milk. Penetrates the placental barrier (the concentration in the fetal blood is approximately 50% of the concentration in the maternal blood serum). Concentrations in placental tissue are 5 times higher than corresponding concentrations in serum.

Distribution volume: approximately 383 liters.

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

Plasma protein binding is low (approximately 10%).

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

It is excreted mainly in bile (concentrations are 15–40 times higher than in serum). About 10% of the administered dose is excreted by the kidneys.

T1/2 after taking 3 million IU of spiramycin is approximately 8 hours. It may be prolonged in elderly patients. In patients with impaired renal function, no dose adjustment of spiramycin is required.

Pharmacodynamics

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

The following microorganisms are usually sensitive to the drug: 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 spiramycin:
Enterobacteriaceae spp., Pseudomonas spp..
There is cross-resistance between spiramycin and erythromycin.

Contraindications

hypersensitivity to spiramycin and other components of the drug;

breastfeeding period;

children's age (tablets of 3 million ME are not used in children);

The use of spiramycin is not recommended in patients with deficiency of the enzyme glucose-6-phosphate dehydrogenase, due to the possible occurrence of acute hemolysis.

Carefully

- with obstruction of the bile ducts or with liver failure.

Use during pregnancy and breastfeeding

Can be prescribed, if necessary, during pregnancy (no teratogenic effects have been detected).

Spiramycin can be excreted in breast milk, therefore, if it is necessary to prescribe the drug during lactation, breastfeeding should be stopped.

Directions for use and doses

Inside.

Adults - 2-3 tablets. 3 million ME (i.e. 6–9 million ME) per day in 2 or 3 doses. The maximum daily dose is 9 million ME.

Prevention of meningococcal meningitis - 3 million IU per 12 hours for 5 days.

Side effects

From the gastrointestinal tract:

nausea, vomiting, diarrhea and very rare cases of pseudomembranous colitis (less than 0.01%). Isolated cases of ulcerative esophagitis and acute colitis have been described. The possibility of developing acute damage to the intestinal mucosa in patients with AIDS when using high doses of spiramycin for cryptosporidiosis has also been noted.

From the peripheral system and 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 “
With caution
”) and thrombocytopenia.

From the cardiovascular system:

possible prolongation of the QT interval on the electrocardiogram.

Hypersensitivity reactions:

skin rash, urticaria, itching. Very rarely (less than 0.01%) - angioedema, anaphylactic shock.

Interaction

Prescribe with caution with drugs containing dehydrated ergot alkaloids.

The combination of levodopa and carbidopa increases the half-life of levodopa, which may be due to the suppression of carbidopa absorption by spiramycin due to changes in gastrointestinal motility.

Unlike erythromycin (a related macrolide), spiramycin is not metabolized by liver P450 isoenzymes and does not interact with cyclosporine or theophylline.

Overdose

Treatment:

there is no specific antidote. If an overdose of spiramycin is suspected, symptomatic therapy is recommended.

special instructions

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 require dose changes.

Pharmgroups

Macrolides and azalides

Pharmaceutical actions

antibacterial, bacteriostatic

Indications for the drug Spiramycin-vero

bacterial infections caused by sensitive microorganisms: acute community-acquired pneumonia (including atypical pneumonia caused by Mycoplasma, Chlamydia, Legionella), exacerbation of chronic bronchitis; sinusitis, tonsillitis, otitis media; osteomyelitis, arthritis; extragenital chlamydia, prostatitis, urethritis of various etiologies; sexually transmitted diseases;

skin infections: erysipelas, infected dermatoses, abscess, phlegmon (including in dentistry);

toxoplasmosis, incl. during pregnancy;

prevention of meningococcal meningitis among persons who were in contact with patients no more than 10 days before hospitalization;

prevention of acute articular rheumatism;

treatment of bacterial carriage of whooping cough and diphtheria pathogens.

Indications for use

• toxoplasmosis (including during pregnancy);
• community-acquired pneumonia (chlamydial, mycoplasma and caused by aerobic gram-negative bacteria);
• exacerbation of chronic bronchitis ;
• rheumatism, unspecified;
• acute bronchitis ;
• acute tonsillitis , sinusitis , otitis ;
• osteomyelitis;
• sexually transmitted diseases;
• urethritis;
• skin infections;
• prevention of meningitis caused by meningococcus (in persons who had contact with patients);
• bacteria carriage of whooping cough and diphtheria .

Side effects

From the gastrointestinal tract: nausea, vomiting, diarrhea and very rare cases of pseudomembranous colitis (less than 0.01%). Isolated cases of ulcerative esophagitis and acute colitis have been described. The possibility of developing acute damage to the intestinal mucosa in patients with AIDS when using high doses of spiramycin for cryptosporidiosis has also been noted.

From the peripheral system and 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 the development of acute hemolysis (see “Contraindications” section “With caution”) and thrombocytopenia.

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

Hypersensitivity reactions: skin rash, urticaria, itching. Very rarely (less than 0.01%) - angioedema, anaphylactic shock.