Spiramycin-vero - Instructions For Use, Price, Reviews, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Spiramycin-vero

Spiramycin-vero: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Drug interactions
14. 14. Analogs
15. 15. Terms and conditions of storage
16. 16. Terms of dispensing from pharmacies
17. 17. Reviews
18. 18. Price in pharmacies

Latin name: Spiramycin-Vero

ATX code: J01FA02

Active ingredient: spiramycin (spiramycin)

Producer: Veropharm OJSC (Russia)

Description and photo updated: 2018-23-11

Prices in pharmacies: from 378 rubles.

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Spiramycin-vero is a bacteriostatic antibacterial drug from the macrolide group.

Release form and composition

Dosage forms of Spiramycin-vero:

• lyophilisate for preparation of solution for intravenous administration: porous mass from slightly yellowish to white [1.5 million International Units (IU) each in colorless glass vials, hermetically sealed with a rubber compound stopper; 1, 30, 50, 85 or 100 vials in a cardboard box];
• coated tablets: oblong, cream-colored (5 pcs. in blister packs, 2 packs in a cardboard box; 10 pcs. in blister packs or dark glass jars, 1 pack / can in a cardboard box);
• film-coated tablets: biconvex, round, white with a cream shade, on one side with ROVA 3 engraving; cross-section - white with a cream shade of color (5 pcs. in blister packs, 2 packs in a cardboard box; 10 pcs. in blister packs or dark glass jars, 1 pack / can in a cardboard box).

The composition of the lyophilisate contained in 1 bottle: active ingredient spiramycin adipate (in terms of spiramycin) - 1.5 million IU.

Composition of 1 coated tablet:

• active substance: spiramycin - 3 million IU (711.74 mg);
• additional components: povidone (polyvinylpyrrolidone), microcrystalline cellulose; crospovidone (polyplasdone X El-10), colloidal silicon dioxide (aerosil), sodium carboxymethyl starch (primogel), magnesium stearate;
• shell: Opadry II.

Composition of 1 film-coated tablet:

• active substance: spiramycin - 3 million IU (711.74 mg);
• additional components: pregelatinized corn starch, colloidal silicon dioxide, croscarmellose sodium, hyprolose, microcrystalline cellulose, magnesium stearate;
• film shell: hypromellose, macrogol 6000, titanium dioxide (E171).

Pharmacological properties

Pharmacodynamics

Spiramycin-vero is an antibiotic of the macrolide group with a bacteriostatic effect, and when administered at high doses, it can exhibit bactericidal properties in relation to more sensitive strains (suppressing intracellular protein production as a result of reversible binding with the 50S subunit of the ribosomes of the microbe, provides a blockade of transpeptidation and translocation reactions). Stable binding of the substance to the ribosome and, as a consequence, a longer antibacterial effect is caused by its ability to bind to three domains of the subunit (I – III), in contrast to 14-membered macrolides, which bind to only one. In high concentrations, the drug can accumulate in the cell of the microorganism.

In contrast to erythromycin, spiramycin does not activate the peristalsis of the gastrointestinal tract (GIT). As a rule, the following microorganisms are sensitive to spiramycin: Streptococcus spp., Staphylococcus spp. (including methicillin-sensitive strains of Staphylococcus aureus), Bordetella pertussis, Neisseria gonorrhoeae, Neisseria meningitidis, Clostridium spp., Corynebacterium diphtheriae, Mycoplasma pneumoniae, Listerma monocytogenes. Chlamydia, Listerma monocytogenes. Campylobacter spp. Moderately sensitive to the drug Haemophilus influenzae, show resistance - Pseudomonas spp.. Enterobacteriaceae spp.

Cross-resistance was found between spiramycin and erythromycin (a related macrolide).

Pharmacokinetics

Spiramycin is characterized by fast, but not complete absorption from the gastrointestinal tract, which is highly variable (10-60%). After oral administration of 6 million IU, the maximum plasma concentration (Cmax) of spiramycin is approximately 3.3 μg / ml.

With intravenous (intravenous) infusion, Cmax is reached by the end of the infusion and when the drug is administered at a dose of 500 mg, it is 2.3 μg / ml.

The binding of spiramycin to plasma proteins is low - 10–25%, the volume of distribution - varies from 383 to 660 liters.

The active substance is well distributed in saliva and tissues, its level in the lungs is 20-60 μg / g, in the tonsils - 20-80 μg / g, in the bone tissue - 5-100 μg / g in the sinuses with inflammation - 75-110 μg / g. The concentration of the agent in the liver, spleen and kidneys 10 days after the completion of the course is 5–7 μg / g.

Spiramycin-vero crosses the placental barrier and enters breast milk, but does not cross the blood-brain barrier (BBB). A high level of content is observed in bile (15-40 times higher than the concentration in blood serum) and in polymorphonuclear leukocytes. Concentrations of the agent in the fetal blood are approximately 50% of those in the mother's blood serum, and in the placental tissue - 5 times higher than the corresponding concentrations in the blood serum.

The process of metabolic transformation of spiramycin occurs in the liver with the formation of active metabolites with an undefined chemical structure. Over 80% of the administered dose is excreted in the bile, about 10% to the kidneys. After taking the drug orally at a dose of 3 million IU, the half-life (T _1/2) is approximately 8 hours, in elderly patients it may be longer. With the on / in the introduction of T _1/2 in young patients is 4.5-6.2 hours, in elderly patients aged 73 to 85 years - 9.8-13.5 hours.

Indications for use

• bacterial infections excited by susceptible microorganisms: acute phase of chronic bronchitis, acute community-acquired pneumonia (including atypical, caused by Chlamydia spp., Mycoplasma pneumoniae, Legionella pneumophila), acute bronchitis (for lyophilisate), tonsillitis, otitis media, osteretomy, arthritis genesis, prostatitis, extragenital chlamydia, sexually transmitted diseases (including gonorrhea, genital chlamydia, syphilis and their combination);
• toxoplasmosis (including pregnancy);
• skin infections: infected dermatoses, erysipelas, abscess, phlegmon (including in dental practice);
• bacteriocarriage of pathogens of diphtheria and whooping cough (therapy);
• acute articular rheumatism (for prevention);
• meningococcal meningitis among persons who had contact with the patient no more than 10 days before his hospitalization (for prevention purposes).

Contraindications

• lactation period;
• childhood;
• deficiency of the enzyme glucose-6-phosphate dehydrogenase (due to the increased risk of acute hemolysis);
• hypersensitivity to any of the constituents of the drug.

According to the instructions, Spiramycin-vero should be used with caution in liver failure or in obstruction of the bile ducts.

Instructions for the use of Spiramycin-vero: method and dosage

Film-coated tablets

Spiramycin-vero is taken orally at 2-3 tablets (6-9 million IU) per day, divided into 2-3 doses. The maximum daily dose should not exceed 3 tablets (9 million IU).

In order to prevent meningococcal meningitis, it is recommended to take 3 million IU every 12 hours for 5 days.

Lyophilisate for preparation of solution for intravenous administration

A solution prepared from a lyophilisate is injected intravenously over 1 hour. Before infusion, the contents of the vial (1.5 million IU) are diluted in 4 ml of water for injection, and then dissolved in 100 ml of 5% dextrose solution.

In the treatment of pneumonia, Spiramycin-vero is administered every 8 hours at a dose of 1.5 million IU, in case of a severe course of the disease, the dose is doubled.

Side effects

• cardiovascular system: prolongation of the QT interval on the electrocardiogram;
• digestive system: nausea, diarrhea, vomiting; extremely rarely - changes in liver function tests (increased activity of alkaline phosphatase, alanine aminotransferase); cholestatic hepatitis, pseudomembranous colitis; for tablets (isolated cases) - ulcerative esophagitis, acute colitis; damage to the intestinal mucosa in acute form, mainly in AIDS patients when using high doses of the drug for cryptosporidiosis;
• hematopoietic system: extremely rarely - thrombocytopenia, for tablets - acute hemolysis;
• nervous system: transient paresthesias;
• allergic reactions: itchy skin, rash, for tablets - urticaria; extremely rare - anaphylactic shock, angioedema;
• local reactions: soreness at the place of intravenous injection.

Overdose

If an overdose with spiramycin is suspected, symptomatic therapy should be carried out. The specific antidote is unknown.

special instructions

During pregnancy, the threat of transmission of toxoplasmosis to the fetus when using Spiramycin-vero solution in the first trimester decreases from 25 to 8%, in the second trimester - from 54 to 19% and in the third - from 65 to 44%.

Influence on the ability to drive vehicles and complex mechanisms

Spiramycin-vero does not adversely affect the ability to drive a car and control complex mechanisms.

Application during pregnancy and lactation

For pregnant women, an antibacterial agent can be used according to indications, since it has not been found to have a teratogenic effect.

Spiramycin can be excreted in breast milk, therefore, if it is necessary to use Spiramycin-vero during lactation, it is necessary to stop breastfeeding.

Pediatric use

The use of Spiramycin-vero in pediatric practice is contraindicated.

With impaired renal function

In the presence of functional renal impairment, dose adjustment is not required due to the insignificant renal excretion of spiramycin.

For violations of liver function

During treatment in the presence of liver disease, periodic monitoring of its function should be carried out.

Patients with hepatic impairment or bile duct obstruction are advised to use antibiotics with caution.

Drug interactions

In the case of using Spiramycin-vero in combination with levodopa and carbidopa, T _{1/2 of} levodopa increases, which may be a consequence of inhibition of carbidopa absorption as a result of changes in gastrointestinal motility.

Medicines containing dehydrated ergot alkaloids in combination with spiramycin must be used with caution.

Cyclosporine and theophylline - their interactions with spiramycin have not been revealed, since isozymes of the P450 system are not involved in the metabolic transformation of the latter (unlike erythromycin).

Analogs

The analogues of Spiramycin-vero are Rovamycin, Bacticap, Spiramycin Adipinat, Spiramisar, Zimbaktar, Klabaks, Clarithromycin, Roxithromycin, Erythromycin and others.

Terms and conditions of storage

Store in a place protected from moisture (for tablets) and light, out of the reach of children, at a temperature not exceeding 25 ° C.

Shelf life of tablets - 2 years, lyophilisate - 1.5 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews of Spiramycin-vero

Reviews of Spiramycin-vero on medical forums are most often associated with a discussion of the possibility of its use during pregnancy. Most patients note the effectiveness of the drug, especially in the treatment of respiratory diseases of an infectious and inflammatory nature. Many women who took Spiramycin-vero during pregnancy indicate that it did not cause any side effects and did not adversely affect the health of the fetus.

However, there is also an opinion that drug therapy is ineffective or does not give a positive result at all. Some patients complain of the development of unwanted effects from the gastrointestinal tract. Others note the unavailability of Spiramycin-vero due to its absence in many pharmacies.

The price of Spiramycin-vero in pharmacies

The price of Spiramycin-vero can be 210–250 rubles per pack containing 10 film-coated tablets.

Spiramycin-vero: prices in online pharmacies

Drug name Price Pharmacy

Spiramycin-vero 3 mlnIU coated tablets 10 pcs. 378 r Buy

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!