Spiramycin-vero (Spiramycin-vero)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceSpiramycinSpiramycin
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    • Dosage form: & nbsp
    lyophilizate for the preparation of a solution for intravenous
    introduction of

    Composition:

    Active substance:

    Spiramycin adipate (in terms of spiramycin) -1.5 million ME

    Description:From white to slightly yellowish porous mass
    Pharmacotherapeutic group:antibiotic-macrolide
    ATX: & nbsp

    J.01.F.A   Macrolides

    J.01.F.A.02   Spiramycin

    Pharmacodynamics:Pharmacodynamics: A natural antibiotic from the macrolide group, acts bacteriostatically (when used at high doses, it can act bactericidally against more sensitive strains): it suppresses protein synthesis in the microbial cell by reversible binding to the 50S subunit of the ribosomes, which results in blockade of transpeptidation and translocation reactions. In contrast to the 14-member macrolides, it is able to bind not to one but to three (I-III) domains of the subunit, which may provide more stable binding to the ribosome and, consequently, a longer antibacterial effect. Can accumulate in high concentrations in a bacterial cell. Unlike erythromycin, it does not stimulate gastrointestinal peristalsis.The following microorganisms are susceptible 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., Streptococcus pneumoniae, Pseudomonas spp. There is cross-resistance between spiramycin and erythromycin.
    Pharmacokinetics:The time to reach the maximum concentration (TCata) with iv introduction - by the end of infusion; the maximum concentration (Stach) with IV injection of 500 mg is 2.3 μg / ml. The connection with plasma proteins is 10-25%. It does not penetrate into the cerebrospinal fluid (CSF), it penetrates well into tissues and body fluids (including breast milk). The concentration in the lungs is 20-60 μg / g, in the tonsils 20-80 μg / g, in sinuses with inflammation 75-110 μg / g, in the bone tissue 5-100 μg / g, in the spleen, liver, kidneys - 5-7 mcg / g. Penetrates through the placental barrier (concentration in the blood of the fetus is 50% of the concentration in the blood serum of the mother). Concentrations in the placental tissue are 5 times higher than the corresponding concentrations in the serum. High concentrations are achieved in the bile (15-40 times higher than in the blood serum), polymorphonuclear leukocytes. The volume of distribution is large and variable - 383-660 liters.Very slowly metabolized in the liver, excreted with bile (more than 80% of the dose) and kidneys (4-14%); hepatic hepatic recirculation is possible. The half-life period (T1 / 2) with / in the introduction: young people (18-32 years) - 4.5-6.2 hours, elderly (73-85 years) - 9.8-13.5 hours.
    Indications:Toxoplasmosis during pregnancy. Bacterial infections caused by sensitive microorganisms: acute community-acquired pneumonia, (including atypical, caused by Mycoplasma, Chlamydia, Legionella), exacerbation of chronic bronchitis, acute bronchitis; sinusitis, tonsillitis, otitis media; osteomyelitis, arthritis; extragenital chlamydia, prostatitis, urethritis of various etiologies; Sexually transmitted diseases (including genital chlamydia, syphilis, gonorrhea and their combination). Skin infections: erysipelas, infected dermatoses, abscess, phlegmon (including in dentistry). Toxoplasmosis; prevention of meningococcal meningitis among persons who have been in contact with patients no more than 10 days before hospitalization. Prevention of acute articular rheumatism. Treatment of bacteriocarriers of pertussis and diphtheria.
    Contraindications:
    Hypersensitivity, children's age, lactation period, deficiency of the enzyme glucose-6-phosphate dehydrogenase (risk of acute hemolysis).

    Carefully:Biliary duct obstruction or liver failure
    Pregnancy and lactation:

    Spiramycin has no teratogenic effect, so the drug can be used for pregnant women but for indications. During the period of lation, the use of spiramycin is contraindicated, because of the possible penetration of the drug into breast milk.

    Dosing and Administration:
    In / in the drip (within 1 h): only adults, dissolving the contents of the vial in 4 ml of water for injection, add to 100 ml of a 5% solution of dextrose. With pneumonia - 1.5 million ME every 8 hours, in severe cases, the dose is doubled.

    Side effects:
    Nausea, vomiting, diarrhea, allergic reactions (skin rash, itching), tenderness in the place of intravenous administration; rarely - increased activity of alanine aminotransferase, alkaline phosphatase. In isolated cases - thrombocytopenia, prolongation of the QT interval on the ECG, cholestatic hepatitis, acute colitis, ulcerative esophagitis, damage to the intestinal mucosa, angioedema, anaphylactic shock, transient paresthesia.

    Overdose:
    There is no specific antidote. If suspected overdose with spiramycin, symptomatic therapy is recommended.

    Interaction:
    With caution appoint with drugs containing dehydrogenated ergot alkaloids. The combination of levodopa and carbidopa is an increase in T1 / 2 levodopa, which may be due to spiramycin suppression of carbidopa absorption due to changes in gastrointestinal peristalsis. Unlike erythromycin (a related macrolide) in the metabolism of spiramycin, isoenzymes of the liver system P450 do not participate, it does not interact with cyclosporine or theophylline.

    Special instructions:
    Even in the presence of severe renal dysfunction, there is no need to adjust the dosing regimen. When appointing during lactation, women need to stop feeding, since it is possible to penetrate into breast milk. Spiramycin has no teratogenic effect, so you can safely use it in pregnant women. Reduction of the risk of transmission of toxoplasmosis to the fetus during pregnancy is noted from 25 to 8% when used in the first trimester, from 54 to 19% - in II and from 65 to 44% - in the III trimester. Patients with liver disease should periodically monitor liver function during treatment.

    Effect on the ability to drive transp. cf. and fur:The use of the drug does not affect the ability to drive vehicles and manage mechanisms
    Form release / dosage:
    Liofilizate for the preparation of a solution for intravenous administration of 1.5 million ME. For 1.5 million ME of active substance in the bottles of colorless glass, hermetically sealed with stoppers made of rubber compound, with the capping of aluminum caps. Each vial with instructions for use is placed in a pack of cardboard.

    Packaging:
    Liofilizate for the preparation of a solution for intravenous administration of 1.5 million ME. For 1.5 million ME of active substance in the bottles of colorless glass, hermetically sealed with stoppers made of rubber compound, with the capping of aluminum caps. Each vial with instructions for use is placed in a pack of cardboard.

    Storage conditions:
    List B. At a temperature of no higher than 25 ° C, in a place protected from light.
    Keep out of the reach of children.

    Shelf life:
    1,5 years. Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-002650
    Date of registration:30.03.2012
    The owner of the registration certificate:LENS-PHARM, LLC LENS-PHARM, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp18.08.2015
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