Spiramycin (Spiramycinum)

Pharmacodynamics Pharmacokinetics Indications Carefully Contraindications Dosing and Administration Side effects
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Clinical and pharmacological group: & nbsp

Macrolides and Azalides

Included in the formulation
  • Rovamycin®
    pills inwards 
    Sanofi-Aventis France     France
  • Rovamycin®
    lyophilizate in / in 
    Aventis Laboratories     France
  • Spiramycin-vero
    lyophilizate in / in 
    LENS-PHARM, LLC     Russia
    • АТХ:

    J.01.F.A   Macrolides

    J.01.F.A.02   Spiramycin

    Pharmacodynamics:

    It disrupts the synthesis of microbial proteins at the level of the ribosomes, binding to the 508 subunit of bacterial ribosomes, inhibits the translocation process. It penetrates into cells and creates a high intracellular concentration.

    Has a bacteriostatic effect, in high concentrations has a bactericidal effect against the causative agents of diphtheria and pertussis, as well as pneumococci.

    Has a high activity against gram-positive cocci (staphylococci, streptococci).

    Spiromycin is also highly active against chlamydia, leptospira, treponem, mycoplasma and toxoplasma.

    Pharmacokinetics:

    After oral administration, regardless of the time of ingestion, up to 30% is absorbed in the gastrointestinal tract. The maximum concentration in blood plasma is achieved after 1.5-3 hours. The connection with plasma proteins is 10%. Penetrates into breast milk.

    Metabolism in the liver.

    The elimination half-life is 8 hours. Elimination with feces and kidneys (up to 10%).

    Indications:

    It is used to treat infectious and inflammatory diseases caused by flora sensitive to spiramycin: with pharyngitis, tonsillitis, sinusitis, otitis, urinary tract infections, osteomyelitis, arthritis, with gynecological diseases - chlamydia and toxoplasmosis.

    ICD-10

    I.A30-A49.A31.0   Pulmonary infection caused by Mycobacterium

    I.A30-A49.A39   Meningococcal infection

    I.A30-A49.A48.1   Legionnaires' disease

    I.A50-A64.A56.0   Chlamydial infections of the lower parts of the genito-urinary tract

    I.A50-A64.A56.1   Chlamydial infections of the pelvic organs and other urogenital organs

    I.A50-A64.A56.4   Chlamydial pharyngitis

    I.B50-B64.B58   Toxoplasmosis

    VIII.H65-H75.H66   Purulent and unspecified otitis media

    IX.I00-I02.I00   Rheumatic fever without mention of involvement of the heart

    IX.I00-I02.I01   Rheumatic fever with involvement of the heart

    X.J00-J06.J00   Acute nasopharyngitis (runny nose)

    X.J00-J06.J01   Acute Sinusitis

    X.J00-J06.J02   Acute pharyngitis

    X.J00-J06.J03   Acute tonsillitis

    X.J00-J06.J04   Acute laryngitis and tracheitis

    X.J10-J18.J15   Bacterial pneumonia, not elsewhere classified

    X.J10-J18.J15.7   Pneumonia caused by Mycoplasma pneumoniae

    X.J10-J18.J16.0   Pneumonia caused by chlamydia

    X.J20-J22.J20   Acute bronchitis

    X.J30-J39.J31   Chronic rhinitis, nasopharyngitis and pharyngitis

    X.J30-J39.J32   Chronic Sinusitis

    X.J30-J39.J35.0   Chronic tonsillitis

    X.J30-J39.J37   Chronic laryngitis and laryngotracheitis

    X.J40-J47.J42   Chronic bronchitis, unspecified

    XII.L00-L08.L01   Impetigo

    XII.L00-L08.L02   Abscess of skin, boil and carbuncle

    XII.L00-L08.L03   Phlegmon

    XII.L00-L08.L08.0   Pyoderma

    XIII.M00-M03.M00   Pyogenic arthritis

    XIII.M86-M90.M86   Osteomyelitis

    XIV.N10-N16.N10   Acute tubulointerstitial nephritis

    XIV.N10-N16.N11   Chronic tubulointerstitial nephritis

    XIV.N30-N39.N30   Cystitis

    XIV.N30-N39.N34   Urethritis and urethral syndrome

    XIV.N40-N51.N41   Inflammatory diseases of the prostate

    XIV.N70-N77.N70   Salpingitis and oophoritis

    XIV.N70-N77.N71   Inflammatory diseases of the uterus, except the cervix

    XIV.N70-N77.N72   Inflammatory disease of the cervix

    Contraindications:

    Individual intolerance.

    Carefully:

    Hepatic failure, obstruction of the bile duct.

    Pregnancy and lactation:

    FDA Recommendations - Category B. Does not have a teratogenic effect. It is used in pregnancy, it is contraindicated during lactation.

    Dosing and Administration:

    Use in children

    Can only be used inside.

    Newborns: 50 mg / kg 2 times / day;

    12-18 years: 1,5 g 2 times / day.

    With tonsillitis: 100 thousand IU / kg 2 times / day.

    Adults

    Inside for 4.5-12 million IU in 2-3 hours.

    Intravenously drip with pneumonia: 1.5 million IU for 1 hour. In severe cases, the dose doubles.

    The highest daily dose: 12 million IU.

    The highest single dose: 4 million IU.

    Side effects:

    Nausea, vomiting, diarrhea, candidiasis of the mucous membranes of the gastrointestinal tract, vagina.

    Allergic reactions.

    Overdose:

    Acute liver failure.

    Treatment is symptomatic.

    Interaction:

    Increases the half-life of levodopa.

    Special instructions:

    1 g Spiromycin is equivalent to 3000 IU.

    When carrying out intravenous infusion, the procedure should be stopped immediately if any signs of an allergic reaction appear.

    Instructions
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