Rovamycin® (Rovamycine® )

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Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceSpiramycinSpiramycin
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  • Rovamycin®
    pills inwards 
    Sanofi-Aventis France     France
  • Rovamycin®
    lyophilizate in / in 
    Aventis Laboratories     France
  • Spiramycin-vero
    lyophilizate in / in 
    LENS-PHARM, LLC     Russia
    • Dosage form: & nbsplyophosphate for the preparation of a solution for intravenous administration
    Composition:
    One bottle contains:
    active substance: 1.5 million ME spiramycin;
    Adjuvant: adipic acid 1500000 / A * x 0.16 mg (ie 60 mg), where A * = 4000 IU.

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

    J.01.F.A   Macrolides

    J.01.F.A.02   Spiramycin

    Pharmacodynamics:

    Pharmacodynamics

    Spiramycin belongs to the antibiotic group of macrolides. The mechanism of antibacterial action is due to the inhibition of protein synthesis in the microbial cell due to binding to 50s- subunit of the ribosome. Antibacterial spectrum of spiramycin Sensitive microorganisms: minimal inhibitory concentration (MIC) <1 mg / l.

    - Gram-positive aerobes Bacillus cereus; Corynebacterium diphtheriae; Enterococcus spp. (50-70 % resistant strains), Rhodococcus equi; Staphylococcus meti-S (methicillin-sensitive staphylococci); Staphylococcus meti-R (methicillin-resistant staphylococci) (70-80 % resistant strains); Streptococcus AT; unclassified streptococcus (30-40 % resistant strains); Streptococcus pneumoniae (35-70 % resistant strains); Streptococcus pyogenes (16-31 % resistant strains).

    • G REMOTRATE aerobes Bordetella pertussis; Branhamella catarrhalis; Campylobacter spp .; Legionella spp .; Moraxella spp.

    • Anaerobes

    Actinomyces spp .; Bacteroides spp. (30-60 % resistant strains); Eubacterium spp .; Mobiluncus spp .; Peptostreptococcus spp. (30-40 % resistant strains); Porphyromonas spp .; Prevotella spp .; Propionibacterium acnes.

    • Different

    Borrelia burgdorferi; Chlamydia spp .; Coxiella spp .; Leptospires spp .; Mycoplasma pneumoniae; Treponema pallidum; Toxoplasma gondii. Moderately sensitive microorganisms: antibiotic moderately active in vitro at antibiotic concentrations in the focus of inflammation> 1 mg / l, but <4 mg / l.

    - Gram-negative aerobes

    Neisseria gonorrhoeae.

    - Anaerobes

    Clostridium perfringens.

    - Different

    Ureaplasma urealyticum.

    Stable microorganisms (IPC> 4 mg / l): at least 50% of the strains are resistant.

    - Gram-positive aerobes

    Corynebacterium jeikeium; Nocardia asteroides.

    - Gram-negative aerobes

    Acinetobacter spp .; Enterobacteria spp .;

    Haemophilus spp .; Pseudomonas spp.

    - Anaerobes

    Fusobacterium spp.

    - Different

    Mycoplasma hominis.

    There is a decrease in the risk of transmission of toxoplasmosis to the fetus during pregnancy from 25 % up to 8 % when used in the I trimester, with 54 % up to 19 % - when used in the second trimester and from 65 % up to 44 % - when used in the III trimester.

    Pharmacokinetics:PAfter intravenous administration, ME spiramycin by a one-hour infusion maximum plasma concentration is 2.3 μg / ml. Period half-life is approximately 5 h.

    With the introduction of 1.5 million ME spiramycin every 8 hours, the equilibrium concentration is reached by the end of the second day (Cmax about 3 μg / ml and Cmin about 0.5 μg / ml). Distribution

    Spiramycin does not penetrate into the cerebrospinal fluid. Spiramycin excreted in breast milk.

    Linkage to plasma proteins is low (about 10%).

    Penetrates through the placental barrier (concentration in the blood of the fetus is about 50 % of concentration in

    blood serum of the mother). Concentrations in the placental tissue are 5 times higher than the corresponding concentrations in the serum. The volume of distribution is approximately 383 liters.

    The drug penetrates well into saliva and tissues (concentration in the lungs - from 20 to 60 mcg / g, tonsils - 20 to 80 mcg / g,

    infected nasal sinuses - from 75 to 110 μg / g, bones - from 5 to 100 μg / g). Ten days after the end of treatment, the concentration of drug in the spleen, liver and kidneys is 5 to 7 μg / g.

    Spiramycin penetrates and accumulates in phagocytes (neutrophils, monocytes and peritoneal and alveolar

    macrophages). In humans, the concentrations of the drug inside the phagocytes are quite high. These properties explain the effect of spiramycin on intracellular bacteria.

    Metabolism

    Spiramycin is metabolized in the liver with formation of active metabolites with an unidentified chemical structure.

    Excretion

    Half-life of blood plasma is approximately 8 hours.

    Isolated from the body, mainly, with bile (concentration in bile is 15-40 times higher than in serum). Renal excretion is about 14% of of the administered dose. The amount of the preparation, excreted through the intestine (with feces), very slightly.

    In patients with impaired renal function, dose adjustment is not required.

    Indications:Yingthe lower respiratory tract adults:

    - Acute pneumonia;

    - exacerbation of chronic bronchitis;

    - Infectious-allergic

    bronchial asthma.

    Contraindications:

    hypersensitivity to spiramycin and other components of the drug.

    - the period of breastfeeding.

    - deficiency of the enzyme glucose-6-phosphate dehydrogenase in view of the possible occurrence of acute hemolysis.

    • children and adolescents under 18 years (for this dosage form).

    • patients with lengthening interval QT

    (congenital or acquired), when combined with medicinal

    drugs that can cause ventricular tachycardia such as "pirouette" (antiarrhythmic agents IA class (quinidine, hydroquinidine, disopyramide), 111 class (amiodarone, sotalol, dofetilide, ibutilide), neuroleptics of the benzamide group (sultopride, sulpiride, amisulpride, tiapride), some phenothiazine antipsychotics (thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, haloperidol, droperidol, plyuzid), halofantrine, pentamidine, moxifloxacin and other drugs, such as: bepridil, cisapride, difemanyl, erythromycin, administered intravenously; misolastine, wincamine, administered intravenously).

    Carefully:
    With obstruction of the bile duct.
    - With hepatic insufficiency.
    - When combined with ergot alkaloids, drugs that cause bradycardia, drugs that reduce the potassium content in the blood serum
    Pregnancy and lactation:
    Pregnancy
    If necessary, Rovamycin® may be administered during pregnancy. A large experience of using spiramycin during pregnancy did not reveal teratogenic or fetotoxic properties.
    Breastfeeding period
    When appointing during lactation it is necessary to stop breastfeeding,since it is possible to penetrate spiramycin into breast milk.

    Dosing and Administration:

    The drug is for adults only: 1.5 million ME every 8 hours (4.5 million. ME per day) by slow intravenous infusion. AT In case of severe infections, the dose can be doubled.

    As soon as the patient's condition permits, the treatment should be continued by taking the drug inside.

    The contents of the vial are dissolved in 4 ml of water for injection. The drug is injected slowly intravenously drip for 1 hour in at least 100 ml of 5 % dextrose (glucose).

    The duration of treatment depends on the severity and characteristics of the course of the infectious process, the sensitivity of the microflora and is determined individually by the treating physician.

    After dilution, the solution is stable for 12 hours under storage conditions at room temperature.

    Side effects:

    The following classification is used to indicate the incidence of undesirable effects: very often (> 10%), often (> 1%, <10%); infrequently (> 0.1%, <1%); rarely (> 0.01%, <0.1%) and very rarely, including individual messages (<0.01%), the frequency is unknown (according to the available data, the frequency can not be determined).

    Disorders from the gastrointestinal tract Nausea, vomiting, diarrhea.

    Very rarely: pseudomembranous colitis (less than 0.01%).

    Frequency unknown: when ingested, ulcerative esophagitis and acute colitis, acute damage to the intestinal mucosa in patients with AIDS with high doses of spiramycin for cryptosporidiosis (only 2 cases).

    Disturbances from the nervous system

    Very rarely (individual cases):

    transient paresthesia.

    Disturbances from the liver and bile ducts In very rare cases (less than 0.01 %) - deviation of functional liver samples from normal parameters;

    Cholestatic and mixed hepatitis.

    On the part of the blood and lymphatic system

    Very rare cases (less than 0.01 %)

    development of acute hemolysis (see "Contraindications"),

    Heart Disease

    Rarely: interval lengthening QT on

    electrocardiogram (ECG).

    Immune system disorders

    Skin rash, hives, itching. Very rarely (less than 0.01%) - angioedema, anaphylactic shock. Individual cases of vasculitis, including purple Shenlaine-Genocha.

    Disturbances from the skin and subcutaneous tissues

    Very rarely: acute generalized exanthematous pustulosis (see "Special instructions").

    General disorders and disorders in place of introduction

    Rarely: moderately severe sensitivity along the vein, which is used for intravenous infusion.

    Overdose:

    There are no known cases of overdose spiramycin.

    Symptoms

    Possible symptoms of an overdose can include nausea, vomiting, diarrhea.

    Cases of lengthening the interval QT, passing with the withdrawal of the drug,

    were observed in newborns, who received high doses of spiramycin,

    or after intravenous administration spiramycin in patients,

    predisposed to lengthen the interval QT. In case of an overdose of spiramycin ECG observation with duration determination is recommended. interval QT, especially if available risk factors (hypokalemia, congenital interval lengthening QT, simultaneous use of drugs that extend interval duration QT and / or causing the development of ventricular tachycardia such as "pirouette").

    Treatment

    There is no specific antidote.

    If you suspect an overdose spiramycin is recommended symptomatic therapy

    Interaction:FROM drugs that cause Bradycardia (blockers of "slow"

    calcium channels: diltiazem, verapamil, beta-blockers, clonidine, guanfacine, digitalis glycosides, cholinesterase inhibitors: donepezil, rivastigmine, tacrine, ambenonium chloride, galantamine, pyridostigmine, neostigmine), as well as with drugs that reduce potassium content in the blood (potassium-withdrawing diuretics, laxative medicinal means of stimulating nature, amphotericin B (intravenously), glucocorticosteroids, mineralocorticosteroids, tetracosactide)

    The risk of developing ventricular arrhythmias, in particular ventricular tachycardia type "pirouette". Before administration of the drug should eliminate hypokalemia. It is recommended to carry out clinical and ECG monitoring, as well as control content electrolytes in blood.

    Slevodopa

    Inhibition of spiramycin absorption carbidopa with a decrease in the concentration of levodopa in plasma. With the simultaneous administration of spiramycin, clinical control and dosage correction of levodopa is necessary.

    With indirect anticoagulants

    Numerous cases of increased activity of indirect anticoagulants have been reported in patients taking antibiotics. The type of infection or the severity of the inflammatory reaction, the age and general condition of the patient are predisposing risk factors.Under such circumstances it is difficult to determine to what extent the infection itself or its treatment play a role in changing the International normalized relationship (INR). However, with the use of certain groups of antibiotics, this effect is observed more often, in particular with the use of fluoroquinolones, macrolides, cyclins, sulfamethoxazole + trimetaprim and some cephalosporins.

    Special instructions:

    During treatment with the drug in patients with liver disease, it is necessary to periodically monitor its function. If at the beginning of treatment the patient develops generalized erythema and pustules accompanied by high body temperature, one should assume acute generalized exanthematous pustulosis (see section "Side effect"); if such a reaction occurs, then treatment should be discontinued, and further use of spiramycin, as in monotherapy.

    Administration of the drug should be Immediately discontinued if signs of any allergic reaction appear.

    In patients with diabetes mellitus (in connection with using 5% dextrose) it is necessary to control the concentration of glucose in the blood.

    Effect on the ability to drive transp. cf. and fur:
    There is no information about the negative effect of the drug on the ability to drive and engage in other potentially hazardous activities. However, one should take into account the severity of the patient's condition, which can affect the attention and speed of psychomotor reactions. Therefore, the decision on the possibility to drive a car or engage in other potentially hazardous activities in a particular patient should be made by the attending physician.

    Form release / dosage:
    Lyophilizate for the preparation of a solution for intravenous administration of 1.5 million ME.
    Packaging:
    Lyophilizate for the preparation of a solution for intravenous administration of 1.5 million ME. 1.5 million ME spiramycin in a clear glass bottle (type I), sealed with a rubber stopper and crimped with an aluminum cap. 1 bottle with instructions for use in a cardboard box.
    Storage conditions:
    Store at a temperature of no higher than + 25 ° C, in a place protected from light.
    Keep out of the reach of children.
    Shelf life:
    18 months.
    Do not use the drug after the expiration date.
    Terms of leave from pharmacies:On prescription
    Registration number:П N013418 / 02
    Date of registration:07/12/2007
    Date of cancellation:2018-02-27
    The owner of the registration certificate:Aventis LaboratoriesAventis Laboratories France
    Manufacturer: & nbsp
    Information update date: & nbsp27.02.2018
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