Rovamycin tablets: instructions for use. Rovamycin for children: instructions for use Rovamycin instructions for use for children tablets

Rovamycin is an antibiotic from the group of macrolides, bacteriostatic action.

Release form and composition

Dosage forms of Rovamycin:

Film-coated tablets: 1.5 million international units (IU) - biconvex, round, white, on a cross section - white, engraved "RPR 107" on one side; 3 million IU - biconvex, round, the color of the shell and on the cross section - white with a cream tint, on one side the engraving "ROVA 3" (1.5 million IU each - 8 pcs. in a PVC / aluminum foil blister, in carton pack 2 blisters, 3 million IU - 5 pieces in a blister made of PVC / aluminum foil, in a carton pack 2 blisters);
Lyophilizate for the preparation of a solution for intravenous administration: a porous mass from white to slightly yellowish in color (1.5 million IU in a transparent glass bottle (type I), sealed with a rubber stopper and crimped with an aluminum cap, 1 bottle in a cardboard box).

1 tablet contains:

Active substance: spiramycin - 1.5 or 3 million IU;
Additional components: microcrystalline cellulose, sodium croscarmellose, hyprolose, pregelatinized corn starch, magnesium stearate, colloidal silicon dioxide; film shell: macrogol, titanium dioxide (E171), hypromellose.

1 bottle with lyophilisate contains:

Active substance: spiramycin - 1.5 million IU;
Additional components: adipic acid.

Indications for use

Acute sinusitis (if there are contraindications to the use of beta-lactam antibiotics);
Acute bronchitis caused by a bacterial infection resulting from acute viral bronchitis;
Chronic and acute pharyngitis caused by beta-hemolytic streptococcus A (with existing contraindications to taking beta-lactam antibiotics or the inability to use them);
Chronic and acute tonsillitis;
Chronic bronchitis in the acute phase;
Pneumonia caused by atypical pathogens (Mycoplasma pneumoniae, Chlamydia trachomatis, Chlamydia pneumoniae, Legionella spp.) diagnosed or suspected;
Community-acquired pneumonia (in the absence of clinical signs of pneumococcal etiology, severe symptoms and the threat of an adverse outcome);
Infections of the genital organs of a non-gonococcal nature;
Infections of the subcutaneous tissue and skin (including infectious dermohypodermatitis (especially erysipelas), ecthyma, impetiginization, impetigo, erythrasma, secondary infected dermatoses);
Infections of the oral cavity (including glossitis, stomatitis);
Connective tissue and musculoskeletal system infections (including periodontium);
Toxoplasmosis (including during pregnancy).

Also, the drug is prescribed for the prevention of recurrence of rheumatism in patients with hypersensitivity to beta-lactam antibiotics.

For the prevention (excluding treatment) of meningococcal meningitis, Rovamycin is used in the eradication of Neisseria meningitidis from the nasopharynx (in case of contraindications to taking rifampicin) in patients after completion of the course and before leaving quarantine, as well as in patients who have been in contact with the patient for 10 days before hospitalization. sick persons.

Acute pneumonia;
Chronic bronchitis in the acute stage;
Infectious-allergic bronchial asthma.

Contraindications

Deficiency of the enzyme glucose-6-phosphate dehydrogenase (due to the possible development of acute hemolysis);
The period of breastfeeding;
Age up to 6 years - for tablets 1.5 million IU, up to 18 years - for tablets 3 million IU and lyophilisate;
Hypersensitivity to the components of the remedy.

Additionally for lyophilisate:

The presence of prolongation of the QT interval (acquired or congenital);
Combination with drugs that can lead to the appearance of ventricular arrhythmias of the "pirouette" type: some phenothiazine antipsychotics (piluzide, droperidol, haloperidol, cyamemazine, trifluoperazine, levomepromazine, chlorpromazine, thioridazine), benzamide antipsychotics (tiapride, amisulpride, sulpiride, sultopride) , class IA antiarrhythmics (disopyramide, hydroquinidine, quinidine), class III (ibutilide, dofetilide, sotalol, amiodarone), moxifloxacin, pentamidine, halofantrine, as well as drugs such as vincamine and erythromycin (intravenously), mizolastine, diphemanil, cisapride , bepridil.

With extreme caution, Rovamycin is used for obstruction of the bile ducts, liver failure, in combination (for lyophilisate) with drugs that reduce the level of potassium in the blood serum, causing bradycardia, with ergot alkaloids.

During pregnancy, the drug is approved for use according to indications (fetotoxic or teratogenic effects have not been identified). If it is necessary to prescribe a remedy during lactation, it is necessary to stop breastfeeding, due to the possible penetration of spiramycin into breast milk.

Method of application and dosage

Film-coated tablets
Tablets are taken orally with a sufficient amount of water.

Adults are prescribed 6-9 million IU of Rovamycin per day (4-6 tablets of 1.5 million IU or 2-3 tablets of 3 million IU) in 2-3 doses. Children and adolescents over 6 years of age are recommended to take only tablets of 1.5 million IU, the dose can be 150-300 thousand IU per 1 kg of body weight per day (but not more than 6-9 million IU), divided into 2- 3 receptions.

The maximum allowable daily dose for adults is 9 million IU, for children - 300 thousand IU per 1 kg of body weight, but not exceeding 9 million IU with a child weighing over 30 kg.

In order to prevent meningococcal meningitis for 5 days twice a day, adults take 3 million IU, children - 75 thousand IU per 1 kg of body weight.

In the presence of functional disorders of the kidneys associated with insignificant renal excretion, it is not necessary to adjust the dose of spiramycin.

Lyophilizate for solution for intravenous administration
The solution prepared from the lyophilisate is administered intravenously only to adult patients.

A slow intravenous infusion of 1.5 million IU is carried out every 8 hours, the daily dose is 4.5 million IU, with severe infections, a dose increase of 2 times is possible.

The lyophilisate contained in the vial is dissolved in 4 ml of injection water, and then diluted in at least 100 ml of a 5% dextrose (glucose) solution. Slowly intravenous drip Rovamycin is administered over 60 minutes.

As soon as the patient's condition allows, he is transferred to oral administration.

The duration of therapy depends on the sensitivity of the microflora, the type of pathogen, the characteristics and severity of the infection, and is set individually by the attending physician.

The prepared solution at room temperature is stable for 12 hours.

Side effects

Gastrointestinal tract: nausea, diarrhea, vomiting; extremely rarely - pseudomembranous colitis; the frequency is unknown (when taken orally) - acute colitis, ulcerative esophagitis, when using high doses in connection with cryptosporidiosis in AIDS patients - damage to the intestinal mucosa (2 cases);
Liver and biliary tract: very rarely - mixed or cholestatic hepatitis, abnormal liver function tests;
Hematopoietic system: very rarely - acute hemolysis;
Nervous system: some cases - transient paresthesia;
Immune system: pruritus, urticaria, skin rash; very rarely - angioedema, anaphylactic shock; isolated cases - vasculitis, including Shenlein-Genoch purpura;
Cardiovascular system: extremely rarely - prolongation of the QT interval on the electrocardiogram (ECG);
Skin and subcutaneous tissues: very rarely - acute generalized exanthematous pustulosis;
Local reactions: general disorders and disorders at the injection site of the solution, moderate pain sensitivity along the vein.

Cases of Rovamycin overdose have not been reported.

Possible overdose symptoms: nausea, diarrhea, vomiting. In newborns who were treated with high doses of spiramycin, as well as in patients at risk of QT prolongation, after intravenous administration, there were cases of prolongation of the QT interval, which disappears when the drug is discontinued.

In case of overdose, an ECG observation is prescribed with a concomitant determination of the duration of the QT interval, especially in patients with risk factors (congenital prolongation of the QT interval, hypokalemia, simultaneous use of agents that prolong the QT interval and provoke the development of ventricular tachycardia of the "pirouette" type). There is no specific antidote, treatment is symptomatic.

special instructions

During the period of application of Rovamycin in the presence of liver diseases, it is necessary to monitor its functional state.

If, at the beginning of therapy, the patient develops pustules and generalized erythema, accompanied by high body temperature, this may be a sign of acute generalized exanthematous pustulosis. With the development of such a reaction, the use of the drug must be canceled (both in monotherapy and in combination).

Intravenous infusions should be stopped immediately if symptoms of any allergic reaction are observed.

When administering the solution to patients suffering from diabetes mellitus, due to the use of 5% dextrose as a solvent, it is required to control the level of glucose in the blood.

Tablets at a dose of 3 million IU are not used in children because of the difficulty in swallowing them and the threat of airway obstruction due to the large diameter of the tablet.

There is no information confirming the negative effect of Rovamycin on the ability to drive a car or other complex mechanisms. At the same time, the severity of the patient's condition should be taken into account, which can negatively affect the attention and speed of psychomotor reactions. The final decision on the possibility of driving vehicles and other mechanisms is made by the attending physician.

drug interaction

With intravenous infusion of a solution of Rovamycin with the simultaneous use of drugs that cause bradycardia (beta-blockers, verapamil, diltiazem, digitalis glycosides, guanfacine, clonidine, cholinesterase inhibitors: neostigmine, pyridostigmine, galantamine, ambenonium chloride, tacrine, rivastigmine, donepezil), as well as means that reduce the content of potassium in the blood (amphotericin B (intravenously), tetracosactide, potassium-releasing diuretics, glucocorticosteroids, mineralocorticoids, stimulant laxatives), the risk of developing ventricular arrhythmias is aggravated, in particular by the "pirouette" type. Before starting the use of Rovamycin, it is required to eliminate hypokalemia, and during therapy it is recommended to monitor the clinical condition, electrolyte levels and ECG monitoring.

Spiramycin inhibits the absorption of carbidopa, thereby reducing the plasma concentration of levodopa. With this combination, clinical monitoring is necessary and, if necessary, dose adjustment of levodopa.

When using antibiotics, an increase in the activity of indirect anticoagulants is possible.

Terms and conditions of storage

Store at a temperature not exceeding 25 ° C, protected from light, out of the reach of children.

Shelf life: lyophilisate - 1.5 years; tablets 1.5 million IU - 3 years; tablets 3 million IU - 4 years.

Tablets - 1 tab.:

Active substance: spiramycin 3 million IU.
Excipients: colloidal silicon dioxide - 2.4 mg, magnesium stearate - 8 mg, pregelatinized corn starch - 32 mg, hyprolose - 16 mg, croscarmellose sodium - 16 mg, microcrystalline cellulose - up to 800 mg.
Shell composition: titanium dioxide (E171) - 2.96 mg, macrogol 6000 - 2.96 mg, hypromellose - 8.88 mg.

5 pieces. - blisters (2) - packs of cardboard.

Description of the dosage form

Film-coated tablets, white with a creamy tint, round, biconvex, debossed "ROVA 3" on one side; cross-sectional view: white with a creamy tint.

pharmachologic effect

Macrolide antibiotic. The mechanism of antibacterial action is due to the inhibition of protein synthesis in the microbial cell due to binding to the 50S subunit of the ribosome.

Susceptible microorganisms (MICs<1 мг/л): грамположительные аэробы - Bacillus cereus, Corynebacterium diphtheriae, Enterococcus spp., Rhodococcus equi, Staphylococcus spp. (метициллин-чувствительные и метициллин-резистентные штаммы), Streptococcus B, неклассицированный стрептококк, Streptococcus pneumoniae, Streptococcus pyogenes; грамотрицательные аэробы - Bordetella pertussis, Branhamella catarrhalis, Campylobacter spp., Legionella spp., Moraxella spp.; анаэробы - Actinomyces spp., Bacteroides spp., Eubacterium spp., Mobiluncus spp., Peptostreptococcus spp., Porphyromonas spp., Prevotella spp., Propionibacterium acnes; разные - Borrelia burgdorferi, Chlamydia spp., Coxiella spp., Leptospirа spp., Mycoplasma pneumoniae, Treponema pallidum, Toxoplasma gondii.

Moderately susceptible organisms (antibiotic is moderately active in vitro at inflammatory antibiotic concentrations ≥ 1 mg/L, but< 4 мг/л): грамотрицательные аэробы - Neisseria gonorrhoeae; аэробы - Clostridium perfringens; разные - Ureaplasma urealyticum.

Resistant microorganisms (MIC> 4 mg / l; at least 50% of strains are resistant): gram-positive aerobes - Corynebacterium jekeium, Nocardia asteroides; gram-negative aerobes - Acinetobacter spp., Enterobacter spp., Haemophilus spp., Pseudomonas spp.; anaerobes - Fusobacterium spp.; different - Mycoplasma hominis.

Pharmacokinetics

Suction

Absorption of spiramycin is rapid but incomplete, with great variability (10% to 60%). After taking Rovamycin orally at a dose of 6 million IU, Cmax of spiramycin in plasma is about 3.3 μg / ml. Eating does not affect absorption.

Distribution

Plasma protein binding is low (approximately 10%). Vd approximately 383 liters. The drug penetrates well into saliva and tissues (the concentration in the lungs is 20-60 mcg / g, in the tonsils - 20-80 mcg / g, in the infected sinuses - 75-110 mcg / g, in the bones - 5-100 mcg / g) . 10 days after the end of treatment, the concentration of spiramycin in the spleen, liver, kidneys is 5-7 mcg / g.

Spiramycin penetrates and accumulates in phagocytes (neutrophils, monocytes and peritoneal and alveolar macrophages). In humans, drug concentrations within phagocytes are quite high. This explains the effectiveness of spiramycin against intracellular bacteria.

Penetrates through the placental barrier (the concentration in the blood of the fetus is approximately 50% of the concentration in the mother's serum). Concentrations in placental tissue are 5 times higher than the corresponding concentrations in blood serum. It is allocated with breast milk.

Spiramycin does not penetrate into the cerebrospinal fluid.

Metabolism and excretion

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

T1 / 2 from plasma is approximately 8 hours. It is excreted mainly in the bile (the concentration is 15-40 times higher than in serum). Renal excretion is about 10% of the administered dose. The amount of the drug excreted through the intestines (with feces) is very small.

Pharmacodynamics

The antibacterial spectrum of spiramycin is as follows: - usually sensitive microorganisms: minimum inhibitory concentration (MIC) 4 mg/l): at least 50% of strains are resistant: methicillin-resistant staphylococci, Enterobacter spp., Pseudomonas spp., Acinetobacter, Nocardia asteroides , Fusobacterium, Haemophilus spp., Mycoplasma hominis.

Clinical pharmacology

Macrolide antibiotic.

Indications for use Rovamycin

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

acute and chronic pharyngitis caused by beta-hemolytic streptococcus A (as an alternative to treatment with beta-lactam antibiotics, especially in case of contraindications to their use);
acute sinusitis (given the sensitivity of the microorganisms most often causing this pathology, the use of Rovamycin® is indicated in case of contraindications to the use of beta-lactam antibiotics);
acute and chronic tonsillitis caused by microorganisms sensitive to spiramycin;
acute bronchitis caused by a bacterial infection that developed after acute viral bronchitis;
exacerbation of chronic bronchitis;
community-acquired pneumonia in patients without risk factors for poor outcome, severe clinical symptoms and clinical signs of pneumococcal pneumonia etiology;
pneumonia caused by atypical pathogens (such as Chlamydia pneumoniae, Chlamydia trachomatis, Mycoplasma pneumoniae, Legionella spp.) or suspicion of it (regardless of severity and the presence or absence of risk factors for an adverse outcome);
infections of the skin and subcutaneous tissue, including impetigo, impetiginization, ecthyma, infectious dermohypodermatitis (especially erysipelas), secondary infected dermatoses, erythrasma;
oral infections (including stomatitis, glossitis);
non-gonococcal infections of the genital organs;
toxoplasmosis, incl. during pregnancy;
infections of the musculoskeletal system and connective tissue, including periodontium.

Prevention of recurrence of rheumatic fever in patients allergic to beta-lactam antibiotics.

Eradication of Neisseria meningitidis from the nasopharynx (with contraindications to taking rifampicin) for the prevention (but not treatment) of meningococcal meningitis:

in patients after treatment and before leaving quarantine;
in patients who were in contact with persons who excreted Neisseria meningitidis with saliva into the environment within 10 days before hospitalization.

Contraindications to the use of Rovamycin

lactation period;
deficiency of glucose-6-phosphate dehydrogenase (risk of acute hemolysis);
children's age (for tablets 1.5 million IU - up to 6 years, for tablets 3 million IU - up to 18 years);
hypersensitivity to the components of the drug.

Rovamycin® is prescribed with caution for obstruction of the bile ducts, with liver failure.

Rovamycin Use in pregnancy and children

Rovamycin® can be prescribed during pregnancy according to indications.

There is extensive experience with the use of the drug Rovamycin® during pregnancy. A decrease in the risk of transmission of toxoplasmosis to the fetus during pregnancy is observed from 25% to 8% when using the drug in the first trimester, from 54% to 19% in the second trimester and from 65% to 44% in the third trimester. No teratogenic or fetotoxic effects were observed.

When prescribing Rovamycin® during lactation, breastfeeding should be stopped, since spiramycin may pass into breast milk.

Use in children

Contraindication: children's age (for tablets 1.5 million IU - up to 6 years, for tablets 3 million IU - up to 18 years).

Rovamycin side effects

The following classification was used to indicate the frequency of occurrence of adverse reactions: very often (≥10%), often (≥ 1%,<10); нечасто (≥ 0.1%, <1%); редко (≥0.01%, <0.1%), очень редко, включая отдельные сообщения (<0.01%), частота неизвестна (по имеющимся данным частоту определить нельзя).

From the digestive system: nausea, vomiting, diarrhea; very rarely - pseudomembranous colitis (<0.01%); частота неизвестна - язвенный эзофагит, острый колит, острое повреждение слизистой оболочки кишечника у пациентов со СПИД при применении спирамицина в высоких дозах по поводу криптоспоридиоза (всего 2 случая).

From the side of the liver and biliary tract: very rarely (<0.01%) - отклонение функциональных проб печени от нормальных показателей; холестатический или смешанный гепатит.

From the nervous system: very rarely (separate cases) - transient paresthesia.

From the hematopoietic system: very rarely (<0.01%) - острый гемолиз.

From the side of the cardiovascular system: very rarely - prolongation of the QT interval on the ECG.

From the immune system: skin rash, urticaria, pruritus; rarely (<0.01%) - ангионевротический отек, анафилактический шок; в отдельных случаях - васкулит, включая пурпуру Шенлейна-Геноха.

On the part of the skin and subcutaneous tissues: very rarely - acute generalized exanthematous pustulosis.

drug interaction

Numerous cases of increased activity of indirect anticoagulants in patients taking antibiotics have been registered. 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 plays a role in changing the MHO. However, with the use of certain groups of antibiotics, this effect is observed more often, in particular with the use of fluoroquinolones, macrolides, cyclins, a combination of sulfamethoxazole + trimethoprim, and some cephalosporins.

Dosage Rovamycin

The drug is taken orally.

Adults appoint 2-3 tab. 3 million IU or 4-6 tab. 1.5 million IU (i.e. 6-9 million IU) per day. The daily dose is divided into 2 or 3 doses. The maximum daily dose is 9 million IU.

In children and adolescents aged 6 to 18 years, only 1.5 million IU tablets should be used.

In children older than 6 years, the daily dose ranges from 150-300 thousand ME per kg of body weight, which is divided into 2 or 3 doses up to 6-9 million ME. The maximum daily dose in children is 300 thousand ME per kg of body weight, but with a child weighing more than 30 kg it should not exceed 9 million ME

For the prevention of meningococcal meningitis, adults are prescribed 3 million IU 2 times / day for 5 days, children - 75 thousand IU / kg of body weight 2 times / day for 5 days.

Patients with impaired renal function due to insignificant renal excretion of spiramycin dose adjustment is not required.

Tablets are taken orally with a sufficient amount of water.

Overdose

There are no known cases of overdose of spiramycin.

Symptoms: possible - nausea, vomiting, diarrhea. Discontinuation QT prolongation has been reported in neonates treated with high doses of spiramycin or after intravenous spiramycin in patients predisposed to QT prolongation.

Treatment: in case of an overdose of spiramycin, ECG monitoring is recommended to determine the duration of the QT interval, especially in the presence of risk factors (hypokalemia, congenital prolongation of the QT interval, simultaneous use of drugs that prolong the duration of the QT interval and cause the development of ventricular tachycardia type "pirouette"). There is no specific antidote. If an overdose of spiramycin is suspected, symptomatic therapy is recommended.

Precautionary measures

During treatment with the drug in patients with liver disease, it is necessary to periodically monitor its function.

If generalized erythema and pustules occur at the beginning of treatment, accompanied by high body temperature, acute generalized exanthematous pustulosis should be assumed; if such a reaction occurs, then treatment should be stopped, and further use of spiramycin, both in monotherapy and in combination, is contraindicated.

Pediatric use

Tablets of 3 million ME are not used in children due to the difficulty of swallowing them in children due to the large diameter of the tablets and the risk of airway obstruction.

Influence on the ability to drive vehicles and control mechanisms

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

The drug should be stored out of the reach of children at a temperature not exceeding 25 ° C.

Expiry date from date of manufacture

Product description

Film-coated tablets, white with a creamy tint, round, biconvex, debossed "ROVA 3" on one side; cross-sectional view: white with a creamy tint.

pharmachologic effect

Macrolide antibiotic. The mechanism of antibacterial action is due to the inhibition of protein synthesis in the microbial cell due to binding to the 50S subunit of the ribosome.
Susceptible organisms (MICs Moderately susceptible organisms (antibiotic is moderately active in vitro at antibiotic concentrations at the site of inflammation ≥ 1 mg/l, but Resistant microorganisms (MIC> 4 mg/l; at least 50% of strains are resistant): gram-positive aerobes - Corynebacterium jekeium, Nocardia asteroides; gram-negative aerobes - Acinetobacter spp., Enterobacter spp., Haemophilus spp., Pseudomonas spp.; anaerobes - Fusobacterium spp.; various - Mycoplasma hominis.

Pharmacokinetics

Suction
Absorption of spiramycin is rapid but incomplete, with great variability (10% to 60%). After taking Rovamycin orally at a dose of 6 million IU, Cmax of spiramycin in plasma is about 3.3 μg / ml. Eating does not affect absorption.
Distribution
Plasma protein binding is low (approximately 10%). Vd approximately 383 liters. The drug penetrates well into saliva and tissues (the concentration in the lungs is 20-60 mcg / g, in the tonsils - 20-80 mcg / g, in the infected sinuses - 75-110 mcg / g, in the bones - 5-100 mcg / g) . 10 days after the end of treatment, the concentration of spiramycin in the spleen, liver, kidneys is 5-7 mcg / g.
Spiramycin penetrates and accumulates in phagocytes (neutrophils, monocytes and peritoneal and alveolar macrophages). In humans, drug concentrations within phagocytes are quite high. This explains the effectiveness of spiramycin against intracellular bacteria.
Penetrates through the placental barrier (the concentration in the blood of the fetus is approximately 50% of the concentration in the mother's serum). Concentrations in placental tissue are 5 times higher than the corresponding concentrations in blood serum. It is allocated with breast milk.
Spiramycin does not penetrate into the cerebrospinal fluid.
Metabolism and excretion
Spiramycin is metabolized in the liver to form active metabolites with an unidentified chemical structure.
T1 / 2 from plasma is approximately 8 hours. It is excreted mainly in the bile (the concentration is 15-40 times higher than in serum). Renal excretion is about 10% of the administered dose. The amount of the drug excreted through the intestines (with feces) is very small.

Indications for use

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:
- acute and chronic pharyngitis caused by beta-hemolytic streptococcus A (as an alternative to treatment with beta-lactam antibiotics, especially in case of contraindications to their use);
- acute sinusitis (taking into account the sensitivity of the microorganisms most often causing this pathology, the use of Rovamycin® is indicated in case of contraindications to the use of beta-lactam antibiotics);
- acute and chronic tonsillitis caused by microorganisms sensitive to spiramycin;
- acute bronchitis caused by a bacterial infection that developed after acute viral bronchitis;
- exacerbation of chronic bronchitis;
- community-acquired pneumonia in patients without risk factors for adverse outcomes, severe clinical symptoms and clinical signs of pneumococcal pneumonia etiology;
- pneumonia caused by atypical pathogens (such as Chlamydia pneumoniae, Chlamydia trachomatis, Mycoplasma pneumoniae, Legionella spp.) or suspicion of it (regardless of severity and the presence or absence of risk factors for an adverse outcome);
- infections of the skin and subcutaneous tissue, including impetigo, impetiginization, ecthyma, infectious dermohypodermatitis (especially erysipelas), secondary infected dermatoses, erythrasma;
- infections of the oral cavity (including stomatitis, glossitis);
- non-gonococcal infections of the genital organs;
- toxoplasmosis, incl. during pregnancy;
- infections of the musculoskeletal system and connective tissue, including periodontium.
Prevention of recurrence of rheumatic fever in patients allergic to beta-lactam antibiotics.
Eradication of Neisseria meningitidis from the nasopharynx (with contraindications to taking rifampicin) for the prevention (but not treatment) of meningococcal meningitis:
- in patients after treatment and before leaving quarantine;
- in patients who were in contact with persons who excreted Neisseria meningitidis with saliva into the environment within 10 days before hospitalization.

Use during pregnancy and lactation

Rovamycin® can be prescribed during pregnancy according to indications.
There is extensive experience with the use of the drug Rovamycin® during pregnancy. A decrease in the risk of transmission of toxoplasmosis to the fetus during pregnancy is observed from 25% to 8% when using the drug in the first trimester, from 54% to 19% in the second trimester and from 65% to 44% in the third trimester. No teratogenic or fetotoxic effects were observed.
When prescribing Rovamycin® during lactation, breastfeeding should be stopped, since spiramycin may pass into breast milk.

special instructions

During treatment with the drug in patients with liver disease, it is necessary to periodically monitor its function.
If generalized erythema and pustules occur at the beginning of treatment, accompanied by high body temperature, acute generalized exanthematous pustulosis should be assumed; if such a reaction occurs, then treatment should be stopped, and further use of spiramycin, both in monotherapy and in combination, is contraindicated.
Pediatric use
Tablets of 3 million ME are not used in children due to the difficulty of swallowing them in children due to the large diameter of the tablets and the risk of airway obstruction.
Influence on the ability to drive vehicles and control mechanisms
There is no information about the negative effect of the drug on the ability to drive a car and engage in other potentially hazardous activities. However, the severity of the patient's condition should be taken into account, which may affect the attention and speed of psychomotor reactions. Therefore, the decision on the possibility of driving a car or engaging in other potentially hazardous activities in a particular patient should be made by the attending physician.

With caution (Precautions)

Rovamycin® is prescribed with caution for obstruction of the bile ducts or for liver failure.
Patients with impaired renal function due to low renal excretion of spiramycin do not need to change the dose.
Contraindication: children's age (for tablets 1.5 million IU - up to 6 years, for tablets 3 million IU - up to 18 years).

Contraindications

lactation period;
- deficiency of glucose-6-phosphate dehydrogenase (risk of acute hemolysis);
- children's age (for tablets 1.5 million IU - up to 6 years, for tablets 3 million IU - up to 18 years);
- Hypersensitivity to the components of the drug.
Rovamycin® is prescribed with caution for obstruction of the bile ducts, with liver failure.

Dosage and administration

The drug is taken orally.
Adults appoint 2-3 tab. 3 million IU or 4-6 tab. 1.5 million IU (i.e. 6-9 million IU) per day. The daily dose is divided into 2 or 3 doses. The maximum daily dose is 9 million IU.
In children and adolescents aged 6 to 18 years, only 1.5 million IU tablets should be used.
In children older than 6 years, the daily dose ranges from 150-300 thousand ME per kg of body weight, which is divided into 2 or 3 doses up to 6-9 million ME. The maximum daily dose in children is 300 thousand ME per kg of body weight, but with a child weighing more than 30 kg it should not exceed 9 million ME
For the prevention of meningococcal meningitis, adults are prescribed 3 million IU 2 times / day for 5 days, children - 75 thousand IU / kg of body weight 2 times / day for 5 days.
Patients with impaired renal function due to insignificant renal excretion of spiramycin dose adjustment is not required.
Tablets are taken orally with a sufficient amount of water.

Overdose

There are no known cases of overdose of spiramycin.
Symptoms: possible - nausea, vomiting, diarrhea. Discontinuation QT prolongation has been reported in neonates treated with high doses of spiramycin or after intravenous spiramycin in patients predisposed to QT prolongation.
Treatment: in case of an overdose of spiramycin, ECG monitoring is recommended to determine the duration of the QT interval, especially in the presence of risk factors (hypokalemia, congenital prolongation of the QT interval, simultaneous use of drugs that prolong the duration of the QT interval and cause the development of ventricular tachycardia type "pirouette"). There is no specific antidote. If an overdose of spiramycin is suspected, symptomatic therapy is recommended.

Side effect

The following classification was used to indicate the frequency of occurrence of adverse reactions: very often (≥10%), often (≥ 1%, On the part of the digestive system: nausea, vomiting, diarrhea; very rarely - pseudomembranous colitis (On the part of the liver and biliary tract: very rarely (On the part of the nervous system: very rarely (separate cases) - transient paresthesia.
On the part of the hematopoietic system: very rarely (On the part of the cardiovascular system: very rarely - prolongation of the QT interval on the ECG.
From the immune system: skin rash, urticaria, pruritus; very rarely (On the part of the skin and subcutaneous tissues: very rarely - acute generalized exanthematous pustulosis.

Compound

1 tab.
spiramycin 3 million IU

Interaction with other drugs

Inhibition of carbidopa absorption by spiramycin with a decrease in plasma concentrations of levodopa. With the simultaneous appointment of spiramycin, clinical monitoring and dose adjustment of levodopa is necessary.
Numerous cases of increased activity of indirect anticoagulants in patients taking antibiotics have been registered. 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 plays a role in changing the MHO. However, with the use of certain groups of antibiotics, this effect is observed more often, in particular with the use of fluoroquinolones, macrolides, cyclins, a combination of sulfamethoxazole + trimethoprim, and some cephalosporins.

Release form

White or creamy white film-coated tablets, round, biconvex, debossed with "RPR 107" on one side; cross-sectional view: white or white with a creamy tint.
1 tab.
spiramycin 1.5 million IU
Excipients: colloidal silicon dioxide - 1.2 mg, magnesium stearate - 4 mg, pregelatinized corn starch - 16 mg, hyprolose - 8 mg, croscarmellose sodium - 8 mg, microcrystalline cellulose - up to 400 mg.
Shell composition: titanium dioxide (E171) - 1.694 mg, macrogol 6000 - 1.694 mg, hypromellose - 5.084 mg.
8 pcs. - blisters (2) - packs of cardboard.
Film-coated tablets, white with a creamy tint, round, biconvex, debossed "ROVA 3" on one side; cross-sectional view: white with a creamy tint.
1 tab.
spiramycin 3 million IU
Excipients: colloidal silicon dioxide - 2.4 mg, magnesium stearate - 8 mg, pregelatinized corn starch - 32 mg, hyprolose - 16 mg, croscarmellose sodium - 16 mg, microcrystalline cellulose - up to 800 mg.
Shell composition: titanium dioxide (E171) - 2.96 mg, macrogol 6000 - 2.96 mg, hypromellose - 8.88 mg.
5 pieces. - blisters (2) - packs of cardboard.

macrolide antibiotic

Active substance

Spiramycin (spiramycin)

Release form, composition and packaging

white or creamy white, round, biconvex, engraved with "RPR 107" on one side; cross-sectional view: white or white with a creamy tint.

Excipients: colloidal silicon dioxide - 1.2 mg, magnesium stearate - 4 mg, pregelatinized corn starch - 16 mg, hyprolose - 8 mg, croscarmellose sodium - 8 mg, microcrystalline cellulose - up to 400 mg.

Shell composition: titanium dioxide (E171) - 1.694 mg, macrogol 6000 - 1.694 mg, hypromellose - 5.084 mg.

8 pcs. - blisters (2) - packs of cardboard.

Film-coated tablets creamy white, round, biconvex, engraved with "ROVA 3" on one side; cross-sectional view: white with a creamy tint.

Excipients: colloidal silicon dioxide - 2.4 mg, magnesium stearate - 8 mg, pregelatinized corn starch - 32 mg, hyprolose - 16 mg, croscarmellose sodium - 16 mg, microcrystalline cellulose - up to 800 mg.

Shell composition: titanium dioxide (E171) - 2.96 mg, macrogol 6000 - 2.96 mg, hypromellose - 8.88 mg.

5 pieces. - blisters (2) - packs of cardboard.

pharmachologic effect

Macrolide antibiotic. The mechanism of antibacterial action is due to the inhibition of protein synthesis in the microbial cell due to binding to the 50S subunit of the ribosome.

Sensitive microorganisms(IPC<1 мг/л): грамположительные аэробы - Bacillus cereus, Corynebacterium diphtheriae, Enterococcus spp., Rhodococcus equi, Staphylococcus spp. (метициллин-чувствительные и метициллин-резистентные штаммы), Streptococcus B, неклассицированный стрептококк, Streptococcus pneumoniae, Streptococcus pyogenes; грамотрицательные аэробы - Bordetella pertussis, Branhamella catarrhalis, Campylobacter spp., Legionella spp., Moraxella spp.; анаэробы - Actinomyces spp., Bacteroides spp., Eubacterium spp., Mobiluncus spp., Peptostreptococcus spp., Porphyromonas spp., Prevotella spp., Propionibacterium acnes; разные - Borrelia burgdorferi, Chlamydia spp., Coxiella spp., Leptospira spp., Mycoplasma pneumoniae, Treponema pallidum, Toxoplasma gondii.

Moderately sensitive microorganisms(antibiotic is moderately active in vitro at inflammatory antibiotic concentrations ≥ 1 mg/l, but< 4 мг/л): грамотрицательные аэробы - Neisseria gonorrhoeae; аэробы - Clostridium perfringens; разные - Ureaplasma urealyticum.

Resistant microorganisms(MIC>4 mg/l; at least 50% of strains are resistant): Gram-positive aerobes - Corynebacterium jekeium, Nocardia asteroides; gram-negative aerobes - Acinetobacter spp., Enterobacter spp., Haemophilus spp., Pseudomonas spp.; anaerobes - Fusobacterium spp.; different - Mycoplasma hominis.

Pharmacokinetics

Suction

Distribution

Dosage

The drug is taken orally.

Adults appoint 2-3 tab. 3 million IU or 4-6 tab. 1.5 million IU (i.e. 6-9 million IU) per day. The daily dose is divided into 2 or 3 doses. The maximum daily dose is 9 million IU.

At children and adolescents aged 6 to 18 years only 1.5 million IU tablets should be used.

At children over 6 years old the daily dose ranges from 150-300 thousand ME per kg of body weight, which is divided into 2 or 3 doses up to 6-9 million ME. The maximum daily dose in children is 300 thousand ME per kg of body weight, but with a child weighing more than 30 kg it should not exceed 9 million ME

For prevention of meningococcal meningitis adults appoint 3 million IU 2 times / day for 5 days, children- 75 thousand IU / kg of body weight 2 times / day for 5 days.

Patients with impaired renal function due to the insignificant renal excretion of spiramycin, dose adjustment is not required.

Tablets are taken orally with a sufficient amount of water.

Side effects

From the digestive system: nausea, vomiting, diarrhea; very rarely - pseudomembranous colitis (<0.01%); частота неизвестна - язвенный эзофагит, острый колит, острое повреждение слизистой оболочки кишечника у пациентов со СПИД при применении спирамицина в высоких дозах по поводу криптоспоридиоза (всего 2 случая).

From the side of the liver and biliary tract: rarely (<0.01%) - отклонение функциональных проб печени от нормальных показателей; холестатический или смешанный гепатит.

From the nervous system: very rarely (in some cases) - transient paresthesia.

From the hematopoietic system: rarely (<0.01%) - острый гемолиз.

From the side of the cardiovascular system: very rarely - prolongation of the QT interval on the ECG.

From the immune system:, urticaria, pruritus; rarely (<0.01%) - ангионевротический отек, анафилактический шок; в отдельных случаях - васкулит, включая пурпуру Шенлейна-Геноха.

From the skin and subcutaneous tissues: very rarely - acute generalized exanthematous pustulosis.

Overdose

There are no known cases of overdose of spiramycin.

Symptoms: possible - nausea, vomiting, diarrhea. Discontinuation QT prolongation has been reported in neonates treated with high doses of spiramycin or after intravenous spiramycin in patients predisposed to QT prolongation.

Treatment: in case of an overdose of spiramycin, ECG monitoring with determination of the duration of the QT interval is recommended, especially in the presence of risk factors (hypokalemia, congenital prolongation of the QT interval, simultaneous use of drugs that prolong the duration of the QT interval and cause the development of ventricular tachycardia type "pirouette"). There is no specific antidote. If an overdose of spiramycin is suspected, symptomatic therapy is recommended.

drug interaction

There have been numerous cases of increased indirect activity 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 plays a role in changing the MHO. However, with the use of certain groups of antibiotics, this effect is observed more often, in particular with the use of fluoroquinolones, macrolides, cyclins, a combination of sulfamethoxazole + trimethoprim, and some cephalosporins.

special instructions

During treatment with the drug in patients with liver disease, it is necessary to periodically monitor its function.

Pediatric use

Tablets of 3 million ME are not used in children due to the difficulty of swallowing them in children due to the large diameter of the tablets and the risk of airway obstruction.

Influence on the ability to drive vehicles and control mechanisms

Pregnancy and lactation

Rovamycin can be prescribed during pregnancy according to indications.

There is extensive experience with the use of the drug Rovamycin during pregnancy. A decrease in the risk of transmission of toxoplasmosis to the fetus during pregnancy is observed from 25% to 8% when using the drug in the first trimester, from 54% to 19% in the second trimester and from 65% to 44% in the third trimester. No teratogenic or fetotoxic effects were observed.

Terms of dispensing from pharmacies

The drug is dispensed by prescription.

Terms and conditions of storage

The drug should be stored out of the reach of children at a temperature not exceeding 25 ° C. Shelf life for tablets 1.5 million IU - 3 years, for tablets 3 million IU - 4 years.

Rovamycin is an antibacterial drug of the macrolide group.

Release form and composition

Dosage forms of Rovamycin:

Film-coated tablets, 8 pcs. in a blister (tablets 1.5 million IU) and 5 pcs. in a blister (tablets 3 million IU), 2 blisters per pack;
Lyophilisate for the preparation of a solution for intravenous administration, 1 vial in a cardboard box.

The active substance of the drug is spiramycin:

In 1 tablet - 1.5 million IU or 3 million IU;
In 1 vial of lyophilisate - 1.5 million IU.

Auxiliary components of tablets: croscarmellose sodium, pregelatinized corn starch, microcrystalline cellulose, magnesium stearate, hyprolose, colloidal silicon dioxide.

The composition of the tablet shell: macrogol 6000, hypromellose and titanium dioxide.

Indications for use

Rovamycin is prescribed for the treatment of the following infectious and inflammatory diseases caused by microorganisms sensitive to spiramycin:

Acute and chronic tonsillitis;
Acute sinusitis (if the patient has contraindications to the use of beta-lactam antibiotics);
Acute and chronic pharyngitis caused by beta-hemolytic streptococcus A (in case of impossibility or contraindications to beta-lactam antibiotics);
Acute bronchitis caused by a bacterial infection that has developed as a result of acute viral bronchitis;
Chronic bronchitis in the acute stage;
Pneumonia caused by atypical pathogens (for example, Mycoplasma pneumoniae, Chlamydia trachomatis, Legionella spp., or Chlamydia pneumoniae) or suspicion of it;
Community-acquired pneumonia (provided there are no severe symptoms, clinical signs of pneumococcal etiology of the disease and risks of adverse outcome);
Infections of the reproductive system of non-gonococcal etiology;
Infections of the skin and subcutaneous tissue - erythrasma, secondary infected dermatoses, dermohypodermatitis (especially erysipelas), ecthyma, impetigo and impetiginization;
Infections of the musculoskeletal system and connective tissue, v.h. periodontium;
Oral infections, including stomatitis and glossitis;
Toxoplasmosis, incl. during pregnancy.

Also indications for the use of Rovamycin are:

Prevention of recurrence of rheumatic fever in patients with hypersensitivity reactions to beta-lactam antibiotics;
Destruction of Neisseria meningitidis in the nasopharynx in order to prevent meningococcal meningitis in patients after the end of the course of treatment and before leaving quarantine, as well as in patients who have been in contact with a sick person for 10 days before hospitalization (if there are contraindications to the use of rifampicin).

In the form of intravenous injections, Rovamycin is mainly used to treat acute conditions, in particular, acute pneumonia, exacerbation of chronic bronchitis and infectious-allergic asthma.

Contraindications

Both dosage forms are contraindicated if the patient is diagnosed with:

Deficiency of the enzyme glucose-6-phosphate dehydrogenase;
Hypersensitivity to spiramycin or any of the excipients.

Tablets, in addition, are not prescribed: at a dose of 1.5 million IU - for children under 3 years old, at a dose of 3 million IU - up to 18 years.

In the form of intravenous injections, the drug is also contraindicated in the following cases:

Age up to 18 years;
The presence of a risk of prolongation of the QT interval;
In combination with drugs that can cause ventricular arrhythmias of the "pirouette" type: with antiarrhythmic drugs of class Ia (quinidine, hydroquinidine and disopyramide) and class III (amiodarone, sotalol, dofetilide, ibutilide);
Simultaneously with sultopride (an antipsychotic of the benzamide group) and some phenothiazine antipsychotics (thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, amisulpride, tiapride, haloperidol, droperidol, pimozide);
In combination with certain other drugs such as moxifloxacin, pentamidine, bepridil, halofantrine, cisapride, mizolastine, diphemanil, erythromycin or vincamine intravenously.

With caution, Rovamycin is prescribed to patients with obstruction of the bile ducts and liver failure.

If necessary, the use of the drug during lactation, breastfeeding should be discontinued.

Method of application and dosage

Tablets are taken orally. Adults appoint 2-3 tablets. 3 million IU or 4-6 tablets. 1.5 million IU per day. The total dose is divided into 2-3 doses. Children weighing at least 20 kg - 150-300 thousand IU per kilogram of body weight per day in 2-3 doses.

The maximum daily dose for adults should not exceed 9 million IU, for children - 300 thousand IU / kg.

For the prevention of meningococcal meningitis, adults are prescribed 3 million IU, children - 75 thousand IU. Take the drug twice a day for 5 days.

Intravenous injections of Rovamycin can only be prescribed to adults. The drug is administered by slow drip infusion (at least 1 hour). The contents of the vial are dissolved in 4 ml of injection water, then in 100 ml of 5% dextrose. The standard dose is 1.5 million IU three times a day, in severe cases it can be doubled. The duration of treatment depends on the type and severity of the infection, the sensitivity of the microflora and the characteristics of the course of the disease. As soon as the patient's condition allows, he is transferred to the oral form of the drug.

Side effects

Relatively common adverse reactions are nausea, vomiting, diarrhea, rash, urticaria, itching.

In rare cases, the following side effects are noted:

Digestive system: pseudomembranous and acute colitis, ulcerative esophagitis. There are 2 cases of acute damage to the intestinal mucosa in patients with AIDS, when Rovamycin is used in high doses in connection with cryptosporidiosis;
Liver and biliary tract: cholestatic or mixed hepatitis, deviation of liver function tests from normal values;
Nervous system: transient paresthesia;
Hematopoietic system: acute hemolysis;
Cardiovascular system: prolongation of the QT interval on the ECG;
Immune system: angioedema, anaphylactic shock, vasculitis, including Henoch-Schonlein purpura;
Skin and subcutaneous tissues: acute generalized exanthematous pustulosis.

Cases of overdose of spiramycin have not been officially registered. Nausea, vomiting, and diarrhea are likely to occur. In patients predisposed to prolongation of the QT interval, as well as in newborns receiving high doses of Rovamycin, there have been cases of prolongation of the QT interval, which disappears after discontinuation of the drug. In case of overdose, ECG monitoring with determination of the duration of the QT interval is recommended, especially in patients with risk factors such as congenital prolongation of the QT interval, hypokalemia, concomitant use of drugs that can prolong the duration of the QT interval and cause the development of ventricular tachycardia of the "pirouette" type . There is no specific antidote for spiramycin. Treatment is symptomatic.

special instructions

If the patient is diagnosed with hypokalemia, it should be eliminated before prescribing the drug.

If pustules and generalized erythema appear at the beginning of treatment, and the condition is accompanied by high body temperature, there is every reason to assume the presence of acute generalized exanthematous pustulosis. For this reason, the drug is canceled. In the future, spiramycin cannot be prescribed, either as a single drug or as part of combination therapy.

Intravenous infusion of the solution should be discontinued if any signs of an allergic reaction appear. Due to the fact that dextrose is used to dilute the lyophilisate, patients with diabetes need control and, if necessary, correction of blood sugar levels.

drug interaction

Spiramycin inhibits the absorption of carbidopa, resulting in a decrease in the concentration of levodopa in the blood plasma. Therefore, when prescribing such a combination, clinical monitoring and dose adjustment of levodopa is necessary.

It is important to be careful when using Rovamycin with preparations containing ergot alkaloids.

The risk of developing ventricular arrhythmias of the "pirouette" type increases with intravenous administration of spiramcin with drugs that cause bradycardia (calcium channel blockers, beta-blockers, cholinesterase inhibitors, digitalis alkaloids, clonidine, guanfacine), as well as with drugs that reduce the level of potassium in the blood (mineralocorticoids, glucocorticosteroids, stimulant laxatives, potassium-releasing diuretics, tetracosactide, amphotericin B intravenously).

Terms and conditions of storage

Store at temperatures up to 25 ° C in a dark place out of the reach of children.

Best before date:

Tablets 1.5 million IU - 3 years;
Tablets 3 million IU - 4 years;
Lyophilisate - 1.5 years;
Solution prepared from lyophilisate - 12 hours.