Rovamycin 3 million instructions for use. Rovamycin tablets - official* instructions for use. Instructions for use and dosage

Instructions for use

Rovamycin instructions for use

Dosage form

Biconvex, round, film-coated tablets, white with a creamy tint. On one side there is an engraving "ROVA 3".

Cross-sectional view: white with a cream tint.

Compound

1 tablet contains:

Active substance: spiramycin - 3 million ME;

Excipients: colloidal silicon dioxide - 2.40 mg, magnesium stearate - 8 mg, pregelatinized corn starch - 32.00 mg, hyprolose - 16.00 mg, croscarmellose sodium - 16.00 mg, microcrystalline cellulose up to 800 mg; shell: titanium dioxide (E 171) - 2.96 mg, macrogol-6000 - 2.96 mg, hypromellose - 8.88 mg.

Pharmacodynamics

Spiramycin belongs to the macrolide group of antibiotics. The mechanism of antibacterial action is due to inhibition of protein synthesis in the microbial cell due to binding to the 508 subunit of the ribosome.

Antibacterial spectrum of spiramycin

Sensitive microorganisms: minimum inhibitory concentration (MIC)< 1 мг/л.

Gram-positive aerobes

Bacillus cereus; Corynebacterium diphtheria; Enterococcus spp, Rhodococcus equi; Staphylococcus meti-S (methicillin-sensitive staphylococci); Staphylococcus meti-R (methicillin-resistant staphylococci); Streptococcus B; unclassified streptococcus; Streptococcus pneumoniae; Streptococcus pyogenes.

Gram-negative aerobes

Bordetella pertussis; Branhamella catarrhalis; Campylobacter spp; Legionella spp; Moraxella spp.

Anaerobes

Actinomyces spp; Bacteroides spp; Eubacterium sp; Mobiluncus spp; Peptostreptococcus spp; Porphyromonas spp; Prevotella spp; Propionibacterium acnes.

Borrelia burgdorferi; Chlamydia spp; Coxiella spp; Leptospires spp; Mycoplasma pneumoniae; Treponema pallidum; Toxoplasma gondii.

Moderately sensitive microorganisms: the antibiotic is moderately active in vitro at antibiotic concentrations at the site of inflammation > 1 mg/l, but< 4 мг/л.

Gram-negative aerobes Neisseria gonorrhoeae.

Anaerobes Clostridium perfringens.

Ureaplasma urealyticum.

Resistant microorganisms (MIC > 4 mg/l): at least 50% of strains are resistant.

Gram-positive aerobes Corynebacterium jeikeium; Nocardia asteroides.

Gram-negative aerobes

Acinetobacter spp; Enterobacteria spp; Haemophilus spp; Pseudomonas spp.

Anaerobes Fusobacterium spp.

Mycoplasma hominis.

Spiramycin has not been found to have a teratogenic effect, so pregnant women can take it without fear. There is a decrease in the risk of transmission of toxoplasmosis to the fetus during pregnancy from 25% to 8% when used in the first trimester, from 54% to 19% when used in the second trimester, and from 65% to 44% when used in the third trimester.

Pharmacokinetics

Suction

Absorption of spiramycin occurs quickly, but not completely, with great variability (from 10 to 60%). Eating does not affect absorption.

After oral administration of 6 million IU of spiramycin, the maximum plasma concentration is about 3.3 μg/ml.

Distribution

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

Plasma protein binding is low (approximately 10%).

Penetrates the placental barrier (the concentration in the fetal blood is approximately 50% of the concentration in the maternal blood serum). Concentrations in placental tissue are 5 times higher than corresponding concentrations in serum. Distribution volume - approximately 383 l.

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

Spiramycin penetrates and accumulates in phagocytes (neutrophils, monocytes and peritoneal and alveolar macrophages). In humans, drug concentrations inside phagocytes are quite high. These properties explain the effect of spiramycin on intracellular bacteria.

Metabolism

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

Removal

The half-life from plasma is approximately 8 hours. It is excreted from the body mainly with bile (concentrations in bile are 15-40 times higher than in serum). Renal excretion is approximately 10% of the administered dose. The amount of the drug excreted through the intestines (with feces) is very small.

Side effects

Gastrointestinal disorders

Nausea, vomiting, diarrhea and very rare cases of pseudomembranous colitis (less than 0.01%). Isolated cases of ulcerative esophagitis and acute colitis have been described. The possibility of developing acute damage to the intestinal mucosa in patients with AIDS when using high doses of spiramycin for cryptosporidiosis was also noted (2 cases in total).

Nervous system disorders

Very rarely (isolated cases) transient paresthesia.

Disorders of the liver and biliary tract

In very rare cases (less than 0.01%) - deviation of liver function tests from normal values; cholestatic hepatitis.

From the blood and lymphatic system

Very rare cases (less than 0.01%) of the development of acute hemolysis (see "Contraindications"); thrombocytopenia.

Heart disorders

Prolongation of the QT interval on the electrocardiogram (ECG) (several cases have been described only after intravenous administration of the drug to newborns) (see section "Overdose"),

Immune system disorders

Skin rash, urticaria, itching. Very rarely (less than 0.01%) - angioedema, anaphylactic shock. Isolated cases of vasculitis, including Henoch-Schönlein purpura.

Skin and subcutaneous tissue disorders

Very rarely, acute generalized exanthematous pustulosis (see "Special Instructions").

Selling Features

prescription

Special conditions

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

Tablets of 3 million ME are not used in children due to the difficulty of swallowing them due to the large diameter of the tablets and the risk of airway obstruction. If at the beginning of treatment the patient develops generalized erythema and pustules, accompanied by high body temperature, acute generalized exanthematous pustulosis should be assumed (see section "Side effects"); if such a reaction occurs, treatment should be stopped, and further use of spiramycin, both in monotherapy and in combination, is contraindicated.

Impact on the ability to drive vehicles and machinery:

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, which may affect attention and speed of psychomotor reactions, should be taken into account. Therefore, the decision about the possibility of driving a car or engaging in other potentially hazardous activities for a particular patient should be made by the attending physician.

Indications

Infectious diseases caused by microorganisms sensitive to this 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 develops after acute viral bronchitis;

Exacerbation of chronic bronchitis;

Community-acquired pneumonia in patients without risk factors for unfavorable outcome, severe clinical symptoms and clinical signs of pneumococcal etiology of pneumonia;

Pneumonia caused by atypical pathogens (such as Chlamydia pneumoniae and trachomatis, Mycoplasma pneumoniae, Legionella spp) or suspicion of it (regardless of severity and the presence or absence of risk factors for an unfavorable outcome);

Infections of the skin and subcutaneous tissue, including impetigo, impetiginization, ecthyma, infectious dermohypodermatitis (especially erysipelas), secondary infected dermatoses, erythrasma;

Oral infections (stomatitis, glossitis, etc.);

Non-gonococcal infections of the genital organs;

Toxoplasmosis, including in pregnant women;

Infections of the musculoskeletal system and connective tissue, including periodontium.

Prevention of relapses of rheumatism in patients with allergies 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 or in patients who were in contact with persons who shed Neisseria meningitidis within 10 days before hospitalization with saliva into the environment.

Contraindications

Hypersensitivity to spiramycin and other components of the drug.

Lactation period.

Deficiency of the enzyme glucose-6-phosphate dehydrogenase (risk of acute hemolysis).

Children's age (up to 6 years - for tablets 1.5 million ME, up to 18 years - for tablets 3 million ME).

Carefully:

Obstruction of the bile ducts.

Liver failure.

Pregnancy and lactation:

Pregnancy

Rovamycin® can be prescribed, if necessary, during pregnancy. Extensive experience with the use of spiramycin during pregnancy has not revealed any teratogenic or fetotoxic properties.

Lactation period

When prescribed during lactation, it is necessary to stop breastfeeding, since spiramycin may pass into breast milk.

Drug interactions

With levodopa

Inhibition of carbidopa absorption by spiramycin with a decrease in plasma levodopa concentrations. When prescribing spiramycin simultaneously, clinical monitoring and dose adjustment of levodopa is necessary.

With indirect anticoagulants

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

Prices for Rovamycin in other cities

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 transmitting 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.

Side effect

The following classification was used to indicate the frequency of occurrence of adverse reactions: very often (≥10%), often (≥1%,
From the digestive system: nausea, vomiting, diarrhea; very rarely - pseudomembranous colitis (
From the liver and biliary tract: very rarely (
From the nervous system: very rarely (isolated cases) - transient paresthesia.

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

From the immune system: skin rash, urticaria, itching; very rarely (
From the skin and subcutaneous tissues: very rarely - acute generalized exanthematous pustulosis.

Release form

White or off-white film-coated tablets, round, biconvex, engraved "RPR 107" on one side; cross-sectional appearance: white or white with a cream tint.
1 tab.
spiramycin 1.5 ml

Interaction with other drugs

Inhibition of carbidopa absorption by spiramycin with a decrease in plasma levodopa concentrations. When prescribing spiramycin simultaneously, clinical monitoring and dose adjustment of levodopa is necessary.

Numerous cases of increased activity of indirect anticoagulants in patients taking antibiotics have been recorded. The type of infection or severity of the inflammatory reaction, age and general condition of the patient are predisposing risk factors. Under these circumstances, it is difficult to determine the extent to which the infection itself or its treatment plays a role in altering MHO. However, when using some groups of antibiotics, this effect is observed more often, in particular when using fluoroquinolones, macrolides, cyclines, the combination of sulfamethoxazole + trimethoprim, and some cephalosporins.

Compound

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) - cardboard packs.

Storage conditions

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

Overdose

There are no known cases of spiramycin overdose.

Symptoms: possible - nausea, vomiting, diarrhea. Cases of prolongation of the QT interval that resolves when the drug is discontinued have been observed in neonates receiving high doses of spiramycin or after intravenous administration of spiramycin in patients predisposed to prolongation of the QT interval.

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 of the "pirouette" type). There is no specific antidote. If an overdose of spiramycin is suspected, symptomatic therapy is recommended.

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, generalized erythema and pustules occur, 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.

Use in pediatrics

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

Impact on the ability to drive vehicles and operate machinery

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

Contraindications

Lactation period;

Glucose-6-phosphate dehydrogenase deficiency (risk of developing 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 in case of bile duct obstruction or liver failure.

With caution (Precautions)

Rovamycin® is prescribed with caution in case of bile duct obstruction or liver failure.

Patients with impaired renal function due to low renal excretion of spiramycin do not require dose changes.

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

Best before date

Product description

White, cream-colored, film-coated tablets, round, biconvex, engraved “ROVA 3” on one side; Cross-sectional view: white with a creamy tint.

pharmachologic effect

Antibiotic from the macrolide group. The mechanism of antibacterial action is due to inhibition of protein synthesis in the microbial cell due to binding to the 50S ribosomal subunit.

Sensitive microorganisms (MIC
Moderately sensitive microorganisms (the 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.; different - Mycoplasma hominis.

Pharmacokinetics

Suction

Absorption of spiramycin occurs quickly, but incompletely, with great variability (from 10% to 60%). After taking Rovamycin orally at a dose of 6 million IU, the 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 l. 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, and kidneys is 5-7 mcg/g.

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

Penetrates the placental barrier (the concentration in the fetal blood is approximately 50% of the concentration in the maternal blood serum). Concentrations in placental tissue are 5 times higher than corresponding concentrations in serum. Excreted in 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 unknown chemical structure.

T1/2 from plasma is approximately 8 hours. It is excreted mainly in bile (concentration 15-40 times higher than in serum). Renal excretion is approximately 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 (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 develops after acute viral bronchitis;

Exacerbation of chronic bronchitis;

Community-acquired pneumonia in patients without risk factors for unfavorable outcome, severe clinical symptoms and clinical signs of pneumococcal etiology of pneumonia;

Pneumonia caused by atypical pathogens (such as Chlamydia pneumoniae, Chlamydia trachomatis, Mycoplasma pneumoniae, Legionella spp.) or suspicion of it (regardless of the severity and the presence or absence of risk factors for an unfavorable 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 relapses of rheumatism in patients with allergies to beta-lactam antibiotics.

Eradication of Neisseria meningitidis from the nasopharynx (if rifampicin is contraindicated) for the prevention (but not treatment) of meningococcal meningitis:

In patients after treatment and before leaving quarantine;

In patients who, within 10 days before hospitalization, were in contact with persons who excreted Neisseria meningitidis with saliva into the environment.

Directions for use and doses

The drug is taken orally.

Adults are prescribed 2-3 tablets. 3 million IU or 4-6 tablets. 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 over 6 years of age, the daily dose ranges from 150-300 thousand IU per kg of body weight, which is divided into 2 or 3 doses up to 6-9 million IU. The maximum daily dose in children is 300 thousand IU per kg of body weight, but if the child’s body weight is more than 30 kg, it should not exceed 9 million IU

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

In patients with impaired renal function due to insignificant renal excretion of spiramycin, no dose adjustment is required.

The tablets are taken orally with a sufficient amount of water.

Streptococci, staphylococci (including Staphylococcus aureus), meningococcus, whooping cough bacillus, diphtheria bacillus, mycoplasma, chlamydia, toxoplasma, hemophilus influenzae, legionella, clostridia, leptospira and other microorganisms are sensitive to Rovamycin. Some types of streptococci, staphylococci, Enterobacter, Acinetobacter, etc. are insensitive to Spiramycin. There is cross-resistance of microorganisms between Erythromycin and Rovamycin (Spiramycin).

After internal administration, Rovamycin is absorbed quickly, but incompletely (only 10-60%). Does not penetrate into the cerebrospinal fluid. It overcomes the placental barrier and creates a concentration in the placental tissue that is 5 times higher than the content of the drug in the blood.

Rovamycin also penetrates well into other tissues: lungs, bone tissue, tonsils, paranasal sinuses, saliva. A high concentration of the drug remains in tissues 10 days after antibiotic use.

It is excreted from the body mainly with bile, and only about 10% with urine. Therefore, dose adjustment is not required in patients with renal pathology. The antibiotic also passes into breast milk.

Release forms

• Tablets of 1.5 million IU - 2 blisters of 8 tablets per package.
• Tablets of 3 million IU - 2 blisters of 5 tablets per package.
• Lyophilisate in bottles of 1.5 million IU (dissolves for intravenous administration); An ampoule with a 4 ml solvent is included.
• Packages of granules for internal use, 0.375 each; 0.75; 1.5 million IU; 10 sachets per package.

Instructions for use of Rovamycin

Indications for use

Rovamycin orally used for the following pathologies:

• diseases of the ENT organs: tonsillitis, pharyngitis, inflammation of the paranasal sinuses; Rovamycin is prescribed as an alternative drug or in cases of insensitivity to beta-lactam antibiotics and the presence of contraindications to them.
• Respiratory infections: community-acquired acute pneumonia of non-pneumococcal etiology (including atypical pneumonia caused by chlamydia, mycoplasma, legionella or if atypical pneumonia is suspected, regardless of the severity of the process), acute and chronic bronchitis.
• Skin infections: erysipelas, ecthyma (staphylococcal infection of all layers of the skin), impetigo (superficial infection of the skin), erythrasma (infection of the stratum corneum of the skin in natural folds by corynebacteria), secondary infected dermatoses.
• Infections of joints and bones.
• Periodontitis (complication of caries, inflammation of tissue near the roots of the tooth).
• Infectious and inflammatory process in the genitourinary organs: urethritis, prostatitis.
• Sexually transmitted diseases (including extragenital and genital chlamydia) with the exception of gonorrhea.
• Toxoplasmosis (including pregnant women).
• Patients with intolerance to beta-lactam antibiotics.

Rovamycin is not used to treat meningococcal meningitis because it does not cross the blood-brain barrier and does not enter the cerebrospinal fluid.

Intravenous administration Rovamycin is used to treat adult diseases of the respiratory tract (upper and lower sections): acute pneumonia, chronic bronchitis and pneumonia, bronchial asthma (infection-dependent).

Contraindications

• Individual intolerance to spiramycin or other components of the drug;
• breast-feeding;
• deficiency of the enzyme glucose-6-phosphate dehydrogenase;
• age up to 3 years – tablets with 1.5 million IU are contraindicated and up to 18 years – tablets with 3 million IU are contraindicated;
• In patients with prolongation of the QT interval on the electrocardiogram, intravenous administration of the drug is contraindicated.

Side effects

• From the digestive organs: diarrhea, nausea, vomiting, acute colitis, pseudomembranous colitis (in very rare cases), ulceration of the esophageal mucosa (in isolated cases), increased liver function tests and the occurrence of cholestatic hepatitis (inflammation of the liver due to impaired outflow of bile) - very rare. Acute damage to the intestinal mucosa can also develop in patients with AIDS when they are prescribed Rovamycin in large doses (for cryptosporidiosis).
• From the nervous system: intermittent paresthesia (numbness of the limbs, crawling sensation).
• From the cardiovascular system: Prolongation of the QT interval may appear on the electrocardiogram.
• From the blood side: in very rare cases, a decrease in the number of platelets in the bloodstream and hemolysis (destruction of red blood cells) is possible.
• Allergic manifestations: rash like urticaria, itching of the skin, in very rare cases - swelling of the skin and subcutaneous tissue and anaphylactic shock. Generalized erythema (redness of the skin) with a pustular rash and an increase in temperature - generalized exanthematous pustulosis - may also develop. In this case, Rovamycin should be discontinued and never used in the future.
• Other reactions: inflammation of blood vessels (in some cases), including Henoch-Schönlein purpura (inflammation of blood vessels with small hemorrhages on the skin). Moderate irritation may also occur (with intravenous administration of the drug) along the vein.

Treatment with Rovamycin

For parenteral administration of the drug, 4 ml of solvent (supplied in an ampoule) is injected into the bottle with the drug; Can also be dissolved with water for injection. The prepared solution of Rovamycin is added to 100 ml (or more) of a 5% glucose solution and slowly injected dripwise into a vein over an hour.

Rovamycin does not have a negative effect on concentration and speed of psychomotor reaction. Therefore, there are no professional restrictions during the course of treatment.

Dosage
The dose of the drug is selected by the doctor individually depending on the clinical form of the disease, the severity of the process, the patient’s age and other characteristics.

For adults, the daily dose of Rovamycin orally is 2-3 tablets of 3 million IU (or 4-6 tablets of 1.5 million IU) in 2-3 doses (total 6-9 million IU per day). The maximum dose per day is 9 million IU.

The dose of Rovamycin for intravenous infusion in adult patients is 4.5 million IU per day, divided into 3 injections at equal intervals. In particularly severe cases, the doctor may double the daily dose of the drug. If the dynamics are positive and the patient’s condition improves, the patient is transferred to internal antibiotic use.

The duration of the course of treatment is also prescribed individually depending on the course of the disease, the sensitivity of the secreted flora and other indicators.

When preventing meningococcal infection, adults are prescribed a 5-day course of Rovamycin, 3 million IU 2 times. in a day.

Rovamycin for children

Daily doses of Rovamycin for children depend on the child’s body weight:

• Children weighing up to 10 kg are prescribed 2-4 sachets of 0.375 million IU per day.
• With a body weight of 10-20 kg - 2-4 sachets of 0.75 million IU/day.
• With a weight of more than 20 kg - 2-4 sachets or 2-4 tablets of 1.5 million IU/day. A more accurate dose calculation would be 1.5 million IU/10 kg of weight.
• For children over 6 years of age, the daily dose is calculated at 150-300 thousand IU/kg of weight (no more than 6-9 million IU).

When preventing meningococcal infection, children are prescribed 75 thousand IU/kg body weight in 2 doses per day (5-day course).

When carrying a child, it is necessary to weigh the benefits of using an antibiotic against the risk to the fetus. And since ureaplasmosis is more dangerous for the fetus than treatment, this is the main argument for prescribing Rovamycin to a pregnant woman if the disease is confirmed by various examination methods.

In many European countries, this antibiotic is used in the treatment of toxoplasmosis, which is especially dangerous during pregnancy, since intrauterine infection of the fetus is possible. The risk for pregnant women from toxoplasmosis is very high: only 20-40% of pregnant women do not have antibodies to toxoplasma in their blood, and 1% become infected during pregnancy. Moreover, the clinical signs of the disease are erased, the disease has a latent course.

It is very important and necessary to determine the time of infection of a pregnant woman. If the infection occurs during the first 3 months of pregnancy, then there is a serious risk of infection of the fetus and the issue of terminating the current pregnancy may be considered.

When infected in the second and third trimesters, the risk of congenital toxoplasmosis is also quite high. The consequences of such infection can be blindness, epilepsy and mental retardation in the unborn child. In these cases, pregnant women are prescribed treatment.

With the use of Rovamycin, the risk of intrauterine infection of the fetus is significantly reduced: in the first trimester from 25% to 8%, in the second – from 54% to 19%, in the third – from 65% to 44%. Indications for the use of therapy are the presence of acute, subacute and asymptomatic forms of the disease. The chronic form of toxoplasmosis is treated depending on clinical indications before or after pregnancy.

During pregnancy up to 15 weeks, Rovamycin is prescribed at a daily dosage of 9 million IU. From 16 to 36 weeks of pregnancy, regardless of previous treatment with Rovamycin, combined treatment with sulfonamide drugs and Pyramethine is carried out for 4 weeks. From 36 weeks of pregnancy until the moment of delivery, Sulfadiazine is replaced with Rovamycin (due to the risk of developing hemolytic jaundice in the newborn).

Treatment of toxoplasmosis in pregnant women when they become infected during pregnancy is relevant. For more information about the treatment of pregnant women, see the section "Rovamycin during pregnancy."

In addition to pregnant women, children with congenital toxoplasmosis and weakened individuals with reduced immunity and clinical manifestations of the disease in the heart, nervous system and lungs are subject to treatment for toxoplasmosis.

Rovamycin for toxoplasmosis is a competitive and highly effective antibiotic. It is more effective than some other drugs (for example, Tindurine). Good tolerability of the drug in the absence of interactions with drugs and high activity, the absence of serious adverse reactions allow the use of Rovamycin for the treatment of toxoplasmosis in any age group of patients (including pregnant women and children with congenital toxoplasmosis).

All of the above requirements are met by Rovamycin, which accumulates at the site of inflammation and acts on intracellular and extracellular pathogens. And although its inhibitory activity against microorganisms is inferior, for example, to Erythromycin, the low toxicity of Rovamycin and its good tolerance by patients make it the drug of choice in the treatment of chlamydia.

For uncomplicated chlamydia (including in pregnant women), Rovamycin is prescribed at a dose of 3 million IU 3 times. per day, the course of treatment lasts 7-10 days.

Drug interactions

• It is not recommended to combine Rovamycin with drugs that can cause cardiac arrhythmia (ventricular flutter or ventricular fibrillation), such as: Quinidine, Disopyramide, Amiodarone, Nibentan, Sotalol, Bretilium tosylate, Vincamine, Sultopride, Cisapride, Erythromycin, Clonidine, beta-blockers , antipsychotics (Sulpiride, Chlorpromazine, Haloperidol, etc.). If their combined use is necessary, careful monitoring of the electrocardiogram is necessary.
• With the simultaneous administration of Rovamycin and Levodopa, Carbidopa, a decrease in the concentration of Levodopa in the blood is observed, which may require dose adjustment of Levodopa, Carbidopa.
• Macrolides, which include Rovamycin, can increase the activity of indirect anticoagulants. When used in combination, it is necessary to control the blood coagulation system and possibly change the dose of the anticoagulant.

Release form

film-coated tablets

Owner/Registrar

SANOFI-AVENTIS France

International Classification of Diseases (ICD-10)

Pharmacological group

Macrolide antibiotic

pharmachologic effect

Antibiotic from the macrolide group. The mechanism of antibacterial action is due to inhibition of protein synthesis in the microbial cell due to binding to the 50S ribosomal subunit.

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., Leptospirа spp., Mycoplasma pneumoniae, Treponema pallidum, Toxoplasma gondii.

Moderately sensitive microorganisms(the antibiotic is moderately active in vitro at antibiotic concentrations at the site of inflammation ≥ 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 occurs quickly, but incompletely, with great variability (from 10% to 60%). After taking Rovamycin orally at a dose of 6 million IU, the Cmax of spiramycin in plasma is about 3.3 μg/ml. Eating does not affect absorption.

Distribution

Plasma protein binding is low (approximately 10%). V d approximately 383 l. 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, and kidneys is 5-7 mcg/g.

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

Penetrates the placental barrier (the concentration in the fetal blood is approximately 50% of the concentration in the maternal blood serum). Concentrations in placental tissue are 5 times higher than corresponding concentrations in serum. Excreted in 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 unknown chemical structure.

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

Indications

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 develops after acute viral bronchitis;

Exacerbation of chronic bronchitis;

Community-acquired pneumonia in patients without risk factors for unfavorable outcome, severe clinical symptoms and clinical signs of pneumococcal etiology of pneumonia;

Pneumonia caused by atypical pathogens (such as Chlamydia pneumoniae, Chlamydia trachomatis, Mycoplasma pneumoniae, Legionella spp.) or suspicion of it (regardless of the severity and the presence or absence of risk factors for an unfavorable 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 relapses of rheumatism in patients with allergies to beta-lactam antibiotics.

Eradication of Neisseria meningitidis from the nasopharynx (if rifampicin is contraindicated) for the prevention (but not treatment) of meningococcal meningitis:

In patients after treatment and before leaving quarantine;

In patients who, within 10 days before hospitalization, were in contact with persons who excreted Neisseria meningitidis with saliva into the environment.

Contraindications

Lactation period;

Glucose-6-phosphate dehydrogenase deficiency (risk of developing 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.

WITH caution Rovamycin ® is prescribed for bile duct obstruction and liver failure.

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 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 (isolated cases) - transient paresthesia.

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

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

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

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

Overdose

There are no known cases of spiramycin overdose.

Symptoms: possible - nausea, vomiting, diarrhea. Cases of prolongation of the QT interval that resolves when the drug is discontinued have been observed in neonates receiving high doses of spiramycin or after intravenous administration of spiramycin in patients predisposed to prolongation of the QT interval.

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 of the "pirouette" type). There is no specific antidote. If an overdose of spiramycin is suspected, symptomatic therapy is recommended.

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, generalized erythema and pustules occur, 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.

Use in pediatrics

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

Impact on the ability to drive vehicles and operate machinery

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

For renal failure

Patients with impaired renal function due to low renal excretion of spiramycin do not require dose changes.

Drug interactions

Inhibition of carbidopa absorption by spiramycin with a decrease in plasma levodopa concentrations. When prescribing spiramycin simultaneously, clinical monitoring and dose adjustment of levodopa is necessary.

Numerous cases of increased activity of indirect anticoagulants in patients taking antibiotics have been recorded. The type of infection or severity of the inflammatory reaction, age and general condition of the patient are predisposing risk factors. Under these circumstances, it is difficult to determine the extent to which the infection itself or its treatment plays a role in altering MHO. However, when using some groups of antibiotics, this effect is observed more often, in particular when using fluoroquinolones, macrolides, cyclines, the combination of sulfamethoxazole + trimethoprim, and some cephalosporins.

Mode of application

The drug is taken orally.

For adults prescribe 2-3 tablets. 3 million IU or 4-6 tablets. 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.

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

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

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

Patients with impaired renal function Due to the insignificant renal excretion of spiramycin, no dose adjustment is required.

The tablets are taken orally with a sufficient amount of water.

Storage conditions and shelf life

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

Rovamycin ® is an antibacterial drug produced by the French pharmaceutical company Sanofi-Aventis ® . The main active ingredient of Rovamycin ® is spiramycin, an antibiotic from the class of natural sixteen-membered macrolides.

The drug has a wide spectrum of antimicrobial activity and a bacteriostatic mechanism of action due to the ability of spiramycin to bind ribosomal 50S subunits and inhibit protein synthesis, preventing the growth and reproduction of bacteria. When prescribed in high dosages, Rovamycin ® has a bactericidal effect. Unlike fourteen-membered macrolides, spiramycin binds not to 1, but to 3 subunits, which ensures its long-term antibacterial effect.

Rovamycin ® instructions for use for adults and children

Unlike the first natural macrolide, erythromycin, spiramycin is able to exhibit activity against toxoplasma and cryptosporidium, some pneumococci and beta-hemolytic streptococci of group A, resistant to other macrolides.

Also spiramycin:

• better tolerated than 14- and 15-membered macrolides;
• does not have a stimulating effect on gastrointestinal motility, which reduces the risk of side effects associated with nausea, pain, bloating, etc.;
• has no clinically significant drug interactions;
• included in the list of antibiotics allowed during pregnancy.

Rovamycin ® has bioavailability independent of food intake and rapid absorption from the gastrointestinal tract. However, it must be taken into account that the absorption of spiramycin is incomplete and quite variable. After oral administration, ten to sixty percent of the drug is absorbed.

Just like azithromycin, spiramycin is able to concentrate in phagocytes. In this regard, Rovamycin ® is highly effective in eradicating intracellular pathogens.

Spiramycin has low binding to plasma elements of the blood and a high degree of concentration in organs and tissues. Spiramycin is most effectively accumulated by the lungs, saliva, tonsils and infected sinuses (paranasal sinuses). Spiramycin is not detected in brain fluid.

Due to the prolonged action, residual concentrations of spiramycin are detected in the tissues of the spleen, liver and kidneys 10 days after completion of therapy. The metabolism of spiramycin occurs in the liver, and the drug is excreted from the body in bile. Therefore, dosage adjustments are not made in individuals with renal dysfunction.

Rovamycin ® is excreted in breast milk. Also, the antibiotic penetrates the placental barrier well and accumulates in the placental tissue. Antibiotic levels in the fetal blood are half as high as in the mother's blood. However, spiramycin does not have a negative effect on the fetus, so Rovamycin ® can be used during pregnancy at any stage. Most often, it is effectively used to treat toxoplasma infection in pregnant women and to reduce the risk of infection of the fetus (congenital toxoplasmosis).

Pharmacological group

Antibiotics - macrolides.

Spectrum of action of spiramycin

The antibiotic is effective against staphylo- and streptococci, meningo- and gonococci, Bordetella, diphtheria corynebacteria, intracellular pathogens, Treponema, Toxoplasma, propionobacteria acne, Moraxella, Campylobacter.

Hemolytic bacillus and ureaplasma are moderately sensitive to the drug.

Pneumococcus, pseudomonas, fusobacteria, methicillin-resistant staphylococci and enterobacter are resistant to the drug.

Composition of Rovamycin ®

Rovamycin ® tablets contain the main active ingredient – ​​spiramycin, in the dosage:

• table 1.5 million IU each;
• table three million IU each.

The content of colloidal Si dioxide, Mg stearate, pregelatinized corn starch, hyprolose, croscarmellose Na, microcrystalline cellulose is indicated as additional auxiliary components.

The tablet shell contains E171, hypromellose and macrogol 6000.

Each bottle of lyophilisate for the preparation of an injection solution contains 1.5 million IU of spiramycin and adiponic acid as an auxiliary component.

Release forms and prices

The original drug Rovamycin ® is produced by the French pharmaceutical company Sanofi-Aventis ® . The price for a package of tablets (16 pieces) of 1.5 million IU of spiramycin is 1060 rubles. The cost of tablets of 3 million IU (10 pieces) is 1600 rubles.

Photo of the packaging of Rovamycin ® in tablets of 3 million IU of spiramycin

There is also an injection form of release - bottles with lyophilisate for the preparation of an injection solution containing 1.5 million IU of spiramycin.

Indications for Rovamycin ®

The drug is often used in the treatment of toxoplasmosis during pregnancy and for the prevention of congenital toxoplasmosis.

Also, Rovamycin ® can be used:

• as a second-line drug in the treatment of community-acquired, atypical pneumonia caused by intracellular pathogens;
• as an alternative in case of allergy to beta-lactam drugs (or other contraindications to their use) for the treatment of pharyngitis and tonsillitis caused by group A B-hemolytic streptococci, as well as acute and chronic sinusitis caused by flora sensitive to spiramycin;
• in the treatment of bacterial bronchitis of varying severity;
• as a prevention of rheumatic complications in persons intolerant to penicillins;
• in the treatment of diseases of a bacterial nature localized in the oral cavity (stomatitis, glossitis), skin and gastrointestinal tract, connective tissue (including periodontal tissue), the musculoskeletal system (arthritis, osteomyelitis), genitals (diseases of non-gonococcal nature), STIs (syphilis, gonorrhea, genital chlamydia);
• as an alternative drug in the treatment of prostatitis;
• as a prophylaxis (post-exposure) whooping cough;
• in the treatment of bacteria carriers of whooping cough and diphtheria.

If the patient has contraindications to rifampicin ®, Rovamycin ® can be used to eradicate Neisseria meningitidis from the nasopharynx. However, it must be remembered that this drug is used only for the prevention, but not for the treatment of meningitis of meningococcal nature. Spiramycin is also effective for post-exposure prophylaxis in persons who have been in contact with a patient with meningitis within 10 days before he was hospitalized. Rovamycin ® can be prescribed before lifting quarantine and after treatment.

Contraindications to the use of Rovamycin ® are:

General contraindications for all dosage forms are:

• breast-feeding;
• non-spherocytic hemolytic anemia (caused by deficiency of glucose-six-phosphate dehydrogenase), since there is a high risk of acute hemolysis while taking spiramycin;
• individual intolerance to the antibiotic or auxiliary components of the product.

There are also age restrictions. Rovamycin ® is contraindicated for children under six years of age in the form of tablets of 1.5 million IU (this is associated with the risk of asphyxia). Instructions for use of Rovamycin ® tablets of 3 million IU and injection form contain information that these forms of release are not used until the age of 18.

If necessary, with caution, the medicine can be prescribed to patients with liver failure and bile duct obstruction. Considering that the metabolism of Rovamycin ® occurs in the liver, and then it is excreted in the bile, in this category of patients the drug should be used strictly according to indications, under the supervision of a physician, in the absence of the possibility of prescribing other drugs.

Also, taking into account the route of elimination of the drug, it is necessary to remember that Rovamycin ® and alcohol are not compatible. Combining medication with alcohol reduces the effectiveness of treatment and increases the risk of liver toxicity.

Certain contraindications to the administration of lyophilisate (injection form of release) are:

• rhythm disturbances accompanied by prolongation of the QT interval;
• taking class 1A antiarrhythmic drugs (quinidine, hydroquinidine, disopyramide), class 3 (amiodarone, sotalol, dofetilide, ibutilide), benzamide class neuroleptics (sultopride), phenothiazine neuroleptics (levomepromazine, cyamemazine, amisulpride, tiapride, haloperidol, droperidol, pimozide and others ); halofantrine, pentamidine, bepridil, cisapride, difemanil, mizolastine;
• intravenous administration of erythromycin, vincamine.

Dosages of Rovamycin ® for adults and children

The drug can be used orally (tablets) or intravenously.

For adults, Rovamycin ® is prescribed in a daily dose of 6 to 9 million, divided into 2-3 doses. That is, 3,000,000 IU every twelve or eight hours. In case of severe disease, the daily dosage can be increased (6 or 7.5 million IU every 12 hours).

In order to prevent meningococcal meningitis, the instructions for Rovamycin ® tablets of 3,000,000 IU recommend taking 1 tablet. (3 million IU) every 12 hours for five days.

Infusion of the drug is prescribed for severe cases of the disease in patients over eighteen years of age. Infusion (drip over an hour) administration every eight hours is recommended. The starting dose is 1.5 million IU per injection; if necessary, it can be increased to 3 million IU. To prepare the solution, the lyophilisate is diluted with four milliliters of water for injection and 100 milliliters of five percent glucose is added.

The duration of the course is from seven to 10 days.

Rovamycin ® for children is prescribed based on the dose based on body weight. It is important to remember that for children under 18 years of age, exceeding the daily dose of 9,000,000 IU is not allowed.

Babies weighing more than twenty kilograms are prescribed 150 thousand IU per kilogram per day, dividing the daily dose into three doses. In severe cases of the disease, 300 thousand per kilogram per day may be prescribed.

If the patient's body weight is less than 20 kilograms, but more than 10 kg, prescribe from 750 thousand to 1.5 million IU twice a day. If the weight is less than 10 GK, 375 to 750 thousand IU are prescribed every two times a day.

When carrying out the prevention of meningococcal meningitis, 75 thousand IU per kilogram of body weight is prescribed twice a day for five days.

Side effect of the drug

Rovamycin ® is low toxic and, as a rule, is well tolerated. Undesirable effects from treatment can be manifested by dyspeptic disorders (nausea, vomiting), and allergic reactions. In isolated cases, phlebitis may occur at the injection site (with intravenous use), increased liver transaminases, decreased platelet counts, cardiac arrhythmias associated with prolongation of the QT interval, and bile stagnation. Colitis and ulcerative esophagitis can occur extremely rarely.

Rovamycin ® during pregnancy

Macolides are on the list of antibiotics approved for use during pregnancy. This is due to their low toxicity, good tolerability, low risk of unwanted effects and lack of terratogenic effects.

Given the ability of spiramycin to cross the placental barrier, Rovamycin ® is effectively used during pregnancy to treat toxoplasma infection, as well as to prevent congenital toxoplasmosis.

Spiramycin can reduce the risk of infection of the fetus, but it does not affect the severity of the disease if the fetus has already been infected (before treatment with Rovamycin ®).

Rovamycin ® analogues

List of cheap analogues of Rovamycin ®:

• Spiramycin ® ;
• Doramycin ® .

In Russian pharmacies, Spiromycin-Vero ®, produced by the Russian pharmaceutical company Veropharm ®, is more common. The cost of a package of tablets of 3,000,000 IU (10 pcs.) is 240 rubles.

Rovamycin ® reviews

Spiramycin is an effective and low-toxic drug. It is well tolerated by patients and rarely causes side effects. Reviews of Rovamycin ® when prescribed to children are mostly positive. Parents and pediatricians note rapid positive dynamics and the absence of microflora disturbances after treatment.

Negative reviews are associated with the high cost of the drug, which makes it inaccessible to many. Also, when prescribing a medicine, it is necessary to take into account the nature of the pathogen and its sensitivity to the drug. Due to the fact that some bacteria are resistant to spiramycin, it is forbidden to use the drug on the recommendation of friends and acquaintances who have been helped by this medicine. Only the attending physician should prescribe antibiotics. Self-medication can lead to serious complications and health consequences.

Also, when prescribing to children, it is important to consider age restrictions.