Rovamycin - instructions for the use of antibiotics, reviews, analogs and forms of release (tablets 1.5 million IU and 3 million IU, injections in ampoules) for the treatment of toxoplasmosis, ureaplasmosis, sinusitis in adults, children and pregnancy

In this article, you can read the instructions for using the drug Rovamycin. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of Rovamycin in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Rovamycin in the presence of existing structural analogues.Use for the treatment of toxoplasmosis, ureaplasmosis, sinusitis in adults, children, as well as during pregnancy and lactation.

Rovamycin - antibiotic from the group of macrolides. 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: gram-positive aerobes - Bacillus cereus, Corynebacterium diphtheriae, Enterococcus spp., Rhodococcus equi, Staphylococcus spp. (methicillin-sensitive and methicillin-resistant strains), 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 spp., Mobiluncus spp., Peptostreptococcus spp., Porphyromonas spp., Prevotella spp., Propionibacterium acnes; different - Borrelia burgdorferi, Chlamydia spp., Coxiella spp., Leptospiria spp., Mycoplasma pneumoniae (mycoplasma), Treponema pallidum, Toxoplasma gondii.

Moderately sensitive microorganisms: Gram-negative aerobes - Neisseria gonorrhoeae; aerobes - Clostridium perfringens; different - Ureaplasma urealyticum (ureaplasma).

Stable microorganisms: gram-positive aerobes - Corynebacterium jekeium, Nocardia asteroides; gram-negative aerobes - Acinetobacter spp., Enterobacter spp., Haemophilus spp., Pseudomonas spp .; anaerobes - Fusobacterium spp .; different - Mycoplasma hominis.

Composition

Spiramycin + excipients.

Pharmacokinetics

Absorption of Rovamycin occurs rapidly, but incompletely, with great variability (from 10% to 60%). Eating does not affect absorption. Binding to plasma proteins is low (about 10%).The drug penetrates well into the saliva and tissues (the concentration in the lungs is 20-60 μg / g, in the tonsils - 20-80 μg / g, in the infected sinuses - 75-110 μg / g, in the bones - 5-100 μg / g) . 10 days after the end of treatment, the spiramycin concentration in the spleen, liver, kidneys is 5-7 μg / g. Rovamycin penetrates and accumulates in phagocytes (neutrophils, monocytes and peritoneal and alveolar macrophages). In humans, the concentrations of the drug inside the phagocytes are quite high. This explains the effectiveness of spiramycin against intracellular bacteria. Penetrates through the placental barrier (concentration in the blood of the fetus is approximately 50% of the concentration in the blood serum of the mother). Concentrations in the placental tissue are 5 times higher than the corresponding concentrations in the serum. Excreted in breast milk. Spiramycin does not penetrate into the cerebrospinal fluid. It is excreted mainly with bile (concentration 15-40 times higher than in serum). Renal excretion is about 10% of the administered dose. The amount of the drug released through the intestine (with feces) is very small.

Indications

Infectious-inflammatory diseases caused by microorganisms sensitive to the preparation:

• acute and chronic pharyngitis caused by beta-hemolytic streptococcus A (as an alternative to treatment with beta-lactam antibiotics, especially in the case of contraindications to their use);
• acute sinusitis (taking into account the sensitivity of microorganisms most often causing this pathology, application of the drug Rovamycin is indicated in case of contraindications to the use of beta-lactam antibiotics);
• acute and chronic tonsillitis caused by spiramycin-sensitive microorganisms;
• 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 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 suspected of it (regardless of severity and the presence or absence of risk factors for adverse outcome);
• infections of the skin and subcutaneous tissue, including impetigo, impetigination, ecthymoma, infectious dermogipodermitis (especially the face), 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 periodontitis
• prevention of recurrence of rheumatism in patients with allergy to beta-lactam antibiotics.

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

• in patients after treatment and before quarantine;
• in patients who were for 10 days before hospitalization in contact with persons who isolated Neisseria meningitidis with saliva into the environment.

Forms of release

Tablets, coated with a coating of 1.5 million IU and 3 million IU.

Powder lyophilized for the preparation of a solution for intravenous administration (injections in ampoules for injection).

Instructions for use and dosage

Pills

The drug is taken orally.

Adults appoint 2-3 tablets of 3 million IU or 4-6 tablets of 1.5 million IU (ie 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 IU per kg of body weight, which is divided into 2 or 3 admission to 6-9 million ME.The maximum daily dose in children is 300,000 ME per kg of body weight, but with a body weight of more than 30 kg the child should not exceed 9 million ME

For the prevention of meningococcal meningitis, adults are prescribed 3 million IU twice a day for 5 days, children - 75,000 IU / kg of body weight 2 times a day for 5 days.

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

Tablets are taken orally by washing with a sufficient amount of water.

Ampoules

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

As soon as the patient's condition permits, the treatment should be continued by taking the drug inside. The contents of the vial are dissolved in 4 ml of water for injection. The drug is injected slowly intravenously drip for 1 hour in at least 100 ml of 5% Dextrose (glucose). The duration of treatment depends on the severity and characteristics of the course of the infectious process, the sensitivity of the microflora and is determined individually by the treating physician. After dilution, the solution is stable for 12 hours under storage conditions at room temperature.

Side effect

• nausea, vomiting;
• diarrhea;
• pseudomembranous colitis;
• ulcerative esophagitis;
• acute colitis;
• transient paresthesia;
• acute hemolysis, thrombocytopenia;
• prolongation of the QT interval on the ECG (several cases have been described only after intravenous injection of the drug to the newborn);
• skin rash;
• hives;
• itching;
• angioedema;
• anaphylactic shock;
• vasculitis, including Shenlen-Henoch purpura;
• acute generalized exanthematous pustulosis.

Contraindications

• lactation period;
• deficiency of glucose-6-phosphate dehydrogenase (risk of developing acute hemolysis);
• children's age (for tablets 1.5 million ME - up to 3 years, for tablets 3 million ME - up to 18 years);
• children and adolescents under 18 years old, in patients at risk of prolonging the QT interval (congenital and acquired) - for the injectable form of the drug;
• hypersensitivity to the components of the drug.

Application in pregnancy and lactation

Rovamycin can be prescribed during pregnancy according to the indications.

There is a wide experience of using the drug Rovamycin during pregnancy. A decrease in the risk of transmission of toxoplasmosis to the fetus during pregnancy is noted from 25% to 8% when the drug is used in 1 trimester, from 54% to 19% in the 2nd trimester and from 65% to 44% in the 3rd trimester.Teratogenic or fetotoxic effects were not observed.

When prescribing Rovamycin during lactation, breastfeeding should be stopped, as spiramycin can penetrate into breast milk.

Use in children

Contraindicated in children aged (for tablets 1.5 million ME - up to 3 years, for tablets 3 million ME - up to 18 years). Tablets of 3 million ME in children are not used because of the difficulty of swallowing them by children because of the large diameter of the tablets and the danger of airway obstruction.

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 discontinued, and further use of spiramycin, both in monotherapy and in combination, is contraindicated.

Impact on the ability to drive vehicles and manage mechanisms

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

Drug Interactions

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

Numerous cases of increased activity of indirect anticoagulants have been reported in patients taking antibiotics. The type of infection or the severity of the inflammatory reaction, the age and general condition of the patient are predisposing risk factors. Under similar circumstances, it is difficult to determine to what extent the infection itself or its treatment play a role in changing 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.

Analogues of the drug Rovamycin

Structural analogs for the active substance:

• Spiramycin is believed;
• Spiramycin adipate.

Analogues on the pharmacological group (macrolides and azalides):

• Azivok;
• Azilide;
• Azimycin;
• Azitral;
• Azitroxy;
• Azithromycin;
• AsitRus;
• Azicid;
• Arvitsin;
• Arvitsin retard;
• Benzamycin;
• Binocular;
• Brilid;
• Wilprafen;
• Wilprafen solute;
• Dynabac;
• Zetamax retard;
• Zimbactur;
• Zitnob;
• Zitrolide;
• Zitrolid forte;
• Zitrocin;
• Ilozon;
• Kispar;
• Klabaks;
• Clarcat;
• Clarithromycin;
• Clarithrosine;
• Claromin;
• Class;
• Clacid;
• Xitrocin;
• Macropean;
• Roxid;
• Roxithromycin;
• Rulid;
• Sumazid;
• Sumaclide;
• Sumamed;
• Sumamed forte;
• Sumamecin;
• Sumamecin forte;
• Sumamox;
• Sumatrolide solute;
• Fromromide;
• Hemomycin;
• Ecomed;
• Erythromycin;
• Eryfluid;
• Hermitsed.

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