Rovamycine, pills 1500000me, 16pcs

Composition

Spiramycin 1.5 million IU.

Auxiliary substances:

colloidal silicon dioxide-1.2 mg,

magnesium stearate-4 mg,

pregelatinized corn starch-16 mg,

giprolose-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

Pharmacological action

An 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 subunit of the ribosome.

Usually sensitive microorganisms (MPC < 1 mg/l):

• Streptococci.
• Methicillin-sensitive staphylococci.
• Enterococci.
• Rhodococcus equi.
• Bacillus cereus.
• Branhamella catarrhalis.
• Bordetella pertussis.
• Helicobacter pylori.
• Campylobacter spp.
• Legionella spp.
• Corynebacterium diphtheriae.
• Moraxella spp.
• Mycoplasma pneumoniae.
• Coxiella spp.
• Chlamydia spp.
• Treponema pallidum.
• Borrelia burgdorferi.
• Leptospira spp.
• Propionibacterium acnes.
• Actinomyces spp.
• Eubacterium spp.
• Porphyromonas spp.
• Mobiluncus spp.
• Bacteroides spp.
• Peptostreptococcus spp.
• Prevotella spp.
• Toxoplasma gondii.

Moderately sensitive microorganisms:

• Neisseria gonorrhoeae.
• Ureaplasma urealyticum.
• Clostridium perfringens.

For these pathogens, the antibiotic is moderately active in vitro; positive results can be observed when the concentration of the antibiotic in the inflammatory focus is higher than the MPC.

Resistant microorganisms (MPC>4 mg / l), at least 50% of the strains are resistant:

• Methicillin-resistant staphylococci.
• Enterobacter spp.
• Pseudomonas spp.
• Acinetobacter spp.
• Nocardia asteroides.
• Fusobacterium spp.
• Haemophilus spp.
• Mycoplasma hominis.
• Corynebacterium jekeium.

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

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 treatment of beta-lactam antibiotics, especially in the case of contraindications to their use);

— acute sinusitis (given the sensitivity of the most commonly causing this pathology microorganisms, the use of the drug Rapamycin® is indicated in the case of contraindications to the use of beta-lactam antibiotics);

acute and chronic tonsillitis, caused by sensitive microorganisms spiramycine;

acute bronchitis caused by 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 it (regardless of severity and the presence or absence of risk factors);

infections of skin and subcutaneous tissue, including impetigo, impetiginosa, ectima, infectious dermolipectomy (especially face), secondary infected dermatoses, erythrasma;

infection of the oral cavity (including stomatitis, glossitis);

— neonatologie infection of the genitals;

— toxoplasmosis, including during pregnancy;

infection of the musculoskeletal system and connective tissues, including the periodontium.

Prevention of relapses of rheumatism in patients with allergy 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 coming out of quarantine;

– in patients who were in contact with persons who released Neisseria meningitidis with saliva into the environment within 10 days before hospitalization.

Use during pregnancy and lactation

Rovamycine can be prescribed during pregnancy according to indications.

There is extensive experience in using Rovamycine® during pregnancy. The risk of transmission of toxoplasmosis to the fetus during pregnancy is reduced 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 Rovamycine® during lactation, breastfeeding should be discontinued, since it is possible that spiramycin can enter breast milk.

Contraindications

-lactation period;

-glucose-6-phosphate dehydrogenase deficiency (risk of acute hemolysis)—

– children’s age (for 1.5 million tablets). IU – up to 6 years, for 3 million tablets. IU-up to 18 years);

– hypersensitivity to the components of the drug.

With caution, Rovamycine is prescribed for obstruction of the bile ducts, with liver failure.

Side effects

The following classification is used to indicate the frequency of adverse reactions: very common (≥10%), common (≥ 1%,

From the digestive system: nausea, vomiting, diarrhea; very rarely – pseudomembranous colitis (

Liver and biliary tract disorders: very rare (

Nervous system disorders: very rare (isolated cases) – transient paresthesia.

Hematopoietic disorders: very rare (

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

Immune system disorders: skin rash, urticaria, pruritus; very rare (

Skin and subcutaneous tissue disorders: very rare – acute generalized exanthematous pustulosis.

Interaction

Inhibition of carbidopa absorption by spiramycin with a decrease in plasma levodopa concentration. Concomitant use of spiramycin requires clinical monitoring and dose adjustment of levodopa.

Numerous cases of increased activity of indirect anticoagulants have been reported in patients taking antibiotics. The type of infection or severity of the inflammatory response, the 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 changing MHO. However, when using certain groups of antibiotics, this effect is observed more often, in particular when using fluoroquinolones, macrolides, cyclins, a combination of sulfamethoxazole+trimethoprim, and some cephalosporins.

How to take, course of use and dosage

The drug is taken orally.

Adults are prescribed 2-3 tablets of 3 million rubles. IU or 4-6 tablets of 1.5 million each. IU (i. e. 6-9 million rubles). IU) per day. The daily dose is divided into 2 or 3 doses. The maximum daily dose is 9 million IU.

Only 1.5 tablets should be used in children and adolescents aged 6-18 years. million ME.

In children over 6 years of age, the daily dose is from 150-300 thousand rubles. IU 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 rubles. IU per kg of body weight, but if the child’s body weight is more than 30 kg, it should not exceed 9 million. ME

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

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

Tablets are taken orally, washed down with a sufficient amount of water.

Overdose

There are no known cases of spiramycin overdose.

Symptoms: possible – nausea, vomiting, diarrhea. Cases of prolongation of the QT interval that occur when the drug is discontinued have been observed in newborns receiving high doses of spiramycin or after iv use 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 diseases, 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 with monotherapy and in combination, is contraindicated.

Use in pediatrics

Tablets of 3 million each. IU in children is not used because of the difficulty of their ingestion by children due to the large diameter of the tablets and the risk of airway obstruction.

Influence on the ability to drive motor vehicles and manage mechanisms

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

Form of production

Film-coated tablets.

Storage conditions

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

Shelf

life is 3 years.

Active ingredient

Spiramycin

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

Adults as prescribed by a doctor

Indications

Infectious Diseases, Tonsillitis, Bronchitis, Sinusitis, Pneumonia, Dermatosis