Rovamycin tablets 3000000ME, No. 10

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 the case of contraindications to their use);

• acute sinusitis (given the sensitivity of the microorganisms most often causing this pathology, the use of RovamycinЃ 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 an unfavorable 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 the severity and presence or absence of risk factors for an adverse outcome);

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

• oral cavity infections (including stomatitis, glossitis);

• non-gonococcal genital infections;

• toxoplasmosis, incl. during pregnancy; infections of the musculoskeletal system and connective tissue, including the periodontium.

• Prevention of recurrence of rheumatism in patients with allergy 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 have been in contact with persons who have excreted Neisseria meningitidis with saliva into the environment within 10 days before hospitalization.

The drug is taken orally.

Adults are prescribed 2-3 tablets. 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 ME tablets should be used.

In children over 6 years of age, 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 IU per kg of body weight, but with a child's body weight of more than 30 kg, it should not exceed 9 million IU.

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 do not require dose adjustment. The tablets are taken orally with plenty of water.

Film-coated tablets, white or white with a cream shade, round, biconvex, engraved with 'RPR 107' on one side; cross-sectional view: white or white with a cream shade.

1 tab. spiramycin

Excipients: colloidal silicon dioxide, magnesium stearate, pregelatinized corn starch, hyprolose, croscarmellose sodium, microcrystalline cellulose

• 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.

• RovamycinЃ is prescribed with caution for obstruction of the bile ducts, with hepatic insufficiency.

Trade name : Rovamycine

International non-proprietary name (INN) : spiramycin.

Dosage form : film-coated tablets.

Composition

Each coated tablet contains 1.5 million IU or 3.0 million IU of spiramycin as active ingredient.
Excipients: colloidal anhydrous silicon, magnesium stearate, pregelatinized starch, hydroxypropyl cellulose, croscarmellose sodium (sodium carboxymethyl cellulose), microcrystalline cellulose.

Description

Dosage 1.5 million IU : biconvex round film- coated tablets, white or white with a cream shade. One side is engraved with 'RPR 107'.
Dosage 3.0 million IU : biconvex round film- coated tablets, white with a cream shade. One side is engraved with 'ROVA 3'.

Pharmacotherapeutic group : antibiotic, macrolide.

ATX code - J01FA02.

Pharmacological action

Pharmacodynamics

Spiramycin belongs to the macrolide antibiotics.
The antibacterial spectrum of spiramycin is as follows:

• Typically susceptible organisms: minimum inhibitory concentration (MIC) Moderately susceptible organisms: the antibiotic is moderately active in vitro. Positive results can be observed when antibiotic concentrations in the inflammatory focus are higher than the MIC (see Pharmacokinetics). Neisseria gonorrhoea, Clostridium perfringens, Ureaplasma urealyticum.

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

Methicillin - resistant staphylococci, Enterobacteria, Pseudomonas, Acinetobacter, Nocardia asteroides, Fusobacterium ,, Haemophilus, Mycoplasma hominis.
Spiramycin activity against Toxoplasma gondii has been proven in vitro and in vivo.
Note: due to the lack of clinical indications, some species of bacteria are not indicated in the spectrum. In France, 20% to 25% of pneumococci are resistant to all macrolides (cross resistance to all macrolides).
Spiramycin penetrates and accumulates in phagocytes (neutrophils, monocytes and peritoneal and alveolar macrobacteriophages). In humans, drug concentrations inside phagocytes are quite high. These properties explain the effects of spiramycin on intracellular bacteria.

Pharmacokinetics

Absorption The
absorption of spiramycin occurs quickly, but not completely, with great variability (from 10 to 60%).
Distribution
After oral administration of 6 million IU of spiramycin, the maximum plasma concentration is about 3.3 ?g / ml.
Spiramycin does not penetrate into the cerebrospinal fluid, but diffuses into breast milk. Penetrates through the placental barrier (the concentration in the blood of the fetus is approximately 50% of the concentration in the serum of the mother).
The concentrations in the tissue of the placenta are 5 times higher than the corresponding concentrations in the blood serum.
The volume of distribution is approximately 383 liters.
The drug penetrates well into saliva and tissues (concentration in the lungs - from 20 to 60 ?g / g, tonsils - 20 to 80 ?g / g, infected sinuses - from 75 to 110 ?g / g, bones - from 5 to 100 ?g / g) ... Ten days after the end of treatment, the concentration of the drug in the spleen, liver and kidneys is from 5 to 7 ?g / g.
Plasma protein binding is low (approximately 10%).
Biotransformation
Spiramycin is metabolized in the liver to form active metabolites with an unknown chemical structure.
Excretion
Excreted mainly in bile (concentrations 15-40 times higher than in serum). Renal excretion of active spiramycin is about 10% of the administered dose.
The half-life after taking 3 million IU of spiramycin is approximately 8 hours. It can get longer in older patients. In patients with impaired renal function, no dose adjustment of spiramycin is required.

Indications

• Infectious diseases caused by microorganisms sensitive to this drug, especially ENT organs (including tonsillitis and sinusitis); lower respiratory tract (acute community-acquired pneumonia, including atypical pneumonia, exacerbation of chronic bronchitis); periodontal; skin and soft tissues (erysipelas, secondary infected dermatoses, impetigo, ecthyma, erythrasma); bones and joints; reproductive system (not gonorrheal in nature).

• Prevention of meningococcal meningitis in cases where rifampicin is contraindicated: eradication of Neisseria meningitidis in the nasopharynx. Spiramycin is not used to treat meningococcal meningitis. The drug is recommended for prophylaxis in patients after treatment, as well as in persons who had contact with the patient 10 days before his hospitalization.

• Prevention of recurrence of acute articular rheumatism in patients with an allergic reaction to penicillins.

• Toxoplasmosis in pregnant women.

Contraindications

Hypersensitivity to spiramycin and other components of the drug, lactation period.
The use of spiramycin in patients with a deficiency of the enzyme glucose-6-phosphate dehydrogenase is not recommended, due to the possible occurrence of acute hemolysis.
The drug should be taken with caution in case of obstruction of the bile ducts or in liver failure.

Pregnancy and breastfeeding

Rovamycin can be given as needed during pregnancy.

Method of administration and dosage

For adults: inside 2-3 tablets of 3 million ME or 4-6 tablets of 1.5 million ME (that is, 6-9 million ME) per day for 2 or 3 doses. The maximum daily dose is 9 million IU.
For children (with a body weight of 20 kg or more): the dosage for children will be from 150-300 thousand IU per kg of body weight per day, divided into 2 or 3 doses. The maximum daily dose in children is 300 thousand IU per kg of body weight per day.
IU 3 million tablets are not used in children.
Prevention of meningococcal meningitis: for adults - 3 million IU in 12 hours for 5 days; for children - 75 thousand ME for 12 hours within 5 days. Patients with impaired renal function: due to low renal excretion, no dose change is required.

Side effect

From the gastrointestinal tract: nausea, vomiting, diarrhea and very rare cases of pseudomembranous colitis (less than 0.01%).
Described isolated cases of ulcerative esophagitis and acute colitis. The possibility of the development of acute damage to the intestinal mucosa in patients with AIDS with the use of high doses of spiramycin for cryptosporidiosis was also noted (only 2 cases).
From the peripheral and central nervous system: transient paresthesias.
From the liver: in very rare cases (less than 0.01%) - changes in liver function tests and the development of cholestatic hepatitis.
On the part of the hematopoietic organs: very rare cases (less than 0.01%) of the development of acute hemolysis (see 'With caution') and thrombocytopenia.
From the side of the cardiovascular system: prolongation of the QT interval on the electrocardiogram is possible.
Hypersensitivity reactions: skin rash, urticaria, pruritus. Very rarely (less than 0.01%) - angioedema, anaphylactic shock.

Overdose

There is no specific antidote. If an overdose with spiramycin is suspected, symptomatic therapy is recommended.

Interaction with other medicinal products

Levodopa: due to inhibition of carbidopa absorption, plasma levodopa levels may decrease. With the simultaneous appointment of spiramycin, clinical monitoring and some change in the dosage of levodopa are necessary.

special instructions

When prescribing to lactating women, it is necessary to stop feeding, since spiramycin may penetrate into breast milk. Spiramycin has no teratogenic effect, so you can safely take it to pregnant women. A decrease in the risk of transmission of toxoplasmosis to the fetus during pregnancy is noted from 25% to 8% when used in the first trimester, from 54% to 19% in the II and from 65% to 44% in the III trimester. In patients with liver diseases, it is necessary to periodically monitor its function during the period of drug treatment.

Release form

Film-coated tablets, 1.5 million ME - 16 tablets in a cardboard box.
Film-coated tablets, 3.0 million ME - 10 tablets in a cardboard box.

Storage conditions

At a temperature not higher than + 25 ? C, out of the reach of children! List B.

Shelf life

For tablets 1.5 million ME - 3 years and for tablets 3 million ME - 4 years. Do not use after the expiration date!

Conditions of dispensing from pharmacies

On prescription.