Rovamycine, pills 3000000me, 10pcs

Composition

Active ingredients:

spiramycin – 3 million IU.

Auxiliary substances:

colloidal silicon dioxide,

magnesium stearate,

pregelatinized corn starch,

hydroxypropylcellulose (hyprolose),

sodium croscarmellose (sodium carboxymethylcellulose),

microcrystalline cellulose.

Shell composition:

titanium dioxide, macrogol 6000, hypromellose.

Pharmacological action

Pharmacodynamics

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.

Pharmacokinetics

Suction

The absorption of spiramycin is rapid, but incomplete, with great variability (from 10% to 60%). After oral use of Rovamycine at a dose of 6 million IU, the cmax of spiramycin in plasma is about 3.3 mcg / ml.

Distribution

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

Spiramycin does not enter the cerebrospinal fluid; it is excreted in breast milk. Penetrates the placental barrier (the fetal blood concentration is approximately 50% of the maternal serum concentration). Placental tissue concentrations are 5 times higher than the corresponding serum concentrations.

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

Metabolism and elimination

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

It is mainly excreted in bile (the concentration is 15-40 times higher than in serum). Renal excretion of active spiramycin is about 10% of the administered dose. T 1/2 after oral use of 3 million mg of spiramycin is approximately 8 h

. Pharmacokinetics in special clinical cases

, T 1/2 is prolonged in the elderly. No dosage adjustment is required in patients with impaired renal function.

Indications

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

• infections of ENT organs: sinusitis; tonsillitis;
• infections of the lower respiratory tract (including acute community-acquired pneumonia, including atypical pneumonia, exacerbation of chronic bronchitis);
• infections of the periodontium;
• infections of skin and soft tissues of the face, secondary infected dermatoses, impetigo, ecthyma, erythrasma;
• infections of bones and joints;
• infections of the reproductive system (neonorange etiology);
• toxoplasmosis, including pregnant women;
• prophylaxis of meningococcal meningitis in cases when rifampicin is contraindicated: eradication of Neisseria meningitidis in the nasopharynx; spiramycin is not used for the treatment of meningococcal meningitis. The drug is recommended for prevention in patients after treatment, as well as in people who had contact with the patient 10 days before his hospitalization;
• prevention of acute joint rheumatism in people with an allergic reaction to penicillins.

Use during pregnancy and lactation

It is possible to use Rovamycine during pregnancy according to indications.

When prescribing Rovamycine during lactation, breastfeeding should be discontinued, since spiramycin may be excreted in breast milk.

Spiramycin was not found to have a teratogenic effect.

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.

Contraindications

• Lactation period;
• glucose-6-phosphate dehydrogenase deficiency (risk of acute hemolysis);
• children under 18 years of age;
• hypersensitivity to spiramycin and other components of the drug.

With caution: in case of obstruction of the bile ducts; hepatic insufficiency.

Side effects

From the digestive system: nausea, vomiting, diarrhea; very rarely (less than 0.01%) – pseudomembranous colitis, changes in liver function tests and the development of cholestatic hepatitis; in isolated cases – ulcerative esophagitis and acute colitis. The possibility of developing acute damage to the intestinal mucosa in patients with AIDS when using spiramycin in high doses for cryptosporidiosis was also noted (only 2 cases).

From the central nervous system and peripheral nervous system: transient paresthesia.

From the hematopoietic system: very rarely (less than 0.01%) – acute hemolysis and thrombocytopenia.

From the cardiovascular system: possible prolongation of the QT interval on the ECG.

Allergic reactions: skin rash, urticaria, pruritus; very rarely (less than 0.01%) – angioedema, anaphylactic shock.

Local reactions: rarely-moderate irritation along the vein, which only in exceptional cases may require discontinuation of treatment.

Other: in some cases-vasculitis, including Schonlein-Heinoch purpura.

Interaction

When used concomitantly with drugs containing a combination of levodopa and carbidopa, a decrease in the level of levodopa in plasma was observed (clinical monitoring and some change in the dose of levodopa is necessary).

How to take, course of use and dosage

Adults are prescribed 2-3 tablets of 3 million IU (i. e. 6-9 million IU)inside per day in 2 or 3 doses. The maximum daily dose is 9 million IU.

For the prevention of meningococcal meningitis

For the prevention of meningococcal meningitis, adults are prescribed a drug of 3 million IU 2 times a day (6 million IU). IU / day) for 5 days.

Use in patients with impaired renal function

Patients with impaired renal function due to low renal excretion of spiramycin do not need to change the dose.

Overdose

Symptoms: Cases of spiramycin overdose are unknown. Possible symptoms include nausea, vomiting, and diarrhea.

Treatment: if necessary, conduct symptomatic therapy. There is no specific antidote.

Special instructions

In patients with impaired liver function during the use of the drug, liver function indicators should be monitored.

The drug containing ergot alkaloids should be used with caution.

Use in patients with liver function disorders

Rovamycine should be used with caution in patients with bile duct obstruction or liver failure.

Use in patients with impaired renal function

Patients with impaired renal function due to low renal excretion of spiramycin do not need to change the dose.

Storage conditions

Store in a dry place at a temperature not exceeding 25°C. Keep out of reach of children.

Shelf

life is 4 years.

Active ingredient

Spiramycin

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Indications

Sinusitis, Pharyngitis, Pneumonia, Bronchitis, Vaginal Infections, Skin Infections, Urinary Tract Infections