Spiramycin, tablets 3000000 me, 10 pcs.

Absorption: Absorption of spiramycin is fast but not complete, with great variability (10 to 60%). Food intake has no effect on 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.

The binding to plasma proteins is low (approximately 10%). It penetrates through the placental barrier (fetal blood concentration is about 50% of the concentration in the blood serum of the mother).

Concentrations in placental tissue are 5 times higher than the corresponding concentrations in blood serum.

The volume of distribution is approximately 383 liters. The drug penetrates well into saliva and tissues (concentrations in lungs 20 to 60 µg/g, tonsils 20 to 80 µg/g, infected sinuses 75 to 110 µg/g, bones 5 to 100 µg/g).

Ten days after the end of treatment, the concentration of the drug substance in the spleen, liver and kidneys is 5 to 7 µg/g.

Spiramycin penetrates and accumulates in phagocytes (neutrophils, monocytes and peritoneal and alveolar macrophages). In humans, drug concentrations within 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 unspecified chemical structure.

Elimation: The elimination half-life from blood plasma is approximately 8 hours.

Extracted from the body mainly with bile (concentrations in bile are 15-40 times higher than in serum). Renal excretion is about 10% of the administered dose. The amount of the drug excreted through the intestine (with feces) is very small.

Indications

Bacterial infections caused by sensitive microorganisms, lower respiratory tract (acute community-acquired pneumonia, (including atypical, caused by Mycoplasma pneumoniae, Chlamydia spp, Legionella pneumophila), exacerbation of chronic bronchitis); ENT-organs (including sinusitis, tonsillitis, otitis); periodontium; osteomyelitis, arthritis; extragenital chlamydia, prostatitis, urethritis of various etiology; sexually transmitted diseases (including genital chlamydia, syphilis, gonorrhea and their combination).

Infections of the skin: rye, infected dermatoses, abscesses, phlegmons (including in dentistry).
Toxoplasmosis, including in pregnant women.

Prevention of meningococcal meningitis among persons in contact with patients no more than 10 days before hospitalization.

Prevention of acute articular rheumatism in patients with an allergic reaction to penicillin.

The treatment of bacteriuria of pertussis and diphtheria pathogens.

Active ingredient

Composition

One tablet contains:

Active ingredients:

Excipients:

Shell

How to take, the dosage

Oral.

Adults: 2 to 3 tablets of 3 million IU (that is, 6-9 million IU) per day in 2 or 3 doses.

The maximum daily dose is 9 million IU.

Prevention of meningococcal meningitis: 3 million IU every 12 hours for 5 days.

Interaction

Caution is used with drugs containing dehydrated ergot alkaloids.

The combination of levodopa and carbidopa increases the half-life of levodopa, which may be due to spiramycin inhibiting absorption of carbidopa due to changes in gastrointestinal peristalsis.

In contrast to erythromycin (a related macrolide), hepatic P450 isoenzymes do not participate in the metabolism of spiramycin and it does not interact with cyclosporine or theophylline.

Special Instructions

In patients with liver disease, its function should be periodically monitored during treatment with the drug.

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

Contraindications

Hypersensitivity to spiramycin and other components of the drug, lactation period.

Childhood (tablets of 3 million IU in children under 18 years of age are not used).

The use of spiramycin in patients with glucose-6-phosphate dehydrogenase enzyme deficiency is not recommended because of the possibility of acute hemolysis.

Side effects

Gastrointestinal tract: nausea, vomiting, diarrhea and very rare cases of pseudomembranous colitis (less than 0.01%).

In isolated cases of ulcerative esophagitis and acute colitis have been described. The possibility of acute intestinal mucosal damage in patients with AIDS when using high doses of spiramycin for cryptosporidiosis has also been noted.

Peripheral and central nervous system disorders: transient paresthesias.

Hepatic disorders: in very rare cases (less than 0.01%) – changes of liver function tests and development of cholestatic hepatitis.

Hematopoietic organs: very rare cases (less than 0.01%) of acute hemolysis (see “Caution”) and thrombocytopenia.

Cardiovascular system disorders: prolongation of the QT interval on electrocardiogram is possible.

Hypersensitivity reactions: skin rash, urticaria, itching.

Very rarely (less than 0.01%) – angioedema, anaphylactic shock.

Occasional cases of vasculitis, including Schoenlein-Henoch purpura.

Overdose

There is no specific antidote.

In case of suspected spiramycin overdose, symptomatic therapy is recommended.

Pregnancy use

The use of Spiramycin-vero in pregnancy is possible under indications. No teratogenic effects of spiramycin have been identified.

Spiramycin may be excreted with breast milk, therefore, if it is necessary to use the drug during lactation, the question of stopping breastfeeding should be decided.

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