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

Skin infections: erysipelas, infected dermatoses, abscess, phlegmon (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.

Treatment of bacterial carriage of whooping cough and diphtheria pathogens.

Pharmacological effect

Absorption: Absorption of spiramycin occurs quickly, but not completely, with great variability (from 10 to 60%). Eating does not affect 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.

Plasma protein binding is low (approximately 10%). Penetrates the placental barrier (the concentration in the fetal blood is approximately 50% of the concentration in the maternal blood serum).

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

Distribution volume – approximately 383 l. The drug penetrates well into saliva and tissues (concentration in the lungs – from 20 to 60 mcg/g, tonsils – 20 to 80 mcg/g, infected sinuses – from 75 to 110 mcg/g, bones – from 5 to 100 mcg/g).

Ten days after the end of treatment, the concentration of the drug in the spleen, liver and kidneys ranges from 5 to 7 mcg/g.

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

Elimination: The half-life from plasma is approximately 8 hours.

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

Special instructions

In patients with liver disease, it is necessary to periodically monitor its function during treatment with the drug.

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

Active ingredient

Spiramycin

Composition

One tablet contains:

Active substance:

Spiramycin base 3 million IU (711.74 mg).

Excipients:

Microcrystalline cellulose 16.71 mg.
Povidone (polyvinylpyrrolidone) 34.0 mg.
Crospovidone (polyplasdon X-El-10) 34.0 mg.
Primogel (sodium carboxymethyl starch) 17.0 mg.
Colloidal silicon dioxide (aerosil) 2.55 mg.
Magnesium stearate 8.5 mg.

Shell

Opadry II 25.0 mg.

Pregnancy

The use of Spiramycin-vero during pregnancy is possible according to indications. No teratogenic effect of spiramycin was detected.

Spiramycin can be excreted in breast milk, therefore, if it is necessary to use the drug during lactation, the issue of stopping breastfeeding should be decided.

Contraindications

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

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

The use of spiramycin is not recommended in patients with deficiency of the enzyme glucose-6-phosphate dehydrogenase, due to the possible occurrence of acute hemolysis.

Side Effects

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

Isolated cases of ulcerative esophagitis and acute colitis have been described. The possibility of developing acute damage to the intestinal mucosa in patients with AIDS when using high doses of spiramycin for cryptosporidiosis was also noted.

From the peripheral and central nervous system: transient paresthesia.

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

From the hematopoietic organs: very rare cases (less than 0.01%) of acute hemolysis (see “With caution”) and thrombocytopenia.

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

Hypersensitivity reactions: skin rash, urticaria, itching.

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

Isolated cases of vasculitis, including Henoch-Schönlein purpura.

Interaction

Prescribe with caution with medications containing dehydrated ergot alkaloids.

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

Unlike erythromycin (a related macrolide), spiramycin is not metabolized by liver P450 isoenzymes and does not interact with cyclosporine or theophylline.

Overdose

There is no specific antidote.

If an overdose of spiramycin is suspected, symptomatic therapy is recommended.

Storage conditions

At a temperature not exceeding 30 °C and out of the reach of children.

Shelf life

2 years.

Manufacturer

Veropharm LLC, Russia