Spiramysar (Tablets) Instructions for Use

ATC Code

J01FA02 (Spiramycin)

Active Substance

Spiramycin (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antibiotic of the macrolide group

Pharmacotherapeutic Group

Antibiotic-macrolide

Pharmacological Action

An antibiotic of the macrolide group. It exerts a bacteriostatic effect by disrupting intracellular protein synthesis.

It is active against gram-positive bacteria: Staphylococcus spp. (including strains producing penicillinase), Streptococcus spp. (including Streptococcus pneumoniae), Corynebacterium diphtheriae, Listeria monocytogenes; gram-negative bacteria: Neisseria meningitidis, Neisseria gonorrhoeae, Bordetella pertussis, Legionella spp., Campylobacter spp.; anaerobic bacteria: Clostridium spp.

Spiramycin is also active against Mycoplasma pneumoniae, Chlamydia spp., Treponema spp., Leptospira spp., Toxoplasma gondii.

Haemophilus influenzae, Bacteroides fragilis, Staphylococcus aureus are moderately susceptible to spiramycin.

Enterobacter spp., Pseudomonas spp. are resistant to spiramycin.

Pharmacokinetics

After oral administration, it is incompletely absorbed from the gastrointestinal tract; the half-absorption period is 20 minutes. The C_max of the active substance in blood plasma is reached within 1.5-3 hours.

It is widely distributed in body tissues but does not penetrate the blood-brain barrier. Plasma protein binding is no more than 10%.

The metabolism has not been sufficiently studied, but it is believed that Spiramycin is metabolized in the liver to form active metabolites. It is excreted in bile, 10% in urine.

Indications

Infectious and inflammatory diseases caused by microorganisms susceptible to spiramycin: diseases of the respiratory tract and ENT organs, including pneumonia (including atypical pneumonia caused by mycoplasmas, chlamydia, legionella), pharyngitis, tonsillitis, sinusitis, otitis; urinary tract infections (including urethritis, prostatitis); skin and soft tissue infections; osteomyelitis and arthritis; gynecological diseases, sexually transmitted infections (including genital and extragenital chlamydial infection).

Prevention of rheumatic fever in patients allergic to penicillins.

Toxoplasmosis, including toxoplasmosis in pregnant women.

Prevention of meningococcal meningitis among persons who have been in contact with a patient no more than 10 days before diagnosis.

ICD codes

Dosage Regimen

For adults and adolescents, administer 2-3 g per day orally in two divided doses.

For severe infections, increase the dose to 4-5 g per day in divided doses.

For children, calculate the dose at 50-100 mg/kg per day in divided doses.

For intravenous administration to adults and adolescents, administer 500 mg every 8 hours.

For severe infections requiring IV therapy, increase the dose to 1 g every 8 hours.

For toxoplasmosis in pregnant women, administer 3 g per day in divided doses.

For meningococcal meningitis prophylaxis, administer 3 g per day for adults and 75 mg/kg twice daily for children for five days.

For rheumatic fever prevention in penicillin-allergic patients, administer 3 g per day in divided doses.

Adjust the total daily dose and frequency based on the severity of the infection and the patient’s clinical response.

Complete the full course of therapy as prescribed, even if symptoms improve.

Adverse Reactions

Allergic reactions skin rash, itching.

From the digestive system rarely – nausea, vomiting, diarrhea, abdominal pain; in isolated cases – cholestatic jaundice.

Contraindications

Hypersensitivity to spiramycin.

Use in Pregnancy and Lactation

Spiramycin can be used during pregnancy if indicated.

Spiramycin is excreted in breast milk, so if its use is necessary during lactation, the issue of discontinuing breastfeeding should be considered.

Use in Hepatic Impairment

Use with caution in patients with impaired liver function.

Pediatric Use

Use is possible according to the dosage regimen.

Special Precautions

Use with caution in patients with impaired liver function, and also concurrently with ergot alkaloids and dihydrogenated ergot alkaloids.

Drug Interactions

With simultaneous use with drugs containing a combination of levodopa and carbidopa, an increase in the T_1/2 of levodopa is observed.

Prescribe with caution with drugs containing dihydrogenated ergot alkaloids.

Liver P450 system isoenzymes are not involved in the metabolism of spiramycin; it does not interact with cyclosporine or theophylline.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.