Macropen^® (Tablets, Granules) Instructions for Use

ATC Code

J01FA03 (Midecamycin)

Active Substance

Midecamycin (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. The mechanism of action is associated with the inhibition of protein synthesis in bacterial cells. In low doses, it has a bacteriostatic effect; in high doses, it has a bactericidal effect.

It is active against gram-positive bacteria: Staphylococcus spp., Streptococcus spp., Corynebacterium diphtheriae; gram-negative bacteria: Listeria monocytogenes, Neisseria gonorrhoeae, Neisseria meningitidis, Bordetella pertussis, some strains of Haemophilus influenzae, Legionella pneumophila; anaerobic bacteria: Clostridium spp.

It is active against Mycoplasma pneumoniae, Erysipelothrix spp., Ureaplasma urealyticum, Chlamydia (including Chlamydia trachomatis), Mycoplasma hominis.

Pharmacokinetics

After oral administration, it is rapidly and sufficiently completely absorbed from the gastrointestinal tract. Concentrations exceeding those detectable in serum are achieved in internal organs (especially in the lungs, parotid and submandibular glands) and skin within 1-2 hours.

It remains at therapeutic concentrations in the blood and tissues for 6 hours. It is metabolized in the liver to form two pharmacologically active metabolites. It is excreted mainly with bile, a small part – by the kidneys (<5%).

Indications

Infectious and inflammatory diseases caused by pathogens sensitive to midecamycin (especially in the presence of contraindications to the use of penicillin antibiotics), including diseases of the upper and lower respiratory tract, oral cavity, skin and soft tissues, genitourinary tract, scarlet fever, erysipelas, diphtheria, whooping cough.

ICD codes

Dosage Regimen

Determine the dosage individually based on the patient’s condition, severity of infection, and pathogen susceptibility.

For adults, administer 400 mg orally three times daily.

Do not exceed the maximum daily dose of 1.6 grams for adult patients.

For pediatric patients, calculate the dose based on body weight.

Administer 30-50 mg/kg per day in two divided doses.

In cases of severe infections, increase the dosing frequency to three times daily.

The standard treatment duration is 7 to 14 days.

Adjust the treatment course based on clinical response and microbiological eradication.

Take tablets and granules before meals to optimize drug absorption.

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

Adverse Reactions

Possible skin rash.

Rarely anorexia, feeling of heaviness in the epigastrium, nausea, vomiting, diarrhea, transient increase in the activity of liver transaminases and the concentration of bilirubin in the blood serum (in predisposed patients).

Contraindications

Hepatic and/or renal insufficiency, hypersensitivity to midecamycin and other macrolides.

Use in Pregnancy and Lactation

Midecamycin should be prescribed with caution during pregnancy and lactation, only in cases where the expected therapeutic effect for the mother outweighs the potential risk of side effects in the fetus or child.

If it is necessary to use during lactation, the issue of stopping breastfeeding should be considered.

Use in Hepatic Impairment

Contraindicated in hepatic insufficiency.

Use in Renal Impairment

Contraindicated in renal insufficiency.

Pediatric Use

Use is possible according to the dosage regimen.

Special Precautions

With prolonged use, it is recommended to monitor laboratory parameters characterizing liver function, especially in patients with a history of liver disease.

Drug Interactions

With simultaneous use with cyclosporine, warfarin – their excretion decreases; with ergot alkaloids, carbamazepine – the intensity of their metabolism in the liver decreases.

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.