Macropen granules d / prig.susp. for oral administration 175mg / 5ml, 115ml

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

• respiratory tract infections, incl. caused by atypical pathogens (mycoplasma, legionella, chlamydia and Ureaplasma urealyticum) - tonsillopharyngitis, acute otitis media, sinusitis, exacerbation of chronic bronchitis, community-acquired pneumonia;

• infections of the genitourinary tract caused by atypical pathogens - mycoplasma, legionella, chlamydia and Ureaplasma urealyticum;

• infections of the skin and subcutaneous tissue;

• enteritis caused by bacteria of the genus Campylobacter;

• diphtheria and whooping cough (treatment and prevention).

Inside, before meals.

Adults and children weighing> 30 kg: 1 tab. (400 mg) 3 times a day. The maximum daily dose for adults is 1600 mg.

Children weighing <30 kg: daily dose - 20-40 mg / kg, divided into 3 doses or 50 mg / kg in 2 doses.

For severe infections: the daily dose is 50 mg / kg, divided into 3 doses.

The scheme of administration of MacropenЃ in the form of a suspension for children (daily dose - 50 mg / kg with 2 doses) is presented in the table.

Body weight (age) Suspension (175 mg / 5 ml),

2 times a day up to 5 kg (approximately 2 months), 3.75 ml (131.25 mg)

up to 10 kg (approximately 1-2 years) 7.5 ml (262.5 mg)

up to 15 kg (approximately 4 years) 10 ml (350 mg)

up to 20 kg (approximately 6 years) 15 ml (525 mg)

up to 30 kg (approximately 10 years) 22.5 ml (787.5 mg)

The duration of treatment is from 7 to 14 days, in the treatment of chlamydial infections - 14 days.

In order to prevent diphtheria, it is recommended in a dose of 50 mg / kg / day, divided into 2 doses, for 7 days. A follow-up bacteriological study is recommended after the end of therapy.

In order to prevent whooping cough, it is recommended at a dose of 50 mg / kg / day for 7-14 days in the first 14 days from the moment of contact.

Suspension preparation

Add 100 ml of water (boiled or distilled) to the contents of the bottle and shake well.

Shake well before use!

Granules for preparation of suspension for oral administration are small, orange in color, with a slight banana odor, without visible impurities; prepared aqueous suspension of orange color, with a slight banana odor.

5 ml ready-made suspension.

midecamycin acetate 175 mg

Excipients: methyl parahydroxybenzoate, propyl parahydroxybenzoate, citric acid, sodium hydrogen phosphate anhydrous, banana flavor, powder, sunset yellow dye FCF (E110), hypromellose, silicone antifoam, sodium saccharinate, mannitol.

• Hypersensitivity to midecamycin / midecamycin acetate and any other components of the drug;

• severe liver failure;

• children under 3 years of age (for tablets).

Carefully:

• pregnancy;

• lactation period;

• the presence of an allergic reaction to acetylsalicylic acid.

pharmachologic effect

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

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.

Active against Mycoplasma pneumoniae, Erysipelothrix spp., Ureaplasma urealyticum, Chlamydia (including Chlamydia trachomatis), Mycoplasma hominis.

Pharmacokinetics

After oral administration, it is rapidly and completely absorbed from the gastrointestinal tract. Concentrations exceeding those found in serum are created in the internal organs (especially in the lungs, parotid and submandibular glands) and skin after 1-2 hours. At a therapeutic concentration in the blood and tissues it remains for 6 hours. It is metabolized in the liver with the formation of two pharmacologically active metabolites. It is excreted mainly in the bile, a small part - by the kidneys (<5%).

Side effect

Possibly: skin rash.

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

Application during pregnancy and lactation

With caution, midecamycin is prescribed 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 necessary, use during lactation should decide on the termination of breastfeeding.

Application for violations of liver function

Contraindicated in liver failure.

Application for impaired renal function

Contraindicated in renal failure.

Application in children

Application is possible according to the dosage regimen.

special instructions

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.