Tablets, film coated: round slightly biconvex form, with slanted edges and dividing risky on one party, have white color, on a break – rough white structure (on 8 pieces in blisters, in a cardboard pack 2 blisters);
Granules for preparation of suspension for intake: orange color, small, without visible impurity, with a light smell of banana, ready water suspension has orange color and light banana aroma (on 20 g in glass bottles of dark color, in a cardboard pack 1 bottle complete with a dosing spoon).

Active ingredient of Makropen:

Tablets: мидекамицин, in 1 tablet – 400 mg;
Granules: a midekamitsina acetate, in 5 ml of ready suspension – 175 mg.

Auxiliary components:

Tablets: magnesium stearate, полакрилин potassium, cellulose microcrystallic, talc;
Granules: пропилпарагидроксибензоат, methylparahydroxybenzoate, citric acid, sodium hydrophosphate anhydrous, dye sunset yellow FCF (E110), powder, fragrance banana, Mannitolum, gipromelloz, sodium saccharinate, defoaming agent silicone.

In addition as a part of a cover of tablets: macrogoal, copolymer of methacrylic acid, titanium dioxide, talc.

Indications to use

Community-acquired pneumonia, chronic bronchitis (in an aggravation stage), acute average otitis, tonzillofaringit, sinusitis, including the atypical respiratory infections caused by Chlamydia spp., Mycoplasma spp., Ureaplasma urealyticum and Legionella spp.;
Prevention and treatment of whooping cough and diphtheria;
The infectious and inflammatory diseases of urinogenital system caused by Legionella spp activators., Chlamydia spp., Ureaplasma urealyticum and Mycoplasma spp.;
Therapy of the enterit caused by Campylobacter spp.;
The infectious pathologies of hypodermic cellulose and skin caused by microorganisms sensitive to drug.

Contraindications

The expressed liver failure;
Breastfeeding period;
Hypersensitivity to drug components.

With care Makropen to patients with the instruction in the anamnesis of hypersensitivity to acetylsalicylic acid is recommended to appoint.

During pregnancy use of drug is shown in case of emergency provided that the estimated clinical effect for mother is much higher than potential threat for a fruit.

Use of tablets contraindicated aged up to 3 years.

Route of administration and dosage

Tablets and the suspension prepared from granules are accepted inside, to food.

Suspension prepares by dissolution of contents of a bottle of 100 ml of the distilled or boiled water. Suspension is suitable for the use within 7 days at the room temperature of storage and 14 days – at storage in the refrigerator. Before each reception suspension should be shaken up well.

The dose and the period of use are appointed by the attending physician on the basis of clinical indications.

The recommended dosing for tablets:

To patients weighing more than 30 kg: on 1 tablet 3 times a day, the daily dose for adults should not exceed 4 tablets;
Children weighing up to 30 kg: purpose of a daily dose is made at the rate of 20-40 mg on 1 kg of body weight of the child with frequency rate of reception 3 times a day, or on 50 mg on 1 kg of weight in 2 receptions. For treatment of severe forms of infections: on 50 mg on 1 kg of body weight in 3 receptions.

The daily dose of suspension for children is appointed at the rate of 50 mg to 1 kg of weight of the child and is accepted in 2 receptions by means of a measured spoon.

The single dose of suspension has weight restrictions:

Children weighing up to 5 kg – on 3,75 ml;
From 5 to 10 kg – on 7,5 ml;
From 10 to 15 kg – on 10 ml;
From 15 to 20 kg – on 15 ml;
From 20 to 30 kg – on 22,5 ml.

Course of treatment of 7-14 days, for chlamydial infections – 14 days.

The daily dose of Makropen for prevention of diphtheria is defined from calculation for 50 mg on 1 kg of weight of the patient and is accepted in 2 receptions. Duration of therapy of 7 days, then is recommended to conduct a control bacteriological research.

Prevention of whooping cough is carried out during the first 14 days after contact with infected in a dose of 50 mg on 1 kg of weight a day, a course of treatment – 7-14 days.

Side effects

Allergic reactions: skin itch and rash, eosinophilia, small tortoiseshell, bronchospasm;
Alimentary system: nausea, a loss of appetite, vomiting, diarrhea, heavy feeling in epigastriums, stomatitis, increase in activity of liver enzymes, jaundice; in some cases – the long and heavy diarrhea characteristic of development of pseudomembranous colitis;
Others: weakness.

Special instructions

Makropen's use can lead for a long time to the excess growth of steady bacteria and development of pseudomembranous colitis which sign is severe long diarrhea.

Long therapy demands regular control of activity of liver enzymes, especially from patients with functional disorders of a liver.

Mannitolum which is a part of granules can become the diarrhea reason.

Patients with hypersensitivity to acetylsalicylic acid in the anamnesis should know that dye a sunset yellow (E110) as a part of granules can become the reason of development of allergic reaction, including a bronchospasm.

Administration of drug does not influence ability of the patient to control of vehicles and mechanisms.

Medicinal interaction

It is necessary to be careful at a drug combination to carbamazepine and alkaloids of an ergot as Makropen's action promotes reduction in the rate of their metabolism in a liver and to increase in level of concentration in blood serum.

The concomitant use with cyclosporine, warfarin and other anticoagulants slows down the speed of their removal.

Drug does not break theophylline pharmacokinetics.