Composition, form of production and packaging
The tablets covered with a film membrane of white color, round, slightly biconcave, with oblique margins and a notch on one side; at the break - a white mass with a rough surface.
1 tab.
midekamycin 400 mg
Excipients: polacrilin potassium, magnesium stearate, talc, microcrystalline cellulose.
Sheath composition: methacrylic acid copolymer, macrogol, titanium dioxide, talc.
8 pcs. - blisters (2) - packs of cardboard.
Granules for the preparation of the suspension for oral administration are small, orange, with a slight smell of banana, without visible impurities; a prepared aqueous orange suspension, with a slight smell of banana.
5 ml of finished couscous.
midecamycin acetate 175 mg
Auxiliary substances: methylparahydroxybenzoate, propyl parahydroxybenzoate, citric acid, sodium hydrophosphate anhydrous, banana flavor, powder, dye sunset yellow FCF (E110), hypromellose, silicone antifoam, sodium saccharinate, mannitol.
20 g - bottles of dark glass (1) complete with a dosage spoon - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2011.
PHARMACHOLOGIC EFFECT
Antibiotic group macrolides. Inhibits the synthesis of proteins in bacterial cells. Reversibly binds to the 50S subunit of the ribosomal membrane of bacteria. In low doses the drug has a bacteriostatic effect, in high - bactericidal.
It is active against intracellular microorganisms: Mycoplasma spp., Chlamydia spp., Legionella spp., Ureaplasma urealyticum; Gram-positive bacteria: Streptococcus spp., Staphylococcus spp., Corynebacterium diphtheriae, Listeria monocytogenes, Clostridium spp .; Gram-negative bacteria: Neisseria spp., Moraxella catarrhalis, Bordetella pertussis, Helicobacter spp., Campylobacter spp., Bacteroides spp.
PHARMACOKINETICS
Suction
After oral administration, midecamycin is quickly and completely absorbed from the digestive tract.
C max in the serum of midecamycin and midekamycin acetate are 0.5-2.5 Ојg / l and 1.31-3.3 Ојg / l, respectively, and are reached 1-2 hours after ingestion.
Distribution
High concentrations of meadecamycin and midecamycin acetate are created in internal organs (especially in lung tissue, parotid and submaxillary glands) and skin.The IPC is maintained for 6 hours.
Midekamycin binds to proteins by 47%, its metabolites by 3-29%.
Metabolism
Midekamycin is metabolized in the liver with the formation of 2 metabolites, which have antimicrobial activity.
Excretion
T 1/2 is approximately 1 hour. Meadecamycin is excreted with bile and to a lesser extent (about 5%) with urine.
Pharmacokinetics in special clinical cases
In liver cirrhosis, plasma concentrations, AUC and T 1/2, significantly increase.
INDICATIONS
Infectious-inflammatory diseases caused by microorganisms sensitive to the preparation:
- respiratory tract infections: tonsillopharyngitis, acute otitis media, sinusitis, exacerbation of chronic bronchitis, community-acquired pneumonia (including those caused by atypical pathogens Mycoplasma spp., Chlamydia spp., Legionella spp., and Ureaplasma urealyticum);
- infections of the genitourinary system caused by Mycoplasma spp., Chlamydia spp., Legionella spp. and Ureaplasma urealyticum;
- infections of the skin and subcutaneous tissue;
treatment of enteritis caused by Campylobacter spp .;
- treatment and prevention of diphtheria and pertussis.
DOSING MODE
The drug should be taken before meals.
Adults and children weighing more than 30 kg Macropen В® are prescribed 400 mg (1 tab.) 3 times / day. The maximum daily intake for adults is 1.6 g.
For children weighing less than 30 kg, the daily dose is 20-40 mg / kg of body weight in 3 divided doses or 50 mg / kg of body weight in 2 divided doses, in severe infections 50 mg / kg of body weight in 3 divided doses.
Scheme of application Macrofen in the form of a suspension for children (daily dose of 50 mg / kg of body weight in 2 divided doses) is presented in the table.
Body weight (approximate age) Suspension (175 mg / 5 mL)
up to 5 kg (about 2 months) for 3.75 ml (131.25 mg) 2 times / day
up to 10 kg (about 1-2 years) of 7.5 ml (262.5 mg) 2 times / day
up to 15 kg (about 4 years) of 10 ml (350 mg) 2 times / day
up to 20 kg (about 6 years) of 15 ml (525 mg) 2 times / day
up to 30 kg (about 10 years) of 22.5 ml (787.5 mg) 2 times / day
Duration of treatment is from 7 to 14 days, with the treatment of chlamydial infections - 14 days.
In order to prevent diphtheria, the drug is prescribed in a dose of 50 mg / kg / day, divided into 2 doses, for 7 days. Recommended control bacteriological study after the termination of therapy.
For the prevention of whooping cough, the drug is prescribed at a dose of 50 mg / kg / day for 7-14 days in the first 14 days from the moment of contact.
To prepare the suspension, add 100 ml of boiled or distilled water to the contents of the vial and shake well. Before use, the prepared suspension should be shaken.
SIDE EFFECT
On the part of the digestive system: decreased appetite, stomatitis, nausea, vomiting, diarrhea, a feeling of heaviness in the epigastrium, an increase in the activity of hepatic transaminases and jaundice; in some cases - severe and prolonged diarrhea, which may indicate the development of pseudomembranous colitis.
Allergic reactions: skin rash, hives, itching, eosinophilia, bronchospasm.
Other: weakness.
CONTRAINDICATIONS
hepatic failure of severe degree;
- Children under 3 years old (for tablets);
- Hypersensitivity to midecamycin / midecamycin acetate and other components of the drug.
Caution should be given to the drug during pregnancy, during lactation, as well as in the presence of a history of allergic reaction to taking acetylsalicylic acid.
PREGNANCY AND LACTATION
Application of Macrofene during pregnancy is possible only if the intended benefit to the mother exceeds the potential risk to the fetus.
Meadecamycin excreted in breast milk. When using Macropene during lactation, breastfeeding should be discontinued.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
The drug is contraindicated in patients with severe hepatic impairment.
With prolonged therapy, hepatic enzyme activity should be monitored, especially in patients with impaired hepatic function.
APPLICATION FOR CHILDREN
The drug is used according to the indications, in the recommended dosage form and in doses taking into account the age of the patients.
Contraindication: children under 3 years (for tablets).
SPECIAL INSTRUCTIONS
As with any other antimicrobial drugs, with prolonged therapy with Macropen, excessive growth of resistant bacteria is possible. Prolonged diarrhea can indicate the development of pseudomembranous colitis.
With prolonged therapy, hepatic enzyme activity should be monitored, especially in patients with impaired hepatic function.
Mannitol contained in granules for the preparation of a suspension can cause diarrhea.
If there is an allergic reaction to the reception of acetylsalicylic acid, the azo dye E110 (dye sunset yellow) can cause an allergic reaction up to the bronchospasm.
Impact on the ability to drive vehicles and manage mechanisms
It was not reported about the influence of Macropen on the speed of psychomotor reactions and the ability to drive and other mechanisms.
OVERDOSE
There are no reports of serious intoxication caused by taking the drug Macropen В® .
Symptoms: nausea and vomiting are possible.
Treatment: symptomatic therapy.
DRUG INTERACTION
With the simultaneous application of Macrofene with ergot alkaloids, carbamazepine, their metabolism in the liver decreases and serum concentration increases.Therefore, with the simultaneous administration of these drugs should be careful.
With the simultaneous use of Macropen with cyclosporine, anticoagulants (warfarin), slowing down the latter.
Macropen В® does not affect the pharmacokinetic parameters of theophylline.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
Tablets should be stored in a dry place inaccessible to children at a temperature of no higher than 25 В° C. Granules for the preparation of the suspension should be stored at a temperature of no higher than 25 В° C. Shelf life - 3 years.
The prepared suspension can be used for 14 days if stored in a refrigerator and for 7 days when stored at a temperature of no higher than 25 В° C.
