Active material: Midekamicin
When ATH: J01FA03
CCF: Macrolide antibiotics
ICD-10 codes (testimony): A04.5, A36, A37, A48.1, A56.0, A56.1, A56.4, B96.0, J01, J03, J04, J15, J15.7, J16.0, J20, J31, J32, J35.0, J42, L01, L02, L03, L08.0, N30, N34, N41, N70, N71, N72, Z29.2
When CSF: 06.07.01
Manufacturer: KRKA d.d. (Slovenia)
Pills, Film-coated white, round, slightly biconcave, with beveled edges and a notch on one side; на изломе – белая масса с шероховатой поверхностью.
| 1 tab. | |
| midekamicin | 400 mg |
Excipients: polacrilin potassium, magnesium stearate, talc, microcrystalline cellulose.
The composition of the shell: methacrylic acid, macrogol, Titanium dioxide, talc.
8 PC. – блистеры (2) – пачки картонные.
Granules for oral suspension fine, orange, with a slight odor of banana, no visible impurities; preparing an aqueous suspension of orange, with a slight odor of banana.
| 5 ml susp hotovoy. | |
| midekamitsina acetate | 175 mg |
Excipients: metilparagidroksiʙenzoat, propilparagidroksibenzoat, lemon acid, sodium hydrogen phosphate (anhydrous), banana flavor, powder, colorant sunset yellow FCF (E110), gipromelloza, Silicone anti-foaming agent, sodium saccharin, mannitol.
20 г – флаконы темного стекла (1) в комплекте с дозировочной ложкой – пачки картонные.
Macrolide antibiotics. It inhibits protein synthesis in bacterial cells. Reversibly binds to the 50S ribosomal subunit of the bacterial membrane. At low doses, the drug has a bacteriostatic effect, в высоких – бактерицидное.
It is active against intracellular bacteria: 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.
Absorption
Once inside midecamycin quickly and adequately absorbed from the gastrointestinal tract.
Cmax serum midecamycin and midecamycin acetate are respectively 0.5-2.5 mg / l 1.31-3.3 ug / l are achieved through 1-2 hours after ingestion.
Distribution
High concentrations midecamycin midecamycin and acetate are in the internal organs (especially in lung tissue, parotid and submandibular glands) and skin. BMD is maintained for 6 no.
Midecamycin binds to proteins in the 47%, его метаболиты – на 3-29%.
Metabolism
Midecamycin metabolized in the liver to form 2 metabolites, having antimicrobial activity.
Deduction
T1/2 approximately 1 no. Midecamycin excreted in the bile and to a lesser extent (about 5%) urine.
Pharmacokinetics in special clinical situations
In cirrhosis of the liver significantly increased plasma concentrations of, AUC and T1/2.
Infectious-inflammatory diseases, caused by susceptible to malaria infections:
- Respiratory tract infections (incl. caused by atypical pathogens Mycoplasma spp., Chlamydia spp., Legionella spp. and Ureaplasma urealyticum): tonzillofaringit, acute otitis media, sinusitis, exacerbation of chronic bronchitis, community-acquired pneumonia;
- 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.
The drug should be taken before meals.
Adults and children weighing more than 30 kg Macropen® appoint 400 mg (1 tab.) 3 times / day. Максимальная суточная доза для взрослых – 1.6 g.
To children weighing less than 30 kg daily dose is 20-40 mg / kg body weight 3 receiving or 50 mg / kg body weight 2 admission, at severe infections – 50 mg / kg body weight 3 admission.
Driving destination macrofoams® in the form of suspensions for children (daily dose 50 mg / kg body weight 2 admission) is shown in Table.
| Body Weight (about the age) | Suspension (175 mg / 5ml) |
| to 5 kg (ca.. 2 of the month) | by 3.75 ml (131.25 mg) 2 times / day |
| to 10 kg (ca.. 1-2 year) | by 7.5 ml (262.5 mg) 2 times / day |
| to 15 kg (ca.. 4 year) | by 10 ml (350 mg) 2 times / day |
| to 20 kg (ca.. 6 years) | by 15 ml (525 mg) 2 times / day |
| to 30 kg (ca.. 10 years) | by 22.5 ml (787.5 mg) 2 times / day |
The duration of treatment ranged from 7 to 14 days, at treatment of chlamydial infections – 14 days.
With the aim of diphtheria the drug is prescribed in a dose 50 mg / kg / day, razdelennoy of 2 admission, during 7 days. It is recommended to control bacteriological examination after therapy.
With the aim of prevention of pertussis the drug is prescribed in a dose 50 mg / kg / day for 7-14 first day 14 days from the time of contact.
To suspension add to the contents of the vial 100 ml of boiled or distilled water and shake well. Before use, shake the finished suspension is recommended.
From the digestive system: decreased appetite, stomatitis, nausea, vomiting, diarrhea, a feeling of heaviness in the epigastric, increase in liver transaminases and jaundice; в отдельных случаях – тяжелая и длительная диарея, which may indicate the development of pseudomembranous colitis.
Allergic reactions: skin rash, hives, itching, eozinofilija, bronchospasm.
Other: weakness.
- Severe hepatic impairment;
- Children up to age 3 years (Pill);
- Hypersensitivity to midecamycin / midecamycin acetate and other ingredients.
FROM caution should be prescribed during pregnancy, lactation, and with a history of allergic reaction to acetylsalicylic acid.
Application macrofoams® Pregnancy may only, when the intended benefits to the mother outweighs the potential risk to the fetus.
Midecamycin excreted in breast milk. When using macrofoams® lactation should stop breastfeeding.
As with any other antimicrobials, during prolonged therapy Makropenom® possible excessive growth of resistant bacteria. Prolonged diarrhea may indicate the development of pseudomembranous colitis.
When long-term therapy should be monitored liver enzymes, especially in patients with impaired hepatic function.
Mannitol, contained in the granules for suspension, It may be the cause of diarrhea.
If you have a history of allergic reaction to acetylsalicylic acid azo dye E110 (colorant sunset yellow) may cause allergic reactions until bronchospasm
Effects on ability to drive vehicles and management mechanisms
Reported impact macrofoams® the speed of psychomotor reactions and ability to drive the car and other mechanisms.
Reports of cases of severe intoxication, drug-induced Macropen®, no.
Symptoms: nausea, vomiting.
Treatment: symptomatic therapy.
In an application macrofoams® with ergot alkaloids, carbamazepine decreases their metabolism in the liver and improved serum concentration. Therefore, while the appointment of these drugs should be careful.
In an application macrofoams® Cyclosporin, anticoagulants (varfarinom) slows down the last.
Macropen® It has no effect on the pharmacokinetic parameters of theophylline.
The drug is released under the prescription.
Tablets should be stored in a dry, inaccessible to children at temperature not exceeding 25 ° C. Granules for suspension should be stored at a temperature no higher than 25 ° C. Shelf life - 3 year.
The obtained suspension can be used for 14 days when stored in a refrigerator and for 7 days when stored at a temperature no higher than 25 ° C.
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